Effectiveness of home blood pressure monitoring, Web communication, and pharmacist care on hypertension control: a randomized controlled trial.

PubMed

Green, Beverly B; Cook, Andrea J; Ralston, James D; Fishman, Paul A; Catz, Sheryl L; Carlson, James; Carrell, David; Tyll, Lynda; Larson, Eric B; Thompson, Robert S

2008-06-25

Treating hypertension decreases mortality and disability from cardiovascular disease, but most hypertension remains inadequately controlled. To determine if a new model of care that uses patient Web services, home blood pressure (BP) monitoring, and pharmacist-assisted care improves BP control. A 3-group randomized controlled trial, the Electronic Communications and Home Blood Pressure Monitoring study was based on the Chronic Care Model. The trial was conducted at an integrated group practice in Washington state, enrolling 778 participants aged 25 to 75 years with uncontrolled essential hypertension and Internet access. Care was delivered over a secure patient Web site from June 2005 to December 2007. Participants were randomly assigned to usual care, home BP monitoring and secure patient Web site training only, or home BP monitoring and secure patient Web site training plus pharmacist care management delivered through Web communications. Percentage of patients with controlled BP (<140/90 mm Hg) and changes in systolic and diastolic BP at 12 months. Of 778 patients, 730 (94%) completed the 1-year follow-up visit. Patients assigned to the home BP monitoring and Web training only group had a nonsignificant increase in the percentage of patients with controlled BP (<140/90 mm Hg) compared with usual care (36% [95% confidence interval {CI}, 30%-42%] vs 31% [95% CI, 25%-37%]; P = .21). Adding Web-based pharmacist care to home BP monitoring and Web training significantly increased the percentage of patients with controlled BP (56%; 95% CI, 49%-62%) compared with usual care (P < .001) and home BP monitoring and Web training only (P < .001). Systolic BP was decreased stepwise from usual care to home BP monitoring and Web training only to home BP monitoring and Web training plus pharmacist care. Diastolic BP was decreased only in the pharmacist care group compared with both the usual care and home BP monitoring and Web training only groups. Compared with usual care, the patients who had baseline systolic BP of 160 mm Hg or higher and received home BP monitoring and Web training plus pharmacist care had a greater net reduction in systolic BP (-13.2 mm Hg [95% CI, -19.2 to -7.1]; P < .001) and diastolic BP (-4.6 mm Hg [95% CI, -8.0 to -1.2]; P < .001), and improved BP control (relative risk, 3.32 [95% CI, 1.86 to 5.94]; P<.001). Pharmacist care management delivered through secure patient Web communications improved BP control in patients with hypertension. Trial Registration clinicaltrials.gov Identifier: NCT00158639.

The use of control groups in music therapy research: a content analysis of articles in the Journal of Music Therapy.

PubMed

Jones, Jennifer D

2006-01-01

The use of a control group is fundamental to experimental research design, though the use with clinical populations must be carefully considered. The purpose of this research was to examine the use of control groups in research with clinical and nonclinical populations published in Journal of Musical Therapy from 1964 through 2004. Criteria for inclusion were music or music therapy as an independent variable applied to one or more groups and at least one control group that did not receive a music treatment. Control groups were qualified as alternative treatment, placebo, no contact, and treatment as usual. Of the 692 articles, 94 met these criteria, 62 clinical and 32 nonclinical, representing 13.5% of the publications. Results indicated that research with clinical populations involved a mean of 38.1 subjects typically divided into two groups, an experimental and a control group. The pretest-posttest design was the most common (55%) as was a treatment as usual control group (45%). These design methods maximized the impact of the experimental music treatment on outcome. Experimental music groups significantly improved over control groups in the vast majority of studies identified. Undoubtedly, the foundation for evidence-based clinical practice is firm.

Systems Training for Emotional Predictability and Problem Solving (STEPPS) for outpatients with borderline personality disorder: a randomized controlled trial and 1-year follow-up.

PubMed

Blum, Nancee; St John, Don; Pfohl, Bruce; Stuart, Scott; McCormick, Brett; Allen, Jeff; Arndt, Stephan; Black, Donald W

2008-04-01

Systems Training for Emotional Predictability and Problem Solving (STEPPS) is a 20-week manual-based group treatment program for outpatients with borderline personality disorder that combines cognitive behavioral elements and skills training with a systems component. The authors compared STEPPS plus treatment as usual with treatment as usual alone in a randomized controlled trial. Subjects with borderline personality disorder were randomly assigned to STEPPS plus treatment as usual or treatment as usual alone. Total score on the Zanarini Rating Scale for Borderline Personality Disorder was the primary outcome measure. Secondary outcomes included measures of global functioning, depression, impulsivity, and social functioning; suicide attempts and self-harm acts; and crisis utilization. Subjects were followed 1 year posttreatment. A linear mixed-effects model was used in the analysis. Data pertaining to 124 subjects (STEPPS plus treatment as usual [N=65]; treatment as usual alone [N=59]) were analyzed. Subjects assigned to STEPPS plus treatment as usual experienced greater improvement in the Zanarini Rating Scale for Borderline Personality Disorder total score and subscales assessing affective, cognitive, interpersonal, and impulsive domains. STEPPS plus treatment as usual also led to greater improvements in impulsivity, negative affectivity, mood, and global functioning. These differences yielded moderate to large effect sizes. There were no differences between groups for suicide attempts, self-harm acts, or hospitalizations. Most gains attributed to STEPPS were maintained during follow-up. Fewer STEPPS plus treatment as usual subjects had emergency department visits during treatment and follow-up. The discontinuation rate was high in both groups. STEPPS, an adjunctive group treatment, can deliver clinically meaningful improvements in borderline personality disorder-related symptoms and behaviors, enhance global functioning, and relieve depression.

Aquatic Exercise Therapy for People With Parkinson Disease: A Randomized Controlled Trial.

PubMed

Carroll, Louise M; Volpe, Daniele; Morris, Meg E; Saunders, Jean; Clifford, Amanda M

2017-04-01

To evaluate the effects of aquatic exercise therapy on gait variability and disability compared with usual care for people with Parkinson disease (PD). Single-blind randomized controlled trial. Community-based hydrotherapy pool. Individuals with PD (Hoehn-Yahr stages I-III) (N=21). Participants were randomly assigned to either an aquatic exercise therapy group (45min, twice a week for 6wk) or a group that received usual care. The primary outcome measure was gait variability as measured using a motion capture system. Secondary outcomes were quality of life measured on the Parkinson's Disease Questionnaire-39 and freezing of gait and motor disability quantified by the Unified Parkinson's Disease Rating Scale. Feasibility was evaluated by measuring safety, adverse events, and participant satisfaction. People in the aquatic therapy group and usual care group showed similar small improvements in gait variability. The aquatic therapy group showed greater improvements in disability than the usual care group (P<.01). No differences between groups or over time were identified for freezing of gait or quality of life. Aquatic therapy sessions were safe and enjoyable with no adverse events. Aquatic therapy appears feasible and safe for some people in the early stages of PD. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Randomized trial of the effect of drug presentation on asthma outcomes: the American Lung Association Asthma Clinical Research Centers.

PubMed

Wise, Robert A; Bartlett, Susan J; Brown, Ellen D; Castro, Mario; Cohen, Rubin; Holbrook, Janet T; Irvin, Charles G; Rand, Cynthia S; Sockrider, Marianna M; Sugar, Elizabeth A

2009-09-01

Information that enhances expectations about drug effectiveness improves the response to placebos for pain. Although asthma symptoms often improve with placebo, it is not known whether the response to placebo or active treatment can be augmented by increasing expectation of benefit. The study objective was to determine whether response to placebo or a leukotriene antagonist (montelukast) can be augmented by messages that increase expectation of benefit. A randomized 20-center controlled trial enrolled 601 asthmatic patients with poor symptom control who were assigned to one of 5 study groups. Participants were randomly assigned to one of 4 treatment groups in a factorial design (ie, placebo with enhanced messages, placebo with neutral messages, montelukast with enhanced messages, or montelukast with neutral messages) or to usual care. Assignment to study drug was double masked, assignment to message content was single masked, and usual care was not masked. The enhanced message aimed to increase expectation of benefit from the drug. The primary outcome was mean change in daily peak flow over 4 weeks. Secondary outcomes included lung function and asthma symptom control. Peak flow and other lung function measures were not improved in participants assigned to the enhanced message groups versus the neutral messages groups for either montelukast or placebo; no differences were noted between the neutral placebo and usual care groups. Placebo-treated participants had improved asthma control with the enhanced message but not montelukast-treated participants; the neutral placebo group did have improved asthma control compared with the usual care group after adjusting for baseline difference. Headaches were more common in participants provided messages that mentioned headache as a montelukast side effect. Optimistic drug presentation augments the placebo effect for patient-reported outcomes (asthma control) but not lung function. However, the effect of montelukast was not enhanced by optimistic messages regarding treatment effectiveness.

Behavioral Outcome Effects of Serious Gaming as an Adjunct to Treatment for Children With Attention-Deficit/Hyperactivity Disorder: A Randomized Controlled Trial.

PubMed

Bul, Kim C M; Kato, Pamela M; Van der Oord, Saskia; Danckaerts, Marina; Vreeke, Leonie J; Willems, Annik; van Oers, Helga J J; Van Den Heuvel, Ria; Birnie, Derk; Van Amelsvoort, Thérèse A M J; Franken, Ingmar H A; Maras, Athanasios

2016-02-16

The need for accessible and motivating treatment approaches within mental health has led to the development of an Internet-based serious game intervention (called "Plan-It Commander") as an adjunct to treatment as usual for children with attention-deficit/hyperactivity disorder (ADHD). The aim was to determine the effects of Plan-It Commander on daily life skills of children with ADHD in a multisite randomized controlled crossover open-label trial. Participants (N=170) in this 20-week trial had a diagnosis of ADHD and ranged in age from 8 to 12 years (male: 80.6%, 137/170; female: 19.4%, 33/170). They were randomized to a serious game intervention group (group 1; n=88) or a treatment-as-usual crossover group (group 2; n=82). Participants randomized to group 1 received a serious game intervention in addition to treatment as usual for the first 10 weeks and then received treatment as usual for the next 10 weeks. Participants randomized to group 2 received treatment as usual for the first 10 weeks and crossed over to the serious game intervention in addition to treatment as usual for the subsequent 10 weeks. Primary (parent report) and secondary (parent, teacher, and child self-report) outcome measures were administered at baseline, 10 weeks, and 10-week follow-up. After 10 weeks, participants in group 1 compared to group 2 achieved significantly greater improvements on the primary outcome of time management skills (parent-reported; P=.004) and on secondary outcomes of the social skill of responsibility (parent-reported; P=.04), and working memory (parent-reported; P=.02). Parents and teachers reported that total social skills improved over time within groups, whereas effects on total social skills and teacher-reported planning/organizing skills were nonsignificant between groups. Within group 1, positive effects were maintained or further improved in the last 10 weeks of the study. Participants in group 2, who played the serious game during the second period of the study (weeks 10 to 20), improved on comparable domains of daily life functioning over time. Plan-It Commander offers an effective therapeutic approach as an adjunct intervention to traditional therapeutic ADHD approaches that improve functional outcomes in daily life. International Standard Randomized Controlled Trial Number (ISRCTN): 62056259; http://www.controlled-trials.com/ISRCTN62056259 (Archived by WebCite at http://www.webcitation.org/6eNsiTDJV).

Behavioral Outcome Effects of Serious Gaming as an Adjunct to Treatment for Children With Attention-Deficit/Hyperactivity Disorder: A Randomized Controlled Trial

PubMed Central

2016-01-01

Background The need for accessible and motivating treatment approaches within mental health has led to the development of an Internet-based serious game intervention (called “Plan-It Commander”) as an adjunct to treatment as usual for children with attention-deficit/hyperactivity disorder (ADHD). Objective The aim was to determine the effects of Plan-It Commander on daily life skills of children with ADHD in a multisite randomized controlled crossover open-label trial. Methods Participants (N=170) in this 20-week trial had a diagnosis of ADHD and ranged in age from 8 to 12 years (male: 80.6%, 137/170; female: 19.4%, 33/170). They were randomized to a serious game intervention group (group 1; n=88) or a treatment-as-usual crossover group (group 2; n=82). Participants randomized to group 1 received a serious game intervention in addition to treatment as usual for the first 10 weeks and then received treatment as usual for the next 10 weeks. Participants randomized to group 2 received treatment as usual for the first 10 weeks and crossed over to the serious game intervention in addition to treatment as usual for the subsequent 10 weeks. Primary (parent report) and secondary (parent, teacher, and child self-report) outcome measures were administered at baseline, 10 weeks, and 10-week follow-up. Results After 10 weeks, participants in group 1 compared to group 2 achieved significantly greater improvements on the primary outcome of time management skills (parent-reported; P=.004) and on secondary outcomes of the social skill of responsibility (parent-reported; P=.04), and working memory (parent-reported; P=.02). Parents and teachers reported that total social skills improved over time within groups, whereas effects on total social skills and teacher-reported planning/organizing skills were nonsignificant between groups. Within group 1, positive effects were maintained or further improved in the last 10 weeks of the study. Participants in group 2, who played the serious game during the second period of the study (weeks 10 to 20), improved on comparable domains of daily life functioning over time. Conclusions Plan-It Commander offers an effective therapeutic approach as an adjunct intervention to traditional therapeutic ADHD approaches that improve functional outcomes in daily life. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): 62056259; http://www.controlled-trials.com/ISRCTN62056259 (Archived by WebCite at http://www.webcitation.org/6eNsiTDJV). PMID:26883052

Should we reconsider the routine use of placebo controls in clinical research?

PubMed

Avins, Andrew L; Cherkin, Daniel C; Sherman, Karen J; Goldberg, Harley; Pressman, Alice

2012-04-27

Modern clinical-research practice favors placebo controls over usual-care controls whenever a credible placebo exists. An unrecognized consequence of this preference is that clinicians are more limited in their ability to provide the benefits of the non-specific healing effects of placebos in clinical practice. We examined the issues in choosing between placebo and usual-care controls. We considered why placebo controls place constraints on clinicians and the trade-offs involved in the choice of control groups. We find that, for certain studies, investigators should consider usual-care controls, even if an adequate placebo is available. Employing usual-care controls would be of greatest value for pragmatic trials evaluating treatments to improve clinical care and for which threats to internal validity can be adequately managed without a placebo-control condition. Intentionally choosing usual-care controls, even when a satisfactory placebo exists, would allow clinicians to capture the value of non-specific therapeutic benefits that are common to all interventions. The result could be more effective, patient-centered care that makes the best use of both specific and non-specific benefits of medical interventions.

The effect of motivational interviewing on glycaemic control and perceived competence of diabetes self-management in patients with type 1 and type 2 diabetes mellitus after attending a group education programme: a randomised controlled trial.

PubMed

Rosenbek Minet, L K; Wagner, L; Lønvig, E M; Hjelmborg, J; Henriksen, J E

2011-07-01

The aim of this study was to measure the efficacy of motivational interviewing (MI) compared with usual care on changes in glycaemic control and competence of diabetes self-management in patients with diabetes mellitus. Patients were eligible if they had type 1 or 2 diabetes mellitus, were over 18 years of age and had participated in a 4 day group education programme offered at a diabetes clinic at a university hospital in Denmark. Exclusion criteria included pregnancy, severe debilitating disease and cognitive deficit. Out of 469 patients who attended the group education programme, 349 patients were randomised to either a usual care control group or an intervention group, which received up to five individual counselling sessions in 1 year based on MI, in addition to usual care. A randomised parallel design was used and open-label allocation was done by random permuted blocks, with allocation concealment by sequentially numbered, sealed, opaque envelopes. The primary outcome was glycated haemoglobin (HbA(1c)). Analysis regarding measurements of glycated haemoglobin (HbA(1c)) and competence of self-management (using the Problem Areas in Diabetes Scale [PAID] and Perceived Competence for Diabetes Scale [PCDS]) was based on 298 participants followed for a 24 month period. Data were collected at the Department of Endocrinology at Odense University Hospital. Our hypotheses were that MI could: (1) reduce HbA(1c) levels; (2) increase self-efficacy; and (3) increase diabetes self-care, compared with usual care. Out of the 176 included in the control group and 173 in the intervention group, 153 and 145 were analysed in the groups, respectively. When using the baseline value as covariate there were no significant differences in change score between the two study groups with regard to mean level of HbA(1c) (0.131, p = 0.221), PAID scores (-1.793, p = 0.191) or PCDS scores (0.017, p = 0.903) at the 24 month follow-up, using a mixed effects regression model. The patients in the intervention group showed significantly higher levels of perceived competence in dealing with diabetes compared with the control group (mean change score = -0.387, p = 0.002) following 1 year of intervention. We were unable to demonstrate any benefit, over or above usual care, of MI in patients with diabetes who have just completed a diabetes education programme, and who have well-regulated diabetes. Clinical Trials NCT00555854.

Cost-effectiveness of an adjustment group for people with multiple sclerosis and low mood: a randomized trial.

PubMed

Humphreys, Ioan; Drummond, Avril E R; Phillips, Ceri; Lincoln, Nadina B

2013-11-01

To evaluate the cost effectiveness of a psychological adjustment group shown to be clinically effective in comparison with usual care for people with multiple sclerosis. Randomized controlled trial with comparison of costs and calculation of incremental cost effectiveness ratio. Community. People with multiple sclerosis were screened on the General Health Questionnaire 12 and Hospital Anxiety and Depression Scale, and those with low mood were recruited. Participants randomly allocated to the adjustment group received six group treatment sessions. The control group received usual care, which did not include psychological interventions. Outcomes were assessed four and eight months after randomization, blind to group allocation. The costs were assessed from a service use questionnaire and information provided on medication. Quality of life was assessed using the EQ-5D. Of the 311 patients identified, 221 (71%) met the criteria for having low mood. Of these, 72 were randomly allocated to receive treatment and 79 to usual care. Over eight months follow-up there was a decrease in the combined average costs of £378 per intervention respondent and an increase in the costs of £297 per patient in the control group, which was a significant difference (p=0.03). The incremental cost-effectiveness ratio indicated that the cost per point reduction on the Beck depression inventory-II was £118. In the short term, the adjustment group programme was cost effective when compared with usual care, for people with multiple sclerosis presenting with low mood. The longer-term costs need to be assessed.

Effects of aromatherapy massage on face-down posture-related pain after vitrectomy: a randomized controlled trial.

PubMed

Adachi, Naho; Munesada, Minako; Yamada, Noriko; Suzuki, Haruka; Futohashi, Ayano; Shigeeda, Takashi; Kato, Satoshi; Nishigaki, Masakazu

2014-06-01

Postoperative face-down posturing (FDP) is recommended to optimize the effects of intraocular gas tamponade after vitrectomy. However, patients undergoing FDP usually experience physical and psychological burdens. This 3-armed, randomized, single-center trial investigated the effects of aromatherapy on FDP-related physical pain. Sixty-three patients under FDP were randomly allocated to one of three treatment groups: aromatherapy massage with essential oil (AT), oil massage without essential oil (OT), and a control group. The AT and OT groups received 10 minutes of massage by ward nurses trained by an aromatherapist, while the control group received usual care. Outcomes were assessed as short-term (pre- to post-intervention) and long-term (first to third postoperative day) changes in physical pain in five body regions using face-scale. The AT and OT groups both revealed similar short-term pain reductions after intervention, compared with the control group. Regarding long-term effects, neither group experienced significant effects until the second day. Significantly more pain reduction compared with usual care occurred on the third day, mainly in the AT group, though there were few significant differences between the AT and OT groups. In conclusion, this study suggests that simple oil massage is an effective strategy for immediate pain reduction in patients undergoing FDP, while aromatherapy may have a long-term effect on pain reduction. Copyright © 2014 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

Intensive versus conventional blood pressure monitoring in a general practice population. The Blood Pressure Reduction in Danish General Practice trial: a randomized controlled parallel group trial.

PubMed

Klarskov, Pia; Bang, Lia E; Schultz-Larsen, Peter; Gregers Petersen, Hans; Benee Olsen, David; Berg, Ronan M G; Abrahamsen, Henrik; Wiinberg, Niels

2018-01-17

To compare the effect of a conventional to an intensive blood pressure monitoring regimen on blood pressure in hypertensive patients in the general practice setting. Randomized controlled parallel group trial with 12-month follow-up. One hundred and ten general practices in all regions of Denmark. One thousand forty-eight patients with essential hypertension. Conventional blood pressure monitoring ('usual group') continued usual ad hoc blood pressure monitoring by office blood pressure measurements, while intensive blood pressure monitoring ('intensive group') supplemented this with frequent home blood pressure monitoring and 24-hour ambulatory blood pressure monitoring. Mean day- and night-time systolic and diastolic 24-hour ambulatory blood pressure. Change in systolic and diastolic office blood pressure and change in cardiovascular risk profile. Of the patients, 515 (49%) were allocated to the usual group, and 533 (51%) to the intensive group. The reductions in day- and night-time 24-hour ambulatory blood pressure were similar (usual group: 4.6 ± 13.5/2.8 ± 82 mmHg; intensive group: 5.6 ± 13.0/3.5 ± 8.2 mmHg; P = 0.27/P = 0.20). Cardiovascular risk scores were reduced in both groups at follow-up, but more so in the intensive than in the usual group (P = 0.02). An intensive blood pressure monitoring strategy led to a similar blood pressure reduction to conventional monitoring. However, the intensive strategy appeared to improve patients' cardiovascular risk profile through other effects than a reduction of blood pressure. Clinical Trials NCT00244660. © The Author 2018. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Comparison of the effectiveness of two styles of case-based learning implemented in lectures for developing nursing students' critical thinking ability: A randomized controlled trial.

PubMed

Hong, Shaohua; Yu, Ping

2017-03-01

To explore and compare the effectiveness of two styles of case-based learning methods, unfolding nursing case and usual nursing case, implemented in lectures for developing nursing students' critical thinking ability. 122 undergraduate nursing students in four classes were taught the subject of medical nursing for one year. Two classes were randomly assigned as the experimental group and the other two the control group. The experimental group received the lectures presenting unfolding nursing cases and the control group was taught the usual cases. Nineteen case-based lectures were provided in 8 months in two semesters to each group. The two groups started with a similar level of critical thinking ability as tested by the instrument of Critical Thinking Disposition Inventory-Chinese version (CTDI-CV). After receiving 19 case-based learning lectures for 8 months, both groups of students significantly improved their critical thinking ability. The improvement in the experimental group was significantly higher than that in the control group (with the average total score of 303.77±15.24 vs. 288.34±13.94, p<0.05). The experimental group also had significantly better improvement in six out of seven dimensions whereas the control group showed improvement in only three out of seven dimensions of CTDI-CV. The study suggests the feasibility of implementing case-based learning in lectures. Unfolding nursing cases appear to be significantly more effective than the usual nursing cases in developing undergraduate nursing students' critical thinking ability in the subject of medical nursing. Further research can implement the unfolding nursing cases in other nursing subjects. Copyright © 2016 Elsevier Ltd. All rights reserved.

Cost effectiveness of a manual based coping strategy programme in promoting the mental health of family carers of people with dementia (the START (STrAtegies for RelaTives) study): a pragmatic randomised controlled trial.

PubMed

Knapp, Martin; King, Derek; Romeo, Renee; Schehl, Barbara; Barber, Julie; Griffin, Mark; Rapaport, Penny; Livingston, Debbie; Mummery, Cath; Walker, Zuzana; Hoe, Juanita; Sampson, Elizabeth L; Cooper, Claudia; Livingston, Gill

2013-10-25

To assess whether the START (STrAtegies for RelatTives) intervention added to treatment as usual is cost effective compared with usual treatment alone. Cost effectiveness analysis nested within a pragmatic randomised controlled trial. Three mental health and one neurological outpatient dementia service in London and Essex, UK. Family carers of people with dementia. Eight session, manual based, coping intervention delivered by supervised psychology graduates to family carers of people with dementia added to usual treatment, compared with usual treatment alone. Costs measured from a health and social care perspective were analysed alongside the Hospital Anxiety and Depression Scale total score (HADS-T) of affective symptoms and quality adjusted life years (QALYs) in cost effectiveness analyses over eight months from baseline. Of the 260 participants recruited to the study, 173 were randomised to the START intervention, and 87 to usual treatment alone. Mean HADS-T scores were lower in the intervention group than the usual treatment group over the 8 month evaluation period (mean difference -1.79 (95% CI -3.32 to -0.33)), indicating better outcomes associated with the START intervention. There was a small improvement in health related quality of life as measured by QALYs (0.03 (-0.01 to 0.08)). Costs were no different between the intervention and usual treatment groups (£252 (-28 to 565) higher for START group). The cost effectiveness calculations suggested that START had a greater than 99% chance of being cost effective compared with usual treatment alone at a willingness to pay threshold of £30,000 per QALY gained, and a high probability of cost effectiveness on the HADS-T measure. The manual based coping intervention START, when added to treatment as usual, was cost effective compared with treatment as usual alone by reference to both outcome measures (affective symptoms for family carers, and carer based QALYs). ISCTRN 70017938.

An innovative brioche enriched in protein and energy improves the nutritional status of malnourished nursing home residents compared to oral nutritional supplement and usual breakfast: FARINE+ project.

PubMed

Van Wymelbeke, Virginie; Brondel, Laurent; Bon, Francis; Martin-Pfitzenmeyer, Isabelle; Manckoundia, Patrick

2016-10-01

To compare the effects of a 12-week nutritional intervention, in which an innovative protein-and-energy-enriched brioche, an oral nutritional supplement or a usual breakfast were eaten, on food intake and nutritional status in nursing home residents. Three-armed, multicentre, controlled trial. Eight nursing homes in Burgundy, France. Sixty-eight malnourished participants aged between 70 and 99 years old. Participants were randomly assigned to one of three groups according to the breakfast provided: brioche group, one portion of 65 g brioche enriched in protein and energy (12.8 g and 180 kcal) added to usual breakfast; supplement group, 200-ml of a ready-to-use, energy-dense liquid (14 g protein and 200 kcal) added to usual breakfast or control group, a usual breakfast only. Total energy intakes were assessed for three days at different periods of the study (day 0, day 30 and day 90); blood parameters, nutritional status (mini nutritional assessment, weight) and functional capacities (grip strength and activity level) were measured at the beginning and at the end of the nutritional intervention study (day 0 and day 90). The participants of the brioche group had higher total energy intakes at day 30 (p value 0.004) and at day 90 (p value 0.018) compared with the supplement group and the control group. At the end of the interventional study, 72% of the participants in the brioche group had reached the recommended minimum level of protein of 0.8 g/kg/day, compared with 53% in the supplement group and 36% in the control group (p value 0.036). In addition, between day 0 and day 90 in the brioche group, blood levels of vitamins B 9 , B 2 , D (all p value <0.001), B 6 (p value 0.026) and B 12 (p value 0.036) had increased and plasma homocysteine had decreased (p value 0.024). The protein-and-energy-enriched brioche effectively increased energy and protein intakes and improved the nutritional status of elderly people living in nursing homes. It could be a good alternative to oral liquid nutritional supplements to counteract protein-energy-malnutrition. Copyright © 2016 European Society for Clinical Nutrition and Metabolism. Published by Elsevier Ltd. All rights reserved.

Effectiveness of fluticasone furoate plus vilanterol on asthma control in clinical practice: an open-label, parallel group, randomised controlled trial.

PubMed

Woodcock, Ashley; Vestbo, Jørgen; Bakerly, Nawar Diar; New, John; Gibson, J Martin; McCorkindale, Sheila; Jones, Rupert; Collier, Susan; Lay-Flurrie, James; Frith, Lucy; Jacques, Loretta; Fletcher, Joanne L; Harvey, Catherine; Svedsater, Henrik; Leather, David

2017-11-18

Evidence for management of asthma comes from closely monitored efficacy trials done in highly selected patient groups. There is a need for randomised trials that are closer to usual clinical practice. We did an open-label, randomised, controlled, two-arm effectiveness trial at 74 general practice clinics in Salford and South Manchester, UK. Patients aged 18 years or older with a general practitioner's diagnosis of symptomatic asthma and on maintenance inhaler therapy were randomly assigned to initiate treatment with a once-daily inhaled combination of either 100 μg or 200 μg fluticasone furoate with 25 μg vilanterol or optimised usual care and followed up for 12 months. The primary endpoint was the percentage of patients who achieved an asthma control test (ACT) score of 20 or greater or an increase in ACT score from baseline of 3 or greater at 24 weeks (termed responders), in patients with a baseline ACT score less than 20 (the primary effectiveness analysis population). All effectiveness analyses were done according to the intention-to-treat principle. This study is registered with ClinicalTrials.gov, number NCT01706198. Between Nov 12, 2012, and Dec 16, 2016, 4725 patients were enrolled and 4233 randomly assigned to initiate treatment with fluticasone furoate and vilanterol (n=2114) or usual care (n=2119). 1207 patients (605 assigned to usual care, 602 to fluticasone furoate and vilanterol) had a baseline ACT score greater than or equal to 20 and were thus excluded from the primary effectiveness analysis population. At week 24, the odds of being a responder were higher for patients who initiated treatment with fluticasone furoate and vilanterol than for those on usual care (977 [71%] of 1373 in the fluticasone furoate and vilanterol group vs 784 [56%] of 1399 in the usual care group; odds ratio [OR] 2·00 [95% CI 1·70-2·34], p<0·0001). At week 24, the adjusted mean ACT score increased by 4·4 points from baseline in patients initiated with fluticasone furoate and vilanterol, compared with 2·8 points in the usual care group (difference 1·6 [95% CI 1·3-2·0], p<0·0001). This result was consistent for the duration of the study. Pneumonia was uncommon, with no differences between groups; there was no difference in other serious adverse events between the groups. In patients with a general practitioner's diagnosis of symptomatic asthma and on maintenance inhaler therapy, initiation of a once-daily treatment regimen of combined fluticasone furoate and vilanterol improved asthma control without increasing the risk of serious adverse events when compared with optimised usual care. GlaxoSmithKline. Copyright © 2017 Elsevier Ltd. All rights reserved.

Effects of allergen and trigger factor avoidance advice in primary care on asthma control: a randomized-controlled trial.

PubMed

Bobb, C; Ritz, T; Rowlands, G; Griffiths, C

2010-01-01

Allergy contributes significantly to asthma exacerbation, yet avoidance of triggers, in particular allergens, is rarely addressed in detail in regular asthma review in primary care. To determine whether structured, individually tailored allergen and trigger avoidance advice, given as part of a primary care asthma review, improves lung function and asthma control. In a randomized-controlled trial 214 adults with asthma in six general practices were either offered usual care during a primary care asthma review or usual care with additional allergen and trigger identification (by skin prick testing and structured allergy assessment) and avoidance advice according to a standardized protocol by trained practice nurses. Main outcome measures were lung function, asthma control, asthma self-efficacy. Both intervention groups were equivalent in demographic and asthma-related variables at baseline. At 3-6-month follow-up, patients receiving the allergen and trigger avoidance review showed significant improvements in lung function (assessed by blinded research nurses) compared with those receiving usual care. Significantly more patients in the intervention group than in the control group showed improvements in forced expiratory volume in 1 s > or =15%. No significant differences were found in self-report measures of asthma control. Asthma-specific self-efficacy improved in both groups but did not differ between groups. Allergen and trigger identification and avoidance advice, given as part of a structured asthma review delivered in primary care by nurses results in clinically important improvements in lung function but not self-report of asthma control. ISRCTN45684820.

Self-managed loaded exercise versus usual physiotherapy treatment for rotator cuff tendinopathy: a pilot randomised controlled trial.

PubMed

Littlewood, Chris; Malliaras, Peter; Mawson, Sue; May, Stephen; Walters, Stephen J

2014-03-01

Rotator cuff tendinopathy is a common source of shoulder pain characterised by persistent and/or recurrent problems for a proportion of sufferers. The aim of this study was to pilot the methods proposed to conduct a substantive study to evaluate the effectiveness of a self-managed loaded exercise programme versus usual physiotherapy treatment for rotator cuff tendinopathy. A single-centre pragmatic unblinded parallel group pilot randomised controlled trial. One private physiotherapy clinic, northern England. Twenty-four participants with rotator cuff tendinopathy. The intervention was a programme of self-managed loaded exercise. The control group received usual physiotherapy treatment. Baseline assessment comprised the Shoulder Pain and Disability Index (SPADI) and the Short-Form 36, repeated three months post randomisation. The recruitment target was met and the majority of participants (98%) were willing to be randomised. 100% retention was attained with all participants completing the SPADI at three months. Exercise adherence rates were excellent (90%). The mean change in SPADI score was -23.7 (95% CI -14.4 to -33.3) points for the self-managed exercise group and -19.0 (95% CI -6.0 to -31.9) points for the usual physiotherapy treatment group. The difference in three month SPADI scores was 0.1 (95% CI -16.6 to 16.9) points in favour of the usual physiotherapy treatment group. In keeping with previous research which indicates the need for further evaluation of self-managed loaded exercise for rotator cuff tendinopathy, these methods and the preliminary evaluation of outcome offer a foundation and stimulus to conduct a substantive study. Copyright © 2013 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

Cost analysis of the Communication and Low Mood (CALM) randomised trial of behavioural therapy for stroke patients with aphasia.

PubMed

Humphreys, Ioan; Thomas, Shirley; Phillips, Ceri; Lincoln, Nadina

2015-01-01

To evaluate the cost effectiveness of a behavioural therapy intervention shown to be clinically effective in comparison with usual care for stroke patients with aphasia. Randomised controlled trial with comparison of costs and calculation of incremental cost effectiveness ratio. Community. Participants identified as having low mood on either the Visual Analog Mood Scale sad item (≥50) or Stroke Aphasic Depression Questionnaire Hospital version 21 (SADQH21) (≥6) were recruited. Participants were randomly allocated to behavioural therapy or usual care using internet-based randomisation generated in advance of the study by a clinical trials unit. Outcomes were assessed at six months after randomisation, blind to group allocation. The costs were assessed from a service use questionnaire. Effectiveness was defined as the change in SADQH21 scores and a cost-effectiveness analysis was performed comparing the behavioural group with the usual care control group. The cost analysis was undertaken from the perspective of the UK NHS and Social Services. The greatest difference was in home help costs where there was a saving of £56.20 in the intervention group compared to an increase of £61.40 in the control group. At six months the SADQH21 score for the intervention group was 17.3 compared to the control group value of 20.4. This resulted in a mean increase of 0.7 in the control group, compared to a mean significant different decrease of 6 in the intervention group (P = 0.003). The Incremental Cost-Effectiveness Ratio indicated that the cost per point reduction on the SADQH21 was £263. Overall the behavioural therapy was found to improve mood and resulted in some encouraging savings in resource utilisation over the six months follow-up. © The Author(s) 2014.

Pilot Trial of a Licensed Practical Nurse Intervention for Hypertension and Depression

PubMed Central

Bogner, Hillary R.; de Vries, Heather F.; Kaye, Elise M.; Morales, Knashawn H.

2014-01-01

BACKGROUND AND OBJECTIVES Depression is a risk factor for hypertension, and risk of depression is increased substantially in patients with hypertension. Our objective was to examine whether an intervention carried out by Licensed Practical Nurses (LPNs) integrating depression treatment into care for hypertension improved blood pressure control and depressive symptoms. METHODS In all, 60 patients ages 41 to 92 years with hypertension and depressive symptoms at a large primary care practice in Philadelphia were randomly assigned to an integrated care intervention carried out by LPNs (n=30) or usual care (n=30). Intervention and control groups did not differ statistically on baseline measures. Outcomes assessed at baseline and 12 weeks included standard laboratory procedures to measure blood pressure control and the Patient Health Questionnaire (PHQ-9) to assess depression. RESULTS Patients in the integrated care intervention had lower diastolic blood pressure (intervention 74.2 mmHg versus usual care 82.0 mmHg) and fewer depressive symptoms (PHQ-9 mean scores, intervention 2.4 versus usual care 7.1) compared with patients in the usual care group at 12 weeks after adjustment for baseline values. Patients in the integrated care intervention also had lower systolic blood pressure (intervention 130.0 mmHg versus usual care 140.6 mmHg) compared with patients in the usual care group at 12 weeks although the results approached but did not reach conventional levels of statistical significance. CONCLUSION Training existing primary care practice office staff will facilitate implementation in real world practices with limited resources and competing demands. PMID:23681683

Effect of adding postoperative noninvasive ventilation to usual care to prevent pulmonary complications in patients undergoing coronary artery bypass grafting: a randomized controlled trial.

PubMed

Al Jaaly, Emad; Fiorentino, Francesca; Reeves, Barnaby C; Ind, Philip W; Angelini, Gianni D; Kemp, Scott; Shiner, Robert J

2013-10-01

We compared the efficacy of noninvasive ventilation with bilevel positive airway pressure added to usual care versus usual care alone in patients undergoing coronary artery bypass grafting. We performed a 2-group, parallel, randomized controlled trial. The primary outcome was time until fit for discharge. Secondary outcomes were partial pressure of carbon dioxide, forced expiratory volume in 1 second, atelectasis, adverse events, duration of intensive care stay, and actual postoperative stay. A total of 129 patients were randomly allocated to bilevel positive airway pressure (66) or usual care (63). Three patients allocated to bilevel positive airway pressure withdrew. The median duration of bilevel positive airway pressure was 16 hours (interquartile range, 11-19). The median duration of hospital stay until fit for discharge was 5 days for the bilevel positive airway pressure group (interquartile range, 4-6) and 6 days for the usual care group (interquartile range, 5-7; hazard ratio, 1.68; 95% confidence interval, 1.08-2.31; P = .019). There was no significant difference in duration of intensive care, actual postoperative stay, and mean percentage of predicted forced expiratory volume in 1 second on day 3. Mean partial pressure of carbon dioxide was significantly reduced 1 hour after bilevel positive airway pressure application, but there was no overall difference between the groups up to 24 hours. Basal atelectasis occurred in 15 patients (24%) in the usual care group and 2 patients (3%) in the bilevel positive airway pressure group. Overall, 30% of patients in the bilevel positive airway pressure group experienced an adverse event compared with 59% in the usual care group. Among patients undergoing elective coronary artery bypass grafting, the use of bilevel positive airway pressure at extubation reduced the recovery time. Supported by trained staff, more than 75% of all patients allocated to bilevel positive airway pressure tolerated it for more than 10 hours. Copyright © 2013 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

The effectiveness of wet-cupping for nonspecific low back pain in Iran: a randomized controlled trial.

PubMed

Farhadi, Khosro; Schwebel, David C; Saeb, Morteza; Choubsaz, Mansour; Mohammadi, Reza; Ahmadi, Alireza

2009-01-01

To determine the efficacy of wet-cupping for treating persistent nonspecific low back pain. Wet-cupping therapy is one of the oldest known medical techniques. It is still used in several contemporary societies. Very minimal empirical study has been conducted on its efficacy. Randomized controlled trial with two parallel groups. Patients in the experimental group were offered the option of referral to the wet-cupping service; all accepted that option. The control group received usual care. Medical clinic in Kermanshah, Iran. In total, 98 patients aged 17-68 years with nonspecific low back pain; 48 were randomly assigned to experimental group and 50 to the control group. Patients in the experimental group were prescribed a series of three staged wet-cupping treatments, placed at 3 days intervals (i.e., 0, 3, and 6 days). Patients in the control group received usual care from their general practitioner. Three outcomes assessed at baseline and again 3 months following intervention: the McGill Present Pain Index, Oswestry Pain Disability Index, and the Medication Quantification Scale. Wet-cupping care was associated with clinically significant improvement at 3-month follow-up. The experimental group who received wet-cupping care had significantly lower levels of pain intensity ([95% confidence interval (CI) 1.72-2.60] mean difference=2.17, p<0.01), pain-related disability (95% CI=11.18-18.82, means difference=14.99, p<0.01), and medication use (95% CI=3.60-9.50, mean difference=6.55, p<0.01) than the control group. The differences in all three measures were maintained after controlling for age, gender, and duration of lower back pain in regression models (p<0.01). Traditional wet-cupping care delivered in a primary care setting was safe and acceptable to patients with nonspecific low back pain. Wet-cupping care was significantly more effective in reducing bodily pain than usual care at 3-month follow-up.

Strength training, walking, and social activity improve sleep in nursing home and assisted living residents: randomized controlled trial.

PubMed

Richards, Kathy C; Lambert, Corinne; Beck, Cornelia K; Bliwise, Donald L; Evans, William J; Kalra, Gurpreet K; Kleban, Morton H; Lorenz, Rebecca; Rose, Karen; Gooneratne, Nalaka S; Sullivan, Dennis H

2011-02-01

To compare the effects of physical resistance strength training and walking (E), individualized social activity (SA), and E and SA (ESA) with a usual care control group on total nocturnal sleep time in nursing home and assisted living residents. Pretest-posttest experimental design with assignment to one of four groups for 7 weeks: E (n=55), SA (n=50), ESA (n=41), and usual care control (n=47). Ten nursing homes and three assisted living facilities. One hundred ninety-three residents were randomly assigned; 165 completed the study. The E group participated in high-intensity physical resistance strength training 3 days a week and on 2 days walked for up to 45 minutes, the SA group received social activity 1 hour daily 5 days a week, the ESA group received both E and SA, and the control group participated in usual activities provided in the homes. Total nocturnal sleep time was measured using 2 nights of polysomnography before and 2 nights of polysomnography after the intervention. Sleep efficiency (SE), non-rapid eye movement (NREM) sleep, rapid eye movement sleep, and sleep onset latency were also analyzed. Total nocturnal sleep time was significantly greater in the ESA group than in the control group (adjusted means 364.2 minutes vs 328.9 minutes), as was SE and NREM sleep. High-intensity physical resistance strength training and walking combined with social activity significantly improved sleep in nursing home and assisted living residents. The interventions by themselves did not have significant effects on sleep in this population. © 2011, Copyright the Authors. Journal compilation © 2011, The American Geriatrics Society.

Economic evaluation of a pharmaceutical care program for elderly diabetic and hypertensive patients in primary health care: a 36-month randomized controlled clinical trial.

PubMed

Obreli-Neto, Paulo Roque; Marusic, Srecko; Guidoni, Camilo Molino; Baldoni, André de Oliveira; Renovato, Rogério Dias; Pilger, Diogo; Cuman, Roberto Kenji Nakamura; Pereira, Leonardo Régis Leira

2015-01-01

Most diabetic and hypertensive patients, principally the elderly, do not achieve adequate disease control and consume 5%-15% of annual health care budgets. Previous studies verified that pharmaceutical care is useful for achieving adequate disease control in diabetes and hypertension. To evaluate the economic cost and the incremental cost-effectiveness ratio (ICER) per quality-adjusted life-year (QALY) of pharmaceutical care in the management of diabetes and hypertension in elderly patients in a primary public health care system in a developing country. A 36-month randomized controlled clinical trial was performed with 200 patients who were divided into a control group (n = 100) and an intervention group (n = 100). The control group received the usual care offered by the Primary Health Care Unit (medical and nurse consultations). The intervention group received the usual care plus a pharmaceutical care intervention. The intervention and control groups were compared with regard to the direct costs of health services (i.e., general practitioner, specialist, nurse, and pharmacist appointments; emergency room visits; and drug therapy costs) and the ICER per QALY. These evaluations used the health system perspective. No statistically significant difference was found between the intervention and control groups in total direct health care costs ($281.97 ± $49.73 per patient vs. $212.28 ± $43.49 per patient, respectively; P = 0.089); pharmaceutical care added incremental costs of $69.60 (± $7.90) per patient. The ICER per QALY was $53.50 (95% CI = $51.60-$54.00; monetary amounts are given in U.S. dollars). Every clinical parameter evaluated improved for the pharmaceutical care group, whereas these clinical parameters remained unchanged in the usual care group. The difference in differences (DID) tests indicated that for each clinical parameter, the patients in the intervention group improved more from pre to post than the control group (P < 0.001). While pharmaceutical care did not significantly increase total direct health care costs, significantly improved health outcomes were seen. The mean ICER per QALY gained suggests a favorable cost-effectiveness.

The addition of a goal-based motivational interview to treatment as usual to enhance engagement and reduce dropouts in a personality disorder treatment service: results of a feasibility study for a randomized controlled trial

PubMed Central

2013-01-01

Background There are high rates of treatment non-completion for personality disorder and those who do not complete treatment have poorer outcomes. A goal-based motivational interview may increase service users’ readiness to engage with therapy and so enhance treatment retention. We conducted a feasibility study to inform the design of a randomized controlled trial. The aims were to test the feasibility of recruitment, randomization and follow-up, and to conduct a preliminary evaluation of the effectiveness of the motivational interview. Methods Patients in an outpatient personality disorder service were randomized to receive the Personal Concerns Inventory plus treatment as usual or treatment as usual only. The main randomized controlled trial feasibility criteria were recruitment of 54% of referrals, and 80% of clients and therapists finding the intervention acceptable. Information was collected on treatment attendance, the clarity of therapy goals and treatment engagement. Results The recruitment rate was 29% (76 of 258). Of 12 interviewed at follow-up, eight (67%) were positive about the Personal Concerns Inventory. Pre-intervention interviews were conducted with 61% (23 out of 38) of the Personal Concerns Inventory group and 74% (28 out of 38) of the treatment as usual group. Participants’ therapy goals were blind-rated for clarity on a scale of 0 to 10. The mean score for the Personal Concerns Inventory group was 6.64 (SD = 2.28) and for the treatment as usual group 2.94 (SD = 1.71). Over 12 weeks, the median percentage session attendance was 83.33% for the Personal Concerns Inventory group (N = 17) and 66.67% for the treatment as usual group (N = 24). Of 59 eligible participants at follow-up, the Treatment Engagement Rating scale was completed for 40 (68%). The mean Treatment Engagement Rating scale score for the Personal Concerns Inventory group was 6.64 (SD = 2.28) and for the treatment as usual group 2.94 (SD = 1.71). Of the 76 participants, 63 (83%) completed the Client Service Receipt Inventory at baseline and 34 of 59 (58%) at follow-up. Conclusion Shortfalls in recruitment and follow-up data collection were explained by major changes to the service. However, evidence of a substantial positive impact of the Personal Concerns Inventory on treatment attendance, clarity of therapy goals and treatment engagement, make a full-scale evaluation worth pursuing. Further preparatory work is required for a multisite trial. Trial registration ClinicalTrials.Gov.UK Identifier - NCT01132976 PMID:23414174

The addition of a goal-based motivational interview to treatment as usual to enhance engagement and reduce dropouts in a personality disorder treatment service: results of a feasibility study for a randomized controlled trial.

PubMed

McMurran, Mary; Cox, W Miles; Whitham, Diane; Hedges, Lucy

2013-02-17

There are high rates of treatment non-completion for personality disorder and those who do not complete treatment have poorer outcomes. A goal-based motivational interview may increase service users' readiness to engage with therapy and so enhance treatment retention. We conducted a feasibility study to inform the design of a randomized controlled trial. The aims were to test the feasibility of recruitment, randomization and follow-up, and to conduct a preliminary evaluation of the effectiveness of the motivational interview. Patients in an outpatient personality disorder service were randomized to receive the Personal Concerns Inventory plus treatment as usual or treatment as usual only. The main randomized controlled trial feasibility criteria were recruitment of 54% of referrals, and 80% of clients and therapists finding the intervention acceptable. Information was collected on treatment attendance, the clarity of therapy goals and treatment engagement. The recruitment rate was 29% (76 of 258). Of 12 interviewed at follow-up, eight (67%) were positive about the Personal Concerns Inventory. Pre-intervention interviews were conducted with 61% (23 out of 38) of the Personal Concerns Inventory group and 74% (28 out of 38) of the treatment as usual group. Participants' therapy goals were blind-rated for clarity on a scale of 0 to 10. The mean score for the Personal Concerns Inventory group was 6.64 (SD = 2.28) and for the treatment as usual group 2.94 (SD = 1.71). Over 12 weeks, the median percentage session attendance was 83.33% for the Personal Concerns Inventory group (N = 17) and 66.67% for the treatment as usual group (N = 24). Of 59 eligible participants at follow-up, the Treatment Engagement Rating scale was completed for 40 (68%). The mean Treatment Engagement Rating scale score for the Personal Concerns Inventory group was 6.64 (SD = 2.28) and for the treatment as usual group 2.94 (SD = 1.71). Of the 76 participants, 63 (83%) completed the Client Service Receipt Inventory at baseline and 34 of 59 (58%) at follow-up. Shortfalls in recruitment and follow-up data collection were explained by major changes to the service. However, evidence of a substantial positive impact of the Personal Concerns Inventory on treatment attendance, clarity of therapy goals and treatment engagement, make a full-scale evaluation worth pursuing. Further preparatory work is required for a multisite trial. ClinicalTrials.Gov.UK Identifier - NCT01132976.

Supported Telemonitoring and Glycemic Control in People with Type 2 Diabetes: The Telescot Diabetes Pragmatic Multicenter Randomized Controlled Trial

PubMed Central

Wild, Sarah H.; Hanley, Janet; Lewis, Stephanie C.; McKnight, John A.; Padfield, Paul L.; Parker, Richard A.; Pinnock, Hilary; Sheikh, Aziz; McKinstry, Brian

2016-01-01

Background Self-monitoring of blood glucose among people with type 2 diabetes not treated with insulin does not appear to be effective in improving glycemic control. We investigated whether health professional review of telemetrically transmitted self-monitored glucose results in improved glycemic control in people with poorly controlled type 2 diabetes. Methods and Findings We performed a randomized, parallel, investigator-blind controlled trial with centralized randomization in family practices in four regions of the United Kingdom among 321 people with type 2 diabetes and glycated hemoglobin (HbA1c) >58 mmol/mol. The supported telemonitoring intervention involved self-measurement and transmission to a secure website of twice-weekly morning and evening glucose for review by family practice clinicians who were not blinded to allocation group. The control group received usual care, with at least annual review and more frequent reviews for people with poor glycemic or blood pressure control. HbA1c assessed at 9 mo was the primary outcome. Intention-to-treat analyses were performed. 160 people were randomized to the intervention group and 161 to the usual care group between June 6, 2011, and July 19, 2013. HbA1c data at follow-up were available for 146 people in the intervention group and 139 people in the control group. The mean (SD) HbA1c at follow-up was 63.0 (15.5) mmol/mol in the intervention group and 67.8 (14.7) mmol/mol in the usual care group. For primary analysis, adjusted mean HbA1c was 5.60 mmol/mol / 0.51% lower (95% CI 2.38 to 8.81 mmol/mol/ 95% CI 0.22% to 0.81%, p = 0·0007). For secondary analyses, adjusted mean ambulatory systolic blood pressure was 3.06 mmHg lower (95% CI 0.56–5.56 mmHg, p = 0.017) and mean ambulatory diastolic blood pressure was 2.17 mmHg lower (95% CI 0.62–3.72, p = 0.006) among people in the intervention group when compared with usual care after adjustment for baseline differences and minimization strata. No significant differences were identified between groups in weight, treatment pattern, adherence to medication, or quality of life in secondary analyses. There were few adverse events and these were equally distributed between the intervention and control groups. In secondary analysis, there was a greater number of telephone calls between practice nurses and patients in the intervention compared with control group (rate ratio 7.50 (95% CI 4.45–12.65, p < 0.0001) but no other significant differences between groups in use of health services were identified between groups. Key limitations include potential lack of representativeness of trial participants, inability to blind participants and health professionals, and uncertainty about the mechanism, the duration of the effect, and the optimal length of the intervention. Conclusions Supported telemonitoring resulted in clinically important improvements in control of glycaemia in patients with type 2 diabetes in family practice. Current Controlled Trials, registration number ISRCTN71674628. Trial Registration Current Controlled Trials ISRCTN 71674628 PMID:27458809

Effectiveness of a Blended Physical Therapist Intervention in People With Hip Osteoarthritis, Knee Osteoarthritis, or Both: A Cluster-Randomized Controlled Trial.

PubMed

Kloek, Corelien J J; Bossen, Daniël; Spreeuwenberg, Peter M; Dekker, Joost; de Bakker, Dinny H; Veenhof, Cindy

2018-05-17

Integrating physical therapy sessions and an online application (e-Exercise) might support people with hip osteoarthritis (OA), knee OA, or both (hip/knee OA) in taking an active role in the management of their chronic condition and may reduce the number of physical therapy sessions. The objective of this study was to investigate the short- and long-term effectiveness of e-Exercise compared to usual physical therapy in people with hip/knee OA. The design was a prospective, single-blind, multicenter, superiority, cluster- randomized controlled trial. The setting included 143 primary care physical therapist practices. The participants were 208 people with hip/knee OA and were 40 to 80 years of age. e-Exercise is a 3-month intervention in which about 5 face-to-face physical therapy sessions were integrated with an online application consisting of graded activity, exercise, and information modules. Usual physical therapy was conducted according to the Dutch physical therapy guidelines on hip and knee osteoarthritis. Primary outcomes, measured at baseline after 3 and 12 months, were physical functioning and free-living physical activity. Secondary outcome measures were pain, tiredness, quality of life, self-efficacy, and the number of physical therapy sessions. The e-Exercise group (N = 109) received, on average, 5 face-to-face sessions; the usual physical therapy group (N = 99) received 12. No significant differences in primary outcomes between the e-Exercise group and the usual physical therapy group were found. Within-group analyses for both groups showed a significant improvement in physical functioning. After 3 months, participants in the e-Exercise group reported an increase in physical activity; however, no objectively measured differences in physical activity were found. With respect to secondary outcomes, after 12 months, sedentary behavior significantly increased in the e-Exercise group compared with the usual physical therapy group. In both groups, there were significant improvements for pain, tiredness, quality of life, and self-efficacy. The response rate at 12 months was 65%. The blended intervention e-Exercise was not more effective than usual physical therapy in people with hip/knee osteoarthritis.

Effect of Information and Telephone-Guided Access to Community Support for People with Chronic Kidney Disease: Randomised Controlled Trial

PubMed Central

Blakeman, Tom; Blickem, Christian; Kennedy, Anne; Reeves, David; Bower, Peter; Gaffney, Hannah; Gardner, Caroline; Lee, Victoria; Jariwala, Praksha; Dawson, Shoba; Mossabir, Rahena; Brooks, Helen; Richardson, Gerry; Spackman, Eldon; Vassilev, Ivaylo; Chew-Graham, Carolyn; Rogers, Anne

2014-01-01

Background Implementation of self-management support in traditional primary care settings has proved difficult, encouraging the development of alternative models which actively link to community resources. Chronic kidney disease (CKD) is a common condition usually diagnosed in the presence of other co-morbidities. This trial aimed to determine the effectiveness of an intervention to provide information and telephone-guided access to community support versus usual care for patients with stage 3 CKD. Methods and Findings In a pragmatic, two-arm, patient level randomised controlled trial 436 patients with a diagnosis of stage 3 CKD were recruited from 24 general practices in Greater Manchester. Patients were randomised to intervention (215) or usual care (221). Primary outcome measures were health related quality of life (EQ-5D health questionnaire), blood pressure control, and positive and active engagement in life (heiQ) at 6 months. At 6 months, mean health related quality of life was significantly higher for the intervention group (adjusted mean difference = 0.05; 95% CI = 0.01, 0.08) and blood pressure was controlled for a significantly greater proportion of patients in the intervention group (adjusted odds-ratio = 1.85; 95% CI = 1.25, 2.72). Patients did not differ significantly in positive and active engagement in life. The intervention group reported a reduction in costs compared with control. Conclusions An intervention to provide tailored information and telephone-guided access to community resources was associated with modest but significant improvements in health related quality of life and better maintenance of blood pressure control for patients with stage 3 CKD compared with usual care. However, further research is required to identify the mechanisms of action of the intervention. Trial Registration Controlled-Trials.com ISRCTN45433299 PMID:25330169

Comprehensive and subacute care interventions improve health-related quality of life for older patients after surgery for hip fracture: a randomised controlled trial.

PubMed

Shyu, Yea-Ing L; Liang, Jersey; Tseng, Ming-Yueh; Li, Hsiao-Juan; Wu, Chi-Chuan; Cheng, Huey-Shinn; Chou, Shih-Wei; Chen, Ching-Yen; Yang, Ching-Tzu

2013-08-01

Elderly patients with hip fracture have been found to benefit from subacute care interventions that usually comprise usual care with added geriatric intervention, early rehabilitation, and supported discharge. However, no studies were found on the effects of combining subacute care and health-maintenance interventions on health outcomes for elders with hip fracture. To compare the effects of an interdisciplinary comprehensive care programme with those of subacute care and usual care programmes on health-related quality of life (HRQoL) for elderly patients with hip fracture. Randomised controlled trial. A 3000-bed medical centre in northern Taiwan. Patients with hip fracture (N=299) were randomised into three groups: subacute care (n=101), comprehensive care (n=99), and usual care (n=99). Subacute care included geriatric consultation, continuous rehabilitation, and discharge planning. Comprehensive care consisted of subacute care plus health-maintenance interventions to manage depressive symptoms, manage malnutrition, and prevent falls. Usual care included only 1-2 in-hospital rehabilitation sessions, discharge planning without environmental assessment, no geriatric consultation, and no in-home rehabilitation. HRQoL was measured using the Medical Outcomes Study Short-Form 36 Taiwan version at 1, 3, 6, and 12 months after discharge. Participants in the comprehensive care group improved more in physical function, role physical, general health and mental health than those in the usual care group. The subacute care group had greater improvement in physical function, role physical, vitality, and social function than the usual care group. The intervention effects for both comprehensive and subacute care increased over time, specifically from 6 months after hip fracture onward, and reached a maximum at 12 months following discharge. Both comprehensive care and subacute care programmes may improve health outcomes of elders with hip fracture. Our results may provide a reference for health care providers in countries using similar programmes with Chinese/Taiwanese immigrant populations. Copyright © 2012 Elsevier Ltd. All rights reserved.

The efficacy of interactive, motion capture-based rehabilitation on functional outcomes in an inpatient stroke population: a randomized controlled trial.

PubMed

Cannell, John; Jovic, Emelyn; Rathjen, Amy; Lane, Kylie; Tyson, Anna M; Callisaya, Michele L; Smith, Stuart T; Ahuja, Kiran Dk; Bird, Marie-Louise

2018-02-01

To compare the efficacy of novel interactive, motion capture-rehabilitation software to usual care stroke rehabilitation on physical function. Randomized controlled clinical trial. Two subacute hospital rehabilitation units in Australia. In all, 73 people less than six months after stroke with reduced mobility and clinician determined capacity to improve. Both groups received functional retraining and individualized programs for up to an hour, on weekdays for 8-40 sessions (dose matched). For the intervention group, this individualized program used motivating virtual reality rehabilitation and novel gesture controlled interactive motion capture software. For usual care, the individualized program was delivered in a group class on one unit and by rehabilitation assistant 1:1 on the other. Primary outcome was standing balance (functional reach). Secondary outcomes were lateral reach, step test, sitting balance, arm function, and walking. Participants (mean 22 days post-stroke) attended mean 14 sessions. Both groups improved (mean (95% confidence interval)) on primary outcome functional reach (usual care 3.3 (0.6 to 5.9), intervention 4.1 (-3.0 to 5.0) cm) with no difference between groups ( P = 0.69) on this or any secondary measures. No differences between the rehabilitation units were seen except in lateral reach (less affected side) ( P = 0.04). No adverse events were recorded during therapy. Interactive, motion capture rehabilitation for inpatients post stroke produced functional improvements that were similar to those achieved by usual care stroke rehabilitation, safely delivered by either a physical therapist or a rehabilitation assistant.

Weight gain in preterm infants following parent-administered Vimala massage: a randomized controlled trial.

PubMed

Gonzalez, Alma Patricia; Vasquez-Mendoza, Guadalupe; García-Vela, Alfonso; Guzmán-Ramirez, Andres; Salazar-Torres, Marcos; Romero-Gutierrez, Gustavo

2009-04-01

Massage has been proposed as a way of facilitating development and growth of newborns through its effects on increasing blood flow, heart rate, digestion, and immunity. Massage might increase basal metabolism and nutrient absorption through endocrine effects such as increase in insulin and adrenaline and decrease in cortisol. Preliminary studies have suggested significant impact on weight gain with shortening of in-hospital stays of up to 6 days. We compared weight gain among preterm infants receiving Vimala massage plus usual care versus usual care alone. A randomized controlled trial was conducted. Sixty clinically stable preterm newborns with a corrected gestational age of 30 to 35 weeks receiving enteral nutrition in the hospital nursery were included. Half of them were assigned at random to receive Vimala massage twice daily for 10 days plus usual nursery care; the others received usual nursery care. Weight, head circumference, caloric intake, and nutritional method were recorded daily. Group characteristics were compared with analysis of variance, T test, and chi (2) test as appropriate. There were no differences between groups in gender, gestational age, initial weight, head circumference, and caloric intake and type of nutrition at baseline. Infants receiving massage had a larger weight gain versus the control group since the third day (188.2 +/- 41.20 g/kg versus 146.7 +/- 56.43 g/kg, P < 0.001). Hospital stay was shorter in infants receiving massage and usual nursery care (15.63 +/- 5.41 days versus 19.33 +/- 7.92 days, P = 0.03). The addition of parent-administered Vimala massage to usual nursery care resulted in increased weight gain and shorter hospital stay among clinically stable preterm newborns.

The effect of supportive emergency department nursing care on pain reduction of patients with Red Sea marine wildlife injuries.

PubMed

Raviv, Osnat; Delbar, Vered; Arad, Jacob; Grinstein-Cohen, Orli

2015-10-01

The emergency department at Yoseftal hospital in Eilat is on the shore of the Red Sea, and it is visited by patients with marine wildlife injuries. The purpose of this study was to examine the effects of supportive nursing care on the pain level of patients with Red Sea marine wildlife injuries. A prospective quantitative study including 102 patients admitted to the emergency department. The study included a study group (N = 50) and a control group (N = 52). Both groups rated their pain level on the VAS before and after receiving treatment. The control group received the usual treatment, and the study group received the usual nursing treatment along with structured patient guidance and support. There was a significant difference in the level of pain after the intervention between the control and the study group. In the study group, the level of pain was significantly reduced compared with the control group (p < 0.001). Nursing training and patient guidance contributed to increasing cooperation with patients and pain reduction. Therefore, training interventions should be structured and assimilated as an integral part of nursing practice. Copyright © 2015 Elsevier Ltd. All rights reserved.

Patient preferences and performance bias in a weight loss trial with a usual care arm☆☆☆

PubMed Central

McCambridge, Jim; Sorhaindo, Annik; Quirk, Alan; Nanchahal, Kiran

2014-01-01

Objectives This qualitative study examines performance bias, i.e. unintended differences between groups, in the context of a weight loss trial in which a novel patient counseling program was compared to usual care in general practice. Methods 14/381 consecutive interviewees (6 intervention group, 8 control group) within the CAMWEL (Camden Weight Loss) effectiveness trial process study were asked about their engagement with various features of the research study and a thematic content analysis undertaken. Results Decisions to participate were interwoven with decisions to change behavior, to the extent that for many participants the two were synonymous. The intervention group were satisfied with their allocation. The control group spoke of their disappointment at having been offered usual care when they had taken part in the trial to access new forms of help. Reactions to disappointment involved both movements toward and away from behavior change. Conclusion There is a prima facie case that reactions to disappointment may introduce bias, as they lead the randomized groups to differ in ways other than the intended experimental contrast. Practice implications In-depth qualitative studies nested within trials are needed to understand better the processes through which bias may be introduced. PMID:24492159

Evaluating the capabilities model of dementia care: a non-randomized controlled trial exploring resident quality of life and care staff attitudes and experiences.

PubMed

Moyle, Wendy; Venturato, Lorraine; Cooke, Marie; Murfield, Jenny; Griffiths, Susan; Hughes, Julian; Wolf, Nathan

2016-07-01

This 12 month, Australian study sought to compare the Capabilities Model of Dementia Care (CMDC) with usual long-term care (LTC), in terms of (1) the effectiveness of the CMDC in assisting care staff to improve Quality Of Life (QOL) for older people with dementia; and (2) whether implementation of the CMDC improved staff attitudes towards, and experiences of working and caring for the person with dementia. A single blind, non-randomized controlled trial design, involving CMDC intervention group (three facilities) and a comparison usual LTC practice control group (one facility), was conducted from August 2010 to September 2011. Eighty-one staff members and 48 family members of a person with dementia were recruited from these four LTC facilities. At baseline, 6 and 12 months, staff completed a modified Staff Experiences of Working with Demented Residents questionnaire (SEWDR), and families completed the Quality of Life - Alzheimer's Disease questionnaire (QOL-AD). LTC staff in the usual care group reported significantly lower SEWDR scores (i.e. less work satisfaction) than those in the CMDC intervention group at 12 months (p = 0.005). Similarly, family members in the comparison group reported significantly lower levels of perceived QOL for their relative with dementia (QOL-AD scores) than their counterparts in the CMDC intervention group at 12 months (p = 0.012). Although the study has a number of limitations the CMDC appears to be an effective model of dementia care - more so than usual LTC practice. The CMDC requires further evaluation with participants from a diverse range of LTC facilities and stages of cognitive impairment.

Randomized controlled trial of clinical pharmacy management of patients with type 2 diabetes in an outpatient diabetes clinic in Jordan.

PubMed

Jarab, Anan Sadeq; Alqudah, Salam Ghazi; Mukattash, Tareq Lewis; Shattat, Ghassan; Al-Qirim, Tariq

2012-09-01

Glycemic goals (hemoglobin A1c < 7%) are often not achieved in patients with type 2 diabetes despite the availability of many effective treatments and the documented benefits of glycemic control in the reduction of long-term microvascular and macrovascular complications. Several studies have established the important positive effects of pharmacist-led management on achieving glycemic control and other clinical outcomes in patients with diabetes. Diabetes prevalence and mortality are increasing rapidly in Jordan. Nevertheless, clinical pharmacists in Jordan do not typically provide pharmaceutical care; instead, the principal responsibilities of pharmacists in Jordan are dispensing and marketing of medical products to physicians. To assess the primary clinical outcome of glycemic control (A1c) and secondary outcomes, including blood pressure, lipid values, self-reported medication adherence, and self-care activities for patients with type 2 diabetes in an outpatient diabetes clinic randomly assigned to either usual care or a pharmacist-led pharmaceutical care intervention program. Patients with type 2 diabetes attending an outpatient diabetes clinic of a large teaching hospital were recruited over a 4-month period from January through April 2011 and randomly assigned to intervention and usual care groups using the Minim software technique. The intervention group at baseline received face-to-face objective-directed education from a clinical pharmacist about type 2 diabetes, prescription medications, and necessary lifestyle changes, followed by 8 weekly telephone follow-up calls to discuss and review the prescribed treatment plan and to resolve any patient concerns. The primary outcome measure was glycemic control (A1c), and secondary measures included systolic and diastolic blood pressure, complete lipid profile (i.e., total cholesterol, low-density lipoprotein cholesterol [LDL-C], high-density lipoprotein cholesterol [HDL-C], serum triglycerides), and self-reported medication adherence (4-item Morisky Scale) and self-care activities (Summary of Diabetes Self-Care Activities questionnaire). Data were collected at baseline and at 6 months follow-up. Changes from baseline to follow-up were calculated for biomarker values, and between-group differences in the change amounts were tested using the t test for independent samples. A P value of < 0.05 was considered statistically significant. A total of 77 of 85 patients (90.6%) randomly assigned to the intervention group and 79 of 86 patients (91.9%) assigned to usual care had baseline and 6-month follow-up values. Compared with baseline values, patients in the intervention group had a mean reduction of 0.8% in A1c versus a mean increase of 0.1% from baseline in the usual care group (P = 0.019). The intervention group compared with the usual care group had small but statistically significant improvements in the secondary measures of fasting blood glucose, systolic and diastolic blood pressure, total cholesterol, LDL-C, serum triglycerides, self-reported medication adherence, and self-care activities. Between-group differences in changes in the secondary measures of HDL-C and body mass index were not significant. Patients with type 2 diabetes who received pharmacist-led pharmaceutical care in an outpatient diabetes clinic experienced reduction in A1c at 6 months compared with essentially no change in the usual care group. Six of 8 secondary biomarkers were improved in the intervention group compared with usual care. Copyright © 2012, Academy of Managed Care Pharmacy. All rights reserved.

Does the addition of two exercise-focussed home visits to usual care improve outcomes for patients with balance impairments? A randomized controlled trial.

PubMed

Whitbourne, Craig; Shields, Nora; Tacey, Mark; Koh, Kenneth Wz; Lawler, Katherine; Hill, Keith D

2018-03-01

To investigate whether two additional home visits improve outcomes for rehabilitation outpatients with balance impairments compared to usual care. Randomized controlled trial. Outpatient rehabilitation. Fifty with balance impairments. Both groups received usual care including weekly group exercise over eight weeks. The intervention group received two home visits to individualize home exercises. Primary outcome measure was the Balance Outcome Measure for Elder Rehabilitation (BOOMER) score, and secondary outcomes included force platform measures using the NeuroCom Balance Master ® , assessed at baseline, after intervention and three-month follow-up. There was no between-group difference for BOOMER score. There were significant between-group differences in favour of the intervention group for limits of stability reaction time at week 9 (mean difference (MD) -0.27, 95% confidence interval (CI) -0.44 to -0.09) and week 22 (MD -0.28, 95% CI -0.45 to -0.10) and for limits of stability maximal excursion at week 9 (MD 8.66, 95% CI 1.67 to 15.65) and week 22 (MD 14.58, 95% CI 7.59 to 21.57). Significant between-group differences favoured the control group for Clinical Test of Sensory Interaction of Balance at week 9 (MD 0.40, 95% CI 0.13 to 0.66) and week 22 (MD 0.45, 95% CI 0.18 to 0.72) and step quick turn time at week 9 (MD 0.56, 95% CI 0.02 to 1.10). Two exercise-focussed home visits improved some dynamic balance outcomes in older patients with balance impairments. Some outcomes showed significant improvements with small effect sizes in favour of the control group which may be chance findings or because they completed a standard home exercise programme.

Cost effectiveness of a manual based coping strategy programme in promoting the mental health of family carers of people with dementia (the START (STrAtegies for RelaTives) study): a pragmatic randomised controlled trial

PubMed Central

King, Derek; Romeo, Renee; Schehl, Barbara; Barber, Julie; Griffin, Mark; Rapaport, Penny; Livingston, Debbie; Mummery, Cath; Walker, Zuzana; Hoe, Juanita; Sampson, Elizabeth L; Cooper, Claudia; Livingston, Gill

2013-01-01

Objective To assess whether the START (STrAtegies for RelatTives) intervention added to treatment as usual is cost effective compared with usual treatment alone. Design Cost effectiveness analysis nested within a pragmatic randomised controlled trial. Setting Three mental health and one neurological outpatient dementia service in London and Essex, UK. Participants Family carers of people with dementia. Intervention Eight session, manual based, coping intervention delivered by supervised psychology graduates to family carers of people with dementia added to usual treatment, compared with usual treatment alone. Primary outcome measures Costs measured from a health and social care perspective were analysed alongside the Hospital Anxiety and Depression Scale total score (HADS-T) of affective symptoms and quality adjusted life years (QALYs) in cost effectiveness analyses over eight months from baseline. Results Of the 260 participants recruited to the study, 173 were randomised to the START intervention, and 87 to usual treatment alone. Mean HADS-T scores were lower in the intervention group than the usual treatment group over the 8 month evaluation period (mean difference −1.79 (95% CI −3.32 to −0.33)), indicating better outcomes associated with the START intervention. There was a small improvement in health related quality of life as measured by QALYs (0.03 (−0.01 to 0.08)). Costs were no different between the intervention and usual treatment groups (£252 (−28 to 565) higher for START group). The cost effectiveness calculations suggested that START had a greater than 99% chance of being cost effective compared with usual treatment alone at a willingness to pay threshold of £30 000 per QALY gained, and a high probability of cost effectiveness on the HADS-T measure. Conclusions The manual based coping intervention START, when added to treatment as usual, was cost effective compared with treatment as usual alone by reference to both outcome measures (affective symptoms for family carers, and carer based QALYs). Trial Registration ISCTRN 70017938 PMID:24162943

Graded activity for low back pain in occupational health care: a randomized, controlled trial.

PubMed

Staal, J Bart; Hlobil, Hynek; Twisk, Jos W R; Smid, Tjabe; Köke, Albère J A; van Mechelen, Willem

2004-01-20

Low back pain is a common medical and social problem frequently associated with disability and absence from work. However, data on effective return to work after interventions for low back pain are scarce. To determine the effectiveness of a behavior-oriented graded activity program compared with usual care. Randomized, controlled trial. Occupational health services department of an airline company in the Netherlands. 134 workers who were absent from work because of low back pain were randomly assigned to either graded activity (n = 67) or usual care (n = 67). Graded activity, a physical exercise program based on operant-conditioning behavioral principles, to stimulate a rapid return to work. Outcomes were the number of days of absence from work because of low back pain, functional status (Roland Disability Questionnaire), and severity of pain (11-point numerical scale). The median number of days of absence from work over 6 months of follow-up was 58 days in the graded activity group and 87 days in the usual care group. From randomization onward, graded activity was effective after 50 days of absence from work (hazard ratio, 1.9 [95% CI, 1.2 to 3.2]; P = 0.009). The graded activity group was more effective in improving functional status and pain than the usual care group. The effects, however, were small and not statistically significant. Graded activity was more effective than usual care in reducing the number of days of absence from work because of low back pain.

Neurofeedback Training as a New Method in Treatment of Crystal Methamphetamine Dependent Patients: A Preliminary Study.

PubMed

Rostami, R; Dehghani-Arani, F

2015-09-01

This study aimed to compare the effectiveness of neurofeedback (NFB) plus pharmacotherapy with pharmacotherapy alone, on addiction severity, mental health, and quality of life in crystal methamphetamine-dependent (CMD) patients. The study included 100 CMD patients undergoing a medical treatment who volunteered for this randomized controlled trial. After being evaluated by a battery of questionnaires that included addiction severity index questionnaire, Symptoms Check List 90 version, and World Health Organization Quality of Life, the participants were randomly assigned to an experimental or a control group. The experimental group received thirty 50-min sessions of NFB in addition to their usual medication over a 2-month period; meanwhile, the control group received only their usual medication. In accordance with this study's pre-test-post-test design, both study groups were evaluated again after completing their respective treatment regimens. Multivariate analysis of covariance showed the experimental group to have lower severity of addiction, better psychological health, and better quality of life in than the control group. The differences between the two groups were statistically significant. These finding suggest that NFB can be used to improve the effectiveness of treatment results in CMD patients.

Exercise and severe major depression: effect on symptom severity and quality of life at discharge in an inpatient cohort.

PubMed

Schuch, F B; Vasconcelos-Moreno, M P; Borowsky, C; Zimmermann, A B; Rocha, N S; Fleck, M P

2015-02-01

Exercise is a potential treatment for depression. However, few studies have evaluated the role of adjunct exercise in the treatment of severely major depressed inpatients. The goal of this study was to evaluate the effects of add-on exercise on the usual treatment of severely depressed inpatients. Fifty participants were randomized to an exercise (exercise + usual treatment) or a control (usual treatment) group. Twenty-five patients were randomly allocated to each group. The participants in the exercise group performed three sessions per week throughout the hospitalization period, with a goal dose of 16.5 kcal/kg/week plus the usual pharmacological treatment. Depressive symptoms and the Quality of Life (QoL) of the participants were assessed at the baseline, the second week, and discharge. A significant group × time interaction was found for depressive symptoms and the physical and psychological domains of QoL. Differences between groups occurred at the second week and discharge with respect to depressive symptoms and the physical and psychological domains of QoL. There was no difference in the remission rate at discharge (48% and 32% for the exercise and control group, respectively). An NNT of 6.25 was found. No significant baseline characteristics predict remission at discharge. Add-on exercise is an efficacious treatment for severely depressed inpatients, improving their depressive symptoms and QoL. Initial acceptance of exercise remains a challenge. Copyright © 2014 Elsevier Ltd. All rights reserved.

Telehealthcare for patients suffering from chronic obstructive pulmonary disease: effects on health-related quality of life: results from the Danish ‘TeleCare North’ cluster-randomised trial

PubMed Central

Lilholt, Pernille Heyckendorff; Witt Udsen, Flemming; Ehlers, Lars; Hejlesen, Ole K

2017-01-01

Objective To assess the effect of telehealthcare compared with usual practice in patients with chronic obstructive pulmonary disease (COPD). Design A cluster-randomised trial with 26 municipal districts that were randomly assigned either to an intervention group whose members received telehealthcare in addition to usual practice or to a control group whose members received usual practice only (13 districts in each arm). Setting Twenty-six municipal districts in the North Denmark Region of Denmark. Participants Patients who fulfilled the Global Initiative for COPD guidelines and one of the following criteria: COPD Assessment Test score ≥10; or Medical Research Dyspnoea Council Scale ≥3; or Modified Medical Research Dyspnoea Council Scale ≥2; or ≥2 exacerbations during the past 12 months. Main outcome measures Health-related quality of life (HRQoL) assessed by the physical component summary (PCS) and mental component summary (MCS) scores of the Short Form 36-Item Health Survey, Version 2. Data were collected at baseline and at 12 month follow-up and analysed according to the intention-to-treat principle with complete cases, n=574 (258 interventions; 316 controls) and imputed data, n=1225 (578 interventions, 647 controls) using multilevel modelling. Results In the intention-to-treat analysis (n=1225), the raw mean difference in PCS from baseline to 12 month follow-up was −2.6 (SD 12.4) in the telehealthcare group and −2.8 (SD 11.9) in the usual practice group. The raw mean difference in MCS scores in the same period was −4.7 (SD 16.5) and −5.3 (SD 15.5) for telehealthcare and usual practice, respectively. The adjusted mean difference in PCS and MCS between groups at 12 months was 0.1 (95% CI −1.4 to 1.7) and 0.4 (95% CI −1.7 to 2.4), respectively. Conclusions The overall sample and all subgroups demonstrated no statistically significant differences in HRQoL between telehealthcare and usual practice. Trial registration number NCT01984840; Results. PMID:28490555

Multiple-modality exercise and mind-motor training to improve mobility in older adults: A randomized controlled trial.

PubMed

Boa Sorte Silva, Narlon C; Gill, Dawn P; Gregory, Michael A; Bocti, John; Petrella, Robert J

2018-03-01

To investigate the effects of multiple-modality exercise with or without additional mind-motor training on mobility outcomes in older adults with subjective cognitive complaints. This was a 24-week randomized controlled trial with a 28-week no-contact follow-up. Community-dwelling older adults underwent a thrice -weekly, Multiple-Modality exercise and Mind-Motor (M4) training or Multiple-Modality (M2) exercise with an active control intervention (balance, range of motion and breathing exercises). Study outcomes included differences between groups at 24weeks and after the no-contact follow-up (i.e., 52weeks) in usual and dual-task (DT, i.e., serial sevens [S7] and phonemic verbal fluency [VF] tasks) gait velocity, step length and cycle time variability, as well as DT cognitive accuracy. 127 participants (mean age 67.5 [7.3] years, 71% women) were randomized to either M2 (n=64) or M4 (n=63) groups. Participants were assessed at baseline, intervention endpoint (24weeks), and study endpoint (52weeks). At 24weeks, the M2 group demonstrated greater improvements in usual gait velocity, usual step length, and DT gait velocity (VF) compared to the M4 group, and no between- or within-group changes in DT accuracy were observed. At 52weeks, the M2 group retained the gains in gait velocity and step length, whereas the M4 group demonstrated trends for improvement (p=0.052) in DT cognitive accuracy (VF). Our results suggest that additional mind-motor training was not effective to improve mobility outcomes. In fact, participants in the active control group experienced greater benefits as a result of the intervention. Copyright © 2017 Elsevier Inc. All rights reserved.

An Approach to Assess Generalizability in Comparative Effectiveness Research: A Case Study of the Whole Systems Demonstrator Cluster Randomized Trial Comparing Telehealth with Usual Care for Patients with Chronic Health Conditions.

PubMed

Steventon, Adam; Grieve, Richard; Bardsley, Martin

2015-11-01

Policy makers require estimates of comparative effectiveness that apply to the population of interest, but there has been little research on quantitative approaches to assess and extend the generalizability of randomized controlled trial (RCT)-based evaluations. We illustrate an approach using observational data. Our example is the Whole Systems Demonstrator (WSD) trial, in which 3230 adults with chronic conditions were assigned to receive telehealth or usual care. First, we used novel placebo tests to assess whether outcomes were similar between the RCT control group and a matched subset of nonparticipants who received usual care. We matched on 65 baseline variables obtained from the electronic medical record. Second, we conducted sensitivity analysis to consider whether the estimates of treatment effectiveness were robust to alternative assumptions about whether "usual care" is defined by the RCT control group or nonparticipants. Thus, we provided alternative estimates of comparative effectiveness by contrasting the outcomes of the RCT telehealth group and matched nonparticipants. For some endpoints, such as the number of outpatient attendances, the placebo tests passed, and the effectiveness estimates were robust to the choice of comparison group. However, for other endpoints, such as emergency admissions, the placebo tests failed and the estimates of treatment effect differed markedly according to whether telehealth patients were compared with RCT controls or matched nonparticipants. The proposed placebo tests indicate those cases when estimates from RCTs do not generalize to routine clinical practice and motivate complementary estimates of comparative effectiveness that use observational data. Future RCTs are recommended to incorporate these placebo tests and the accompanying sensitivity analyses to enhance their relevance to policy making. © The Author(s) 2015.

Peer mentoring and financial incentives to improve glucose control in African American veterans: a randomized trial.

PubMed

Long, Judith A; Jahnle, Erica C; Richardson, Diane M; Loewenstein, George; Volpp, Kevin G

2012-03-20

Compared with white persons, African Americans have a greater incidence of diabetes, decreased control, and higher rates of microvascular complications. A peer mentorship model could be a scalable approach to improving control in this population and reducing disparities in diabetic outcomes. To determine whether peer mentors or financial incentives are superior to usual care in helping African American veterans decrease their hemoglobin A(1c) (HbA(1c)) levels. A 6-month randomized, controlled trial. (ClinicalTrials.gov registration number: NCT01125956) Philadelphia Veterans Affairs Medical Center. African American veterans aged 50 to 70 years with persistently poor diabetes control. 118 patients were randomly assigned to 1 of 3 groups: usual care, a peer mentoring group, and a financial incentives group. Usual care patients were notified of their starting HbA(1c) level and recommended goals for HbA(1c). Those in the peer mentoring group were assigned a mentor who formerly had poor glycemic control but now had good control (HbA(1c) level ≤7.5%). The mentor was asked to talk with the patient at least once per week. Peer mentors were matched by race, sex, and age. Patients in the financial incentive group could earn $100 by decreasing their HbA(1c) level by 1% and $200 by decreasing it by 2% or to an HbA(1c) level of 6.5%. Change in HbA(1c) level at 6 months. Mentors and mentees talked the most in the first month (mean calls, 4; range, 0 to 30), but calls decreased to a mean of 2 calls (range, 0 to 10) by the sixth month. Levels of HbA(1c) decreased from 9.9% to 9.8% in the control group, from 9.8% to 8.7% in the peer mentor group, and from 9.5% to 9.1% in the financial incentive group. Mean change in HbA(1c) level from baseline to 6 months relative to control was -1.07% (95% CI, -1.84% to -0.31%) in the peer mentor group and -0.45% (CI, -1.23% to 0.32%) in the financial incentive group. The study included only veterans and lasted only 6 months. Peer mentorship improved glucose control in a cohort of African American veterans with diabetes. National Institute on Aging Roybal Center.

Prevention and treatment of hand oedema after stroke.

PubMed

Kuppens, Stefanie P M; Pijlman, Hanneke C P; Hitters, Minou W M G C; van Heugten, Caroline M

2014-01-01

As there is no evidence for a specific treatment for post-stroke-induced hand oedema, rehabilitation centre Blixembosch formalized a best practice protocol. We investigated whether the Blixembosch hand oedema protocol is usable in daily practice and leads to lower incidence (prevention) and shorter duration (treatment) compared with care as usual. In a non-randomised comparative trial, we investigated 206 post-stroke patients admitted to two Dutch rehabilitation centres. Hand volumes were measured at least bi-weekly using a volumeter. Treatment was started according the protocol (Blixembosch) or following care as usual (Leijpark). Usability was assessed with a survey among professionals. In the Blixembosch group, 16% developed oedema after admission, compared with 21% in the control group (p = 0.019). Average duration of oedema (both developed before and after admission) was 6.5 weeks in the Blixembosch group compared with 3.1 weeks in the control group (p = 0.000). Professionals were positive about the protocol. The study showed that the protocol is usable in daily practice and has a small beneficial effect on hand oedema incidence rates compared with care as usual. The negative effect on duration of hand oedema could also be caused by the difference in prognosis between the two groups.

Intensive client-centred occupational therapy in the home improves older adults' occupational performance. Results from a Danish randomized controlled trial.

PubMed

Nielsen, Tove Lise; Andersen, Niels Trolle; Petersen, Kirsten Schultz; Polatajko, Helene; Nielsen, Claus Vinther

2018-01-12

There is growing interest in enabling older adults' occupational performance. We tested whether 11 weeks of intensive client-centred occupational therapy (ICC-OT) was superior to usual practice in improving the occupational performance of home-dwelling older adults. An assessor-masked randomized controlled trial among adults 60 + with chronic health issues, who received or applied for homecare services. Recruitment took place September 2012 to April 2014. All participants received practical and personal assistance and meal delivery as needed. In addition, they were randomized to receive either a maximum 22 sessions of occupation-based ICC-OT (N = 59) or to receive usual practice with a maximum three sessions of occupational therapy (N = 60). The primary outcome was self-rated occupational performance assessed with the Canadian Occupational Performance Measure (COPM). No important adverse events occurred. ICC-OT was accepted by 46 participants (88%), usual practice by 60 (100%). After 3 months, the ICC-OT-group had improved 1.86 points on COPM performance; the Usual-Practice group had improved 0.61 points. The between-group difference was statistically significant (95% confidence interval 0.50 to 2.02), t-test: p = 0.001. ICC-OT improved older adults' occupational performance more effectively than usual practice. This result may benefit older adults and support programmatic changes.

The Effectiveness of Web-Based Asthma Self-Management System, My Asthma Portal (MAP): A Pilot Randomized Controlled Trial

PubMed Central

Ernst, Pierre; Bartlett, Susan J; Valois, Marie-France; Zaihra, Tasneem; Paré, Guy; Grad, Roland; Eilayyan, Owis; Perreault, Robert; Tamblyn, Robyn

2016-01-01

Background Whether Web-based technologies can improve disease self-management is uncertain. My Asthma Portal (MAP) is a Web-based self-management support system that couples evidence-based behavioral change components (self-monitoring of symptoms, physical activity, and medication adherence) with real-time monitoring, feedback, and support from a nurse case manager. Objective The aim of this study was to compare the impact of access to a Web-based asthma self-management patient portal linked to a case-management system (MAP) over 6 months compared with usual care on asthma control and quality of life. Methods A multicenter, parallel, 2-arm, pilot, randomized controlled trial was conducted with 100 adults with confirmed diagnosis of asthma from 2 specialty clinics. Asthma control was measured using an algorithm based on overuse of fast-acting bronchodilators and emergency department visits, and asthma-related quality of life was assessed using the Mini-Asthma Quality of Life Questionnaire (MAQLQ). Secondary mediating outcomes included asthma symptoms, depressive symptoms, self-efficacy, and beliefs about medication. Process evaluations were also included. Results A total of 49 individuals were randomized to MAP and 51 to usual care. Compared with usual care, participants in the intervention group reported significantly higher asthma quality of life (mean change 0.61, 95% CI 0.03 to 1.19), and the change in asthma quality of life for the intervention group between baseline and 3 months (mean change 0.66, 95% CI 0.35 to 0.98) was not seen in the control group. No significant differences in asthma quality of life were found between the intervention and control groups at 6 (mean change 0.46, 95% CI –0.12 to 1.05) and 9 months (mean change 0.39, 95% CI –0.2 to 0.98). For poor control status, there was no significant effect of group, time, or group by time. For all self-reported measures, the intervention group had a significantly higher proportion of individuals, demonstrating a minimal clinically meaningful improvement compared with the usual care group. Conclusions This study supported the use of MAP to enhance asthma quality of life but not asthma control as measured by an administrative database. Implementation of MAP beyond 6 months with tailored protocols for monitoring symptoms and health behaviors as individuals’ knowledge and self-management skills improve may result in long-term gains in asthma control. ClinicalTrial International Standard Randomized Controlled Trial Number (ISRCTN): 34326236; http://www.isrctn.com/ISRCTN34326236 (Archived by Webcite at http://www.webcitation.org/6mGxoI1R7). PMID:27908846

A multicenter, randomized, controlled trial of osteopathic manipulative treatment on preterms.

PubMed

Cerritelli, Francesco; Pizzolorusso, Gianfranco; Renzetti, Cinzia; Cozzolino, Vincenzo; D'Orazio, Marianna; Lupacchini, Mariacristina; Marinelli, Benedetta; Accorsi, Alessandro; Lucci, Chiara; Lancellotti, Jenny; Ballabio, Silvia; Castelli, Carola; Molteni, Daniela; Besana, Roberto; Tubaldi, Lucia; Perri, Francesco Paolo; Fusilli, Paola; D'Incecco, Carmine; Barlafante, Gina

2015-01-01

Despite some preliminary evidence, it is still largely unknown whether osteopathic manipulative treatment improves preterm clinical outcomes. The present multi-center randomized single blind parallel group clinical trial enrolled newborns who met the criteria for gestational age between 29 and 37 weeks, without any congenital complication from 3 different public neonatal intensive care units. Preterm infants were randomly assigned to usual prenatal care (control group) or osteopathic manipulative treatment (study group). The primary outcome was the mean difference in length of hospital stay between groups. A total of 695 newborns were randomly assigned to either the study group (n= 352) or the control group (n=343). A statistical significant difference was observed between the two groups for the primary outcome (13.8 and 17.5 days for the study and control group respectively, p<0.001, effect size: 0.31). Multivariate analysis showed a reduction of the length of stay of 3.9 days (95% CI -5.5 to -2.3, p<0.001). Furthermore, there were significant reductions with treatment as compared to usual care in cost (difference between study and control group: 1,586.01€; 95% CI 1,087.18 to 6,277.28; p<0.001) but not in daily weight gain. There were no complications associated to the intervention. Osteopathic treatment reduced significantly the number of days of hospitalization and is cost-effective on a large cohort of preterm infants.

The efficacy of interactive, motion capture-based rehabilitation on functional outcomes in an inpatient stroke population: a randomized controlled trial

PubMed Central

Cannell, John; Jovic, Emelyn; Rathjen, Amy; Lane, Kylie; Tyson, Anna M; Callisaya, Michele L; Smith, Stuart T; Ahuja, Kiran DK; Bird, Marie-Louise

2017-01-01

Objective: To compare the efficacy of novel interactive, motion capture-rehabilitation software to usual care stroke rehabilitation on physical function. Design: Randomized controlled clinical trial. Setting: Two subacute hospital rehabilitation units in Australia. Participants: In all, 73 people less than six months after stroke with reduced mobility and clinician determined capacity to improve. Interventions: Both groups received functional retraining and individualized programs for up to an hour, on weekdays for 8–40 sessions (dose matched). For the intervention group, this individualized program used motivating virtual reality rehabilitation and novel gesture controlled interactive motion capture software. For usual care, the individualized program was delivered in a group class on one unit and by rehabilitation assistant 1:1 on the other. Main measures: Primary outcome was standing balance (functional reach). Secondary outcomes were lateral reach, step test, sitting balance, arm function, and walking. Results: Participants (mean 22 days post-stroke) attended mean 14 sessions. Both groups improved (mean (95% confidence interval)) on primary outcome functional reach (usual care 3.3 (0.6 to 5.9), intervention 4.1 (−3.0 to 5.0) cm) with no difference between groups (P = 0.69) on this or any secondary measures. No differences between the rehabilitation units were seen except in lateral reach (less affected side) (P = 0.04). No adverse events were recorded during therapy. Conclusion: Interactive, motion capture rehabilitation for inpatients post stroke produced functional improvements that were similar to those achieved by usual care stroke rehabilitation, safely delivered by either a physical therapist or a rehabilitation assistant. PMID:28719977

Classroom based cognitive behavioural therapy in reducing symptoms of depression in high risk adolescents: pragmatic cluster randomised controlled trial

PubMed Central

Sayal, Kapil; Phillips, Rhiannon; Taylor, John A; Spears, Melissa; Anderson, Rob; Araya, Ricardo; Lewis, Glyn; Millings, Abigail; Montgomery, Alan A

2012-01-01

Objective To compare the effectiveness of classroom based cognitive behavioural therapy with attention control and usual school provision for adolescents at high risk of depression. Design Three arm parallel cluster randomised controlled trial. Setting Eight UK secondary schools. Participants Adolescents (n=5030) aged 12-16 years in school year groups 8-11. Year groups were randomly assigned on a 1:1:1 ratio to cognitive behavioural therapy, attention control, or usual school provision. Allocation was balanced by school, year, number of students and classes, frequency of lessons, and timetabling. Participants were not blinded to treatment allocation. Interventions Cognitive behavioural therapy, attention control, and usual school provision provided in classes to all eligible participants. Main outcome measures Outcomes were collected by self completed questionnaire administered by researchers. The primary outcome was symptoms of depression assessed at 12 months by the short mood and feelings questionnaire among those identified at baseline as being at high risk of depression. Secondary outcomes included negative thinking, self worth, and anxiety. Analyses were undertaken on an intention to treat basis and accounted for the clustered nature of the design. Results 1064 (21.2%) adolescents were identified at high risk of depression: 392 in the classroom based cognitive behavioural therapy arm, 374 in the attention control arm, and 298 in the usual school provision arm. At 12 months adjusted mean scores on the short mood and feelings questionnaire did not differ for cognitive behavioural therapy versus attention control (−0.63, 95% confidence interval −1.85 to 0.58, P=0.41) or for cognitive behavioural therapy versus usual school provision (0.97, −0.20 to 2.15, P=0.12). Conclusion In adolescents with depressive symptoms, outcomes were similar for attention control, usual school provision, and cognitive behavioural therapy. Classroom based cognitive behavioural therapy programmes may result in increased self awareness and reporting of depressive symptoms but should not be undertaken without further evaluation and research. Trial registration Current Controlled Trials ISRCTN19083628. PMID:23043090

Evaluation of the effect of motivational interviewing counselling on hypertension care.

PubMed

Ma, Chunhua; Zhou, Ying; Zhou, Wei; Huang, Chunfeng

2014-05-01

This study tests the effectiveness of motivational interviewing compared with the usual care for Chinese hypertensive patients. A randomised controlled trial was used. One hundred and twenty eligible participants were randomly assigned to either the control group (usual care group) or the intervention group (motivational interviewing group). The results of this study demonstrated that the total scores and the mean scores for each dimension of the adherence questionnaire were increased in the intervention group (P<0.05), and the systolic blood pressure and diastolic blood pressure of the hypertensive patients greatly decreased in the intervention group during the six months of the motivational interviewing counselling (P<0.05). The application of motivational interviewing for hypertensive patients is a promising approach for sustaining the clinical benefits of adherence behaviour. Motivational interviewing should be provided to hypertensive patients at hospitals and community health centres to assist patients in controlling their BP and to enhance treatment adherence. A series of training courses on the motivational interviewing technique should be provided to nurses. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

A 60-Week Prospective RCT of a Self-Management Intervention for Individuals With Serious Mental Illness and Diabetes Mellitus.

PubMed

Sajatovic, Martha; Gunzler, Douglas D; Kanuch, Stephanie W; Cassidy, Kristin A; Tatsuoka, Curtis; McCormick, Richard; Blixen, Carol E; Perzynski, Adam T; Einstadter, Douglas; Thomas, Charles L; Lawless, Mary E; Martin, Siobhan; Falck-Ytter, Corinna; Seeholzer, Eileen L; McKibben, Christine L; Bauer, Mark S; Dawson, Neal V

2017-09-01

A 60-week randomized controlled trial assessed the effects of targeted training in illness management (TTIM) versus treatment as usual among 200 individuals with serious mental illness and diabetes mellitus. The study used the Clinical Global Impression (CGI), the Montgomery-Asberg Depression Rating Scale (MADRS), and the Brief Psychiatric Rating Scale (BPRS) to assess psychiatric symptoms; the Global Assessment of Functioning (GAF) and the Sheehan Disability Scale (SDS) to assess functioning; the 36-Item Short-Form Health Survey (SF-36) to assess general health, and serum glycosylated hemoglobin (HbA1c) to assess diabetes control. Participants' mean±SD age was 52.7±9.5 years, and 54% were African American. They were diagnosed as having depression (48%), schizophrenia (25%), and bipolar disorder (28%). At baseline, depression severity was substantial but psychosis severity was modest. At 60 weeks, there was greater improvement among TTIM participants versus treatment-as-usual recipients on the CGI (p<.001), the MADRS (p=.016), and the GAF (p=.003). Diabetes knowledge was significantly improved among TTIM participants but not in the treatment-as-usual group. In post hoc analyses among participants whose HbA1c levels at baseline met recommendations set by the American Diabetes Association for persons with high comorbidity (53%), TTIM participants had minimal change in HbA1c over the 60-week follow-up, whereas HbA1c levels worsened in the treatment-as-usual group. TTIM was associated with improved psychiatric symptoms, functioning, and diabetes knowledge compared with treatment as usual. Among participants with better diabetes control at baseline, TTIM participants had better diabetes control at 60 weeks compared with recipients of treatment as usual.

Effect of individualized goal-setting on college biology students' locus of control

NASA Astrophysics Data System (ADS)

Schafer, John E.

This study investigated the effect of Individualized Goal-Setting A-T, relative to Classic A-T, on a student's locus of control (generalized and academic). This study also examined the effect of pretesting, relative to no pretesting, on a student's locus of control. Sixty students in an introductory, Audio-Tutorial, college zoology course were randomly assigned to treatment and control groups. Control groups (Classic A-T) completed the course in the usual manner. Treatment groups (IGS A-T) completed the course in the usual manner with one exception. That is, they used a different format for Optional Minicourse mastery. This new format released greater control to students over means as well as ends of minicourse mastery. Data were collected through use of the Solomon Four-Group design, with two levels of treatment (Classic A-T, IGS A-T) and two levels of pretesting (pretest, no pretest). Instruments included the Rotter I-E and Schafer Academic I-E Locus of Control Scales. Posttest scores were analyzed by a 2 × 2 multivariate analysis of variance (MANOVA).The following conclusions were made (p < 0.10).1IGS A-T, relative to Classic A-T, has no significant effect on a student's locus of control.2Pretesting, relative to no pretesting, has no significant effect on posttest locus of control.

Very high volume hemofiltration with the Cascade system in septic shock patients.

PubMed

Quenot, Jean-Pierre; Binquet, Christine; Vinsonneau, Christophe; Barbar, Saber-David; Vinault, Sandrine; Deckert, Valerie; Lemaire, Stéphanie; Hassain, Ali Ait; Bruyère, Rémi; Souweine, Bertrand; Lagrost, Laurent; Adrie, Christophe

2015-12-01

We compared hemodynamic and biological effects of the Cascade system, which uses very high volume hemofiltration (HVHF) (120 mL kg(-1) h(-1)), with those of usual care in patients with septic shock. Multicenter, prospective, randomized, open-label trial in three intensive care units (ICU). Adults with septic shock with administration of epinephrine/norepinephrine were eligible. Patients were randomized to usual care plus HVHF (Cascade group), or usual care alone (control group). Primary end point was the number of catecholamine-free days up to 28 days after randomization. Secondary end points were number of days free of mechanical ventilation, renal replacement therapy (RRT) or ICU up to 90 days, and 7-, 28-, and 90-day mortality. We included 60 patients (29 Cascade, 31 usual care). Baseline characteristics were comparable. Median number of catecholamine-free days was 22 [IQR 11-23] vs 20 [0-25] for Cascade vs control; there was no significant difference even after adjustment. There was no significant difference in number of mechanical ventilation-free days or ICU requirement. Median number of RRT-free days was 85 [46-90] vs 74 [0-90] for Cascade vs control groups, p = 0.42. By multivariate analysis, the number of RRT-free days was significantly higher in the Cascade group (up to 25 days higher after adjustment). There was no difference in mortality at 7, 28, or 90 days. Very HVHF using the Cascade system can safely be used in patients presenting with septic shock, but it was not associated with a reduction in the need for catecholamines during the first 28 days.

The Cost-Effectiveness of Using PARO, a Therapeutic Robotic Seal, to Reduce Agitation and Medication Use in Dementia: Findings from a Cluster-Randomized Controlled Trial.

PubMed

Mervin, Merehau C; Moyle, Wendy; Jones, Cindy; Murfield, Jenny; Draper, Brian; Beattie, Elizabeth; Shum, David H K; O'Dwyer, Siobhan; Thalib, Lukman

2018-01-09

To examine the within-trial costs and cost-effectiveness of using PARO, compared with a plush toy and usual care, for reducing agitation and medication use in people with dementia in long-term care. An economic evaluation, nested within a cluster-randomized controlled trial. Twenty-eight facilities in South-East Queensland, Australia. A total of 415 residents, all aged 60 years or older, with documented diagnoses of dementia. Facilities were randomized to 1 of 3 groups: PARO (individual, nonfacilitated 15-minute sessions, 3 afternoons per week for 10 weeks); plush toy (as per PARO but with artificial intelligence disabled); and usual care. The incremental cost per Cohen-Mansfield Agitation Inventory-Short Form (CMAI-SF) point averted from a provider's perspective. Australian New Zealand Clinical Trials Registry (BLINDED FOR REVIEW). For the within-trial costs, the PARO group was $50.47 more expensive per resident compared with usual care, whereas the plush toy group was $37.26 more expensive than usual care. There were no statistically significant between-group differences in agitation levels after the 10-week intervention. The point estimates of the incremental cost-effectiveness ratios were $13.01 for PARO and $12.85 for plush toy per CMAI-SF point averted relative to usual care. The plush toy used in this study offered marginally greater value for money than PARO in improving agitation. However, these costs are much lower than values estimated for psychosocial group activities and sensory interventions, suggesting that both a plush toy and the PARO are cost-effective psychosocial treatment options for agitation. Copyright © 2017 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

A randomized controlled trial of a nursing psychotherapeutic intervention for anxiety in adult psychiatric outpatients.

PubMed

Sampaio, Francisco Miguel Correia; Araújo, Odete; Sequeira, Carlos; Lluch Canut, María Teresa; Martins, Teresa

2018-05-01

To evaluate the short-term efficacy of a psychotherapeutic intervention in nursing on Portuguese adult psychiatric outpatients with the nursing diagnosis "anxiety." Several efficacious forms of treatment for anxiety are available, including different forms of psychotherapy and pharmacotherapy. However, literature tends to favour findings from studies on the efficacy of psychotherapies and therapies provided by nurses to the detriment of those arising from studies on the efficacy of nursing psychotherapeutic interventions (interventions which are classified, for instance, on Nursing Interventions Classification). Randomized controlled trial. The study was performed, between November 2016 - April 2017, at a psychiatry outpatient ward. Participants were randomly allocated to an intervention group (N = 29) or a treatment-as-usual control group (N = 31). Patients in the intervention group received psychopharmacotherapy with interventions integrated in the Nursing Interventions Classification for the nursing diagnosis "anxiety." A treatment-as-usual control group received only psychopharmacotherapy (if applicable). Anxiety level and anxiety self-control were the primary outcomes. Patients from both groups had reduced anxiety levels, between the pre-test and the posttest assessment; however, according to analysis of means, patients in the intervention group displayed significantly better results than those of the control group. Furthermore, only patients in the intervention group presented significant improvements in anxiety self-control. This study demonstrated the short-term efficacy of this psychotherapeutic intervention model in nursing in the decrease of anxiety level and improvement of anxiety self-control in a group of psychiatric outpatients with pathological anxiety. NCT02930473. © 2017 John Wiley & Sons Ltd.

Pharmacist Intervention for Blood Pressure Control in Patients with Diabetes and/or Chronic Kidney Disease.

PubMed

Anderegg, Maxwell D; Gums, Tyler H; Uribe, Liz; MacLaughlin, Eric J; Hoehns, James; Bazaldua, Oralia V; Ives, Timothy J; Hahn, David L; Coffey, Christopher S; Carter, Barry L

2018-03-01

The objectives of this study were to determine if hypertensive patients with comorbid diabetes mellitus (DM) and/or chronic kidney disease (CKD) receiving a pharmacist intervention had a greater reduction in mean blood pressure (BP) and improved BP control at 9 months compared with those receiving usual care; and compare Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) guideline and 2014 guideline (JNC 8) BP control rates in patients with DM and/or CKD. This cluster randomized trial included 32 medical offices in 15 states. Clinical pharmacists made treatment recommendations to physicians at intervention sites. This post hoc analysis evaluated mean BP and BP control rates in the intervention and control groups. The study included 335 patients (227 intervention, 108 control) when mean BP and control rates were evaluated by JNC 7 inclusion and control criteria. When JNC 8 inclusion and control criteria were applied, 241 patients (165 intervention, 76 control) remained and were included in the analysis. The pharmacist-intervention group had significantly greater mean systolic blood pressure reduction compared with usual care at 9 months (8.64 mm Hg; 95% confidence interval [CI] -12.8 to -4.49, p<0.001). The pharmacist-intervention group had significantly higher BP control at 9 months than usual care by either the JNC 7 or JNC 8 inclusion and control groups (adjusted odds ratio [OR] 1.97, 95% CI 1.01-3.86, p=0.0470 and OR 2.16, 95% CI 1.21-3.85, p=0.0102, respectively). This study demonstrated that a physician-pharmacist collaborative intervention was effective in reducing mean systolic BP and improving BP control in patients with uncontrolled hypertension with DM and/or CKD, regardless of which BP guidelines were used. © 2018 Pharmacotherapy Publications, Inc.

Efficacy of self-monitored blood pressure, with or without telemonitoring, for titration of antihypertensive medication (TASMINH4): an unmasked randomised controlled trial.

PubMed

McManus, Richard J; Mant, Jonathan; Franssen, Marloes; Nickless, Alecia; Schwartz, Claire; Hodgkinson, James; Bradburn, Peter; Farmer, Andrew; Grant, Sabrina; Greenfield, Sheila M; Heneghan, Carl; Jowett, Susan; Martin, Una; Milner, Siobhan; Monahan, Mark; Mort, Sam; Ogburn, Emma; Perera-Salazar, Rafael; Shah, Syed Ahmar; Yu, Ly-Mee; Tarassenko, Lionel; Hobbs, F D Richard

2018-03-10

Studies evaluating titration of antihypertensive medication using self-monitoring give contradictory findings and the precise place of telemonitoring over self-monitoring alone is unclear. The TASMINH4 trial aimed to assess the efficacy of self-monitored blood pressure, with or without telemonitoring, for antihypertensive titration in primary care, compared with usual care. This study was a parallel randomised controlled trial done in 142 general practices in the UK, and included hypertensive patients older than 35 years, with blood pressure higher than 140/90 mm Hg, who were willing to self-monitor their blood pressure. Patients were randomly assigned (1:1:1) to self-monitoring blood pressure (self-montoring group), to self-monitoring blood pressure with telemonitoring (telemonitoring group), or to usual care (clinic blood pressure; usual care group). Randomisation was by a secure web-based system. Neither participants nor investigators were masked to group assignment. The primary outcome was clinic measured systolic blood pressure at 12 months from randomisation. Primary analysis was of available cases. The trial is registered with ISRCTN, number ISRCTN 83571366. 1182 participants were randomly assigned to the self-monitoring group (n=395), the telemonitoring group (n=393), or the usual care group (n=394), of whom 1003 (85%) were included in the primary analysis. After 12 months, systolic blood pressure was lower in both intervention groups compared with usual care (self-monitoring, 137·0 [SD 16·7] mm Hg and telemonitoring, 136·0 [16·1] mm Hg vs usual care, 140·4 [16·5]; adjusted mean differences vs usual care: self-monitoring alone, -3·5 mm Hg [95% CI -5·8 to -1·2]; telemonitoring, -4·7 mm Hg [-7·0 to -2·4]). No difference between the self-monitoring and telemonitoring groups was recorded (adjusted mean difference -1·2 mm Hg [95% CI -3·5 to 1·2]). Results were similar in sensitivity analyses including multiple imputation. Adverse events were similar between all three groups. Self-monitoring, with or without telemonitoring, when used by general practitioners to titrate antihypertensive medication in individuals with poorly controlled blood pressure, leads to significantly lower blood pressure than titration guided by clinic readings. With most general practitioners and many patients using self-monitoring, it could become the cornerstone of hypertension management in primary care. National Institute for Health Research via Programme Grant for Applied Health Research (RP-PG-1209-10051), Professorship to RJM (NIHR-RP-R2-12-015), Oxford Collaboration for Leadership in Applied Health Research and Care, and Omron Healthcare UK. Copyright © 2018 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.

Mud-Bath Therapy in Addition to Usual Care in Bilateral Knee Osteoarthritis: An Economic Evaluation Alongside a Randomized Controlled Trial.

PubMed

Ciani, Oriana; Pascarelli, Nicola Antonio; Giannitti, Chiara; Galeazzi, Mauro; Meregaglia, Michela; Fattore, Giovanni; Fioravanti, Antonella

2017-07-01

To perform a cost-effectiveness analysis of mud-bath therapy (MBT) in addition to usual treatment compared to usual treatment alone in patients with bilateral knee osteoarthritis (OA). An economic evaluation alongside a randomized controlled trial was conducted. Patients were randomly assigned to receive either a 2-week cycle of MBT in addition to their usual treatment or to continue routine care alone. The EuroQol 5-domain questionnaire was administered at baseline, 2 weeks, and at 3, 6, 9, and 12 months. Direct health care resource consumption data up until 12 months were derived from a daily diary given to patients and returned at prescheduled followup visits. A total of 103 patients were included (n = 53 for MBT patients; n = 50 for controls). Overall, patients in the MBT group accrued mean ± SD 0.835 ± 0.10 quality-adjusted life years (QALYs) compared to 0.753 ± 0.11 in the control group (P < 0.001). Average direct costs per patient (€303 versus €975; P < 0.001) were higher in the control group, primarily because of hospitalization for total knee replacement and use of intraarticular hyaluronic acid. Bootstrapping replications of costs and QALY sample distributions consistently indicated that the MBT therapy combined with standard therapy represents a dominant strategy as compared with standard therapy alone. The probability of MBT being cost-effective at standard cost-effectiveness thresholds (e.g., €20,000/QALY) is 100%. The results of this cost-effectiveness analysis support the use of MBT as midterm complementary therapy in the management of knee OA. © 2016, American College of Rheumatology.

A cluster randomised controlled trial of a brief couple-focused psychoeducational intervention to prevent common postnatal mental disorders among women: study protocol.

PubMed

Rowe, Heather; Wynter, Karen; Lorgelly, Paula; Amir, Lisa H; Ranasinha, Sanjeeva; Proimos, Jenny; Cann, Warren; Hiscock, Harriet; Bayer, Jordana; Burns, Joanna; Ride, Jemimah; Bobevski, Irene; Fisher, Jane

2014-09-23

Postnatal common mental disorders among women are an important public health problem internationally. Interventions to prevent postnatal depression have had limited success. What Were We Thinking (WWWT) is a structured, gender-informed, psychoeducational group programme for parents and their first infant that addresses two modifiable risks to postnatal mental health. This paper describes the protocol for a cluster randomised controlled trial to test the clinical effectiveness and cost-effectiveness of WWWT when implemented in usual primary care. 48 maternal and child health (MCH) centres from six diverse Local Government Areas, in Victoria, Australia are randomly allocated to the intervention group (usual care plus WWWT) or the control group (usual care). The required sample size is 184 women in each group. English-speaking primiparous women receiving postpartum healthcare in participating MCH centres complete two computer-assisted telephone interviews: baseline at 4 weeks and outcome at 6 months postpartum. Women attending intervention MCH centres are invited to attend WWWT in addition to usual care. The primary outcome is meeting Diagnostic and Statistical Manual-IV (DSM-IV) diagnostic criteria for major depressive episode; generalised anxiety disorder; panic disorder with or without agoraphobia, agoraphobia with or without panic, social phobia, adult separation anxiety or adjustment disorder with depressed mood, anxiety or mixed depressed mood and anxiety within the past 30 days at 6 months postpartum. Secondary outcomes are self-rated general and emotional health, infant sleep problems, method of infant feeding, quality of mother-infant relationship and intimate partner relationship, and healthcare costs and outcomes. Approval to conduct the study has been granted. A comprehensive dissemination plan has been devised. Australian New Zealand Clinical Trials Registry ACTRN12613000506796. UTN: U1111-1125-8208. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Community-based peer support significantly improves metabolic control in people with Type 2 diabetes in Yaoundé, Cameroon.

PubMed

Assah, F K; Atanga, E N; Enoru, S; Sobngwi, E; Mbanya, J C

2015-07-01

To examine the effectiveness of a community-based multilevel peer support intervention in addition to usual diabetes care on improving glycaemic levels, blood pressure and lipids in patients with Type 2 diabetes in Yaoundé, Cameroon. A total of 96 subjects with poorly controlled Type 2 diabetes (intervention group) and 96 age- and sex-matched controls were recruited and followed up over 6 months. The intervention subjects underwent a peer support intervention through peer-led group meetings, personal encounters and telephone calls. Both intervention subjects and controls continued their usual clinical care. HbA1c , blood pressure, blood lipids and self-care behaviours were measured at 0 and 6 months. There was significant reduction in HbA1c in the intervention group [-33 mmol/mol (-3.0%)] compared with controls [-14 mmol/mol (-1.3%)]; P < 0.001. Peer support also led to significant reductions in fasting blood sugar (-0.83 g/l P < 0.001), cholesterol (-0.54 g/l P < 0.001), HDL (-0.09 g/l, P < 0.001), BMI (-2.71 kg/m² P < 0.001) and diastolic pressure (-6.77 mmHg, P < 0.001) over the 6-month period. Also, diabetes self-care behaviours in the intervention group improved significantly over the 6 months of peer support. Community-based peer support, in addition to usual care, significantly improved metabolic control in patients with uncontrolled Type 2 diabetes in Yaoundé, Cameroon. This could provide a model for optimizing diabetes care and control in other settings with limited healthcare and financial resources. © 2015 The Authors. Diabetic Medicine © 2015 Diabetes UK.

MEDication reminder APPs to improve medication adherence in Coronary Heart Disease (MedApp-CHD) Study: a randomised controlled trial protocol

PubMed Central

Chow, Clara K; Thiagalingam, Aravinda; Rogers, Kris; Chalmers, John; Redfern, Julie

2017-01-01

Introduction The growing number of smartphone health applications available in the app stores makes these apps a promising tool to help reduce the global problem of non-adherence to long-term medications. However, to date, there is limited evidence that available medication reminder apps are effective. This study aims to determine the impact of medication reminder apps on adherence to cardiovascular medication when compared with usual care for people with coronary heart disease (CHD) and to determine whether an advanced app compared with a basic app is associated with higher adherence. Methods and analysis Randomised controlled trial with follow-up at 3 months to evaluate the feasibility and effectiveness of medication reminder apps on medication adherence compared with usual care. An estimated sample size of 156 patients with CHD will be randomised to one of three groups (usual care group, basic medication reminder app group and advanced medication reminder app group). The usual care group will receive standard care for CHD with no access to a medication reminder app. The basic medication reminder app group will have access to a medication reminder app with a basic feature of providing simple daily reminders with no interactivity. The advanced medication reminder app group will have access to a medication reminder app with additional interactive and customisable features. The primary outcome is medication adherence measured by the eight-item Morisky Medication Adherence Scale at 3 months. Secondary outcomes include clinical measurements of blood pressure and cholesterol levels, and medication knowledge. A process evaluation will also be performed to assess the feasibility of the intervention by evaluating the acceptability, utility and engagement with the apps. Ethics and dissemination Ethical approval has been obtained from the Western Sydney Local Health Network Human Research Ethics Committee (AU/RED/HREC/1/WMEAD/3). Study findings will be disseminated via usual scientific forums. Trial registration number ACTRN12616000661471; Pre-results PMID:28993388

Effectiveness of systemic family therapy versus treatment as usual for young people after self-harm: a pragmatic, phase 3, multicentre, randomised controlled trial.

PubMed

Cottrell, David J; Wright-Hughes, Alexandra; Collinson, Michelle; Boston, Paula; Eisler, Ivan; Fortune, Sarah; Graham, Elizabeth H; Green, Jonathon; House, Allan O; Kerfoot, Michael; Owens, David W; Saloniki, Eirini-Christina; Simic, Mima; Lambert, Fiona; Rothwell, Justine; Tubeuf, Sandy; Farrin, Amanda J

2018-03-01

Self-harm in adolescents is common and repetition occurs in a high proportion of these cases. Scarce evidence exists for effectiveness of interventions to reduce self-harm. This pragmatic, multicentre, randomised, controlled trial of family therapy versus treatment as usual was done at 40 UK Child and Adolescent Mental Health Services (CAMHS) centres. We recruited young people aged 11-17 years who had self-harmed at least twice and presented to CAMHS after self-harm. Participants were randomly assigned (1:1) to receive manualised family therapy delivered by trained and supervised family therapists or treatment as usual by local CAMHS. Participants and therapists were aware of treatment allocation; researchers were masked. The primary outcome was hospital attendance for repetition of self-harm in the 18 months after group assignment. Primary and safety analyses were done in the intention-to-treat population. The trial is registered at the ISRCTN registry, number ISRCTN59793150. Between Nov 23, 2009, and Dec 31, 2013, 3554 young people were screened and 832 eligible young people consented to participation and were randomly assigned to receive family therapy (n=415) or treatment as usual (n=417). Primary outcome data were available for 795 (96%) participants. Numbers of hospital attendances for repeat self-harm events were not significantly different between the groups (118 [28%] in the family therapy group vs 103 [25%] in the treatment as usual group; hazard ratio 1·14 [95% CI 0·87-1·49] p=0·33). Similar numbers of adverse events occurred in both groups (787 in the family therapy group vs 847 in the treatment as usual group). For adolescents referred to CAMHS after self-harm, having self-harmed at least once before, our family therapy intervention conferred no benefits over treatment as usual in reducing subsequent hospital attendance for self-harm. Clinicians are therefore still unable to recommend a clear, evidence-based intervention to reduce repeated self-harm in adolescents. National Institute for Health Research Health Technology Assessment programme. Copyright © 2018 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.

Plaque and gingivitis in the elderly: a randomized, single-blind clinical trial on the outcome of intensified mechanical or antibacterial oral hygiene measures.

PubMed

Schiffner, Ulrich; Bahr, Mathias; Effenberger, Susanne

2007-12-01

To study the outcome of intensified mechanical oral hygiene compared with the effect of an adjunctive antibacterial mouth rinse on plaque and gingivitis in elderly people. In a randomized, single-blind, 6-month controlled clinical study, 106 subjects, 55 years or older, were divided into four groups: (I) Participants were instructed on improved mechanical oral hygiene, including interdental hygiene; (II) subjects used an antibacterial mouth rinse containing amine and stannous fluoride in addition to their usual oral hygiene practices; (III) both intensive mechanical and antibacterial measures were combined; and (IV) a control group with no specific regimen. Gingivitis and plaque were examined. After 6 months, both plaque and gingivitis scores were significantly lower than at baseline in all groups. Reductions in gingivitis differed significantly between the control group and all other groups but not between the three intervention groups. Only groups with improved mechanical oral hygiene showed significant improvements in plaque scores compared with control. Intensive mechanical oral hygiene resulted in greater plaque reduction than the combination of an antibacterial rinse and usual oral hygiene procedures. Gingivitis was reduced by both intensive oral hygiene and use of the amine/stannous fluoride rinse. Combining intensive mechanical oral hygiene with the antibacterial rinse did not result in further gingivitis reduction.

Integrated management of type 2 diabetes mellitus and depression treatment to improve medication adherence: a randomized controlled trial.

PubMed

Bogner, Hillary R; Morales, Knashawn H; de Vries, Heather F; Cappola, Anne R

2012-01-01

Depression commonly accompanies diabetes, resulting in reduced adherence to medications and increased risk for morbidity and mortality. The objective of this study was to examine whether a simple, brief integrated approach to depression and type 2 diabetes mellitus (type 2 diabetes) treatment improved adherence to oral hypoglycemic agents and antidepressant medications, glycemic control, and depression among primary care patients. We undertook a randomized controlled trial conducted from April 2010 through April 2011 of 180 patients prescribed pharmacotherapy for type 2 diabetes and depression in primary care. Patients were randomly assigned to an integrated care intervention or usual care. Integrated care managers collaborated with physicians to offer education and guideline-based treatment recommendations and to monitor adherence and clinical status. Adherence was assessed using the Medication Event Monitoring System (MEMS). We used glycated hemoglobin (HbA(1c)) assays to measure glycemic control and the 9-item Patient Health Questionnaire (PHQ-9) to assess depression. Intervention and usual care groups did not differ statistically on baseline measures. Patients who received the intervention were more likely to achieve HbA(1c) levels of less than 7% (intervention 60.9% vs. usual care 35.7%; P < .001) and remission of depression (PHQ-9 score of less than 5: intervention 58.7% vs. usual care 30.7%; P < .001) in comparison with patients in the usual care group at 12 weeks. A randomized controlled trial of a simple, brief intervention integrating treatment of type 2 diabetes and depression was successful in improving outcomes in primary care. An integrated approach to depression and type 2 diabetes treatment may facilitate its deployment in real-world practices with competing demands for limited resources.

A repeated short educational intervention improves asthma control and quality of life.

PubMed

Plaza, Vicente; Peiró, Meritxell; Torrejón, Montserrat; Fletcher, Monica; López-Viña, Antolín; Ignacio, José María; Quintano, José Antonio; Bardagí, Santiago; Gich, Ignasi

2015-11-01

We assessed the effectiveness of an asthma educational programme based on a repeated short intervention (AEP-RSI) to improve asthma control (symptom control and future risk) and quality of life. A total of 230 adults with mild-to-moderate persistent uncontrolled asthma participated in a 1-year cluster randomised controlled multicentre study. The AEP-RSI was given in four face-to-face sessions at 3-month intervals, and included administration of a written personalised action plan and training on inhaler technique. Centres were randomised to the AEP-RSI (intervention) group or usual clinical practice group. Specialised centres using a standard educational programme were the gold standard group. A significant improvement in the Asthma Control Test score was observed in all three groups (p<0.001), but improvements were higher in the intervention and gold standard groups than in the usual clinical practice group (p=0.042), which also showed fewer exacerbations (mean±sd; 1.20±2.02 and 0.56±1.5 versus 2.04±2.72, respectively) and greater increases in the Mini Asthma Quality of Life Questionnaire scores (0.95±1.04 and 0.89±0.84 versus 0.52±0.97, respectively). The AEP-RSI was effective in improving asthma symptom control, future risk and quality of life. Copyright ©ERS 2015.

Alerts in electronic medical records to promote a colorectal cancer screening programme: a cluster randomised controlled trial in primary care.

PubMed

Guiriguet, Carolina; Muñoz-Ortiz, Laura; Burón, Andrea; Rivero, Irene; Grau, Jaume; Vela-Vallespín, Carmen; Vilarrubí, Mercedes; Torres, Miquel; Hernández, Cristina; Méndez-Boo, Leonardo; Toràn, Pere; Caballeria, Llorenç; Macià, Francesc; Castells, Antoni

2016-07-01

Participation rates in colorectal cancer screening are below recommended European targets. To evaluate the effectiveness of an alert in primary care electronic medical records (EMRs) to increase individuals' participation in an organised, population-based colorectal cancer screening programme when compared with usual care. Cluster randomised controlled trial in primary care centres of Barcelona, Spain. Participants were males and females aged 50-69 years, who were invited to the first round of a screening programme based on the faecal immunochemical test (FIT) (n = 41 042), and their primary care professional. The randomisation unit was the physician cluster (n = 130) and patients were blinded to the study group. The control group followed usual care as per the colorectal cancer screening programme. In the intervention group, as well as usual care, an alert to health professionals (cluster level) to promote screening was introduced in the individual's primary care EMR for 1 year. The main outcome was colorectal cancer screening participation at individual participant level. In total, 67 physicians and 21 619 patients (intervention group) and 63 physicians and 19 423 patients (control group) were randomised. In the intention-to-treat analysis screening participation was 44.1% and 42.2% respectively (odds ratio 1.08, 95% confidence interval [CI] = 0.97 to 1.20, P = 0.146). However, in the per-protocol analysis screening uptake in the intervention group showed a statistically significant increase, after adjusting for potential confounders (OR, 1.11; 95% CI = 1.02 to 1.22; P = 0.018). The use of an alert in an individual's primary care EMR is associated with a statistically significant increased uptake of an organised, FIT-based colorectal cancer screening programme in patients attending primary care centres. © British Journal of General Practice 2016.

Effectiveness of a Brief Home-Based Social Work Motivational Intervention for Male Methamphetamine Users in Tehran: A Randomized Clinical Trial.

PubMed

Danaee-Far, Morteza; Maarefvand, Masoomeh; Rafiey, Hassan

2016-12-05

Methamphetamine, a highly addictive psychostimulant drug, is widely used by substance users who are not motivated to undergo treatment throughout the world, including Iran. This research was conducted to evaluate the effectiveness of a brief home-based social work motivational intervention (HSWMI) to encourage male methamphetamine users to participate in a treatment program. Fifty-six unmotivated male methamphetamine users participated in a randomized controlled trial. The case group received the HSWMI in addition to the usual consulting services in the clinic; the control group just received the usual consulting services. Data were collected 7 and 90 days after the intervention to evaluate participation and retention in a treatment program. Data were analyzed using the chi-square test. Drug users with a mean age of 32.55 years and mean duration of drug use of 7.73 years, participated in the case (n = 28) and control (n = 28) groups. The case group participated in treatment programs significantly more than the control group and the retention rate for the case group was significantly higher than for the control group. This brief HSWMI was effective to increase the motivation of methamphetamine users to participate and remain in treatment programs. This intervention can be implemented by social workers in substance use treatment centers.

Next-generation audit and feedback for inpatient quality improvement using electronic health record data: a cluster randomised controlled trial.

PubMed

Patel, Sajan; Rajkomar, Alvin; Harrison, James D; Prasad, Priya A; Valencia, Victoria; Ranji, Sumant R; Mourad, Michelle

2018-03-05

Audit and feedback improves clinical care by highlighting the gap between current and ideal practice. We combined best practices of audit and feedback with continuously generated electronic health record data to improve performance on quality metrics in an inpatient setting. We conducted a cluster randomised control trial comparing intensive audit and feedback with usual audit and feedback from February 2016 to June 2016. The study subjects were internal medicine teams on the teaching service at an urban tertiary care hospital. Teams in the intensive feedback arm received access to a daily-updated team-based data dashboard as well as weekly inperson review of performance data ('STAT rounds'). The usual feedback arm received ongoing twice-monthly emails with graphical depictions of team performance on selected quality metrics. The primary outcome was performance on a composite discharge metric (Discharge Mix Index, 'DMI'). A washout period occurred at the end of the trial (from May through June 2016) during which STAT rounds were removed from the intensive feedback arm. A total of 40 medicine teams participated in the trial. During the intervention period, the primary outcome of completion of the DMI was achieved on 79.3% (426/537) of patients in the intervention group compared with 63.2% (326/516) in the control group (P<0.0001). During the washout period, there was no significant difference in performance between the intensive and usual feedback groups. Intensive audit and feedback using timely data and STAT rounds significantly increased performance on a composite discharge metric compared with usual feedback. With the cessation of STAT rounds, performance between the intensive and usual feedback groups did not differ significantly, highlighting the importance of feedback delivery on effecting change. The trial was registered with ClinicalTrials.gov (NCT02593253). © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Manual therapy, exercise therapy, or both, in addition to usual care, for osteoarthritis of the hip or knee: a randomized controlled trial. 1: clinical effectiveness.

PubMed

Abbott, J H; Robertson, M C; Chapple, C; Pinto, D; Wright, A A; Leon de la Barra, S; Baxter, G D; Theis, J-C; Campbell, A J

2013-04-01

To evaluate the clinical effectiveness of manual physiotherapy and/or exercise physiotherapy in addition to usual care for patients with osteoarthritis (OA) of the hip or knee. In this 2 × 2 factorial randomized controlled trial, 206 adults (mean age 66 years) who met the American College of Rheumatology criteria for hip or knee OA were randomly allocated to receive manual physiotherapy (n = 54), multi-modal exercise physiotherapy (n = 51), combined exercise and manual physiotherapy (n = 50), or no trial physiotherapy (n = 51). The primary outcome was change in the Western Ontario and McMaster osteoarthritis index (WOMAC) after 1 year. Secondary outcomes included physical performance tests. Outcome assessors were blinded to group allocation. Of 206 participants recruited, 193 (93.2%) were retained at follow-up. Mean (SD) baseline WOMAC score was 100.8 (53.8) on a scale of 0-240. Intention to treat analysis showed adjusted reductions in WOMAC scores at 1 year compared with the usual care group of 28.5 (95% confidence interval (CI) 9.2-47.8) for usual care plus manual therapy, 16.4 (-3.2 to 35.9) for usual care plus exercise therapy, and 14.5 (-5.2 to 34.1) for usual care plus combined exercise therapy and manual therapy. There was an antagonistic interaction between exercise therapy and manual therapy (P = 0.027). Physical performance test outcomes favoured the exercise therapy group. Manual physiotherapy provided benefits over usual care, that were sustained to 1 year. Exercise physiotherapy also provided physical performance benefits over usual care. There was no added benefit from a combination of the two therapies. Australian New Zealand Clinical Trials Registry ACTRN12608000130369. Copyright © 2013 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Prevention of hand eczema: effect of an educational program versus treatment as usual - results of the randomized clinical PREVEX trial.

PubMed

Fisker, Maja H; Ebbehøj, Niels E; Vejlstrup, Søren Grove; Lindschou, Jane; Gluud, Christian; Winkel, Per; Bonde, Jens Peter; Agner, Tove

2018-03-01

Objective Occupational hand eczema has adverse health and socioeconomic impacts for the afflicted individuals and society. Prevention and treatment strategies are needed. This study aimed to assess the effectiveness of an educational intervention on sickness absence, quality of life and severity of hand eczema. Methods PREVEX (PreVention of EXema) is an individually randomized, parallel-group superiority trial investigating the pros and cons of one-time, 2-hour, group-based education in skin-protective behavior versus treatment as usual among patients with newly notified occupational hand eczema, with follow-up after one year. Co-primary outcomes were total sickness absence, health-related quality of life (HR-QoL), and self-reported severity of hand eczema. Results Patients (N=1668) with notified occupational skin diseases from July 2012 to November 2014 were invited to participate in the trial. Of these, 756 were randomized to the intervention (N= 376) versus control (N=380) group. The intervention group had 21% fewer sickness absence days compared with the control group [95% confidence interval (CI) -55-40%, P=0.43]. We found no significant difference in the change of HR-QoL for the intervention compared with the control group (4% lower in the intervention group, 95% CI -18-13%, P=0.67). The ordinal odds of scoring worse on self-reported hand eczema severity was 15% lower in the intervention compared with the control group (95% CI -39-18%, P=0.34). Post-hoc sub-group analyses indicated that the effect of the intervention on severity differed between occupations, being detrimental to healthcare workers and beneficial in all other occupations. Conclusion The educational skincare program had no marked effect on the primary outcomes sickness absence, HR-QoL, and severity of hand eczema when compared with treatment as usual.

A Multicenter, Randomized, Controlled Trial of Osteopathic Manipulative Treatment on Preterms

PubMed Central

Cerritelli, Francesco; Pizzolorusso, Gianfranco; Renzetti, Cinzia; Cozzolino, Vincenzo; D’Orazio, Marianna; Lupacchini, Mariacristina; Marinelli, Benedetta; Accorsi, Alessandro; Lucci, Chiara; Lancellotti, Jenny; Ballabio, Silvia; Castelli, Carola; Molteni, Daniela; Besana, Roberto; Tubaldi, Lucia; Perri, Francesco Paolo; Fusilli, Paola; D’Incecco, Carmine; Barlafante, Gina

2015-01-01

Background Despite some preliminary evidence, it is still largely unknown whether osteopathic manipulative treatment improves preterm clinical outcomes. Materials and Methods The present multi-center randomized single blind parallel group clinical trial enrolled newborns who met the criteria for gestational age between 29 and 37 weeks, without any congenital complication from 3 different public neonatal intensive care units. Preterm infants were randomly assigned to usual prenatal care (control group) or osteopathic manipulative treatment (study group). The primary outcome was the mean difference in length of hospital stay between groups. Results A total of 695 newborns were randomly assigned to either the study group (n= 352) or the control group (n=343). A statistical significant difference was observed between the two groups for the primary outcome (13.8 and 17.5 days for the study and control group respectively, p<0.001, effect size: 0.31). Multivariate analysis showed a reduction of the length of stay of 3.9 days (95% CI -5.5 to -2.3, p<0.001). Furthermore, there were significant reductions with treatment as compared to usual care in cost (difference between study and control group: 1,586.01€; 95% CI 1,087.18 to 6,277.28; p<0.001) but not in daily weight gain. There were no complications associated to the intervention. Conclusions Osteopathic treatment reduced significantly the number of days of hospitalization and is cost-effective on a large cohort of preterm infants. PMID:25974071

Influence of arm crank ergometry on development of lymphedema in breast cancer patients after axillary dissection: A randomized controlled trail.

PubMed

Schmidt, Thorsten; Berner, Jette; Jonat, Walter; Weisser, Burkhard; Röcken, Christioph; van Mackelenbergh, Marion; Mundhenke, Christoph

2017-01-19

To investigate the safety and efficacy of arm crank ergometry in breast cancer patients after axillary lymph node dissection, with regard to changes in bioelectrical impedance analysis, arm circumference, muscular strength, quality of life and fatigue. Randomized controlled clinical intervention trial. Forty-nine patients with breast cancer after axillary lymph node dissection. Arm crank ergometer training twice-weekly was compared with usual care over 12 weeks. The arm crank ergometer group improved significantly in terms of lean body mass and skeletal muscle mass, and showed a significant decrease in body fat. In the arm crank ergometer group, as well as the usual care group, a significant increase in armpit circumference was detected during the training period. The magnitude of the gain was higher in the usual care group. For all other measured regions of the arm a significant decrease in circumference was seen in both groups. Muscular strength of the upper extremity increased significantly in both groups, with a greater improvement in the arm crank ergometer group. In both groups a non-significant trend towards improvement in quality of life was observed. The arm crank ergometer group showed significant improvements in physical functioning, general fatigue and physical fatigue. These results confirm the feasibility of arm crank ergometer training after axillary lymph node dissection and highlight improvements in strength, quality of life and reduced arm symptoms with this training.

A restorative home care intervention in New Zealand: perceptions of paid caregivers.

PubMed

King, Anna I I; Parsons, Matthew; Robinson, Elizabeth

2012-01-01

Paid caregivers possess an essential role in home care services. However, recruitment and retention issues are extensive within this workforce, largely in relation to poor working conditions. This article primarily focuses on the qualitative data extracted from a large randomised controlled trial in New Zealand and is supported by some quantitative findings. The aim was to explore paid caregiver perceptions of a restorative home care intervention in comparison with usual home care. The purpose of the qualitative exploration was to gather rich descriptive data that highlight differences between the two services with an emphasis on the workforce viewpoint. Four focus groups were undertaken with paid caregivers, two at baseline (4 and 5 participants in the control and intervention groups, respectively) and two at 14 months (eight participants in each focus group). Focus group data were collected in December 2005 and February 2007. A general inductive approach was used to analyse focus group transcripts. Two themes emerged from both the control and intervention focus groups: relationship with older people and issues with home care service delivery. A further two themes were pertinent to the intervention group: job satisfaction and preintervention. Findings revealed the intervention had a substantial positive impact on paid caregiver job satisfaction in comparison with usual care. This appeared to be due to improved training, increased support and supervision, and more flexibility. The intervention resulted in positive changes from the paid caregiver perspective and substantially reduced turnover in comparison with usual home care. However, both groups identified the need for further improvements to their working conditions. In addition, the need to regulate this vulnerable workforce is discussed. © 2011 Blackwell Publishing Ltd.

Home-based Reach-to-Grasp training for people after stroke is feasible: a pilot randomised controlled trial.

PubMed

Turton, A J; Cunningham, P; van Wijck, F; Smartt, Hjm; Rogers, C A; Sackley, C M; Jowett, S; Wolf, S L; Wheatley, K; van Vliet, P

2017-07-01

To determine feasibility of a randomised controlled trial (RCT) of home-based Reach-to-Grasp training after stroke. single-blind parallel group RCT. Residual arm deficit less than 12 months post-stroke. Reach-to-Grasp training in 14 one-hour therapist's visits over 6 weeks, plus one hour self-practice per day (total 56 hours). Usual care. Action Research Arm Test (ARAT), Wolf Motor Function Test (WMFT), pre-randomisation, 7, 12, 24 weeks post-randomisation. Forty-seven participants (Reach-to-Grasp=24, usual care=23) were randomised over 17 months. Reach-to-Grasp participants received a median (IQR) 14 (13,14) visits, and performed 157 (96,211) repetitions per visit; plus 30 minutes (22,45) self-practice per day. Usual care participants received 10.5 (5,14) therapist visits, comprising 38.6 (30,45) minutes of arm therapy with 16 (6,24) repetitions of functional tasks per visit. Median ARAT scores in the reach-to-grasp group were 8.5 (3.0,24.0) at baseline and 14.5 (3.5,26.0) at 24 weeks compared to median of 4 at both time points (IQR: baseline (3.0,14.0), 24 weeks (3.0,30.0)) in the usual-care group. Median WMFT tasks completed at baseline and 24 weeks were 6 (3.0,11.5) and 8.5 (4.5,13.5) respectively in the reach-to-grasp group and 4 (3.0,10.0), 6 (3.0,14.0) in the usual care group. Incidence of arm pain was similar between groups. The study was stopped before 11 patients reached the 24 weeks assessment. An RCT of home-based Reach-to-Grasp training after stroke is feasible and safe. With ARAT being our preferred measure it is estimated that 240 participants will be needed for a future two armed trial.

Usual Dose of Caffeine Has a Positive Effect on Somatosensory Related Postural Stability in Hemiparetic Stroke Patients

PubMed Central

Kim, Woo Sub; Choi, Chang Kweon; Yoon, Sang Ho

2014-01-01

Objective To evaluate the effect of caffeine on balance control of hemiparetic stroke patients, we investigated the difference in postural stability before and after drinking coffee by observing changes in stability index (SI) from posturography. Methods Thirty patients with history of stroke and 15 age-matched healthy subjects participated in this study. Effect of group factor (of the control and stroke groups) and treatment factor (pre- and post-drinking of coffee) on SI were tested in three conditions: with eyes opened, with eyes closed, and with a pillow support. The effects of these factors on visual deprivation and somatosensory change of subjects were also tested. Results Under all conditions, SI was higher in the stroke group than in the control group. Under eyes-open condition, the treatment factor was not statistically significant. Under eyes-closed condition, the interaction between group and treatment factor was statistically significant. After the subjects drank coffee, SI in the control group was increased. However, SI in the stroke group was decreased. Under pillow-supported condition, the interaction between group and treatment factor appeared marginally significant. For visual deprivation effect, the interaction between treatment and group factor was statistically significant. After caffeine consumption, the visual deprivation effect was increased in control group but decreased in the stroke group. For somatosensory change effect, the interaction between group and treatment factor was not statistically significant. Conclusion Postural stability of hemiparetic stroke patients related to somatosensory information was improved after intake of usual dose of caffeine. PMID:25566476

Leukocyte telomere length and depression, anxiety and stress and adjustment disorders in primary health care patients.

PubMed

Wang, Xiao; Sundquist, Kristina; Hedelius, Anna; Palmér, Karolina; Memon, Ashfaque A; Sundquist, Jan

2017-04-24

The primary aim was to examine possible differences in telomere length between primary health care patients, with depression, anxiety or stress and adjustment disorders, and healthy controls. The second aim was to examine the association between telomere length and baseline characteristics in the patients. The third aim was to examine the potential effects of the 8-week treatments (mindfulness-based group therapy or treatment as usual, i.e. mostly cognitive-based therapy) on telomere length, and to examine whether there was a difference in the potential effect on telomere length between the two groups. A total of 501 individuals including 181 patients (aged 20-64 years), with depression, anxiety and stress and adjustment disorders, and 320 healthy controls (aged 19-70 years) were recruited in the study. Patient data were collected from a randomized controlled trial comparing mindfulness-based group therapy with treatment as usual. We isolated genomic DNA from blood samples, collected at baseline and after the 8-week follow-up. Telomere length was measured by quantitative real-time (qRT)-PCR. Telomere length was significantly shorter in the patients (mean = 0.77 ± 0.12,), compared to the controls (mean = 0.81 ± 0.14) (p = 0.006). The difference in telomere length remained significant after controlling for age and sex. Old age, male sex and being overweight were associated with shorter telomere length. There was no significant difference in telomere length between baseline and at the 8-week follow-up in any of the treatment groups and no difference between the two groups. Our findings confirm that telomere length, as compared with healthy controls, is shortened in patients with depression, anxiety and stress and adjustment disorders. In both groups (mindfulness-based group therapy or treatment as usual), the telomere length remained unchanged after the 8-week treatment/follow-up and there was no difference between the two groups. (ClinicalTrials.gov ID: NCT01476371 ) Registered November 11, 2011.

ProCare Trial: a phase II randomized controlled trial of shared care for follow-up of men with prostate cancer.

PubMed

Emery, Jon D; Jefford, Michael; King, Madeleine; Hayne, Dickon; Martin, Andrew; Doorey, Juanita; Hyatt, Amelia; Habgood, Emily; Lim, Tee; Hawks, Cynthia; Pirotta, Marie; Trevena, Lyndal; Schofield, Penelope

2017-03-01

To test the feasibility and efficacy of a multifaceted model of shared care for men after completion of treatment for prostate cancer. Men who had completed treatment for low- to moderate-risk prostate cancer within the previous 8 weeks were eligible. Participants were randomized to usual care or shared care. Shared care entailed substituting two hospital visits with three visits in primary care, a survivorship care plan, recall and reminders, and screening for distress and unmet needs. Outcome measures included psychological distress, prostate cancer-specific quality of life, satisfaction and preferences for care and healthcare resource use. A total of 88 men were randomized (shared care n = 45; usual care n = 43). There were no clinically important or statistically significant differences between groups with regard to distress, prostate cancer-specific quality of life or satisfaction with care. At the end of the trial, men in the intervention group were significantly more likely to prefer a shared care model to hospital follow-up than those in the control group (intervention 63% vs control 24%; P<0.001). There was high compliance with prostate-specific antigen monitoring in both groups. The shared care model was cheaper than usual care (shared care AUS$1411; usual care AUS$1728; difference AUS$323 [plausible range AUS$91-554]). Well-structured shared care for men with low- to moderate-risk prostate cancer is feasible and appears to produce clinically similar outcomes to those of standard care, at a lower cost. © 2016 The Authors BJU International © 2016 BJU International Published by John Wiley & Sons Ltd.

Effect of screening on ovarian cancer mortality: the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Randomized Controlled Trial.

PubMed

Buys, Saundra S; Partridge, Edward; Black, Amanda; Johnson, Christine C; Lamerato, Lois; Isaacs, Claudine; Reding, Douglas J; Greenlee, Robert T; Yokochi, Lance A; Kessel, Bruce; Crawford, E David; Church, Timothy R; Andriole, Gerald L; Weissfeld, Joel L; Fouad, Mona N; Chia, David; O'Brien, Barbara; Ragard, Lawrence R; Clapp, Jonathan D; Rathmell, Joshua M; Riley, Thomas L; Hartge, Patricia; Pinsky, Paul F; Zhu, Claire S; Izmirlian, Grant; Kramer, Barnett S; Miller, Anthony B; Xu, Jian-Lun; Prorok, Philip C; Gohagan, John K; Berg, Christine D

2011-06-08

Screening for ovarian cancer with cancer antigen 125 (CA-125) and transvaginal ultrasound has an unknown effect on mortality. To evaluate the effect of screening for ovarian cancer on mortality in the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial. Randomized controlled trial of 78,216 women aged 55 to 74 years assigned to undergo either annual screening (n = 39,105) or usual care (n = 39,111) at 10 screening centers across the United States between November 1993 and July 2001. Intervention The intervention group was offered annual screening with CA-125 for 6 years and transvaginal ultrasound for 4 years. Participants and their health care practitioners received the screening test results and managed evaluation of abnormal results. The usual care group was not offered annual screening with CA-125 for 6 years or transvaginal ultrasound but received their usual medical care. Participants were followed up for a maximum of 13 years (median [range], 12.4 years [10.9-13.0 years]) for cancer diagnoses and death until February 28, 2010. Mortality from ovarian cancer, including primary peritoneal and fallopian tube cancers. Secondary outcomes included ovarian cancer incidence and complications associated with screening examinations and diagnostic procedures. Ovarian cancer was diagnosed in 212 women (5.7 per 10,000 person-years) in the intervention group and 176 (4.7 per 10,000 person-years) in the usual care group (rate ratio [RR], 1.21; 95% confidence interval [CI], 0.99-1.48). There were 118 deaths caused by ovarian cancer (3.1 per 10,000 person-years) in the intervention group and 100 deaths (2.6 per 10,000 person-years) in the usual care group (mortality RR, 1.18; 95% CI, 0.82-1.71). Of 3285 women with false-positive results, 1080 underwent surgical follow-up; of whom, 163 women experienced at least 1 serious complication (15%). There were 2924 deaths due to other causes (excluding ovarian, colorectal, and lung cancer) (76.6 per 10,000 person-years) in the intervention group and 2914 deaths (76.2 per 10,000 person-years) in the usual care group (RR, 1.01; 95% CI, 0.96-1.06). Among women in the general US population, simultaneous screening with CA-125 and transvaginal ultrasound compared with usual care did not reduce ovarian cancer mortality. Diagnostic evaluation following a false-positive screening test result was associated with complications. Trial Registration clinicaltrials.gov Identifier: NCT00002540.

The Effectiveness of Web-Based Asthma Self-Management System, My Asthma Portal (MAP): A Pilot Randomized Controlled Trial.

PubMed

Ahmed, Sara; Ernst, Pierre; Bartlett, Susan J; Valois, Marie-France; Zaihra, Tasneem; Paré, Guy; Grad, Roland; Eilayyan, Owis; Perreault, Robert; Tamblyn, Robyn

2016-12-01

Whether Web-based technologies can improve disease self-management is uncertain. My Asthma Portal (MAP) is a Web-based self-management support system that couples evidence-based behavioral change components (self-monitoring of symptoms, physical activity, and medication adherence) with real-time monitoring, feedback, and support from a nurse case manager. The aim of this study was to compare the impact of access to a Web-based asthma self-management patient portal linked to a case-management system (MAP) over 6 months compared with usual care on asthma control and quality of life. A multicenter, parallel, 2-arm, pilot, randomized controlled trial was conducted with 100 adults with confirmed diagnosis of asthma from 2 specialty clinics. Asthma control was measured using an algorithm based on overuse of fast-acting bronchodilators and emergency department visits, and asthma-related quality of life was assessed using the Mini-Asthma Quality of Life Questionnaire (MAQLQ). Secondary mediating outcomes included asthma symptoms, depressive symptoms, self-efficacy, and beliefs about medication. Process evaluations were also included. A total of 49 individuals were randomized to MAP and 51 to usual care. Compared with usual care, participants in the intervention group reported significantly higher asthma quality of life (mean change 0.61, 95% CI 0.03 to 1.19), and the change in asthma quality of life for the intervention group between baseline and 3 months (mean change 0.66, 95% CI 0.35 to 0.98) was not seen in the control group. No significant differences in asthma quality of life were found between the intervention and control groups at 6 (mean change 0.46, 95% CI -0.12 to 1.05) and 9 months (mean change 0.39, 95% CI -0.2 to 0.98). For poor control status, there was no significant effect of group, time, or group by time. For all self-reported measures, the intervention group had a significantly higher proportion of individuals, demonstrating a minimal clinically meaningful improvement compared with the usual care group. This study supported the use of MAP to enhance asthma quality of life but not asthma control as measured by an administrative database. Implementation of MAP beyond 6 months with tailored protocols for monitoring symptoms and health behaviors as individuals' knowledge and self-management skills improve may result in long-term gains in asthma control. International Standard Randomized Controlled Trial Number (ISRCTN): 34326236; http://www.isrctn.com/ISRCTN34326236 (Archived by Webcite at http://www.webcitation.org/6mGxoI1R7). ©Sara Ahmed, Pierre Ernst, Susan J Bartlett, Marie-France Valois, Tasneem Zaihra, Guy Paré, Roland Grad, Owis Eilayyan, Robert Perreault, Robyn Tamblyn. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 01.12.2016.

Effect of intensive structured care on individual blood pressure targets in primary care: multicentre randomised controlled trial.

PubMed

Stewart, Simon; Carrington, Melinda J; Swemmer, Carla H; Anderson, Craig; Kurstjens, Nicol P; Amerena, John; Brown, Alex; Burrell, Louise M; de Looze, Ferdinandus J; Harris, Mark; Hung, Joseph; Krum, Henry; Nelson, Mark; Schlaich, Markus; Stocks, Nigel P; Jennings, Garry L

2012-11-20

To determine the effectiveness of intensive structured care to optimise blood pressure control based on individual absolute risk targets in primary care. Pragmatic multicentre randomised controlled trial. General practices throughout Australia, except Northern Territory, 2009-11. Of 2185 patients from 119 general practices who were eligible for drug treatment for hypertension according to national guidelines 416 (19.0%) achieved their individual blood pressure target during a 28 day run-in period of monotherapy. After exclusions, 1562 participants not at target blood pressure (systolic 150 (SD 17) mm Hg, diastolic 88 (SD 11) mm Hg) were randomised (1:2 ratio) to usual care (n=524) or the intervention (n=1038). Computer assisted clinical profiling and risk target setting (all participants) with intensified follow-up and stepwise drug titration (initial angiotensin receptor blocker monotherapy or two forms of combination therapy using angiotensin receptor blockers) for those randomised to the intervention. The control group received usual care. The primary outcome was individual blood pressure target achieved at 26 weeks. Secondary outcomes were change in mean sitting systolic and diastolic blood pressure, absolute risk for cardiovascular disease within five years based on the Framingham risk score, and proportion and rate of adverse events. On an intention to treat basis, there was an 8.8% absolute difference in individual blood pressure target achieved at 26 weeks in favour of the intervention group compared with usual care group (358/988 (36.2%) v 138/504 (27.4%)): adjusted relative risk 1.28 (95% confidence interval 1.10 to 1.49, P=0.0013). There was also a 9.5% absolute difference in favour of the intervention group for achieving the classic blood pressure target of ≤ 140/90 mm Hg (627/988 (63.5%) v 272/504 (54.0%)): adjusted relative risk 1.18 (1.07 to 1.29, P<0.001). The intervention group achieved a mean adjusted reduction in systolic blood pressure of 13.2 mm Hg (95% confidence interval -12.3 to -14.2 mm Hg) and diastolic blood pressure of 7.7 mm Hg (-7.1 to -8.3 mm Hg) v 10.1 mm Hg (-8.8 to 11.3 mm Hg) and 5.5 mm Hg (-4.7 to -6.2 mm Hg) in the usual care group (P<0.001). Among 1141 participants in whom five year absolute cardiovascular risk scores were calculated from baseline to the 26 week follow-up, the reduction in risk scores was greater in the intervention group than usual care group (14.7% (SD 9.3%) to 10.9% (SD 8.0%); difference -3.7% (SD 4.5%) and 15.0% (SD 10.1%) to 12.4% (SD 9.4%); -2.6% (SD 4.5%): adjusted mean difference -1.13% (95% confidence interval -0.69% to -1.63%; P<0.001). Owing to adverse events 82 (7.9%) participants in the intervention group and 10 (1.9%) in the usual care group had their drug treatment modified. In a primary care setting intensive structured care resulted in higher levels of blood pressure control, with clinically lower blood pressure and absolute risk of future cardiovascular events overall and with more people achieving their target blood pressure. An important gap in treatment remains though and applying intensive management and achieving currently advocated risk based blood pressure targets is challenging.

Cognitive behavioural therapy as an adjunct to pharmacotherapy for primary care based patients with treatment resistant depression: results of the CoBalT randomised controlled trial.

PubMed

Wiles, Nicola; Thomas, Laura; Abel, Anna; Ridgway, Nicola; Turner, Nicholas; Campbell, John; Garland, Anne; Hollinghurst, Sandra; Jerrom, Bill; Kessler, David; Kuyken, Willem; Morrison, Jill; Turner, Katrina; Williams, Chris; Peters, Tim; Lewis, Glyn

2013-02-02

Only a third of patients with depression respond fully to antidepressant medication but little evidence exists regarding the best next-step treatment for those whose symptoms are treatment resistant. The CoBalT trial aimed to examine the effectiveness of cognitive behavioural therapy (CBT) as an adjunct to usual care (including pharmacotherapy) for primary care patients with treatment resistant depression compared with usual care alone. This two parallel-group multicentre randomised controlled trial recruited 469 patients aged 18-75 years with treatment resistant depression (on antidepressants for ≥6 weeks, Beck depression inventory [BDI] score ≥14 and international classification of diseases [ICD]-10 criteria for depression) from 73 UK general practices. Participants were randomised, with a computer generated code (stratified by centre and minimised according to baseline BDI score, whether the general practice had a counsellor, previous treatment with antidepressants, and duration of present episode of depression) to one of two groups: usual care or CBT in addition to usual care, and were followed up for 12 months. Because of the nature of the intervention it was not possible to mask participants, general practitioners, CBT therapists, or researchers to the treatment allocation. Analyses were by intention to treat. The primary outcome was response, defined as at least 50% reduction in depressive symptoms (BDI score) at 6 months compared with baseline. This trial is registered, ISRCTN38231611. Between Nov 4, 2008, and Sept 30, 2010, we assigned 235 patients to usual care, and 234 to CBT plus usual care. 422 participants (90%) were followed up at 6 months and 396 (84%) at 12 months, finishing on Oct 31, 2011. 95 participants (46%) in the intervention group met criteria for response at 6 months compared with 46 (22%) in the usual care group (odds ratio 3·26, 95% CI 2·10-5·06, p<0·001). Before this study, no evidence from large-scale randomised controlled trials was available for the effectiveness of augmentation of antidepressant medication with CBT as a next-step for patients whose depression has not responded to pharmacotherapy. Our study has provided robust evidence that CBT as an adjunct to usual care that includes antidepressants is an effective treatment, reducing depressive symptoms in this population. National Institute for Health Research Health Technology Assessment. Copyright © 2013 Elsevier Ltd. All rights reserved.

A Randomized Double-Blind Controlled Trial Comparing Davanloo Intensive Short-Term Dynamic Psychotherapy as Internet-Delivered Vs Treatment as Usual for Medically Unexplained Pain: A 6-Month Pilot Study.

PubMed

Chavooshi, Behzad; Mohammadkhani, Parvaneh; Dolatshahi, Behrouz

2016-01-01

Research has shown that Intensive Short-Term Dynamic Psychotherapy (ISTDP) can effectively decrease pain intensity and improve quality of life in patients with medically unexplained pain. Understanding that not all patients with medically unexplained pain have access to in-person ISTDP, this study aims to investigate the efficacy of an Internet-delivered ISTDP for individuals with medically unexplained pain using Skype in comparison with treatment as usual. In this randomized controlled trial, 100 patients were randomly allocated into Internet-delivered ISTDP (n = 50) and treatment-as- usual (n = 50) groups. Treatment intervention consisted of 16 weekly, hour-long therapy sessions. The primary outcome was perceived pain assessed using the Numeric Pain Rating Scale. The secondary outcome included Depression Anxiety Stress Scale-21, Emotion Regulation Questionnaire, Mindful Attention Awareness Scale, and Quality-of-Life Inventory. Blind assessments were conducted at the baseline, posttreatment, and at a 6-month follow-up. In the intention-to-treat analysis, pain symptoms in the intervention group were significantly reduced (p < 0.001), whereas a reduction was not observed in the treatment as usual group (p = 0.651). Moreover, there were significant decreases in depression, anxiety, and stress, as well as a greater increase in emotion regulation functioning, mindfulness, and quality of life observed in the intervention group 6 months after the treatment compared with the treatment as usual condition. The results of this pilot trial demonstrate that 16 weeks of ISTDP delivered by Skype can significantly improve pain intensity and clinical symptoms of medically unexplained pain. Copyright © 2016 The Academy of Psychosomatic Medicine. Published by Elsevier Inc. All rights reserved.

Effects of Distant Reiki On Pain, Anxiety and Fatigue in Oncology Patients in Turkey: A Pilot Study.

PubMed

Demir, Melike; Can, Gulbeyaz; Kelam, Ayhan; Aydıner, Aydın

2015-01-01

Fatigue, stress and pain are common symptoms among cancer patients, affecting the quality of life. The purpose of the present study was to determine the effect of distant Reiki on pain, anxiety and fatigue in oncology patients. Participants in the control group received usual medical and nursing care during their stay. The intervention group received usual care plus five distant Reiki sessions, one each night for 30 min. A face to face interview was performed and patient personal and illness related characteristics were evaluated using the Patient Characteristics form. Pain, stress and fatigue were evaluated according to a numeric rating scale. The experimental group was predominantly composed of women (71.4%), married individuals (40%), and primary school graduates (40%). The control group was predominantly male (72.7%), married (60%), and primary school graduates (60%). The control group demonstrated greater levels of pain (p=0.002), stress (p=0.001) and fatigue (p=0.001). The Reiki group pain score (p<0.0001), stress score (p<0.001) and fatigue score were also significantly lower. The results of this study indicate that Reiki may decreasepain, anxiety and fatigue in oncology patients.

Effects of Self-Management Support on Structure, Process, and Outcomes Among Vulnerable Patients With Diabetes

PubMed Central

Schillinger, Dean; Handley, Margaret; Wang, Frances; Hammer, Hali

2009-01-01

OBJECTIVE Despite the importance of self-management support (SMS), few studies have compared SMS interventions, involved diverse populations, or entailed implementation in safety net settings. We examined the effects of two SMS strategies across outcomes corresponding to the Chronic Care Model. RESEARCH DESIGN AND METHODS A total of 339 outpatients with poorly controlled diabetes from county-run clinics were enrolled in a three-arm trial. Participants, more than half of whom spoke limited English, were uninsured, and/or had less than a high school education, were randomly assigned to usual care, interactive weekly automated telephone self-management support with nurse follow-up (ATSM), or monthly group medical visits with physician and health educator facilitation (GMV). We measured 1-year changes in structure (Patient Assessment of Chronic Illness Care [PACIC]), communication processes (Interpersonal Processes of Care [IPC]), and outcomes (behavioral, functional, and metabolic). RESULTS Compared with the usual care group, the ATSM and GMV groups showed improvements in PACIC, with effect sizes of 0.48 and 0.50, respectively (P < 0.01). Only the ATSM group showed improvements in IPC (effect sizes 0.40 vs. usual care and 0.25 vs. GMV, P < 0.05). Both SMS arms showed improvements in self-management behavior versus the usual care arm (P < 0.05), with gains being greater for the ATSM group than for the GMV group (effect size 0.27, P = 0.02). The ATSM group had fewer bed days per month than the usual care group (−1.7 days, P = 0.05) and the GMV group (−2.3 days, P < 0.01) and less interference with daily activities than the usual care group (odds ratio 0.37, P = 0.02). We observed no differences in A1C change. CONCLUSIONS Patient-centered SMS improves certain aspects of diabetes care and positively influences self-management behavior. ATSM seems to be a more effective communication vehicle than GMV in improving behavior and quality of life. PMID:19131469

A case-control study of the effectiveness of tissue plasminogen activator on 6 month patients--reported outcomes and health care utilization.

PubMed

Lang, Catherine E; Bland, Marghuretta D; Cheng, Nuo; Corbetta, Maurizio; Lee, Jin-Moo

2014-01-01

We examined the benefit of tissue plasminogen activator (tPA), delivered as part of usual stroke management, on patient-reported outcomes and health care utilization. Using a case control design, patients who received tPA as part of usual stroke management were compared with patients who would have received tPA had they arrived to the hospital within the therapeutic time window. Data were collected from surveys 6 months after stroke using standardized patient-reported outcome measures and questions about health care utilization. Demographic and medical data were acquired from hospital records. Patients were matched on stroke severity, age, race, and gender. Matching was done with 1:2 ratio of tPA to controls. Results were compared between groups with 1-tailed tests because of a directionally specific hypothesis in favor of the tPA group. The tPA (n = 78) and control (n = 156) groups were matched across variables, except for stroke severity, which was better in the control group; subsequent analyses controlled for this mismatch. The tPA group reported better physical function, communication, cognitive ability, depressive symptomatology, and quality of life/participation compared with the control group. Fewer people in the tPA group reported skilled nursing facility stays, emergency department visits, and rehospitalizations after their stroke compared with controls. Reports of other postacute services were not different between groups. Although it is known that tPA reduces disability, this is the first study to demonstrate the effectiveness of tPA in improving meaningful, patient-reported outcomes. Thus, use of tPA provides a large benefit to the daily lives of people with ischemic stroke. Copyright © 2014 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Economic evaluation of a multifactorial, interdisciplinary intervention versus usual care to reduce frailty in frail older people.

PubMed

Fairhall, Nicola; Sherrington, Catherine; Kurrle, Susan E; Lord, Stephen R; Lockwood, Keri; Howard, Kirsten; Hayes, Alison; Monaghan, Noeline; Langron, Colleen; Aggar, Christina; Cameron, Ian D

2015-01-01

To compare the costs and cost-effectiveness of a multifactorial interdisciplinary intervention versus usual care for older people who are frail. Cost-effectiveness study embedded within a randomized controlled trial. Community-based intervention in Sydney, Australia. A total of 241 community-dwelling people 70 years or older who met the Cardiovascular Health Study criteria for frailty. A 12-month multifactorial, interdisciplinary intervention targeting identified frailty characteristics versus usual care. Health and social service use, frailty, and health-related quality of life (EQ-5D) were measured over the 12-month intervention period. The difference between the mean cost per person for 12 months in the intervention and control groups (incremental cost) and the ratio between incremental cost and effectiveness were calculated. A total of 216 participants (90%) completed the study. The prevalence of frailty was 14.7% lower in the intervention group compared with the control group at 12 months (95% CI 2.4%-27.0%; P = .02). There was no significant between-group difference in EQ-5D utility scores. The cost for 1 extra person to transition out of frailty was $A15,955 (at 2011 prices). In the "very frail" subgroup (participants met >3 Cardiovascular Health Study frailty criteria), the intervention was both more effective and less costly than the control. A cost-effectiveness acceptability curve shows that the intervention would be cost-effective with 80% certainty if decision makers were willing to pay $A50,000 per extra person transitioning from frailty. In the very frail subpopulation, this reduced to $25,000. For frail older people residing in the community, a 12-month multifactorial intervention provided better value for money than usual care, particularly for the very frail, in whom it has a high probability of being cost saving, as well as effective. Trial registration: ACTRN12608000250336. Copyright © 2015 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

Clinical verification of a unilateral otolith test

NASA Astrophysics Data System (ADS)

Wetzig, J.; Hofstetter-Degen, K.; Maurer, J.; von Baumgarten, R. J.

In a previous study 13 we reported promising results for a new test to differentiate in vivo unilateral otolith functions. That study pointed to a need for further validation on known pathological cases. In this presentation we will detail the results gathered on a group of clinically verified vestibular defectives (verum) and a normal (control) group. The subjects in the verum group were former patients of the ENT clinic of the university hospital. These subjects had usually suffered from neurinoma of the VIIth cranial nerve or inner ear infections. All had required surgical intervention including removal of the vestibular system. The patients were contacted usually two or more years postoperatively. A group of students from the pre- and clinical phase of medical training served as control. Both groups were subjected to standardized clinical tests. These tests served to reconfirm the intra- or postoperative diagnosis of unilateral vestibular loss in the verum group. In the control group they had to establish the normalcy of the responses of the vestibular system. Both groups then underwent testing on our exccentric rotary chair in the manner described before 13. Preliminary results of the trials indicate that this test may indeed for the first time offer a chance to look at isolated otolith apparati in vivo.

Improving patient emotional functioning and psychological morbidity: evaluation of a consultation skills training program for oncologists.

PubMed

Girgis, Afaf; Cockburn, Jill; Butow, Phyllis; Bowman, Deborah; Schofield, Penelope; Stojanovski, Elizabeth; D'Este, Catherine; Tattersall, Martin H N; Doran, Christopher; Turner, Jane

2009-12-01

To evaluate whether a consultation skills training (CST) program with oncologists and trainees would improve skills in detecting and responding to patient distress, thereby improving their patients' emotional functioning and reducing psychological distress. Randomized-controlled trial with 29 medical and radiation oncologists from Australia randomized to CST group (n=15) or usual-care group (n=14). The CST consisted of a 1.5-day face-to-face workshop incorporating presentation of principles, a DVD modelling ideal behaviour and role-play practice, and four 1.5h monthly video-conferences. At the CST conclusion, patients of participating doctors were recruited (n=192 in CST group, n=183 in usual-care group), completing telephone surveys at baseline, 1 week and 3 months to assess quality of life, anxiety, depression and unmet psychosocial needs. Despite high patient functioning at baseline, anxiety significantly improved at 1-week follow-up in the CST group, compared to the control group. There were no statistically significant differences in emotional functioning, depression or unmet supportive care need between the groups. Consistent trends for greater improvements were observed in intervention compared to control group patients, suggesting the CST program deserves wider evaluation. Video-conferencing after a short training course may be an effective strategy for delivering CST.

Impact of Booster Breaks and Computer Prompts on Physical Activity and Sedentary Behavior Among Desk-Based Workers: A Cluster-Randomized Controlled Trial.

PubMed

Taylor, Wendell C; Paxton, Raheem J; Shegog, Ross; Coan, Sharon P; Dubin, Allison; Page, Timothy F; Rempel, David M

2016-11-17

The 15-minute work break provides an opportunity to promote health, yet few studies have examined this part of the workday. We studied physical activity and sedentary behavior among office workers and compared the results of the Booster Break program with those of a second intervention and a control group to determine whether the Booster Break program improved physical and behavioral health outcomes. We conducted a 3-arm, cluster-randomized controlled trial at 4 worksites in Texas from 2010 through 2013 to compare a group-based, structured Booster Break program to an individual-based computer-prompt intervention and a usual-break control group; we analyzed physiologic, behavioral, and employee measures such as work social support, quality of life, and perceived stress. We also identified consistent and inconsistent attendees of the Booster Break sessions. We obtained data from 175 participants (mean age, 43 y; 67% racial/ethnic minority). Compared with the other groups, the consistent Booster Break attendees had greater weekly pedometer counts (P < .001), significant decreases in sedentary behavior and self-reported leisure-time physical activity (P < .001), and a significant increase in triglyceride concentrations (P = .02) (levels remained within the normal range). Usual-break participants significantly increased their body mass index, whereas Booster Break participants maintained body mass index status during the 6 months. Overall, Booster Break participants were 6.8 and 4.3 times more likely to have decreases in BMI and weekend sedentary time, respectively, than usual-break participants. Findings varied among the 3 study groups; however, results indicate the potential for consistent attendees of the Booster Break intervention to achieve significant, positive changes related to physical activity, sedentary behavior, and body mass index.

Impact of Booster Breaks and Computer Prompts on Physical Activity and Sedentary Behavior Among Desk-Based Workers: A Cluster-Randomized Controlled Trial

PubMed Central

Paxton, Raheem J.; Shegog, Ross; Coan, Sharon P.; Dubin, Allison; Page, Timothy F.; Rempel, David M.

2016-01-01

Introduction The 15-minute work break provides an opportunity to promote health, yet few studies have examined this part of the workday. We studied physical activity and sedentary behavior among office workers and compared the results of the Booster Break program with those of a second intervention and a control group to determine whether the Booster Break program improved physical and behavioral health outcomes. Methods We conducted a 3-arm, cluster-randomized controlled trial at 4 worksites in Texas from 2010 through 2013 to compare a group-based, structured Booster Break program to an individual-based computer-prompt intervention and a usual-break control group; we analyzed physiologic, behavioral, and employee measures such as work social support, quality of life, and perceived stress. We also identified consistent and inconsistent attendees of the Booster Break sessions. Results We obtained data from 175 participants (mean age, 43 y; 67% racial/ethnic minority). Compared with the other groups, the consistent Booster Break attendees had greater weekly pedometer counts (P < .001), significant decreases in sedentary behavior and self-reported leisure-time physical activity (P < .001), and a significant increase in triglyceride concentrations (P = .02) (levels remained within the normal range). Usual-break participants significantly increased their body mass index, whereas Booster Break participants maintained body mass index status during the 6 months. Overall, Booster Break participants were 6.8 and 4.3 times more likely to have decreases in BMI and weekend sedentary time, respectively, than usual-break participants. Conclusion Findings varied among the 3 study groups; however, results indicate the potential for consistent attendees of the Booster Break intervention to achieve significant, positive changes related to physical activity, sedentary behavior, and body mass index. PMID:27854422

Impact of an educational DVD on anxiety and glycaemic control in women diagnosed with gestational diabetes mellitus (GDM): A randomised controlled trial.

PubMed

Draffin, Claire R; Alderdice, Fiona A; McCance, David R; Maresh, Michael; Harper, Roy; Patterson, Christopher C; Bernatavicius, Giovanna; Brennan, Sarah F; Gough, Aisling; McSorley, Oonagh; Holmes, Valerie A

2017-04-01

The diagnosis of gestational diabetes mellitus (GDM) during pregnancy can lead to anxiety. This study evaluated the impact of an innovative patient-centred educational DVD on anxiety and glycaemic control in women newly diagnosed with GDM. 150 multi-ethnic women, aged 19-44years, from three UK hospitals were randomised to either usual care plus DVD (DVD group, n=77) or usual care alone (control group, n=73) at GDM diagnosis. Primary outcomes were anxiety (State-Trait Anxiety Inventory) and mean 1-h postprandial capillary self-monitored blood glucose for all meals, on day prior to follow-up. No significant difference between the DVD and control group were reported, for anxiety (37.7±11.7 vs 36.2±10.9; mean difference after adjustment for covariates (95% CI) 2.5 (-0.8, 5.9) or for mean 1-h postprandial glucose for all meals (6.9±0.9 vs 7.0±1.2mmol/L; -0.2 (-0.5, 0.2). However, the DVD group had significantly lower postprandial breakfast glucose compared to the control group (6.8±1.2 vs 7.4±1.9mmol/L; -0.5 (-1.1, -<0.1; p=0.04). The results in this trial did not highlight any differences between those who received the intervention and those who received usual care. It is possible that women already felt supported by their frequent attendance at specialist clinics for monitoring and advice. Healthcare professional and family support are key elements to empowering women with GDM and require further consideration in future interventions. Nonetheless, educational resources such as this will be beneficial to help support women given the current resource and time implications of the year on year rises in the incidence of gestational diabetes. Copyright © 2017 Elsevier B.V. All rights reserved.

Effectiveness of a group-based self-management program for people with chronic fatigue syndrome: a randomized controlled trial.

PubMed

Pinxsterhuis, Irma; Sandvik, Leiv; Strand, Elin Bolle; Bautz-Holter, Erik; Sveen, Unni

2017-01-01

To evaluate the effectiveness of a group-based self-management program for people with chronic fatigue syndrome. A randomized controlled trial. Four mid-sized towns in southern Norway and two suburbs of Oslo. A total of 137 adults with chronic fatigue syndrome. A self-management program including eight biweekly meetings of 2.5 hours duration. The control group received usual care. Primary outcome measure: Medical Outcomes Study-Short Form-36 physical functioning subscale. Fatigue severity scale, self-efficacy scale, physical and mental component summary of the Short Form-36, and the illness cognition questionnaire (acceptance subscale). Assessments were performed at baseline, and at six-month and one-year follow-ups. At the six-month follow-up, a significant difference between the two groups was found concerning fatigue severity ( p = 0.039) in favor of the control group, and concerning self-efficacy in favor of the intervention group ( p = 0.039). These significant differences were not sustained at the one-year follow-up. No significant differences were found between the groups concerning physical functioning, acceptance, and health status at any of the measure points. The drop-out rate was 13.9% and the median number of sessions attended was seven (out of eight). The evaluated self-management program did not have any sustained effect, as compared with receiving usual care.

lmplementing lifestyle change through phone-based motivational interviewing in rural-based women with previous gestational diabetes mellitus.

PubMed

Reinhardt, Judith A; van der Ploeg, Hidde P; Grzegrzulka, Richard; Timperley, Jennifer G

2012-04-01

Substantial numbers of women with past gestational diabetes mellitus (GDM) develop type 2 diabetes mellitus (T2DM). In northern New South Wales 23% of women attending diabetes services between 2007 and 2010 with T2DM previously had GDM. This study investigated whether phone-based lifestyle education using motivational interviewing resulted in positive lifestyle change post GDM for women in a large rural area. Thirty-eight women were recruited to this pilot study following GDM diagnosis and randomly allocated to either the control or intervention group. Following baseline assessment, the intervention group received a 6-month phone-based motivational interviewing program, and access to usual care. The control group received usual care only. Measures were collected at baseline (6 weeks postnatal), and at 6 months follow-up. Outcome measures included body mass index, diet, and physical activity. At follow-up, the intervention group compared to the control group significantly reduced total fat intake by -19 g/d (95%CI: -37 to -1), total carbohydrate intake by -42 g/d (95%CI: -82 to -1), and glycaemic load by -26 units (95%CI: -48 to -4). These women also increased leisure physical activity compared to the control group by 11 min/d (95%CI: 1 to 22); no significant change in total physical activity levels occurred. At follow-up, body mass index in the intervention group improved by -1.5 kg/m2 (95%CI: -2.8 to -0.1) compared to the control group. The intervention group showed positive trends across lifestyle variables compared to the control group. Further large-scale research on the effectiveness of phone-based lifestyle counselling following GDM is warranted.

Comprehensive self management and routine monitoring in chronic obstructive pulmonary disease patients in general practice: randomised controlled trial.

PubMed

Bischoff, Erik W M A; Akkermans, Reinier; Bourbeau, Jean; van Weel, Chris; Vercoulen, Jan H; Schermer, Tjard R J

2012-11-28

To assess the long term effects of two different modes of disease management (comprehensive self management and routine monitoring) on quality of life (primary objective), frequency and patients' management of exacerbations, and self efficacy (secondary objectives) in patients with chronic obstructive pulmonary disease (COPD) in general practice. 24 month, multicentre, investigator blinded, three arm, pragmatic, randomised controlled trial. 15 general practices in the eastern part of the Netherlands. Patients with COPD confirmed by spirometry and treated in general practice. Patients with very severe COPD or treated by a respiratory physician were excluded. A comprehensive self management programme as an adjunct to usual care, consisting of four tailored sessions with ongoing telephone support by a practice nurse; routine monitoring as an adjunct to usual care, consisting of 2-4 structured consultations a year with a practice nurse; or usual care alone (contacts with the general practitioner at the patients' own initiative). The primary outcome was the change in COPD specific quality of life at 24 months as measured with the chronic respiratory questionnaire total score. Secondary outcomes were chronic respiratory questionnaire domain scores, frequency and patients' management of exacerbations measured with the Nijmegen telephonic exacerbation assessment system, and self efficacy measured with the COPD self-efficacy scale. 165 patients were allocated to self management (n=55), routine monitoring (n=55), or usual care alone (n=55). At 24 months, adjusted treatment differences between the three groups in mean chronic respiratory questionnaire total score were not significant. Secondary outcomes did not differ, except for exacerbation management. Compared with usual care, more exacerbations in the self management group were managed with bronchodilators (odds ratio 2.81, 95% confidence interval 1.16 to 6.82) and with prednisolone, antibiotics, or both (3.98, 1.10 to 15.58). Comprehensive self management or routine monitoring did not show long term benefits in terms of quality of life or self efficacy over usual care alone in COPD patients in general practice. Patients in the self management group seemed to be more capable of appropriately managing exacerbations than did those in the usual care group. Clinical trials NCT00128765.

Embedding an enriched environment in an acute stroke unit increases activity in people with stroke: a controlled before-after pilot study.

PubMed

Rosbergen, Ingrid Cm; Grimley, Rohan S; Hayward, Kathryn S; Walker, Katrina C; Rowley, Donna; Campbell, Alana M; McGufficke, Suzanne; Robertson, Samantha T; Trinder, Janelle; Janssen, Heidi; Brauer, Sandra G

2017-11-01

To determine whether an enriched environment embedded in an acute stroke unit could increase activity levels in acute stroke patients and reduce adverse events. Controlled before-after pilot study. An acute stroke unit in a regional Australian hospital. Acute stroke patients admitted during (a) initial usual care control period, (b) an enriched environment period and (c) a sustainability period. Usual care participants received usual one-on-one allied health intervention and nursing care. The enriched environment participants were provided stimulating resources, communal areas for eating and socializing and daily group activities. Change management strategies were used to implement an enriched environment within existing staffing levels. Behavioural mapping was used to estimate patient activity levels across groups. Participants were observed every 10 minutes between 7.30 am and 7.30 pm within the first 10 days after stroke. Adverse and serious adverse events were recorded using a clinical registry. The enriched environment group ( n = 30, mean age 76.7 ± 12.1) spent a significantly higher proportion of their day engaged in 'any' activity (71% vs. 58%, P = 0.005) compared to the usual care group ( n = 30, mean age 76.0 ± 12.8). They were more active in physical (33% vs. 22%, P < 0.001), social (40% vs. 29%, P = 0.007) and cognitive domains (59% vs. 45%, P = 0.002) and changes were sustained six months post implementation. The enriched group experienced significantly fewer adverse events (0.4 ± 0.7 vs.1.3 ± 1.6, P = 0.001), with no differences found in serious adverse events (0.5 ± 1.6 vs.1.0 ± 2.0, P = 0.309). Embedding an enriched environment in an acute stroke unit increased activity in stroke patients.

Improved facial affect recognition in schizophrenia following an emotion intervention, but not training attention-to-facial-features or treatment-as-usual.

PubMed

Tsotsi, Stella; Kosmidis, Mary H; Bozikas, Vasilis P

2017-08-01

In schizophrenia, impaired facial affect recognition (FAR) has been associated with patients' overall social functioning. Interventions targeting attention or FAR per se have invariably yielded improved FAR performance in these patients. Here, we compared the effects of two interventions, one targeting FAR and one targeting attention-to-facial-features, with treatment-as-usual on patients' FAR performance. Thirty-nine outpatients with schizophrenia were randomly assigned to one of three groups: FAR intervention (training to recognize emotional information, conveyed by changes in facial features), attention-to-facial-features intervention (training to detect changes in facial features), and treatment-as-usual. Also, 24 healthy controls, matched for age and education, were assigned to one of the two interventions. Two FAR measurements, baseline and post-intervention, were conducted using an original experimental procedure with alternative sets of stimuli. We found improved FAR performance following the intervention targeting FAR in comparison to the other patient groups, which in fact was comparable to the pre-intervention performance of healthy controls in the corresponding intervention group. This improvement was more pronounced in recognizing fear. Our findings suggest that compared to interventions targeting attention, and treatment-as-usual, training programs targeting FAR can be more effective in improving FAR in patients with schizophrenia, particularly assisting them in perceiving threat-related information more accurately. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

32 CFR 513.5 - Procedures governing nonactive duty or discharged personnel.

Code of Federal Regulations, 2013 CFR

2013-07-01

... control. (See AR 140-1, para 1-6.) (iii) ARPERCEN for nonunit soldiers assigned to Control Groups of the... control the personal affairs of nonactive duty personnel. These personnel usually are in a civilian status.... (iii) That the Army no longer has control or authority over the discharged personnel. Therefore, the...

Supplemental parenteral nutrition versus usual care in critically ill adults: a pilot randomized controlled study.

PubMed

Ridley, Emma J; Davies, Andrew R; Parke, Rachael; Bailey, Michael; McArthur, Colin; Gillanders, Lyn; Cooper, D James; McGuinness, Shay

2018-01-23

In the critically ill, energy delivery from enteral nutrition (EN) is often less than the estimated energy requirement. Parenteral nutrition (PN) as a supplement to EN may increase energy delivery. We aimed to determine if an individually titrated supplemental PN strategy commenced 48-72 hours following ICU admission and continued for up to 7 days would increase energy delivery to critically ill adults compared to usual care EN delivery. This study was a prospective, parallel group, phase II pilot trial conducted in six intensive care units in Australia and New Zealand. Mechanically ventilated adults with at least one organ failure and EN delivery below 80% of estimated energy requirement in the previous 24 hours received either a supplemental PN strategy (intervention group) or usual care EN delivery. EN in the usual care group could be supplemented with PN if EN remained insufficient after usual methods to optimise delivery were attempted. There were 100 patients included in the study and 99 analysed. Overall, 71% of the study population were male, with a mean (SD) age of 59 (17) years, Acute Physiology and Chronic Health Evaluation II score of 18.2 (6.7) and body mass index of 29.6 (5.8) kg/m 2 . Significantly greater energy (mean (SD) 1712 (511) calories vs. 1130 (601) calories, p < 0.0001) and proportion of estimated energy requirement (mean (SD) 83 (25) % vs. 53 (29) %, p < 0.0001) from EN and/or PN was delivered to the intervention group compared to usual care. Delivery of protein and proportion of estimated protein requirements were also greater in the intervention group (mean (SD) 86 (25) g, 86 (23) %) compared to usual care (mean (SD) 53 (29) g, 51 (25) %, p < 0.0001). Antibiotic use, ICU and hospital length of stay, mortality and functional outcomes were similar between the two groups. This individually titrated supplemental PN strategy applied over 7 days significantly increased energy delivery when compared to usual care delivery. Clinical and functional outcomes were similar between the two patient groups. Clinical Trial registry details: NCT01847534 (First registered 22 April 2013, last updated 31 July 2016).

Cost-effectiveness of acupuncture in an employee population: A retrospective analysis.

PubMed

Borah, Bijan J; Naessens, James M; Glasgow, Amy E; Bauer, Brent A; Chon, Tony Y

2017-04-01

To determine whether acupuncture is a cost-effective adjunct to usual care for Mayo Clinic employees and their dependents experiencing pain symptoms. Retrospective review of the medical and billing records of 466 employee-patients and their dependents who had received acupuncture as part of their care and 466 propensity score-matched control patients. Usual care in combination with acupuncture compared with usual care alone. The primary outcome measure was the total costs of care for all medical care and pharmacy services incurred from 1year before the index visit to 14 months after the index date. Secondary outcomes included the number of hospital visits, total inpatient days, emergency department visits, primary care or general medicine office visits, specialty office visits, and physical therapy services. Pain scores (patient-rated scores from 0 to 10) were extracted from the medical record, if available. Costs of care were similar between the 2 groups. No cost savings were noted for the acupuncture group. Several limitations to the study may have precluded a finding of cost-effectiveness. Future studies should include prospective evaluation of costs and other outcomes in a comparison between acupuncture and usual care in a randomized control trial. Copyright © 2017 Elsevier Ltd. All rights reserved.

Levonorgestrel intrauterine system versus medical therapy for menorrhagia.

PubMed

Gupta, Janesh; Kai, Joe; Middleton, Lee; Pattison, Helen; Gray, Richard; Daniels, Jane

2013-01-10

Menorrhagia is a common problem, yet evidence to inform decisions about therapy is limited. In a pragmatic, multicenter, randomized trial, we compared the levonorgestrel-releasing intrauterine system (levonorgestrel-IUS) with usual medical treatment in women with menorrhagia who presented to their primary care providers. We randomly assigned 571 women with menorrhagia to treatment with levonorgestrel-IUS or usual medical treatment (tranexamic acid, mefenamic acid, combined estrogen-progestogen, or progesterone alone). The primary outcome was the patient-reported score on the Menorrhagia Multi-Attribute Scale (MMAS) (ranging from 0 to 100, with lower scores indicating greater severity), assessed over a 2-year period. Secondary outcomes included general quality-of-life and sexual-activity scores and surgical intervention. MMAS scores improved from baseline to 6 months in both the levonorgestrel-IUS group and the usual-treatment group (mean increase, 32.7 and 21.4 points, respectively; P<0.001 for both comparisons). The improvements were maintained over a 2-year period but were significantly greater in the levonorgestrel-IUS group than in the usual-treatment group (mean between-group difference, 13.4 points; 95% confidence interval, 9.9 to 16.9; P<0.001). Improvements in all MMAS domains (practical difficulties, social life, family life, work and daily routine, psychological well-being, and physical health) were significantly greater in the levonorgestrel-IUS group than in the usual-treatment group, and this was also true for seven of the eight quality-of-life domains. At 2 years, more of the women were still using the levonorgestrel-IUS than were undergoing the usual medical treatment (64% vs. 38%, P<0.001). There were no significant between-group differences in the rates of surgical intervention or sexual-activity scores. There were no significant differences in serious adverse events between groups. In women with menorrhagia who presented to primary care providers, the levonorgestrel-IUS was more effective than usual medical treatment in reducing the effect of heavy menstrual bleeding on quality of life. (Funded by the National Institute of Health Research Health Technology Assessment Programme; ECLIPSE Controlled-Trials.com number, ISRCTN86566246.).

Enhanced interdisciplinary care improves self-care ability and decreases emergency department visits for older Taiwanese patients over 2 years after hip-fracture surgery: A randomised controlled trial.

PubMed

Shyu, Yea-Ing L; Liang, Jersey; Tseng, Ming-Yueh; Li, Hsiao-Juan; Wu, Chi-Chuan; Cheng, Huey-Shinn; Chou, Shih-Wei; Chen, Ching-Yen; Yang, Ching-Tzu

2016-04-01

Little evidence is available on the longer-term effects (beyond 12 months) of intervention models consisting of hip fracture-specific care in conjunction with management of malnutrition, depression, and falls. To compare the relative effects of an interdisciplinary care, and a comprehensive care programme with those of usual care for elderly patients with a hip fracture on self-care ability, health care use, and mortality. Randomised experimental trial. A 3000-bed medical centre in northern Taiwan. Patients with hip fracture aged 60 years or older (N=299). Patients were randomly assigned to three groups: comprehensive care (n=99), interdisciplinary care (n=101), and usual care (control) (n=99). Usual care entailed only one or two in-hospital rehabilitation sessions. Interdisciplinary care included not only hospital rehabilitation, but also geriatric consultation, discharge planning, and 4-month in-home rehabilitation. Building upon interdisciplinary care, comprehensive care extended in-home rehabilitation to 12 months and added management of malnutrition and depressive symptoms, and fall prevention. Patients' self-care ability was measured by activities of daily living and instrumental activities of daily living using the Chinese Barthel Index and Chinese version Instrumental Activities of Daily Living scale, respectively. Outcomes were assessed before discharge, and 1, 3, 6, 12, 18, 24 months following hip fracture. Hierarchical linear models were used to analyse health outcomes and health care utilisation, including emergency department visit and hospital re-admission. The comprehensive care group had better performance trajectories for both measures of activities of daily living and fewer emergency department visits than the usual care group, but no difference in hospital readmissions. The interdisciplinary care and usual care groups did not differ in trajectories of self-care ability and service utilisation. The three groups did not differ in mortality during the 2-year follow-up. Comprehensive care, with enhanced rehabilitation, management of malnutrition and depressive symptoms, and fall prevention, improved self-care ability and decreased emergency department visits for elders up to 2 years after hip-fracture surgery, above and beyond the effects of usual care and interdisciplinary care. Copyright © 2015 Elsevier Ltd. All rights reserved.

PAin SoluTions In the Emergency Setting (PASTIES)--patient controlled analgesia versus routine care in emergency department patients with pain from traumatic injuries: randomised trial.

PubMed

Smith, Jason E; Rockett, Mark; S, Siobhan Creanor; Squire, Rosalyn; Hayward, Chris; Ewings, Paul; Barton, Andy; Pritchard, Colin; Eyre, Victoria; Cocking, Laura; Benger, Jonathan

2015-06-21

To determine whether patient controlled analgesia (PCA) is better than routine care in patients presenting to emergency departments with moderate to severe pain from traumatic injuries. Pragmatic, multicentre, parallel group, randomised controlled trial. Five English hospitals. 200 adults (71% (n = 142) male), aged 18 to 75 years, who presented to the emergency department requiring intravenous opioid analgesia for the treatment of moderate to severe pain from traumatic injuries and were expected to be admitted to hospital for at least 12 hours. PCA (n = 99) or nurse titrated analgesia (treatment as usual; n = 101). The primary outcome was total pain experienced over the 12 hour study period, derived by standardised area under the curve (scaled from 0 to 100) of each participant's hourly pain scores, captured using a visual analogue scale. Pre-specified secondary outcomes included total morphine use, percentage of study period in moderate/severe pain, percentage of study period asleep, length of hospital stay, and satisfaction with pain management. 200 participants were included in the primary analyses. Mean total pain experienced was 47.2 (SD 21.9) for the treatment as usual group and 44.0 (24.0) for the PCA group. Adjusted analyses indicated slightly (but not statistically significantly) lower total pain experienced in the PCA group than in the routine care group (mean difference 2.7, 95% confidence interval -2.4 to 7.8). Participants allocated to PCA used more morphine in total than did participants in the treatment as usual group (mean 44.3 (23.2) v 27.2 (18.2) mg; mean difference 17.0, 11.3 to 22.7). PCA participants spent, on average, less time in moderate/severe pain (36.2% (31.0) v 44.1% (31.6)), but the difference was not statistically significant. A higher proportion of PCA participants reported being perfectly or very satisfied compared with the treatment as usual group (86% (78/91) v 76% (74/98)), but this was also not statistically significant. PCA provided no statistically significant reduction in pain compared with routine care for emergency department patients with traumatic injuries. Trial registration European Clinical Trials Database EudraCT2011-000194-31; Current Controlled Trials ISRCTN25343280. © Smith et al 2015.

Improving youth question-asking and provider education during pediatric asthma visits.

PubMed

Sleath, Betsy; Carpenter, Delesha M; Davis, Scott A; Watson, Claire Hayes; Lee, Charles; Loughlin, Ceila E; Garcia, Nacire; Reuland, Daniel S; Tudor, Gail

2018-06-01

We conducted a pragmatic randomized controlled trial to test the effectiveness of an asthma question prompt list with video intervention to increase youth question-asking and provider education during visits. English or Spanish-speaking youth ages 11-17 with persistent asthma and their parents were enrolled from four rural and suburban pediatric clinics. Youth were randomized to the intervention or usual care groups. Intervention group adolescents watched the video on an iPad and then completed an asthma question prompt list before their visits. Generalized estimating equations were used to analyze the data. Forty providers and 359 patients participated. Intervention group youth were significantly more likely to ask one or more questions about medications, triggers, and environmental control than usual care youth. Providers were significantly more likely to educate intervention group youth about rescue medications, triggers, and environmental control. Intervention group caregivers were not significantly more likely to ask questions. The intervention increased youth question-asking and provider education about medications, triggers, and environmental control. The intervention did not impact caregiver question-asking. Providers/practices should consider having youth complete question prompt lists and watch the video with their parents before visits to increase youth question-asking during visits. Copyright © 2018 Elsevier B.V. All rights reserved.

Antenatal hypnosis training and childbirth experience: a randomized controlled trial.

PubMed

Werner, Anette; Uldbjerg, Niels; Zachariae, Robert; Wu, Chun Sen; Nohr, Ellen A

2013-12-01

Childbirth is a demanding event in a woman's life. The aim of this study was to explore whether a brief intervention in the form of an antenatal course in self-hypnosis to ease childbirth could improve the childbirth experience. In a randomized, controlled, single-blinded trial, 1,222 healthy nulliparous women were allocated to one of three groups during pregnancy: A hypnosis group participating in three 1-hour sessions teaching self-hypnosis to ease childbirth, a relaxation group receiving three 1-hour lessons in various relaxation methods and Mindfulness, and a usual care group receiving ordinary antenatal care only. Wijmas Delivery Expectancy/Experience Questionnaire (W-DEQ) was used to measure the childbirth experience 6 weeks postpartum. The intention-to-treat analysis indicated that women in the hypnosis group experienced their childbirth as better compared with the other two groups (mean W-DEQ score of 42.9 in the Hypnosis group, 47.2 in the Relaxation group, and 47.5 in the Care as usual group (p = 0.01)). The tendency toward a better childbirth experience in the hypnosis group was also seen in subgroup analyses for mode of delivery and for levels of fear. In this large randomized controlled trial, a brief course in self-hypnosis improved the women's childbirth experience. © 2013, Copyright the Authors Journal compilation © 2013, Wiley Periodicals, Inc.

Reducing falls after hospital discharge: a protocol for a randomised controlled trial evaluating an individualised multimodal falls education programme for older adults.

PubMed

Hill, Anne-Marie; Etherton-Beer, Christopher; McPhail, Steven M; Morris, Meg E; Flicker, Leon; Shorr, Ronald; Bulsara, Max; Lee, Den-Ching; Francis-Coad, Jacqueline; Waldron, Nicholas; Boudville, Amanda; Haines, Terry

2017-02-02

Older adults frequently fall after discharge from hospital. Older people may have low self-perceived risk of falls and poor knowledge about falls prevention. The primary aim of the study is to evaluate the effect of providing tailored falls prevention education in addition to usual care on falls rates in older people after discharge from hospital compared to providing a social intervention in addition to usual care. The 'Back to My Best' study is a multisite, single blind, parallel-group randomised controlled trial with blinded outcome assessment and intention-to-treat analysis, adhering to CONSORT guidelines. Patients (n=390) (aged 60 years or older; score more than 7/10 on the Abbreviated Mental Test Score; discharged to community settings) from aged care rehabilitation wards in three hospitals will be recruited and randomly assigned to one of two groups. Participants allocated to the control group shall receive usual care plus a social visit. Participants allocated to the experimental group shall receive usual care and a falls prevention programme incorporating a video, workbook and individualised follow-up from an expert health professional to foster capability and motivation to engage in falls prevention strategies. The primary outcome is falls rates in the first 6 months after discharge, analysed using negative binomial regression with adjustment for participant's length of observation in the study. Secondary outcomes are injurious falls rates, the proportion of people who become fallers, functional status and health-related quality of life. Healthcare resource use will be captured from four sources for 6 months after discharge. The study is powered to detect a 30% relative reduction in the rate of falls (negative binomial incidence ratio 0.70) for a control rate of 0.80 falls per person over 6 months. Results will be presented in peer-reviewed journals and at conferences worldwide. This study is approved by hospital and university Human Research Ethics Committees. ACTRN12615000784516. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

MEDication reminder APPs to improve medication adherence in Coronary Heart Disease (MedApp-CHD) Study: a randomised controlled trial protocol.

PubMed

Santo, Karla; Chow, Clara K; Thiagalingam, Aravinda; Rogers, Kris; Chalmers, John; Redfern, Julie

2017-10-08

The growing number of smartphone health applications available in the app stores makes these apps a promising tool to help reduce the global problem of non-adherence to long-term medications. However, to date, there is limited evidence that available medication reminder apps are effective. This study aims to determine the impact of medication reminder apps on adherence to cardiovascular medication when compared with usual care for people with coronary heart disease (CHD) and to determine whether an advanced app compared with a basic app is associated with higher adherence. Randomised controlled trial with follow-up at 3 months to evaluate the feasibility and effectiveness of medication reminder apps on medication adherence compared with usual care. An estimated sample size of 156 patients with CHD will be randomised to one of three groups (usual care group, basic medication reminder app group and advanced medication reminder app group). The usual care group will receive standard care for CHD with no access to a medication reminder app. The basic medication reminder app group will have access to a medication reminder app with a basic feature of providing simple daily reminders with no interactivity. The advanced medication reminder app group will have access to a medication reminder app with additional interactive and customisable features. The primary outcome is medication adherence measured by the eight-item Morisky Medication Adherence Scale at 3 months. Secondary outcomes include clinical measurements of blood pressure and cholesterol levels, and medication knowledge. A process evaluation will also be performed to assess the feasibility of the intervention by evaluating the acceptability, utility and engagement with the apps. Ethical approval has been obtained from the Western Sydney Local Health Network Human Research Ethics Committee (AU/RED/HREC/1/WMEAD/3). Study findings will be disseminated via usual scientific forums. ACTRN12616000661471; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Electroacupuncture for insomnia disorder: study protocol for a randomized controlled trial.

PubMed

Kim, Sung-Phil; Kim, Joo-Hee; Kim, Bo-Kyung; Kim, Hyeong-Jun; Jung, In Chul; Cho, Jung Hyo; Kim, Jung-Eun; Kim, Mi-Kyung; Kwon, O-Jin; Kim, Ae-Ran; Park, Hyo-Ju; Seo, Bok-Nam

2017-04-13

Insomnia is a common sleep disorder that affects many adults either transiently or chronically. The societal cost of insomnia is on the rise, while long-term use of current drug treatments can involve adverse effects. Recently, electroacupuncture (EA) has been used to treat various conditions including insomnia. The objective of this study is to provide scientific evidence for the effect and safety of using EA to treat insomnia. In this multicentre, assessor-blind, three-arm, parallel-design, randomised controlled trial, 150 participants will be assigned to the EA group, the sham EA (SEA) group, or the usual care group. The EA and SEA groups will receive the specific treatments 2-3 times a week for 4 weeks, for a total of 10 sessions, whereas the usual care group will not receive EA and will continue with usual care during the same time period. The primary outcome measure will be changes in the Insomnia Severity Index 5 weeks after randomisation. The secondary outcomes will include the Pittsburgh Sleep Quality Index, the Hospital Anxiety and Depression Scale, a sleep diary, the EuroQoL-5 dimension questionnaire, the levels of melatonin and cortisol, and the Patient Global Impression of Change. Safety will be assessed at each visit. The results of this multicentre randomised controlled trial will contribute to provide rigorous clinical evidence for the effects and safety of EA for insomnia disorder. Korean Clinical Trial Registry, CRIS, KCT0001685 . Registered on 2 November 2015 (retrospectively registered). Date of enrolment of the first participant to the trial 13 October 2015.

Randomised controlled trial of integrated care to reduce disability from chronic low back pain in working and private life.

PubMed

Lambeek, Ludeke C; van Mechelen, Willem; Knol, Dirk L; Loisel, Patrick; Anema, Johannes R

2010-03-16

To evaluate the effectiveness of an integrated care programme, combining a patient directed and a workplace directed intervention, for patients with chronic low back pain. Population based randomised controlled trial. Primary care (10 physiotherapy practices, one occupational health service, one occupational therapy practice) and secondary care (five hospitals). 134 adults aged 18-65 sick listed for at least 12 weeks owing to low back pain. Patients were randomly assigned to usual care (n=68) or integrated care (n=66). Integrated care consisted of a workplace intervention based on participatory ergonomics, involving a supervisor, and a graded activity programme based on cognitive behavioural principles. The primary outcome was the duration of time off work (work disability) due to low back pain until full sustainable return to work. Secondary outcome measures were intensity of pain and functional status. The median duration until sustainable return to work was 88 days in the integrated care group compared with 208 days in the usual care group (P=0.003). Integrated care was effective on return to work (hazard ratio 1.9, 95% confidence interval 1.2 to 2.8, P=0.004). After 12 months, patients in the integrated care group improved significantly more on functional status compared with patients in the usual care group (P=0.01). Improvement of pain between the groups did not differ significantly. The integrated care programme substantially reduced disability due to chronic low back pain in private and working life. Trial registration Current Controlled Trials ISRCTN28478651.

MAXCOG-Maximizing Cognition: A Randomized Controlled Trial of the Efficacy of Goal-Oriented Cognitive Rehabilitation for People with Mild Cognitive Impairment and Early Alzheimer Disease.

PubMed

Regan, Bridget; Wells, Yvonne; Farrow, Maree; O'Halloran, Paul; Workman, Barbara

2017-03-01

To review the efficacy of a home-based four-session individualized face-to-face cognitive rehabilitation (MAXCOG) intervention for clients with mild cognitive impairment (MCI) or early dementia and their close supporters. Randomized controlled trial comparing the intervention group (MAXCOG) with treatment as usual (control). A total of 55 client-supporter dyads were enrolled in the study and 40 completed; 25 client-supporter dyads completed MAXCOG and 15 completed treatment as usual. Both MAXCOG and control groups included more MCI cases than dementia (22 versus 3 and 12 versus 3, respectively). Four weekly individual sessions of MAXCOG consisting of personalized interventions to address individually relevant goals, supported by the provision of the MAXCOG information resource. The primary outcomes were goal performance and satisfaction, assessed using the Canadian Occupational Performance Measure (COPM). Questionnaires assessing mood, illness adjustment, quality of life, and carer burden were also administered. The intervention group displayed significantly higher performance and satisfaction with primary goals on the COPM post-intervention than the control group, using a per-protocol analysis. The MAXCOG intervention is effective in improving goal performance and satisfaction in clients with MCI and early dementia. Copyright © 2017 American Association for Geriatric Psychiatry. All rights reserved.

Training Nonnursing Staff to Assist with Nutritional Care Delivery in Nursing Homes: A Cost-Effectiveness Analysis.

PubMed

Simmons, Sandra F; Hollingsworth, Emily K; Long, Emily A; Liu, Xulei; Shotwell, Matthew S; Keeler, Emmett; An, Ruopeng; Silver, Heidi J

2017-02-01

To determine the effect and cost-effectiveness of training nonnursing staff to provide feeding assistance for nutritionally at-risk nursing home (NH) residents. Randomized, controlled trial. Five community NHs. Long-stay NH residents with an order for caloric supplementation (N = 122). Research staff provided an 8-hour training curriculum to nonnursing staff. Trained staff were assigned to between-meal supplement or snack delivery for the intervention group; the control group received usual care. Research staff used standardized observations and weighed-intake methods to measure frequency of between-meal delivery, staff assistance time, and resident caloric intake. Fifty staff (mean 10 per site) completed training. The intervention had a significant effect on between-meal caloric intake (F = 56.29, P < .001), with the intervention group consuming, on average, 163.33 (95% CI = 120.19-206.47) calories per person per day more than the usual care control group. The intervention costs were $1.27 per person per day higher than usual care (P < .001). The incremental cost-effectiveness ratio for the intervention was 134 kcal per dollar. The increase in cost was due to the higher frequency and number of snack items given per person per day and the associated staff time to provide assistance. It is cost effective to train nonnursing staff to provide caloric supplementation, and this practice has a positive effect on residents' between-meal intake. © 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.

Mini-intervention for subacute low back pain: a randomized controlled trial.

PubMed

Karjalainen, Kaija; Malmivaara, Antti; Pohjolainen, Timo; Hurri, Heikki; Mutanen, Pertti; Rissanen, Pekka; Pahkajärvi, Helena; Levon, Heikki; Karpoff, Hanna; Roine, Risto

2003-03-15

Randomized controlled trial. To investigate the effectiveness and costs of a mini-intervention, provided in addition to the usual care, and the incremental effect of a work site visit for patients with subacute disabling low back pain. There is lack of data on cost-effectiveness of brief interventions for patients with prolonged low back pain. A total of 164 patients with subacute low back pain were randomized to a mini-intervention group (A), a work site visit group (B), or a usual care group (C). Groups A (n = 56) and B (n = 51) underwent one assessment by a physician plus a physiotherapist. Group B received a work site visit in addition. Group C served as controls (n = 57) and was treated in municipal primary health care. All patients received a leaflet on back pain. Pain, disability, specific and generic health-related quality of life, satisfaction with care, days on sick leave, and use and costs of health care consumption were measured at 3-, 6-, and 12-month follow-ups. During follow-up, fewer subjects had daily pain in Groups A and B than in Group C (Group A Group C, = 0.002; Group B Group C, = 0.030). In Group A, pain was less bothersome (Group A Group C, = 0.032) and interfered less with daily life (Group A Group C, = 0.040) than among controls. Average days on sick leave were 19 in Group A, 28 in Group B, and 41 in Group C (Group A Group C, = 0.019). Treatment satisfaction was better in the intervention groups than among the controls, and costs were lowest in the mini-intervention group. Mini-intervention reduced daily back pain symptoms and sickness absence, improved adaptation to pain and patient satisfaction among patients with subacute low back pain, without increasing health care costs. A work site visit did not increase effectiveness.

Reproductive health knowledge among African American women enrolled in a clinic-based randomized controlled trial to reduce psychosocial and behavioral risk, Project DC-HOPE

PubMed Central

Backonja, Uba; Robledo, Candace A.; Wallace, Maeve E.; Flores, Katrina F.; Kiely, Michele

2016-01-01

Background Washington, D.C. has among the highest rates of sexually transmitted infections (STIs) and unintended pregnancy in the United States. Increasing women’s reproductive health knowledge may help address these reproductive health issues. This analysis assessed whether high-risk pregnant African American women in Washington, D.C. who participated in an intervention to reduce behavioral and psychosocial risks had greater reproductive health knowledge than women receiving usual care. Methods Project DC-HOPE was a randomized controlled trial that included pregnant African American women in Washington, D.C., recruited during prenatal care. Women in the intervention group were provided reproductive health education and received tailored counseling sessions to address their psychosocial and behavioral risk(s) (cigarette smoking, environmental tobacco smoke exposure, depression, and intimate partner violence). Women in the control group received usual prenatal care. Participants completed a 10-item reproductive knowledge assessment at baseline (n=1,044) and postpartum (n=830). Differences in total reproductive health knowledge scores at baseline and postpartum between groups were examined via chi-squared tests. Differences in postpartum mean total score by group were assessed via multiple linear regression. Results Women in both groups and at both time points scored approximately 50% on the knowledge assessments. At postpartum, women in the intervention group had higher total scores compared to women receiving usual care (mean 5.40 [SD 1.60] vs. 5.03 [SD 1.53] out of 10, respectively; p<0.001). Conclusions While intervention participants increased reproductive health knowledge, overall scores remained low. Development of interventions designed to impart accurate, individually tailored information to women may promote reproductive health knowledge among high-risk pregnant African American women residing in Washington, D.C. PMID:27094910

The effects of inpatient exercise therapy on the length of hospital stay in stages I-III colon cancer patients: randomized controlled trial.

PubMed

Ahn, Ki-Yong; Hur, Hyuk; Kim, Dong-Hyun; Min, Jihee; Jeong, Duck Hyoun; Chu, Sang Hui; Lee, Ji Won; Ligibel, Jennifer A; Meyerhardt, Jeffrey A; Jones, Lee W; Jeon, Justin Y; Kim, Nam Kyu

2013-05-01

This study aimed to examine the effects of a postsurgical, inpatient exercise program on postoperative recovery in operable colon cancer patients We conducted the randomized controlled trial with two arms: postoperative exercise vs. usual care. Patients with stages I-III colon cancer who underwent colectomy between January and December 2011 from the Colorectal Cancer Clinic, were recruited for the study. Subjects in the intervention group participated in the postoperative inpatient exercise program consisted of twice daily exercise, including stretching, core, balance, and low-intensity resistance exercises. The usual care group was not prescribed a structured exercise program. The primary endpoint was the length of hospital stay. Secondary endpoints were time to flatus, time to first liquid diet, anthropometric measurements, and physical function measurements. A total of 31 (86.1 %) patients completed the trial, with adherence to exercise interventions at 84.5 %. The mean length of hospital stay was 7.82 ± 1.07 days in the exercise group compared with 9.86 ± 2.66 days in usual care (mean difference, 2.03 days; 95 % confidence interval (CI), -3.47 to -0.60 days; p = 0.005) in per-protocol analysis. The mean time to flatus was 52.18 ± 21.55 h in the exercise group compared with 71.86 ± 29.2 h in the usual care group (mean difference, 19.69 h; 95 % CI, -38.33 to -1.04 h; p = 0.036). Low-to-moderate-intensity postsurgical exercise reduces length of hospital stay and improves bowel motility after colectomy procedure in patients with stages I-III colon cancer.

Two decision aids for mode of delivery among women with previous caesarean section: randomised controlled trial.

PubMed

Montgomery, Alan A; Emmett, Clare L; Fahey, Tom; Jones, Claire; Ricketts, Ian; Patel, Roshni R; Peters, Tim J; Murphy, Deirdre J

2007-06-23

To determine the effects of two computer based decision aids on decisional conflict and mode of delivery among pregnant women with a previous caesarean section. Randomised trial, conducted from May 2004 to August 2006. Four maternity units in south west England, and Scotland. 742 pregnant women with one previous lower segment caesarean section and delivery expected at >or=37 weeks. Non-English speakers were excluded. Usual care: standard care given by obstetric and midwifery staff. Information programme: women navigated through descriptions and probabilities of clinical outcomes for mother and baby associated with planned vaginal birth, elective caesarean section, and emergency caesarean section. Decision analysis: mode of delivery was recommended based on utility assessments performed by the woman combined with probabilities of clinical outcomes within a concealed decision tree. Both interventions were delivered via a laptop computer after brief instructions from a researcher. Total score on decisional conflict scale, and mode of delivery. Women in the information programme (adjusted difference -6.2, 95% confidence interval -8.7 to -3.7) and the decision analysis (-4.0, -6.5 to -1.5) groups had reduced decisional conflict compared with women in the usual care group. The rate of vaginal birth was higher for women in the decision analysis group compared with the usual care group (37% v 30%, adjusted odds ratio 1.42, 0.94 to 2.14), but the rates were similar in the information programme and usual care groups. Decision aids can help women who have had a previous caesarean section to decide on mode of delivery in a subsequent pregnancy. The decision analysis approach might substantially affect national rates of caesarean section. Trial Registration Current Controlled Trials ISRCTN84367722.

Interprofessional stroke rehabilitation for stroke survivors using home care.

PubMed

Markle-Reid, Maureen; Orridge, Camille; Weir, Robin; Browne, Gina; Gafni, Amiram; Lewis, Mary; Walsh, Marian; Levy, Charissa; Daub, Stacey; Brien, Heather; Roberts, Jacqueline; Thabane, Lehana

2011-03-01

To compare a specialized interprofessional team approach to community-based stroke rehabilitation with usual home care for stroke survivors using home care services. Randomized controlled trial of 101 community-living stroke survivors (<18 months post-stroke) using home care services. Subjects were randomized to intervention (n=52) or control (n=49) groups. The intervention was a 12-month specialized, evidence-based rehabilitation strategy involving an interprofessional team. The primary outcome was change in health-related quality of life and functioning (SF-36) from baseline to 12 months. Secondary outcomes were number of strokes during the 12-month follow-up, and changes in community reintegration (RNLI), perceived social support (PRQ85-Part 2), anxiety and depressive symptoms (Kessler-10), cognitive function (SPMSQ), and costs of use of health services from baseline to 12 months. A total of 82 subjects completed the 12-month follow-up. Compared with the usual care group, stroke survivors in the intervention group showed clinically important (although not statistically significant) greater improvements from baseline in mean SF-36 physical functioning score (5.87, 95% CI -3.98 to 15.7; p=0.24) and social functioning score (9.03, CI-7.50 to 25.6; p=0.28). The groups did not differ for any of the secondary effectiveness outcomes. There was a higher total per-person costs of use of health services in the intervention group compared to usual home care although the difference was not statistically significant (p=0.76). A 12-month specialized, interprofessional team is a feasible and acceptable approach to community-based stroke rehabilitation that produced greater improvements in quality of life compared to usual home care. Clinicaltrials.gov identifier: NCT00463229.

Impact of a supervised worksite exercise program on back and core muscular endurance in firefighters.

PubMed

Mayer, John M; Quillen, William S; Verna, Joe L; Chen, Ren; Lunseth, Paul; Dagenais, Simon

2015-01-01

Low back pain is a leading cause of disability in firefighters and is related to poor muscular endurance. This study examined the impact of supervised worksite exercise on back and core muscular endurance in firefighters. A cluster randomized controlled trial was used for this study. The study occurred in fire stations of a municipal fire department (Tampa, Florida). Subjects were 96 full-duty career firefighters who were randomly assigned by fire station to exercise (n = 54) or control (n = 42) groups. Exercise group participants completed a supervised exercise targeting the back and core muscles while on duty, two times per week for 24 weeks, in addition to their usual fitness regimen. Control group participants continued their usual fitness regimen. Back and core muscular endurance was assessed with the Biering-Sorensen test and plank test, respectively. Changes in back and core muscular endurance from baseline to 24 weeks were compared between groups using analysis of covariance and linear mixed effects models. After 24 weeks, the exercise group had 12% greater (p = .021) back muscular endurance and 21% greater (p = .0006) core muscular endurance than did the control group. The exercise intervention did not disrupt operations or job performance. A supervised worksite exercise program was safe and effective in improving back and core muscular endurance in firefighters, which could protect against future low back pain.

Prospective study of the effects of ventilation tubes on hearing after radiotherapy for carcinoma of nasopharynx

DOE Office of Scientific and Technical Information (OSTI.GOV)

Chowdhury, C.R.; Ho, J.H.; Wright, A.

1988-03-01

In patients with nasopharyngeal carcinoma, deafness sometimes occurs following radiotherapy. It is usually conductive, but may be sensorineural. Tinnitus is present frequently and usually is distressing. The role of ventilation tubes (grommets) in relieving these problems was assessed in a prospective randomized controlled trial of 115 patients. In the group with grommets, there was an improvement in hearing, with a reduction of the averaged air-bone gap (p less than .01). This was not found in the control group without ventilation tubes, who developed a larger conductive loss (p less than .01) and, in addition, a slight deterioration of the averagedmore » bone conduction threshold (p less than .01). Surprisingly, the group with grommets did not develop this sensorineural loss (p less than .01). In addition, tinnitus was improved significantly by the insertion of ventilation tubes (p less than .01). Neither necrosis nor stenosis of the external auditory meatus was found in either group.« less

Prospective study of the effects of ventilation tubes on hearing after radiotherapy for carcinoma of nasopharynx

DOE Office of Scientific and Technical Information (OSTI.GOV)

Chowdhury, C.R.; Ho, J.H.; Wright, A.

In patients with nasopharyngeal carcinoma, deafness sometimes occurs following radiotherapy. It is usually conductive, but may be sensorineural. Tinnitus is present frequently and usually is distressing. The role of ventilation tubes (grommets) in relieving these problems was assessed in a prospective randomized controlled trial of 115 patients. In the group with grommets, there was an improvement in hearing, with a reduction of the averaged air-bone gap (p less than .01). This was not found in the control group without ventilation tubes, who developed a larger conductive loss (p less than .01) and, in addition, a slight deterioration of the averagedmore » bone conduction threshold (p less than .01). Surprisingly, the group with grommets did not develop this sensorineural loss (p less than .01). In addition, tinnitus was improved significantly by the insertion of ventilation tubes (p less than .01). Neither necrosis nor stenosis of the external auditory meatus was found in either group.« less

Assessing treatment-as-usual provided to control groups in adherence trials: Exploring the use of an open-ended questionnaire for identifying behaviour change techniques.

PubMed

Oberjé, Edwin J M; Dima, Alexandra L; Pijnappel, Frank J; Prins, Jan M; de Bruin, Marijn

2015-01-01

Reporting guidelines call for descriptions of control group support in equal detail as for interventions. However, how to assess the active content (behaviour change techniques (BCTs)) of treatment-as-usual (TAU) delivered to control groups in trials remains unclear. The objective of this study is to pre-test a method of assessing TAU in a multicentre cost-effectiveness trial of an HIV-treatment adherence intervention. HIV-nurses (N = 21) completed a semi-structured open-ended questionnaire enquiring about TAU adherence counselling. Two coders independently coded BCTs. Completeness and clarity of nurse responses, inter-coder reliabilities and the type of BCTs reported were examined. The clarity and completeness of nurse responses were adequate. Twenty-three of the 26 identified BCTs could be reliably coded (mean κ = .79; mean agreement rate = 96%) and three BCTs scored below κ = .60. Total number of BCTs reported per nurse ranged between 7 and 19 (M = 13.86, SD = 3.35). This study suggests that the TAU open-ended questionnaire is a feasible and reliable tool to capture active content of support provided to control participants in a multicentre adherence intervention trial. Considerable variability in the number of BCTs provided to control patients was observed, illustrating the importance of reliably collecting and accurately reporting control group support.

Electroacupuncture to treat painful diabetic neuropathy: study protocol for a three-armed, randomized, controlled pilot trial.

PubMed

Lee, Seunghoon; Kim, Joo-Hee; Shin, Kyung-Min; Kim, Jung-Eun; Kim, Tae-Hun; Kang, Kyung-Won; Lee, Minhee; Jung, So-Young; Shin, Mi-Suk; Kim, Ae-Ran; Park, Hyo-Ju; Hong, Kwon-Eui; Choi, Sun-Mi

2013-07-18

The purpose of this study is to conduct a basic analysis of the effectiveness and safety of electroacupuncture in the treatment of painful diabetic neuropathy (PDN) as compared to placebo and usual care and to evaluate the feasibility of large-scale clinical research. This study is a protocol for a three-armed, randomized, patient-assessor-blinded (to the type of treatment), controlled pilot trial. Forty-five participants with a ≥ six month history of PDN and a mean weekly pain score of ≥ 4 on the 11-point Pain Intensity Numerical Rating Scale (PI-NRS) will be assigned to the electroacupuncture group (n = 15), sham group (n = 15) or usual care group (n = 15). The participants assigned to the electroacupuncture group will receive electroacupuncture (remaining for 30 minutes with a mixed current of 2 Hz/120 Hz and 80% of the bearable intensity) at 12 standard acupuncture points (bilateral ST36, GB39, SP9, SP6, LR3 and GB41) twice per week for eight weeks (a total of 16 sessions) as well as the usual care. The participants in the sham group will receive sham electroacupuncture (no electrical current will be passed to the needle, but the light will be seen, and the sound of the pulse generator will be heard by the participants) at non-acupuncture points as well as the usual care. The participants in the usual care group will not receive electroacupuncture treatment during the study period and will receive only the usual care. The follow-up will be in the 5th, 9th and 17th weeks after random allocation. The PI-NRS score assessed at the ninth week will be the primary outcome measurement used in this study. The Short-Form McGill Pain Questionnaire (SF-MPQ), a sleep disturbance score (11-point Likert scale), the Short-Form 36v2 Health Survey (SF-36), the Beck Depression Inventory (BDI) and the Patient Global Impression of Change (PGIC) will be used as outcome variables to evaluate the effectiveness of the acupuncture. Safety will be assessed at every visit. The result of this trial will provide a basis for the effectiveness and safety of electroacupuncture for PDN. Clinical Research information Service. Unique identifier: KCT0000466.

Electroacupuncture to treat painful diabetic neuropathy: study protocol for a three-armed, randomized, controlled pilot trial

PubMed Central

2013-01-01

Background The purpose of this study is to conduct a basic analysis of the effectiveness and safety of electroacupuncture in the treatment of painful diabetic neuropathy (PDN) as compared to placebo and usual care and to evaluate the feasibility of large-scale clinical research. Methods/design This study is a protocol for a three-armed, randomized, patient-assessor-blinded (to the type of treatment), controlled pilot trial. Forty-five participants with a ≥ six month history of PDN and a mean weekly pain score of ≥ 4 on the 11-point Pain Intensity Numerical Rating Scale (PI-NRS) will be assigned to the electroacupuncture group (n = 15), sham group (n = 15) or usual care group (n = 15). The participants assigned to the electroacupuncture group will receive electroacupuncture (remaining for 30 minutes with a mixed current of 2 Hz/120 Hz and 80% of the bearable intensity) at 12 standard acupuncture points (bilateral ST36, GB39, SP9, SP6, LR3 and GB41) twice per week for eight weeks (a total of 16 sessions) as well as the usual care. The participants in the sham group will receive sham electroacupuncture (no electrical current will be passed to the needle, but the light will be seen, and the sound of the pulse generator will be heard by the participants) at non-acupuncture points as well as the usual care. The participants in the usual care group will not receive electroacupuncture treatment during the study period and will receive only the usual care. The follow-up will be in the 5th, 9th and 17th weeks after random allocation. The PI-NRS score assessed at the ninth week will be the primary outcome measurement used in this study. The Short-Form McGill Pain Questionnaire (SF-MPQ), a sleep disturbance score (11-point Likert scale), the Short-Form 36v2 Health Survey (SF-36), the Beck Depression Inventory (BDI) and the Patient Global Impression of Change (PGIC) will be used as outcome variables to evaluate the effectiveness of the acupuncture. Safety will be assessed at every visit. Discussion The result of this trial will provide a basis for the effectiveness and safety of electroacupuncture for PDN. Trial registration Clinical Research information Service. Unique identifier: KCT0000466. PMID:23866906

Cognitive-behavioral group therapy is an effective treatment for major depression in hemodialysis patients.

PubMed

Duarte, Priscila Silveira; Miyazaki, Maria Cristina; Blay, Sergio Luís; Sesso, Ricardo

2009-08-01

Depression is an important target of psychological assessment in patients with end-stage renal disease because it predicts their morbidity, mortality, and quality of life. We assessed the effectiveness of cognitive-behavioral therapy in chronic hemodialysis patients diagnosed with major depression by the Mini International Neuropsychiatric Interview (MINI). In a randomized trial conducted in Brazil, an intervention group of 41 patients was given 12 weekly sessions of cognitive-behavioral group therapy led by a trained psychologist over 3 months while a control group of 44 patients received the usual treatment offered in the dialysis unit. In both groups, the Beck Depression Inventory, the MINI, and the Kidney Disease and Quality of Life-Short Form questionnaires were administered at baseline, after 3 months of intervention or usual treatment, and after 9 months of follow-up. The intervention group had significant improvements, compared to the control group, in the average scores of the Beck Depression Inventory overall scale, MINI scores, and in quality-of-life dimensions that included the burden of renal disease, sleep, quality of social interaction, overall health, and the mental component summary. We conclude that cognitive-behavioral group therapy is an effective treatment of depression in chronic hemodialysis patients.

The ANTOP study: focal psychodynamic psychotherapy, cognitive-behavioural therapy, and treatment-as-usual in outpatients with anorexia nervosa - a randomized controlled trial

PubMed Central

Wild, Beate; Friederich, Hans-Christoph; Gross, Gaby; Teufel, Martin; Herzog, Wolfgang; Giel, Katrin E; de Zwaan, Martina; Schauenburg, Henning; Schade-Brittinger, Carmen; Schäfer, Helmut; Zipfel, Stephan

2009-01-01

Background Anorexia nervosa is a serious eating disorder leading to high morbidity and mortality as a result of both malnutrition and suicide. The seriousness of the disorder requires extensive knowledge of effective treatment options. However, evidence for treatment efficacy in this area is remarkably weak. A recent Cochrane review states that there is an urgent need for large, well-designed treatment studies for patients with anorexia nervosa. The aim of this particular multi-centre study is to evaluate the efficacy of two standardized outpatient treatments for patients with anorexia nervosa: focal psychodynamic (FPT) and cognitive behavioural therapy (CBT). Each therapeutic approach is compared to a "treatment-as-usual" control group. Methods/Design 237 patients meeting eligibility criteria are randomly and evenly assigned to the three groups – two intervention groups (CBT and FPT) and one control group. The treatment period for each intervention group is 10 months, consisting of 40 sessions respectively. Body weight, eating disorder related symptoms, and variables of therapeutic alliance are measured during the course of treatment. Psychotherapy sessions are audiotaped for adherence monitoring. The treatment in the control group, both the dosage and type of therapy, is not regulated in the study protocol, but rather reflects the current practice of established outpatient care. The primary outcome measure is the body mass index (BMI) at the end of the treatment (10 months after randomization). Discussion The study design surmounts the disadvantages of previous studies in that it provides a randomized controlled design, a large sample size, adequate inclusion criteria, an adequate treatment protocol, and a clear separation of the treatment conditions in order to avoid contamination. Nevertheless, the study has to deal with difficulties specific to the psychopathology of anorexia nervosa. The treatment protocol allows for dealing with the typically occurring medical complications without dropping patients from the protocol. However, because patients are difficult to recruit and often ambivalent about treatment, a drop-out rate of 30% is assumed for sample size calculation. Due to the ethical problem of denying active treatment to patients with anorexia nervosa, the control group is defined as "treatment-as-usual". Trial registration Current Controlled Trials ISRCTN72809357 PMID:19389245

Alerts in electronic medical records to promote a colorectal cancer screening programme: a cluster randomised controlled trial in primary care

PubMed Central

Guiriguet, Carolina; Muñoz-Ortiz, Laura; Burón, Andrea; Rivero, Irene; Grau, Jaume; Vela-Vallespín, Carmen; Vilarrubí, Mercedes; Torres, Miquel; Hernández, Cristina; Méndez-Boo, Leonardo; Toràn, Pere; Caballeria, Llorenç; Macià, Francesc; Castells, Antoni

2016-01-01

Background Participation rates in colorectal cancer screening are below recommended European targets. Aim To evaluate the effectiveness of an alert in primary care electronic medical records (EMRs) to increase individuals’ participation in an organised, population-based colorectal cancer screening programme when compared with usual care. Design and setting Cluster randomised controlled trial in primary care centres of Barcelona, Spain. Method Participants were males and females aged 50–69 years, who were invited to the first round of a screening programme based on the faecal immunochemical test (FIT) (n = 41 042), and their primary care professional. The randomisation unit was the physician cluster (n = 130) and patients were blinded to the study group. The control group followed usual care as per the colorectal cancer screening programme. In the intervention group, as well as usual care, an alert to health professionals (cluster level) to promote screening was introduced in the individual’s primary care EMR for 1 year. The main outcome was colorectal cancer screening participation at individual participant level. Results In total, 67 physicians and 21 619 patients (intervention group) and 63 physicians and 19 423 patients (control group) were randomised. In the intention-to-treat analysis screening participation was 44.1% and 42.2% respectively (odds ratio 1.08, 95% confidence interval [CI] = 0.97 to 1.20, P = 0.146). However, in the per-protocol analysis screening uptake in the intervention group showed a statistically significant increase, after adjusting for potential confounders (OR, 1.11; 95% CI = 1.02 to 1.22; P = 0.018). Conclusion The use of an alert in an individual’s primary care EMR is associated with a statistically significant increased uptake of an organised, FIT-based colorectal cancer screening programme in patients attending primary care centres. PMID:27266861

5HTTLPR genotype moderates the longitudinal impact of early caregiving on externalizing behavior

PubMed Central

Smyke, Anna T.; Gleason, Mary Margaret; Nelson, Charles A.; Zeanah, Charles H.; Fox, Nathan A; Drury, Stacy S.

2014-01-01

We examined caregiver report of externalizing behavior from 12 to 54 months of age in 102 children randomized to care as usual in institutions or to newly-created high quality foster care. At baseline no differences by group or genotype in externalizing were found. However, changes in externalizing from baseline to 42 months of age were moderated by 5HTTLPR genotype and intervention group, where the slope for s/s individuals differed as a function of intervention group. The slope for individuals carrying the l allele did not significantly differ between groups. At 54 months of age, s/s children in the foster care group had the lowest levels of externalizing behavior, while children with the s/s genotype in the care as usual group demonstrated the highest rates of externalizing behavior. No intervention group differences were found in externalizing behavior among children who carried the l allele. These findings, within a randomized control trial of foster care compared to continued care as usual, indicate that 5HTTLPR genotype moderates the relation between early caregiving environments to predict externalizing behavior in children exposed to early institutional care in a manner most consistent with differential susceptibility. PMID:25640827

Impact of multifamily psychoeducational psychotherapy in treating children aged 8 to 12 years with mood disorders.

PubMed

Fristad, Mary A; Verducci, Joseph S; Walters, Kimberly; Young, Matthew E

2009-09-01

Childhood mood disorders lack sufficient evidence-based treatments. While psychosocial treatments are recommended for both childhood depression and bipolar disorder, empirical support is scarce. To determine whether adjunctive multifamily psychoeducational psychotherapy would improve outcome for children aged 8 to 12 years with depression or bipolar disorder. One hundred sixty-five children were studied in a randomized controlled trial of multifamily psychoeducational psychotherapy plus treatment as usual (n = 78) compared with a wait-list control (WLC) condition plus treatment as usual (n = 87). Assessments occurred at baseline and at 6, 12, and 18 months. Intervention occurred between baseline and 6 months for the immediate treatment group and between 12 and 18 months for the WLC group. University medical center. Children were recruited from mental health and physical health care providers, media contacts, and word of mouth. All had a major mood disorder (major depressive disorder or dysthymic disorder, 30%; bipolar disorder type I, type II, or not otherwise specified, 70%). Intervention Children and 1 or more parents participated in eight 90-minute multifamily psychoeducational psychotherapy sessions. Parent and child groups met separately but began and ended sessions together. The Mood Severity Index (MSI) combines Mania Rating Scale and Children's Depression Rating Scale-Revised scores. Multifamily psychoeducational psychotherapy plus treatment as usual was associated with lower MSI scores at follow-up in intent-to-treat analyses compared with WLC plus treatment as usual (MSI: chi(2)(1) = 4.55; P = .03). The WLC group showed a similar decrease in MSI scores 1 year later, when also following their treatment (MSI decrease = 3.24 units per 6 months in the immediate treatment group and 3.50 units per 6 months in the WLC group). Brief, adjunctive psychoeducational group psychotherapy is associated with improved outcome for children aged 8 to 12 years with major mood disorders. Trial Registration clinicaltrials.gov Identifier: NCT00050557.

The efficacy of a brief motivational enhancement education program on CPAP adherence in OSA: a randomized controlled trial.

PubMed

Lai, Agnes Y K; Fong, Daniel Y T; Lam, Jamie C M; Weaver, Terri E; Ip, Mary S M

2014-09-01

Poor adherence to CPAP treatment in OSA adversely affects the effectiveness of this therapy. This randomized controlled trial (RCT) examined the efficacy of a brief motivational enhancement education program in improving adherence to CPAP treatment in subjects with OSA. Subjects with newly diagnosed OSA were recruited into this RCT. The control group received usual advice on the importance of CPAP therapy and its care. The intervention group received usual care plus a brief motivational enhancement education program directed at enhancing the subjects' knowledge, motivation, and self-efficacy to use CPAP through the use of a 25-min video, a 20-min patient-centered interview, and a 10-min telephone follow-up. Self-reported daytime sleepiness adherence-related cognitions and quality of life were assessed at 1 month and 3 months. CPAP usage data were downloaded at the completion of this 3-month study. One hundred subjects with OSA (mean ± SD, age 52 ± 10 years; Epworth Sleepiness Scales [ESS], 9 ± 5; median [interquartile range] apnea-hypopnea index, 29 [20, 53] events/h) prescribed CPAP treatment were recruited. The intervention group had better CPAP use (higher daily CPAP usage by 2 h/d [Cohen d = 1.33, P < .001], a fourfold increase in the number using CPAP for ≥ 70% of days with ≥ 4 h/d [P < .001]), and greater improvements in daytime sleepiness (ESS) by 2.2 units (P = .001) and treatment self-efficacy by 0.2 units (P = .012) compared with the control group. Subjects with OSA who received motivational enhancement education in addition to usual care were more likely to show better adherence to CPAP treatment, with greater improvements in treatment self-efficacy and daytime sleepiness. ClinicalTrials.gov; No.: NCT01173406; URL: www.clinicaltrials.gov.

Effectiveness of a healthy lifestyle intervention for chronic low back pain: a randomised controlled trial.

PubMed

Williams, Amanda; Wiggers, John; OʼBrien, Kate M; Wolfenden, Luke; Yoong, Sze Lin; Hodder, Rebecca K; Lee, Hopin; Robson, Emma K; McAuley, James H; Haskins, Robin; Kamper, Steven J; Rissel, Chris; Williams, Christopher M

2018-06-01

We assessed the effectiveness of a 6-month healthy lifestyle intervention, on pain intensity in patients with chronic low back pain who were overweight or obese. We conducted a pragmatic randomised controlled trial, embedded within a cohort multiple randomised controlled trial of patients on a waiting list for outpatient orthopaedic consultation at a tertiary hospital in NSW, Australia. Eligible patients with chronic low back pain (>3 months in duration) and body mass index ≥27 kg/m and <40 kg/m were randomly allocated, using a central concealed random allocation process, to receive advice and education and referral to a 6-month telephone-based healthy lifestyle coaching service, or usual care. The primary outcome was pain intensity measured using an 11-point numerical rating scale, at baseline, 2 weeks, and monthly for 6 months. Data analysis was by intention-to-treat according to a prepublished analysis plan. Between May 13, 2015, and October 27, 2015, 160 patients were randomly assigned in a 1:1 ratio to the intervention or usual care. We found no difference between groups for pain intensity over 6 months (area under the curve, mean difference = 6.5, 95% confidence interval -8.0 to 21.0; P = 0.38) or any secondary outcome. In the intervention group, 41% (n = 32) of participants reported an adverse event compared with 56% (n = 45) in the control group. Our findings show that providing education and advice and telephone-based healthy lifestyle coaching did not benefit patients with low back pain who were overweight or obese, compared with usual care. The intervention did not influence the targeted healthy lifestyle behaviours proposed to improve pain in this patient group.

Disease activity guided dose reduction and withdrawal of adalimumab or etanercept compared with usual care in rheumatoid arthritis: open label, randomised controlled, non-inferiority trial.

PubMed

van Herwaarden, Noortje; van der Maas, Aatke; Minten, Michiel J M; van den Hoogen, Frank H J; Kievit, Wietske; van Vollenhoven, Ronald F; Bijlsma, Johannes W J; van den Bemt, Bart J F; den Broeder, Alfons A

2015-04-09

To evaluate whether a disease activity guided strategy of dose reduction of two tumour necrosis factor (TNF) inhibitors, adalimumab or etanercept, is non-inferior in maintaining disease control in patients with rheumatoid arthritis compared with usual care. Randomised controlled, open label, non-inferiority strategy trial. Two rheumatology outpatient clinics in the Netherlands, from December 2011 to May 2014. 180 patients with rheumatoid arthritis and low disease activity using adalimumab or etanercept; 121 allocated to the dose reduction strategy, 59 to usual care. Disease activity guided dose reduction (advice to stepwise increase the injection interval every three months, until flare of disease activity or discontinuation) or usual care (no dose reduction advice). Flare was defined as increase in DAS28-CRP (a composite score measuring disease activity) greater than 1.2, or increase greater than 0.6 and current score of at least 3.2. In the case of flare, TNF inhibitor use was restarted or escalated. Difference in proportions of patients with major flare (DAS28-CRP based flare longer than three months) between the two groups at 18 months, compared against a non-inferiority margin of 20%. Secondary outcomes included TNF inhibitor use at study end, functioning, quality of life, radiographic progression, and adverse events. Dose reduction of adalimumab or etanercept was non-inferior to usual care (proportion of patients with major flare at 18 months, 12% v 10%; difference 2%, 95% confidence interval -12% to 12%). In the dose reduction group, TNF inhibitor use could successfully be stopped in 20% (95% confidence interval 13% to 28%), the injection interval successfully increased in 43% (34% to 53%), but no dose reduction was possible in 37% (28% to 46%). Functional status, quality of life, relevant radiographic progression, and adverse events did not differ between the groups, although short lived flares (73% v 27%) and minimal radiographic progression (32% v 15%) were more frequent in dose reduction than usual care. A disease activity guided, dose reduction strategy of adalimumab or etanercept to treat rheumatoid arthritis is non-inferior to usual care with regard to major flaring, while resulting in the successful dose reduction or stopping in two thirds of patients.Trial registration Dutch trial register (www.trialregister.nl), NTR 3216. © van Herwaarden et al 2015.

Physical activity levels in locally advanced rectal cancer patients following neoadjuvant chemoradiotherapy and an exercise training programme before surgery: a pilot study.

PubMed

Loughney, Lisa; West, Malcolm A; Dimitrov, Borislav D; Kemp, Graham J; Grocott, Michael Pw; Jack, Sandy

2017-01-01

The aim of this pilot study was to measure changes in physical activity level (PAL) variables, as well as sleep duration and efficiency in people with locally advanced rectal cancer (1) before and after neoadjuvant chemoradiotherapy (CRT) and (2) after participating in a pre-operative 6-week in-hospital exercise training programme, following neoadjuvant CRT prior to major surgery, compared to a usual care control group. We prospectively studied 39 consecutive participants (27 males). All participants completed standardised neoadjuvant CRT: 23 undertook a 6-week in-hospital exercise training programme following neoadjuvant CRT. These were compared to 16 contemporaneous non-randomised participants (usual care control group). All participants underwent a continuous 72-h period of PA monitoring by SenseWear biaxial accelerometer at baseline, immediately following neoadjuvant CRT (week 0), and at week 6 (following the exercise training programme). Of 39 recruited participants, 23 out of 23 (exercise) and 10 out of 16 (usual care control) completed the study. In all participants ( n  = 33), there was a significant reduction from baseline (pre-CRT) to week 0 (post-CRT) in daily step count: median (IQR) 4966 (4435) vs. 3044 (3265); p  < 0.0001, active energy expenditure (EE) (kcal): 264 (471) vs. 154 (164); p  = 0.003, and metabolic equivalent (MET) (1.3 (0.6) vs. 1.2 (0.3); p  = 0.010). There was a significant improvement in sleep efficiency (%) between week 0 and week 6 in the exercise group compared to the usual care control group (80 (13) vs. 78 (15) compared to (69 ((24) vs. 76 (20); p  = 0.022), as well as in sleep duration and lying down time ( p  < 0.05) while those in active EE (kcal) (152 (154) vs. 434 (658) compared to (244 (198) vs. 392 (701) or in MET (1.3 (0.4) vs. 1.5 (0.5) compared to (1.1 (0.2) vs. 1.5 (0.5) were also of importance but did not reach statistical significance ( p  > 0.05). An apparent improvement in daily step count and overall PAL in the exercise group was not statistically significant. PAL variables, daily step count, EE and MET significantly reduced following neoadjuvant CRT in all participants. A 6-week pre-operative in-hospital exercise training programme improved sleep efficiency, sleep duration and lying down time when compared to participants receiving usual care. Clinicaltrials.gov NCT01325909.

Effectiveness of an Integrated Multidisciplinary Osteoarthritis Outpatient Program versus Outpatient Clinic as Usual: A Randomized Controlled Trial.

PubMed

Moe, Rikke Helene; Grotle, Margreth; Kjeken, Ingvild; Olsen, Inge Christoffer; Mowinckel, Petter; Haavardsholm, Espen A; Hagen, Kåre Birger; Kvien, Tore K; Uhlig, Till

2016-02-01

Osteoarthritis (OA) is one of the leading causes of pain and disability. Given the constraint in the provision of care, there is a need to develop and assess effectiveness of new treatment models. The objective was to compare satisfaction with and effectiveness of a new integrated multidisciplinary outpatient program with usual care in an outpatient clinic for patients with OA. Patients with clinical OA referred to a rheumatology outpatient clinic were randomized to a 3.5-h multidisciplinary group-based educational program followed by individual consultations, or to usual care. The primary outcome was satisfaction with the health service evaluated on a numerical rating scale (0 = extremely unsatisfied, 10 = extremely satisfied) after 4 months. Secondary outcomes included health-related quality of life measures. Of 391 patients, 86.4% (n = 338) were women, and mean age was 61.2 (SD 8.0) years. At 4 months, patients who received integrated multidisciplinary care were significantly more satisfied with the health service compared with controls, with a mean difference of -1.05 (95% CI -1.68 to -0.43, p < 0.001). Among secondary outcomes, only self-efficacy with other symptoms scale (10-100) improved significantly in the multidisciplinary group compared with controls at 4 months (3.59, 95% CI 0.69-6.5, p = 0.02). At 12 months, the Australian/Canadian Hand Osteoarthritis Index pain (0-10) and fatigue scores (0-10) were slightly worse in the multidisciplinary group with differences of 0.38 (95% CI 0.06-0.71, p = 0.02) and 0.55 (95% CI 0.02-1.07, p = 0.04), respectively. Patients receiving an integrated multidisciplinary care model were more satisfied with healthcare than those receiving usual care, whereas there were no clinically relevant improvements in health outcomes.

Cost-effectiveness of a preferred intensity exercise programme for young people with depression compared with treatment as usual: an economic evaluation alongside a clinical trial in the UK.

PubMed

Turner, David; Carter, Tim; Sach, Tracey; Guo, Boliang; Callaghan, Patrick

2017-11-26

To assess the cost-effectiveness of preferred intensity exercise programme for young people with depression compared with a treatment as usual control group. A 'within trial' cost-effectiveness and cost-utility analysis conducted alongside a randomised controlled trial. The perspective of the analysis was the UK National Health Service and social services. The intervention was provided in a community leisure centre setting. 86 young people aged 14-17 years attending Tier 2 and Tier 3 CAMHS (Child and Adolescent Mental Health Services) outpatient services presenting with depression. The intervention comprised 12 separate sessions of circuit training over a 6-week period. Sessions were supervised by a qualified exercise therapist. Participants also received treatment as usual. The comparator group received treatment as usual. We found improvements in the Children's Depression Inventory-2 (CDI-2) and estimated cost-effectiveness at £61 per point improvement in CDI-2 for the exercise group compared with control. We found no evidence that the exercise intervention led to differences in quality-adjusted life years (QALY). QALYs were estimated using the EQ-5D-5L (5-level version of EuroQol-5 dimension). There is evidence that exercise can be an effective intervention for adolescents with depression and the current study shows that preferred intensity exercise could also represent a cost-effective intervention in terms of the CDI-2. NCT01474837. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Direct versus indirect and individual versus group modes of language therapy for children with primary language impairment: principal outcomes from a randomized controlled trial and economic evaluation.

PubMed

Boyle, James M; McCartney, Elspeth; O'Hare, Anne; Forbes, John

2009-01-01

Many school-age children with language impairments are enrolled in mainstream schools and receive indirect language therapy, but there have been, to the authors' knowledge, no previous controlled studies comparing the outcomes and costs of direct and indirect intervention delivered by qualified therapists and therapy assistants, and each delivery mode offered to children individually or in groups. To investigate the relative effectiveness of indirect and direct intervention therapy modes delivered individually or in groups for children with primary language impairment. A multi-centre randomized controlled trial investigated 161 children with primary language impairment aged 6-11 years randomized to a usual-therapy control group or to direct individual, indirect individual, direct group or indirect group therapy modes. Intervention was delivered three times a week for 30-40-min sessions in mainstream schools over 15 weeks. Language performance was assessed at baseline, post-therapy and at 12 months. Cost analysis was based on salary and travel costs for intervention modes and usual therapy. Compared with controls, children receiving project therapy made short-term improvements in expressive (p = 0.031), but not receptive, language immediately following intervention. Children with specific expressive language delay were more likely to show improvement than those with mixed receptive-expressive difficulties. The four project therapy modes did not differ on primary language outcomes (all p-values>0.392) and there were no further improvements evident at follow-up. Indirect group therapy was the least costly mode, with direct individual therapy the most costly. Intervention in this age group can be effective for expressive language and can be delivered equally effectively though speech and language therapy assistants and to children in groups.

A Promotora-administered group education intervention to promote breast and cervical cancer screening in a rural community along the U.S.-Mexico border: a randomized controlled trial.

PubMed

Nuño, Tomas; Martinez, Maria Elena; Harris, Robin; García, Francisco

2011-03-01

Breast cancer is the most common neoplasm among Hispanic women. Cervical cancer has a higher incidence and mortality among Hispanic women compared with non-Hispanic White women. To assess the effectiveness of a promotora-administered educational intervention to promote breast and cervical cancer screening among post-reproductive age, medically underserved Hispanic women residing along the U.S.-Mexico border. Women age 50 or older were eligible to participate in this intervention study. A total of 381 subjects agreed to participate. Women were randomly assigned into one of two groups, educational intervention or usual care. The primary outcomes were self-reported mammogram and Pap smear screening. Logistic regression analysis was used to compute odds ratios for comparisons between intervention and control groups. Women in the intervention group were 2.0 times more likely to report having had a mammogram within the last year when compared with the usual care group (95% CI = 1.3-3.1). Likewise, women in the intervention group were 1.5 times more likely to report having a Pap smear within the last year when compared with the usual care group, although this was not statistically significant (95% CI = 0.9-2.6). In a secondary analysis, the intervention suggests a stronger effect on those that had not had a mammogram or Pap smear within the past year at baseline. A promotora-based educational intervention can be used to increase breast and cervical cancer screening utilization among Hispanic women.

Two weeks of additional standing balance circuit classes during inpatient rehabilitation are cost saving and effective: an economic evaluation.

PubMed

Treacy, Daniel; Howard, Kirsten; Hayes, Alison; Hassett, Leanne; Schurr, Karl; Sherrington, Catherine

2018-01-01

Among people admitted for inpatient rehabilitation, is usual care plus standing balance circuit classes more cost-effective than usual care alone? Cost-effectiveness study embedded within a randomised controlled trial with concealed allocation, assessor blinding and intention-to-treat analysis. 162 rehabilitation inpatients from a metropolitan hospital in Sydney, Australia. The experimental group received a 1-hour standing balance circuit class, delivered three times a week for 2 weeks, in addition to usual therapy. The circuit classes were supervised by one physiotherapist and one physiotherapy assistant for up to eight patients. The control group received usual therapy alone. Costs were estimated from routinely collected hospital use data in the 3 months after randomisation. The functional outcome measure was mobility measured at 3 months using the Short Physical Performance Battery administered by a blinded assessor. An incremental analysis was conducted and the joint probability distribution of costs and outcomes was examined using bootstrapping. The median cost savings for the intervention group was AUD4,741 (95% CI 137 to 9,372) per participant; 94% of bootstraps showed that the intervention was both effective and cost saving. Two weeks of additional standing balance circuit classes delivered in addition to usual therapy resulted in decreased healthcare costs at 3 months in hospital inpatients admitted for rehabilitation. There is a high probability that this intervention is both cost saving and effective. ACTRN12611000412932. [Treacy D, Howard K, Hayes A, Hassett L, Schurr K, Sherrington C (2018) Two weeks of additional standing balance circuit classes during inpatient rehabilitation are cost saving and effective: an economic evaluation. Journal of Physiotherapy 64: 41-47]. Copyright © 2017 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.

Efficacy of the Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training (USMART) program among patients with mild cognitive impairment: a randomized controlled crossover trial.

PubMed

Han, Ji Won; Son, Kyung Lak; Byun, Hye Jin; Ko, Ji Won; Kim, Kayoung; Hong, Jong Woo; Kim, Tae Hyun; Kim, Ki Woong

2017-06-06

Spaced retrieval training (SRT) is a nonpharmacological intervention for mild cognitive impairment (MCI) and dementia that trains the learning and retention of target information by recalling it over increasingly long intervals. We recently developed the Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training (USMART) program as a convenient, self-administered tablet-based SRT program. We also demonstrated the utility of USMART for improving memory in individuals with MCI through an open-label uncontrolled trial. This study had an open-label, single-blind, randomized, controlled, two-period crossover design. Fifty patients with MCI were randomized into USMART-usual care and usual care-USMART treatment sequences. USMART was completed or usual care was provided biweekly over a 4-week treatment period with a 2-week washout period between treatment periods. Primary outcome measures included the Word List Memory Test, Word List Recall Test (WLRT), and Word List Recognition Test. Outcomes were measured at baseline, week 5, and week 11 by raters who were blinded to intervention type. An intention-to-treat analysis and linear mixed modeling were used. Of 50 randomized participants, 41 completed the study (18% dropout rate). The USMART group had larger improvements in WLRT score (effect size = 0.49, p = 0.031) than the usual care group. There were no significant differences in other primary or secondary measures between the USMART and usual care groups. Moreover, no USMART-related adverse events were reported. The 4-week USMART modestly improved information retrieval in older people with MCI, and was well accepted with minimal technical support. ClinicalTrials.gov NCT01688128 . Registered 12 September 2012.

Spa therapy in the treatment of knee osteoarthritis: a large randomised multicentre trial

PubMed Central

Forestier, R; Desfour, H; Tessier, J-M; Françon, A; Foote, A M; Genty, C; Rolland, C; Roques, C-F; Bosson, J-L

2010-01-01

Objective To determine whether spa therapy, plus home exercises and usual medical treatment provides any benefit over exercises and usual treatment, in the management of knee osteoarthritis. Methods Large multicentre randomised prospective clinical trial of patients with knee osteoarthritis according to the American College of Rheumatology criteria, attending French spa resorts as outpatients between June 2006 and April 2007. Zelen randomisation was used so patients were ignorant of the other group and spa personnel were not told which patients were participating. The main endpoint criteria were patient self-assessed. All patients continued usual treatments and performed daily standardised home exercises. The spa therapy group also received 18 days of spa therapy (massages, showers, mud and pool sessions). Main Endpoint The number of patients achieving minimal clinically important improvement (MCII) at 6 months, defined as ≥19.9 mm on the visual analogue pain scale and/or ≥9.1 points in a normalised Western Ontario and McMaster Universities osteoarthritis index function score and no knee surgery. Results The intention to treat analysis included 187 controls and 195 spa therapy patients. At 6 months, 99/195 (50.8%) spa group patients had MCII and 68/187 (36.4%) controls (χ2=8.05; df=1; p=0.005). However, no improvement in quality of life (Short Form 36) or patient acceptable symptom state was observed at 6 months. Conclusion For patients with knee osteoarthritis a 3-week course of spa therapy together with home exercises and usual pharmacological treatments offers benefit after 6 months compared with exercises and usual treatment alone, and is well tolerated. Trial registration number NCT00348777. PMID:19734131

Culture-specific programs for children and adults from minority groups who have asthma.

PubMed

Bailey, Emily J; Cates, Christopher J; Kruske, Sue G; Morris, Peter S; Chang, Anne B; Brown, Ngiare

2009-01-21

People with asthma who come from minority groups have poorer asthma outcomes and more asthma related visits to Emergency Departments (ED). Various programmes are used to educate and empower people with asthma and these have previously been shown to improve certain asthma outcomes. Models of care for chronic diseases in minority groups usually include a focus of the cultural context of the individual and not just the symptoms of the disease. Therefore, questions about whether culturally specific asthma education programmes for people from minority groups are effective at improving asthma outcomes, are feasible and are cost-effective need to be answered. To determine whether culture-specific asthma programmes, in comparison to generic asthma education programmes or usual care, improve asthma related outcomes in children and adults with asthma who belong to minority groups. We searched the Cochrane Register of Controlled Trials (CENTRAL), the Cochrane Airways Group Specialised Register, MEDLINE, EMBASE, review articles and reference lists of relevant articles. The latest search was performed in May 2008. All randomised controlled trials (RCTs) comparing the use of culture-specific asthma education programmes with generic asthma education programmes, or usual care, in adults or children from minority groups who suffer from asthma. Two review authors independently selected, extracted and assessed the data for inclusion. We contacted authors for further information if required. Four studies were eligible for inclusion in the review. A total of 617 patients, aged from 5 to 59 years were included in the meta-analysis of data. Use of a culture-specific programme was superior to generic programmes or usual care, in improving asthma quality of life scores in adults, pooled WMD 0.25 (95% CI 0.09 to 0.41), asthma knowledge scores in children, WMD 3.30 (95% CI 1.07 to 5.53), and in a single study, reducing asthma exacerbation in children (risk ratio for hospitalisations 0.32, 95%CI 0.15, 0.70). Current limited data show that culture-specific programmes for adults and children from minority groups with asthma, are more effective than generic programmes in improving most (quality of life, asthma knowledge, asthma exacerbations, asthma control) but not all asthma outcomes. This evidence is limited by the small number of included studies and the lack of reported outcomes. Further trials are required to answer this question conclusively.

Culture-specific programs for children and adults from minority groups who have asthma.

PubMed

Bailey, Emily J; Cates, Christopher J; Kruske, Sue G; Morris, Peter S; Brown, Ngiare; Chang, Anne B

2009-04-15

People with asthma who come from minority groups have poorer asthma outcomes and more asthma related visits to Emergency Departments (ED). Various programmes are used to educate and empower people with asthma and these have previously been shown to improve certain asthma outcomes. Models of care for chronic diseases in minority groups usually include a focus of the cultural context of the individual and not just the symptoms of the disease. Therefore, questions about whether culturally specific asthma education programmes for people from minority groups are effective at improving asthma outcomes, are feasible and are cost-effective need to be answered. To determine whether culture-specific asthma programmes, in comparison to generic asthma education programmes or usual care, improve asthma related outcomes in children and adults with asthma who belong to minority groups. We searched the Cochrane Register of Controlled Trials (CENTRAL), the Cochrane Airways Group Specialised Register, MEDLINE, EMBASE, review articles and reference lists of relevant articles. The latest search was performed in May 2008. All randomised controlled trials (RCTs) comparing the use of culture-specific asthma education programmes with generic asthma education programmes, or usual care, in adults or children from minority groups who suffer from asthma. Two review authors independently selected, extracted and assessed the data for inclusion. We contacted authors for further information if required. Four studies were eligible for inclusion in the review. A total of 617 patients, aged from 5 to 59 years were included in the meta-analysis of data. Use of a culture-specific programme was superior to generic programmes or usual care, in improving asthma quality of life scores in adults, pooled WMD 0.25 (95% CI 0.09 to 0.41), asthma knowledge scores in children, WMD 3.30 (95% CI 1.07 to 5.53), and in a single study, reducing asthma exacerbation in children (risk ratio for hospitalisations 0.32, 95%CI 0.15, 0.70). Current limited data show that culture-specific programmes for adults and children from minority groups with asthma, are more effective than generic programmes in improving most (quality of life, asthma knowledge, asthma exacerbations, asthma control) but not all asthma outcomes. This evidence is limited by the small number of included studies and the lack of reported outcomes. Further trials are required to answer this question conclusively.

Efficacy and Safety of Exercise Training in Patients With Chronic Heart Failure: HF-ACTION Randomized Controlled Trial

PubMed Central

O’Connor, Christopher M.; Whellan, David J.; Lee, Kerry L.; Keteyian, Steven J.; Cooper, Lawton S.; Ellis, Stephen J.; Leifer, Eric S.; Kraus, William E.; Kitzman, Dalane W.; Blumenthal, James A.; Rendall, David S.; Miller, Nancy Houston; Fleg, Jerome L.; Schulman, Kevin A.; McKelvie, Robert S.; Zannad, Faiez; Piña, Ileana L.

2010-01-01

Context Guidelines recommend that exercise training be considered for medically stable outpatients with heart failure. Previous studies have not had adequate statistical power to measure the effects of exercise training on clinical outcomes. Objective To test the efficacy and safety of exercise training among patients with heart failure. Design, Setting, and Patients Multicenter, randomized controlled trial among 2331 medically stable outpatients with heart failure and reduced ejection fraction. Participants in Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) were randomized from April 2003 through February 2007 at 82 centers within the United States, Canada, and France; median follow-up was 30 months. Interventions Usual care plus aerobic exercise training, consisting of 36 supervised sessions followed by home-based training, or usual care alone. Main Outcome Measures Composite primary end point of all-cause mortality or hospitalization and prespecified secondary end points of all-cause mortality, cardiovascular mortality or cardiovascular hospitalization, and cardiovascular mortality or heart failure hospitalization. Results The median age was 59 years, 28% were women, and 37% had New York Heart Association class III or IV symptoms. Etiology was ischemic in 51%. Median left ventricular ejection fraction was 25%. Exercise adherence decreased from a median of 95 minutes per week during months 4 through 6 of follow-up to 74 minutes per week during months 10 through 12. A total of 759 (65%) patients in the exercise group died or were hospitalized, compared with 796 (68%) in the usual care group (hazard ratio [HR], 0.93; 95% confidence interval [CI], 0.84–1.02; P = .13). There were nonsignificant reductions in the exercise training group for mortality (189 [16%] in the exercise group vs 198 [17%] in the usual care group; HR, 0.96; 95% CI, 0.79–1.17; P = .70), cardiovascular mortality or cardiovascular hospitalization (632 [55%] in the exercise group vs 677 [58%] in the usual care group; HR, 0.92; 95% CI, 0.83–1.03; P = .14), and cardiovascular mortality or heart failure hospitalization (344 [30%] in the exercise group vs 393 [34%] in the usual care group; HR, 0.87; 95% CI, 0.75–1.00; P = .06). In prespecified supplementary analyses adjusting for highly prognostic baseline characteristics, the HRs were 0.89 (95% CI, 0.81–0.99; P = .03) for all-cause mortality or hospitalization, 0.91 (95% CI, 0.82–1.01; P = .09) for cardiovascular mortality or cardiovascular hospitalization, and 0.85 (95% CI, 0.74–0.99; P = .03) for cardiovascular mortality or heart failure hospitalization. Other adverse events were similar between the groups. Conclusions In the protocol-specified primary analysis, exercise training resulted in nonsignificant reductions in the primary end point of all-cause mortality or hospitalization and in key secondary clinical end points. After adjustment for highly prognostic predictors of the primary end point, exercise training was associated with modest significant reductions for both all-cause mortality or hospitalization and cardiovascular mortality or heart failure hospitalization. Trial Registration clinicaltrials.gov Identifier: NCT00047437 PMID:19351941

Efficacy and safety of very early mobilisation within 24 h of stroke onset (AVERT): a randomised controlled trial.

PubMed

2015-07-04

Early mobilisation after stroke is thought to contribute to the effects of stroke-unit care; however, the intervention is poorly defined and not underpinned by strong evidence. We aimed to compare the effectiveness of frequent, higher dose, very early mobilisation with usual care after stroke. We did this parallel-group, single-blind, randomised controlled trial at 56 acute stroke units in five countries. Patients (aged ≥18 years) with ischaemic or haemorrhagic stroke, first or recurrent, who met physiological criteria were randomly assigned (1:1), via a web-based computer generated block randomisation procedure (block size of six), to receive usual stroke-unit care alone or very early mobilisation in addition to usual care. Treatment with recombinant tissue plasminogen activator was allowed. Randomisation was stratified by study site and stroke severity. Patients, outcome assessors, and investigators involved in trial and data management were masked to treatment allocation. The primary outcome was a favourable outcome 3 months after stroke, defined as a modified Rankin Scale score of 0-2. We did analysis on an intention-to-treat basis. The trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12606000185561. Between July 18, 2006, and Oct 16, 2014, we randomly assigned 2104 patients to receive either very early mobilisation (n=1054) or usual care (n=1050); 2083 (99%) patients were included in the 3 month follow-up assessment. 965 (92%) patients were mobilised within 24 h in the very early mobilisation group compared with 623 (59%) patients in the usual care group. Fewer patients in the very early mobilisation group had a favourable outcome than those in the usual care group (n=480 [46%] vs n=525 [50%]; adjusted odds ratio [OR] 0·73, 95% CI 0·59-0·90; p=0·004). 88 (8%) patients died in the very early mobilisation group compared with 72 (7%) patients in the usual care group (OR 1·34, 95% CI 0·93-1·93, p=0·113). 201 (19%) patients in the very early mobilisation group and 208 (20%) of those in the usual care group had a non-fatal serious adverse event, with no reduction in immobility-related complications with very early mobilisation. First mobilisation took place within 24 h for most patients in this trial. The higher dose, very early mobilisation protocol was associated with a reduction in the odds of a favourable outcome at 3 months. Early mobilisation after stroke is recommended in many clinical practice guidelines worldwide, and our findings should affect clinical practice by refining present guidelines; however, clinical recommendations should be informed by future analyses of dose-response associations. National Health and Medical Research Council, Singapore Health, Chest Heart and Stroke Scotland, Northern Ireland Chest Heart and Stroke, UK Stroke Association, National Institute of Health Research. Copyright © 2015 Bernhardt et al. Open Access article distributed under the terms of CC BY-NC-ND. Published by Elsevier Ltd.. All rights reserved.

Protocolised Management In Sepsis (ProMISe): a multicentre randomised controlled trial of the clinical effectiveness and cost-effectiveness of early, goal-directed, protocolised resuscitation for emerging septic shock.

PubMed

Mouncey, Paul R; Osborn, Tiffany M; Power, G Sarah; Harrison, David A; Sadique, M Zia; Grieve, Richard D; Jahan, Rahi; Tan, Jermaine C K; Harvey, Sheila E; Bell, Derek; Bion, Julian F; Coats, Timothy J; Singer, Mervyn; Young, J Duncan; Rowan, Kathryn M

2015-11-01

Early goal-directed therapy (EGDT) is recommended in international guidance for the resuscitation of patients presenting with early septic shock. However, adoption has been limited and uncertainty remains over its clinical effectiveness and cost-effectiveness. The primary objective was to estimate the effect of EGDT compared with usual resuscitation on mortality at 90 days following randomisation and on incremental cost-effectiveness at 1 year. The secondary objectives were to compare EGDT with usual resuscitation for requirement for, and duration of, critical care unit organ support; length of stay in the emergency department (ED), critical care unit and acute hospital; health-related quality of life, resource use and costs at 90 days and at 1 year; all-cause mortality at 28 days, at acute hospital discharge and at 1 year; and estimated lifetime incremental cost-effectiveness. A pragmatic, open, multicentre, parallel-group randomised controlled trial with an integrated economic evaluation. Fifty-six NHS hospitals in England. A total of 1260 patients who presented at EDs with septic shock. EGDT (n = 630) or usual resuscitation (n = 630). Patients were randomly allocated 1 : 1. All-cause mortality at 90 days after randomisation and incremental net benefit (at £20,000 per quality-adjusted life-year) at 1 year. Following withdrawals, data on 1243 (EGDT, n = 623; usual resuscitation, n = 620) patients were included in the analysis. By 90 days, 184 (29.5%) in the EGDT and 181 (29.2%) patients in the usual-resuscitation group had died [p = 0.90; absolute risk reduction -0.3%, 95% confidence interval (CI) -5.4 to 4.7; relative risk 1.01, 95% CI 0.85 to 1.20]. Treatment intensity was greater for the EGDT group, indicated by the increased use of intravenous fluids, vasoactive drugs and red blood cell transfusions. Increased treatment intensity was reflected by significantly higher Sequential Organ Failure Assessment scores and more advanced cardiovascular support days in critical care for the EGDT group. At 1 year, the incremental net benefit for EGDT versus usual resuscitation was negative at -£725 (95% CI -£3000 to £1550). The probability that EGDT was more cost-effective than usual resuscitation was below 30%. There were no significant differences in any other secondary outcomes, including health-related quality of life, or adverse events. Recruitment was lower at weekends and out of hours. The intervention could not be blinded. There was no significant difference in all-cause mortality at 90 days for EGDT compared with usual resuscitation among adults identified with early septic shock presenting to EDs in England. On average, costs were higher in the EGDT group than in the usual-resuscitation group while quality-adjusted life-years were similar in both groups; the probability that it is cost-effective is < 30%. The ProMISe (Protocolised Management In Sepsis) trial completes the planned trio of evaluations of EGDT across the USA, Australasia and England; all have indicated that EGDT is not superior to usual resuscitation. Recognising that each of the three individual, large trials has limited power for evaluating potentially important subgroups, the harmonised approach adopted provides the opportunity to conduct an individual patient data meta-analysis, enhancing both knowledge and generalisability. Current Controlled Trials ISRCTN36307479. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 97. See the NIHR Journals Library website for further project information.

Improving Navy Recruit Confidence Expectancies and Knowledge in a Simulated Chemical Warfare Environment

DTIC Science & Technology

1988-06-27

Hamman, HTSC D. M. Trefsger, ENCS J. E. Pernice, and their supporting personnel at the Damage Control and Firefighting School. 9 %S NTSC TR88-010 EXECUTIVE...standard training group served as the control condition; here, no changes were made to the usual training procedure. The no-film group was included as...an additional control in this research because, at the time of implementation, the CBR-D training program was being conducted without showing film MN

A protocol for a trial of homeopathic treatment for irritable bowel syndrome

PubMed Central

2012-01-01

Background Irritable bowel syndrome is a chronic condition with no known cure. Many sufferers seek complementary and alternative medicine including homeopathic treatment. However there is much controversy as to the effectiveness of homeopathic treatment. This three-armed study seeks to explore the effectiveness of individualised homeopathic treatment plus usual care compared to both an attention control plus usual care and usual care alone, for patients with irritable bowel syndrome. Methods/design This is a three-armed pragmatic randomised controlled trial using the cohort multiple randomised trial methodology. Patients are recruited to an irritable bowel syndrome cohort from primary and secondary care using GP databases and consultants lists respectively. From this cohort patients are randomly selected to be offered, 5 sessions of homeopathic treatment plus usual care, 5 sessions of supportive listening plus usual care or usual care alone. The primary clinical outcome is the Irritable Bowel Syndrome Symptom Severity at 26 weeks. From a power calculation, it is estimated that 33 people will be needed for the homeopathic treatment arm and 132 for the usual care arm, to detect a minimal clinical difference at 80 percent power and 5 percent significance allowing for loss to follow up. An unequal group size has been used for reasons of cost. Analysis will be by intention to treat and will compare homeopathic treatment with usual care at 26 weeks as the primary analysis, and homeopathic treatment with supportive listening as an additional analysis. Discussion This trial has received NHS approval and results are expected in 2013. Trial registration Current Controlled Trials ISRCTN90651143 PMID:23131064

A cluster randomized controlled trial on the effects and costs of advance care planning in elderly care: study protocol.

PubMed

Korfage, Ida J; Rietjens, Judith A C; Overbeek, Anouk; Jabbarian, Lea J; Billekens, Pascalle; Hammes, Bernard J; Hansen-van der Meer, Ellen; Polinder, Suzanne; Severijnen, Johan; Swart, Siebe J; Witkamp, Frederika E; van der Heide, Agnes

2015-07-22

Currently, health care and medical decision-making at the end of life for older people are often insufficiently patient-centred. In this trial we study the effects of Advance Care Planning (ACP), a formalised process of timely communication about care preferences at the end of life, for frail older people. We will conduct a cluster randomised controlled trial among older people residing in care homes or receiving home care in the Netherlands. The intervention group will receive the ACP program Respecting Choices® in addition to usual care. The control group will receive usual care only. Participants in both groups will fill out questionnaires at baseline and after 12 months. We hypothesize that ACP will lead to better patient activation in medical decision making and quality of life, while reducing the number of medical interventions and thus health care costs. Multivariate analysis will be used to compare differences between the intervention group and the control group at baseline and to compare differences in changes after 12 months following the inclusion. Our study can contribute to more understanding of the effects of ACP on patient activation and quality of life in frail older people. Further, we will gain insight in the costs and cost-effectiveness of ACP. This study will facilitate ACP policy for older people in the Netherlands. Nederlands Trial Register: NTR4454.

Japanese Quality Control Circles.

ERIC Educational Resources Information Center

Nishiyama, Kazuo

In recent years, United States scholars with an interest in international business and organizational communication have begun to notice the success of Japanese "quality control circles." These are small groups, usually composed of seven to ten workers, who are organized at the production levels within most large Japanese factories. A…

A Comparison of the Effects of 2 Types of Massage and Usual Care on Chronic Low Back Pain: A Randomized, Controlled Trial

PubMed Central

Cherkin, Daniel C.; Sherman, Karen J.; Kahn, Janet; Wellman, Robert; Cook, Andrea J.; Johnson, Eric; Erro, Janet; Delaney, Kristin; Deyo, Richard A.

2013-01-01

Background Few studies have evaluated the effectiveness of massage for back pain. Objective To evaluate the effectiveness of two types of massage for chronic back pain. Design Single-blind parallel group randomized controlled trial. Setting Integrated health care delivery system in Seattle area. Patients 401 persons 20 to 65 years of age with non-specific chronic low back pain. Interventions Ten treatments over 10 weeks of Structural Massage (intended to identify and alleviate musculoskeletal contributors to pain through focused soft-tissue manipulation) (n=132) or Relaxation Massage (intended to decrease pain and dysfunction by inducing relaxation) (n=136). Treatments provided by 27 experienced licensed massage therapists. Comparison group received continued usual care (n=133). Study presented as comparison of usual care with two types of massage. Measurements Primary outcomes were the Roland Disability Questionnaire (RDQ) and the Symptom Bothersomeness scale measured at 10 weeks. Outcomes also measured after 26 and 52 weeks. Results At 10 weeks, the massage groups had similar functional outcomes that were superior to those for usual care. The adjusted mean RDQ scores were 2.9 and 2.4 points lower for the relaxation and structural massage groups, respectively, compared to usual care (95% CIs: [1.8, 4.0] and [1.4, 3.5]). Adjusted mean symptom bothersomeness scores were 1.7 points and 1.4 points lower with relaxation and structural massage, respectively, versus usual care (95% CIs: [1.2, 2.2] and [0.8, 1.9]). The beneficial effects of relaxation massage on function (but not on symptom reduction) persisted at 52 weeks, but were small. Limitations Restricted to single site; therapists and patients not blinded to treatment. Conclusions This study confirms the results of smaller trials that massage is an effective treatment for chronic back pain with benefits lasting at least 6 months, and also finds no evidence of a clinically-meaningful difference in the effectiveness of two distinct types of massage. Primary Funding Source National Center for Complementary and Alternative Medicine PMID:21727288

Effectiveness of Standardized Physical Therapy Exercises for Patients With Difficulty Returning to Usual Activities After Decompression Surgery for Subacromial Impingement Syndrome: Randomized Controlled Trial.

PubMed

Christiansen, David Høyrup; Frost, Poul; Falla, Deborah; Haahr, Jens Peder; Frich, Lars Henrik; Andrea, Linda Christie; Svendsen, Susanne Wulff

2016-06-01

Little is known about the effectiveness of exercise programs after decompression surgery for subacromial impingement syndrome. For patients with difficulty returning to usual activities, special efforts may be needed to improve shoulder function. The purpose of this study was to evaluate the effectiveness at 3 and 12 months of a standardized physical therapy exercise intervention compared with usual care in patients with difficulty returning to usual activities after subacromial decompression surgery. A multicenter randomized controlled trial was conducted. The study was conducted in 6 public departments of orthopedic surgery, 2 departments of occupational medicine, and 2 physical therapy training centers in Central Denmark Region. One hundred twenty-six patients reporting difficulty returning to usual activities at the postoperative clinical follow-up 8 to 12 weeks after subacromial decompression surgery participated. A standardized exercise program consisting of physical therapist-supervised individual training sessions and home training was used. The primary outcome measure was the Oxford Shoulder Score. Secondary outcome measures were the Constant Score and the Fear-Avoidance Beliefs Questionnaire. At 3 and 12 months, follow-up data were obtained for 92% and 83% of the patients, respectively. Intention-to-treat analyses suggested a between-group difference on the Oxford Shoulder Score favoring the exercise group at 3 months, with an adjusted mean difference of 2.0 (95% confidence interval=-0.5, 4.6), and at 12 months, with an adjusted mean difference of 5.8 (95% confidence interval=2.8, 8.9). Significantly larger improvements for the exercise group were observed for most secondary and supplementary outcome measures. The nature of the exercise intervention did not allow blinding of patients and care providers. The standardized physical therapy exercise intervention resulted in statistically significant and clinically relevant improvement in shoulder pain and function at 12 months compared with usual care. © 2016 American Physical Therapy Association.

Te Ira Tangata: a Zelen randomised controlled trial of a culturally informed treatment compared to treatment as usual in Māori who present to hospital after self-harm.

PubMed

Hatcher, Simon; Coupe, Nicole; Wikiriwhi, Karen; Durie, Sir Mason; Pillai, Avinesh

2016-06-01

Indigenous people have high rates of suicide and self-harm compared to other population groups. The aim of this trial was to see if a package of interventions delivered in a culturally appropriate way improved outcomes at one year in Maori who presented with intentional self-harm to emergency departments. Participants were Maori who presented with intentional self-harm to emergency departments in New Zealand. The study design was a double consent Zelen randomised controlled trial. The intervention included regular postcards, problem solving therapy, patient support, risk management, improved access to primary care and cultural assessment in addition to usual care. The control group received usual care. The main outcome measure was the self-rated change in scores on the Beck Hopelessness Scale at one year. 182 people were randomized to the intervention group 95 of whom consented to take part in the study. 183 people were randomized to the control group 72 of whom consented to take part in the study. For those who consented comparing the intervention group with the control group there was a statistically significant greater change in hopelessness scores at 3 months (difference -1.7 95 % CI -3.4 to -0.01, p = 0.05) but not at one year (difference -1.6 95 % CI -3.4 to 0.3, p = 0.11). Maori who consented and received the intervention were also significantly less likely to present to hospital for non-self-harm reasons in the year after the index episode (44.2 vs. 61.1 %, p = 0.03). Those participants randomised to the intervention were less likely to re-present with self-harm at 3 months (10.4 vs. 18 %, p = 0.04) but not at 12 months compared to the control group. In Maori who presented to hospital with intentional self-harm a culturally informed intervention had an effect on hopelessness and re-presentation with self-harm in the short term but not at 12 months. There was a significant decrease in hospital presentations for non-self harm over the next year. Australian and New Zealand Clinical Trials Registry ACTRN12609000952246.

Reducing falls after hospital discharge: a protocol for a randomised controlled trial evaluating an individualised multimodal falls education programme for older adults

PubMed Central

Hill, Anne-Marie; Etherton-Beer, Christopher; McPhail, Steven M; Morris, Meg E; Flicker, Leon; Bulsara, Max; Lee, Den-Ching; Francis-Coad, Jacqueline; Waldron, Nicholas; Boudville, Amanda; Haines, Terry

2017-01-01

Introduction Older adults frequently fall after discharge from hospital. Older people may have low self-perceived risk of falls and poor knowledge about falls prevention. The primary aim of the study is to evaluate the effect of providing tailored falls prevention education in addition to usual care on falls rates in older people after discharge from hospital compared to providing a social intervention in addition to usual care. Methods and analyses The ‘Back to My Best’ study is a multisite, single blind, parallel-group randomised controlled trial with blinded outcome assessment and intention-to-treat analysis, adhering to CONSORT guidelines. Patients (n=390) (aged 60 years or older; score more than 7/10 on the Abbreviated Mental Test Score; discharged to community settings) from aged care rehabilitation wards in three hospitals will be recruited and randomly assigned to one of two groups. Participants allocated to the control group shall receive usual care plus a social visit. Participants allocated to the experimental group shall receive usual care and a falls prevention programme incorporating a video, workbook and individualised follow-up from an expert health professional to foster capability and motivation to engage in falls prevention strategies. The primary outcome is falls rates in the first 6 months after discharge, analysed using negative binomial regression with adjustment for participant's length of observation in the study. Secondary outcomes are injurious falls rates, the proportion of people who become fallers, functional status and health-related quality of life. Healthcare resource use will be captured from four sources for 6 months after discharge. The study is powered to detect a 30% relative reduction in the rate of falls (negative binomial incidence ratio 0.70) for a control rate of 0.80 falls per person over 6 months. Ethics and dissemination Results will be presented in peer-reviewed journals and at conferences worldwide. This study is approved by hospital and university Human Research Ethics Committees. Trial registration number ACTRN12615000784516. PMID:28153933

Building Kindergartners' Number Sense: A Randomized Controlled Study.

PubMed

Jordan, Nancy C; Glutting, Joseph; Dyson, Nancy; Hassinger-Das, Brenna; Irwin, Casey

2012-08-01

Math achievement in elementary school is mediated by performance and growth in number sense during kindergarten. The aim of the present study was to test the effectiveness of a targeted small group number sense intervention for high-risk kindergartners from low-income communities. Children were randomly assigned to one of three groups ( n = 44 in each group): a number sense intervention group, a language intervention group, or a business as usual control group. Accounting for initial skill level in mathematical knowledge, children who received the number sense intervention performed better than controls at immediate post test, with meaningful effects on measures of number competencies and general math achievement. Many of the effects held eight weeks after the intervention was completed, suggesting that children internalized what they had learned. There were no differences between the language and control groups on any math-related measures.

Weight change in control group participants in behavioural weight loss interventions: a systematic review and meta-regression study

PubMed Central

2012-01-01

Background Unanticipated control group improvements have been observed in intervention trials targeting various health behaviours. This phenomenon has not been studied in the context of behavioural weight loss intervention trials. The purpose of this study is to conduct a systematic review and meta-regression of behavioural weight loss interventions to quantify control group weight change, and relate the size of this effect to specific trial and sample characteristics. Methods Database searches identified reports of intervention trials meeting the inclusion criteria. Data on control group weight change and possible explanatory factors were abstracted and analysed descriptively and quantitatively. Results 85 trials were reviewed and 72 were included in the meta-regression. While there was no change in control group weight, control groups receiving usual care lost 1 kg more than control groups that received no intervention, beyond measurement. Conclusions There are several possible explanations why control group changes occur in intervention trials targeting other behaviours, but not for weight loss. Control group participation may prevent weight gain, although more research is needed to confirm this hypothesis. PMID:22873682

Weight change in control group participants in behavioural weight loss interventions: a systematic review and meta-regression study.

PubMed

Waters, Lauren; George, Alexis S; Chey, Tien; Bauman, Adrian

2012-08-08

Unanticipated control group improvements have been observed in intervention trials targeting various health behaviours. This phenomenon has not been studied in the context of behavioural weight loss intervention trials. The purpose of this study is to conduct a systematic review and meta-regression of behavioural weight loss interventions to quantify control group weight change, and relate the size of this effect to specific trial and sample characteristics. Database searches identified reports of intervention trials meeting the inclusion criteria. Data on control group weight change and possible explanatory factors were abstracted and analysed descriptively and quantitatively. 85 trials were reviewed and 72 were included in the meta-regression. While there was no change in control group weight, control groups receiving usual care lost 1 kg more than control groups that received no intervention, beyond measurement. There are several possible explanations why control group changes occur in intervention trials targeting other behaviours, but not for weight loss. Control group participation may prevent weight gain, although more research is needed to confirm this hypothesis.

Cost-effectiveness of a distance lifestyle counselling programme among overweight employees from a company perspective, ALIFE@Work: a randomized controlled trial.

PubMed

Gussenhoven, A H M; van Wier, M F; Bosmans, J E; Dekkers, J C; van Mechelen, W

2013-01-01

The objective of this study was to determine whether a lifestyle intervention with individual counselling was cost-effective for reducing body weight compared with usual care from a company perspective. Overweight employees were recruited and randomly assigned to the intervention groups, either phone or Internet, or the control group. The intervention was based on a cognitive behavioural approach and addressed physical activity and diet. Self-reported body weight was collected at baseline and 12 months follow-up. Intervention costs and costs of sick leave days based on gross and net lost productivity days (GLPDs/NLPDs) obtained from the participating companies were calculated. Missing data were imputed using multiple imputation techniques. Uncertainty surrounding the differences in costs and the incremental cost-effectiveness ratios (ICER) was estimated by bootstrapping techniques, and presented on cost-effectiveness planes and cost-effectiveness acceptability curves. No statistically significant differences in total costs were found between the intervention groups and control group, though mean total costs in both intervention groups tended to be higher than those in the control group. The ICER of the Internet group compared with the control group was €59 per kilogram of weight loss based on GLPD costs. The probability of cost effectiveness of the Internet intervention was 45% at a willingness-to-pay of €0 per extra kilogram weight loss and 75% at a willingness-to-pay of €1500 per extra kilogram body weight loss. Comparable results were found for the phone intervention. The intervention was not cost effective in comparison with usual care from the company perspective. Due to the large amount of missing data, it is not possible to draw firm conclusions.

Ultrasound imaging to tailor the treatment of acute shoulder pain: a randomised controlled trial in general practice.

PubMed

Ottenheijm, Ramon P G; Cals, Jochen W L; Winkens, Bjorn; Weijers, René E; de Bie, Rob A; Dinant, Geert-Jan

2016-11-21

To determine the clinical effectiveness of ultrasound tailored treatment in patients with acute subacromial disorders. Pragmatic randomised controlled trial. Dutch general practice. Patients aged 18-65 years with acute (duration <3 months) unilateral shoulder pain and no previous treatment, in whom the general practitioner suspected a subacromial disorder was enrolled. All patients underwent ultrasound imaging of the affected shoulder. Patients who were still symptomatic after a qualification period of 2 weeks with standard treatment were randomised to treatment tailored to ultrasound diagnosis (disclosure of the ultrasound diagnosis) or usual care (non-disclosure of the ultrasound diagnosis). Patient-perceived recovery using the Global Perceived Effect questionnaire at 1 year. 129 patients were included. 18 patients recovered during the 2-week qualification period, resulting in 111 randomised patients; 56 were allocated to ultrasound tailored treatment and 55 to usual care. After 1 year, no statistically significant differences in recovery were found between the ultrasound tailored treatment group (72.5% (37/51)) and the usual care group (60% (30/50), OR 2.24 (95% CI 0.72 to 6.89; p=0.16)). Also, healthcare use was similar. This study has shown no clinically significant difference in the primary outcome measure between the ultrasound tailored treatment and usual care groups. Furthermore, there was no overall difference in healthcare resources used between groups. Although no formal cost data are included, one can only assume that the ultrasound examinations are additional costs for the intervention group, which cannot be justified in routine practice based on this trial. Based on this study, no change in current pragmatic guidelines to incorporate early ultrasound imaging can be recommended. NTR2403; Results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

An intervention study exploring the effects of providing older adult hip fracture patients with an information booklet in the early postoperative period.

PubMed

Murphy, Siobhan; Conway, Col; McGrath, Niamh B; O'Leary, Breda; O'Sullivan, Mary P; O'Sullivan, Dawn

2011-12-01

To determine whether the provision of an information booklet on mobilisation improves early mobility postsurgical repair of hip fracture. Hip fracture among older people can have long-lasting consequences with the majority of patients failing to achieve their prefracture functional status. Early postoperative mobility may have a positive effect on long-term recovery. The importance of providing postoperative information on mobility has been highlighted. It is suggested that patients remain passive in their recovery when they do not understand the importance of mobilisation. The study used a pretest-post-test design of two treatments and a usual care control group. Eighty-three adults postsurgical repair of hip fracture, aged 65 years and older, were recruited to the study. Participants were assigned to one of three groups, a usual care group, treatment group 1 (T(1)) usual care plus basic information booklet or treatment group 2 (T(2)) usual care plus detailed information booklet. Data collection three days postsurgery and prior to discharge included the Mini-Mental State Examination, a Demographic Questionnaire, the Elderly Mobility Scale and a Numerical Pain Scale. Greatest improvements in Elderly Mobility Scale scores occurred in T(1), with least changes observed in T(2). Changes did not reach significance level (p=0·105). The results of the study suggest that the provision of basic information is preferable and highlights a deficiency of education in usual care. Hip fracture patients should be provided with an educational booklet containing basic information on mobility to promote optimal recovery. © 2011 Blackwell Publishing Ltd.

A Randomized, Controlled Trial of a Shared Panel Management Program for Small Practices.

PubMed

Bishop, Tara F; Ryan, Andrew M; Chen, Melinda A; Mendelsohn, Jayme; Gottlieb, Daniel; Shih, Sarah; Desai, Priya; Wolff, Elizabeth A; Casalino, Lawrence P

2016-10-01

To determine whether a shared panel management program was effective at improving quality of care for patients with uncontrolled chronic disease. Data were extracted from electronic health records. Randomized controlled trial of a panel management program initiated by New York City Department of Health and Mental Hygiene. Patients from 20 practices with an uncontrolled chronic disease and a lapse in care were assigned to the intervention (a phone call requesting that the patient schedule a physician appointment) or usual care. Outcomes were visits to physician practices, body mass index measurement, blood pressure measurement and control, use of antithrombotics, and low-density lipoprotein measurement and control. Panel managers were able to successfully speak with 1,676 patients (14.7 percent of the intervention group). There were no significant differences in outcomes between the intervention and usual care groups. Successfully contacted patients were more likely to have an office visit within 1 year of randomization (45.6 percent [95 percent CI: 22.8, 26.9] vs. 38.1 percent [95 percent CI: 36.8, 39.3]) and more likely to be on antithrombotics (24.4 percent [95 percent CI: 17.7, 31.0]) versus those in the usual care group (17.0 percent [95 percent CI: 13.9, 20.0]) but had no other difference in quality. A shared, low-intensity panel management program run by a city health department did not improve quality of care for patients with chronic illnesses and lapses in care. © Health Research and Educational Trust.

Improving Hypertension Control and Patient Engagement Using Digital Tools.

PubMed

Milani, Richard V; Lavie, Carl J; Bober, Robert M; Milani, Alexander R; Ventura, Hector O

2017-01-01

Hypertension is present in 30% of the adult US population and is a major contributor to cardiovascular disease. The established office-based approach yields only 50% blood pressure control rates and low levels of patient engagement. Available home technology now provides accurate, reliable data that can be transmitted directly to the electronic medical record. We evaluated blood pressure control in 156 patients with uncontrolled hypertension enrolled into a home-based digital-medicine blood pressure program and compared them with 400 patients (matched to age, sex, body mass index, and blood pressure) in a usual-care group after 90 days. Digital-medicine patients completed questionnaires online, were asked to submit at least one blood pressure reading/week, and received medication management and lifestyle recommendations via a clinical pharmacist and a health coach. Blood pressure units were commercially available that transmitted data directly to the electronic medical record. Digital-medicine patients averaged 4.2 blood pressure readings per week. At 90 days, 71% of digital-medicine vs 31% of usual-care patients had achieved target blood pressure control. Mean decrease in systolic/diastolic blood pressure was 14/5 mm Hg in digital medicine, vs 4/2 mm Hg in usual care (P < .001). Excess sodium consumption decreased from 32% to 8% in the digital-medicine group (P = .004). Mean patient activation increased from 41.9 to 44.1 (P = .008), and the percentage of patients with low patient activation decreased from 15% to 6% (P = .03) in the digital-medicine group. A digital hypertension program is feasible and associated with significant improvement in blood pressure control rates and lifestyle change. Utilization of a virtual health intervention using connected devices improves patient activation and is well accepted by patients. Copyright © 2016 Elsevier Inc. All rights reserved.

Effects of a multifactorial falls prevention program for people with stroke returning home after rehabilitation: a randomized controlled trial.

PubMed

Batchelor, Frances A; Hill, Keith D; Mackintosh, Shylie F; Said, Catherine M; Whitehead, Craig H

2012-09-01

To determine whether a multifactorial falls prevention program reduces falls in people with stroke at risk of recurrent falls and whether this program leads to improvements in gait, balance, strength, and fall-related efficacy. A single blind, multicenter, randomized controlled trial with 12-month follow-up. Participants were recruited after discharge from rehabilitation and followed up in the community. Participants (N=156) were people with stroke at risk of recurrent falls being discharged home from rehabilitation. Tailored multifactorial falls prevention program and usual care (n=71) or control (usual care, n=85). Primary outcomes were rate of falls and proportion of fallers. Secondary outcomes included injurious falls, falls risk, participation, activity, leg strength, gait speed, balance, and falls efficacy. There was no significant difference in fall rate (intervention: 1.89 falls/person-year, control: 1.76 falls/person-year, incidence rate ratio=1.10, P=.74) or the proportion of fallers between the groups (risk ratio=.83, 95% confidence interval=.60-1.14). There was no significant difference in injurious fall rate (intervention: .74 injurious falls/person-year, control: .49 injurious falls/person-year, incidence rate ratio=1.57, P=.25), and there were no significant differences between groups on any other secondary outcome. This multifactorial falls prevention program was not effective in reducing falls in people with stroke who are at risk of falls nor was it more effective than usual care in improving gait, balance, and strength in people with stroke. Further research is required to identify effective interventions for this high-risk group. Copyright © 2012 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Specific balance training included in an endurance-resistance exercise program improves postural balance in elderly patients undergoing haemodialysis.

PubMed

Frih, Bechir; Mkacher, Wajdi; Jaafar, Hamdi; Frih, Ameur; Ben Salah, Zohra; El May, Mezry; Hammami, Mohamed

2018-04-01

The purpose of this study was to evaluate the effects of 6 months of specific balance training included in endurance-resistance program on postural balance in haemodialysis (HD) patients. Forty-nine male patients undergoing HD were randomly assigned to an intervention group (balance training included in an endurance-resistance training, n = 26) or a control group (resistance-endurance training only, n = 23). Postural control was assessed using six clinical tests; Timed Up and Go test, Tinetti Mobility Test, Berg Balance Scale, Unipodal Stance test, Mini-Balance Evaluation Systems Test and Activities Balance Confidence scale. All balance measures increased significantly after the period of rehabilitation training in the intervention group. Only the Timed Up and Go, Berg Balance Scale, Mini-Balance Evaluation Systems Test and Activities Balance Confidence scores were improved in the control group. The ranges of change in these tests were greater in the balance training group. In HD patients, specific balance training included in a usual endurance-resistance training program improves static and dynamic balance better than endurance-resistance training only. Implications for rehabilitation Rehabilitation using exercise in haemodialysis patients improved global mobility and functional abilities. Specific balance training included in usual endurance resistance training program could lead to improved static and dynamic balance.

A Randomized Controlled Study of the Virginia Student Threat Assessment Guidelines in Kindergarten through Grade 12

ERIC Educational Resources Information Center

Cornell, Dewey G.; Allen, Korrie; Fan, Xitao

2012-01-01

This randomized controlled study examined disciplinary outcomes for 201 students who made threats of violence at school. The students attended 40 schools randomly assigned to use the Virginia Student Threat Assessment Guidelines or follow a business-as-usual disciplinary approach in a control group. Logistic regression analyses found, after…

A video to improve patient and surrogate understanding of cardiopulmonary resuscitation choices in the ICU: a randomized controlled trial.

PubMed

Wilson, Michael E; Krupa, Artur; Hinds, Richard F; Litell, John M; Swetz, Keith M; Akhoundi, Abbasali; Kashyap, Rahul; Gajic, Ognjen; Kashani, Kianoush

2015-03-01

To determine if a video depicting cardiopulmonary resuscitation and resuscitation preference options would improve knowledge and decision making among patients and surrogates in the ICU. Randomized, unblinded trial. Single medical ICU. Patients and surrogate decision makers in the ICU. The usual care group received a standard pamphlet about cardiopulmonary resuscitation and cardiopulmonary resuscitation preference options plus routine code status discussions with clinicians. The video group received usual care plus an 8-minute video that depicted cardiopulmonary resuscitation, showed a simulated hospital code, and explained resuscitation preference options. One hundred three patients and surrogates were randomized to usual care. One hundred five patients and surrogates were randomized to video plus usual care. Median total knowledge scores (0-15 points possible for correct answers) in the video group were 13 compared with 10 in the usual care group, p value of less than 0.0001. Video group participants had higher rates of understanding the purpose of cardiopulmonary resuscitation and resuscitation options and terminology and could correctly name components of cardiopulmonary resuscitation. No statistically significant differences in documented resuscitation preferences following the interventions were found between the two groups, although the trial was underpowered to detect such differences. A majority of participants felt that the video was helpful in cardiopulmonary resuscitation decision making (98%) and would recommend the video to others (99%). A video depicting cardiopulmonary resuscitation and explaining resuscitation preference options was associated with improved knowledge of in-hospital cardiopulmonary resuscitation options and cardiopulmonary resuscitation terminology among patients and surrogate decision makers in the ICU, compared with receiving a pamphlet on cardiopulmonary resuscitation. Patients and surrogates found the video helpful in decision making and would recommend the video to others.

A Randomised Controlled Trial of Ion-Exchange Water Softeners for the Treatment of Eczema in Children

PubMed Central

Thomas, Kim S.; Dean, Tara; O'Leary, Caroline; Sach, Tracey H.; Koller, Karin; Frost, Anthony; Williams, Hywel C.

2011-01-01

Background Epidemiological studies and anecdotal reports suggest a possible link between household use of hard water and atopic eczema. We sought to test whether installation of an ion-exchange water softener in the home can improve eczema in children. Methods and Findings This was an observer-blind randomised trial involving 336 children (aged 6 months to 16 years) with moderate/severe atopic eczema. All lived in hard water areas (≥200 mg/l calcium carbonate). Participants were randomised to either installation of an ion-exchange water softener plus usual eczema care, or usual eczema care alone. The primary outcome was change in eczema severity (Six Area Six Sign Atopic Dermatitis Score, SASSAD) at 12 weeks, measured by research nurses who were blinded to treatment allocation. Analysis was based on the intent-to-treat population. Eczema severity improved for both groups during the trial. The mean change in SASSAD at 12 weeks was −5.0 (20% improvement) for the water softener group and −5.7 (22% improvement) for the usual care group (mean difference 0.66, 95% confidence interval −1.37 to 2.69, p = 0.53). No between-group differences were noted in the use of topical corticosteroids or calcineurin inhibitors. Conclusions Water softeners provided no additional benefit to usual care in this study population. Small but statistically significant differences were found in some secondary outcomes as reported by parents, but it is likely that such improvements were the result of response bias, since participants were aware of their treatment allocation. A detailed report for this trial is also available at http://www.hta.ac.uk. Trial registration Current Controlled Trials ISRCTN71423189 Please see later in the article for the Editors' Summary PMID:21358807

Economic Evaluation of the HF-ACTION Randomized Controlled Trial: An Exercise Training Study of Patients With Chronic Heart Failure

PubMed Central

Reed, Shelby D.; Whellan, David J.; Li, Yanhong; Friedman, Joëlle Y.; Ellis, Stephen J.; Piña, Ileana L.; Settles, Sharon J.; Davidson-Ray, Linda; Johnson, Johanna L.; Cooper, Lawton S.; O’Connor, Christopher M.; Schulman, Kevin A.

2011-01-01

Background HF-ACTION assigned 2331 outpatients with medically stable heart failure to exercise training or usual care. We compared medical resource use and costs incurred by these patients during follow-up. Methods and Results Extensive data on medical resource use and hospital bills were collected throughout the trial for estimates of direct medical costs. Intervention costs were estimated using patient-level trial data, administrative records, and published unit costs. Mean follow-up was 2.5 years. There were 2297 hospitalizations in the exercise group and 2332 in the usual care group (P = .92). The mean number of inpatient days was 13.6 (SD, 27.0) in the exercise group and 15.0 (SD, 31.4) in the usual care group (P = .23). Other measures of resource use were similar between groups, except for trends indicating that fewer patients in the exercise group underwent high-cost inpatient procedures. Total direct medical costs per participant were an estimated $50,857 (SD, $81,488) in the exercise group and $56,177 (SD, $92,749) in the usual care group (95% confidence interval for the difference, $–12,755 to $1547; P = .10). The direct cost of exercise training was an estimated $1006 (SD, $337). Patient time costs were an estimated $5018 (SD, $4600). Conclusions The cost of exercise training was relatively low for the health care system, but patients incurred significant time costs. In this economic evaluation, there was little systematic benefit in terms of overall medical resource use with this intervention. Trial Registration clinicaltrials.gov Identifier: NCT00047437 PMID:20551371

Does vibration training reduce the fall risk profile of frail older people admitted to a rehabilitation facility? A randomised controlled trial.

PubMed

Parsons, J; Mathieson, S; Jull, A; Parsons, M

2016-01-01

To determine the effect of Vibration Training (VT) on functional ability and falls risk among a group of frail older people admitted to an inpatient rehabilitation unit in a regional hospital in New Zealand. A randomized controlled trial of 56 participants (mean 82.01 years in the intervention group and 81.76 years in the control group). VT targeting lower limb muscles with a frequency 30-50 Hz occurred three times per week until discharge. Amplitude progressively increased from 2 to 5 mm to allow the programme to be individually tailored to the participant. The control group received usual care physiotherapy sessions. Outcome measures were: Physiological profile assessment (PPA); and Functional Independence measure (FIM) and Modified Falls Efficacy Scale (MFES). There was a statistically significant difference observed between the two groups in terms of FIM score (F = 5.09, p = 0.03) and MFES (F = 3.52, p = 0.007) but no difference was observed in terms of PPA scores (F = 0.96, p = 0.36). Among older people admitted to an inpatient rehabilitation facility there may be some beneficial effect to the use of VT in conjunction with usual care physiotherapy in terms of improved functional ability. The study design and the small dosage of VT provided may have precluded any change in falls risk among participants. Vibration training (VT) may assist in reducing the risk of falling among at risk older people. Current pressures on health systems (ageing population, reduced hospital length of stay) necessitate the development of innovative strategies to maximise the rehabilitation potential of older people. Among older people admitted to an inpatient rehabilitation facility there may be some beneficial effect to the use of vibration training in conjunction with usual care physiotherapy in terms of improved functional ability.

Integrating Total Physical Response Strategy in a Level I Spanish Class.

ERIC Educational Resources Information Center

Wolfe, David E.; Jones, Gwendolyn

1982-01-01

Reports on an experiment in which one group of high school students was taught using Total Physical Response (TPR) for 20 minutes a day and a control group was taught by the usual manner. Results showed students in the TPR group scored better on standard unit tests and expressed greater satisfaction with their teacher and course. (EKN)

76 FR 59132 - Agency Information Collection Request. 60-Day Public Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-23

... counterfactual, or the ``business as usual'' services received by youth in the control group. This information... Evaluation (ASPE), the Centers for Disease Control and Prevention (CDC), and the Administration for Children... Evaluation). The TPP Replication Evaluation will be an experimental evaluation which will determine the...

A manual-based phenomenological art therapy for individuals diagnosed with moderate to severe depression (PATd): A randomized controlled study.

PubMed

Blomdahl, Christina; Guregård, Suzanne; Rusner, Marie; Wijk, Helle

2018-05-14

This study investigated the effects of manual-based Phenomenological Art Therapy for individuals living with depression in addition to treatment as usual (PATd/TAU) compared with only treatment as usual (TAU) for individuals diagnosed with moderate to severe depression. 79 adults (men = 29.1%) were included in this randomized-controlled-trial (RCT), multicenter study in Sweden with an intention-to-treat design. Participants were randomized into either the PATd/TAU-group (n = 43) or TAU-group (n = 36). Data were collected at baseline and at end of treatment. The main outcomes were depression levels and self-esteem. Secondary outcomes were suicide ideation and sickness absence. The PATd/TAU-group showed a significant decrease of depression levels. The PATd/TAU-group returned to work to a higher degree than the TAU-group. Self-esteem significantly improved in both groups. Suicide ideation was unaffected. Manual-based PATd works as expected, being an effective treatment, and contributes to recovery for individuals with moderate to severe depression. This outcome needs to be confirmed and its long-term effects examined in further studies. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

The effect of a telephone-based cognitive behavioral therapy on quality of life: a randomized controlled trial.

PubMed

Ngai, Fei-Wan; Wong, Paul Wai-Ching; Chung, Ka-Fai; Leung, Kwok-Yin

2017-06-01

Health-related quality of life (HRQoL) has emerged as a major public health concern in perinatal care. The purpose of this study was to examine the effect of telephone-based cognitive behavioral therapy (T-CBT) on HRQoL among Chinese mothers at risk of postnatal depression at 6 weeks and 6 months postpartum. A multi-center randomized controlled trial was conducted at the postnatal units of three regional hospitals. Three hundred and ninety-seven women at risk of postnatal depression were recruited and were randomly assigned to the T-CBT (n = 197) or usual care (n = 200). Assessment was conducted at baseline, 6 weeks and 6 months postpartum for HRQoL. Women in the T-CBT experienced greater improvement in the physical component of HRQoL from baseline to 6 weeks and 6 months postpartum than the usual care group. At 6 months postpartum, the T-CBT group also experienced better HRQoL in the mental component of HRQoL than the usual care group. The T-CBT appears to be feasible and effective in improving HRQoL in women at risk of postnatal depression in the primary care practice.

A practice-based intervention to improve primary care for falls, urinary incontinence, and dementia.

PubMed

Wenger, Neil S; Roth, Carol P; Shekelle, Paul G; Young, Roy T; Solomon, David H; Kamberg, Caren J; Chang, John T; Louie, Rachel; Higashi, Takahiro; MacLean, Catherine H; Adams, John; Min, Lillian C; Ransohoff, Kurt; Hoffing, Marc; Reuben, David B

2009-03-01

To determine whether a practice-based intervention can improve care for falls, urinary incontinence, and cognitive impairment. Controlled trial. Two community medical groups. Community-dwelling patients (357 at intervention sites and 287 at control sites) aged 75 and older identified as having difficulty with falls, incontinence, or cognitive impairment. Intervention and control practices received condition case-finding, but only intervention practices received a multicomponent practice-change intervention. Percentage of quality indicators satisfied measured using a 13-month medical record abstraction. Before the intervention, the quality of care was the same in intervention and control groups. Screening tripled the number of patients identified as needing care for falls, incontinence, or cognitive impairment. During the intervention, overall care for the three conditions was better in the intervention than the control group (41%, 95% confidence interval (CI)=35-46% vs 25%, 95% CI=20-30%, P<.001). Intervention group patients received better care for falls (44% vs 23%, P<.001) and incontinence (37% vs 22%, P<.001) but not for cognitive impairment (44% vs 41%, P=.67) than control group patients. The intervention was more effective for conditions identified by screening than for conditions identified through usual care. A practice-based intervention integrated into usual clinical care can improve primary care for falls and urinary incontinence, although even with the intervention, less than half of the recommended care for these conditions was provided. More-intensive interventions, such as embedding intervention components into an electronic medical record, will be needed to adequately improve care for falls and incontinence.

Cognitive Behavioral Therapy for Children with Dental Anxiety: A Randomized Controlled Trial.

PubMed

Shahnavaz, S; Hedman, E; Grindefjord, M; Reuterskiöld, L; Dahllöf, G

2016-10-01

Dental anxiety affects approximately 9% of children and is associated with poor oral health, pain, and psychosocial problems. The objective of this study was to investigate the efficacy of cognitive behavioral therapy (CBT) for children with dental anxiety in specialist pediatric dentistry. The study used a parallel-group superiority randomized controlled trial design. The primary outcome measure was the behavioral avoidance test; assessors were blind to treatment allocation. Participants were 8 boys and 22 girls 7 to 18 y old (mean ± SD, 10 ± 3.1). Children fulfilling the diagnostic criteria for dental anxiety were randomized to CBT (n = 13) or treatment as usual (n = 17), such as various sedation methods. Psychologists provided 10 h of CBT based on a treatment manual. Treatments were conducted in a naturalistic real-world clinical setting. Assessments were conducted before the treatment, 3 mo after the start of treatment, and at 1-y follow-up. The analyses of the primary outcome measure by repeated-measures analysis of variance and independent t test showed that children receiving CBT made superior, statistically significant improvements at follow-up (16.8 ± 2.4) compared with treatment as usual (11.4 ± 3.1, P < 0.01). A large between-group effect size (Cohen's d = 1.9) was found. Following treatment, 73% of those in the CBT group managed all stages of the dental procedures included in the behavioral avoidance test compared with 13% in the treatment-as-usual group. Furthermore, 91% in the CBT group compared with 25% in the treatment-as-usual group no longer met the diagnostic criteria for dental anxiety at the 1-y follow-up according to the secondary outcome measure. Measures of dental anxiety and self-efficacy showed larger improvements in the CBT group compared with controls. We conclude that CBT is an efficacious treatment for children and adolescents with dental anxiety and should be made accessible in pediatric dentistry (ClinicalTrials.gov: NCT01798355). Knowledge transfer statement: The results of this study can be used by decision makers and clinicians when planning to implement evidence-based treatment in pediatric dentistry and give children and adolescents access to methods for treating dental anxiety. The results can also be used by parents of children with dental anxiety when asking dentists to cooperate with psychologists using cognitive behavioral therapy.

Long-Term Effect of Pravastatin on Carotid Intima–Media Complex Thickness

PubMed Central

Toyoda, Kazunori; Minematsu, Kazuo; Yasaka, Masahiro; Nagai, Yoji; Aoki, Shiro; Nezu, Tomohisa; Hosomi, Naohisa; Kagimura, Tatsuo; Origasa, Hideki; Kamiyama, Kenji; Suzuki, Rieko; Ohtsuki, Toshiho; Maruyama, Hirofumi; Kitagawa, Kazuo; Uchiyama, Shinichiro; Matsumoto, Masayasu

2018-01-01

Background and Purpose— The effect of statins on progression of carotid intima–media complex thickness (IMT) has been shown exclusively in nonstroke Western patients. This study aimed to determine the effect of low-dose pravastatin on carotid IMT in Japanese patients with noncardioembolic ischemic stroke. Methods— This is a substudy of the J-STARS trial (Japan Statin Treatment Against Recurrent Stroke), a multicenter, randomized, open-label, parallel-group trial to examine whether pravastatin reduces stroke recurrence. Patients were randomized to receive pravastatin (10 mg daily, usual dose in Japan; pravastatin group) or not to receive any statins (control group). The primary outcome was IMT change of the common carotid artery for a 5-year observation period. IMT change was compared using mixed-effects models for repeated measures. Results— Of 864 patients registered in this substudy, 71 without baseline ultrasonography were excluded, and 388 were randomly assigned to the pravastatin group and 405 to the control group. Baseline characteristics were not significantly different, except National Institutes of Health Stroke Scale scores (median, 0 [interquartile range, 0–2] versus 1 [interquartile range, 0–2]; P=0.019) between the 2 groups. Baseline IMT (mean±SD) was 0.887±0.155 mm in the pravastatin group and 0.887±0.152 mm in the control group (P=0.99). The annual change in the IMT at 5-year visit was significantly reduced in the pravastatin group as compared with that in the control group (0.021±0.116 versus 0.040±0.118 mm; P=0.010). Conclusions— The usual Japanese dose of pravastatin significantly reduced the progression of carotid IMT at 5 years in patients with noncardioembolic stroke. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00361530. PMID:29191850

The costs and benefits of technology-enabled, home-based cardiac rehabilitation measured in a randomised controlled trial.

PubMed

Whittaker, Frank; Wade, Victoria

2014-10-01

We conducted a cost benefit analysis of a home telehealth-based cardiac rehabilitation programme compared to the standard hospital-based programme. A total of 120 participants were enrolled in a trial, with 60 randomised to the telehealth group and 60 randomised to usual care. Participants in the telehealth group received a mobile phone, Wellness Diary and a Wellness web portal, with daily text messaging. Participants in the usual care group received the standard 6-week hospital-based outpatient cardiac rehabilitation programme, including gym sessions. The cost of delivery by telehealth was slightly lower than for patients attending a rehabilitation service in person. From the provider's perspective, the telehealth intervention could be delivered for $1633 per patient, compared to $1845 for the usual care group. From the participant's perspective, patient travel costs for home rehabilitation were substantially less than for hospital attendance ($80 vs $400). Cardiac rehabilitation by telehealth offers obvious advantages and the option should be available to all patients who are eligible for cardiac rehabilitation. © The Author(s) 2014 Reprints and permissions:]br]sagepub.co.uk/journalsPermissions.nav.

The effect of a sweet potato, footbath, and acupressure intervention in preventing constipation in hospitalized patients with acute coronary syndromes.

PubMed

Ren, Kai; Qiu, Jingbo; Wang, Xiaohua; Niu, Fenglin; Jiang, Tingbo

2012-01-01

Constipation is a common health problem that adversely affects quality of life and the prognosis of hospitalized patients with acute coronary syndromes (ACS). The purpose of this study was to develop and test the sweet potato/footbath/acupressure massage (SFA) intervention as a safe treatment for prevention of constipation and to increase satisfaction with bowel emptying in hospitalized patients with ACS. The study was a prospective, randomized controlled trial with a sample of 93 patients (SFA group, n = 44; usual care group, n = 49). Patients in the SFA group received SFA intervention combined with usual care. The results showed that there were statistical differences between the two groups in terms of (1) the incidence of constipation; (2) the use of laxatives and enemas; (3) patients' subjective satisfaction with their bowel emptying during hospitalization; and (4) sensation of incomplete evacuation and anorectal obstruction/blockade. The SFA intervention was more effective, economical, and practical than usual care alone in managing constipation and satisfaction with defecation in patients hospitalized with ACS.

The effect of a disease management intervention on quality and outcomes of dementia care: a randomized, controlled trial.

PubMed

Vickrey, Barbara G; Mittman, Brian S; Connor, Karen I; Pearson, Marjorie L; Della Penna, Richard D; Ganiats, Theodore G; Demonte, Robert W; Chodosh, Joshua; Cui, Xinping; Vassar, Stefanie; Duan, Naihua; Lee, Martin

2006-11-21

Adherence to dementia guidelines is poor despite evidence that some guideline recommendations can improve symptoms and delay institutionalization of patients. To test the effectiveness of a dementia guideline-based disease management program on quality of care and outcomes for patients with dementia. Clinic-level, cluster randomized, controlled trial. 3 health care organizations collaborating with 3 community agencies in southern California. 18 primary care clinics and 408 patients with dementia age 65 years or older paired with 408 informal caregivers. Disease management program led by care managers and provided to 238 patient-caregiver pairs at 9 intervention clinics for more than 12 months. Adherence to 23 guideline recommendations (primary outcome) and receipt of community resources and patient and caregiver health and quality-of-care measures (secondary outcomes). The mean percentage of per-patient guideline recommendations to which care was adherent was significantly higher in the intervention group than in the usual care group (63.9% vs. 32.9%, respectively; adjusted difference, 30.1% [95% CI, 25.2% to 34.9%]; P < 0.001). Participants who received the intervention had higher care quality on 21 of 23 guidelines (P < or = 0.013 for all), and higher proportions received community agency assistance (P < or = 0.03) than those who received usual care. Patient health-related quality of life, overall quality of patient care, caregiving quality, social support, and level of unmet caregiving assistance needs were better for participants in the intervention group than for those in the usual care group (P < 0.05 for all). Caregiver health-related quality of life did not differ between the 2 groups. Participants were well-educated, were predominantly white, had a usual source of care, and were not institutionalized. Generalizability to other patients and geographic regions is unknown. Also, costs of a care management program under fee-for-service reimbursement may impede adoption. A dementia guideline-based disease management program led to substantial improvements in quality of care for patients with dementia. Current Controlled Trials identifier: ISRCTN72577751.

Long-term effectiveness of a community-based model of care in Māori and Pacific patients with type 2 diabetes and chronic kidney disease: a 4-year follow up of the DElay Future End Stage Nephropathy due to Diabetes (DEFEND) study.

PubMed

Tan, J; Manley, P; Gamble, G; Collins, J; Bagg, W; Hotu, C; Braatvedt, G

2015-08-01

The Delay Future End Stage Nephropathy due to Diabetes study was a randomised controlled trial of Māori and Pacific patients with advanced diabetic nephropathy, comparing a community-based model of care with usual care. The intervention group achieved lower blood pressure (BP), proteinuria and less end-organ damage. After the intervention ended, all patients reverted to usual care, and were followed to review the sustainability of the intervention. A retrospective observation of 65 patients (aged 47-75 years) with type 2 diabetes, hypertension, chronic kidney disease 3/4 and proteinuria (>0.5 g/day) previously randomised to intervention/community care or usual care for 11-21 months. Follow up thereafter was until death, end-stage renal disease (ESRD) (estimated glomerular filtration rate (eGFR) ≤ 10 mL/min/1.73 m(2) )/dialysis or 1 February 2014. Primary end-points were death and ESRD/dialysis. Secondary outcomes were annualised glomerular filtration rate decline, non-fatal vascular events and hospitalisations. Median (interquartile ranges (IQR)) post-trial follow up was 49 (21-81) months and similar in both groups. The median (IQR) eGFR decline was -3.1 (-5.5, -2.3) and -5.5 (-7.1, -3.0) mL/min/year in the intervention and usual care groups respectively (P = 0.11). Similar number of deaths, renal and vascular events were observed in both groups. At the end of follow up, the number of prescribed antihypertensive medications was similar (3.4 ± 1.0 vs 3.3 ± 1.4; P = 0.78). There were fewer median (IQR) hospital days (8 (3, 18) vs 15.5 (6, 49) days, P = 0.03) in the intervention group. Short-term intensive BP control followed by usual care did not translate into reduction in long-term mortality or ESRD rates, but was associated with reduced hospitalisations. © 2015 Royal Australasian College of Physicians.

Treatment-as-usual (TAU) is anything but usual: a meta-analysis of CBT versus TAU for anxiety and depression.

PubMed

Watts, Sarah E; Turnell, Adrienne; Kladnitski, Natalie; Newby, Jill M; Andrews, Gavin

2015-04-01

There were three aims of this study, the first was to examine the efficacy of CBT versus treatment-as-usual (TAU) in the treatment of anxiety and depressive disorders, the second was to examine how TAU is defined in TAU control groups for those disorders, and the third was to explore whether the type of TAU condition influences the estimate of effects of CBT. A systematic search of Cochrane Central Register of Controlled Trials, PsycINFO, and CINAHL was conducted. 48 studies of CBT for depressive or anxiety disorders (n=6926) that specified that their control group received TAU were identified. Most (n=45/48) provided an explanation of the TAU group however there was significant heterogeneity amongst TAU conditions. The meta-analysis showed medium effects favoring CBT over TAU for both anxiety (g=0.69, 95% CI 0.47-0.92, p<0.001, n=1318) and depression (g=0.70, 95% CI 0.49-0.90, p<0.001, n=5054), with differential effects observed across TAU conditions. CBT is superior to TAU and the size of the effect of CBT compared to TAU depends on the nature of the TAU condition. The term TAU is used in different ways and should be more precisely described. The four key details to be reported can be thought of as "who, what, how many, and any additional treatments?" Copyright © 2014 Elsevier B.V. All rights reserved.

Efficacy of cognitive rehabilitation using computer software with individuals living with schizophrenia: A randomized controlled trial in Japan.

PubMed

Iwata, Kazuhiko; Matsuda, Yasuhiro; Sato, Sayaka; Furukawa, Shunichi; Watanabe, Yukako; Hatsuse, Norifumi; Ikebuchi, Emi

2017-03-01

Cognitive impairment is common in schizophrenia, and is associated with poor psychosocial functioning. Previous studies had inconsistently shown improvement in cognitive functions with cognitive remediation therapy. This study examined whether cognitive remediation is effective in improving both cognitive and social functions in schizophrenia in outpatient settings that provide learning-based psychiatric rehabilitation. This study is the first randomized controlled trial of cognitive remediation in Japan. Study participants were individuals with schizophrenia from 6 outpatient psychiatric medical facilities who were randomly assigned either a cognitive remediation program or treatment as usual. The cognitive remediation intervention includes Cognitive training using computer software (CogPack; Japanese version) administered twice a week and a weekly group over 12 weeks and was based on the Thinking Skills for Work program. Most study participants were attending day treatment services where social skills training, psychoeducation for knowledge about schizophrenia, group activities such as recreation and sport, and other psychosocial treatment were offered. Cognitive and social functioning were assessed using the Brief Assessment of Cognition in Schizophrenia (BACS) and Life Assessment Scale for Mentally Ill (LASMI) at pre- and postintervention. Of the 60 people with schizophrenia enrolled, 29 were allocated to the cognitive remediation group and 31 were allocated to the treatment as usual group. Processing speed, executive function, and the composite score of the BACS showed significantly greater improvement for the cognitive remediation group than the treatment as usual group. In addition, there was significant improvement in interpersonal relationships and work skills on the LASMI for the cognitive remediation group compared with the treatment as usual group. Changes from pretreatment to posttreatment in verbal fluency and interpersonal relationships were significantly correlated, as well as changes in attention and work skills. The present findings showed that providing cognitive remediation on addition to psychiatric rehabilitation contributed to greater improvement in both cognitive and social functioning than psychiatric rehabilitation alone. Cognitive remediation may enhance the efficacy of psychiatric rehabilitation improving social functioning. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Health outcomes can be improved by implementing an occupational physiotherapy provider programme.

PubMed

Pizzari, Tania; Davidson, Megan

2013-03-01

To evaluate the return to work and health outcomes of a physiotherapy network provider programme. A prospective case-control study was conducted with 21 clients of network occupational physiotherapy (OP) providers and 21 matched clients of non-network providers. Health outcomes and return to work were recorded 3 and 6 months following the commencement of physiotherapy. Health outcomes included the Short Form (SF)-12, return to usual activities and the global perceived effect of treatment. Within-group changes and between-group differences were analysed. Within-group changes showed the OP group improved significantly in physical functioning (p = 0.006), and the control group deteriorated in mental health status (p = 0.016) as measured by the SF-12. Mean change over time between groups from the 3-month to 6-month follow-ups showed a significant difference favouring the OP group for return to usual activities (p = 0.027) and the physical component of the SF-12 (p = 0.009). All job-attached participants returned to work following their accident, so there was no difference between the groups. The OP clients demonstrated a greater change in physical functioning health outcomes over time. This study provides preliminary support for the implementation of the OP scheme. Copyright © 2012 John Wiley & Sons, Ltd.

Serotonin transporter linked polymorphic region (5-HTTLPR) genotype moderates the longitudinal impact of early caregiving on externalizing behavior.

PubMed

Brett, Zoë H; Humphreys, Kathryn L; Smyke, Anna T; Gleason, Mary Margaret; Nelson, Charles A; Zeanah, Charles H; Fox, Nathan A; Drury, Stacy S

2015-02-01

We examined caregiver report of externalizing behavior from 12 to 54 months of age in 102 children randomized to care as usual in institutions or to newly created high-quality foster care. At baseline no differences by group or genotype in externalizing were found. However, changes in externalizing from baseline to 42 months of age were moderated by the serotonin transporter linked polymorphic region genotype and intervention group, where the slope for short-short (S/S) individuals differed as a function of intervention group. The slope for individuals carrying the long allele did not significantly differ between groups. At 54 months of age, S/S children in the foster care group had the lowest levels of externalizing behavior, while children with the S/S genotype in the care as usual group demonstrated the highest rates of externalizing behavior. No intervention group differences were found in externalizing behavior among children who carried the long allele. These findings, within a randomized controlled trial of foster care compared to continued care as usual, indicate that the serotonin transporter linked polymorphic region genotype moderates the relation between early caregiving environments to predict externalizing behavior in children exposed to early institutional care in a manner most consistent with differential susceptibility.

Exercise-based cardiac rehabilitation increases daily physical activity of patients following myocardial infarction: subanalysis of two randomised controlled trials.

PubMed

Ribeiro, F; Oliveira, N L; Silva, G; Campos, L; Miranda, F; Teixeira, M; Alves, A J; Oliveira, J

2017-03-01

To assess the effects of an exercise-based cardiac rehabilitation programme on daily physical activity levels of patients following myocardial infarction. Subanalysis of two randomised, prospective controlled trials. Outpatient clinic of a secondary hospital. Fifty consecutive patients randomised to the exercise group {n=25; 23 males; mean age 54 [standard deviation (SD) 9] years} or the control group [n=25; 20 males; mean age 58 (SD 9) years]. The exercise group participated in an 8-week aerobic exercise programme plus usual medical care and follow-up. The control group received usual medical care and follow-up. The primary outcome measure was change in time spent undertaking moderate-to-vigorous physical activity per day, assessed by accelerometer over 7 consecutive days. Secondary outcome measures were cardiorespiratory fitness, body mass, and resting blood pressure and heart rate. Moderate-to-vigorous physical activity levels increased significantly in the exercise group [43.2 (SD 36.3) to 53.5 (SD 31.9) minutes/day, P=0.030], and remained unchanged in the control group [40.8 (SD 26.2) to 36.8 (SD 26.5) minutes/day, P=0.241] from baseline to the end of the programme. Cardiorespiratory fitness increased significantly in the exercise group (mean difference 2.8; 95% of the difference 1.3 to 4.4ml/kg/minute, P=0.001) after the 8-week programme. In patients under optimal medication following myocardial infarction, participation in an 8-week exercise-based cardiac rehabilitation programme was found to improve physical activity levels consistent with health-related benefits. Future studies are needed to determine whether the increase in physical activity is maintained in the long term. Copyright © 2015 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

Temporal patterns of change in vital signs and Cardiac Arrest Risk Triage scores over the 48 hours preceding fatal in-hospital cardiac arrest.

PubMed

Oh, HyunSoo; Lee, KangIm; Seo, WhaSook

2016-05-01

To determine temporal patterns of vital sign and Cardiac Arrest Risk Triage score changes over the 48-hour period preceding cardiac arrest in an ICU setting. Vital sign instability usually occurs prior to cardiac arrest. However, few studies have been conducted on the temporal patterns of individual vital signs preceding cardiac arrest. A retrospective case-control study. The study subjects were 140 ICU patients (1 June 2011-31 December 2012): 46 died of cardiac arrest (case group), 45 died of other illnesses (control I group) and 49 were discharged after recovering (control II group). Initial detectable changes in blood pressure appeared 18-20 hours and became dramatic at 5-10 hours before cardiac arrest. Noticeable changes in heart rates began at 4 hours and became more prominent at 2 hours pre-arrest. No apparent patterns in respiratory rate changes were observed. Body temperatures usually indicated a hypothermic state pre-arrest. Cardiac Arrest Risk Triage scores were 16-18 at 48 hours pre-arrest and then continuously increased to 20. Only mean values of systolic blood pressures were significantly different between the three study groups. Mean diastolic blood pressures, heart rates, respiratory rates and Cardiac Arrest Risk Triage scores differed between the case and control II groups and between the control I and II groups. The study demonstrates vital sign instability preceded cardiac arrest and that the temporal patterns of changes in individual vital signs and Cardiac Arrest Risk Triage scores differed between groups. The findings of this study may aid the development of management strategies for cardiac arrest. © 2016 John Wiley & Sons Ltd.

Personal navigation increases colorectal cancer screening uptake.

PubMed

Ritvo, Paul G; Myers, Ronald E; Paszat, Lawrence F; Tinmouth, Jill M; McColeman, Joshua; Mitchell, Brian; Serenity, Mardie; Rabeneck, Linda

2015-03-01

Prior randomized, controlled trials (RCTs) indicate that patient navigation can boost colorectal cancer screening rates in primary care. The sparse literature on pragmatic trials of interventions designed to increase colorectal cancer screening adherence motivated this trial on the impact of a patient navigation intervention that included support for performance of the participants' preferred screening test (colonoscopy or stool blood testing). Primary care patients (n = 5,240), 50 to 74 years of age, with no prior diagnosis of bowel cancer and no record of a recent colorectal cancer screening test, were identified at the Group Health Centre in northern Ontario. These patients were randomly assigned to an intervention group (n = 2,629) or a usual care control group (n = 2,611). Intervention group participants were contacted by a trained nurse navigator by telephone to discuss colorectal cancer screening. Interested patients met with the navigator, who helped them identify and arrange for performance of the preferred screening test. Control group participants received usual care. Multivariate analyses were conducted using medical records data to assess intervention impact on screening adherence within 12 months after randomization. Mean patient age was 59 years, and 50% of participants were women. Colorectal cancer screening adherence was higher in the intervention group (35%) than in the control group (20%), a difference that was statistically significant (OR, 2.11; confidence interval, 1.87-2.39). Preference-based patient navigation increased screening uptake in a pragmatic RCT. Patient navigation increased colorectal cancer screening rates in a pragmatic RCT in proportions similar to those observed in explanatory RCTs. ©2014 American Association for Cancer Research.

Improving Vocabulary and Pre-Literacy Skills of At-Risk Preschoolers through Teacher Professional Development

ERIC Educational Resources Information Center

Wasik, Barbara A.; Hindman, Annemarie H.

2011-01-01

In a randomized control study, Head Start teachers were assigned to either an intervention group that received intensive, ongoing professional development (PD) or to a comparison group that received the "business as usual" PD provided by Head Start. The PD intervention provided teachers with conceptual knowledge and instructional…

A nurse-led education and cognitive behaviour therapy-based intervention among adults with uncontrolled type 2 diabetes: A randomised controlled trial.

PubMed

Whitehead, Lisa C; Crowe, Marie T; Carter, Janet D; Maskill, Virginia R; Carlyle, Dave; Bugge, Carol; Frampton, Chris M A

2017-08-01

Diabetes mellitus is associated with significant morbidity, mortality, and escalating health care costs. Research has consistently demonstrated the importance of glycaemic control in delaying the onset, and decreasing the incidence, of both the short-term and long-term complications of diabetes. Although glycaemic control is difficult to achieve and challenging to maintain, it is key to reducing negative disease outcomes. The aim of this study was to determine whether a nurse-led educational intervention alone or a nurse-led intervention using education and acceptance and commitment therapy (ACT) was effective in reducing hemoglobin A 1c (HbA 1c ) in people living with uncontrolled type 2 diabetes compared to usual care. Adults over the age of 18 years, with a confirmed diagnosis of type 2 diabetes and HbA 1c outside of the recommended range (4%-7%, 20-53 mmol/mol) for 12 months or more, were eligible to participate. Participants were randomised to either a nurse-led education intervention, a nurse-led education plus ACT intervention, or a usual care. One hundred and eighteen participants completed baseline data collection (N = 34 education group, N = 39 education plus ACT, N = 45 control group). An intention to treat analysis was used. A statistically significant reduction in HbA 1c in the education intervention group was found (P = .011 [7.48, 8.14]). At 6 months, HbA 1c was reduced in both intervention groups (education group -0.21 and education and ACT group -0.04) and increased in the control group (+0.32). A positive change in HbA 1c (HbA 1c reduced) was noted in 50 participants overall. Twice as many participants in the intervention groups demonstrated an improvement as compared to the control group (56% of the education group, 51% education plus ACT, and 24% control group. At 6 months post intervention, HbA 1c was reduced in both intervention groups with a greater reduction noted in the nurse-led education intervention. © 2017 John Wiley & Sons, Ltd.

Management of type 2 diabetes in China: the Happy Life Club, a pragmatic cluster randomised controlled trial using health coaches

PubMed Central

Browning, Colette; Chapman, Anna; Yang, Hui; Liu, Shuo; Zhang, Tuohong; Enticott, Joanne C; Thomas, Shane A

2016-01-01

Objective To assess the effectiveness of a coach-led motivational interviewing (MI) intervention in improving glycaemic control, as well as clinical, psychosocial and self-care outcomes of individuals with type 2 diabetes mellitus (T2DM) compared with usual care. Design Pragmatic cluster randomised controlled trial (RCT). Setting Community Health Stations (CHSs) in Fengtai district, Beijing, China. Participants Of the 41 randomised CHSs (21 intervention and 20 control), 21 intervention CHSs (372 participants) and 18 control CHSs (296 participants) started participation. Intervention Intervention participants received telephone and face-to-face MI health coaching in addition to usual care from their CHS. Control participants received usual care only. Medical fees were waived for both groups. Outcome measures Outcomes were assessed at baseline, 6 and 12 months. Primary outcome measure was glycated haemoglobin (HbA1c). Secondary outcomes included a suite of anthropometric, blood pressure (BP), fasting blood, psychosocial and self-care measures. Results At 12 months, no differential treatment effect was found for HbA1c (adjusted difference 0.02, 95% CI −0.40 to 0.44, p=0.929), with both treatment and control groups showing significant improvements. However, two secondary outcomes: psychological distress (adjusted difference −2.38, 95% CI −4.64 to −0.12, p=0.039) and systolic BP (adjusted difference −3.57, 95% CI −6.08 to −1.05, p=0.005) were robust outcomes consistent with significant differential treatment effects, as supported in sensitivity analyses. Interestingly, in addition to HbA1c, both groups displayed significant improvements in triglycerides, LDL cholesterol and HDL cholesterol. Conclusions In line with the current Chinese primary healthcare reform, this study is the first large-scale cluster RCT to be implemented within real-world CHSs in China, specifically addressing T2DM. Although a differential treatment effect was not observed for HbA1c, numerous outcomes (including HbA1c) improved in both groups, supporting the establishment of regular, free clinical health checks for people with T2DM in China. Trial registration number ISRCTN01010526; Pre-results. PMID:26944692

Association of Structured Virtual Visits for Hypertension Follow-Up in Primary Care with Blood Pressure Control and Use of Clinical Services.

PubMed

Levine, David Michael; Dixon, Ronald F; Linder, Jeffrey A

2018-04-23

Optimal management of hypertension requires frequent monitoring and follow-up. Novel, pragmatic interventions have the potential to engage patients, maintain blood pressure control, and enhance access to busy primary care practices. "Virtual visits" are structured asynchronous online interactions between a patient and a clinician to extend medical care beyond the initial office visit. To compare blood pressure control and healthcare utilization between patients who received virtual visits compared to usual hypertension care. Propensity score-matched, retrospective cohort study with adjustment by difference-in-differences. Primary care patients with hypertension. Patient participation in at least one virtual visit for hypertension. Usual care patients did not use a virtual visit but were seen in-person for hypertension. Adjusted difference in mean systolic blood pressure, primary care office visits, specialist office visits, emergency department visits, and inpatient admissions in the 180 days before and 180 days after the in-person visit. Of the 1051 virtual visit patients and 24,848 usual care patients, we propensity score-matched 893 patients from each group. Both groups were approximately 61 years old, 44% female, 85% White, had about five chronic conditions, and about 20% had a mean pre-visit systolic blood pressure of 140-160 mmHg. Compared to usual care, virtual visit patients had an adjusted 0.8 (95% CI, 0.3 to 1.2) fewer primary care office visits. There was no significant adjusted difference in systolic blood pressure control (0.6 mmHg [95% CI, - 2.0 to 3.1]), specialist visits (0.0 more visits [95% CI, - 0.3 to 0.3]), emergency department visits (0.0 more visits [95% CI, 0.0 to 0.01]), or inpatient admissions (0.0 more admissions [95% CI, 0.0 to 0.1]). Among patients with reasonably well-controlled hypertension, virtual visit participation was associated with equivalent blood pressure control and reduced in-office primary care utilization.

Implementation and evaluation of a pharmacist-led hypertension management service in primary care: outcomes and methodological challenges.

PubMed

Bajorek, Beata; Lemay, Kate S; Magin, Parker; Roberts, Christopher; Krass, Ines; Armour, Carol L

2016-01-01

Suboptimal utilisation of pharmacotherapy, non-adherence to prescribed treatment, and a lack of monitoring all contribute to poor blood (BP) pressure control in patients with hypertension. The objective of this study was to evaluate the implementation of a pharmacist-led hypertension management service in terms of processes, outcomes, and methodological challenges. A prospective, controlled study was undertaken within the Australian primary care setting. Community pharmacists were recruited to one of three study groups: Group A (Control - usual care), Group B (Intervention), or Group C (Short Intervention). Pharmacists in Groups B and C delivered a service comprising screening and monitoring of BP, as well as addressing poor BP control through therapeutic adjustment and adherence strategies. Pharmacists in Group C delivered the shortened version of the service. Significant changes to key outcome measures were observed in Group C: reduction in systolic and diastolic BPs at the 3-month visit (P<0.01 and P<0.01, respectively), improvement in medication adherence scores (P=0.01), and a slight improvement in quality of life (EQ-5D-3L Index) scores (P=0.91). There were no significant changes in Group B (the full intervention), and no differences in comparison to Group A (usual care). Pharmacists fed-back that patient recruitment was a key barrier to service implementation, highlighting the methodological implications of screening. A collaborative, pharmacist-led hypertension management service can help monitor BP, improve medication adherence, and optimise therapy in a step-wise approach. However, blood pressure screening can effect behaviour change in patients, presenting methodological challenges in the evaluation of services in this context.

Implementation and evaluation of a pharmacist-led hypertension management service in primary care: outcomes and methodological challenges

PubMed Central

2016-01-01

Background: Suboptimal utilisation of pharmacotherapy, non-adherence to prescribed treatment, and a lack of monitoring all contribute to poor blood (BP) pressure control in patients with hypertension. Objective: The objective of this study was to evaluate the implementation of a pharmacist-led hypertension management service in terms of processes, outcomes, and methodological challenges. Method: A prospective, controlled study was undertaken within the Australian primary care setting. Community pharmacists were recruited to one of three study groups: Group A (Control – usual care), Group B (Intervention), or Group C (Short Intervention). Pharmacists in Groups B and C delivered a service comprising screening and monitoring of BP, as well as addressing poor BP control through therapeutic adjustment and adherence strategies. Pharmacists in Group C delivered the shortened version of the service. Results: Significant changes to key outcome measures were observed in Group C: reduction in systolic and diastolic BPs at the 3-month visit (P<0.01 and P<0.01, respectively), improvement in medication adherence scores (P=0.01), and a slight improvement in quality of life (EQ-5D-3L Index) scores (P=0.91). There were no significant changes in Group B (the full intervention), and no differences in comparison to Group A (usual care). Pharmacists fed-back that patient recruitment was a key barrier to service implementation, highlighting the methodological implications of screening. Conclusion: A collaborative, pharmacist-led hypertension management service can help monitor BP, improve medication adherence, and optimise therapy in a step-wise approach. However, blood pressure screening can effect behaviour change in patients, presenting methodological challenges in the evaluation of services in this context. PMID:27382427

The Effects of Highly Challenging Balance Training in Elderly With Parkinson's Disease: A Randomized Controlled Trial.

PubMed

Conradsson, David; Löfgren, Niklas; Nero, Håkan; Hagströmer, Maria; Ståhle, Agneta; Lökk, Johan; Franzén, Erika

2015-10-01

Highly challenging exercises have been suggested to induce neuroplasticity in individuals with Parkinson's disease (PD); however, its effect on clinical outcomes remains largely unknown. To evaluate the short-term effects of the HiBalance program, a highly challenging balance-training regimen that incorporates both dual-tasking and PD-specific balance components, compared with usual care in elderly with mild to moderate PD. Participants with PD (n = 100) were randomized, either to the 10-week HiBalance program (n = 51) or to the control group (n = 49). Participants were evaluated before and after the intervention. The main outcomes were balance performance (Mini-BESTest), gait velocity (during normal and dual-task gait), and concerns about falling (Falls Efficacy Scale-International). Performance of a cognitive task while walking, physical activity level (average steps per day), and activities of daily living were secondary outcomes. A total of 91 participants completed the study. After the intervention, the between group comparison showed significantly improved balance and gait performance in the training group. Moreover, although no significant between group difference was observed regarding gait performance during dual-tasking; the participants in the training group improved their performance of the cognitive task while walking, as compared with the control group. Regarding physical activity levels and activities of daily living, in comparison to the control group, favorable results were found for the training group. No group differences were found for concerns about falling. The HiBalance program significantly benefited balance and gait abilities when compared with usual care and showed promising transfer effects to everyday living. Long-term follow-up assessments will further explore these effects. © The Author(s) 2015.

Building Kindergartners’ Number Sense: A Randomized Controlled Study

PubMed Central

Jordan, Nancy C.; Glutting, Joseph; Dyson, Nancy; Hassinger-Das, Brenna; Irwin, Casey

2015-01-01

Math achievement in elementary school is mediated by performance and growth in number sense during kindergarten. The aim of the present study was to test the effectiveness of a targeted small group number sense intervention for high-risk kindergartners from low-income communities. Children were randomly assigned to one of three groups (n = 44 in each group): a number sense intervention group, a language intervention group, or a business as usual control group. Accounting for initial skill level in mathematical knowledge, children who received the number sense intervention performed better than controls at immediate post test, with meaningful effects on measures of number competencies and general math achievement. Many of the effects held eight weeks after the intervention was completed, suggesting that children internalized what they had learned. There were no differences between the language and control groups on any math-related measures. PMID:25866417

Impact of a Work-Focused Intervention on the Productivity and Symptoms of Employees with Depression

PubMed Central

Lerner, Debra; Adler, David; Hermann, Richard C.; Chang, Hong; Ludman, Evette J.; Greenhill, Annabel; Perch, Katherine; McPeck, William C.; Rogers, William H.

2012-01-01

Objective To test a new program’s effectiveness in reducing depression’s work burden. Methods A brief telephonic program to improve work functioning was tested in an early-stage randomized controlled trial (RCT) involving 79 Maine State Government employees who screened-in for depression and at-work limitations (treatment group=59; usual care group=27). Group differences in baseline to follow-up change scores on The Work Limitations Questionnaire (WLQ), WLQ Absence Module and PHQ-9 depression severity scale were tested with analysis of covariance. Results While there were no baseline group differences (p≥.05), by follow-up the treatment group had significantly better scores on every outcome and differences in the longitudinal changes were all statistically significant (p=.0.27 to .0001). Conclusions The new program was superior to usual care. The estimated productivity cost savings are $6041.70 per participant annually. PMID:22252528

A smartphone application to support recovery from alcoholism: A randomized controlled trial

PubMed Central

Gustafson, David H.; McTavish, Fiona M.; Chih, Ming-Yuan; Atwood, Amy K.; A. Johnson, Roberta; G. Boyle, Michael; S. Levy, Michael; Driscoll, Hilary; M. Chisholm, Steven; Dillenburg, Lisa; Isham, Andrew; Shah, Dhavan

2014-01-01

Importance: Patients leaving treatment for alcohol-use disorders (AUDs) are not typically offered evidence-based continuing care, although research suggests that continuing care is associated with better outcomes. A smartphone-based application could provide effective continuing care. Objective: To determine whether patients leaving residential treatment for AUDs with a smartphone application to support recovery have fewer risky drinking days than control-group patients. Design: An un-blinded randomized controlled trial. Patients were randomized to treatment as usual or treatment as usual plus a smartphone with A-CHESS, an application designed to improve continuing care for AUDs. “A-CHESS” stands for Addiction – Comprehensive Health Enhancement Support System. Setting: Three residential programs operated by one treatment organization in the Midwestern US and 2 residential programs operated by one organization in the Northeastern US. Participants: 349 patients who met the criteria for DSM-IV alcohol dependence when they entered residential treatment. 179 were randomized to the control group and 170 to the treatment group. Intervention: Treatment as usual varied across programs; none offered patients coordinated continuing care after discharge. A-CHESS provides monitoring, information, communication, and support services to patients, including ways for patients and counselors to stay in contact. The intervention lasted 8 months and the follow-up period lasted 4 months. Main Outcome Measure: Risky drinking days—the number of days during which a patient’s drinking in a 2-hour period exceeded, for men, 4 standard drinks and for women, 3 standard drinks. Patients were asked to report their risky drinking days in the previous 30 days on surveys taken 4, 8, and 12 months after discharge from residential treatment. Results: For the 8 months of the intervention and 4 months of follow-up, patients in the A-CHESS group reported significantly fewer risky drinking days than patients in the control group (M = 1.39 vs. 2.75, respectively; P = .003; 95% CI [.46, 2.27]). Conclusions and Relevance: The findings suggest that a multi-featured smartphone application may have significant benefit to patients in continuing care for AUDs. Trial registration: clinicaltrials.gov Identifier: NCT01003119 PMID:24671165

Medication education program for Indian children with asthma: A feasibility stud.

PubMed

Grover, C; Goel, N; Armour, C; Van Asperen, P P; Gaur, S N; Moles, R J; Saini, B

2016-01-01

It is postulated that children with asthma who receive an interactive, comprehensive, culturally relevant education program would improve their asthma knowledge (AK), asthma control, and adherence compared with children receiving usual care. The aim of this study was to develop, implement, and evaluate the efficacy of a culturally relevant asthma education intervention for children with asthma and their parents in India. Children with asthma (7-12 years) and their parents were recruited from an outpatient clinic in a Chest Diseases Hospital in New Delhi, and were randomly assigned to either an intervention or usual care group. At baseline, outcome data collected included pediatric asthma caregiver quality of life (PACQL, primary outcome), AK, asthma control, adherence, inhaler technique, action plan ownership, and goal achievement. These data were collected again at 1 and 6 months after baseline. Outcomes were compared within and between groups using ANOVA techniques. Forty parent-child pairs were recruited. Of these, 24 pairs of children with asthma and their parents received the educational intervention. The PACQL significantly improved from baseline to 6 months in the intervention (5.87 ± 0.94-7.00 ± 0.03) versus the usual care group (5.90 ± 0.52-6.34 ± 0.56) (P < 0.001). Other outcomes such as the parents' and child's AK, child's asthma control and inhaler technique were significantly improved in the intervention group across the study. All the participants possessed a written asthma action plan at the end of the intervention. Eighty-five goals were set by children with asthma across all the visits and were achieved by completion. An asthma educator delivered interactive program simultaneously involving children with asthma and their parents, improved quality of life, empowered and promoted better self-management skills.

Group cognitive behavioural therapy and weight regain after diet in type 2 diabetes: results from the randomised controlled POWER trial.

PubMed

Berk, Kirsten A; Buijks, Hanneke I M; Verhoeven, Adrie J M; Mulder, Monique T; Özcan, Behiye; van 't Spijker, Adriaan; Timman, Reinier; Busschbach, Jan J; Sijbrands, Eric J

2018-04-01

Weight-loss programmes for adults with type 2 diabetes are less effective in the long term owing to regain of weight. Our aim was to determine the 2 year effectiveness of a cognitive behavioural group therapy (group-CBT) programme in weight maintenance after diet-induced weight loss in overweight and obese adults with type 2 diabetes, using a randomised, parallel, non-blinded, pragmatic study design. We included 158 obese adults (median BMI 36.3 [IQR 32.5-40.0] kg/m 2 ) with type 2 diabetes from the outpatient diabetes clinic of Erasmus MC, the Netherlands, who achieved ≥5% weight loss on an 8 week very low calorie diet. Participants were randomised (stratified by weight loss) to usual care or usual care plus group-CBT (17 group sessions). The primary outcomes were the between-group differences after 2 years in: (1) body weight; and (2) weight regain. Secondary outcomes were HbA 1c levels, insulin dose, plasma lipid levels, depression, anxiety, self-esteem, quality of life, fatigue, physical activity, eating disorders and related cognitions. Data were analysed using linear mixed modelling. During the initial 8 week dieting phase, the control group (n = 75) lost a mean of 10.0 (95% CI 9.1, 10.9) kg and the intervention group (n = 83) lost 9.2 (95% CI 8.4, 10.0) kg (p = 0.206 for the between-group difference). During 2 years of follow-up, mean weight regain was 4.7 (95% CI 3.0, 6.3) kg for the control group and 4.0 (95% CI 2.3, 5.6) kg for the intervention group, with a between-group difference of -0.7 (95% CI -3.1, 1.6) kg (p = 0.6). The mean difference in body weight at 2 years was -1.2 (95% CI -7.7, 5.3) kg (p = 0.7). None of the secondary outcomes differed between the two groups. Despite increased treatment contact, a group-CBT programme for long-term weight maintenance after an initial ≥5% weight loss from dieting in obese individuals with type 2 diabetes was not superior to usual care alone. Trialregister.nl NTR2264 FUNDING: The study was funded by the Erasmus MC funding programme 'Zorgonderzoek' (grant 2008-8303).

Telehealth to improve asthma control in pregnancy: A randomized controlled trial.

PubMed

Zairina, Elida; Abramson, Michael J; McDonald, Christine F; Li, Jonathan; Dharmasiri, Thanuja; Stewart, Kay; Walker, Susan P; Paul, Eldho; George, Johnson

2016-07-01

Poorly controlled asthma during pregnancy is hazardous for both mother and foetus. Better asthma control may be achieved if patients are involved in regular self-monitoring of symptoms and self-management according to a written asthma action plan. Telehealth applications to optimize asthma management and outcomes in pregnant women have not yet been evaluated. This study evaluated the efficacy of a telehealth programme supported by a handheld respiratory device in improving asthma control during pregnancy. Pregnant women with asthma (n = 72) from two antenatal clinics in Melbourne, Australia, were randomized to one of two groups: (i) intervention-involving a telehealth programme (management of asthma with supportive telehealth of respiratory function in pregnancy (MASTERY(©) )) supported by a handheld respiratory device and an Android smart phone application (Breathe-easy(©) ) and written asthma action plan or (ii) control-usual care. The primary outcome was change in asthma control at 3 and 6 months (prenatal). Secondary outcomes included changes in quality of life and lung function, and perinatal/neonatal outcomes. At baseline, participants' mean (± standard deviation) age was 31.4 ± 4.5 years and gestational age 16.7 ± 3.1 weeks. At 6 months, the MASTERY group had better asthma control (P = 0.02) and asthma-related quality of life (P = 0.002) compared with usual care. There were no significant differences between groups in lung function, unscheduled health-care visits, days off work/study, oral corticosteroid use, or perinatal outcomes. Differences between groups were not significant at 3 months. Telehealth interventions supporting self-management are feasible and could potentially improve asthma control and asthma-related quality of life during pregnancy. © 2016 Asian Pacific Society of Respirology.

Impact of Computerized Decision Support on Blood Pressure Management and Control: A Randomized Controlled Trial

PubMed Central

Sequist, Thomas D.; Ayanian, John Z.; Shaykevich, Shimon; Fairchild, David G.; Orav, E. John; Bates, David W.

2008-01-01

BACKGROUND We conducted a cluster randomized controlled trial to examine the effectiveness of computerized decision support (CDS) designed to improve hypertension care and outcomes in a racially diverse sample of primary care patients. METHODS We randomized 2,027 adult patients receiving hypertension care in 14 primary care practices to either 18 months of their physicians receiving CDS for each hypertensive patient or to usual care without computerized support for the control group. We assessed prescribing of guideline-recommended drug therapy and levels of blood pressure control for patients in each group and examined if the effects of the intervention differed by patients’ race/ethnicity using interaction terms. MEASUREMENTS AND MAIN RESULTS Rates of blood pressure control were 42% at baseline and 46% at the outcome visit with no significant differences between groups. After adjustment for patients’ demographic and clinical characteristics, number of prior visits, and levels of baseline blood pressure control, there were no differences between intervention groups in the odds of outcome blood pressure control. The use of CDS to providers significantly improved Joint National Committee (JNC) guideline adherent medication prescribing compared to usual care (7% versus 5%, P < 0.001); the effects of the intervention remained after multivariable adjustment (odds ratio [OR] 1.39 [CI, 1.13–1.72]) and the effects of the intervention did not differ by patients’ race and ethnicity. CONCLUSIONS CDS improved appropriate medication prescribing with no improvement in disparities in care and overall blood pressure control. Future work focusing on improvement of these interventions and the study of other practical interventions to reduce disparities in hypertension-related outcomes is needed. PMID:18373141

Treatment of clozapine-associated obesity and diabetes with exenatide in adults with schizophrenia: A randomized controlled trial (CODEX).

PubMed

Siskind, Dan J; Russell, Anthony W; Gamble, Clare; Winckel, Karl; Mayfield, Karla; Hollingworth, Sam; Hickman, Ingrid; Siskind, Victor; Kisely, Steve

2018-04-01

Clozapine causes obesity and type 2 diabetes (T2DM). Glucagon-like peptide-1 (GLP-1) receptor agonists (e.g. exenatide) can counter clozapine-associated GLP-1 dysregulation in animals, and may be beneficial in people on clozapine. This randomized, controlled, open-label, pilot trial evaluated weekly exenatide for weight loss among clozapine-treated obese adults with schizophrenia, with or without T2DM. A total of 28 outpatients were randomized to once-weekly extended-release subcutaneous exenatide or usual care for 24 weeks. The primary outcome was proportion of participants with >5% weight loss. All 28 participants completed the study; 3/14 in the exenatide group and 2/14 in the usual care group had T2DM. Six people on exenatide achieved >5% weight loss vs one receiving usual care (P = .029). Compared with usual care, participants on exenatide had greater mean weight loss (-5.29 vs -1.12 kg; P = .015) and body mass index reduction (-1.78 vs -0.39 kg/m 2 ; P = .019), and reduced fasting glucose (-0.34 vs 0.39 mmol/L; P = .036) and glycated haemoglobin levels (-0.21% vs 0.03%; P = .004). There were no significant differences in other metabolic syndrome components. Exenatide may be a promising therapeutic agent for glycaemic control and weight loss in clozapine-treated people with obesity, and could assist in reducing clozapine-associated cardio-metabolic morbidity and mortality. © 2017 John Wiley & Sons Ltd.

Neurologic music therapy in upper-limb rehabilitation in children with severe bilateral cerebral palsy: a randomized controlled trial.

PubMed

Marrades-Caballero, Eugenio; Santonja-Medina, Clara S; Sanz-Mengibar, Jose M; Santonja-Medina, Fernando

2018-02-26

After receiving neurologic music therapy, functional improvements in children with severe bilateral cerebral palsy have not been found in the literature. Musical training with instruments allows interrelationships between movement, emotions and cognition for task-based learning, in order to improve motor control. To understand whether neurologic music therapy has an impact on the functionality of children with severe cerebral palsy. A randomized controlled assessor-blind trial was carried out. Children were recruited and treated in their own community center. Eighteen children with severe bilateral cerebral palsy between 4 and 16 years old were studied. The intervention group (n=18) received music therapy for 16 weeks, in addition to its usual physiotherapy input. Two music therapists implemented a neurologic music therapy program of therapeutic instrumental music performance. The control group (n=9) received its usual therapeutic input, similar to the intervention group, but not neurologic music therapy. Overall and specific "Chailey levels of Ability" were quantified, as well as the Locomotor Stages. Significant improvements in the overall and specific "arm and hand position" as well as "activities" from the Chailey Levels of Ability and the Locomotor Stages were observed (p<.05) in the group which received the music therapy (corregir si se acepta en la editing proofs). All these improvements persisted after 4 months. The control group showed no improvements after a four-month follow-up. Optimized intervention of neurologic music therapy can improve the functionality of children with severe bilateral cerebral palsy. Music therapy is a useful tool in rehabilitation and its positive effects remain four months after completing the treatment.

The Effectiveness of a New Model in Managing Pregnant Women with Iron Deficiency Anemia in Indonesia: A Nonrandomized Controlled Intervention Study.

PubMed

Widyawati, Widyawati; Jans, Suze; Bor, Hans H J; van Dillen, Jeroen; Lagro-Janssen, Antoine L M

2015-12-01

Indonesia has a major problem with iron deficiency anemia among pregnant women. A new model named the Four Pillars Approach was designed to improve antenatal care for these women. This study aimed to measure the effectiveness of the model in managing pregnant women with iron deficiency anemia. We used a nonrandomized controlled intervention study. The study, with the Four Pillars Approach as intervention versus usual care as its control, was conducted in two provinces in Java (Indonesia) during the period from March 2012 until May 2013. Main outcome measures were a difference of Hb level ≥ 0.5 g/dL, the number of women who attended five or more antenatal care visits, and birthing with a skilled birth attendant. Three hundred fifty-four participants were enrolled in the study. Participants in the intervention group had an adjusted odds ratio of 25.0 (95% CI 12.03-52.03, p = 0.001) for increased hemoglobin of ≥ 0.5 g/dL at 35-37 weeks of gestation, compared with the control group. In the intervention group, 95.0 percent of women had five or more antenatal care visits, compared with 57.2 percent (p = 0.001) in the control group. All births in both groups were assisted by skilled birth attendants. The Four Pillars Approach is effective in increasing the hemoglobin level and the frequency of antenatal care visits of participants when compared with the usual care for pregnant women with anemia. © 2015 Wiley Periodicals, Inc.

Can Additional Homeopathic Treatment Save Costs? A Retrospective Cost-Analysis Based on 44500 Insured Persons

PubMed Central

Ostermann, Julia K.; Reinhold, Thomas; Witt, Claudia M.

2015-01-01

Objectives The aim of this study was to compare the health care costs for patients using additional homeopathic treatment (homeopathy group) with the costs for those receiving usual care (control group). Methods Cost data provided by a large German statutory health insurance company were retrospectively analysed from the societal perspective (primary outcome) and from the statutory health insurance perspective. Patients in both groups were matched using a propensity score matching procedure based on socio-demographic variables as well as costs, number of hospital stays and sick leave days in the previous 12 months. Total cumulative costs over 18 months were compared between the groups with an analysis of covariance (adjusted for baseline costs) across diagnoses and for six specific diagnoses (depression, migraine, allergic rhinitis, asthma, atopic dermatitis, and headache). Results Data from 44,550 patients (67.3% females) were available for analysis. From the societal perspective, total costs after 18 months were higher in the homeopathy group (adj. mean: EUR 7,207.72 [95% CI 7,001.14–7,414.29]) than in the control group (EUR 5,857.56 [5,650.98–6,064.13]; p<0.0001) with the largest differences between groups for productivity loss (homeopathy EUR 3,698.00 [3,586.48–3,809.53] vs. control EUR 3,092.84 [2,981.31–3,204.37]) and outpatient care costs (homeopathy EUR 1,088.25 [1,073.90–1,102.59] vs. control EUR 867.87 [853.52–882.21]). Group differences decreased over time. For all diagnoses, costs were higher in the homeopathy group than in the control group, although this difference was not always statistically significant. Conclusion Compared with usual care, additional homeopathic treatment was associated with significantly higher costs. These analyses did not confirm previously observed cost savings resulting from the use of homeopathy in the health care system. PMID:26230412

Toward a Developmentally-Informed Approach to Parenting Interventions: Seeking Hidden Effects

PubMed Central

Brock, Rebecca L.; Kochanska, Grazyna

2015-01-01

Drawing from developmental psychology and psychopathology, we propose a new, developmentally-informed approach to parenting interventions that focuses on elucidating changes in the unfolding developmental process between the parent and child. We present data from 186 low-income mothers of toddlers, randomly assigned to Child-Oriented Play group or Play-as-Usual group. We examined the maladaptive cascade from child difficulty to mother adversarial, negative parenting to child maladjustment, well documented in the literature. The measures incorporated multiple observations and reports. As expected, the sequence from child difficulty (Pretest) to mother adversarial, negative parenting (Posttest 1, after 3-month intervention) to child maladjustment (Posttest 2, 6 months later) was present in Play-as-Usual group, but absent, or defused, in Child-Oriented Play group. The findings are consistent with a view of intervention presumably enhancing the mother-child relationship, which in turn served to moderate future mother-child dynamics, altering its otherwise anticipated negative trajectory. A closer examination of the cascade revealed that, at Posttest 1, mothers in Play-as-Usual group engaged in more adversarial, negative parenting (controlling for Pretest) than mothers in Child-Oriented Play group when their children were of high difficulty. The intervention appears to exert its primary influence on the cascade by weakening the link between child difficulty and maternal adversarial, negative parenting. PMID:27063895

Balance circuit classes to improve balance among rehabilitation inpatients: a protocol for a randomised controlled trial

PubMed Central

2013-01-01

Background Impaired balance and mobility are common among rehabilitation inpatients. Poor balance and mobility lead to an increased risk of falling. Specific balance exercise has been shown to improve balance and reduce falls within the community setting. However few studies have measured the effects of balance exercises on balance within the inpatient setting. The aim of this randomised controlled trial is to investigate whether the addition of circuit classes targeting balance to usual therapy lead to greater improvements in balance among rehabilitation inpatients than usual therapy alone. Methods/Design A single centre, randomised controlled trial with concealed allocation, assessor blinding and intention-to-treat analysis. One hundred and sixty two patients admitted to the general rehabilitation ward at Bankstown-Lidcombe Hospital will be recruited. Eligible participants will have no medical contraindications to exercise and will be able to: fully weight bear; stand unaided independently for at least 30 seconds; and participate in group therapy sessions with minimal supervision. Participants will be randomly allocated to an intervention group or usual-care control group. Both groups will receive standard rehabilitation intervention that includes physiotherapy mobility training and exercise for at least two hours on each week day. The intervention group will also receive six 1-hour circuit classes of supervised balance exercises designed to maximise the ability to make postural adjustments in standing, stepping and walking. The primary outcome is balance. Balance will be assessed by measuring the total time the participant can stand unsupported in five different positions; feet apart, feet together, semi-tandem, tandem and single-leg-stance. Secondary outcomes include mobility, self reported physical functioning, falls and hospital readmissions. Performance on the outcome measures will be assessed before randomisation and at two-weeks and three-months after randomisation by physiotherapists unaware of intervention group allocation. Discussion This study will determine the impact of additional balance circuit classes on balance among rehabilitation inpatients. The results will provide essential information to guide evidence-based physiotherapy at the study site as well as across other rehabilitation inpatient settings. Trial registration The protocol for this study is registered with the Australian New Zealand, Clinical Trials Registry: ACTRN=12611000412932 PMID:23870654

Cost-effectiveness of a combined physical exercise and psychosocial training intervention for children with cancer: Results from the quality of life in motion study.

PubMed

Braam, K I; van Dijk-Lokkart, E M; van Dongen, J M; van Litsenburg, R R L; Takken, T; Huisman, J; Merks, J H M; Bosmans, J E; Hakkenbrak, N A G; Bierings, M B; van den Heuvel-Eibrink, M M; Veening, M A; van Dulmen-den Broeder, E; Kaspers, G J L

2017-11-01

This study was performed to estimate the cost-effectiveness of a combined physical exercise and psychosocial intervention for children with cancer compared with usual care. Sixty-eight children, aged 8-18 years old, during or within the first year post-cancer treatment were randomised to the intervention (n = 30) and control group (n = 38). Health outcomes included fitness, muscle strength and quality adjusted life years; all administered at baseline, 4- and 12-month follow-up. Costs were gathered by 1 monthly cost questionnaires over 12 months, supplemented by medication data obtained from pharmacies. Results showed no significant differences in costs and effects between the intervention and control group at 12-month follow-up. On average, societal costs were €299 higher in the intervention group than in the control group, but this difference was not significant. Cost-effectiveness acceptability curves indicated that the intervention needs large societal investments to reach reasonable probabilities of cost-effectiveness for quality of life and lower body muscle strength. Based on the results of this study, the intervention is not cost-effective in comparison with usual care. © 2016 John Wiley & Sons Ltd.

Healthy Colon, Healthy Life

PubMed Central

Walsh, Judith M.E.; Salazar, Rene; Nguyen, Tung T.; Kaplan, Celia; Nguyen, Lamkieu; Hwang, Jimmy; McPhee, Stephen J.; Pasick, Rena J.

2014-01-01

Background Colorectal cancer (CRC) screening rates are increasing, but they are still low, particularly in ethnic minority groups. In many resource-poor settings, fecal occult blood test (FOBT) is the main screening option. Intervention Culturally tailored telephone counseling by community health advisors employed by a community-based organization, culturally tailored brochures, and customized FOBT kits. Design RCT. Participants were randomized to (1) basic intervention: culturally tailored brochure plus FOBT kit (n=765); (2) enhanced intervention: brochure, FOBT plus telephone counseling (n=768); or (3) usual care (n=256). Setting/participants Latino and Vietnamese primary care patients at a large public hospital. Main outcome measures Self-reported receipt of FOBT or any CRC screening at 1-year follow-up. Results 1358 individuals (718 Latinos and 640 Vietnamese) completed the follow-up survey. Self-reported FOBT screening rates increased by 7.8 % in the control group, by 15.1 % in the brochure group, and by 25.1 % in the brochure/telephone counseling group (p<0.01 for differences between each intervention and usual care and for the difference between brochure/telephone counseling and brochure alone). For any CRC screening, rates increased by 4.1 % in the usual care group, by 11.9 % in the FOBT/brochure group, and by 21.4 % in the brochure/telephone counseling group (p<0.01 for differences between each intervention and usual care and for the difference between the basic and the enhanced intervention). Conclusions An intervention that included culturally tailored brochures and tailored telephone counseling increased CRC screening in Latinos and the Vietnamese. Brochure and telephone counseling together had the greatest impact. Future research should address replication and dissemination of this model for Latinos and Vietnamese in other communities, and adaptation of the model for other groups. PMID:20547275

Behavioral and technological interventions targeting glycemic control in a racially/ethnically diverse population: a randomized controlled trial

PubMed Central

2014-01-01

Background Diabetes self-care by patients has been shown to assist in the reduction of disease severity and associated medical costs. We compared the effectiveness of two different diabetes self-care interventions on glycemic control in a racially/ethnically diverse population. We also explored whether reductions in glycated hemoglobin (HbA1c) will be more marked in minority persons. Methods We conducted an open-label randomized controlled trial of 376 patients with type 2 diabetes aged ≥18 years and whose last measured HbA1c was ≥7.5% (≥58 mmol/mol). Participants were randomized to: 1) a Chronic Disease Self-Management Program (CDSMP; n = 101); 2) a diabetes self-care software on a personal digital assistant (PDA; n = 81); 3) a combination of interventions (CDSMP + PDA; n = 99); or 4) usual care (control; n = 95). Enrollment occurred January 2009-June 2011 at seven regional clinics of a university-affiliated multi-specialty group practice. The primary outcome was change in HbA1c from randomization to 12 months. Data were analyzed using a multilevel statistical model. Results Average baseline HbA1c in the CDSMP, PDA, CDSMP + PDA, and control arms were 9.4%, 9.3%, 9.2%, and 9.2%, respectively. HbA1c reductions at 12 months for the groups averaged 1.1%, 0.7%, 1.1%, and 0.7%, respectively and did not differ significantly from baseline based on the model (P = .771). Besides the participants in the PDA group reporting eating more high-fat foods compared to their counterparts (P < .004), no other significant differences were observed in participants’ diabetes self-care activities. Exploratory sub-analysis did not reveal any marked reductions in HbA1c for minority persons but rather modest reductions for all racial/ethnic groups. Conclusions Although behavioral and technological interventions can result in some modest improvements in glycemic control, these interventions did not fare significantly better than usual care in achieving glycemic control. More research is needed to understand how these interventions can be most effective in clinical practice. The reduction in HbA1c levels found in our control group that received usual care also suggests that good routine care in an integrated healthcare system can lead to better glycemic control. Trial registration Clinicaltrials.gov Identifier: NCT01221090. PMID:24450992

Osteoporosis improvement: a large-scale randomized controlled trial of patient and primary care physician education.

PubMed

Solomon, Daniel H; Katz, Jeffrey N; Finkelstein, Joel S; Polinski, Jennifer M; Stedman, Margaret; Brookhart, M Alan; Arnold, Marilyn; Gauthier, Suzanne; Avorn, Jerry

2007-11-01

We conducted a randomized controlled trial within the setting of a large drug benefit plan for Medicare beneficiaries. Primary care physicians and their patients were randomized to usual care, patient intervention only, physician intervention only, or both interventions. There was no difference in the probability of the primary composite endpoint (BMD test or osteoporosis medication) or in either of its components comparing the combined intervention group with usual care (risk ratio = 1.04; 95% CI, 0.85-1.26). Fractures from osteoporosis are associated with substantial morbidity, mortality, and cost. However, only a minority of at-risk older adults receives screening and/or treatment for this condition. We evaluated the effect of educational interventions for osteoporosis targeting at-risk patients, primary care physicians, or both. We conducted a randomized controlled trial within the setting of a large drug benefit plan for Medicare beneficiaries. Primary care physicians and their patients were randomized to usual care, patient intervention only, physician intervention only, or both interventions. The at-risk patients were women >or=65 yr of age, men and women >or=65 yr of age with a prior fracture, and men and women >or=65 yr of age who used oral glucocorticoids. The primary outcome studied was a composite of either undergoing a BMD test or initiating a medication used for osteoporosis. The secondary outcome was a hip, humerus, spine, or wrist fracture. We randomized 828 primary care physicians and their 13,455 eligible at-risk patients into four study arms. Physician and patient characteristics were very similar across all four groups. Across all four groups, the rate of the composite outcome was 10.3 per 100 person-years and did not differ between the usual care and the combined intervention groups (p = 0.5). In adjusted Cox proportional hazards models, there was no difference in the probability of the primary composite endpoint comparing the combined intervention group with usual care (risk ratio = 1.04; 95% CI, 0.85-1.26). There was also no difference in either of the components of the composite endpoint. The probability of fracture during follow-up was 4.2 per 100 person-years and did not differ by treatment assignment (p = 0.9). In this trial, a relatively brief program of patient and/or physician education did not work to improve the management of osteoporosis. More intensive efforts should be considered for future quality improvement programs for osteoporosis.

Cost-utility analysis of a three-month exercise programme vs usual care following multidisciplinary rehabilitation for chronic low back pain.

PubMed

Henchoz, Yves; Pinget, Christophe; Wasserfallen, Jean-Blaise; Paillex, Roland; de Goumoëns, Pierre; Norberg, Michael; Kai-Lik So, Alexander

2010-10-01

To assess the cost-utility of an exercise programme vs usual care after functional multidisciplinary rehabilitation in patients with chronic low back pain. Cost-utility analysis alongside a randomized controlled trial. A total of 105 patients with chronic low back pain. Chronic low back pain patients completing a 3-week functional multidisciplinary rehabilitation were randomized to either a 3-month exercise programme (n = 56) or usual care (n = 49). The exercise programme consisted of 24 training sessions during 12 weeks. At the end of functional multidisciplinary rehabilitation and at 1-year follow-up quality of life was measured with the SF-36 questionnaire, converted into utilities and transformed into quality--adjusted life years. Direct and indirect monthly costs were measured using cost diaries. The incremental cost-effectiveness ratio was calculated as the incremental cost of the exercise programme divided by the difference in quality-adjusted life years between both groups. Quality of life improved significantly at 1-year follow-up in both groups. Similarly, both groups significantly reduced total monthly costs over time. No significant difference was observed between groups. The incremental cost-effectiveness ratio was 79,270 euros. Adding an exercise programme after functional multidisciplinary rehabilitation compared with usual care does not offer significant long-term benefits in quality of life and direct and indirect costs.

Improving outcomes in heart failure in the community: long-term survival benefit of a disease-management program.

PubMed

Akosah, Kwame O; Schaper, Ana M; Haus, Lindsay M; Mathiason, Michelle A; Barnhart, Sharon I; McHugh, Vicki L

2005-06-01

The purpose of our current study was to determine whether our disease-management model was associated with long-term survival benefits. A secondary objective was to determine whether program involvement was associated with medication maintenance and reduced hospitalization over time compared to usual care management of heart failure. A retrospective chart review was conducted in patients who had been hospitalized for congestive heart failure between April 1999 and March 31, 2000, and had been discharged from the hospital for follow-up in the Heart Failure Clinic vs usual care. An integrated health-care center serving a tristate area. Patients (n = 101) were followed up for 4 years after their index hospitalization for congestive heart failure. The patients followed up in the Heart Failure Clinic comprised group 1 (n = 38), and the patients receiving usual care made up group 2 (n = 63). The mean (+/- SD) age of the patients in group 1 was 68 +/- 16 years compared to 76 +/- 11 years for the patients in group 2 (p = 0.002). The patients in group 1 were more likely to have renal failure (p = 0.035), a lower left ventricular ejection fraction (p = 0.005), and hypotension at baseline (p = 0.002). At year 2, more patients in group 1 were maintained by therapy with angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) [p = 0.036]. The survival rate over 4 years was better for group 1. Univariate Cox proportional hazard ratios revealed that age, not receiving ACEIs or ARBs, and renal disease or cancer at baseline were associated with mortality. When controlling for these variables in a multivariate Cox proportional hazards ratio model, survival differences between groups remained significant (p = 0.021). Subjects in group 2 were 2.4 times more likely to die over the 4-year period than those in group 1. Our study demonstrated that, after controlling for baseline variables, patients participating in a heart failure clinic enjoyed improved survival.

Incremental costs associated with physician and pharmacist collaboration to improve blood pressure control.

PubMed

Kulchaitanaroaj, Puttarin; Brooks, John M; Ardery, Gail; Newman, Dana; Carter, Barry L

2012-08-01

To compare costs associated with a physician-pharmacist collaborative intervention with costs of usual care. Cost analysis using health care utilization and outcome data from two prospective, cluster-randomized, controlled clinical trials. Eleven community-based medical offices. A total of 496 patients with hypertension; 244 were in the usual care (control) group and 252 were in the intervention group. To compare the costs, we combined cost data from the two trials. Total costs included costs of provider time, laboratory tests, and antihypertensive drugs. Provider time was calculated based on an online survey of intervention pharmacists and the National Ambulatory Medical Care Survey. Cost parameters were taken from the Bureau of Labor Statistics for average wage rates, the Medicare laboratory fee schedule, and a publicly available Web site for drug prices. Total costs were adjusted for patient characteristics. Adjusted total costs were $774.90 in the intervention group and $445.75 in the control group (difference $329.16, p<0.001). In a sensitivity analysis, the difference in adjusted total costs between the two groups ranged from $224.27-515.56. The intervention cost required to have one additional patient achieve blood pressure control within 6 months was $1338.05, determined by the difference in costs divided by the difference in hypertension control rates between the groups ($329.16/24.6%). The cost over 6 months to lower systolic and diastolic blood pressure 1 mm Hg was $36.25 and $94.32, respectively. The physician-pharmacist collaborative intervention increased not only blood pressure control but also the cost of care. Additional research, such as a cost-benefit or a cost-minimization analysis, is needed to assess whether financial savings related to reduced morbidity and mortality achieved from better blood pressure control outweigh the cost of the intervention. © 2012 Pharmacotherapy Publications, Inc. All rights reserved.

Effectiveness of an intervention to improve diabetes self-management on clinical outcomes in patients with low educational level.

PubMed

Olry de Labry Lima, Antonio; Bermúdez Tamayo, Clara; Pastor Moreno, Guadalupe; Bolívar Muñoz, Julia; Ruiz Pérez, Isabel; Johri, Mira; Quesada Jiménez, Fermín; Cruz Vela, Pilar; de Los Ríos Álvarez, Ana M; Prados Quel, Miguel Ángel; Moratalla López, Enrique; Domínguez Martín, Susana; Lopez de Hierro, José Andrés; Ricci Cabello, Ignacio

To determine whether an intervention based on patient-practitioner communication is more effective than usual care in improving diabetes self-management in patients with type 2 diabetes with low educational level. 12-month, pragmatic cluster randomised controlled trial. Nine physicians and 184 patients registered at two practices in a deprived area of Granada (Andalusia, Spain) participated in the study. Adult patients with type 2 diabetes, low educational level and glycated haemoglobin (HbA1c) > 7% (53.01 mmol/mol) were eligible. The physicians in the intervention group received training on communication skills and the use of a tool for monitoring glycaemic control and providing feedback to patients. The control group continued standard care. The primary outcome was difference in HbA1c after 12 months. Dyslipidaemia, blood pressure, body mass index and waist circumference were also assessed as secondary outcomes. Two-level (patient and provider) regression analyses controlling for sex, social support and comorbidity were conducted. The HbA1c levels at 12 months decreased in both groups. Multilevel analysis showed a greater improvement in the intervention group (between-group HbA1c difference= 0.16; p=0.049). No statistically significant differences between groups were observed for dyslipidaemia, blood pressure, body mass index and waist circumference. In this pragmatic study, a simple and inexpensive intervention delivered in primary care showed a modest benefit in glycaemic control compared with usual care, although no effect was observed in the secondary outcomes. Further research is needed to design and assess interventions to promote diabetes self-management in socially vulnerable patients. Copyright © 2016 SESPAS. All rights reserved.

Mindfulness meditation in older adults with postherpetic neuralgia: a randomized controlled pilot study.

PubMed

Meize-Grochowski, Robin; Shuster, George; Boursaw, Blake; DuVal, Michelle; Murray-Krezan, Cristina; Schrader, Ron; Smith, Bruce W; Herman, Carla J; Prasad, Arti

2015-01-01

This parallel-group, randomized controlled pilot study examined daily meditation in a diverse sample of older adults with postherpetic neuralgia. Block randomization was used to allocate participants to a treatment group (n = 13) or control group (n = 14). In addition to usual care, the treatment group practiced daily meditation for six weeks. All participants completed questionnaires at enrollment in the study, two weeks later, and six weeks after that, at the study's end. Participants recorded daily pain and fatigue levels in a diary, and treatment participants also noted meditation practice. Results at the 0.10 level indicated improvement in neuropathic, affective, and total pain scores for the treatment group, whereas affective pain worsened for the control group. Participants were able to adhere to the daily diary and meditation requirements in this feasibility pilot study. Copyright © 2015 Elsevier Inc. All rights reserved.

Is BodyThink an efficacious body image and self-esteem program? A controlled evaluation with adolescents.

PubMed

Richardson, Shanel M; Paxton, Susan J; Thomson, Julie S

2009-03-01

This study aimed to evaluate the efficacy of BodyThink, a widely disseminated body image and self-esteem program. Participants were 277, grade 7 students from 4 secondary schools in Australia. The intervention group (62 girls, 85 boys) participated in BodyThink during four 50-min lessons, while the control group (65 girls, 65 boys) received their usual classes. All participants completed baseline, postintervention and 3-month follow-up questionnaires. For girls, the intervention group reported higher media literacy and lower internalization of the thin ideal compared to the control group. For boys, the intervention group reported higher media literacy and body satisfaction than the control group. Although some positive outcomes were observed, it would be valuable to find ways to enhance the impact of BodyThink, especially in light of its wide dissemination. Suggestions for improving BodyThink are presented.

A Randomized Trial of Long-Term Reinforcement of Cocaine Abstinence in Methadone-Maintained Patients Who Inject Drugs

ERIC Educational Resources Information Center

Silverman, Kenneth; Robles, Elias; Mudric, Timothy; Bigelow, George E.; Stitzer, Maxine L.

2004-01-01

This study determined whether long-term abstinence reinforcement could maintain cocaine abstinence throughout a yearlong period. Patients who injected drugs and used cocaine during methadone treatment (n = 78) were randomly assigned to 1 of 2 abstinence-reinforcement groups or to a usual care control group. Participants in the 2…

Sedative music reduces anxiety and pain during chair rest after open-heart surgery.

PubMed

Voss, Jo A; Good, Marion; Yates, Bernice; Baun, Mara M; Thompson, Austin; Hertzog, Melody

2004-11-01

Open-heart surgery patients report anxiety and pain with chair rest despite opioid analgesic use. The effectiveness of non-pharmacological complementary methods (sedative music and scheduled rest) in reducing anxiety and pain during chair rest was tested using a three-group pretest-posttest experimental design with 61 adult postoperative open-heart surgery patients. Patients were randomly assigned to receive 30 min of sedative music (N=19), scheduled rest (N=21), or treatment as usual (N=21) during chair rest. Anxiety, pain sensation, and pain distress were measured with visual analogue scales at chair rest initiation and 30 min later. Repeated measures MANOVA indicated significant group differences in anxiety, pain sensation, and pain distress from pretest to posttest, P<0.001. Univariate repeated measures ANOVA (P< or =0.001) and post hoc dependent t-tests indicated that in the sedative music and scheduled rest groups, anxiety, pain sensation, and pain distress all decreased significantly, P<0.001-0.015; while in the treatment as usual group, no significant differences occurred. Further, independent t-tests indicated significantly less posttest anxiety, pain sensation, and pain distress in the sedative music group than in the scheduled rest or treatment as usual groups (P<0.001-0.006). Thus, in this randomized control trial, sedative music was more effective than scheduled rest and treatment as usual in decreasing anxiety and pain in open-heart surgery patients during first time chair rest. Patients should be encouraged to use sedative music as an adjuvant to medication during chair rest.

One-year follow-up of mud-bath therapy in patients with bilateral knee osteoarthritis: a randomized, single-blind controlled trial

NASA Astrophysics Data System (ADS)

Fioravanti, A.; Bacaro, G.; Giannitti, C.; Tenti, S.; Cheleschi, S.; Guidelli, G. M.; Pascarelli, N. A.; Galeazzi, M.

2015-09-01

The objective of this prospective parallel randomized single-blind study was to assess that a cycle of mud-bath therapy (MBT) provides any benefits over usual treatment in patients with bilateral knee osteoarthritis (OA). Patients with symptomatic primary bilateral knee OA, according to ACR criteria, were included in the study and randomized to one of two groups: one group received a cycle of MBT at spa center of Chianciano Terme (Italy) in addition to the usual treatment, and one group continued their regular care routine alone. Clinical assessments were performed 7 days before enrollment (screening visit), at the time of enrollment (basal time), after 2 weeks, and after 3, 6, 9, and 12 months after the beginning of the study. All assessments were conducted by two researchers blinded to treatment allocation. The primary efficacy outcomes were the global pain score evaluated by Visual Analog Scale (VAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subscore for physical function (W-TPFS). Of the 235 patients screened, 103 met the inclusion criteria: 53 patients were included in the MBT group and 50 in the control group. In the group of patients treated with MBT, we observed a statistically significant ( p < 0.001) reduction of VAS and W-TPFS score at the end of the treatment; this improvement was significant ( p < 0.05) also at 3 months of follow-up. The control group did not show significant differences between baseline time and all other times. The differences between one group were significant for both primary parameters already from the 15th day and persisted up to the 9th month. This beneficial effect was confirmed by the significant reduction of symptomatic drug consumption. Tolerability of MBT seemed to be good, with light and transitory side effects. Our results confirm that a cycle of MBT added to usual treatment provides a beneficial effect on the painful symptoms and functional capacities in patients with knee OA that lasts over time. Mud-bath therapy can represent a useful backup to pharmacologic treatment of knee OA or a valid alternative for patients who do not tolerate pharmacological treatments.

Mobile diabetes intervention study: testing a personalized treatment/behavioral communication intervention for blood glucose control.

PubMed

Quinn, Charlene C; Gruber-Baldini, Ann L; Shardell, Michelle; Weed, Kelly; Clough, Suzanne S; Peeples, Malinda; Terrin, Michael; Bronich-Hall, Lauren; Barr, Erik; Lender, Dan

2009-07-01

National data find glycemic control is within target (A1c<7.0%) for 37% of patients with diabetes, and only 7% meet recommended glycemic, lipid, and blood pressure goals. To compare active interventions and usual care for glucose control in a randomized clinical trial (RCT) among persons with diabetes cared for by primary care physicians (PCPs) over the course of 1 year. Physician practices (n=36) in 4 geographic areas are randomly assigned to 1 of 4 study groups. The intervention is a diabetes communication system, using mobile phones and patient/physician portals to allow patient-specific treatment and communication. All physicians receive American Diabetes Association (ADA) Guidelines for diabetes care. Patients with poor diabetes control (A1c> or =7.5%) at baseline (n=260) are enrolled in study groups based on PCP randomization. All study patients receive blood glucose (BG) meters and a year's supply of testing materials. Patients in three treatment groups select one of two mobile phone models, receive one-year unlimited mobile phone data and service plan, register on the web-based individual patient portal and receive study treatment phone software based on study assignment. Control group patients receive usual care from their PCP. The primary outcome is mean change in A1c over a 12-month intervention period. Traditional methods of disease management have not achieved adequate control for BG and other conditions important to persons with diabetes. Tools to improve communication between patients and PCPs may improve patient outcomes and be satisfactory to patients and physicians. This RCT is ongoing.

A Multinational Cluster Randomised Controlled Trial to Assess the Efficacy of '11+ Kids': A Warm-Up Programme to Prevent Injuries in Children's Football.

PubMed

Rössler, Roland; Junge, Astrid; Bizzini, Mario; Verhagen, Evert; Chomiak, Jiri; Aus der Fünten, Karen; Meyer, Tim; Dvorak, Jiri; Lichtenstein, Eric; Beaudouin, Florian; Faude, Oliver

2018-06-01

The objective of this study was to assess the efficacy of a newly developed warm-up programme ('11+ Kids') regarding its potential to reduce injuries in children's football. Children's football teams (under 9 years, under 11 years, and under 13 years age groups) from Switzerland, Germany, the Czech Republic and the Netherlands were invited. Clubs were randomised to an intervention group and a control group, and followed for one season. The intervention group replaced their usual warm-up by '11+ Kids', while the control group warmed up as usual. The primary outcome was the overall risk of football-related injuries. Secondary outcomes were the risks of severe and lower extremity injuries. We calculated hazard ratios using extended Cox models, and performed a compliance analysis. In total, 292,749 h of football exposure of 3895 players were recorded. The mean age of players was 10.8 (standard deviation 1.4) years. During the study period, 374 (intervention group = 139; control group = 235) injuries occurred. The overall injury rate in the intervention group was reduced by 48% compared with the control group (hazard ratio 0.52; 95% confidence interval 0.32-0.86). Severe (74% reduction, hazard ratio 0.26; 95% confidence interval 0.10-0.64) and lower extremity injuries (55% reduction, hazard ratio 0.45; 95% confidence interval 0.24-0.84) were also reduced. Injury incidence decreased with increasing compliance. '11+ Kids' is efficacious in reducing injuries in children's football. We observed considerable effects for overall, severe and lower extremity injuries. The programme should be performed at least once per week to profit from an injury preventive effect. However, two sessions per week can be recommended to further increase the protective benefit. ClinicalTrials.gov identifier: NCT02222025.

A novel telemonitoring device for improving diabetes control: protocol and results from a randomized clinical trial.

PubMed

Pressman, Alice R; Kinoshita, Linda; Kirk, Susan; Barbosa, Gina Monraz; Chou, Cathy; Minkoff, Jerome

2014-02-01

Telemedicine is one approach to managing patients with chronic illness. Several telephone-based monitoring studies of diabetes patients have shown improved glycosylated hemoglobin (HbA1c), blood pressure (BP), and low-density lipoprotein (LDL) levels. The purpose of this study was to evaluate an investigational in-home telemetry device for improving glucose and BP control over 6 months for patients with type 2 diabetes. The device was used to transmit weekly blood glucose, weight, and BP readings to a diabetes care manager. We conducted a two-arm, parallel-comparison, single-blind, randomized controlled trial among Kaiser Permanente Northern California members 18-75 years old with type 2 diabetes mellitus and entry HbA1c levels between 7.5% and 10.0%. Participants were randomly assigned to either the telemonitoring arm or the usual care arm. We observed very small, nonsignificant changes in fructosamine (telemonitoring, -54.9 μmol; usual care, -59.4 μmol) and systolic BP (telemonitoring, -6.3 mm Hg; usual care, -3.2 mm Hg) from baseline to 6 weeks in both groups. At 6 months, we observed no significant intergroup differences in change from baseline for HbA1c, fructosamine, or self-efficacy. However, LDL cholesterol in the telemonitoring arm decreased more than in the usual care arm (-17.1 mg/dL versus -5.4 mg/dL; P=0.045). Although HbA1c improved significantly over 6 months in both groups, the difference in improvement between the groups was not significant. This lack of significance may be due to the relatively healthy status of the volunteers in our study and to the high level of care provided by the care managers in the Santa Rosa, CA clinic. Further study in subgroups of less healthy diabetes patients is recommended.

The effect of an educational programme consisting of group and individual arthritis education for patients with polyarthritis--a randomised controlled trial.

PubMed

Grønning, Kjersti; Skomsvoll, Johan F; Rannestad, Toril; Steinsbekk, Aslak

2012-07-01

The aim of this study was to investigate the effect of an educational programme for patients with polyarthritis compared to usual care. Patients with rheumatoid arthritis, psoriatic arthritis and unspecified polyarthritis were randomised to the intervention (n=71) or usual care (n=70). The intervention consisted of three group educational sessions followed by one individual educational session. The primary outcomes were a patient's global well-being and arthritis self-efficacy. Secondary outcomes were patient activation, physical and psychological health status, educational needs and disease activity. After four months the intervention group had significantly better global well-being, 95% CI (2.3-14.1), p=0.01, and self-efficacy, 95% CI (0.2-8.1), p=0.04, than the control group. There were also trends for improved disease activity, and a statistically significant improvement in patient activation and pain in the intervention group. This patient educational programme consisting of group sessions and nurse-delivered individual education has statistically significant benefits for global well-being and maintaining a level of self-efficacy in managing other symptoms in patients with polyarthritis. This educational programme allows patients to learn from each other in addition to addressing individual educational needs. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Combined therapy versus usual care for the treatment of depression in oncologic patients: a randomized controlled trial.

PubMed

Rodríguez Vega, B; Palao, A; Torres, G; Hospital, A; Benito, G; Pérez, E; Dieguez, M; Castelo, B; Bayón, C

2011-09-01

To compare narrative therapy (NT) plus escitalopram versus escitalopram plus usual care on quality of life and depressive symptomatology of depressed patients with oncologic disease. A total of 72 subjects (mean age 54.6 years), predominantly female with non-metastatic breast, lung and colon cancer and depressive disorder (DSM-IV-TR) were randomized to receive treatment with NT plus escitalopram (n=39) or escitalopram (10-20 mg QD) plus usual care (n=33). Main endpoints were improvement in dimensions of quality of life measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 and reduction of depressive symptoms using the Hospital Anxiety and Depression Scale at weeks 12 and 24. The combined therapy group showed significantly greater improvement in all the functioning dimensions (p<0.01), pain scale (p=0.02), global health (p=0.02), and global quality of life (p=0.007) at weeks 12 and 24. There were no statistically significant differences in depressive symptomatology between the groups. From week 12 to week 24 study retention was higher in the combined treatment group (p=0.01). Brief NT in combination with escitalopram was superior to usual care and escitalopram in improving functioning dimensions of quality life. Copyright © 2010 John Wiley & Sons, Ltd.

Effectiveness of a self-management intervention with personalised genetic and lifestyle-related risk information on coronary heart disease and diabetes-related risk in type 2 diabetes (CoRDia): study protocol for a randomised controlled trial.

PubMed

Davies, Anna K; McGale, Nadine; Humphries, Steve E; Hirani, Shashivadan P; Beaney, Katherine E; Bappa, Dauda A S; McCabe, John G; Newman, Stanton P

2015-12-02

Many patients with type 2 diabetes fail to achieve good glycaemic control. Poor control is associated with complications including coronary heart disease (CHD). Effective self-management and engagement in health behaviours can reduce risks of complications. However, patients often struggle to adopt and maintain these behaviours. Self-management interventions have been found to be effective in improving glycaemic control. Recent developments in the field of genetics mean that patients can be given personalised information about genetic- and lifestyle-associated risk of developing CHD. Such information may increase patients' motivation to engage in self-management. The Coronary Risk in Diabetes (CoRDia) trial will compare the effectiveness of a self-management intervention, with and without provision of personalised genetic- and lifestyle-associated risk information, with usual care, on clinical and behavioural outcomes, the cognitive predictors of behaviour, and psychological wellbeing. Participants will be adults aged 25-74 years registered with general practices in the East of England, diagnosed with type 2 diabetes, with no history of heart disease, and with a glycated haemoglobin level of ≥6.45% (47 mmol/mol). Consenting participants will be randomised to one of three arms: usual care control, group self-management only, group self-management plus personalised genetic- and lifestyle-associated risk information. The self-management groups will receive four weekly 2-hour group sessions, focusing on knowledge and information sharing, problem solving, goal setting and action planning to promote medication adherence, healthy eating, and physical activity. Primary outcomes are glycaemic control and CHD risk. Clinical data will be collected from GP records, including HbA1c, weight, body mass index, blood pressure, and HDL and total cholesterol. Self-reported health behaviours, including medication adherence, healthy eating and physical activity, and cognitive outcomes will be assessed by questionnaire. Measures will be taken at baseline, 3 months (questionnaire only), 6 months and 12 months post-baseline. This study will determine whether the addition of personalised genetic- and lifestyle-associated CHD risk information to a group self-management intervention improves diabetes control and CHD risk compared with group self-management and usual care. Effectiveness of the combined intervention on health behaviours cognitions theorised to predict them, and psychological outcomes will also be investigated. This study has been registered at ClinicalTrials.gov; registration identifier NCT01891786 , registered 28 June 2013.

A Pilot Study to Determine the Effect of an Educational DVD in Philippine Languages on Cancer Clinical Trial Participation among Filipinos in Hawai'i.

PubMed

Felicitas-Perkins, Jamie Q; Palalay, Melvin Paul; Cuaresma, Charlene; Ho, Reginald Cs; Chen, Moon S; Dang, Julie; Loui, William S

2017-07-01

We conducted an experimental pilot study in an oncology clinic in Honolulu, Hawai'i to determine the effect of a culturally-tailored educational DVD on cancer clinical trial participation among Filipino cancer patients. Thirty-seven patients participated in the study, with 17 randomized into the control group (ie, usual education) and 20 into the intervention group (ie, usual education plus educational DVD). Participants completed pre- and post-educational questionnaires with items asking about understanding of several cancer topics, behavioral outcomes, and attitudes regarding several treatment and physician related topics. A Fisher's exact test was conducted to explore the association between enrollment into a clinical trial and group assignment. General linear models were created to determine significant differences between study groups in post-education response scores for each questionnaire item after controlling for age, gender, education, and pre-education response scores. Two participants from the control group and three participants from the intervention group enrolled into clinical trials. Results showed no significant association between clinical trial enrollment and study group assignment ( P > .99). A significant difference was found between study groups on surety of joining the clinical trial suggested to them ( P = .013). A multilingual educational DVD to supplement clinical trial education may positively influence Filipino cancer patients to move forward with the decision to join a cancer clinical trial. However, health literacy may serve as a major barrier to actual enrollment into the particular clinical trial available to a patient.

Pilates-based therapeutic exercise: effect on subjects with nonspecific chronic low back pain and functional disability: a randomized controlled trial.

PubMed

Rydeard, Rochenda; Leger, Andrew; Smith, Drew

2006-07-01

A randomized controlled trial, prestest-posttest design, with a 3-, 6-, and 12-month follow-up. To investigate the efficacy of a therapeutic exercise approach in a population with chronic low back pain (LBP). Therapeutic approaches developed from the Pilates method are becoming increasingly popular; however, there have been no reports on their efficacy. Thirty-nine physically active subjects between 20 and 55 years old with chronic LBP were randomly assigned to 1 of 2 groups. The specific-exercise-training group participated in a 4-week program consisting of training on specialized (Pilates) exercise equipment, while the control group received the usual care, defined as consultation with a physician and other specialists and healthcare professionals, as necessary. Treatment sessions were designed to train the activation of specific muscles thought to stabilize the lumbar-pelvic region. Functional disability outcomes were measured with The Roland Morris Disability Questionnaire (RMQ/RMDQ-HK) and average pain intensity using a 101-point numerical rating scale. There was a significantly lower level of functional disability (P = .023) and average pain intensity (P = .002) in the specific-exercise-training group than in the control group following the treatment intervention period. The posttest adjusted mean in functional disability level in the specific-exercise-training group was 2.0 (95% CI, 1.3 to 2.7) RMQ/RMDQ-HK points compared to a posttest adjusted mean in the control group of 3.2 (95% CI, 2.5 to 4.0) RMQ/RMDQ-HK points. The posttest adjusted mean in pain intensity in the specific-exercise-training group was 18.3 (95% CI, 11.8 to 24.8), as compared to 33.9 (95% CI, 26.9 to 41.0) in the control group. Improved disability scores in the specific-exercise-training group were maintained for up to 12 months following treatment intervention. The individuals in the specific-exercise-training group reported a significant decrease in LBP and disability, which was maintained over a 12-month follow-up period. Treatment with a modified Pilates-based approach was more efficacious than usual care in a population with chronic, unresolved LBP.

The effectiveness of a Housing First adaptation for ethnic minority groups: findings of a pragmatic randomized controlled trial.

PubMed

Stergiopoulos, Vicky; Gozdzik, Agnes; Misir, Vachan; Skosireva, Anna; Sarang, Aseefa; Connelly, Jo; Whisler, Adam; McKenzie, Kwame

2016-10-21

Little is known about the effectiveness of Housing First (HF) among ethnic minority groups, despite its growing popularity for homeless adults experiencing mental illness. This randomized controlled trial tests the effectiveness of a HF program using rent supplements and intensive case management, enhanced by anti-racism and anti-oppression practices for homeless adults with mental illness from diverse ethnic minority backgrounds. This unblinded pragmatic field trial was carried out in community settings in Toronto, Canada. Participants were 237 adults from ethnic minority groups experiencing mental illness and homelessness, who met study criteria for moderate needs for mental health services. Participants were randomized to either adapted HF (n = 135) or usual care (n = 102) and followed every 3 months for 24 months. The primary study outcome was housing stability; secondary outcomes included physical and mental health, social functioning, quality of life, arrests and health service use. Intention to treat statistical analyses examined the effectiveness of the intervention compared to usual care. During the 24-month study period, HF participants were stably housed a significantly greater proportion of time compared to usual care participants, 75 % (95 % CI 70 to 81) vs. 41 % (95 % CI 35 to 48), respectively, for a difference of 34 %, 95 % CI 25 to 43. HF also led to improvements in community integration over the course of the study: the change in the mean difference between treatment groups from baseline to 24-months was significantly greater among HF participants compared to those in usual care (change in mean difference = 2.2, 95 % CI 0.06 to 4.3). Baseline diagnosis of psychosis was associated with reduced likelihood of being housed ≥ 50 % of the study period (OR = 0.37, 95 % CI 0.18 to 0.72). Housing First enhanced with anti-racism and anti-oppression practices can improve housing stability and community functioning among ethnically diverse homeless adults with mental illness. International Standard Randomized Control Trial Number Register Identifier: ISRCTN42520374 , assigned August 18, 2009.

A novel approach to quality improvement in a safety-net practice: concurrent peer review visits.

PubMed

Fiscella, Kevin; Volpe, Ellen; Winters, Paul; Brown, Melissa; Idris, Amna; Harren, Tricia

2010-12-01

Concurrent peer review visits are structured office visits conducted by clinician peers of the primary care clinician that are specifically designed to reduce competing demands, clinical inertia, and bias. We assessed whether a single concurrent peer review visit reduced clinical inertia and improved control of hypertension, hyperlipidemia, and diabetes control among underserved patients. We conducted a randomized encouragement trial to evaluate concurrent peer review visits with a community health center. Seven hundred twenty-seven patients with hypertension, hyperlipidemia, and/or diabetes who were not at goal for systolic blood pressure (SBP), low-density lipoprotein cholesterol (LDL-C), and/or glycated hemoglobin (A1c) were randomly assigned to an invitation to participate in a concurrent peer review visit or to usual care. We compared change in these measures using mixed models and rates of therapeutic intensification during concurrent peer review visits with control visits. One hundred seventy-one patients completed a concurrent peer review visit. SBP improved significantly (p < .01) more among those completing concurrent peer review visits than among those who failed to respond to a concurrent peer review invitation or those randomized to usual care. There were no differences seen for changes in LDL-C or A1c. Concurrent peer review visits were associated with statistically significant greater clinician intensification of blood pressure (p < .001), lipid (p < .001), and diabetes (p < .005) treatment than either for control visits for patients in either the nonresponse group or usual care group. Concurrent peer review visits represent a promising strategy for improving blood pressure control and improving therapeutic intensification in community health centers.

Comparative effectiveness and cost-effectiveness of Chuna manual therapy versus conventional usual care for nonacute low back pain: study protocol for a pilot multicenter, pragmatic randomized controlled trial (pCRN study).

PubMed

Shin, Byung-Cheul; Kim, Me-Riong; Cho, Jae-Heung; Jung, Jae-Young; Kim, Koh-Woon; Lee, Jun-Hwan; Nam, Kibong; Lee, Min Ho; Hwang, Eui-Hyoung; Heo, Kwang-Ho; Kim, Namkwen; Ha, In-Hyuk

2017-01-17

While Chuna manual therapy is a Korean manual therapy widely used primarily for low back pain (LBP)-related disorders in Korea, well-designed studies on the comparative effectiveness of Chuna manual therapy are scarce. This study is the protocol for a three-armed, multicenter, pragmatic randomized controlled pilot trial. Sixty severe nonacute LBP patients (pain duration of at least 3 weeks, Numeric Rating Scale (NRS) ≥5) will be recruited at four Korean medicine hospitals. Participants will be randomly allocated to the Chuna group (n = 20), usual care group (n = 20), or Chuna plus usual care group (n = 20) for 6 weeks of treatment. Usual care will consist of orally administered conventional medicine, physical therapy, and back pain care education. The trial will be conducted with outcome assessor and statistician blinding. The primary endpoint will be NRS of LBP at week 7 post randomization. Secondary outcomes include NRS of leg pain, the Oswestry Disability Index (ODI), the Patient Global Impression of Change (PGIC), the Credibility and Expectancy Questionnaire, lumbar range of motion (ROM), the EuroQol-5 Dimension (EQ-5D) health survey, the Health Utility Index III (HUI-III), and economic evaluation and safety data. Post-treatment follow-ups will be conducted at 1, 4, and 10 weeks after conclusion of treatment. This study will assess the comparative effectiveness of Chuna manual therapy compared to conventional usual care. Costs and effectiveness (utility) data will be analyzed for exploratory cost-effectiveness analysis. If this pilot study does not reach a definite conclusion due to its small sample size, these results will be used as preliminary results to calculate sample size for future large-scale clinical trials and contribute in the assessment of feasibility of a full-scale multicenter trial. Clinical Research Information Service (CRIS), KCT0001850 . Registered on 17 March 2016.

Clinical outcomes of Joint Crisis Plans to reduce compulsory treatment for people with psychosis: a randomised controlled trial.

PubMed

Thornicroft, Graham; Farrelly, Simone; Szmukler, George; Birchwood, Max; Waheed, Waquas; Flach, Clare; Barrett, Barbara; Byford, Sarah; Henderson, Claire; Sutherby, Kim; Lester, Helen; Rose, Diana; Dunn, Graham; Leese, Morven; Marshall, Max

2013-05-11

The CRIMSON (CRisis plan IMpact: Subjective and Objective coercion and eNgagement) study is an individual level, randomised controlled trial that compared the effectiveness of Joint Crisis Plans (JCPs) with treatment as usual for people with severe mental illness. The JCP is a negotiated statement by a patient of treatment preferences for any future psychiatric emergency, when he or she might be unable to express clear views. We assessed whether the additional use of JCPs improved patient outcomes compared with treatment as usual. Patients were eligible if they had at least one psychiatric admission in the previous 2 years and were on the Enhanced Care Programme Approach register. The study was done with 64 generic and specialist community mental health teams in four English mental health care provider organisations (trusts). Hypotheses tested were that, compared with the control group, the intervention group would experience: fewer compulsory admissions (primary outcome); fewer psychiatric admissions; shorter psychiatric stays; lower perceived coercion; improved therapeutic relationships; and improved engagement. We stratified participants by centre. The research team but not participants nor clinical staff were masked to allocation. This study is registered with ClinicalTrials.gov, number ISRCTN11501328. 569 participants were randomly assigned (285 to the intervention group and 284 to the control group). No significant treatment effect was seen for the primary outcome (56 [20%] sectioned in the control group and 49 [18%] in the JCP group; odds ratio 0·90 [95% CI 0·58-1·39, p=0·63]) or any secondary outcomes, with the exception of an improved secondary outcome of therapeutic relationships (17·3 [7·6] vs 16·0 [7·1]; adjusted difference -1·28 [95% CI -2·56 to -0·01, p=0·049]). Qualitative data supported this finding. Our findings are inconsistent with two earlier JCP studies, and show that the JCP is not significantly more effective than treatment as usual. There is evidence to suggest the JCPs were not fully implemented in all study sites, and were combined with routine clinical review meetings which did not actively incorporate patients' preferences. The study therefore raises important questions about implementing new interventions in routine clinical practice. Medical Research Council UK and the National Institute for Health Research. Copyright © 2013 Elsevier Ltd. All rights reserved.

Effectiveness of early intensive therapy on β-cell preservation in type 1 diabetes.

PubMed

Buckingham, Bruce; Beck, Roy W; Ruedy, Katrina J; Cheng, Peiyao; Kollman, Craig; Weinzimer, Stuart A; DiMeglio, Linda A; Bremer, Andrew A; Slover, Robert; Tamborlane, William V

2013-12-01

To assess effectiveness of inpatient hybrid closed-loop control (HCLC) followed by outpatient sensor-augmented pump (SAP) therapy initiated within 7 days of diagnosis of type 1 diabetes on the preservation of β-cell function at 1 year. Sixty-eight individuals (mean age 13.3 ± 5.7 years; 35% female, 92% Caucasian) were randomized to HCLC followed by SAP therapy (intensive group; N = 48) or to the usual-care group treated with multiple daily injections or insulin pump therapy (N = 20). Primary outcome was C-peptide concentrations during mixed-meal tolerance tests at 12 months. Intensive-group participants initiated HCLC a median of 6 days after diagnosis for a median duration of 71.3 h, during which median participant mean glucose concentration was 140 mg/dL (interquartile range 134-153 mg/dL). During outpatient SAP, continuous glucose monitor (CGM) use decreased over time, and at 12 months, only 33% of intensive participants averaged sensor use ≥6 days/week. In the usual-care group, insulin pump and CGM use were initiated prior to 12 months by 15 and 5 participants, respectively. Mean HbA1c levels were similar in both groups throughout the study. At 12 months, the geometric mean (95% CI) of C-peptide area under the curve was 0.43 (0.34-0.52) pmol/mL in the intensive group and 0.52 (0.32-0.75) pmol/mL in the usual-care group (P = 0.49). Thirty-seven (79%) intensive and 16 (80%) usual-care participants had a peak C-peptide concentration ≥0.2 pmol/mL (P = 0.30). In new-onset type 1 diabetes, HCLC followed by SAP therapy did not provide benefit in preserving β-cell function compared with current standards of care.

Effect of guided self-determination youth intervention integrated into outpatient visits versus treatment as usual on glycemic control and life skills: a randomized clinical trial in adolescents with type 1 diabetes.

PubMed

Husted, Gitte R; Thorsteinsson, Birger; Esbensen, Bente Appel; Gluud, Christian; Winkel, Per; Hommel, Eva; Zoffmann, Vibeke

2014-08-12

Providing care for adolescents with type 1 diabetes is complex, demanding, and often unsuccessful. Guided self-determination (GSD) is a life skills approach that has been proven effective in caring for adults with type 1 diabetes. To improve care, GSD was revised for adolescents, their parents, and interdisciplinary healthcare providers (HCP) to create GSD-Youth (GSD-Y). We evaluated the impact of GSD-Y after it was integrated into pediatric outpatient visits versus treatment-as-usual, focusing on glycemic control and the development of life skills in adolescents with type 1 diabetes. Seventy-one adolescents (mean age: 15 years, mean duration of diabetes: 5.7 years, mean HbA1c: 77 mmol/mol (9.1%), upon entering the study) from two pediatric departments were randomized into a GSD-Y group (n = 37, GSD-Y was provided during individual outpatient sessions) versus a treatment-as-usual group (n = 34). The primary outcome was the HbA1c measurement. The secondary outcomes were life skills development (assessed by self-reported psychometric scales), self-monitored blood glucose levels, and hypo- and hyperglycemic episodes. The analysis followed an intention-to-treat basis. Fifty-seven adolescents (80%) completed the trial, and 53 (75%) completed a six-month post-treatment follow-up. No significant effect of GSD-Y on the HbA1c could be detected in a mixed-model analysis after adjusting for the baseline HbA1c levels and the identity of the HCP (P = 0.85). GSD-Y significantly reduced the amotivation for diabetes self-management after adjusting for the baseline value (P = 0.001). Compared with the control group, the trial completion was prolonged in the GSD-Y group (P <0.001), requiring more visits (P = 0.05) with a higher rate of non-attendance (P = 0.01). GSD-Y parents participated in fewer of the adolescents' visits (P = 0.05) compared with control parents. Compared with treatment-as-usual, GSD-Y did not improve HbA1c levels, but it did decrease adolescents' amotivation for diabetes self-management. ISRCTN 54243636, registered on 10 January 2010. Life skills for adolescents with type 1 diabetes and their parents.

Your Health, an Intervention at Senior Vocational Schools to Promote Adolescents' Health and Health Behaviors

ERIC Educational Resources Information Center

Bannink, Rienke; Broeren, Suzanne; Heydelberg, Jurriën; van 't Klooster, Els; van Baar, Cathelijn; Raat, Hein

2014-01-01

This study evaluates the appreciation, application and effects of an intervention (Your Health), in which adolescents received a consultation with the school nurse. A cluster randomized controlled trial with an intervention and control group (care-as-usual) was conducted among first-grade senior vocational students. Adolescents (n = 418) completed…

Low-Cost Computer-Controlled Current Stimulator for the Student Laboratory

ERIC Educational Resources Information Center

Guclu, Burak

2007-01-01

Electrical stimulation of nerve and muscle tissues is frequently used for teaching core concepts in physiology. It is usually expensive to provide every student group in the laboratory with an individual stimulator. This article presents the design and application of a low-cost [about $100 (U.S.)] isolated stimulator that can be controlled by two…

Integrated collaborative care for major depression comorbid with a poor prognosis cancer (SMaRT Oncology-3): a multicentre randomised controlled trial in patients with lung cancer.

PubMed

Walker, Jane; Hansen, Christian Holm; Martin, Paul; Symeonides, Stefan; Gourley, Charlie; Wall, Lucy; Weller, David; Murray, Gordon; Sharpe, Michael

2014-09-01

The management of depression in patients with poor prognosis cancers, such as lung cancer, creates specific challenges. We aimed to assess the efficacy of an integrated treatment programme for major depression in patients with lung cancer compared with usual care. Symptom Management Research Trials (SMaRT) Oncology-3 is a parallel-group, multicentre, randomised controlled trial. We enrolled patients with lung cancer and major depression from three cancer centres and their associated clinics in Scotland, UK. Participants were randomly assigned in a 1:1 ratio to the depression care for people with lung cancer treatment programme or usual care by a database software algorithm that used stratification (by trial centre) and minimisation (by age, sex, and cancer type) with allocation concealment. Depression care for people with lung cancer is a manualised, multicomponent collaborative care treatment that is systematically delivered by a team of cancer nurses and psychiatrists in collaboration with primary care physicians. Usual care is provided by primary care physicians. The primary outcome was depression severity (on the Symptom Checklist Depression Scale [SCL-20], range 0-4) averaged over the patient's time in the trial (up to a maximum of 32 weeks). Trial statisticians and data collection staff were masked to treatment allocation, but patients and clinicians could not be masked to the allocations. Analyses were by intention to treat. This trial is registered with Current Controlled Trials, number ISRCTN75905964. 142 participants were recruited between Jan 5, 2009, and Sept 9, 2011; 68 were randomly allocated to depression care for people with lung cancer and 74 to usual care. 43 (30%) of 142 patients had died by 32 weeks, all of which were cancer-related deaths. No intervention-related serious adverse events occurred. 131 (92%) of 142 patients provided outcome data (59 in the depression care for people with lung cancer group and 72 in the usual care group) and were included in the intention-to-treat primary analysis. Average depression severity was significantly lower in patients allocated to depression care for people with lung cancer (mean score on the SCL-20 1·24 [SD 0·64]) than in those allocated to usual care (mean score 1·61 [SD 0·58]); difference -0·38 (95% CI -0·58 to -0·18); standardised mean difference -0·62 (95% CI -0·94 to -0·29). Self-rated depression improvement, anxiety, quality of life, role functioning, perceived quality of care, and proportion of patients achieving a 12-week treatment response were also significantly better in the depression care for people with lung cancer group than in the usual care group. Our findings suggest that major depression can be treated effectively in patients with a poor prognosis cancer; integrated depression care for people with lung cancer was substantially more efficacious than was usual care. Larger trials are now needed to estimate the effectiveness and cost-effectiveness of this care programme in this patient population, and further adaptation of the treatment will be necessary to address the unmet needs of patients with major depression and even shorter life expectancy. Cancer Research UK and Chief Scientist Office of the Scottish Government. Copyright © 2014 Elsevier Ltd. All rights reserved.

Enhanced fitness: a randomized controlled trial of the effects of home-based physical activity counseling on glycemic control in older adults with prediabetes mellitus.

PubMed

Morey, Miriam C; Pieper, Carl F; Edelman, David E; Yancy, William S; Green, Jennifer B; Lum, Helen; Peterson, Matthew J; Sloane, Richard; Cowper, Patricia A; Bosworth, Hayden B; Huffman, Kim M; Cavanaugh, James T; Hall, Katherine S; Pearson, Megan P; Taylor, Gregory A

2012-09-01

To determine whether a home-based multicomponent physical activity counseling (PAC) intervention is effective in reducing glycemic measures in older outpatients with prediabetes mellitus. Controlled clinical trial. Primary care clinics of the Durham Veterans Affairs (VA) Medical Center between September 29, 2008, and March 25, 2010. Three hundred two overweight (body mass index 25-45 kg/m(2) ), older (60-89) outpatients with impaired glucose tolerance (fasting blood glucose 100-125 mg/dL, glycosylated hemoglobin (HbA1c) <7%) randomly assigned to a PAC intervention group (n = 180) or a usual care control group (n = 122). A 12-month, home-based multicomponent PAC program including one in-person baseline counseling session, regular telephone counseling, physician endorsement in clinic with monthly automated encouragement, and customized mailed materials. All study participants, including controls, received a consultation in a VA weight management program. The primary outcome was a homeostasis model assessment of insulin resistance (HOMA-IR), calculated from fasting insulin and glucose levels at baseline and 3 and 12 months. HbA1c was the secondary indicator of glycemic control. Other secondary outcomes were anthropometric measures and self-reported physical activity, health-related quality of life, and physical function. There were no significant differences between the PAC and control groups over time for any of the glycemic indicators. Both groups had small declines over time of approximately 6% in fasting blood glucose (P < .001), and other glycemic indicators remained stable. The declines in glucose were not sufficient to affect the change in HOMA-IR scores due to fluctuations in insulin over time. Endurance physical activity increased significantly in the PAC group (P < .001) and not in the usual care group. Home-based telephone counseling increased physical activity levels but was insufficient to improve glycemic indicators in older outpatients with prediabetes mellitus. © 2012, Copyright the Authors Journal compilation © 2012, The American Geriatrics Society.

[Evaluation of an education program for patients with asthma who use inhalers].

PubMed

Lee, Jong Kyung; Yang, Young Hee

2010-04-01

This study was done to evaluate the effectiveness of an education program for patients with asthma who use inhalers. The research design for this study was a non-equivalent control group quasi-experimental study. Participants in this study were 36 patients for the control group, and 43 patients for the experimental group. The experimental group participated in the education program. The control group received the usual care. Data were collected before and 1 month and 2 months after the program finished and were analyzed using the SPSS 12.0 program. The experimental group had significantly higher scores of knowledge of inhalers, and inhalation technique compared to the control group. However, no significant differences were found between two groups for PEFR, asthma instability, and satisfaction with inhalers. According to the results, the education program was effective in improving knowledge of inhalers, and inhalation technique. Therefore, it is recommended that this education program be used in clinical practice as an effective nursing intervention for patients with asthma on inhalers.

Effecting attitudinal change towards rational drug use.

PubMed

Singh, T; Natu, M V

1995-01-01

Attitudes of 40 interns towards rational drug use (RDU) were assessed, using a standardized Likert type scale. The assessment was repeated after 4 months to evaluate the effect of usual working conditions of the hospital. After this period, the attitudes had slided towards negative side (p < 0.01). At this point, an intervention in the form of a workshop was provided for half the group while other half served as control. A repeat assessment after another period of 4 months revealed that the attitudes of test group returned towards positive side (p < 0.01) while control group maintained its negative attitudes.

Design of the integrative medical group visits randomized control trial for underserved patients with chronic pain and depression.

PubMed

Gardiner, Paula; Lestoquoy, Anna Sophia; Gergen-Barnett, Katherine; Penti, Brian; White, Laura F; Saper, Robert; Fredman, Lisa; Stillman, Sarah; Lily Negash, N; Adelstein, Pamela; Brackup, Ivy; Farrell-Riley, Christine; Kabbara, Karim; Laird, Lance; Mitchell, Suzanne; Bickmore, Timothy; Shamekhi, Ameneh; Liebschutz, Jane M

2017-03-01

Given the public health crisis of opioid overprescribing for pain, there is a need for evidence-based non pharmacological treatment options that effectively reduce pain and depression. We aim to examine the effectiveness of the Integrative Medical Group Visits (IMGV) model in reducing chronic pain and depressive symptoms, as well as increasing pain self-management. This paper details the study design and implementation of an ongoing randomized controlled trial of the IMGV model as compared to primary care visits. The research aims to determine if the IMGV model is effective in achieving: a) a reduction in self-reported pain and depressive symptoms and 2) an improvement in the self-management of pain, through increasing pain self-efficacy and reducing use of self-reported pain medication. We intend to recruit 154 participants to be randomized in our intervention, the IMGV model (n=77) and to usual care (n=77). Usual care of chronic pain through pharmacological treatment has mixed evidence of efficacy and may not improve quality of life or functional status. We aim to conduct a randomized controlled trial to evaluate the effectiveness of the IMGV model as compared to usual care in reducing self-reported pain and depressive symptoms as well as increasing pain management skills. Copyright © 2016 Elsevier Inc. All rights reserved.

A cluster randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of classroom-based cognitive-behavioural therapy (CBT) in reducing symptoms of depression in high-risk adolescents.

PubMed

Stallard, P; Phillips, R; Montgomery, A A; Spears, M; Anderson, R; Taylor, J; Araya, R; Lewis, G; Ukoumunne, O C; Millings, A; Georgiou, L; Cook, E; Sayal, K

2013-10-01

Depression in adolescents is a significant problem that impairs everyday functioning and increases the risk of severe mental health disorders in adulthood. Although this is a major problem, relatively few adolescents with, or at risk of developing, depression are identified and referred for treatment. This suggests the need to investigate alternative approaches whereby preventative interventions are made widely available in schools. To investigate the clinical effectiveness and cost-effectiveness of classroom-based cognitive-behavioural therapy (CBT) in reducing symptoms of depression in high-risk adolescents. Cluster randomised controlled trial. Year groups ( n = 28) randomly allocated on a 1 : 1 : 1 basis to one of three trial arms once all schools were recruited and balanced for number of classes, number of students, Personal, Social and Health Education (PSHE) lesson frequency, and scheduling of PSHE. Year groups 8 to 11 (ages 12-16 years) in mixed-sex secondary schools in the UK. Data were collected between 2009 and 2011. Young people who attended PSHE at participating schools were eligible ( n = 5503). Of the 5030 who agreed to participate, 1064 (21.2%) were classified as 'high risk': 392 in the classroom-based CBT arm, 374 in the attention control PSHE arm and 298 in the usual PSHE arm. Primary outcome data on the high-risk group at 12 months were available for classroom-based CBT ( n = 296), attention control PSHE ( n = 308) and usual PSHE ( n = 242). The Resourceful Adolescent Programme (RAP) is a focused CBT-based intervention adapted for the UK (RAP-UK) and delivered by two facilitators external to the school. Control groups were usual PSHE (usual school curriculum delivered by teachers) and attention control (usual school PSHE with additional support from two facilitators). Interventions were delivered universally to whole classes. Clinical effectiveness: symptoms of depression [Short Mood and Feelings Questionnaire (SMFQ)] in adolescents at high risk of depression 12 months from baseline. Cost-effectiveness: incremental cost-effectiveness ratios (ICERs) based on SMFQ score and quality-adjusted life-years (from European Quality of Life-5 Dimensions scores) between baseline and 12 months. Process evaluation: reach, attrition and qualitative feedback from service recipients and providers. SMFQ scores had decreased for high-risk adolescents in all trial arms at 12 months, but there was no difference between arms [classroom-based CBT vs. usual PSHE adjusted difference in means 0.97, 95% confidence interval (CI) -0.34 to 2.28; classroom-based CBT vs. attention control PSHE -0.63, 95% CI -1.99 to 0.73]. Costs of interventions per child were estimated at £41.96 for classroom-based CBT and £34.45 for attention control PSHE. Fieller's method was used to obtain a parametric estimate of the 95% CI for the ICERs and construct the cost-effectiveness acceptability curve, confirming that classroom-based CBT was not cost-effective relative to the controls. Reach of classroom-based CBT was good and attrition was low (median 80% attending ≥ 60% of sessions), but feedback indicated some difficulties with acceptability and sustainability. Classroom-based CBT, attention control PSHE and usual PSHE produced similar outcomes. Classroom-based CBT may result in increased self-awareness and reporting of depressive symptoms. Classroom-based CBT was not shown to be cost-effective. While schools are a convenient way of reaching a wide range of young people, implementing classroom-based CBT within schools is challenging, particularly with regard to fitting programmes into a busy timetable, the lack of value placed on PSHE, and difficulties engaging with teachers and young people. Wider use of classroom-based depression prevention programmes should not be undertaken without further research. If universal preventative approaches are to be pursued, their clinical effectiveness and cost-effectiveness with younger children (aged 10-11 years), before the incidence of depression increases, should be investigated. Alternatively, the clinical effectiveness of indicated school-based programmes targeting those already displaying symptoms of depression should be investigated. Current Controlled Trials ISRCTN19083628. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 17, No. 47. See the HTA programme website for further project information.

Use of a knowledge-attitude-behaviour education programme for Chinese adults undergoing maintenance haemodialysis: Randomized controlled trial.

PubMed

Liu, Li; Liu, Yue-Ping; Wang, Jing; An, Li-Wei; Jiao, Jian-Mei

2016-06-01

To investigate the effects of a knowledge-attitude-behaviour health education model on acquisition of disease-related knowledge and self-management behaviour by patients undergoing maintenance haemodialysis. Patients recently prescribed MHD were randomly assigned to a control group or an intervention group. Control group patients were treated with usual care and general education models. A specialist knowledge-attitude-behaviour health education model was applied to patients in the intervention group. Eighty-six patients were included (n = 43 per group). Before intervention, there were no significant between-group differences in disease knowledge and self-management behaviour. After 6 months' intervention, a significant between-group difference in acquisition of disease knowledge was observed. Self-management behaviour scores (control of body mass, reasonable diet, correct drug intake, physical activity, correct fistula care, disease condition monitoring, psychological and social behaviours) for the intervention group were also higher than those for the control group. These preliminary findings suggest that the knowledge-attitude-behaviour model appears to be a valuable tool for the health education of MHD patients. © The Author(s) 2016.

Use of a knowledge-attitude-behaviour education programme for Chinese adults undergoing maintenance haemodialysis: Randomized controlled trial

PubMed Central

Liu, Li; Wang, Jing; An, Li-Wei; Jiao, Jian-Mei

2016-01-01

Objective To investigate the effects of a knowledge-attitude-behaviour health education model on acquisition of disease-related knowledge and self-management behaviour by patients undergoing maintenance haemodialysis. Methods Patients recently prescribed MHD were randomly assigned to a control group or an intervention group. Control group patients were treated with usual care and general education models. A specialist knowledge-attitude-behaviour health education model was applied to patients in the intervention group. Results Eighty-six patients were included (n = 43 per group). Before intervention, there were no significant between-group differences in disease knowledge and self-management behaviour. After 6 months’ intervention, a significant between-group difference in acquisition of disease knowledge was observed. Self-management behaviour scores (control of body mass, reasonable diet, correct drug intake, physical activity, correct fistula care, disease condition monitoring, psychological and social behaviours) for the intervention group were also higher than those for the control group. Conclusion These preliminary findings suggest that the knowledge-attitude-behaviour model appears to be a valuable tool for the health education of MHD patients. PMID:26951842

The effect of coix seed on the nutritional status of peritoneal dialysis patients: a pilot study.

PubMed

Wu, Yifan; Li, Yin; Tong, Xiaozhen; Lu, Fuhua; Mao, Wei; Fu, Lizhe; Deng, Lili; Liu, Xi; Li, Chuang; Zhang, Lei; Liu, Xusheng

2014-02-01

To observe the effect of coix seed diet therapy on the nutritional status of peritoneal dialysis patients and to discuss the potential reasons. 30 dialysis patients with regular return visit to peritoneal dialysis center of Guangdong Provincial Hospital of Traditional Chinese Medicine were recruited and divided into two groups according to their willingness. 13 patients in control group continued their usual dialysis prescriptions and medications, whereas 30g of coix seed per day was added to the usual therapies of 17 patients in coix seed group. Changes in nutritional status of dialysis patients in two groups were evaluated after a 12-week treatment. Two patients (one in each group) quitted the study because of pulmonary infection. After treatment, the nutritional parameters of serum albumin level (P=0.004), total protein level (P=0.008), and body mass index (P=0.023) were increased significantly in coix seed group. And the statistical differences of serum albumin level and body mass index were significantly compared to control group (P=0.008 and P=0.032, respectively). Moreover, the C-reactive protein level had a significant decrease (P=0.001) and the clinical symptoms of dialysis patients including tiredness, anorexia, xerostomia, and abdominal distension showed a significant improvement (P<0.05) in coix seed group. And urinary volume of dialysis patients in coix seed group also had a significant increase (P=0.027). However, there is no significant difference showed in control group. Coix seed diet therapy plays a role in improving the nutritional status of peritoneal dialysis patients by relieving digestive tract symptoms, increasing urinary volume, and meliorating micro-inflammatory state. But as a pilot study, the results still need to be validated by further large-scale researches. Copyright © 2013 Elsevier Ltd. All rights reserved.

Cognitive-behavioural therapy-based intervention to reduce fear of falling in older people: therapy development and randomised controlled trial - the Strategies for Increasing Independence, Confidence and Energy (STRIDE) study.

PubMed

Parry, Steve W; Bamford, Claire; Deary, Vincent; Finch, Tracy L; Gray, Jo; MacDonald, Claire; McMeekin, Peter; Sabin, Neil J; Steen, I Nick; Whitney, Sue L; McColl, Elaine M

2016-07-01

Falls cause fear, anxiety and loss of confidence, resulting in activity avoidance, social isolation and increasing frailty. The umbrella term for these problems is 'fear of falling', seen in up to 85% of older adults who fall. Evidence of effectiveness of physical and psychological interventions is limited, with no previous studies examining the role of an individually delivered cognitive-behavioural therapy (CBT) approach. Primary objective To develop and then determine the effectiveness of a new CBT intervention (CBTi) delivered by health-care assistants (HCAs) plus usual care compared with usual care alone in reducing fear of falling. Secondary objectives To measure the impact of the intervention on falls, injuries, functional abilities, anxiety/depression, quality of life, social participation and loneliness; investigate the acceptability of the intervention for patients, family members and professionals and factors that promote or inhibit its implementation; and measure the costs and benefits of the intervention. Phase I CBTi development. Phase II Parallel-group patient randomised controlled trial (RCT) of the new CBTi plus usual care compared with usual care alone. Multidisciplinary falls services. Consecutive community-dwelling older adults, both sexes, aged ≥ 60 years, with excessive or undue fear of falling per Falls Efficacy Scale-International (FES-I) score of > 23. Phase I Development of the CBTi. The CBTi was developed following patient interviews and taught to HCAs to maximise the potential for uptake and generalisability to a UK NHS setting. Phase II RCT. The CBTi was delivered by HCAs weekly for 8 weeks, with a 6-month booster session plus usual care. These were assessed at baseline, 8 weeks, 6 months and 12 months. Primary outcome measure Fear of falling measured by change in FES-I scores at 12 months. Secondary outcome measures These comprised falls, injuries, anxiety/depression [Hospital Anxiety and Depression Scale (HADS)], quality of life, social participation, loneliness and measures of physical function. There were process and health-economic evaluations alongside the trial. Four hundred and fifteen patients were recruited, with 210 patients randomised to CBTi group and 205 to the control group. There were significant reductions in mean FES-I [-4.02; 95% confidence interval (CI) -5.95 to -2.1], single-item numerical fear of falling scale (-1.42; 95% CI -1.87 to 1.07) and HADS (-1; 95% CI -1.6 to -0.3) scores at 12 months in the CBTi group compared with the usual care group. There were no differences in the other secondary outcome measures. Most patients found the CBTi acceptable. Factors affecting the delivery of the CBTi as part of routine practice were identified. There was no evidence that the intervention was cost-effective. Our new CBTi delivered by HCAs significantly improved fear of falling and depression scores in older adults who were attending falls services. There was no impact on other measures. Further work should focus on a joint CBTi and physical training approach to fear of falling, more rational targeting of CBTi, the possibility of mixed group and individual CBTi, and the cost-effectiveness of provision of CBTi by non-specialists. Current Controlled Trials ISRCTN78396615. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 56. See the NIHR Journals Library website for further project information.

The effectiveness of high-intensity versus low-intensity back schools in an occupational setting: a pragmatic randomized controlled trial.

PubMed

Heymans, Martijn W; de Vet, Henrica C W; Bongers, Paulien M; Knol, Dirk L; Koes, Bart W; van Mechelen, Willem

2006-05-01

Randomized controlled trial. To compare high- and low-intensity back schools with usual care in occupational health care. The content and intensity of back schools vary widely and the methodologic quality of randomized controlled trials is generally weak. Until now, no back school has proven to be superior for workers sick-listed because of subacute nonspecific low back pain. Workers (n = 299) sick-listed for a period of 3 to 6 weeks because of nonspecific low back pain were recruited by the occupational physician and randomly assigned to a high-intensity back school, a low-intensity back school, or care as usual. Outcome measures were days until return to work, total days of sick-leave, pain, functional status, kinesiophobia, and perceived recovery and were assessed at baseline and at 3 and 6 months of follow-up. Principal analyses were performed according to the intention-to-treat principle. We randomly allocated 299 workers. Workers in the low-intensity back school returned to work faster compared with usual care and the high-intensity back school, with hazard ratios of 1.4 (P = 0.06) and 1.3 (P = 0.09), respectively. The comparison between high-intensity back school and usual care resulted in a hazard ratio of 1.0 (P = 0.83). The median number of sick-leave days was 68, 75, and 85 in the low-intensity back school, usual care, and high-intensity back school, respectively. Beneficial effects on functional status and kinesiophobia were found at 3 months in favor of the low-intensity back school. No substantial differences on pain and perceived recovery were found between groups. The low-intensity back school was most effective in reducing work absence, functional disability, and kinesiophobia, and more workers in this group scored a higher perceived recovery during the 6-month follow-up.

Effectiveness of a brief psychoeducational group intervention for relatives on the course of disease in patients after inpatient depression treatment compared with treatment as usual--study protocol of a multisite randomised controlled trial.

PubMed

Frank, Fabian; Wilk, Juliette; Kriston, Levente; Meister, Ramona; Shimodera, Shinji; Hesse, Klaus; Bitzer, Eva-Maria; Berger, Mathias; Hölzel, Lars P

2015-10-23

Relapses and rehospitalisations are common after acute inpatient treatment in depressive disorders. Interventions for stabilising treatment outcomes are urgently needed. Psychoeducational group interventions for relatives were shown to be suitable for improving the course of disease in schizophrenia and bipolar disorders. A small Japanese monocentre randomised controlled trial also showed promising results for depressive disorders. However, the evidence regarding psychoeducation for relatives of patients with depressive disorders is unclear. The study is conducted as a two-arm multisite randomised controlled trial to evaluate the incremental effect of a brief psychoeducational group intervention for relatives as a maintenance treatment on the course of disease compared to treatment as usual. Primary outcome is the estimated number of depression-free-days in patients within one year after discharge from inpatient treatment. 180 patients diagnosed with unipolar depressive disorders as well as one key relative per patient will be included during inpatient treatment and randomly allocated to the conditions at discharge. In the intervention group, relatives will participate in a brief psychoeducational group intervention following the patient's discharge. The intervention consists of four group sessions lasting 90 to 120 min each. Every group session contains informational parts as well as structured training in problem-solving. In both study conditions, patients will receive treatment as usual. Patients as well as relatives will be surveyed by means of questionnaires at discharge and three, six, nine and twelve months after discharge. In addition to the primary outcome, several patient-related and relative-related secondary outcomes will be considered and health economics will be investigated. Our study will provide evidence on the incremental effect of a brief psychoeducational intervention for relatives as a maintenance treatment after inpatient depression treatment. Positive results may have a major impact on health care for depression. German Clinical Trials Register (DRKS): DRKS00006819; Trial registration date: 2014 Oktober 31; Universal Trial Number (UTN): U1111-1163-5391.

Skin care education and individual counselling versus treatment as usual in healthcare workers with hand eczema: randomised clinical trial.

PubMed

Ibler, Kristina Sophie; Jemec, Gregor B E; Diepgen, Thomas L; Gluud, Christian; Lindschou Hansen, Jane; Winkel, Per; Thomsen, Simon Francis; Agner, Tove

2012-12-12

To evaluate the effect of a secondary prevention programme with education on skin care and individual counselling versus treatment as usual in healthcare workers with hand eczema. Randomised, observer blinded parallel group superiority clinical trial. Three hospitals in Denmark. 255 healthcare workers with self reported hand eczema within the past year randomised centrally and stratified by profession, severity of eczema, and hospital. 123 were allocated to the intervention group and 132 to the control group. Education in skin care and individual counselling based on patch and prick testing and assessment of work and domestic related exposures. The control was treatment as usual. The primary outcome was clinical severity of disease at five month follow-up measured by scores on the hand eczema severity index. The secondary outcomes were scores on the dermatology life quality index, self evaluated severity of hand eczema, skin protective behaviours, and knowledge of hand eczema from onset to follow-up. Follow-up data were available for 247 of 255 participants (97%). At follow-up, the mean score on the hand eczema severity index was significantly lower (improved) in the intervention group than control group: difference of means, unadjusted -3.56 (95% confidence interval -4.92 to -2.14); adjusted -3.47 (-4.80 to -2.14), both P<0.001 for difference. The mean score on the dermatology life quality index was also significantly lower (improved) in the intervention group at follow-up: difference of means: unadjusted -0.78, non-parametric test P=0.003; adjusted -0.92, -1.48 to -0.37). Self evaluated severity and skin protective behaviour by hand washings and wearing of protective gloves were also statistically significantly better in the intervention group, whereas this was not the case for knowledge of hand eczema. A secondary prevention programme for hand eczema improved severity and quality of life and had a positive effect on self evaluated severity and skin protective behaviour by hand washings and wearing of protective gloves. ClinicalTrials.gov NCT01012453.

Prenatal diagnosis of Bartter syndrome: amniotic fluid aldosterone.

PubMed

Rachid, Myriam; Dreux, Sophie; Pean de Ponfilly, Gauthier; Vargas-Poussou, Rosa; Czerkiewicz, Isabelle; Chevenne, Didier; Oury, Jean-François; Deschênes, Georges; Muller, Françoise

2017-04-01

Bartter syndrome is a severe inherited tubulopathy characterized at birth by salt wasting, severe polyuria, dehydration, growth retardation and secondary hyperaldosteronism. Prenatally, the disease is usually discovered following onset of severe polyhydramnios. We studied amniotic fluid aldosterone concentration in cases of Bartter syndrome and in control groups. Amniotic fluid aldosterone was assayed by radioimmunoassay. We undertook a retrospective case-control study based on 36 cases of postnatally diagnosed Bartter syndrome and 144 controls matched for gestational age. Two controls groups were defined: controls with polyhydramnios (n=72) and control without polyhydramnios (n=72). Amniotic fluid aldosterone was compared between the three groups. The median amniotic fluid aldosterone concentration in the Bartter syndrome group (90 pg/mL) did not differ significantly from that in the controls with polyhydramnios (90 pg/mL, p=0.33) or the controls without polyhydramnios (87 pg/mL, p=0.41). In conclusion, amniotic fluid aldosterone assay cannot be used for prenatal diagnosis of Bartter syndrome.

AN EVALUATION OF HIGH SCHOOL MATHEMATICS PROGRAMMED TEXTS WHEN USED WITH DEAF STUDENTS.

ERIC Educational Resources Information Center

BORNSTEIN, HARRY

A COMPARISON WAS MADE OF THE RATE AND LEVEL OF ACHIEVEMENT OF 150 DEAF STUDENTS RESULTING FROM THE USE OF PROGRAMED TEXTS AS AGAINST THE USUAL LECTURE METHODS IN HIGH SCHOOL MATHEMATICS. EACH OF FOUR MATHEMATICS TEACHERS HAD TWO COMPARABLE CLASSES. THE CONTROL GROUP RECEIVED INFORMATION BY SIMULTANEOUS LECTURE AND THE EXPERIMENTAL GROUPS USED THE…

Effects of labor support from close female relative on labor and maternal satisfaction in a Thai setting.

PubMed

Yuenyong, Siriwan; O'Brien, Beverley; Jirapeet, Veena

2012-01-01

To evaluate the efficacy of a close female relative providing emotional and physical support during active labor and birth. Randomized, two-group controlled clinical trial. Regional teaching hospital in the eastern part of Thailand with 782 beds. Primiparous women (N = 120) whose gestational ages were ≥ 36 weeks and who had uncomplicated pregnancies. Participants were randomly assigned to receive usual care and support from a chosen close female relative from admission until 2 hours after birth or usual care only. Within 24 hours of birth, labor outcomes (length of labor & type of birth) and levels of maternal satisfaction were assessed. Those in the experimental group had a significantly shorter duration of active labor and were more satisfied with their childbirth experiences than those in the control group. Differences between groups with respect to incidence of spontaneous delivery were not found. A close female relative was effective in providing supportive care during labor and delivery. The integration of this nursing intervention for women and their families at public hospitals in Thailand is supported. © 2012 AWHONN, the Association of Women's Health, Obstetric and Neonatal Nurses.

The effect of occupational therapy in patients with chronic obstructive pulmonary disease: A randomized controlled trial.

PubMed

Martinsen, Unni; Bentzen, Hege; Holter, Morag Kelly; Nilsen, Tove; Skullerud, Hallvard; Mowinckel, Petter; Kjeken, Ingvild

2017-03-01

Aim The main aim of this study was to evaluate the effect of individualized occupational therapy in patients with chronic obstructive pulmonary disease (COPD). Additionally, the authors wanted to explore the occupational problems experienced in daily life by individuals with COPD. Methods A total of 52 patients were randomly assigned to the intervention group (occupational therapy) or control group (treatment as usual). The primary outcome was assessed using the Canadian Occupational Performance Measure (COPM), and participants were assessed at baseline and after four and 12 months. Results There were no treatment effects on occupational performance or satisfaction with performance, as measured by the COPM. However, we found a significant effect in favour of the intervention group at exertion when performing an individually chosen activity, and in the activity dimension of St George's Respiratory Questionnaire. A total of 595 occupational problems were reported, most frequently within mobility, active recreation, and household management. Conclusions The results show that, compared with the usual care, individualized occupational therapy did not improve occupational performance or satisfaction with performance. Small but significant changes in activity performance in favour of the intervention group were found in some of the secondary outcomes.

The impact of cognitive behavioral group training on event-free survival in patients with myocardial infarction: the ENRICHD experience.

PubMed

Saab, Patrice G; Bang, Heejung; Williams, Redford B; Powell, Lynda H; Schneiderman, Neil; Thoresen, Carl; Burg, Matthew; Keefe, Francis

2009-07-01

Although the Enhancing Recovery in Coronary Heart Disease (ENRICHD) treatment was designed to include individual therapy and cognitive behavioral group training for patients with depression and/or low perceived social support, only 31% of treated participants received group training. Secondary analyses classified intervention participants into two subgroups, (1) individual therapy only or (2) group training (i.e., coping skills training) plus individual therapy, to determine whether medical outcomes differed in participants who received the combination of group training and individual therapy compared to participants who received individual therapy only or usual care. Secondary analyses of 1243 usual care, 781 individual therapy only, and 356 group plus individual therapy myocardial infarction (MI) patients were performed. Depression was diagnosed using modified Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria; low perceived social support was determined by the ENRICHD Social Support Instrument. Psychosocial treatment followed MI, and for participants with severe or unremitting depression, was supplemented with a selective serotonin reuptake inhibitor. Cox proportional hazards regression was used to estimate intervention effects on time to first occurrence of the composite end point of death plus nonfatal MI. To control for confounding of group participation with survival (because individual sessions preceded group), we used risk set sampling to match minimal survival time of those receiving or not receiving group training. Analyses correcting for differential survival among comparison groups showed that group plus individual therapy was associated with a 33% reduction (hazard ratio=0.67; 95% confidence interval, 0.49-0.92, P=.01) in medical outcome compared to usual care. No significant effect on event-free survival was associated with individual therapy alone. The group training benefit was reduced to 23% (hazard ratio=0.77; 95% confidence interval: 0.56-1.07, P=.11) in the multivariate-adjusted model. Findings suggest that adding group training to individual therapy may be associated with reduction in the composite end point. A randomized controlled trial is warranted to definitively resolve this issue.

Proof of Concept of a Mobile Health Short Message Service Text Message Intervention That Promotes Adherence to Oral Anticancer Agent Medications: A Randomized Controlled Trial.

PubMed

Spoelstra, Sandra L; Given, Charles W; Sikorskii, Alla; Coursaris, Constantinos K; Majumder, Atreyee; DeKoekkoek, Tracy; Schueller, Monica; Given, Barbara A

2016-06-01

This multisite, randomized controlled trial assigned 75 adult cancer patients prescribed an oral anticancer agent to either an experimental group that received daily text messages for adherence for 21 days plus usual care or a control group that received usual care. Measures were administered at baseline, weekly (Weeks 1-8), and at exit (Week 9). A satisfaction survey was conducted following the intervention. Acceptability, feasibility, and satisfaction were examined. Primary outcomes were adherence and symptoms. Secondary outcomes were depressive symptoms, self-efficacy, cognition, physical function, and social support. Mixed or general linear models were used for the analyses comparing trial groups. Effect sizes (ES) were estimated to gauge clinical significance. Regarding acceptability, 57.2% (83 of 145) of eligible patients consented, 88% (n = 37 of 42) receiving text messages read them most or all of the time, and 90% (n = 38) were satisfied. The differences between experimental and control groups' ES were 0.29 for adherence, 0.21 for symptom severity, and 0.21 for symptom interference, and differences were not statistically significant. Furthermore, perceived social support was higher (p = 0.04; ES = 0.54) in the experimental group. Proof of concept and preliminary efficacy of a mobile health intervention using text messages to promote adherence for patients prescribed oral anticancer agents were demonstrated. Patients accepted and had high satisfaction with the intervention, and adherence improved after the intervention. Text messages show promise. Additional research is needed prior to use in practice.

Effectiveness of a Brief Psychosocial Intervention on Quality of Life of Primary Caregivers of Iranian Children With Cancer: A Randomized Controlled Trial.

PubMed

Safarabadi-Farahani, Atefeh; Maarefvand, Masoomeh; Biglarian, Akbar; Khubchandani, Jagdish

2016-01-01

Cancer in children has a great impact on primary caregiver quality of life (QOL). This study examined the effectiveness of a brief psychosocial intervention (BPI) on QOL of Primary Caregivers of Children with Cancer (PCCCs). Sixty-five PCCCs participated in a randomized controlled trial in Mahak Hospital and Rehabilitation Complex in Tehran, Iran. A 5-week long BPI (which comprised of counseling sessions and telephone follow-up) was delivered to the intervention group in addition to usual service, while the control group was provided with usual service. Data were collected using the Caregiver Quality of Life Index-Cancer-Persian version (CQOLC-P) prior to intervention, post-intervention, and at follow-up (i.e. 30days after the intervention). Repeated measures analysis of variance analysis (ANOVA) was used to evaluate outcomes. Majority of the participants were mothers (95%), between ages of 24-47 years (95%) with children between ages of 2-12 years. Most child cancer diagnoses were for brain tumors (n=31) and blood cancers (n=17). Significant improvement was found within the intervention group on QOL (p<0.001) including improvements on subscale measures of mental/emotional burden (p<0.001), disruption (p<0.001), and positive adaptation (p<0.001), compared with the control group over time. There was no difference between the intervention and control groups on the financial subscale measure after intervention (p>0.05). BPI was an effective strategy to improve the quality of life of PCCCs. Similar interventions can be planned by practitioners to reduce the burden of childhood cancer on PCCCs. Copyright © 2016 Elsevier Inc. All rights reserved.

Brief Exposure to Cognitive Behavioral Therapy Reduces Side-Effect Symptoms in Patients on Antiretroviral Therapy.

PubMed

Doerfler, R Eric; Goodfellow, Linda

2016-01-01

No study has tested the effectiveness of individualized cognitive behavioral therapy (CBT) interventions to reduce persistent nausea, pain, anxiety, and fatigue in patients on continuous antiretroviral therapy (ART). Our objective was to determine if CBT could reduce nausea, pain, anxiety, and fatigue in patients with HIV on ART. Men ages 40 to 56 years on ART (n = 18) at a suburban HIV clinic were randomly assigned to a control group or the CBT intervention. Usual adherence education and side-effect management were provided to both groups. Symptoms, health perception, medication adherence, and side-effect-reducing medication use were measured at four time points over 3 months. Participants in the intervention group rated usual fatigue and worst fatigue at 60 days, and nausea duration at 90 days significantly lower than controls (p < .05). Brief CBT training may reduce fatigue and nausea in patients with HIV undergoing ART. Copyright © 2016 Association of Nurses in AIDS Care. Published by Elsevier Inc. All rights reserved.

Interventions to increase physician efficiency and comfort with an electronic health record system.

PubMed

Jalota, L; Aryal, M R; Mahmood, M; Wasser, T; Donato, A

2015-01-01

To determine comfort when using the Electronic Health Record (EHR) and increase in documentation efficiency after an educational intervention for physicians to improve their transition to a new EHR. This study was a single-center randomized, parallel, non-blinded controlled trial of real-time, focused educational interventions by physician peers in addition to usual training in the intervention arm compared with usual training in the control arm. Participants were 44 internal medicine physicians and residents stratified to groups using a survey of comfort with electronic media during rollout of a system-wide EHR and order entry system. Outcomes were median time to complete a progress note, notes completed after shift, and comfort with EHR at 20 and 40 shifts. In the intervention group, 73 education sessions averaging 14.4 (SD: 7.7) minutes were completed with intervention group participants, who received an average of 3.47 (SD: 2.1) interventions. Intervention group participants decreased their time to complete a progress note more quickly than controls over 30 shifts (p < 0.001) and recorded significantly fewer progress notes after scheduled duty hours (77 versus 292, p < 0.001). Comfort with EHRs increased significantly in both groups from baseline but did not differ significantly by group. Intervention group participants felt that the intervention was more helpful than their standard training (3.47 versus 1.95 on 4-point scale). Physicians teaching physicians during clinical work improved physician efficiency but not comfort with EHRs. More study is needed to determine best methods to assist those most challenged with new EHR rollouts.

[Telephone support for breastfeeding by primary care: a randomised multicentre trial].

PubMed

Balaguer Martínez, Josep Vicent; Valcarce Pérez, Inmaculada; Esquivel Ojeda, Jessica Noelia; Hernández Gil, Alicia; Martín Jiménez, María Del Pilar; Bernad Albareda, Mercè

2018-03-22

To evaluate a telephone support programme for mothers who breastfeed for the first 6 months. A randomised unmasked clinical trial was conducted in 5 urban Primary Care centres that included mothers with healthy newborns who were breastfeeding exclusively (EBF) or partially (PBF). The control group received the usual care. The intervention group also received telephone support for breastfeeding on a weekly basis for the first 2months and then every 2weeks until the sixth month. The type of breastfeeding was recorded in the usual check-up visit (1, 2, 4 and 6 months). The study included 193 patients in the intervention group, and 187 in a control group. The greatest increase in the percentage of EBF was observed at 6 months: 21.4% in the control group compared to 30.1% in the intervention group. However, in the adjusted odds ratios analysis, confidence intervals did not show statistical significance. The odds ratio at 1 month, 2 months, 4 months, and 6 months for EBF were 1.45 (0.91-2.31), 1.35 (0.87-2.08), 1.21 (0.80-1.81), and 1.58 (0.99-2.53), respectively. The odds ratio in the same age groups for any type of breastfeeding (EBF + PBF) were 1.65 (0.39-7.00), 2.08 (0.94-4.61), 1.37 (0.79-2.38), and 1.60 (0.98-2.61), respectively. Telephone intervention was not effective enough to generalise it. Copyright © 2018. Publicado por Elsevier España, S.L.U.

Angiotensin II type 1 and 2 receptors and lymphatic vessels modulate lung remodeling and fibrosis in systemic sclerosis and idiopathic pulmonary fibrosis.

PubMed

Parra, Edwin Roger; Ruppert, Aline Domingos Pinto; Capelozzi, Vera Luiza

2014-01-01

To validate the importance of the angiotensin II receptor isotypes and the lymphatic vessels in systemic sclerosis and idiopathic pulmonary fibrosis. We examined angiotensin II type 1 and 2 receptors and lymphatic vessels in the pulmonary tissues obtained from open lung biopsies of 30 patients with systemic sclerosis and 28 patients with idiopathic pulmonary fibrosis. Their histologic patterns included cellular and fibrotic non-specific interstitial pneumonia for systemic sclerosis and usual interstitial pneumonia for idiopathic pulmonary fibrosis. We used immunohistochemistry and histomorphometry to evaluate the number of cells in the alveolar septae and the vessels stained by these markers. Survival curves were also used. We found a significantly increased percentage of septal and vessel cells immunostained for the angiotensin type 1 and 2 receptors in the systemic sclerosis and idiopathic pulmonary fibrosis patients compared with the controls. A similar percentage of angiotensin 2 receptor positive vessel cells was observed in fibrotic non-specific interstitial pneumonia and usual interstitial pneumonia. A significantly increased percentage of lymphatic vessels was present in the usual interstitial pneumonia group compared with the non-specific interstitial pneumonia and control groups. A Cox regression analysis showed a high risk of death for the patients with usual interstitial pneumonia and a high percentage of vessel cells immunostained for the angiotensin 2 receptor in the lymphatic vessels. We concluded that angiotensin II receptor expression in the lung parenchyma can potentially control organ remodeling and fibrosis, which suggests that strategies aimed at preventing high angiotensin 2 receptor expression may be used as potential therapeutic target in patients with pulmonary systemic sclerosis and idiopathic pulmonary fibrosis.

Effect of two contrasting interventions on upper limb chronic pain and disability: a randomized controlled trial.

PubMed

Sundstrup, Emil; Jakobsen, Markus D; Andersen, Christoffer H; Jay, Kenneth; Persson, Roger; Aagaard, Per; Andersen, Lars L

2014-01-01

Chronic pain and disability of the arm, shoulder, and hand severely affect labor market participation. Ergonomic training and education is the default strategy to reduce physical exposure and thereby prevent aggravation of pain. An alternative strategy could be to increase physical capacity of the worker by physical conditioning. To investigate the effect of 2 contrasting interventions, conventional ergonomic training (usual care) versus resistance training, on pain and disability in individuals with upper limb chronic pain exposed to highly repetitive and forceful manual work. Examiner-blinded, parallel-group randomized controlled trial with allocation concealment. Slaughterhouses located in Denmark, Europe. Sixty-six adults with chronic pain in the shoulder, elbow/forearm, or hand/wrist and work disability were randomly allocated to 10 weeks of specific resistance training for the shoulder, arm, and hand muscles for 3 x 10 minutes per week, or ergonomic training and education (usual care control group). Pain intensity (average of shoulder, arm, and hand, scale 0 - 10) was the primary outcome, and disability (Work module of DASH questionnaire) as well as isometric shoulder and wrist muscle strength were secondary outcomes. Pain intensity, disability, and muscle strength improved more following resistance training than usual care (P < 0.001, P = 0.05, P <0.0001, respectively [corrected]). Pain intensity decreased by 1.5 points (95% confidence interval -2.0 to -0.9) following resistance training compared with usual care, corresponding to an effect size of 0.91 (Cohen's d). Blinding of participants is not possible in behavioral interventions. However, at baseline outcome expectations of the 2 interventions were similar. Resistance training at the workplace results in clinical relevant improvements in pain, disability, and muscle strength in adults with upper limb chronic pain exposed to highly repetitive and forceful manual work. NCT01671267.

Improving the effectiveness of psychological interventions for depression and anxiety in the cardiac rehabilitation pathway using group-based metacognitive therapy (PATHWAY Group MCT): study protocol for a randomised controlled trial.

PubMed

Wells, Adrian; McNicol, Kirsten; Reeves, David; Salmon, Peter; Davies, Linda; Heagerty, Anthony; Doherty, Patrick; McPhillips, Rebecca; Anderson, Rebecca; Faija, Cintia; Capobianco, Lora; Morley, Helen; Gaffney, Hannah; Shields, Gemma; Fisher, Peter

2018-04-03

Anxiety and depression are prevalent among cardiac rehabilitation patients but pharmacological and psychological treatments have limited effectiveness in this group. Furthermore, psychological interventions have not been systematically integrated into cardiac rehabilitation services despite being a strategic priority for the UK National Health Service. A promising new treatment, metacognitive therapy, may be well-suited to the needs of cardiac rehabilitation patients and has the potential to improve outcomes. It is based on the metacognitive model, which proposes that a thinking style dominated by rumination, worry and threat monitoring maintains emotional distress. Metacognitive therapy is highly effective at reducing this thinking style and alleviating anxiety and depression in mental health settings. This trial aims to evaluate the effectiveness and cost-effectiveness of group-based metacognitive therapy for cardiac rehabilitation patients with elevated anxiety and/or depressive symptoms. The PATHWAY Group-MCT trial is a multicentre, two-arm, single-blind, randomised controlled trial comparing the clinical- and cost-effectiveness of group-based metacognitive therapy plus usual cardiac rehabilitation to usual cardiac rehabilitation alone. Cardiac rehabilitation patients (target sample n = 332) with elevated anxiety and/or depressive symptoms will be recruited across five UK National Health Service Trusts. Participants randomised to the intervention arm will receive six weekly sessions of group-based metacognitive therapy delivered by either cardiac rehabilitation professionals or research nurses. The intervention and control groups will both be offered the usual cardiac rehabilitation programme within their Trust. The primary outcome is severity of anxiety and depressive symptoms at 4-month follow-up measured by the Hospital Anxiety and Depression Scale total score. Secondary outcomes are severity of anxiety/depression at 12-month follow-up, health-related quality of life, severity of post-traumatic stress symptoms and strength of metacognitive beliefs at 4- and 12-month follow-up. Qualitative interviews will help to develop an account of barriers and enablers to the effectiveness of the intervention. This trial will evaluate the effectiveness and cost-effectiveness of group-based metacognitive therapy in alleviating anxiety and depression in cardiac rehabilitation patients. The therapy, if effective, offers the potential to improve psychological wellbeing and quality of life in this large group of patients. UK Clinical Trials Gateway, ISRCTN74643496 , Registered on 8 April 2015.

Mentalization-based treatment in groups for adolescents with borderline personality disorder (BPD) or subthreshold BPD versus treatment as usual (M-GAB): study protocol for a randomized controlled trial.

PubMed

Beck, Emma; Bo, Sune; Gondan, Matthias; Poulsen, Stig; Pedersen, Liselotte; Pedersen, Jesper; Simonsen, Erik

2016-07-12

Evidence-based outpatient psychotherapeutic programs are first-line treatment of borderline personality disorder (BPD). Early and effective treatment of BPD is crucial to the prevention of its individual, psychosocial, and economic consequences. However, in spite of recent advantages in diagnosing adolescent BPD, there is a lack of cost-effective evidence-based treatment programs for adolescents. Mentalization-based treatment is an evidence-based program for BPD, originally developed for adults. We will investigate whether a specifically designed mentalization-based treatment in groups is an efficacious treatment for adolescents with BPD or subthreshold BPD compared to treatment as usual. The trial is a four-center, two-armed, parallel-group, assessor-blinded randomized clinical superiority trial. One hundred twelve patients aged 14 to 17 referred to Child and Adolescent Psychiatric Clinics in Region Zealand are randomized to 1 year of either mentalization-based treatment in groups or treatment as usual. Patients will be included if they meet at least four DSM-5 criteria for BPD. The primary outcome is self-reported borderline features at discharge. Secondary outcomes will include self-harm, depression, BPD criteria, externalizing and internalizing symptoms, and social functioning, together with parental reports on borderline features, externalizing and internalizing symptoms. Measures of attachment and mentalization will be included as mediational variables. Follow-up assessment will take place at 3 and 12 months after end of treatment. This is the first randomized controlled trial to test the efficacy of a group-based mentalization-based treatment for adolescents with BPD or subthreshold BPD. If the results confirm our hypothesis, this trial will add to the treatment options of cost-effective treatment of adolescent BPD. Clinicaltrials.gov NCT02068326 , February 19, 2014.

Nursing Case Management and Glycemic Control Among Brazilians With Type 2 Diabetes: Pragmatic Clinical Trial.

PubMed

Moreira, Ricardo Castanho; Mantovani, Maria de Fátima; Soriano, José Verdú

2015-01-01

Type 2 diabetes mellitus is a chronic condition that requires ongoing, life-long care in order to be controlled. The aims of the study were to assess the effect of nursing case management on glycated hemoglobin (HbA1c) levels compared to usual care in people with type 2 diabetes mellitus and to determine if effects of nursing case management varied by gender, age, duration of disease, education, and income. This is a pragmatic clinical trial, conducted in the municipality of Bandeirantes, Paraná, Brazil, in 2011 and 2012. Eighty individuals were recruited and randomized equally to receive nursing case management or usual care. Covariates were sociodemographic and clinical factors. The outcome was HbA1c measured at baseline, 6 months, and 12 months. The sample consisted predominately of women; most had been diagnosed with type 2 diabetes mellitus within the previous 5 years. Mean age was 50.14 (SD = 7.00), with 5.27 (SD = 4.39) years of schooling and an average HbA1c of 9.90% (SD = 2.49). Hemoglobin A1c was reduced from an average of 10.33% to 9.0% (p < .01) in the nursing case management group and from 9.57% to 8.93% (p = .05) in the usual care group; the group by time effect was not significant. Case management effects varied by younger age (p = .05), duration of type 2 diabetes less than 5 years (p = .03), up to 4 years of schooling (p = .04), and being in the lowest-income stratum (p = .02). Both groups showed a statistically significant reduction of HbA1c at 6 and 12 months following baseline. The difference in proportional reduction of HbA1c between groups was not statistically significant.

A multi-centre, randomised controlled trial of cognitive therapy to prevent harmful compliance with command hallucinations.

PubMed

Birchwood, Max; Peters, Emmanuelle; Tarrier, Nicholas; Dunn, Graham; Lewis, Shon; Wykes, Til; Davies, Linda; Lester, Helen; Michail, Maria

2011-09-30

Command hallucinations are among the most distressing, high risk and treatment resistant symptoms for people with psychosis; however, currently, there are no evidence-based treatment options available for this group. A cognitive therapy grounded in the principles of the Social Rank Theory, is being evaluated in terms of its effectiveness in reducing harmful compliance with command hallucinations. This is a single blind, intention-to-treat, multi-centre, randomized controlled trial comparing Cognitive Therapy for Command Hallucinations + Treatment as Usual with Treatment as Usual alone. Eligible participants have to fulfil the following inclusion criteria: i) ≥16 years; ii) ICD-10 diagnosis of schizophrenia or related disorder; iii) command hallucinations for at least 6 months leading to risk of harm to self or others. Following the completion of baseline assessments, eligible participants will be randomly allocated to either the Cognitive Therapy for Command Hallucinations + Treatment as Usual group or the Treatment as Usual group. Outcome will be assessed at 9 and 18 months post randomization with assessors blind to treatment allocation. The primary outcome is compliance behaviour and secondary outcomes include beliefs about voices' power, distress, psychotic symptoms together with a health economic evaluation. Qualitative interviews with services users will explore the acceptability of Cognitive Therapy for Command Hallucinations. Cognitive behaviour therapy is recommended for people with psychosis; however, its focus and evaluation has primarily revolved around the reduction of psychotic symptoms. In this trial, however, the focus of the cognitive behavioural intervention is on individuals' appraisals, behaviour and affect and not necessarily symptoms; this is also reflected in the outcome measures used. If successful, the results will mark a significant breakthrough in the evidence base for service users and clinicians and will provide a treatment option for this group where none currently exist. The trial will open the way for further breakthrough work with the 'high risk' population of individuals with psychosis, which we would intend to pursue. ISRCTN: ISRCTN62304114.

A randomized controlled study of exposure therapy as aftercare for alcohol use disorder: study protocol.

PubMed

Mellentin, Angelina Isabella; Nielsen, Bent; Nielsen, Anette Søgaard; Yu, Fei; Stenager, Elsebeth

2016-04-21

It is well documented that individuals with Alcohol Use Disorder (AUD) respond well during evidence-based psychological treatment, but also that a large proportion relapses when discharged from treatment and confronted with alcohol in real life. Cue Exposure Treatment (CET) focuses on exposing individuals to alcohol cues in order to reduce cravings as well as the likelihood of relapse. The aims of the study are: 1) to investigate whether CET aftercare delivered via a smartphone or in group sessions increases the effect of Cognitive Behavioural Treatment in groups of alcohol dependent individuals; 2) to investigate whether CET as a smartphone application is as or more effective than CET group therapy, and 3) to investigate whether CET as a smartphone application is more cost-effective than CET group aftercare and Aftercare as Usual. The study will be implemented as an investigator-blinded randomized controlled trial. A total of 300 consecutively enrolled alcohol use disorder individuals recruited from an alcohol outpatient clinic will be randomized into one of the three following aftercare groups after concluding primary treatment: (1) CET as a smartphone application; (2) CET as group therapy, and (3) Aftercare as Usual. It is hypothesized that the two experimental groups will achieve better treatment outcomes compared to the control group (3). Individuals in the CET groups are given the opportunity to practise coping strategies during exposure to alcohol stimuli before being unavoidably confronted with alcohol and associated stimuli in real life. Thus, CET may help prevent patients from relapsing after concluding treatment, and in the long term. Moreover, the CET application has the potential to improve AUD treatment and continuing care by offering psychological treatment whenever and wherever the patient finds it convenient. ClinicalTrials.gov ID: NCT02298751 Registration date: 6 November 2014.

Effect of rural-to-urban within-country migration on cardiovascular risk factors in low- and middle-income countries: a systematic review.

PubMed

Hernández, Adrián V; Pasupuleti, Vinay; Deshpande, Abhishek; Bernabé-Ortiz, Antonio; Miranda, J Jaime

2012-02-01

Limited information is available of effects of rural-to-urban within-country migration on cardiovascular (CV) risk factors in low- and middle- income countries (LMIC). A systematic review of studies evaluating these effects was performed with rural and/or urban control groups. Two teams of investigators searched observational studies in Medline, Web of Science and Scopus until May 2011. Studies evaluating international migration were excluded. Three investigators extracted the information stratified by gender. Information on 17 known CV risk factors was obtained. Eighteen studies (n=58,536) were included. Studies were highly heterogeneous with respect to study design, migrant sampling frame, migrant urban exposure and reported CV risk factors. In migrants, commonly reported CV risk factors-systolic and diastolic blood pressure, body mass index, obesity, total cholesterol and low-density lipoprotein-were usually higher or more common than in the rural group and usually lower or less common than in the urban group. This gradient was usually present in both genders. Anthropometric (waist-to-hip ratio, hip/waist circumference, triceps skinfolds) and metabolic (fasting glucose/insulin, insulin resistance) risk factors usually followed the same gradient, but conclusions were weak as information was insufficient. Hypertension, high-density lipoprotein, fibrinogen and C-reactive protein did not follow any pattern. In LMIC, most but not all, CV risk factors are higher or more common in migrants than in rural groups but lower or less common than in urban groups. Such gradients may or may not be associated with differential CV events and long-term evaluations are necessary.

Toward a developmentally informed approach to parenting interventions: Seeking hidden effects.

PubMed

Brock, Rebecca L; Kochanska, Grazyna

2016-05-01

Drawing from developmental psychology and psychopathology, we propose a new, developmentally informed approach to parenting interventions that focuses on elucidating changes in the unfolding developmental process between the parent and child. We present data from 186 low-income mothers of toddlers, randomly assigned to a child-oriented play group or a play-as-usual group. We examined the maladaptive cascade from child difficulty to mother adversarial, negative parenting to child maladjustment, well documented in the literature. The measures incorporated multiple observations and reports. As expected, the sequence from child difficulty (pretest) to mother adversarial, negative parenting (Posttest 1, after 3-month intervention) to child maladjustment (Posttest 2, 6 months later) was present in the play-as-usual group, but absent, or defused, in the child-oriented play group. The findings are consistent with a view of intervention presumably enhancing the mother-child relationship, which in turn served to moderate future mother-child dynamics, altering its otherwise anticipated negative trajectory. A closer examination of the cascade revealed that, at Posttest 1, mothers in the play-as-usual group engaged in more adversarial, negative parenting (controlling for pretest) than did mothers in the child-oriented play group when their children were of high difficulty. The intervention appears to exert its primary influence on the cascade by weakening the link between child difficulty and maternal adversarial, negative parenting.

Enhancing “usual practice” Treatment Foster Care: Findings from a randomized trial on improving youth outcomes

PubMed Central

Farmer, Elizabeth M.Z.; Burns, Barbara J.; Wagner, H. Ryan; Murray, Maureen; Southerland, Dannia G.

2009-01-01

Objectives This article reports the initial findings from a randomized trial to enhance Treatment Foster Care (TFC) in “usual care” agencies. The intervention, Together Facing the Challenge, was built upon a combination of practice-based elements from a prior descriptive study of TFC and selected elements from Chamberlain’s evidence-based model (MTFC) to fill conspicuous gaps in usual practice. The study was designed to examine whether additional training and consultation to staff and treatment parents improved outcomes for youth. Methods The study was conducted with 247 youth in TFC and their treatment parents from 14 TFC agencies in a southeastern state. Half of the agencies were randomized to the intervention condition and received study-provided training and consultation. Control agencies continued to provide training and treatment as usual. Data for the current analyses come from interviews with treatment parents at baseline, 6, and 12 months. Results Youth in the intervention group showed significant improvement (compared to the youth in the control group) on the three focal domains – symptoms, behaviors, and strengths. Effects were larger for behaviors and symptoms than for strengths. Conclusions This study employs a “hybrid” model to improve practice. It builds upon current practices in existing agencies and infuses additional training and consultation to overcome observed deficits. Such an approach has tremendous potential for moving beyond a singular focus on disseminating evidence-based interventions to a broader view of improving practice in a wide range of agencies. PMID:20513677

Seated T'ai Chi in Older Taiwanese People Using Wheelchairs: A Randomized Controlled Trial Investigating Mood States and Self-Efficacy.

PubMed

Hsu, Chen-Yuan; Moyle, Wendy; Cooke, Marie; Jones, Cindy

2016-12-01

There is growing interest in t'ai chi, but little research has addressed whether t'ai chi is effective in older people using wheelchairs for mobilization. The aim of this study was to compare the effects of seated t'ai chi exercise and usual standard activities on mood states and self-efficacy in older people living in a long-term care facility and using wheelchairs for mobilization. Randomized controlled trial (trial registration no. ACTRN12613000029796). One long-term-care facility in Taiwan. Sixty participants were randomly assigned by a computer-generated random sequence to a t'ai chi group (n = 30) or a usual exercise and entertainment activities group (n = 30). Seated t'ai chi exercise for 40 minutes three times a week for 26 weeks was provided. Mood states (Profile of Mood States Short Form [POMS-SF]) and self-efficacy (Self-Efficacy for Exercise [SEE]). At week 26, participants in the t'ai chi group reported significantly lower mood states on the fatigue-inertia dimension of the POMS-SF (mean score ± standard deviation, 3.56 ± 3.71) than did the control group (mean score, 7.16 ± 6.36) (F [1, 58] = 7.15; p < 0.05). The t'ai chi group recorded significantly higher SEE levels (mean, 35.66 ± 36.83) than did those in the control group (mean, 15.30 ± 26.43) (F [1, 58] = 6.05; p < 0.05). The findings highlight the importance of t'ai chi for a reduction in the fatigue-inertia mood state and an increase in self-efficacy for older people using wheelchairs.

A Randomized Controlled Trial Translating the Diabetes Prevention Program to a University Worksite, Ohio, 2012–2014

PubMed Central

Weinhold, Kellie R.; Marrero, David G.; Nagaraja, Haikady N.; Focht, Brian C.; Gascon, Gregg M.

2015-01-01

Introduction Working adults spend much time at the workplace, an ideal setting for wellness programs targeting weight loss and disease prevention. Few randomized trials have evaluated the efficacy of worksite diabetes prevention programs.This study evaluated the efficacy of a worksite lifestyle intervention on metabolic and behavioral risk factors compared with usual care. Methods A pretest–posttest control group design with 3-month follow-up was used. Participants with prediabetes were recruited from a university worksite and randomized to receive a 16-week lifestyle intervention (n = 35) or usual care (n = 34). Participants were evaluated at baseline, postintervention, and 3-month follow-up. Dietary intake was measured by a food frequency questionnaire and level of physical activity by accelerometers. Repeated measures analysis of variance compared the change in outcomes between and within groups. Results Mean (standard error [SE]) weight loss was greater in the intervention (−5.5% [0.6%]) than in the control (−0.4% [0.5%]) group (P < .001) postintervention and was sustained at 3-month follow-up (P < .001). Mean (SE) reductions in fasting glucose were greater in the intervention (−8.6 [1.6] mg/dL) than in the control (−3.7 [1.6] mg/dL) group (P = .02) postintervention; both groups had significant glucose reductions at 3-month follow-up (P < .001). In the intervention group, the intake of total energy and the percentage of energy from all fats, saturated fats, and trans fats decreased, and the intake of dietary fiber increased (all P < .01) postintervention. Conclusion The worksite intervention improved metabolic and behavioral risk factors among employees with prediabetes. The long-term impact on diabetes prevention and program sustainability warrant further investigation. PMID:26605710

[Efficacy of motivational interviewing for reducing medication errors in chronic patients over 65 years with polypharmacy: Results of a cluster randomized trial].

PubMed

Pérula de Torres, Luis Angel; Pulido Ortega, Laura; Pérula de Torres, Carlos; González Lama, Jesús; Olaya Caro, Inmaculada; Ruiz Moral, Roger

2014-10-21

To evaluate the effectiveness of an intervention based on motivational interviewing to reduce medication errors in chronic patients over 65 with polypharmacy. Cluster randomized trial that included doctors and nurses of 16 Primary Care centers and chronic patients with polypharmacy over 65 years. The professionals were assigned to the experimental or the control group using stratified randomization. Interventions consisted of training of professionals and revision of patient treatments, application of motivational interviewing in the experimental group and also the usual approach in the control group. The primary endpoint (medication error) was analyzed at individual level, and was estimated with the absolute risk reduction (ARR), relative risk reduction (RRR), number of subjects to treat (NNT) and by multiple logistic regression analysis. Thirty-two professionals were randomized (19 doctors and 13 nurses), 27 of them recruited 154 patients consecutively (13 professionals in the experimental group recruited 70 patients and 14 professionals recruited 84 patients in the control group) and completed 6 months of follow-up. The mean age of patients was 76 years (68.8% women). A decrease in the average of medication errors was observed along the period. The reduction was greater in the experimental than in the control group (F=5.109, P=.035). RRA 29% (95% confidence interval [95% CI] 15.0-43.0%), RRR 0.59 (95% CI:0.31-0.76), and NNT 3.5 (95% CI 2.3-6.8). Motivational interviewing is more efficient than the usual approach to reduce medication errors in patients over 65 with polypharmacy. Copyright © 2013 Elsevier España, S.L.U. All rights reserved.

A Randomized Controlled Trial Translating the Diabetes Prevention Program to a University Worksite, Ohio, 2012-2014.

PubMed

Weinhold, Kellie R; Miller, Carla K; Marrero, David G; Nagaraja, Haikady N; Focht, Brian C; Gascon, Gregg M

2015-11-25

Working adults spend much time at the workplace, an ideal setting for wellness programs targeting weight loss and disease prevention. Few randomized trials have evaluated the efficacy of worksite diabetes prevention programs. This study evaluated the efficacy of a worksite lifestyle intervention on metabolic and behavioral risk factors compared with usual care. A pretest-posttest control group design with 3-month follow-up was used. Participants with prediabetes were recruited from a university worksite and randomized to receive a 16-week lifestyle intervention (n = 35) or usual care (n = 34). Participants were evaluated at baseline, postintervention, and 3-month follow-up. Dietary intake was measured by a food frequency questionnaire and level of physical activity by accelerometers. Repeated measures analysis of variance compared the change in outcomes between and within groups. Mean (standard error [SE]) weight loss was greater in the intervention (-5.5% [0.6%]) than in the control (-0.4% [0.5%]) group (P < .001) postintervention and was sustained at 3-month follow-up (P < .001). Mean (SE) reductions in fasting glucose were greater in the intervention (-8.6 [1.6] mg/dL) than in the control (-3.7 [1.6] mg/dL) group (P = .02) postintervention; both groups had significant glucose reductions at 3-month follow-up (P < .001). In the intervention group, the intake of total energy and the percentage of energy from all fats, saturated fats, and trans fats decreased, and the intake of dietary fiber increased (all P < .01) postintervention. The worksite intervention improved metabolic and behavioral risk factors among employees with prediabetes. The long-term impact on diabetes prevention and program sustainability warrant further investigation.

Effectiveness of Personalized Feedback Alone or Combined with Peer Support to Improve Physical Activity in Sedentary Older Malays with Type 2 Diabetes: A Randomized Controlled Trial.

PubMed

Sazlina, Shariff-Ghazali; Browning, Colette Joy; Yasin, Shajahan

2015-01-01

Regular physical activity is an important aspect of self-management among older people with type 2 diabetes but many remain inactive. Interventions to improve physical activity levels have been studied but few studies have evaluated the effects of personalized feedback (PF) or peer support (PS); and there was no study on older people of Asian heritage. Hence, this trial evaluated whether PF only or combined with PS improves physical activity among older Malays with type 2 diabetes (T2DM) compared to usual care only. A three-arm randomized controlled trial was conducted in a primary healthcare clinic in Malaysia. Sixty-nine sedentary Malays aged 60 years and older with T2DM who received usual diabetes care were randomized to PF or PS interventions or as controls for 12 weeks with follow-ups at weeks 24 and 36. Intervention groups performed unsupervised walking activity and received written feedback on physical activity. The PS group also received group and telephone contacts from trained peer mentors. The primary outcome was pedometer steps. Secondary outcomes were self-reported physical activity, cardiovascular risk factors, cardiorespiratory fitness, balance, quality of life, and psychosocial wellbeing. Fifty-two (75.4%) completed the 36-week study. The PS group showed greater daily pedometer readings than the PF and controls (p = 0.001). The PS group also had greater improvement in weekly duration (p < 0.001) and frequency (p < 0.001) of moderate intensity physical activity, scores on the Physical Activity Scale for Elderly (p = 0.003), 6-min walk test (p < 0.001), and social support from friends (p = 0.032) than PF and control groups. The findings suggest that PF combined with PS in older Malays with T2DM improved their physical activity levels, cardiorespiratory fitness, and support from friends. Current Controlled Trials ISRCTN71447000.

Nurse home visits with or without alert buttons versus usual care in the frail elderly: a randomized controlled trial

PubMed Central

Favela, Jesús; Castro, Luis A; Franco-Marina, Francisco; Sánchez-García, Sergio; Juárez-Cedillo, Teresa; Bermudez, Claudia Espinel; Mora-Altamirano, Julia; Rodriguez, Marcela D; García-Peña, Carmen

2013-01-01

Objective To assess whether an intervention based on nurse home visits including alert buttons (NV+AB) is effective in reducing frailty compared to nurse home visits alone (NV-only) and usual care (control group) for older adults. Design Unblinded, randomized, controlled trial. Setting Insured population covered by the Mexican Social Security Institute living in the city of Ensenada, Baja California, Mexico. Participants Patients were aged over 60 years with a frailty index score higher than 0.14. Intervention After screening and informed consent, participants were allocated randomly to the control, NV+AB, or NV-only groups. Measurements The primary outcome was the frailty score 9 months later. Quality of life, depression, comorbidities, health status, and health service utilization were also considered. Results The framing sample included 819 patients. Of those, 591 were not located because they did not have a landline/telephone (341 patients), they had died (107), they were ill (50), or they were not currently living in the city (28). A screening interview was applied to 228 participants, and 57 had a score ≤0.14, 171 had ≥0.14, and 16 refused to complete the baseline questionnaire. A home visit was scheduled for 155 patients. However, 22 did not complete the baseline questionnaire. The final 133 subjects were randomized into the NV+AB (n = 45), NV-only (n = 44), and control (n = 44) groups. There were no statistically significant differences in the baseline characteristics of the groups. The mean age overall was 76.3 years (standard deviation 4.7) and 45% were men. At the baseline, 61.65% were classified as frail. At end of follow-up the adjusted prevalence of frailty in NV+AB group was 23.3% versus 58.3% in the control group. Conclusion: An intervention based on NV+AB seems to have a positive effect on frailty scores. PMID:23378751

Resource use and costs of type 2 diabetes patients receiving managed or protocolized primary care: a controlled clinical trial.

PubMed

van der Heijden, Amber A W A; de Bruijne, Martine C; Feenstra, Talitha L; Dekker, Jacqueline M; Baan, Caroline A; Bosmans, Judith E; Bot, Sandra D M; Donker, Gé A; Nijpels, Giel

2014-06-25

The increasing prevalence of diabetes is associated with increased health care use and costs. Innovations to improve the quality of care, manage the increasing demand for health care and control the growth of health care costs are needed. The aim of this study is to evaluate the care process and costs of managed, protocolized and usual care for type 2 diabetes patients from a societal perspective. In two distinct regions of the Netherlands, both managed and protocolized diabetes care were implemented. Managed care was characterized by centralized organization, coordination, responsibility and centralized annual assessment. Protocolized care had a partly centralized organizational structure. Usual care was characterized by a decentralized organizational structure. Using a quasi-experimental control group pretest-posttest design, the care process (guideline adherence) and costs were compared between managed (n = 253), protocolized (n = 197), and usual care (n = 333). We made a distinction between direct health care costs, direct non-health care costs and indirect costs. Multivariate regression models were used to estimate differences in costs adjusted for confounding factors. Because of the skewed distribution of the costs, bootstrapping methods (5000 replications) with a bias-corrected and accelerated approach were used to estimate 95% confidence intervals (CI) around the differences in costs. Compared to usual and protocolized care, in managed care more patients were treated according to diabetes guidelines. Secondary health care use was higher in patients under usual care compared to managed and protocolized care. Compared to usual care, direct costs were significantly lower in managed care (€-1.181 (95% CI: -2.597 to -334)) while indirect costs were higher (€ 758 (95% CI: -353 to 2.701), although not significant. Direct, indirect and total costs were lower in protocolized care compared to usual care (though not significantly). Compared to usual care, managed care was significantly associated with better process in terms of diabetes care, fewer secondary care consultations and lower health care costs. The same trends were seen for protocolized care, however they were not statistically significant. Current Controlled trials: ISRCTN66124817.

Resource use and costs of type 2 diabetes patients receiving managed or protocolized primary care: a controlled clinical trial

PubMed Central

2014-01-01

Background The increasing prevalence of diabetes is associated with increased health care use and costs. Innovations to improve the quality of care, manage the increasing demand for health care and control the growth of health care costs are needed. The aim of this study is to evaluate the care process and costs of managed, protocolized and usual care for type 2 diabetes patients from a societal perspective. Methods In two distinct regions of the Netherlands, both managed and protocolized diabetes care were implemented. Managed care was characterized by centralized organization, coordination, responsibility and centralized annual assessment. Protocolized care had a partly centralized organizational structure. Usual care was characterized by a decentralized organizational structure. Using a quasi-experimental control group pretest-posttest design, the care process (guideline adherence) and costs were compared between managed (n = 253), protocolized (n = 197), and usual care (n = 333). We made a distinction between direct health care costs, direct non-health care costs and indirect costs. Multivariate regression models were used to estimate differences in costs adjusted for confounding factors. Because of the skewed distribution of the costs, bootstrapping methods (5000 replications) with a bias-corrected and accelerated approach were used to estimate 95% confidence intervals (CI) around the differences in costs. Results Compared to usual and protocolized care, in managed care more patients were treated according to diabetes guidelines. Secondary health care use was higher in patients under usual care compared to managed and protocolized care. Compared to usual care, direct costs were significantly lower in managed care (€-1.181 (95% CI: -2.597 to -334)) while indirect costs were higher (€758 (95% CI: -353 to 2.701), although not significant. Direct, indirect and total costs were lower in protocolized care compared to usual care (though not significantly). Conclusions Compared to usual care, managed care was significantly associated with better process in terms of diabetes care, fewer secondary care consultations and lower health care costs. The same trends were seen for protocolized care, however they were not statistically significant. Trial registration Current Controlled trials: ISRCTN66124817. PMID:24966055

[Efficacy and safety of tertiary hospital guided and community-driven family self-help cardiac rehabilitation model].

PubMed

Ding, R J; Gao, L M; Chu, L; Xie, W L; Wang, X R; Tang, Q; Wang, H L; Hu, D Y

2017-03-24

Objective: To explore the efficacy and safety of tertiary hospital guided and community-driven family self-help cardiac rehabilitation model. Methods: This study was a prospective randomized controlled study, 80 patients from Beijing Electrical Power Hospital and Beijing Jingmei Group General Hospital with acute coronary syndrome were included from June to December 2015 and divided into 2 groups. Patients in rehabilitation group ( n =52) received tertiary hospital(Peiking University Peoples' Hospital) guided and community-driven family self-help cardiac rehabilitation for 3 months, and patients in control group ( n =28) received routine secondary treatment for 3 months. Following parameters including 6 minutes walk distance, score of life quality (evaluated by Short Form-12), score of anxiety (evaluated by Generalized Anxiety Disorder-7), score of depression (evaluated by Perceived Health Questionnaire-9), self-management competency (evaluated by questionnaire) were collected at baseline and after treatment for 3 months. Results: Compared with control group, 6 minutes walk distance was longer in rehabilitation group((60.2±6.8) meters vs. (24.9±10.5)meters, P <0.01). The difference values between after and before intervention of life quality scores((0.14±3.90)scores vs.(-7.44±5.85)scores, P >0.05), anxiety scores((-0.16±2.12 ) scores vs.(0.70±1.13)scores, P >0.05) and depression scores((-1.17±2.79) scores vs.(0.60±0.36)scores, P >0.05) were similar between the 2 groups. The amplification of patients with regular exercise (50.26% vs. 0, P <0.05), limit sugary foods usually and always (53.22% vs. 3.98%, P <0.05), eat 200-400 g fruits usually and always (78.61 % vs. 0, P <0.05), eat 300-500 g vegetables usually and always (9.74% vs. 0, P <0.05), and answering very confident to questions such as let the physicians know about your diseases (40.17% vs. 5.00%, P <0.05), know how to take medicines (44.52% vs. 5.00%, P <0.05), know how much exercise was right for yourself (26.43% vs.0, P <0.05) were significantly higher in rehabilitation group than in control group. There were no cardiac rehabilitation training related cardiovascular events. Conclusion: Tertiary hospital guided and community-driven family self-help cardiac rehabilitation model is an effective and safe management model of cardiovascular disease in chronic phase, and it is necessary to further expand the study population to verify the efficacy of this model.

Comparing Relaxation Programs for Breast Cancer Patients Receiving Radiotherapy

Cancer.gov

In this study, women with breast cancer who have had surgery and are scheduled to undergo radiation therapy will be randomly assigned to one of two different stretching and relaxation programs or to a control group that will receive usual care.

Effect of integrated care for sick listed patients with chronic low back pain: economic evaluation alongside a randomised controlled trial.

PubMed

Lambeek, Ludeke C; Bosmans, Judith E; Van Royen, Barend J; Van Tulder, Maurits W; Van Mechelen, Willem; Anema, Johannes R

2010-11-30

To evaluate the cost effectiveness, cost utility, and cost-benefit of an integrated care programme compared with usual care for sick listed patients with chronic low back pain. Economic evaluation alongside a randomised controlled trial with 12 months' follow-up. Primary care (10 physiotherapy practices, one occupational health service, one occupational therapy practice) and secondary care (five hospitals) in the Netherlands, 2005-9. 134 adults aged 18-65 sick listed because of chronic low back pain: 66 were randomised to integrated care and 68 to usual care. Integrated care consisted of a workplace intervention based on participatory ergonomics, with involvement of a supervisor, and a graded activity programme based on cognitive behavioural principles. Usual care was provided by general practitioners and occupational physicians according to Dutch guidelines. The primary outcome was duration until sustainable return to work. The secondary outcome was quality adjusted life years (QALYs), measured using EuroQol. Total costs in the integrated care group (£13 165, SD £13 600) were significantly lower than in the usual care group (£18 475, SD £13 616). Cost effectiveness planes and acceptability curves showed that integrated care was cost effective compared with usual care for return to work and QALYs gained. The cost-benefit analyses showed that every £1 invested in integrated care would return an estimated £26. The net societal benefit of integrated care compared with usual care was £5744. Implementation of an integrated care programme for patients sick listed with chronic low back pain has a large potential to significantly reduce societal costs, increase effectiveness of care, improve quality of life, and improve function on a broad scale. Integrated care therefore has large gains for patients and society as well as for employers.

Nevasic audio program for the prevention of chemotherapy induced nausea and vomiting: A feasibility study using a randomized controlled trial design.

PubMed

Moradian, Saeed; Walshe, Catherine; Shahidsales, Soodabeh; Ghavam Nasiri, Mohammad Reza; Pilling, Mark; Molassiotis, Alexander

2015-06-01

Pharmacological therapy is only partially effective in preventing or treating chemotherapy induced nausea and vomiting (CINV). Therefore, exploring the complementary role of non-pharmacological approaches used in addition to pharmacological agents is important. Nevasic uses specially constructed audio signals hypothesized to generate an antiemetic reaction. The aim of this study was to examine the feasibility of conducting a randomized controlled trial (RCT) to evaluate the effectiveness of Nevasic to control CINV. A mixed methods design incorporating an RCT and focus group interviews. For the RCT, female breast cancer patients were randomized to receive either Nevasic plus usual care, music plus usual care, or usual care only. Data were analysed using descriptive statistics and linear mixed-effects models. Five focus group interviews were conducted to obtain participants' views regarding the acceptability of the interventions in the trial. 99 participants were recruited to the RCT and 15 participated in focus group interviews. Recruitment targets were achieved. Issues of Nevasic acceptability were highlighted as weaknesses of the program. This study did not detect any evidence for the effectiveness of Nevasic; however, the results showed statistically significant less use of anti-emetics (p = 0.003) and borderline non-significant improvement in quality of life (p = 0.06). Conducting a non-pharmacological intervention using such an audio program is feasible, although difficulties and limitations exist with its use. Further studies are required to investigate the effectiveness of Nevasic from perspectives such as anti-emetic use, as well as its overall effect on the levels of nausea and vomiting. Copyright © 2014 Elsevier Ltd. All rights reserved.

THE COST-EFFECTIVENESS OF COGNITIVE BEHAVIOR THERAPY FOR BORDERLINE PERSONALITY DISORDER: RESULTS FROM THE BOSCOT TRIAL

PubMed Central

Palmer, Stephen; Davidson, Kate; Tyrer, Peter; Gumley, Andrew; Tata, Philip; Norrie, John; Murray, Heather; Seivewright, Helen

2007-01-01

Borderline personality disorder places a significant burden on healthcare providers and other agencies. This study evaluated the cost-effectiveness of cognitive behavior therapy plus treatment as usual compared to treatment as usual alone for patients with borderline personality disorder. The economic analysis was conducted alongside a multi-center, randomized controlled trial. The costs of primary and secondary healthcare utilization, alongside the wider economic costs, were estimated from medical records and patient self-report. The primary outcome measure used was the quality-adjusted life year (QALY), assessed using EuroQol. On average, total costs per patient in the cognitive behavior therapy group were lower than patients receiving usual care alone (−£689), although this group also reported a lower quality of life (−0.11 QALYs). These differences were small and did not approach conventional levels of statistical significance. The use of cognitive therapy for borderline personality disorder does not appear to demonstrate any significant cost-effective advantage based on the results of this study. PMID:17032159

Childhood outcomes after hypothermia for neonatal encephalopathy.

PubMed

Shankaran, Seetha; Pappas, Athina; McDonald, Scott A; Vohr, Betty R; Hintz, Susan R; Yolton, Kimberly; Gustafson, Kathryn E; Leach, Theresa M; Green, Charles; Bara, Rebecca; Petrie Huitema, Carolyn M; Ehrenkranz, Richard A; Tyson, Jon E; Das, Abhik; Hammond, Jane; Peralta-Carcelen, Myriam; Evans, Patricia W; Heyne, Roy J; Wilson-Costello, Deanne E; Vaucher, Yvonne E; Bauer, Charles R; Dusick, Anna M; Adams-Chapman, Ira; Goldstein, Ricki F; Guillet, Ronnie; Papile, Lu-Ann; Higgins, Rosemary D

2012-05-31

We previously reported early results of a randomized trial of whole-body hypothermia for neonatal hypoxic-ischemic encephalopathy showing a significant reduction in the rate of death or moderate or severe disability at 18 to 22 months of age. Long-term outcomes are now available. In the original trial, we assigned infants with moderate or severe encephalopathy to usual care (the control group) or whole-body cooling to an esophageal temperature of 33.5°C for 72 hours, followed by slow rewarming (the hypothermia group). We evaluated cognitive, attention and executive, and visuospatial function; neurologic outcomes; and physical and psychosocial health among participants at 6 to 7 years of age. The primary outcome of the present analyses was death or an IQ score below 70. Of the 208 trial participants, primary outcome data were available for 190. Of the 97 children in the hypothermia group and the 93 children in the control group, death or an IQ score below 70 occurred in 46 (47%) and 58 (62%), respectively (P=0.06); death occurred in 27 (28%) and 41 (44%) (P=0.04); and death or severe disability occurred in 38 (41%) and 53 (60%) (P=0.03). Other outcome data were available for the 122 surviving children, 70 in the hypothermia group and 52 in the control group. Moderate or severe disability occurred in 24 of 69 children (35%) and 19 of 50 children (38%), respectively (P=0.87). Attention-executive dysfunction occurred in 4% and 13%, respectively, of children receiving hypothermia and those receiving usual care (P=0.19), and visuospatial dysfunction occurred in 4% and 3% (P=0.80). The rate of the combined end point of death or an IQ score of less than 70 at 6 to 7 years of age was lower among children undergoing whole-body hypothermia than among those undergoing usual care, but the differences were not significant. However, hypothermia resulted in lower death rates and did not increase rates of severe disability among survivors. (Funded by the National Institutes of Health and the Eunice Kennedy Shriver NICHD Neonatal Research Network; ClinicalTrials.gov number, NCT00005772.).

Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE): a randomized controlled trial protocol.

PubMed

Winstein, Carolee J; Wolf, Steven L; Dromerick, Alexander W; Lane, Christianne J; Nelsen, Monica A; Lewthwaite, Rebecca; Blanton, Sarah; Scott, Charro; Reiss, Aimee; Cen, Steven Yong; Holley, Rahsaan; Azen, Stanley P

2013-01-11

Residual disability after stroke is substantial; 65% of patients at 6 months are unable to incorporate the impaired upper extremity into daily activities. Task-oriented training programs are rapidly being adopted into clinical practice. In the absence of any consensus on the essential elements or dose of task-specific training, an urgent need exists for a well-designed trial to determine the effectiveness of a specific multidimensional task-based program governed by a comprehensive set of evidence-based principles. The Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE) Stroke Initiative is a parallel group, three-arm, single blind, superiority randomized controlled trial of a theoretically-defensible, upper extremity rehabilitation program provided in the outpatient setting.The primary objective of ICARE is to determine if there is a greater improvement in arm and hand recovery one year after randomization in participants receiving a structured training program termed Accelerated Skill Acquisition Program (ASAP), compared to participants receiving usual and customary therapy of an equivalent dose (DEUCC). Two secondary objectives are to compare ASAP to a true (active monitoring only) usual and customary (UCC) therapy group and to compare DEUCC and UCC. Following baseline assessment, participants are randomized by site, stratified for stroke duration and motor severity. 360 adults will be randomized, 14 to 106 days following ischemic or hemorrhagic stroke onset, with mild to moderate upper extremity impairment, recruited at sites in Atlanta, Los Angeles and Washington, D.C. The Wolf Motor Function Test (WMFT) time score is the primary outcome at 1 year post-randomization. The Stroke Impact Scale (SIS) hand domain is a secondary outcome measure.The design includes concealed allocation during recruitment, screening and baseline, blinded outcome assessment and intention to treat analyses. Our primary hypothesis is that the improvement in log-transformed WMFT time will be greater for the ASAP than the DEUCC group. This pre-planned hypothesis will be tested at a significance level of 0.05. ICARE will test whether ASAP is superior to the same number of hours of usual therapy. Pre-specified secondary analyses will test whether 30 hours of usual therapy is superior to current usual and customary therapy not controlled for dose. www.ClinicalTrials.gov Identifier: NCT00871715

Effectiveness of a stepped-care intervention to prevent major depression in patients with type 2 diabetes mellitus and/or coronary heart disease and subthreshold depression: A pragmatic cluster randomized controlled trial.

PubMed

Pols, Alide D; van Dijk, Susan E; Bosmans, Judith E; Hoekstra, Trynke; van Marwijk, Harm W J; van Tulder, Maurits W; Adriaanse, Marcel C

2017-01-01

Given the public health significance of poorly treatable co-morbid major depressive disorders (MDD) among patients with type 2 diabetes mellitus (DM2) and coronary heart disease (CHD), we need to investigate whether strategies to prevent the development of major depression could reduce its burden of disease. We therefore evaluated the effectiveness of a stepped-care program for subthreshold depression in comparison with usual care in patients with DM2 and/or CHD. A cluster randomized controlled trial, with 27 primary care centers serving as clusters. A total of 236 DM2 and/or CHD patients with subthreshold depression (nine item Patient Health Questionnaire (PHQ-9) score ≥ 6, no current MDD according to DSM-IV criteria) were allocated to the intervention group (N = 96) or usual care group (n = 140). The stepped-care program was delivered by trained practice nurses during one year and consisted of four sequential treatment steps: watchful waiting, guided self-help, problem solving treatment and referral to the general practitioner. The primary outcome was the 12-month cumulative incidence of MDD as measured with the Mini International Neuropsychiatric Interview (MINI). Secondary outcomes included severity of depression (measured by PHQ-9) at 3, 6, 9 and 12 months. Of 236 patients (mean age, 67,5 (SD 10) years; 54.7% men), 210 (89%) completed the MINI at 12 months. The cumulative incidence of MDD was 9 of 89 (10.1%) participants in the intervention group and 12 of 121 (9.9%) participants in the usual care group. We found no statistically significant overall effect of the intervention (OR = 1.21; 95% confidence interval (0.12 to 12.41)) and there were no statistically significant differences in the course or severity of depressive symptoms between the two groups. This study suggest that Step-Dep was not more effective in preventing MDD than usual care in a primary care population with DM2 and/or CHD and subthreshold depression.

Effect of family nursing therapeutic conversations on health-related quality of life, self-care and depression among outpatients with heart failure: A randomized multi-centre trial.

PubMed

Østergaard, Birte; Mahrer-Imhof, Romy; Wagner, Lis; Barington, Torben; Videbæk, Lars; Lauridsen, Jørgen

2018-03-07

To evaluate the short-term (3 months) effects of family nursing therapeutic conversations (FNTC) on health-related quality of life, self-care and depression in outpatients with Heart failure (HF). A randomised multi-centre trial was conducted in three Danish HF clinics. The control group (n = 167) received usual care, and the intervention group (n = 180) received FNTCs as supplement to usual care. Primary outcome was clinically significant changes (6 points) in Kansas City Cardiomyopathy Questionnaire (KCCQ) summary score between groups. Secondary outcomes were changes in self-care behaviour and depression scores. Data were assessed before first consultation and repeated after three months. No statistically significant difference was found in the change of KCCQ, self-care and depression scores between the groups. KCCQ scores of patients in the FNTC group changed clinically significant in seven domains, compared to one domain in the control group, with the highest improvement in self-efficacy, social limitation and symptom burden. FNTC was not superior to standard care of patients with HF regarding health-related quality of life, self-care and depression. Addressing the impact of the disease on the family, might improve self-efficacy, social limitation and symptom burden in patients with heart failure. Copyright © 2018 Elsevier B.V. All rights reserved.

Outcomes of usual chiropractic, harm & efficacy, the ouch study: study protocol for a randomized controlled trial.

PubMed

Walker, Bruce F; Losco, Barrett; Clarke, Brenton R; Hebert, Jeff; French, Simon; Stomski, Norman J

2011-10-31

Previous studies have demonstrated that adverse events occur during chiropractic treatment. However, because of these studies design we do not know the frequency and extent of these events when compared to sham treatment. The principal aims of this study are to establish the frequency and severity of adverse effects from short term usual chiropractic treatment of the spine when compared to a sham treatment group. The secondary aim of this study is to establish the efficacy of usual short term chiropractic care for spinal pain when compared to a sham intervention. One hundred and eighty participants will be randomly allocated to either usual chiropractic care or a sham intervention group. To be considered for inclusion the participants must have experienced non-specific spinal pain for at least one week. The study will be conducted at the clinics of registered chiropractors in Western Australia. Participants in each group will receive two treatments at intervals no less than one week. For the usual chiropractic care group, the selection of therapeutic techniques will be left to the chiropractors' discretion. For the sham intervention group, de-tuned ultrasound and de-tuned activator treatment will be applied by the chiropractors to the regions where spinal pain is experienced. Adverse events will be assessed two days after each appointment using a questionnaire developed for this study. The efficacy of short term chiropractic care for spinal pain will be examined at two week follow-up by assessing pain, physical function, minimum acceptable outcome, and satisfaction with care, with the use of the following outcome measures: Numerical Rating Scale, Functional Rating Index, Neck Disability Index, Minimum Acceptable Outcome Questionnaire, Oswestry Disability Index, and a global measure of treatment satisfaction. The statistician, outcome assessor, and participants will be blinded to treatment allocation. Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12611000542998.

Outcomes of usual chiropractic, harm & efficacy, the ouch study: study protocol for a randomized controlled trial

PubMed Central

2011-01-01

Background Previous studies have demonstrated that adverse events occur during chiropractic treatment. However, because of these studies design we do not know the frequency and extent of these events when compared to sham treatment. The principal aims of this study are to establish the frequency and severity of adverse effects from short term usual chiropractic treatment of the spine when compared to a sham treatment group. The secondary aim of this study is to establish the efficacy of usual short term chiropractic care for spinal pain when compared to a sham intervention. Methods One hundred and eighty participants will be randomly allocated to either usual chiropractic care or a sham intervention group. To be considered for inclusion the participants must have experienced non-specific spinal pain for at least one week. The study will be conducted at the clinics of registered chiropractors in Western Australia. Participants in each group will receive two treatments at intervals no less than one week. For the usual chiropractic care group, the selection of therapeutic techniques will be left to the chiropractors' discretion. For the sham intervention group, de-tuned ultrasound and de-tuned activator treatment will be applied by the chiropractors to the regions where spinal pain is experienced. Adverse events will be assessed two days after each appointment using a questionnaire developed for this study. The efficacy of short term chiropractic care for spinal pain will be examined at two week follow-up by assessing pain, physical function, minimum acceptable outcome, and satisfaction with care, with the use of the following outcome measures: Numerical Rating Scale, Functional Rating Index, Neck Disability Index, Minimum Acceptable Outcome Questionnaire, Oswestry Disability Index, and a global measure of treatment satisfaction. The statistician, outcome assessor, and participants will be blinded to treatment allocation. Trial registration Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12611000542998 PMID:22040597

Comparison of interactive voice response, patient mailing, and mailed registry to encourage screening for osteoporosis: a randomized controlled trial.

PubMed

Heyworth, L; Kleinman, K; Oddleifson, S; Bernstein, L; Frampton, J; Lehrer, M; Salvato, K; Weiss, T W; Simon, S R; Connelly, M

2014-05-01

Guidelines recommend screening for osteoporosis with bone mineral density (BMD) testing in menopausal women, particularly those with additional risk factors for fracture. Many eligible women remain unscreened. This randomized study demonstrates that a single outreach interactive voice response phone call improves rates of BMD screening among high-risk women age 50-64. Osteoporotic fractures are a major cause of disability and mortality. Guidelines recommend screening with BMD for menopausal women, particularly those with additional risk factors for fracture. However, many women remain unscreened. We examined whether telephonic interactive voice response (IVR) or patient mailing could increase rates of BMD testing in high risk, menopausal women. We studied 4,685 women age 50-64 years within a not-for-profit health plan in the United States. All women had risk factors for developing osteoporosis and no prior BMD testing or treatment for osteoporosis. Patients were randomly allocated to usual care, usual care plus IVR, or usual care plus mailed educational materials. To avoid contamination, patients within a single primary care physician practice were randomized to receive the same intervention. The primary endpoint was BMD testing at 12 months. Secondary outcomes included BMD testing at 6 months and medication use at 12 months. Mean age was 57 years. Baseline demographic and clinical characteristics were similar across the three study groups. In adjusted analyses, the incidence of BMD screening was 24.6% in the IVR group compared with 18.6% in the usual care group (P < 0.001). There was no difference between the patient mailing group and the usual care group (P = 0.3). In this large community-based randomized trial of high risk, menopausal women age 50-64, IVR, but not patient mailing, improved rates of BMD screening. IVR remains a viable strategy to incorporate in population screening interventions.

An economic analysis of robot-assisted therapy for long-term upper-limb impairment after stroke.

PubMed

Wagner, Todd H; Lo, Albert C; Peduzzi, Peter; Bravata, Dawn M; Huang, Grant D; Krebs, Hermano I; Ringer, Robert J; Federman, Daniel G; Richards, Lorie G; Haselkorn, Jodie K; Wittenberg, George F; Volpe, Bruce T; Bever, Christopher T; Duncan, Pamela W; Siroka, Andrew; Guarino, Peter D

2011-09-01

Stroke is a leading cause of disability. Rehabilitation robotics have been developed to aid in recovery after a stroke. This study determined the additional cost of robot-assisted therapy and tested its cost-effectiveness. We estimated the intervention costs and tracked participants' healthcare costs. We collected quality of life using the Stroke Impact Scale and the Health Utilities Index. We analyzed the cost data at 36 weeks postrandomization using multivariate regression models controlling for site, presence of a prior stroke, and Veterans Affairs costs in the year before randomization. A total of 127 participants were randomized to usual care plus robot therapy (n=49), usual care plus intensive comparison therapy (n=50), or usual care alone (n=28). The average cost of delivering robot therapy and intensive comparison therapy was $5152 and $7382, respectively (P<0.001), and both were significantly more expensive than usual care alone (no additional intervention costs). At 36 weeks postrandomization, the total costs were comparable for the 3 groups ($17 831 for robot therapy, $19 746 for intensive comparison therapy, and $19 098 for usual care). Changes in quality of life were modest and not statistically different. The added cost of delivering robot or intensive comparison therapy was recuperated by lower healthcare use costs compared with those in the usual care group. However, uncertainty remains about the cost-effectiveness of robotic-assisted rehabilitation compared with traditional rehabilitation. Clinical Trial Registration- URL: http://clinicaltrials.gov. Unique identifier: NCT00372411.

76 FR 18073 - Track Safety Standards; Concrete Crossties

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-01

... metrics would be undesirable and restrict certain fastener assembly designs and capabilities to control... Track Safety Standards Working Group IV. FRA's Approach to Concrete Crossties A. Rail Cant B. Automated... and non-compliant track geometry can cause high- concentrated non-uniform dynamic loading, usually...

Management of Musculoskeletal Conditions in Rural South Australia: A Randomised Controlled Trial.

PubMed

Dent, E; Hoon, E; Karnon, J; Kitson, A; Dollard, J; Newbury, J; Harvey, G; Gill, T; Beilby, J

2017-01-01

With age, the prevalence of musculoskeletal conditions increases markedly. This rural-based study determined the benefits of two approaches for managing musculoskeletal conditions: a multiple-component 'Self-management Plus' intervention, and usual care. The intervention combined self-management education with physical activity and health professional support. 6-month outcomes included: Clinical Global Impression-Improvement Scale (CGI-IS) and Quality of Life (QoL). A total of 145 people were recruited; mean (SD) age was 66.1 (11.1) and 63.3 (10.9) years for intervention and control groups respectively. The intervention resulted in greater improvements in global functioning (CGI-IS mean (SD) = 3.2 (1.3)) than usual care (CGI-IS mean (SD) = 4.2 (1.5)). There was no difference in QoL improvement between study groups. A multiple-component 'Self-management Plus' intervention had a positive effect on physical functioning for older adults with musculoskeletal conditions. However, recruitment and retention of participants was problematic, which raises questions about the intervention's feasibility in its current form.

Motivational Interviewing or Reminders for Glaucoma Medication Adherence? Results of a Multi-Site Randomized Controlled Trial

PubMed Central

Schmiege, Sarah J.; Mansberger, Steven L.; Sheppler, Christina; Kammer, Jeffrey; Fitzgerald, Timothy; Kahook, Malik Y.

2017-01-01

Objective Nonadherence reduces glaucoma treatment efficacy. Motivational interviewing (MI) is a well-studied adherence intervention, but has not been tested in glaucoma. Reminder interventions also may improve adherence. Design 201 patients with glaucoma or ocular hypertension were urn-randomized to receive MI delivered by an ophthalmic technician (OT), usual care, or a minimal behavioral intervention (reminder calls). Main Outcome Measures Outcomes included electronic monitoring with Medication Event Monitoring System (MEMS) bottles, two self-report adherence measures, patient satisfaction, and clinical outcomes. Multilevel modeling was used to test differences in MEMS results by group over time; ANCOVA was used to compare groups on other measures. Results Reminder calls increased adherence compared to usual care based on MEMS, p = .005, and self-report, p = .04. MI had a nonsignificant effect but produced higher satisfaction than reminder calls, p = .007. Treatment fidelity was high on most measures, with observable differences in behavior between groups. All groups had high baseline adherence that limited opportunities for change. Conclusion Reminder calls, but not MI, led to better adherence than usual care. Although a large literature supports MI, reminder calls might be a cost-effective intervention for patients with high baseline adherence. Replication is needed with less adherent participants. PMID:27701902

Pharmacist intervention in primary care to improve outcomes in patients with left ventricular systolic dysfunction.

PubMed

Lowrie, Richard; Mair, Frances S; Greenlaw, Nicola; Forsyth, Paul; Jhund, Pardeep S; McConnachie, Alex; Rae, Brian; McMurray, John J V

2012-02-01

Meta-analysis of small trials suggests that pharmacist-led collaborative review and revision of medical treatment may improve outcomes in heart failure. We studied patients with left ventricular systolic dysfunction in a cluster-randomized controlled, event driven, trial in primary care. We allocated 87 practices (1090 patients) to pharmacist intervention and 87 practices (1074 patients) to usual care. The intervention was delivered by non-specialist pharmacists working with family doctors to optimize medical treatment. The primary outcome was a composite of death or hospital admission for worsening heart failure. This trial is registered, number ISRCTN70118765. The median follow-up was 4.7 years. At baseline, 86% of patients in both groups were treated with an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker. In patients not receiving one or other of these medications, or receiving less than the recommended dose, treatment was started, or the dose increased, in 33.1% of patients in the intervention group and in 18.5% of the usual care group [odds ratio (OR) 2.26, 95% CI 1.64-3.10; P< 0.001]. At baseline, 62% of each group were treated with a β-blocker and the proportions starting or having an increase in the dose were 17.9% in the intervention group and 11.1% in the usual care group (OR 1.76, 95% CI 1.31-2.35; P< 0.001). The primary outcome occurred in 35.8% of patients in the intervention group and 35.4% in the usual care group (hazard ratio 0.97, 95% CI 0.83-1.14; P = 0.72). There was no difference in any secondary outcome. A low-intensity, pharmacist-led collaborative intervention in primary care resulted in modest improvements in prescribing of disease-modifying medications but did not improve clinical outcomes in a population that was relatively well treated at baseline.

Motivational interviewing as a smoking cessation strategy with nurses: an exploratory randomised controlled trial.

PubMed

Mujika, Agurtzane; Forbes, Angus; Canga, Navidad; de Irala, Jokin; Serrano, Inmaculada; Gascó, Plácido; Edwards, Margaret

2014-08-01

Despite the important role that health professionals have in reducing tobacco use, many have a smoking habit themselves. The prevalence of smoking is particularly high among nurses. To test the efficacy, acceptability and feasibility of a motivational interviewing (MI) based smoking cessation intervention with nurses. Two group parallel experimental design with random allocation to groups. A large teaching hospital in the North of Spain. Nurses who smoked (n=30) were randomised into two groups: motivational interviewing based intervention (n=15) and usual care (n=15). Motivational interviewing based intervention consisted of four individual MI sessions. Usual care consisted of brief advice. Variables considered to assess efficacy were biochemically verified smoking cessation, mean cigarettes smoked, stages of change, self-efficacy and depression score. Variables to assess acceptability and feasibility included participant satisfaction, adherence to MI, and duration of sessions. Data were collected at: baseline, end of intervention and three months after the end of the intervention. At three month follow up, compared with the control group, more nurses in the intervention group had quit (absolute difference 33.3%; 95% confidence interval [CI] 2.6-58.2). In the nurses who did not quit, there was no significant difference between the intervention and control groups in the number of cigarettes smoked per day, although progress in the stages of change was greater in the intervention group compared to the control group. Measures of acceptability and feasibility indicated good satisfaction with the intervention, with high levels of attendance and completion. This study found a beneficial effect of motivational interviewing on nurses' smoking cessation. The intervention was acceptable for nurses and a number of aspects were identified that need to be considered prior to conducting a larger scale in order to optimise the intervention. Using MI might be a novel approach to the problem of health professionals who smoke. Copyright © 2013 Elsevier Ltd. All rights reserved.

Mortality results from a randomized prostate-cancer screening trial.

PubMed

Andriole, Gerald L; Crawford, E David; Grubb, Robert L; Buys, Saundra S; Chia, David; Church, Timothy R; Fouad, Mona N; Gelmann, Edward P; Kvale, Paul A; Reding, Douglas J; Weissfeld, Joel L; Yokochi, Lance A; O'Brien, Barbara; Clapp, Jonathan D; Rathmell, Joshua M; Riley, Thomas L; Hayes, Richard B; Kramer, Barnett S; Izmirlian, Grant; Miller, Anthony B; Pinsky, Paul F; Prorok, Philip C; Gohagan, John K; Berg, Christine D

2009-03-26

The effect of screening with prostate-specific-antigen (PSA) testing and digital rectal examination on the rate of death from prostate cancer is unknown. This is the first report from the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial on prostate-cancer mortality. From 1993 through 2001, we randomly assigned 76,693 men at 10 U.S. study centers to receive either annual screening (38,343 subjects) or usual care as the control (38,350 subjects). Men in the screening group were offered annual PSA testing for 6 years and digital rectal examination for 4 years. The subjects and health care providers received the results and decided on the type of follow-up evaluation. Usual care sometimes included screening, as some organizations have recommended. The numbers of all cancers and deaths and causes of death were ascertained. In the screening group, rates of compliance were 85% for PSA testing and 86% for digital rectal examination. Rates of screening in the control group increased from 40% in the first year to 52% in the sixth year for PSA testing and ranged from 41 to 46% for digital rectal examination. After 7 years of follow-up, the incidence of prostate cancer per 10,000 person-years was 116 (2820 cancers) in the screening group and 95 (2322 cancers) in the control group (rate ratio, 1.22; 95% confidence interval [CI], 1.16 to 1.29). The incidence of death per 10,000 person-years was 2.0 (50 deaths) in the screening group and 1.7 (44 deaths) in the control group (rate ratio, 1.13; 95% CI, 0.75 to 1.70). The data at 10 years were 67% complete and consistent with these overall findings. After 7 to 10 years of follow-up, the rate of death from prostate cancer was very low and did not differ significantly between the two study groups. (ClinicalTrials.gov number, NCT00002540.) 2009 Massachusetts Medical Society

Reducing patient delay in Acute Coronary Syndrome (RAPiD): research protocol for a web-based randomized controlled trial examining the effect of a behaviour change intervention.

PubMed

Farquharson, Barbara; Johnston, Marie; Smith, Karen; Williams, Brian; Treweek, Shaun; Dombrowski, Stephan U; Dougall, Nadine; Abhyankar, Purva; Grindle, Mark

2017-05-01

To evaluate the efficacy of a behaviour change technique-based intervention and compare two possible modes of delivery (text + visual and text-only) with usual care. Patient delay prevents many people from achieving optimal benefit of time-dependent treatments for acute coronary syndrome. Reducing delay would reduce mortality and morbidity, but interventions to change behaviour have had mixed results. Systematic inclusion of behaviour change techniques or a visual mode of delivery might improve the efficacy of interventions. A three-arm web-based, parallel randomized controlled trial of a theory-based intervention. The intervention comprises 12 behaviour change techniques systematically identified following systematic review and a consensus exercise undertaken with behaviour change experts. We aim to recruit n = 177 participants who have experienced acute coronary syndrome in the previous 6 months from a National Health Service Hospital. Consenting participants will be randomly allocated in equal numbers to one of three study groups: i) usual care, ii) usual care plus text-only behaviour change technique-based intervention or iii) usual care plus text + visual behaviour change technique-based intervention. The primary outcome will be the change in intention to phone an ambulance immediately with symptoms of acute coronary syndrome ≥15-minute duration, assessed using two randomized series of eight scenarios representing varied symptoms before and after delivery of the interventions or control condition (usual care). Funding granted January 2014. Positive results changing intentions would lead to a randomized controlled trial of the behaviour change intervention in clinical practice, assessing patient delay in the event of actual symptoms. Registered at ClinicalTrials.gov: NCT02820103. © 2016 John Wiley & Sons Ltd.

The Effect of Group Discussion-based Education on Self-management of Adults with Type 2 Diabetes Mellitus Compared with Usual Care: A Randomized Control Trial.

PubMed

Habibzadeh, Hosein; Sofiani, Akbar; Alilu, Leyla; Gillespie, Mark

2017-11-01

We sought to determine the effect of group discussion-based education on the self-management capability of patients with type 2 diabetes in Iran. This randomized control trial was conducted on 90 patients with type 2 diabetes. Participants were allocated randomly into one of two groups; intervention and control. The intervention group received the group discussion-based education while the control group received routine care only. The Lin's self-management questionnaire was completed at baseline and three months post-intervention. Statistical analysis, including the use of independent t -test, identified that in comparison to the control group, significant increases were observed in the scores of self-organization ( t =11.24, p < 0.001), self-adjustment ( t = 7.53, p < 0.001), interaction with health experts ( t = 7.31, p < 0.001), blood sugar self-monitoring ( t = 6.42, p < 0.001), adherence to the proposed diet ( t = 5.22, p < 0.001), and total self-management ( t = 10.82, p < 0.001) in the intervention group. Sharing experiences through group discussions and receiving instructive feedback can improve the ability to self-manage diabetes.

Eye movement desensitization and reprocessing therapy in subsyndromal bipolar patients with a history of traumatic events: a randomized, controlled pilot-study.

PubMed

Novo, Patricia; Landin-Romero, Ramon; Radua, Joaquim; Vicens, Victor; Fernandez, Isabel; Garcia, Francisca; Pomarol-Clotet, Edith; McKenna, Peter J; Shapiro, Francine; Amann, Benedikt L

2014-09-30

Traumatic events are frequent in bipolar patients and can worsen the course of the disease. Psychotherapeutic interventions for these events have not been studied so far. Twenty DSM-IV bipolar I and II patients with subsyndromal mood symptoms and a history of traumatic events were randomly assigned to Eye Movement Desensitization and Reprocessing therapy (n=10) or treatment as usual (n=10). The treatment group received between 14 and 18 Eye Movement Desensitization and Reprocessing sessions during 12 weeks. Evaluations of affective symptoms, symptoms of trauma and trauma impact were carried out by a blind rater at baseline, 2 weeks, 5 weeks, 8 weeks, 12 weeks and at 24 weeks follow-up. Patients in the treatment group showed a statistically significant improvement in depressive and hypomanic symptoms, symptoms of trauma and trauma impact compared to the treatment as usual group after intervention. This effect was only partly maintained in trauma impact at the 24 weeks follow-up visit. One patient dropped from Eye Movement Desensitization and Reprocessing group whereas four from the treatment as usual group. This pilot study suggests that Eye Movement Desensitization and Reprocessing therapy may be an effective and safe intervention to treat subsyndromal mood and trauma symptoms in traumatized bipolar patients. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

The effect of therapeutic touch on pain and fatigue of cancer patients undergoing chemotherapy.

PubMed

Aghabati, Nahid; Mohammadi, Eesa; Pour Esmaiel, Zahra

2010-09-01

Despite major advances in pain management, cancer pain is managed poorly in 80% of the patients with cancer. Due to deleterious side effects of pharmacology therapy in these people, there is an urgent need for clinical trials of non-pharmacological interventions. To examine the effect of therapeutic touch (TT) on the pain and fatigue of the cancer patients undergoing chemotherapy, a randomized and three-groups experimental study-experimental (TT), placebo (placebo TT), and control (usual care)-was carried out. Ninety patients undergoing chemotherapy, exhibiting pain and fatigue of cancer, were randomized into one of the three groups in the Cancer Center of Imam Khomeini Hospital in Tehran, Iran. Pain and fatigue were measured and recorded by participants before and after the intervention for 5 days (once a day). The intervention consisted of 30 min TT given once a day for 5 days between 10:00 a.m. and 10:30 a.m. The Visual Analogue Scale (VAS) of pain and the Rhoten Fatigue Scale (RFS) were completed for 5 days before and after the intervention by the subjects. The TT (significant) was more effective in decreasing pain and fatigue of the cancer patients undergoing chemotherapy than the usual care group, while the placebo group indicated a decreasing trend in pain and fatigue scores compared with the usual care group.

The Effect of Therapeutic Touch on Pain and Fatigue of Cancer Patients Undergoing Chemotherapy

PubMed Central

Aghabati, Nahid; Pour Esmaiel, Zahra

2010-01-01

Despite major advances in pain management, cancer pain is managed poorly in 80% of the patients with cancer. Due to deleterious side effects of pharmacology therapy in these people, there is an urgent need for clinical trials of non-pharmacological interventions. To examine the effect of therapeutic touch (TT) on the pain and fatigue of the cancer patients undergoing chemotherapy, a randomized and three-groups experimental study—experimental (TT), placebo (placebo TT), and control (usual care)—was carried out. Ninety patients undergoing chemotherapy, exhibiting pain and fatigue of cancer, were randomized into one of the three groups in the Cancer Center of Imam Khomeini Hospital in Tehran, Iran. Pain and fatigue were measured and recorded by participants before and after the intervention for 5 days (once a day). The intervention consisted of 30 min TT given once a day for 5 days between 10:00 a.m. and 10:30 a.m. The Visual Analogue Scale (VAS) of pain and the Rhoten Fatigue Scale (RFS) were completed for 5 days before and after the intervention by the subjects. The TT (significant) was more effective in decreasing pain and fatigue of the cancer patients undergoing chemotherapy than the usual care group, while the placebo group indicated a decreasing trend in pain and fatigue scores compared with the usual care group. PMID:18955319

Counseling African Americans to Control Hypertension (CAATCH) Trial: A Multi-level Intervention to Improve Blood Pressure Control in Hypertensive African Americans

PubMed Central

Ogedegbe, Gbenga; Tobin, Jonathan N.; Fernandez, Senaida; Gerin, William; Diaz-Gloster, Marleny; Cassells, Andrea; Khalida, Chamanara; Pickering, Thomas; Schoenthaler, Antoinette; Ravenell, Joseph

2009-01-01

Background Despite strong evidence of effective interventions targeted at blood pressure (BP) control, there is little evidence on the translation of these approaches to routine clinical practice in care of hypertensive African Americans. The goal of this study is to evaluate the effectiveness of a multi-level, multi-component, evidence-based intervention compared to usual care in improving BP control among hypertensive African Americans who receive care in Community Health Centers (CHCs). The primary outcomes are BP control rate at 12 months; and maintenance of intervention one year after the trial. The secondary outcomes are within-patient change in BP from baseline to 12 months and cost effectiveness of the intervention. Methods and Results Counseling African Americans to Control Hypertension (CAATCH) is a group randomized clinical trial with two conditions: Intervention Condition (IC) and Usual Care (UC). Thirty CHCs were randomly assigned equally to the IC group (N=15) or the UC group (N=15). The intervention is comprised of three components targeted at patients (interactive computerized hypertension education; home BP monitoring; and monthly behavioral counseling on lifestyle modification) and two components targeted at physicians (monthly case rounds based on JNC-7 guidelines; chart audit and provision of feedback on clinical performance and patients’ home BP readings). All outcomes are assessed at quarterly study visits for one year. Chart review is conducted at 24 months to evaluate maintenance of intervention effects and sustainability of the intervention. Conclusions Poor BP control is one of the major reasons for the mortality gap between African Americans and whites. Findings from this study, if successful, will provide salient information needed for translation and dissemination of evidence-based interventions targeted at BP control into clinical practice for this high-risk population. PMID:20031845

One-year outcomes of a randomized controlled trial of housing first with ACT in five Canadian cities.

PubMed

Aubry, Tim; Tsemberis, Sam; Adair, Carol E; Veldhuizen, Scott; Streiner, David; Latimer, Eric; Sareen, Jitender; Patterson, Michelle; McGarvey, Kathleen; Kopp, Brianna; Hume, Catharine; Goering, Paula

2015-05-01

Housing First is a groundbreaking approach to ending chronic homelessness among people with mental illness. This article presents one-year findings from a multisite randomized controlled trial (RCT) comparing Housing First with treatment as usual. The study was a nonblind, parallel-group RCT conducted in five Canadian cities. A sample of 950 high-need participants with severe mental illness, who were either absolutely homeless or precariously housed, was randomly assigned to Housing First (N=469) or treatment as usual (N=481). Housing First participants received a rent supplement, assistance to find housing, and assertive community treatment. Treatment-as-usual participants had access to all other existing programs. At one-year follow-up, 73% of Housing First participants and 31% of treatment-as-usual participants resided in stable housing (p<.001, odds ratio=6.35, covariate adjusted difference=42%, 95% confidence interval [CI]=36%-48%). Improvement in overall quality of life was significantly greater among Housing First participants compared with treatment-as-usual participants (p<.001, d=.31, CI=.16-.46). Housing First participants also showed greater improvements in community functioning compared with treatment-as-usual participants (p=.003, d=.25, CI=.09-.41). Compared with treatment as usual, Housing First produced greater improvements in housing stability, quality of life, and community functioning after one year of enrollment. The study provides support for adopting Housing First as an approach for ending chronic homelessness among persons with severe mental illness, even if they are actively symptomatic or using substances.

Evaluation of a mobile phone telemonitoring system for glycaemic control in patients with diabetes.

PubMed

Istepanian, Robert S H; Zitouni, Karima; Harry, Diane; Moutosammy, Niva; Sungoor, Ala; Tang, Bee; Earle, Kenneth A

2009-01-01

We conducted a randomized controlled trial using mobile health technology in an ethnically diverse sample of 137 patients with complicated diabetes. Patients in the intervention group (n = 72) were trained to measure their blood glucose with a sensor which transmitted the readings to a mobile phone via a Bluetooth wireless link. Clinicians were then able to examine and respond to the readings which were viewed with a web-based application. Patients in the control arm of the study (n = 65) did not transmit their readings and received care with their usual doctor in the outpatient and/or primary care setting. The mean follow-up period was 9 months in each group. The default rate was higher in the patients in the intervention arm due to technical problems. In an intention-to-treat analysis there were no differences in HbA(1c) between the intervention and control groups. In a sub-group analysis of the patients who completed the study, the telemonitoring group had a lower HbA(1c) than those in the control group: 7.76% and 8.40%, respectively (P = 0.06).

Effect of interferential current therapy on pain perception and disability level in subjects with chronic low back pain: a randomized controlled trial.

PubMed

Albornoz-Cabello, Manuel; Maya-Martín, Julián; Domínguez-Maldonado, Gabriel; Espejo-Antúnez, Luis; Heredia-Rizo, Alberto Marcos

2017-02-01

To assess the short-term efficacy of transregional interferential current therapy on pain perception and disability level in chronic non-specific low back pain. A randomized, single-blinded (the assessor collecting the outcome data was blinded), controlled trial. A private physiotherapy research clinic. A total of 64 individuals, 20 men and 44 women, mean (SD) age was 51 years (11.93), with low back pain of more than three months, with or without pain radiating to the lower extremities above the knee, were distributed into a control ( n = 20) or an experimental group ( n = 44). A 2:1 randomization ratio was used in favour of the latter. A transregional interferential current electrotherapy protocol was performed for participants in the experimental group, while the control group underwent a 'usual care' treatment (massage, mobilization and soft-tissue techniques). All subjects received up to 10 treatment sessions of 25 minutes over a two-week period, and completed the intervention and follow-up evaluations. Self-perceived pain was assessed with a Visual Analogue Scale. Secondary measure included the Oswestry Low Back Disability Index. Evaluations were collected at baseline and after the intervention protocol. Significant between-group differences were found for interferential current therapy on pain perception ( p = 0.032) and disability level ( p = 0.002). The observed differences in the between-group mean changes were of 11.34 mm (1.77/20.91) and 13.38 points (4.97/21.78), respectively. A two-week transregional interferential current treatment has shown significant short-term efficacy, when compared with a 'usual care' protocol, on self-perceived pain and functionality in subjects with chronic low back pain.

Motivational interviewing increases physical activity and self-efficacy in people living in the community after hip fracture: a randomized controlled trial.

PubMed

O'Halloran, Paul D; Shields, Nora; Blackstock, Felicity; Wintle, Elizabeth; Taylor, Nicholas F

2016-11-01

To investigate if motivational interviewing improved physical activity, self-efficacy, quality of life, mobility and mental health in people living in the community after hip fracture. Single-blind randomized controlled trial. Community. A total of 30 adults after hip fracture who had been discharged from rehabilitation to independent living in the community and allocated to a control group ( n = 14) or an intervention group ( n = 16). All participants received usual care. The intervention group also received eight weekly sessions of motivational interviewing as additional input, with the control group having no additional matching input. The primary outcome was physical activity levels as measured by an accelerometer (steps taken per day, time spent walking per day, and time spent sitting or lying each day). Secondary outcomes included self-efficacy (confidence about walking and not falling), health-related quality of life, mobility and mental health. Relative to usual care, the motivational interviewing group took significantly more steps per day (mean = 1237 steps, 95% confidence interval (CI) 12 to 2463), walked for longer per day (mean = 14.4 minutes, 95% CI 0.6 to 28.8), had improved self-efficacy evidenced by being more confident about walking (mean = 1.6 units out of 10, 95% CI 0.3 to 2.9) and not falling (mean = 1.1 units out of 10, 95% CI 0.3 to 1.9) and improved health-related quality of life and mental health. This study provides preliminary evidence that motivational interviewing can result in clinically meaningful improvements in physical activity and psychosocial outcomes for people recovering from hip fracture.

Perception, satisfaction and utilization of the VALUE home telehealth service.

PubMed

Finkelstein, Stanley M; Speedie, Stuart M; Zhou, Xinyu; Potthoff, Sandra; Ratner, Edward R

2011-01-01

We conducted a randomized controlled trial to evaluate the perception, satisfaction and utilization of a home telehealth service for frail elderly people living independently in their home communities. Control group subjects continued with their usual care and intervention group subjects were able to supplement their usual care with the use of a web portal. The web portal allowed videoconferencing and electronic messaging between home care nurses and clients, ordering health-related and home care services, access to health-related information and general access to the Internet. A total of 99 eligible people (59 female, 40 male) from one urban and one rural study site agreed to participate in the study. Eighty-four subjects were active participants for nine months. There were no significant differences in perception of technology between the two groups at baseline. At 60-day follow-up, the intervention group was significantly more positive towards technology compared to their own baseline (P < 0.001) and compared to the 60-day scores for the controls (P < 0.001). The intervention group indicated that overall the telehealth service met their expectations (mean score 9 out of 10) and they would recommend it to others (mean score 9.5 out of 10). All subjects were able to use the portal without difficulty after brief instructions from the nurses. A total of 1054 videoconferences were conducted with the intervention subjects. Fifty-six of these (5%) had to be discontinued after successful connection because of technical problems. Intervention subjects made fewer emergency department visits than control subjects, more visits to the eye doctor, fewer visits in all categories of home care utilization, and lower use of transportation services. Frail elderly people are able to adopt home telehealth technologies which may enable them to maintain independent living arrangements.

Effects of psychosocial stimulation on growth and development of severely malnourished children in a nutrition unit in Bangladesh.

PubMed

Nahar, B; Hamadani, J D; Ahmed, T; Tofail, F; Rahman, A; Huda, S N; Grantham-McGregor, S M

2009-06-01

Young children with severe malnutrition usually have poor mental development. Psychosocial stimulation may reduce their cognitive deficit, but it is not usually provided. The aim of the study was to incorporate stimulation into the routine treatment of severely malnourished children in a nutrition unit and evaluate the impact on their growth and development. Time-lagged controlled study. Nutritional Rehabilitation Unit (NRU) in ICDDR,B Dhaka Hospital. Severely malnourished children, aged 6-24 months, admitted to the NRU were enrolled. All received standard nutritional care. A control group of 43 children was studied initially, followed by an intervention group of 54 children. The intervened mothers and children participated in daily group meetings and individual play sessions for 2 weeks in hospital and were visited at home for 6 months. Children's growth was measured and development assessed using the Bayley Scales of Infant Development. Twenty-seven children were lost to the study. In the remaining children, both groups had similar developmental scores and anthropometry initially. After 6 months, the intervention group had improved more than the controls did by a mean of 6.9 (P<0.001; 95% CI: 3.9, 10.0) mental and 3.1 (P=0.024; 95% CI: 0.4, 5.7) motor raw scores and a mean of 0.4 (P=0.029; 95% CI: 0.1, 0.8) weight-for-age z scores, controlling for background variables. Psychosocial stimulation integrated into treatment of severely malnourished children in hospital, followed by home visits for 6 months, was effective in improving children's growth and development and should be an integral part of their treatment.

Culture-specific programs for children and adults from minority groups who have asthma.

PubMed

Bailey, E J; Kruske, S G; Morris, P S; Cates, C J; Chang, A B

2008-04-16

People with asthma who come from minority groups have poorer asthma outcomes and more asthma related visits to Emergency Departments (ED). Various programmes are used to educate and empower people with asthma and these have previously been shown to improve certain asthma outcomes. Models of care for chronic diseases in minority groups usually include a focus of the cultural context of the individual and not just the symptoms of the disease. Therefore, questions about whether culturally specific asthma education programmes for people from minority groups are effective at improving asthma outcomes, are feasible and are cost-effective need to be answered. To determine whether culture-specific asthma programmes, in comparison to generic asthma education programmes or usual care, improve asthma related outcomes in children and adults with asthma who belong to minority groups. We searched the Cochrane Register of Controlled Trials (CENTRAL), the Cochrane Airways Group Specialised Register, MEDLINE, EMBASE, review articles and reference lists of relevant articles. The latest search was performed in March 2007. All randomised controlled trials (RCTs) comparing the use of culture-specific asthma education programmes with generic asthma education programmes, or usual care, in adults or children from minority groups who suffer from asthma. Two review authors independently selected, extracted and assessed the data for inclusion. We contacted authors for further information if required. Three studies were eligible for inclusion in the review. A total of 396 patients, aged from 7 to 59 years were included in the meta-analysis of data. Use of a culture-specific programme was superior to generic programmes or usual care, in improving asthma quality of life scores in adults, pooled WMD 0.25 (95% CI 0.09 to 0.41) and asthma knowledge scores in children, WMD 3.30 (95% CI 1.07 to 5.53). There was no significant difference between groups in occurrence of asthma exacerbations, but the width of the confidence interval means that effects on exacerbation rates cannot be ruled out, rate ratio 0.93 (95% CI 0.80 to 1.10). Culture-specific programmes for adults and children from minority groups with asthma, have been found to be more effective than generic programmes in improving some (Quality of Life and asthma knowledge) but not all asthma outcomes. This evidence is limited by the small number of included studies and the lack of reported outcomes. Further trials are required to answer this question conclusively.

Effectiveness of a Proactive Primary Care Program on Preserving Daily Functioning of Older People: A Cluster Randomized Controlled Trial.

PubMed

Bleijenberg, Nienke; Drubbel, Irene; Schuurmans, Marieke J; Dam, Hester Ten; Zuithoff, Nicolaas P A; Numans, Mattijs E; de Wit, Niek J

2016-09-01

To determine the effectiveness of a proactive primary care program on the daily functioning of older people in primary care. Single-blind, three-arm, cluster-randomized controlled trial with 1-year follow-up. Primary care setting, 39 general practices in the Netherlands. Community-dwelling people aged 60 and older (N = 3,092). A frailty screening intervention using routine electronic medical record data to identify older people at risk of adverse events followed by usual care from a general practitioner; after the screening intervention, a nurse-led care program consisting of a comprehensive geriatric assessment, evidence-based care planning, care coordination, and follow-up; usual care. Primary outcome was daily functioning measured using the Katz-15 (6 activities of daily living (ADLs), 8 instrumental activities of daily living (IADLs), one mobility item (range 0-15)); higher scores indicate greater dependence. Secondary outcomes included quality of life, primary care consultations, hospital admissions, emergency department visits, nursing home admissions, and mortality. The participants in both intervention arms had less decline in daily functioning than those in the usual care arm at 12 months (mean Katz-15 score: screening arm, 1.87, 95% confidence interval (CI) = 1.77-1.97; screening and nurse-led care arm, 1.88, 95% CI = 1.80-1.96; control group, 2.03, 95% CI = 1.92-2.13; P = .03). No differences in quality of life were observed. Participants in both intervention groups had less decline than those in the control group at 1-year follow-up. Despite the statistically significant effect, the clinical relevance is uncertain at this point because of the small differences. Greater customizing of the intervention combined with prolonged follow-up may lead to more-robust results. © 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.

Increasing Recreational Physical Activity in Patients With Chronic Low Back Pain: A Pragmatic Controlled Clinical Trial.

PubMed

Ben-Ami, Noa; Chodick, Gabriel; Mirovsky, Yigal; Pincus, Tamar; Shapiro, Yair

2017-02-01

Study Design Prospective, pragmatic, nonrandomized controlled clinical trial. Background Clinical guidelines recommend physical activity for the treatment of chronic low back pain. But engaging patients in physical activity has proven difficult. Known obstacles to physical activity include low self-efficacy and fear avoidance. Objectives This study tested the effectiveness of an enhanced transtheoretical model intervention (ETMI) aimed at increasing recreational physical activity in patients with chronic low back pain, in comparison to usual physical therapy. Methods Patients (n = 220) referred to physical therapy for chronic low back pain were allocated to ETMI or to a control group. The ETMI was delivered by physical therapists and based on behavior-change principles, combined with increased reassurance, therapeutic alliance, and exposure to reduce fear avoidance. The primary outcome was back pain-related disability (Roland-Morris Disability Questionnaire). Secondary outcomes included pain intensity, mental and physical health, and levels of physical activity. Results Intention-to-treat analysis in 189 patients at 12 months indicated that patients in the ETMI group had significantly lower disability compared to usual physical therapy. The difference in mean change from baseline between the interventions was 2.7 points (95% confidence interval: 0.9, 4.5) on the Roland-Morris Disability Questionnaire. At 12 months, worst pain, physical activity, and physical health were all significantly better in patients receiving ETMI. The average number of sessions was 3.5 for the ETMI group and 5.1 for controls. Conclusion Targeting obstacles to physical activity with an intervention that includes components to address self-efficacy and fear avoidance appears to be more effective than usual physical therapy care in reducing long-term disability. Further research is needed to explore the mechanisms that impact outcomes in this intervention package. Level of Evidence Therapy, level 2b. Registered June 7, 2012 at ClinicalTrials.gov (NCT01631344). J Orthop Sports Phys Ther 2017;47(2):57-66. doi:10.2519/jospt.2017.7057.

Multistrategy childcare-based intervention to improve compliance with nutrition guidelines versus usual care in long day care services: a study protocol for a randomised controlled trial

PubMed Central

Seward, Kirsty; Finch, Meghan; Wiggers, John; Wyse, Rebecca; Jones, Jannah; Gillham, Karen; Yoong, Sze Lin

2016-01-01

Introduction Interventions to improve child diet are recommended as dietary patterns developed in childhood track into adulthood and influence the risk of chronic disease. For child health, childcare services are required to provide foods to children consistent with nutrition guidelines. Research suggests that foods and beverages provided by services to children are often inconsistent with nutrition guidelines. The primary aim of this study is to assess, relative to a usual care control group, the effectiveness of a multistrategy childcare-based intervention in improving compliance with nutrition guidelines in long day care services. Methods and analysis The study will employ a parallel group randomised controlled trial design. A sample of 58 long day care services that provide all meals (typically includes 1 main and 2 mid-meals) to children while they are in care, in the Hunter New England region of New South Wales, Australia, will be randomly allocated to a 6-month intervention to support implementation of nutrition guidelines or a usual care control group in a 1:1 ratio. The intervention was designed to overcome barriers to the implementation of nutrition guidelines assessed using the theoretical domains framework. Intervention strategies will include the provision of staff training and resources, audit and feedback, ongoing support and securing executive support. The primary outcome of the trial will be the change in the proportion of long day care services that have a 2-week menu compliant with childcare nutrition guidelines, measured by comprehensive menu assessments. As a secondary outcome, child dietary intake while in care will also be assessed. To assess the effectiveness of the intervention, the measures will be undertaken at baseline and ∼6 months postbaseline. Ethics and dissemination The study was approved by the Hunter New England Human Research Ethics Committee. Study findings will be disseminated widely through peer-reviewed publications. PMID:27301484

Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects: the PROMOTE study.

PubMed

Hensel, Kendi L; Buchanan, Steve; Brown, Sarah K; Rodriguez, Mayra; Cruser, des Anges

2015-01-01

The purpose of this study was to evaluate the efficacy of osteopathic manipulative treatment (OMT) to reduce low back pain and improve functioning during the third trimester in pregnancy and to improve selected outcomes of labor and delivery. Pregnancy research on osteopathic manipulation optimizing treatment effects was a randomized, placebo-controlled trial of 400 women in their third trimester. Women were assigned randomly to usual care only (UCO), usual care plus OMT (OMT), or usual care plus placebo ultrasound treatment (PUT). The study included 7 treatments over 9 weeks. The OMT protocol included specific techniques that were administered by board-certified OMT specialists. Outcomes were assessed with the use of self-report measures for pain and back-related functioning and medical records for delivery outcomes. There were 136 women in the OMT group: 131 women in the PUT group and 133 women in the UCO group. Characteristics at baseline were similar across groups. Findings indicate significant treatment effects for pain and back-related functioning (P < .001 for both groups), with outcomes for the OMT group similar to that of the PUT group; however, both groups were significantly improved compared with the UCO group. For secondary outcome of meconium-stained amniotic fluid, there were no differences among the groups. OMT was effective for mitigating pain and functional deterioration compared with UCO; however, OMT did not differ significantly from PUT. This may be attributed to PUT being a more active treatment than intended. There was no higher likelihood of conversion to high-risk status based on treatment group. Therefore, OMT is a safe, effective adjunctive modality to improve pain and functioning during the third trimester. Copyright © 2015 Elsevier Inc. All rights reserved.

The Effects of Intensive Nutrition Education on Late Middle-Aged Adults with Type 2 Diabetes.

PubMed

Li, Ye; Xu, Meihong; Fan, Rui; Ma, Xiaotao; Gu, Jiaojiao; Cai, Xiaxia; Liu, Rui; Chen, Qihe; Ren, Jinwei; Mao, Ruixue; Bao, Lei; Zhang, Zhaofeng; Wang, Junbo; Li, Yong

2016-09-08

Many patients with type 2 diabetes find it difficult to maintain good glycemic control. Undesirable glycemic control occurs greatly due to deficiencies of nutritional knowledge and difficulty in obtaining dietary prescriptions. The late middle-aged and elder individuals are the main populations that are affected by type 2 diabetes. The main purpose of this study was to investigate whether intensive nutrition education would make benefits for late middle-aged patients with type 2 diabetes. 196 patients between 50 to 65 years old meeting type 2 diabetes criteria and eligible for the program were included in a single-blinded, 30-day centralized management of an education program in China. Participants in the program were randomly divided into a usual nutrition education group or an intensive nutrition education group. The usual nutrition education group was used as a control group and received only basic health advice and principles of diabetic diets at the beginning and the end of the study. Participants in the intensive nutrition education group were arranged to receive intensive nutritional lectures about diabetes for 30 days. The primary outcomes were the changes in weight, body mass index (BMI), fasting plasma glucose (FPG), 2-h postprandial plasma glucose (PG), glycosylated hemoglobin (HbA1c), total glycerin (TG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-c), and low-density lipoprotein cholesterol (LDL-c). After 30 days of intervention, FPG, PG, and HbA1c in the treatment group decreased significantly than the control group (p < 0.05). HbA1c reduced significantly by 0.6% in the intervention group. No significant differences in the change of blood lipids were observed between groups. However, TG, TC, and HDL-c made improvements compared with the baseline in the experimental group. Both groups had a reduction in weight and BMI within groups, especially in intensive nutrition education group. However, there was no statistical significance between groups. Intensive nutrition education has significant effects on blood glucose control in late middle-aged adults with type 2 diabetes. Intensive education can cultivate good diet habits and increase physical activity, which are important for diabetes patients in the short and long terms. These findings may contribute to improving education methodology and nutrition therapy in patients with type 2 diabetes.

A Pilot Randomized Controlled Trial of a Guided Self-Help Intervention to Manage Chronic Orofacial Pain.

PubMed

Goldthorpe, Joanna; Lovell, Karina; Peters, Sarah; McGowan, Linda; Nemeth, Imola; Roberts, Christopher; Aggarwal, Vishal R

2017-01-01

To conduct a pilot trial to test the feasibility of a guided self-help intervention for chronic orofacial pain. A pilot randomized controlled trial was conducted to compare the intervention with usual treatment. A total of 37 patients with chronic orofacial pain were randomized into either the intervention group (n = 19) or the usual treatment (control) group (n = 18). Validated outcome measures were used to measure the potential effectiveness of the intervention over a number of domains: physical and mental functioning (Short Form 36 [SF-36]); anxiety and depression (Hospital Anxiety and Depression Scale [HADS]); pain intensity and interference with life (Brief Pain Inventory [BPI]); disability (Manchester Orofacial Pain Disability Scale [MOPDS]); and illness behavior (Revised Illness Perceptions Questionnaire [IPQr]). Bootstrap confidence intervals were computed for the treatment effect (ES) posttreatment and at 3 months follow-up and adjusted for baseline values of the outcome measure by using analysis of covariance. At posttreatment and the 3-month follow-up, 11 participants in the intervention group and 7 in the control group failed to complete outcome measures. The intervention was acceptable and could be feasibly delivered face to face or over the telephone. Although the pilot trial was not powered to draw conclusions about the effectiveness, it showed significant (P < .05) effects of the intervention on physical and mental functioning and treatment control. The self-help intervention was acceptable to patients and allowed them to better understand and self-manage chronic orofacial pain. It showed potential effectiveness on outcome domains related to functioning and illness perception. Further research is needed to understand the cost effectiveness of the intervention for chronic orofacial pain.

The effect of therapeutic touch on behavioral symptoms of persons with dementia.

PubMed

Woods, Diana Lynn; Craven, Ruth F; Whitney, Joie

2005-01-01

Approximately 80% of nursing home residents who suffer from Alzheimer's disease and related dementia develop behavioral symptoms of dementia. Given the deleterious side effects of pharmacologic therapy in this population there is an urgent need for clinical trials of nonpharmacologic interventions. To examine the effect of therapeutic touch on the frequency and intensity of behavioral symptoms of dementia. A randomized, double-blind, three-group experimental study: experimental (therapeutic touch), placebo (placebo therapeutic touch), and control (usual care). Fifty-seven residents, aged 67 to 93 years, exhibiting behavioral symptoms of dementia, were randomized to one of the three groups within each of three Special Care Units within three Long-Term Care facilities in a western Canadian province. Behavioral observation was completed every 20 minutes from 8:00AM to 6:00PM for three days pre-intervention and for three days post-intervention by trained observers who were blind to group assignment. The intervention consisted of therapeutic touch given twice daily for 5-7 minutes for three days between 10:00AM and 11:30PM and between 3:00PM and 4:30PM (N = 57). The main outcome variable was overall behavioral symptoms of dementia, consisting of six categories of behaviors: manual manipulation (restlessness), escape restraints, searching and wandering, tapping and banging, pacing and walking, and vocalization. Analysis of variance (ANOVA) (F = 3.331, P = .033) and the Kruskal-Wallis test (chi2 = 6.661, P = .036) indicated a significant difference in overall behavioral symptoms of dementia, manual manipulation and vocalization when the experimental group was compared to the placebo and control groups. The experimental (significant) was more effective in decreasing behavioral symptoms of dementia than usual care, while the placebo group indicated a decreasing trend in behavioral symptoms of dementia compared to usual care. Therapeutic touch offers a nonpharmacological, clinically relevant modality that could be used to decrease behavioral symptoms of dementia, specifically manual manipulation (restlessness) and vocalization, two prevalent behaviors.

Intervention to improve social and family support for caregivers of dependent patients: ICIAS study protocol

PubMed Central

2014-01-01

Background Despite the existence of formal professional support services, informal support (mainly family members) continues to be the main source of eldercare, especially for those who are dependent or disabled. Professionals on the primary health care are the ideal choice to educate, provide psychological support, and help to mobilize social resources available to the informal caregiver. Controversy remains concerning the efficiency of multiple interventions, taking a holistic approach to both the patient and caregiver, and optimum utilization of the available community resources. .For this reason our goal is to assess whether an intervention designed to improve the social support for caregivers effectively decreases caregivers burden and improves their quality of life. Methods/design Design: Controlled, multicentre, community intervention trial, with patients and their caregivers randomized to the intervention or control group according to their assigned Primary Health Care Team (PHCT). Study area: Primary Health Care network (9 PHCTs). Study participants: Primary informal caregivers of patients receiving home health care from participating PHCTs. Sample: Required sample size is 282 caregivers (141 from PHCTs randomized to the intervention group and 141 from PHCTs randomized to the control group. Intervention: a) PHCT professionals: standardized training to implement caregivers intervention. b) Caregivers: 1 individualized counselling session, 1 family session, and 4 educational group sessions conducted by participating PHCT professionals; in addition to usual home health care visits, periodic telephone follow-up contact and unlimited telephone support. Control: Caregivers and dependent patients: usual home health care, consisting of bimonthly scheduled visits, follow-up as needed, and additional attention upon request. Data analysis Dependent variables: Caregiver burden (short-form Zarit test), caregivers’ social support (Medical Outcomes Study), and caregivers’ reported quality of life (SF-12) Independent variables: a) Caregiver: sociodemographic data, Goldberg Scale, Apgar family questionnaire, Holmes and Rahe Psychosocial Stress Scale, number of chronic diseases. b) Dependent patient: sociodemographic data, level of dependency (Barthel Index), cognitive impairment (Pfeiffer test). Discussion If the intervention intended to improve social and family support is effective in reducing the burden on primary informal caregivers of dependent patients, this model can be readily applied throughout usual PHCT clinical practice. Trial registration Clinical trials registrar: NCT02065427 PMID:24666438

Effect of self-hypnosis on duration of labor and maternal and neonatal outcomes: a randomized controlled trial.

PubMed

Werner, Anette; Uldbjerg, Niels; Zachariae, Robert; Nohr, Ellen A

2013-07-01

To examine the effect of a brief course in self-hypnosis for childbirth on duration of the labor and other birth outcomes. A randomized, controlled, single-blind trial. Aarhus University Hospital Skejby, Denmark. A total of 1222 healthy nulliparous women. A hypnosis group receiving three 1-h lessons in self-hypnosis with additional audio-recordings to ease childbirth, a relaxation group receiving three 1-h lessons in various relaxation methods and mindfulness with audio-recordings for additional training, and a usual-care group receiving only the usual antenatal care were compared. Duration of labor, birth complications, lactation success, caring for the child, and preferred future mode of delivery. No differences were found across the three groups on duration from arriving at the birth department until the expulsive phase of second stage of labor, the duration of the expulsive phase, or other birth outcomes. Fewer emergency and more elective cesarean sections occurred in the hypnosis group. No difference was seen across the groups for lactation success or caring for the child but fewer women in the hypnosis group preferred a cesarean section in future pregnancies because of fear of childbirth and negative birth experiences. Learning self-hypnosis to ease childbirth taught as a brief course failed to show any effects on duration of childbirth and other birth outcomes. © 2013 The Authors Acta Obstetricia et Gynecologica Scandinavica © 2013 Nordic Federation of Societies of Obstetrics and Gynecology.

Rationale and design of the Investigator-Steered Project on Intravascular Renal Denervation for Management of Drug-Resistant Hypertension (INSPiRED) trial.

PubMed

Jin, Yu; Jacobs, Lotte; Baelen, Marie; Thijs, Lutgarde; Renkin, Jean; Hammer, Frank; Kefer, Joelle; Petit, Thibault; Verhamme, Peter; Janssens, Stefan; Sinnaeve, Peter; Lengelé, Jean-Philippe; Persu, Alexandre; Staessen, Jan A

2014-06-01

The SYMPLICITY studies showed that renal denervation (RDN) is feasible as novel treatment for resistant hypertension. However, RDN is a costly and invasive procedure, the long-term efficacy and safety of which has not yet been proven. Therefore, we designed the INSPiRED trial to compare the blood pressure lowering efficacy and safety of RDN vs usual medical therapy. INSPiRED is a randomized controlled trial enrolling 240 treatment-resistant hypertensive patients at 16 expert hypertension centres in Belgium. Eligible patients, aged 20-69 years old, have a 24-h ambulatory blood pressure of 130 mmHg systolic or 80 mmHg diastolic or more, while taking at least three antihypertensive drugs. They are randomized to RDN (EnligHTN(TM), SJM system) plus usual care (intervention group) or usual care alone (control group) in a ratio of 1:1. The primary endpoints for efficacy and safety, measured after 6 months, are the baseline-adjusted between-group differences in 24h systolic blood pressure and in glomerular filtration rate as estimated by the Chronic Kidney Disease Epidemiology Collaboration equation. Follow-up will continue up to 36 months after randomization. INSPiRED is powered to demonstrate a 10-mmHg difference in systolic blood pressure between randomized groups with a two-sided p-value of 0.01 and 90% power. It will generate long-term efficacy and safety data, identify the subset of treatment-resistant hypertensive patients responsive to RDN, provide information on cost-effectiveness, and by doing so INSPiRED will inform guideline committees and health policy makers. ClinicalTrials.gov Identifier: NCT 01505010.

Rationale and design of the Investigator-Steered Project on intravascular Renal Denervation for Management of Drug-Resistant Hypertension (INSPiRED) trial

PubMed Central

Jin, Yu; Jacobs, Lotte; Baelen, Marie; Thijs, Lutgarde; Renkin, Jean; Hammer, Frank; Kefer, Joelle; Petit, Thibault; Verhamme, Peter; Janssens, Stefan; Sinnaeve, Peter; Lengelé, Jean-Philippe; Persu, Alexandre

2014-01-01

The SYMPLICITY studies showed that renal denervation (RDN) is feasible as novel treatment for resistant hypertension. However, RDN is a costly and invasive procedure, the long-term efficacy and safety of which has not yet been proven. Therefore, we designed the INSPiRED trial to compare the blood pressure lowering efficacy and safety of RDN vs usual medical therapy. INSPiRED is a randomized controlled trial enrolling 240 treatment-resistant hypertensive patients at 16 expert hypertension centres in Belgium. Eligible patients, aged 20–69 years old, have a 24-h ambulatory blood pressure of 130 mmHg systolic or 80 mmHg diastolic or more, while taking at least three antihypertensive drugs. They are randomized to RDN (EnligHTNTM, SJM system) plus usual care (intervention group) or usual care alone (control group) in a ratio of 1:1. The primary endpoints for efficacy and safety, measured after 6 months, are the baseline-adjusted between-group differences in 24h systolic blood pressure and in glomerular filtration rate as estimated by the Chronic Kidney Disease Epidemiology Collaboration equation. Follow-up will continue up to 36 months after randomization. INSPiRED is powered to demonstrate a 10-mmHg difference in systolic blood pressure between randomized groups with a two-sided p-value of 0.01 and 90% power. It will generate long-term efficacy and safety data, identify the subset of treatment-resistant hypertensive patients responsive to RDN, provide information on cost-effectiveness, and by doing so INSPiRED will inform guideline committees and health policy makers. Trial registration: ClinicalTrials.gov Identifier: NCT 01505010. PMID:24742341

Aerobic or Resistance Training and Pulse Wave Velocity in Kidney Transplant Recipients: A 12-Week Pilot Randomized Controlled Trial (the Exercise in Renal Transplant [ExeRT] Trial).

PubMed

Greenwood, Sharlene A; Koufaki, Pelagia; Mercer, Thomas H; Rush, Robert; O'Connor, Ellen; Tuffnell, Rachel; Lindup, Herolin; Haggis, Lynda; Dew, Tracy; Abdulnassir, Lyndsey; Nugent, Eilish; Goldsmith, David; Macdougall, Iain C

2015-10-01

Cardiovascular disease remains the leading cause of death in kidney transplant recipients. This pilot study examined the potential effect of aerobic training or resistance training on vascular health and indexes of cardiovascular risk in kidney transplant recipients. Single-blind, randomized, controlled, parallel trial. 60 participants (mean age, 54 years; 34 men) were randomly assigned to aerobic training (n=20), resistance training (n=20), or usual care (n=20). Participants were included if they had a kidney transplant within 12 months prior to baseline assessment. Patients were excluded if they had unstable medical conditions or had recently started regular exercise. Aerobic training and resistance training were delivered 3 days per week for a 12-week period. The usual-care group received standard care. Pulse wave velocity, peak oxygen uptake (Vo2peak), sit-to-stand 60, isometric quadriceps force, and inflammatory biomarkers were assessed at 0 and 12 weeks. The anticipated 60 participants were recruited within 12 months. 46 participants completed the study (aerobic training, n=13; resistance training, n=13; and usual care, n=20), resulting in a 23% attrition rate. Analyses of covariance, adjusted for baseline values, age, and dialysis vintage pretransplantation, revealed significant mean differences between aerobic training and usual care in pulse wave velocity of -2.2±0.4 (95% CI, -3.1 to -1.3) m/s (P<0.001) and between resistance training and usual care of -2.6±0.4 (95% CI, -3.4 to -1.7) m/s (P<0.001) at 12 weeks. Secondary analyses indicated significant improvements in Vo2peak in the aerobic training group and in Vo2peak, sit-to-stand 60, and isometric muscle force in the resistance training group compared with usual care at 12 weeks. There were no reported adverse events, cardiovascular events, or hospitalizations as a result of the intervention. Pilot study, small sample size, no measure of endothelial function. Both aerobic training and resistance training interventions appear to be feasible and clinically beneficial in this patient population. Copyright © 2015 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Effect of affordable technology on physical activity levels and mobility outcomes in rehabilitation: a protocol for the Activity and MObility UsiNg Technology (AMOUNT) rehabilitation trial.

PubMed

Hassett, Leanne; van den Berg, Maayken; Lindley, Richard I; Crotty, Maria; McCluskey, Annie; van der Ploeg, Hidde P; Smith, Stuart T; Schurr, Karl; Killington, Maggie; Bongers, Bert; Howard, Kirsten; Heritier, Stephane; Togher, Leanne; Hackett, Maree; Treacy, Daniel; Dorsch, Simone; Wong, Siobhan; Scrivener, Katharine; Chagpar, Sakina; Weber, Heather; Pearson, Ross; Sherrington, Catherine

2016-06-06

People with mobility limitations can benefit from rehabilitation programmes that provide a high dose of exercise. However, since providing a high dose of exercise is logistically challenging and resource-intensive, people in rehabilitation spend most of the day inactive. This trial aims to evaluate the effect of the addition of affordable technology to usual care on physical activity and mobility in people with mobility limitations admitted to inpatient aged and neurological rehabilitation units compared to usual care alone. A pragmatic, assessor blinded, parallel-group randomised trial recruiting 300 consenting rehabilitation patients with reduced mobility will be conducted. Participants will be individually randomised to intervention or control groups. The intervention group will receive technology-based exercise to target mobility and physical activity problems for 6 months. The technology will include the use of video and computer games/exercises and tablet applications as well as activity monitors. The control group will not receive any additional intervention and both groups will receive usual inpatient and outpatient rehabilitation care over the 6-month study period. The coprimary outcomes will be objectively assessed physical activity (proportion of the day spent upright) and mobility (Short Physical Performance Battery) at 6 months after randomisation. Secondary outcomes will include: self-reported and objectively assessed physical activity, mobility, cognition, activity performance and participation, utility-based quality of life, balance confidence, technology self-efficacy, falls and service utilisation. Linear models will assess the effect of group allocation for each continuously scored outcome measure with baseline scores entered as a covariate. Fall rates between groups will be compared using negative binomial regression. Primary analyses will be preplanned, conducted while masked to group allocation and use an intention-to-treat approach. The protocol has been approved by the relevant Human Research Ethics Committees and the results will be disseminated widely through peer-reviewed publication and conference presentations. ACTRN12614000936628. Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Cost-effectiveness of a nurse-led internet-based vascular risk factor management programme: economic evaluation alongside a randomised controlled clinical trial.

PubMed

Greving, J P; Kaasjager, H A H; Vernooij, J W P; Hovens, M M C; Wierdsma, J; Grandjean, H M H; van der Graaf, Y; de Wit, G A; Visseren, F L J

2015-05-20

To assess the cost-effectiveness of an internet-based, nurse-led vascular risk factor management programme in addition to usual care compared with usual care alone in patients with a clinical manifestation of a vascular disease. Cost-effectiveness analysis alongside a randomised controlled trial (the Internet-based vascular Risk factor Intervention and Self-management (IRIS) study). Multicentre trial in a secondary and tertiary healthcare setting. 330 patients with a recent clinical manifestation of atherosclerosis in the coronary, cerebral, or peripheral arteries and with ≥2 treatable vascular risk factors not at goal. The intervention consisted of a personalised website with an overview and actual status of patients' vascular risk factors, and mail communication with a nurse practitioner via the website for 12 months. The intervention combined self-management support, monitoring of disease control and pharmacotherapy. Societal costs, quality-adjusted life-years (QALYs) and incremental cost-effectiveness. Patients experienced equal health benefits, that is, 0.86 vs 0.85 QALY (intervention vs usual care) at 1 year. Adjusting for baseline differences, the incremental QALY difference was -0.014 (95% CI -0.034 to 0.007). The intervention was associated with lower total costs (€4859 vs €5078, difference €219, 95% CI -€2301 to €1825). The probability that the intervention is cost-effective at a threshold value of €20,000/QALY, is 65%. At mean annual cost of €220 per patient, the intervention is relatively cheap. An internet-based, nurse-led intervention in addition to usual care to improve vascular risk factors in patients with a clinical manifestation of a vascular disease does not result in a QALY gain at 1 year, but has a small effect on vascular risk factors and is associated with lower costs. NCT00785031. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Study Protocol: effects of acupuncture on hot flushes in perimenopausal and postmenopausal women – a multicenter randomized clinical trial

PubMed Central

Kim, Kun-Hyung; Kang, Kyung-Won; Jung, Hee-Jung; Park, Ji-Eun; Jung, So-Young; Choi, Jun-Yong; Choi, Sun-Mi

2008-01-01

Background Hot flushes are the most frequent climacteric symptom and a major cause of suffering among menopausal women. The condition negatively influences many aspects of women's lives. To date, conventional hormone replacement therapy (HRT) is considered the most effective treatment for hot flushes. However, HRT is associated with a host of negative side effects. Complementary and alternative medical (CAM) approaches have been employed to relieve symptoms and to avoid these side effects. Acupuncture is one of the most strongly preferred CAM treatments for many diseases, causing few serious adverse effects, and is frequently used in Korea. We aim to evaluate the effectiveness of Traditional Korean Acupuncture (TKA) in conjunction with usual care, compared to usual care alone, on hot flushes in perimenopausal and postmenopausal women in Korea. Methods This study consists of a multi-center randomized controlled trial with 2 parallel arms. Participants included in the study will meet the following criteria: 1) a documented daily average hot flush score ≥ 10 for one week prior to the screening visit 2) not taking HRT and other pharmaceutical therapies which might affect hot flushes or other vasomotor symptoms. While maintaining usual care, the treatment group will receive acupuncture 3 times a week, for a total of 12 sessions over 4 weeks. The control group will receive usual care alone during the same period. Post-treatment follow-up will be performed one month after completing 12 sessions of acupuncture. Discussion This trial will provide evidence for the effectiveness of acupuncture as a treatment for hot flushes. The primary endpoint in both groups is a change in hot flush score from baseline to week 4 and/or week 8. As the secondary endpoint, we will employ the Menopause Rating Scale (MRS), a health-related quality of life questionnaire. Further analysis will examine the frequency, severity and difference in symptoms for daytime vs. nighttime hot flushes, sub-domain analysis of MRS, and participants' expectations of acupuncture treatment. Trial registration Current Controlled Trials ISRCTN49335612 PMID:19055763

Orofacial manual therapy improves cervical movement impairment associated with headache and features of temporomandibular dysfunction: a randomized controlled trial.

PubMed

von Piekartz, Harry; Hall, Toby

2013-08-01

There is evidence that temporomandibular disorder (TMD) may be a contributing factor to cervicogenic headache (CGH), in part because of the influence of dysfunction of the temporomandibular joint on the cervical spine. The purpose of this randomized controlled trial was to determine whether orofacial treatment in addition to cervical manual therapy, was more effective than cervical manual therapy alone on measures of cervical movement impairment in patients with features of CGH and signs of TMD. In this study, 43 patients (27 women) with headache for more than 3-months and with some features of CGH and signs of TMD were randomly assigned to receive either cervical manual therapy (usual care) or orofacial manual therapy to address TMD in addition to usual care. Subjects were assessed at baseline, after 6 treatment sessions (3-months), and at 6-months follow-up. 38 subjects (25 female) completed all analysis at 6-months follow-up. The outcome criteria were: cervical range of movement (including the C1-2 flexion-rotation test) and manual examination of the upper 3 cervical vertebra. The group that received orofacial treatment in addition to usual care showed significant reduction in all aspects of cervical impairment after the treatment period. These improvements persisted to the 6-month follow-up, but were not observed in the usual care group at any point. These observations together with previous reports indicate that manual therapists should look for features of TMD when examining patients with headache, particularly if treatment fails when directed to the cervical spine. Copyright © 2013. Published by Elsevier Ltd.

A mindfulness-based intervention to increase resilience to stress in university students (the Mindful Student Study): a pragmatic randomised controlled trial.

PubMed

Galante, Julieta; Dufour, Géraldine; Vainre, Maris; Wagner, Adam P; Stochl, Jan; Benton, Alice; Lathia, Neal; Howarth, Emma; Jones, Peter B

2018-02-01

The rising number of young people going to university has led to concerns about an increasing demand for student mental health services. We aimed to assess whether provision of mindfulness courses to university students would improve their resilience to stress. We did this pragmatic randomised controlled trial at the University of Cambridge, UK. Students aged 18 years or older with no severe mental illness or crisis (self-assessed) were randomly assigned (1:1), via remote survey software using computer-generated random numbers, to receive either an 8 week mindfulness course adapted for university students (Mindfulness Skills for Students [MSS]) plus mental health support as usual, or mental health support as usual alone. Participants and the study management team were aware of group allocation, but allocation was concealed from the researchers, outcome assessors, and study statistician. The primary outcome was self-reported psychological distress during the examination period, as measured with the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM), with higher scores indicating more distress. The primary analysis was by intention to treat. This trial is registered with the Australia and New Zealand Clinical Trials Registry, number ACTRN12615001160527. Between Sept 28, 2015, and Jan 15, 2016, we randomly assigned 616 students to the MSS group (n=309) or the support as usual group (n=307). 453 (74%) participants completed the CORE-OM during the examination period and 182 (59%) MSS participants completed at least half of the course. MSS reduced distress scores during the examination period compared with support as usual, with mean CORE-OM scores of 0·87 (SD 0·50) in 237 MSS participants versus 1·11 (0·57) in 216 support as usual participants (adjusted mean difference -0·14, 95% CI -0·22 to -0·06; p=0·001), showing a moderate effect size (β -0·44, 95% CI -0·60 to -0·29; p<0·0001). 123 (57%) of 214 participants in the support as usual group had distress scores above an accepted clinical threshold compared with 88 (37%) of 235 participants in the MSS group. On average, six students (95% CI four to ten) needed to be offered the MSS course to prevent one from experiencing clinical levels of distress. No participants had adverse reactions related to self-harm, suicidality, or harm to others. Our findings show that provision of mindfulness training could be an effective component of a wider student mental health strategy. Further comparative effectiveness research with inclusion of controls for non-specific effects is needed to define a range of additional, effective interventions to increase resilience to stress in university students. University of Cambridge and National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care East of England. Copyright © 2018 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.

Effectiveness of physiotherapy for seniors with recurrent headaches associated with neck pain and dysfunction: a randomized controlled trial.

PubMed

Uthaikhup, Sureeporn; Assapun, Jenjira; Watcharasaksilp, Kanokwan; Jull, Gwendolen

2017-01-01

A previous study demonstrated that in seniors, the presence of cervical musculoskeletal impairment was not specific to cervicogenic headache but was present in various recurrent headache types. Physiotherapy treatment is indicated in those seniors diagnosed with cervicogenic headache but could also be adjunct treatment for those with cervical musculoskeletal signs who are suspected of having transitional headaches. This study aimed to determine the effectiveness of a physiotherapy program for seniors with recurrent headaches associated with neck pain and cervical musculoskeletal dysfunction, irrespective of the headache classification. This is a prospective, stratified, randomized controlled trial with blinded outcome assessment. Sixty-five participants with recurrent headache, aged 50-75 years, were randomly assigned to either a physiotherapy (n=33) or a usual care group (n=32). The primary outcome was headache frequency. Secondary outcomes were headache intensity and duration, neck pain and disability, cervical range of motion, quality of life, participant satisfaction, and medication intake. Participants in the physiotherapy group received 14 treatment sessions. Participants in the usual care group continued with their usual care. Outcome measures were recorded at baseline, 11 weeks, 6 months, and 9 months. This study was funded by a government research fund of $6,850. No conflict of interest is declared. There was no loss to follow-up for the primary outcome measure. Compared with usual care, participants receiving physiotherapy reported significant reductions in headache frequency immediately after treatment (mean difference -1.6 days, 95% confidence interval [CI] -2.5 to -0.6), at 6-month follow-up (-1.7 days, 95% CI -2.6 to -0.8), and at 9-month follow-up (-2.4 days, 95% CI -3.2 to -1.5), and significant improvements in all secondary outcomes immediately posttreatment and at 6- and 9-month follow-ups, (p<.05 for all). No adverse events were reported. Physiotherapy treatment provided benefits over usual care for seniors with recurrent headache associated with neck pain and dysfunction. Copyright © 2016 Elsevier Inc. All rights reserved.

The feasibility of a randomised controlled trial to compare the cost-effectiveness of palliative cardiology or usual care in people with advanced heart failure: Two exploratory prospective cohorts.

PubMed

Johnson, Miriam J; McSkimming, Paula; McConnachie, Alex; Geue, Claudia; Millerick, Yvonne; Briggs, Andrew; Hogg, Karen

2018-06-01

The effectiveness of cardiology-led palliative care is unknown; we have insufficient information to conduct a full trial. To assess the feasibility (recruitment/retention, data quality, variability/sample size estimation, safety) of a clinical trial of palliative cardiology effectiveness. Non-randomised feasibility. Unmatched symptomatic heart failure patients on optimal cardiac treatment from (1) cardiology-led palliative service (caring together group) and (2) heart failure liaison service (usual care group). Outcomes/safety: Symptoms (Edmonton Symptom Assessment Scale), Kansas City Cardiomyopathy Questionnaire, performance, understanding of disease, anticipatory care planning, cost-effectiveness, survival and carer burden. A total of 77 participants (caring together group = 43; usual care group = 34) were enrolled (53% men; mean age 77 years (33-100)). The caring together group scored worse in Edmonton Symptom Assessment Scale (43.5 vs 35.2) and Kansas City Cardiomyopathy Questionnaire (35.4 vs 39.9). The caring together group had a lower consent/screen ratio (1:1.7 vs 1: 2.8) and few died before approach (0.08% vs 16%) or declined invitation (17% vs 37%). Data quality: At 4 months, 74% in the caring together group and 71% in the usual care group provided data. Most attrition was due to death or deterioration. Data quality in self-report measures was otherwise good. There was no difference in survival. Symptoms and quality of life improved in both groups. A future trial requires 141 (202 allowing 30% attrition) to detect a minimal clinical difference (1 point) in Edmonton Symptom Assessment Scale score for breathlessness (80% power). More participants (176; 252 allowing 30% attrition) are needed to detect a 10.5 change in Kansas City Cardiomyopathy Questionnaire score (80% power; minimum clinical difference = 5). A trial to test the clinical effectiveness (improvement in breathlessness) of cardiology-led palliative care is feasible.

The feasibility of a randomised controlled trial to compare the cost-effectiveness of palliative cardiology or usual care in people with advanced heart failure: Two exploratory prospective cohorts

PubMed Central

McSkimming, Paula; McConnachie, Alex; Geue, Claudia; Millerick, Yvonne; Briggs, Andrew; Hogg, Karen

2018-01-01

Background: The effectiveness of cardiology-led palliative care is unknown; we have insufficient information to conduct a full trial. Aim: To assess the feasibility (recruitment/retention, data quality, variability/sample size estimation, safety) of a clinical trial of palliative cardiology effectiveness. Design: Non-randomised feasibility. Setting/participants: Unmatched symptomatic heart failure patients on optimal cardiac treatment from (1) cardiology-led palliative service (caring together group) and (2) heart failure liaison service (usual care group). Outcomes/safety: Symptoms (Edmonton Symptom Assessment Scale), Kansas City Cardiomyopathy Questionnaire, performance, understanding of disease, anticipatory care planning, cost-effectiveness, survival and carer burden. Results: A total of 77 participants (caring together group = 43; usual care group = 34) were enrolled (53% men; mean age 77 years (33–100)). The caring together group scored worse in Edmonton Symptom Assessment Scale (43.5 vs 35.2) and Kansas City Cardiomyopathy Questionnaire (35.4 vs 39.9). The caring together group had a lower consent/screen ratio (1:1.7 vs 1: 2.8) and few died before approach (0.08% vs 16%) or declined invitation (17% vs 37%). Data quality: At 4 months, 74% in the caring together group and 71% in the usual care group provided data. Most attrition was due to death or deterioration. Data quality in self-report measures was otherwise good. Safety: There was no difference in survival. Symptoms and quality of life improved in both groups. A future trial requires 141 (202 allowing 30% attrition) to detect a minimal clinical difference (1 point) in Edmonton Symptom Assessment Scale score for breathlessness (80% power). More participants (176; 252 allowing 30% attrition) are needed to detect a 10.5 change in Kansas City Cardiomyopathy Questionnaire score (80% power; minimum clinical difference = 5). Conclusion: A trial to test the clinical effectiveness (improvement in breathlessness) of cardiology-led palliative care is feasible. PMID:29688127

Effectiveness of certified diabetes educators following pre-approved protocols to redesign diabetes care delivery in primary care: Results of the REMEDIES 4D trial.

PubMed

Zgibor, Janice C; Maloney, Maura A; Malmi, Markku; Fabio, Anthony; Kuo, Shihchen; Solano, Francis X; Tilves, Debra; Tu, Lichuan; Davidson, Mayer B

2018-01-01

To evaluate changes in HbA1c, blood pressure, and LDLc levels in participants from practices where certified diabetes educators (CDEs) implemented standardized protocols to intensify treatment compared with those receiving usual care. This clustered, randomized, clinical trial was implemented in community-based primary care practices. Fifteen primary care practices and 240 patients with type 2 diabetes were randomized to the intervention (n=175) or usual care (n=65). Participants had uncontrolled HbA1c, blood pressure, or LDLc. The one-year intervention included CDEs implementing pre-approved protocols to intensify treatment. Diabetes self-management education was also provided in both study groups. The population was 50.8% male with a mean age of 61years. The HbA1c in the intervention group decreased from 8.8% to 7.8%, (p=0.001) while the HbA1c in the usual care group increased slightly from 8.2% to 8.3%. There was also a significant difference in HbA1c between the two groups (p=0.004). There was not a significant difference between groups for systolic blood pressure (SBP) or LDLc at the end of the intervention. Those in the intervention group were more likely to have glucose-lowering medications intensified and were more likely to have their HbA1c (35% vs 15%), SBP (80% vs 77%) and HbA1c, SBP, and LDLc at goal (11% vs 1.5%) compared with the usual care group. There was no significant difference in intensification of blood pressure or cholesterol medication. Findings suggest that CDEs following standardized protocols in primary care is feasible and can effectively intensify treatment and improve glycemic control. Copyright © 2017 Elsevier Inc. All rights reserved.

Living with chronic pain: Evaluating patient experiences with a medical group visit focused on mindfulness and non-pharmacological strategies.

PubMed

Lestoquoy, Anna Sophia; Laird, Lance D; Mitchell, Suzanne; Gergen-Barnett, Katherine; Negash, N Lily; McCue, Kelly; Enad, Racquel; Gardiner, Paula

2017-12-01

Little is known about the acceptance of non-pharmacological group strategies delivered to low income racially diverse patients with chronic pain and depression. This paper examines how the Integrative Medical Group Visit (IMGV) addresses many of the deficits identified with usual care. Six IMGVs cohorts were held at a safety net hospital and two federally funded community health centres. Data was gathered through focus groups. Transcripts were analysed using both a priori codes and inductive coding. The intervention included ten sessions of Integrative Medical Group Visits with a primary care provider and a meditation instructor. The curriculum uses principles of Mindfulness Based Stress Reduction and evidence based integrative medicine. The visit is structured similarly to other group medical visits. Data was gathered through four focus groups held after the cohorts were completed. Participants (N=20) were largely low income minority adults with chronic pain and comorbid depression. Six themes emerged from the coding including: chronic pain is isolating; group treatment contributes to better coping with pain; loss of control and autonomy because of the unpredictability of pain as well as dependence on medication and frequent medical appointments; groups improve agency and control over one's health condition; navigating the healthcare system and unsatisfactory treatment options; and changes after the IMGV due to non-pharmacological health management. The IMGV is a promising format of delivering integrative care for chronic pain and depression which addresses many of the problems identified by patients in usual care. Copyright © 2017 Elsevier Ltd. All rights reserved.

Intensive group training protocol versus guideline physiotherapy for patients with chronic low back pain: a randomised controlled trial.

PubMed

van der Roer, Nicole; van Tulder, Maurits; Barendse, Johanna; Knol, Dirk; van Mechelen, Willem; de Vet, Henrica

2008-09-01

Intensive group training using principles of graded activity has been proven to be effective in occupational care for workers with chronic low back pain. Objective of the study was to compare the effects of an intensive group training protocol aimed at returning to normal daily activities and guideline physiotherapy for primary care patients with non-specific chronic low back pain. The study was designed as pragmatic randomised controlled trial with a setup of 105 primary care physiotherapists in 49 practices and 114 patients with non-specific low back pain of more than 12 weeks duration participated in the study. In the intensive group training protocol exercise therapy, back school and operant-conditioning behavioural principles are combined. Patients were treated during 10 individual sessions along 20 group sessions. Usual care consisted of physiotherapy according to the Dutch guidelines for Low Back Pain. Main outcome measures were functional disability (Roland Morris disability questionnaire), pain intensity, perceived recovery and sick leave because of low back pain assessed at baseline and after 6, 13, 26 and 52 weeks. Both an intention-to-treat analysis and a per-protocol analysis were performed. Multilevel analysis did not show significant differences between both treatment groups on any outcome measures during the complete follow-up period, with one exception. After 26 weeks the protocol group showed more reduction in pain intensity than the guideline group, but this difference was absent after 52 weeks. We finally conclude that an intensive group training protocol was not more effective than usual physiotherapy for chronic low back pain.

Community-Based Intervention to Improve Cardiometabolic Targets in Patients With Stroke: A Randomized Controlled Trial.

PubMed

Olaiya, Muideen T; Cadilhac, Dominique A; Kim, Joosup; Nelson, Mark R; Srikanth, Velandai K; Gerraty, Richard P; Bladin, Christopher F; Fitzgerald, Sharyn M; Phan, Thanh; Frayne, Judith; Thrift, Amanda G

2017-09-01

Many guidelines for secondary prevention of stroke focus on controlling cardiometabolic risk factors. We investigated the effectiveness of a management program for attaining cardiometabolic targets in survivors of stroke/transient ischemic attack. Randomized controlled trial of survivors of stroke/transient ischemic attack aged ≥18 years. General practices were randomized to usual care (control) or an intervention comprising specialist review of care plans and nurse education in addition to usual care. The outcome is attainment of pre-defined cardiometabolic targets based on Australian guidelines. Multivariable regression was undertaken to determine efficacy and identify factors associated with attaining targets. Overall, 283 subjects were randomized to the intervention and 280 to controls. Although we found no between-group difference in overall cardiometabolic targets achieved at 12 months, the intervention group more often achieved control of low-density lipoprotein cholesterol (odds ratio, 1.97; 95% confidence interval, 1.18-3.29) than controls. At 24 months, no between-group differences were observed. Medication adherence was ≥80% at follow-up, but uptake of lifestyle/behavioral habits was poor. Older age, being male, being married/living with partner, and having greater functional ability or a history of diabetes mellitus were associated with attaining targets. The intervention in this largely negative trial only had a detectable effect on attaining target for lipids but not for other factors at 12 months or any factor at 24 months. This limited effect may be attributable to inadequate uptake of behavioral/lifestyle interventions, highlighting the need for new or better approaches to achieve meaningful behavioral change. URL: http://www.clinicaltrials.gov. Unique identifier: ACTRN12608000166370. © 2017 American Heart Association, Inc.

Rates of detection of developmental problems at the 18-month well-baby visit by family physicians' using four evidence-based screening tools compared to usual care: a randomized controlled trial.

PubMed

Thomas, R E; Spragins, W; Mazloum, G; Cronkhite, M; Maru, G

2016-05-01

Early and regular developmental screening can improve children's development through early intervention but is insufficiently used. Most developmental problems are readily evident at the 18-month well-baby visit. This trial's purpose is to: (1) compare identification rates of developmental problems by GPs/family physicians using four evidence-based tools with non-evidence based screening, and (2) ascertain whether the four tools can be completed in 10-min pre-visit on a computer. We compared two approaches to early identification via random assignment of 54 families to either: 'usual care' (informal judgment including ad-hoc milestones, n = 25); or (2) 'Evidence-based' care (use of four validated, accurate screening tools, n = 29), including: the Parents' Evaluation of Developmental Status (PEDS), the PEDS-Developmental Milestones (PEDS-DM), the Modified Checklist for Autism in Toddlers (M-CHAT) and PHQ9 (maternal depression). In the 'usual care' group four (16%) and in the evidence-based tools group 18 (62%) were identified as having a possible developmental problem. In the evidence-based tools group three infants were to be recalled at 24 months for language checks (no specialist referrals made). In the 'usual care' group four problems were identified: one child was referred for speech therapy, two to return to check language at 24 months and a mother to discuss depression. All forms were completed on-line within 10 min. Despite higher early detection rates in the evidence-based care group, there were no differences in referral rates between evidence-based and usual-care groups. This suggests that clinicians: (1) override evidence-based screening results with informal judgment; and/or (2) need assistance understanding test results and making referrals. Possible solutions are improve the quality of information obtained from the screening process, improved training of physicians, improved support for individual practices and acceptance by the regional health authority for overall responsibility for screening and creation of a comprehensive network. © 2016 John Wiley & Sons Ltd.

Effectiveness of Fluticasone Furoate-Vilanterol for COPD in Clinical Practice.

PubMed

Vestbo, Jørgen; Leather, David; Diar Bakerly, Nawar; New, John; Gibson, J Martin; McCorkindale, Sheila; Collier, Susan; Crawford, Jodie; Frith, Lucy; Harvey, Catherine; Svedsater, Henrik; Woodcock, Ashley

2016-09-29

Evidence for the management of chronic obstructive pulmonary disease (COPD) comes from closely monitored efficacy trials involving groups of patients who were selected on the basis of restricted entry criteria. There is a need for randomized trials to be conducted in conditions that are closer to usual clinical practice. In a controlled effectiveness trial conducted in 75 general practices, we randomly assigned 2799 patients with COPD to a once-daily inhaled combination of fluticasone furoate at a dose of 100 μg and vilanterol at a dose of 25 μg (the fluticasone furoate-vilanterol group) or to usual care (the usual-care group). The primary outcome was the rate of moderate or severe exacerbations among patients who had had an exacerbation within 1 year before the trial. Secondary outcomes were the rates of primary care contact (contact with a general practitioner, nurse, or other health care professional) and secondary care contact (inpatient admission, outpatient visit with a specialist, or visit to the emergency department), modification of the initial trial treatment for COPD, and the rate of exacerbations among patients who had had an exacerbation within 3 years before the trial, as assessed in a time-to-event analysis. The rate of moderate or severe exacerbations was significantly lower, by 8.4% (95% confidence interval, 1.1 to 15.2), with fluticasone furoate-vilanterol therapy than with usual care (P=0.02). There was no significant difference in the annual rate of COPD-related contacts to primary or secondary care. There were no significant between-group differences in the rates of the first moderate or severe exacerbation and the first severe exacerbation in the time-to-event analyses. There were no excess serious adverse events of pneumonia in the fluticasone furoate-vilanterol group. The numbers of other serious adverse events were similar in the two groups. In patients with COPD and a history of exacerbations, a once-daily treatment regimen of combined fluticasone furoate and vilanterol was associated with a lower rate of exacerbations than usual care, without a greater risk of serious adverse events. (Funded by GlaxoSmithKline; Salford Lung Study ClinicalTrials.gov number, NCT01551758 .).

Upper limb training using Wii Sports Resort for children with hemiplegic cerebral palsy: a randomized, single-blind trial.

PubMed

Chiu, Hsiu-Ching; Ada, Louise; Lee, Hsin-Min

2014-10-01

To investigate whether Wii Sports Resort training is effective and if any benefits are maintained. Randomized, single-blind trial. Sixty-two hemiplegic children with cerebral palsy (6-13 years). Experimental group undertook six weeks of home-based Wii Sports Resort training plus usual therapy, while the control group received usual therapy. Outcomes were coordination, strength, hand function, and carers' perception of hand function, measured at baseline, six, and 12 weeks by a blinded assessor. There was a trend of mean difference (MD) for the experimental group to have more grip strength by six (MD 4.0 N, 95% confidence interval (CI) -0.8 to 8.8, p = 0.10) and 12 (MD 4.1 N, 95% CI -2.1 to 10.3, p = 0.19) weeks, and to have a higher quantity of hand function according to carers' perception by six (MD 4.5 N, 95% CI -0.7 to 9.7, p = 0.09) and strengthened by 12 (MD 6.4, 95% CI 0.6 to 12.3, p = 0.03) weeks than the control group. There was no difference between groups in coordination and hand function by six or 12 weeks. Wii training did not improve coordination, strength, or hand function. Beyond the intervention, carers perceived that the children used their hands more. © The Author(s) 2014.

Randomized Controlled Pilot Trial of a Novel Dissonance-Based Group Treatment for Eating Disorders

PubMed Central

Stice, Eric; Rohde, Paul; Butryn, Meghan; Menke, Katharine S.; Marti, C. Nathan

2015-01-01

Objective Conduct a pilot trial of a new dissonance-based group eating disorder treatment designed to be a cost-effective front-line transdiagnostic treatment that could be more widely disseminated than extant individual or family treatments that are more expensive and difficult to deliver. Method Young women with a DSM-5 eating disorder (N = 72) were randomized to an 8-week dissonance-based Body Acceptance Therapy group treatment or a usual care control condition, completing diagnostic interviews and questionnaires at pre, post, and 2-month follow-up. Results Intent-to-treat analyses revealed that intervention participants showed greater reductions in outcomes than usual care controls in a multivariate multilevel model (χ2[6] = 34.1, p < .001), producing large effects for thin-ideal internalization (d = 0.79), body dissatisfaction (d = 1.14), and blinded interview-assessed eating disorder symptoms (d = .95), and medium effects for dissonance regarding perpetuating the thin ideal (d = .65) and negative affect (d = .55). Midway through this pilot we refined engagement procedures, which was associated with increased effect sizes (e.g., the d for eating disorder symptoms increased from .51 to 2.30). Conclusions This new group treatment produced large reductions in eating disorder symptoms, which is encouraging because it requires about 1/20th the therapist time necessary for extant individual and family treatments, and has the potential to provide a cost-effective and efficacious approach to reaching the majority of individuals with eating disorders who do not presently received treatment. PMID:25577189

Family Economic Strengthening and Parenting Stress Among Caregivers of AIDS-Orphaned Children: Results from a Cluster Randomized Clinical Trial in Uganda.

PubMed

Nabunya, Proscovia; Ssewamala, Fred M; Ilic, Vilma

2014-09-01

This study examines the impact of a family economic strengthening intervention on parenting stress among caregivers of AIDS-orphaned children in Uganda. The study uses data from a 4-year (2008-2012) NIMH randomized clinical trial for AIDS-orphaned children known as Suubi-Maka (N=346 dyads). Child-caregiver dyads from 10 comparable primary schools were randomly assigned to either the control group (n=167 dyads) receiving usual care for school-going orphaned children (such as food aid and scholastic materials) or the treatment group (n=179 dyads) receiving a family economic strengthening intervention (focused on a matched savings account), financial planning and management workshops over and above the usual care. Interviews were conducted at baseline, 12 months and 24 months follow-up. This study uses data from baseline and 24 months post-intervention. We use multivariate regression methods, controlling for socioeconomic characteristics. At 24 months, caregivers in the treatment group reported significantly lower levels of parenting stress compared to caregivers in the control group. Findings from this study point to the potential of a family economic strengthening intervention to improve caregiver's psychosocial wellbeing and that of their families. We conclude that programs and policies aimed at improving the psychosocial wellbeing of families caring for AIDS-orphaned children may consider incorporating economic strengthening components in their programming to help support these kinds of families, caregivers of AIDS-orphaned children especially those residing in developing countries.

Long-term incidence of serious fall-related injuries after bariatric surgery in Swedish obese subjects.

PubMed

Carlsson, Lena M S; Sjöholm, Kajsa; Ahlin, Sofie; Jacobson, Peter; Andersson-Assarsson, Johanna C; Karlsson Lindahl, Linda; Maglio, Cristina; Karlsson, Cecilia; Hjorth, Stephan; Taube, Magdalena; Carlsson, Björn; Svensson, Per-Arne; Peltonen, Markku

2018-05-24

Obesity increases risk of falling, but the effect of bariatric surgery on fall-related injuries is unknown. The aim of this study was therefore to study the association between bariatric surgery and long-term incidence of fall-related injuries in the prospective, controlled Swedish Obese Subjects study. At inclusion, body mass index was ≥ 34 kg/m 2 in men and ≥38 kg/m 2 in women. The surgery per-protocol group (n = 2007) underwent gastric bypass (n = 266), banding (n = 376), or vertical banded gastroplasty (n = 1365), and controls (n = 2040) received usual care. At the time of analysis (31 December 2013), median follow-up was 19 years (maximal 26 years). Fall-related injuries requiring hospital treatment were captured using data from the Swedish National Patient Register. During follow-up, there were 617 first-time fall-related injuries in the surgery group and 513 in the control group (adjusted hazard ratio 1.21, 95% CI, 1.07-1.36; P = 0.002). The incidence differed between treatment groups (P < 0.001, log-rank test) and was higher after gastric bypass than after usual care, banding and vertical banded gastroplasty (adjusted hazard ratio 0.50-0.52, P < 0.001 for all three comparisons). In conclusion, gastric bypass surgery was associated with increased risk of serious fall-related injury requiring hospital treatment.

Randomized controlled pilot study of an educational video plus telecare for the early outpatient management of musculoskeletal pain among older emergency department patients.

PubMed

Platts-Mills, Timothy F; Hollowell, Allison G; Burke, Gary F; Zimmerman, Sheryl; Dayaa, Joseph A; Quigley, Benjamin R; Bush, Montika; Weinberger, Morris; Weaver, Mark A

2018-01-05

Musculoskeletal pain is a common reason for emergency department (ED) visits. Following discharge from the ED, patients, particularly older patients, often have difficulty controlling their pain and managing analgesic side effects. We conducted a pilot study of an educational video about pain management with and without follow-up telephone support for older adults presenting to the ED with musculoskeletal pain. ED patients aged 50 years and older with musculoskeletal pain were randomized to: (1) usual care, (2) a brief educational video only, or (3) a brief educational video plus a protocol-guided follow-up telephone call from a physician 48-72 hours after discharge (telecare). The primary outcome was the change from the average pain severity before the ED visit to the average pain severity during the past week assessed one month after the ED visit. Pain was assessed using a 0-10 numerical rating scale. Of 75 patients randomized (mean age 64 years), 57 (76%) completed follow up at one month. Of the 18 patients lost to follow up, 12 (67%) had non-working phone numbers. Among patients randomized to the video (arms 2 and 3), 46/50 viewed the entire video; among the 25 patients randomized to the video plus telecare (arm 3), 23 were reached for telecare. Baseline pain scores for the usual care, video, and video plus telecare groups were 7.3, 7.1, and 7.5. At one month, pain scores were 5.8, 4.9, and 4.5, corresponding to average decreases in pain of -1.5, -2.2, and -3.0, respectively. In the pairwise comparison between intervention groups, the video plus telecare group had a 1.7-point (95% CI 1.2, 2.1) greater decrease in pain compared to usual care, and the video group had a 1.1-point (95% CI 0.6, 1.6) greater decrease in pain compared to usual care after adjustment for baseline pain, age, and gender. At one month, clinically important differences were also observed between the video plus telecare and usual care groups for analgesic side effects, ongoing opioid use, and physical function. Results of this pilot trial suggest the potential value of an educational video plus telecare to improve outcomes for older adults presenting to the ED with musculoskeletal pain. Changes to the protocol are identified to increase retention for assessment of outcomes. ClinicalTrials.gov, NCT02438384 . Registered on 5 May 2015.

Randomized clinical trial to assess the effectiveness of remote patient monitoring and physician care in reducing office blood pressure.

PubMed

Kim, Yoon-Nyun; Shin, Dong Gu; Park, Sungha; Lee, Chang Hee

2015-07-01

The effectiveness of remote patient monitoring and physician care for the treatment of hypertension has not been demonstrated in a randomized clinical trial. The objective of this study was to evaluate the effectiveness of remote patient monitoring with or without remote physician care in reducing office blood pressure in patients with hypertension. A total of 374 hypertensive patients over 20 years of age were randomized into the following three groups: group (1) control, the patients received usual clinical care with home BP monitoring; group (2) the patients were remotely monitored and received office follow-up; and group (3) the patients received remote monitoring without physician office care using the remote monitoring device. For each group, in-office follow-up care was scheduled every 8 weeks for 24 weeks. The primary end point was the difference in sitting SBP at the 24-week follow-up. No difference between the three groups was observed in the primary end point (adjusted mean sitting SBP was as follows: group 1: -8.9±15.5 mm Hg, group 2: -11.3±15.9 mm Hg, group 3: -11.6±19.8 mm Hg, (NS). Significant differences in achieving the target BP at the 24th week of follow-up were observed between groups 1 and 2. The subjects over 55-years old had a significant decrease in the adjusted mean sitting SBP in groups 2 and 3 compared with that of the control group. Remote monitoring alone or remote monitoring coupled with remote physician care was as efficacious as the usual office care for reducing blood pressure with comparable safety and efficacy in hypertensive patients.

A patient decision aid regarding antithrombotic therapy for stroke prevention in atrial fibrillation: a randomized controlled trial.

PubMed

Man-Son-Hing, M; Laupacis, A; O'Connor, A M; Biggs, J; Drake, E; Yetisir, E; Hart, R G

1999-08-25

Decision aids are tools designed to help patients participate in the clinical decision-making process. To determine whether use of an audiobooklet (AB) decision aid explaining the results of a clinical trial affected the decision-making process of study participants. Randomized controlled trial conducted from May 1997 to April 1998. Fourteen centers that participated in the Stroke Prevention in Atrial Fibrillation (SPAF) III trial. A total of 287 patients from the SPAF III aspirin cohort study, in which patients with atrial fibrillation and a relatively low risk of stroke received 325 mg/d of aspirin and were followed up for a mean of 2 years. At the end of SPAF III, participants were randomized to be informed of the study results with usual care plus use of an AB (AB group) vs usual care alone (control group). The AB included pertinent information to help patients decide whether to continue taking aspirin or switch to warfarin. Patients' ability to make choices regarding antithrombotic therapy, and 6-month adherence to these decisions. Their knowledge, expectations, decisional conflict (the amount of uncertainty about the course of action to take), and satisfaction with the decision-making process were also measured. More patients in the AB group made a choice about antithrombotic therapy than in the control group (99% vs 94%; P = .02). Patients in the AB group were more knowledgeable and had more realistic expectations about the risk of stroke and hemorrhage (in the AB group, 53%-80% correctly estimated different risks; in the control group, 16%-28% gave correct estimates). Decisional conflict and satisfaction were similar for the 2 groups. After 6 months, a similar percentage of patients were still taking their initial choice of antithrombotic therapy (95% vs 93%; P = .44). For patients with atrial fibrillation who had participated in a major clinical trial, the use of an AB decision aid improved their understanding of the benefits and risks associated with different treatment options and helped them make definitive choices about which therapy to take. Further studies are necessary to evaluate the acceptability and impact of decision aids in other clinical settings.

Moxibustion for treating knee osteoarthritis: study protocol of a multicentre randomised controlled trial

PubMed Central

2013-01-01

Background The treatment of knee osteoarthritis, which is a major cause of disability among the elderly, is typically selected from multidisciplinary options, including complementary and alternative medicine. Moxibustion has been used in the treatment of knee osteoarthritis in Korea to reduce pain and improve physical activity. However, there is no sufficient evidence of its effectiveness, and it cannot therefore be widely recommended for treating knee osteoarthritis. We designed a randomised controlled clinical trial to evaluate the effectiveness, safety, cost-effectiveness, and qualitative characteristics of moxibustion treatment of knee osteoarthritis compared to usual care. Methods/designs This is a protocol for a multicentre, pragmatic, randomised, assessor-blinded, controlled, parallel-group study. A total of 212 participants will be assigned to the moxibustion group (n = 106) and the usual care group (n = 106) at 4 clinical research centres. The participants assigned to the moxibustion group will receive moxibustion treatment of the affected knee(s) at 6 standard acupuncture points (ST36, ST35, ST34, SP9, Ex-LE04, and SP10) 3 times per week for 4 weeks (a total of 12 sessions). Participants in the usual care group will not receive moxibustion treatment during the study period. Follow-up will be performed on the 5th and 13th weeks after random allocation. Both groups will be allowed to use any type of treatment, including surgery, conventional medication, physical treatment, acupuncture, herbal medicine, over-the-counter drugs, and other active treatments. Educational material that explains knee osteoarthritis, the current management options, and self-exercise will be provided to each group. The global scale of the Korean Western Ontario and McMaster Osteoarthritis Index (K-WOMAC) will be the primary outcome measurement used in this study. Other subscales (pain, stiffness, and function) of the K-WOMAC, the Short-Form 36v2 Health Survey, the Beck Depression Inventory, the Physical Function test, Patient Global Assessment, and the Pain Numerical Rating Scale will be used as outcome variables to evaluate the effectiveness of moxibustion. Safety will be assessed at every visit. In addition, an economic evaluation and a qualitative study will be conducted as a mixed-methods approach. Discussion This trial may contribute to developing evidence for the effectiveness and safety of moxibustion for treating knee osteoarthritis. Trial registration Trial registration number: KCT0000130 PMID:23497032

Partner-delivered reflexology: effects on cancer pain and anxiety.

PubMed

Stephenson, Nancy L N; Swanson, Melvin; Dalton, Joann; Keefe, Frances J; Engelke, Martha

2007-01-01

To compare the effects of partner-delivered foot reflexology and usual care plus attention on patients' perceived pain and anxiety. The experimental pretest/post-test design included patient-partner dyads randomly assigned to an experimental or control group. Four hospitals in the southeastern United States. 42 experimental and 44 control subjects comprised 86 dyads of patients with metastatic cancer and their partners, representing 16 different types of cancer; 23% of patients had lung cancer, followed by breast, colorectal, and head and neck cancer and lymphoma. The subjects had a mean age of 58.3 years, 51% were female, 66% had a high school education or less, and 58% were Caucasian, 40% were African American, and 1% were Filipino. The intervention included a 15- to 30-minute teaching session on foot reflexology to the partner by a certified reflexologist, an optional 15- to 30-minute foot reflexology session for the partner, and a 30-minute, partner-delivered foot reflexology intervention for the patient. The control group received a 30-minute reading session from their partners. Pain and anxiety. Following the initial partner-delivered foot reflexology, patients experienced a significant decrease in pain intensity and anxiety. A nurse reflexologist taught partners how to perform reflexology on patients with metastatic cancer pain in the hospital, resulting in an immediate decrease in pain intensity and anxiety; minimal changes were seen in the control group, who received usual care plus attention. Hospitals could have qualified professionals offer reflexology as a complementary therapy and teach interested partners the modality.

Managing the space between visits: a randomized trial of disease management for diabetes in a community health center.

PubMed

Anderson, Daren R; Christison-Lagay, Joan; Villagra, Victor; Liu, Haibei; Dziura, James

2010-10-01

Diabetes outcomes are worse for underserved patients from certain ethnic/racial minority populations. Telephonic disease management is a cost-effective strategy to deliver self-management services and possibly improve diabetes outcomes for such patients. We conducted a trial to test the effectiveness of a supplemental telephonic disease management program compared to usual care alone for patients with diabetes cared for in a community health center. Randomized controlled trial. All patients had type 2 diabetes, and the majority was Hispanic or African American. Most were urban-dwelling with low socioeconomic status, and nearly all had Medicaid or were uninsured. Clinical measures included glycemic control, blood pressure, lipid levels, and body mass index. Validated surveys were used to measure dietary habits and physical activity. A total of 146 patients were randomized to the intervention and 149 to the control group. Depressive symptoms were highly prevalent in both groups. Using an intention to treat analysis, there were no significant differences in the primary outcome (HbA1c) between the intervention and control groups at 12 months. There were also no significant differences for secondary clinical or behavioral outcome measures including BMI, systolic or diastolic blood pressure, LDL cholesterol, smoking, or intake of fruits and vegetables, or physical activity. A clinic-based telephonic disease management support for underserved patients with diabetes did not improve clinical or behavioral outcomes at 1 year as compared to patients receiving usual care alone.

A Newly Designed Mobile-Based Computerized Cognitive Addiction Therapy App for the Improvement of Cognition Impairments and Risk Decision Making in Methamphetamine Use Disorder: Randomized Controlled Trial.

PubMed

Zhu, Youwei; Jiang, Haifeng; Su, Hang; Zhong, Na; Li, Runji; Li, Xiaotong; Chen, Tianzhen; Tan, Haoye; Du, Jiang; Xu, Ding; Yan, Huan; Xu, Dawen; Zhao, Min

2018-06-20

Cognitive rehabilitation therapy has been found to improve cognitive deficits and impulse control problems in methamphetamine use disorder (MUD). However, there is limited research regarding this therapy's feasibility when using mobile-based health technologies in supporting recovery from MUD in China. The main aim of this study was to test whether 4 weeks of a newly designed computerized cognitive addiction therapy (CCAT) app can improve cognitive impairments, eliminate drug-related attention bias, and attenuate risk decision-making behaviors in participants with MUD. Forty MUD participants were assigned randomly to either the CCAT group (n=20), who received 4 weeks of CCAT plus regular detoxification treatment as usual, or the control group (n=20), who only received the regular detoxification treatment as usual, in drug rehabilitation centers in Shanghai. The CCAT was designed by combine methamphetamine use-related picture stimuli with cognitive training with the aim of improving cognitive function and eliminating drug-related attention bias. The CogState Battery, Delay Discounting Task (DDT), Iowa Gambling Task (IGT), and Balloon Analog Risk Task (BART) were administered face-to-face to all participants before and after CCAT interventions. Forty male patients were recruited. The mean age was 32.70 (SD 5.27) years in the CCAT group and mean 35.05 (SD 8.02) years in the control group. Compared to the control group, CCAT improved working memory in the CCAT group (P=.01). Group×time interactions were observed among DDT, IGT, and BART tasks, with rates of discounting delayed rewards, IGT, and BART scores (P<.001) being reduced among those who received CCAT, whereas no changes were found in the control group. The newly designed CCAT can help to improve cognitive impairment and impulsive control in MUD. Further study is needed to understand the underlying brain mechanisms of the cognitive therapy. ClinicalTrials.gov NCT03318081; https://clinicaltrials.gov/ct2/show/NCT03318081 (Archived by WebCite at https://clinicaltrials.gov/ct2/show/NCT03318081). ©Youwei Zhu, Haifeng Jiang, Hang Su, Na Zhong, Runji Li, Xiaotong Li, Tianzhen Chen, Haoye Tan, Jiang Du, Ding Xu, Huan Yan, Dawen Xu, Min Zhao. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 20.06.2018.

Resistance Training Improves Muscle Function and Cardiometabolic Risks But Not Quality of Life in Older People With Type 2 Diabetes Mellitus: A Randomized Controlled Trial.

PubMed

Hsieh, Ping-Lun; Tseng, Chin-Hsiao; Tseng, Yufeng Jane; Yang, Wei-Shiung

In older people with type 2 diabetes mellitus (T2DM), the effects of aging and T2DM may compromise the function of skeletal muscle, deteriorate metabolic status, and jeopardize physical performance, aerobic capacity, and quality of life (QoL). The purpose of this study was to investigate the effects of 12 weeks of resistance training (RT) on muscle function, physical performance, cardiometabolic risks, and QoL in older people with T2DM. This study was a randomized controlled trial that employed block randomization, assessor blinding, and the intention-to-treat principle. Thirty people 65 years or older with a diagnosis of T2DM were randomly assigned to either an exercise group or a control group and were further stratified by gender. The exercise group performed 8 RT exercises in 3 sets of 8 to 12 repetitions at 75% 1-repetition maximum (1-RM) 3 times per week for 12 weeks. The control group received usual care and maintained their daily activities and lifestyle. Muscle function (1-RM and muscle oxygenation responses), physical performance (5-repetition sit-to-stand test and Timed Up and Go test), cardiometabolic risks (aerobic capacity, blood pressure, body composition, glycemic control, lipids levels, and high-sensitivity C-reactive protein levels), and QoL (Audit of Diabetes-Dependent Quality of Life 19) were assessed at baseline (week 0) and after the 12-week interventions (week 12). The 1-RM chest-press and leg-press strength and physical performance in 5-repetition sit-to-stand test were significantly improved in the exercise group compared with the controls after the interventions. The exercise group had significantly lower resting systolic blood pressure (by -12.1 mm Hg, P = 0.036) than did the controls after 12 weeks of RT, without any significant within-group change in either group after intervention. The waist circumference, fasting glucose levels, and peak diastolic blood pressure tended to favor RT over usual care after the interventions. Twelve weeks of RT increased the maximal strength in chest-press and leg-press tests, and improved 5-repetition sit-to-stand performance in older people with T2DM. Our study demonstrated that supervised, structured RT was able to promote muscle function and alleviate cardiometabolic risks in people with T2DM 65 years or older.

Design and methods for a pilot randomized clinical trial involving exercise and behavioral activation to treat comorbid type 2 diabetes and major depressive disorder

PubMed Central

Schneider, Kristin L.; Pagoto, Sherry L.; Handschin, Barbara; Panza, Emily; Bakke, Susan; Liu, Qin; Blendea, Mihaela; Ockene, Ira S.; Ma, Yunsheng

2011-01-01

Background The comorbidity of type 2 diabetes mellitus (T2DM) and depression is associated with poor glycemic control. Exercise has been shown to improve mood and glycemic control, but individuals with comorbid T2DM and depression are disproportionately sedentary compared to the general population and report more difficulty with exercise. Behavioral activation, an evidence-based depression psychotherapy, was designed to help people with depression make gradual behavior changes, and may be helpful to build exercise adherence in sedentary populations. This pilot randomized clinical trial will test the feasibility of a group exercise program enhanced with behavioral activation strategies among women with comorbid T2DM and depression. Methods/Design Sedentary women with inadequately controlled T2DM and depression (N=60) will be randomly assigned to one of two conditions: exercise or usual care. Participants randomized to the exercise condition will attend 38 behavioral activation-enhanced group exercise classes over 24 weeks in addition to usual care. Participants randomized to the usual care condition will receive depression treatment referrals and print information on diabetes management via diet and physical activity. Assessments will occur at baseline and 3-, 6-, and 9-months following randomization. The goals of this pilot study are to demonstrate feasibility and intervention acceptability, estimate the resources and costs required to deliver the intervention and to estimate the standard deviation of continuous outcomes (e.g., depressive symptoms and glycosylated hemoglobin) in preparation for a fully-powered randomized clinical trial. Discussion A novel intervention that combines exercise and behavioral activation strategies could potentially improve glycemic control and mood in women with comorbid type 2 diabetes and depression. Trial registration NCT01024790 PMID:21765864

Early intensive hand rehabilitation after spinal cord injury ("Hands On"): a protocol for a randomised controlled trial.

PubMed

Harvey, Lisa A; Dunlop, Sarah A; Churilov, Leonid; Hsueh, Ya-Seng Arthur; Galea, Mary P

2011-01-17

Loss of hand function is one of the most devastating consequences of spinal cord injury. Intensive hand training provided on an instrumented exercise workstation in conjunction with functional electrical stimulation may enhance neural recovery and hand function. The aim of this trial is to compare usual care with an 8-week program of intensive hand training and functional electrical stimulation. A multicentre randomised controlled trial will be undertaken. Seventy-eight participants with recent tetraplegia (C2 to T1 motor complete or incomplete) undergoing inpatient rehabilitation will be recruited from seven spinal cord injury units in Australia and New Zealand and will be randomised to a control or experimental group. Control participants will receive usual care. Experimental participants will receive usual care and an 8-week program of intensive unilateral hand training using an instrumented exercise workstation and functional electrical stimulation. Participants will drive the functional electrical stimulation of their target hands via a behind-the-ear bluetooth device, which is sensitive to tooth clicks. The bluetooth device will enable the use of various manipulanda to practice functional activities embedded within computer-based games and activities. Training will be provided for one hour, 5 days per week, during the 8-week intervention period. The primary outcome is the Action Research Arm Test. Secondary outcomes include measurements of strength, sensation, function, quality of life and cost effectiveness. All outcomes will be taken at baseline, 8 weeks, 6 months and 12 months by assessors blinded to group allocation. Recruitment commenced in December 2009. The results of this trial will determine the effectiveness of an 8-week program of intensive hand training with functional electrical stimulation. NCT01086930 (12th March 2010)ACTRN12609000695202 (12th August 2009).

Effectiveness of Functional Progressive Resistance Exercise Training on Walking Ability in Children with Cerebral Palsy: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Scholtes, Vanessa A.; Becher, Jules G.; Janssen-Potten, Yvonne J.; Dekkers, Hurnet; Smallenbroek, Linda; Dallmeijer, Annet J.

2012-01-01

The objective of the study was to evaluate the effectiveness of functional progressive resistance exercise (PRE) training on walking ability in children with cerebral palsy (CP). Fifty-one ambulant children with spastic CP (mean age 10 years 5 months, 29 boys) were randomized to an intervention (n=26) or control group (n=25, receiving usual care).…

Randomized, Controlled Trial of CBT Training for PTSD Providers

DTIC Science & Technology

2016-10-01

implement and evaluate a cost effective, web based self-paced training program to provide skills-oriented continuing education for mental health...professionals. The objective is to learn whether novel, internet-based training methods, with or without web -centered supervision, may provide an...condition: a) Web -based training plus web -centered supervision; b) Web - based training alone; and c) Training-as-usual control group. An equal number of

Cognitive Behaviour Therapy versus a Counselling Intervention for Anxiety in Young People with High-Functioning Autism Spectrum Disorders: A Pilot Randomised Controlled Trial

ERIC Educational Resources Information Center

Murphy, Suzanne M.; Chowdhury, Uttom; White, Susan W.; Reynolds, Laura; Donald, Louisa; Gahan, Hilary; Iqbal, Zeinab; Kulkarni, Mahesh; Scrivener, Louise; Shaker-Naeeni, Hadi; Press, Dee A.

2017-01-01

The use of cognitive-behavioural therapy (CBT) as a treatment for children and adolescents with autism spectrum disorder (ASD) has been explored in a number of trials. Whilst CBT appears superior to no treatment or treatment as usual, few studies have assessed CBT against a control group receiving an alternative therapy. Our randomised controlled…

A randomised controlled feasibility trial of Group Cognitive Behavioural Therapy for people with severe asthma.

PubMed

Yorke, Janelle; Adair, Pauline; Doyle, Anne-Marie; Dubrow-Marshall, Linda; Fleming, Sharon; Holmes, Leanne; Menzies-Gow, Andrew; Niven, Rob; Pilling, Mark; Shuldham, Caroline

2017-06-01

Evidence for the efficacy of Cognitive Behavioural Therapy (CBT) in asthma is developing but it is not known if this translates to benefits in severe asthma or if a group approach is acceptable to this patient group. This study aimed to assess the feasibility and acceptability of Group-CBT in severe asthma. This was a two-centre, randomised controlled parallel group feasibility study. Eligible participants (patients with severe asthma and a clinically significant diagnosis of anxiety and/or depression - Hospital Anxiety and Depression Scale (HAD) score greater than 8 for the anxiety or depression sub-scale) received Group-CBT in weekly sessions for eight consecutive weeks and usual care or usual care only. Follow-up was for 16 weeks and end points were: Asthma Quality of Life Questionnaire, Asthma Control Questionnaire, HAD, Dyspnoea-12, EuroQual-5D and EuroQuol-VAS. 51 patients were randomised: 36% (51 out of 140) consent rate and attrition at week 16 was 12. Screening logs indicated that study take-up was influenced by patients living long distances from the treatment centre and inability to commit to the weekly demands of the programme. Drop-out was higher in Group-CBT compared due to inability to commit to the weekly programme because of poor health. Participants who contributed to focus group discussions reported that Group-CBT contributed to a better understanding of their illness and related approaches to anxiety management and acceptance of their asthma condition. Although weekly face-to-face sessions were challenging, this was the preferred method of delivery for these participants. This feasibility study shows that Group-CBT warrants further investigation as a potentially promising treatment option for patients with severe asthma. It has been possible but not easy to recruit and retain the sample. Options for a less demanding intervention schedule, such as less frequent face-to-face visits and the use of web-based interventions, require careful consideration.

Entertainment education for breast cancer surgery decisions: a randomized trial among patients with low health literacy.

PubMed

Jibaja-Weiss, Maria L; Volk, Robert J; Granchi, Thomas S; Neff, Nancy E; Robinson, Emily K; Spann, Stephen J; Aoki, Noriaki; Friedman, Lois C; Beck, J Robert

2011-07-01

To evaluate an entertainment-based patient decision aid for early stage breast cancer surgery in low health literacy patients. Newly diagnosed female patients with early stage breast cancer from two public hospitals were randomized to receive an entertainment-based decision aid for breast cancer treatment along with usual care (intervention arm) or to receive usual care only (control arm). Pre-decision (baseline), pre-surgery, and 1-year follow-up assessments were conducted. Patients assigned to the intervention arm of the study were more likely than the controls to choose mastectomy rather than breast-conserving surgery; however, they appeared better informed and clearer about their surgical options than women assigned to the control group. No differences in satisfaction with the surgical decision or the decision-making process were observed between the patients who viewed the intervention and those assigned to the control group. Entertainment education may be a desirable strategy for informing lower health literate women about breast cancer surgery options. Incorporating patient decision aids, particularly computer-based decision aids, into standard clinical practice remains a challenge; however, patients may be directed to view programs at home or at public locations (e.g., libraries, community centers). Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

Examination of the association between announced inspections and inspection scores.

PubMed

Waters, A Blake; VanDerslice, James; Porucznik, Christina A; Kim, Jaewhan; DeLegge, Royal; Durrant, Lynne

2013-09-01

In 2010 the Salt Lake Valley Health Department conducted a pilot of an announced inspection program utilizing a randomized assignment of restaurants to an intervention group with announced inspections and a control group that remained on the usual schedule of unannounced inspections. After adjusting for food type, visible kitchen, outside quality assurance, season, and standardized inspector, significant reductions were found in the odds ratios of personal hygiene (adjusted odds ratios [aOR] = 0.11, p = .00) and equipment cleanliness (aOR = 0.19, p = .00) violations. In the models for the control group, none of the odds ratios were statistically different from one, indicating no change in the postintervention time period as compared to the preintervention period.

Psychological advocacy toward healing (PATH): study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Domestic violence and abuse (DVA), defined as threatening behavior or abuse by adults who are intimate partners or family members, is a key public health and clinical priority. The prevalence of DVA in the United Kingdom and worldwide is high, and its impact on physical and mental health is detrimental and persistent. There is currently little support within healthcare settings for women experiencing DVA. Psychological problems in particular may be difficult to manage outside specialist services, as conventional forms of therapy such as counseling that do not address the violence may be ineffective or even harmful. The aim of this study is to assess the overall effectiveness and cost-effectiveness of a novel psychological intervention tailored specifically for survivors of DVA and delivered by domestic violence advocates based in third-sector organizations. Methods and study design This study is an open, pragmatic, parallel group, individually randomized controlled trial. Women ages 16 years and older experiencing domestic violence are being enrolled and randomly allocated to receive usual DVA agency advocacy support (control) or usual DVA agency support plus psychological intervention (intervention). Those in the intervention group will receive eight specialist psychological advocacy (SPA) sessions weekly or fortnightly, with two follow-up sessions, 1 month and then 3 months later. This will be in addition to any advocacy support sessions each woman receives. Women in the control group will receive usual DVA agency support but no additional SPA sessions. The aim is to recruit 250 women to reach the target sample size. The primary outcomes are psychological well-being and depression severity at 1 yr from baseline, as measured by the Clinical Outcomes in Routine Evaluation–Outcome Measure (CORE-OM) and the Patient Health Questionnaire (PHQ-9), respectively. Secondary outcome measures include anxiety, posttraumatic stress, severity and frequency of abuse, quality of life and cost-effectiveness of the intervention. Data from a subsample of women in both groups will contribute to a nested qualitative study with repeat interviews during the year of follow-up. Discussion This study will contribute to the evidence base for management of the psychological needs of women experiencing DVA. The findings will have important implications for healthcare commissioners and providers, as well as third sector specialist DVA agencies providing services to this client group. Trial registration ISRCTN58561170 PMID:23866771

Psychological advocacy toward healing (PATH): study protocol for a randomized controlled trial.

PubMed

Brierley, Gwen; Agnew-Davies, Roxane; Bailey, Jayne; Evans, Maggie; Fackrell, Morgan; Ferrari, Giulia; Hollinghurst, Sandra; Howard, Louise; Howarth, Emma; Malpass, Alice; Metters, Carol; Peters, Tim J; Saeed, Fayeza; Sardhina, Lynnmarie; Sharp, Debbie; Feder, Gene S

2013-07-17

Domestic violence and abuse (DVA), defined as threatening behavior or abuse by adults who are intimate partners or family members, is a key public health and clinical priority. The prevalence of DVA in the United Kingdom and worldwide is high, and its impact on physical and mental health is detrimental and persistent. There is currently little support within healthcare settings for women experiencing DVA. Psychological problems in particular may be difficult to manage outside specialist services, as conventional forms of therapy such as counseling that do not address the violence may be ineffective or even harmful. The aim of this study is to assess the overall effectiveness and cost-effectiveness of a novel psychological intervention tailored specifically for survivors of DVA and delivered by domestic violence advocates based in third-sector organizations. This study is an open, pragmatic, parallel group, individually randomized controlled trial. Women ages 16 years and older experiencing domestic violence are being enrolled and randomly allocated to receive usual DVA agency advocacy support (control) or usual DVA agency support plus psychological intervention (intervention). Those in the intervention group will receive eight specialist psychological advocacy (SPA) sessions weekly or fortnightly, with two follow-up sessions, 1 month and then 3 months later. This will be in addition to any advocacy support sessions each woman receives. Women in the control group will receive usual DVA agency support but no additional SPA sessions. The aim is to recruit 250 women to reach the target sample size. The primary outcomes are psychological well-being and depression severity at 1 yr from baseline, as measured by the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) and the Patient Health Questionnaire (PHQ-9), respectively. Secondary outcome measures include anxiety, posttraumatic stress, severity and frequency of abuse, quality of life and cost-effectiveness of the intervention. Data from a subsample of women in both groups will contribute to a nested qualitative study with repeat interviews during the year of follow-up. This study will contribute to the evidence base for management of the psychological needs of women experiencing DVA. The findings will have important implications for healthcare commissioners and providers, as well as third sector specialist DVA agencies providing services to this client group. ISRCTN58561170.

Efficacy of an adjunctive brief psychodynamic psychotherapy to usual inpatient treatment of depression: rationale and design of a randomized controlled trial

PubMed Central

2012-01-01

Background A few recent studies have found indications of the effectiveness of inpatient psychotherapy for depression, usually of an extended duration. However, there is a lack of controlled studies in this area and to date no study of adequate quality on brief psychodynamic psychotherapy for depression during short inpatient stay exists. The present article describes the protocol of a study that will examine the relative efficacy, the cost-effectiveness and the cost-utility of adding an Inpatient Brief Psychodynamic Psychotherapy to pharmacotherapy and treatment-as-usual for inpatients with unipolar depression. Methods/Design The study is a one-month randomized controlled trial with a two parallel group design and a 12-month naturalistic follow-up. A sample of 130 consecutive adult inpatients with unipolar depression and Montgomery-Asberg Depression Rating Scale score over 18 will be recruited. The study is carried out in the university hospital section for mood disorders in Lausanne, Switzerland. Patients are assessed upon admission, and at 1-, 3- and 12- month follow-ups. Inpatient therapy is a manualized brief intervention, combining the virtues of inpatient setting and of time-limited dynamic therapies (focal orientation, fixed duration, resource-oriented interventions). Treatment-as-usual represents the best level of practice for a minimal treatment condition usually proposed to inpatients. Final analyses will follow an intention–to-treat strategy. Depressive symptomatology is the primary outcome and secondary outcome includes measures of psychiatric symptomatology, psychosocial role functioning, and psychodynamic-emotional functioning. The mediating role of the therapeutic alliance is also examined. Allocation to treatment groups uses a stratified block randomization method with permuted block. To guarantee allocation concealment, randomization is done by an independent researcher. Discussion Despite the large number of studies on treatment of depression, there is a clear lack of controlled research in inpatient psychotherapy during the acute phase of a major depressive episode. Research on brief therapy is important to take into account current short lengths of stay in psychiatry. The current study has the potential to scientifically inform appropriate inpatient treatment. This study is the first to address the issue of the economic evaluation of inpatient psychotherapy. Trial registration Australian New Zealand Clinical Trial Registry (ACTRN12612000909820) PMID:23110608

Effect of affordable technology on physical activity levels and mobility outcomes in rehabilitation: a protocol for the Activity and MObility UsiNg Technology (AMOUNT) rehabilitation trial

PubMed Central

Hassett, Leanne; van den Berg, Maayken; Lindley, Richard I; Crotty, Maria; McCluskey, Annie; van der Ploeg, Hidde P; Smith, Stuart T; Schurr, Karl; Killington, Maggie; Bongers, Bert; Howard, Kirsten; Heritier, Stephane; Togher, Leanne; Hackett, Maree; Treacy, Daniel; Dorsch, Simone; Wong, Siobhan; Scrivener, Katharine; Chagpar, Sakina; Weber, Heather; Pearson, Ross; Sherrington, Catherine

2016-01-01

Introduction People with mobility limitations can benefit from rehabilitation programmes that provide a high dose of exercise. However, since providing a high dose of exercise is logistically challenging and resource-intensive, people in rehabilitation spend most of the day inactive. This trial aims to evaluate the effect of the addition of affordable technology to usual care on physical activity and mobility in people with mobility limitations admitted to inpatient aged and neurological rehabilitation units compared to usual care alone. Methods and analysis A pragmatic, assessor blinded, parallel-group randomised trial recruiting 300 consenting rehabilitation patients with reduced mobility will be conducted. Participants will be individually randomised to intervention or control groups. The intervention group will receive technology-based exercise to target mobility and physical activity problems for 6 months. The technology will include the use of video and computer games/exercises and tablet applications as well as activity monitors. The control group will not receive any additional intervention and both groups will receive usual inpatient and outpatient rehabilitation care over the 6-month study period. The coprimary outcomes will be objectively assessed physical activity (proportion of the day spent upright) and mobility (Short Physical Performance Battery) at 6 months after randomisation. Secondary outcomes will include: self-reported and objectively assessed physical activity, mobility, cognition, activity performance and participation, utility-based quality of life, balance confidence, technology self-efficacy, falls and service utilisation. Linear models will assess the effect of group allocation for each continuously scored outcome measure with baseline scores entered as a covariate. Fall rates between groups will be compared using negative binomial regression. Primary analyses will be preplanned, conducted while masked to group allocation and use an intention-to-treat approach. Ethics and dissemination The protocol has been approved by the relevant Human Research Ethics Committees and the results will be disseminated widely through peer-reviewed publication and conference presentations. Trial registration number ACTRN12614000936628. Pre-results. PMID:27266776

A feasibility randomised controlled trial of pre-operative occupational therapy to optimise recovery for patients undergoing primary total hip replacement for osteoarthritis (PROOF-THR).

PubMed

Jepson, Paul; Sands, Gina; Beswick, Andrew D; Davis, Edward T; Blom, Ashley W; Sackley, Catherine M

2016-02-01

To assess the feasibility of a pre-operative occupational therapy intervention for patients undergoing primary total hip replacement. Single blinded feasibility randomised controlled trial, with data collection prior to the intervention, and at 4, 12, and 26 weeks following surgery. Recruitment from two NHS orthopaedic outpatient centres in the West Midlands, UK. Patients awaiting primary total hip replacement due to osteoarthritis were recruited. Following pre-operative assessment, patients were individually randomised to intervention or control by a computer-generated block randomisation algorithm stratified by age and centre. The intervention group received a pre-surgery home visit by an occupational therapist who discussed expectations, assessed home safety, and provided appropriate adaptive equipment. The control group received treatment as usual. The study assessed the feasibility of recruitment procedures, delivery of the intervention, appropriateness of outcome measures and data collection methods. Health related quality of life and resource use were recorded at 4, 12 and 26 weeks. Forty-four participants were recruited, 21 were randomised to the occupational therapy intervention and 23 to usual care. Analysis of 26 week data included 18 participants in the intervention group and 21 in the control. The intervention was delivered successfully with no withdrawals or crossovers; 5/44 were lost to follow-up with further missing data for participation and resource use. The feasibility study provided the information required to conduct a definitive trial. Burden of assessment would need to be addressed. A total of 219 patients would be required in an efficacy trial. © The Author(s) 2015.

A Computerized Decision Support System for Depression in Primary Care

PubMed Central

Kurian, Benji T.; Trivedi, Madhukar H.; Grannemann, Bruce D.; Claassen, Cynthia A.; Daly, Ella J.; Sunderajan, Prabha

2009-01-01

Objective: In 2004, results from The Texas Medication Algorithm Project (TMAP) showed better clinical outcomes for patients whose physicians adhered to a paper-and-pencil algorithm compared to patients who received standard clinical treatment for major depressive disorder (MDD). However, implementation of and fidelity to the treatment algorithm among various providers was observed to be inadequate. A computerized decision support system (CDSS) for the implementation of the TMAP algorithm for depression has since been developed to improve fidelity and adherence to the algorithm. Method: This was a 2-group, parallel design, clinical trial (one patient group receiving MDD treatment from physicians using the CDSS and the other patient group receiving usual care) conducted at 2 separate primary care clinics in Texas from March 2005 through June 2006. Fifty-five patients with MDD (DSM-IV criteria) with no significant difference in disease characteristics were enrolled, 32 of whom were treated by physicians using CDSS and 23 were treated by physicians using usual care. The study's objective was to evaluate the feasibility and efficacy of implementing a CDSS to assist physicians acutely treating patients with MDD compared to usual care in primary care. Primary efficacy outcomes for depression symptom severity were based on the 17-item Hamilton Depression Rating Scale (HDRS17) evaluated by an independent rater. Results: Patients treated by physicians employing CDSS had significantly greater symptom reduction, based on the HDRS17, than patients treated with usual care (P < .001). Conclusions: The CDSS algorithm, utilizing measurement-based care, was superior to usual care for patients with MDD in primary care settings. Larger randomized controlled trials are needed to confirm these findings. Trial Registration: clinicaltrials.gov Identifier: NCT00551083 PMID:19750065

A computerized decision support system for depression in primary care.

PubMed

Kurian, Benji T; Trivedi, Madhukar H; Grannemann, Bruce D; Claassen, Cynthia A; Daly, Ella J; Sunderajan, Prabha

2009-01-01

In 2004, results from The Texas Medication Algorithm Project (TMAP) showed better clinical outcomes for patients whose physicians adhered to a paper-and-pencil algorithm compared to patients who received standard clinical treatment for major depressive disorder (MDD). However, implementation of and fidelity to the treatment algorithm among various providers was observed to be inadequate. A computerized decision support system (CDSS) for the implementation of the TMAP algorithm for depression has since been developed to improve fidelity and adherence to the algorithm. This was a 2-group, parallel design, clinical trial (one patient group receiving MDD treatment from physicians using the CDSS and the other patient group receiving usual care) conducted at 2 separate primary care clinics in Texas from March 2005 through June 2006. Fifty-five patients with MDD (DSM-IV criteria) with no significant difference in disease characteristics were enrolled, 32 of whom were treated by physicians using CDSS and 23 were treated by physicians using usual care. The study's objective was to evaluate the feasibility and efficacy of implementing a CDSS to assist physicians acutely treating patients with MDD compared to usual care in primary care. Primary efficacy outcomes for depression symptom severity were based on the 17-item Hamilton Depression Rating Scale (HDRS(17)) evaluated by an independent rater. Patients treated by physicians employing CDSS had significantly greater symptom reduction, based on the HDRS(17), than patients treated with usual care (P < .001). The CDSS algorithm, utilizing measurement-based care, was superior to usual care for patients with MDD in primary care settings. Larger randomized controlled trials are needed to confirm these findings. clinicaltrials.gov Identifier: NCT00551083.

An Economic Analysis of Robot-Assisted Therapy for Long-Term Upper-Limb Impairment After Stroke

PubMed Central

Wagner, Todd H.; Lo, Albert C.; Peduzzi, Peter; Bravata, Dawn M.; Huang, Grant D.; Krebs, Hermano I.; Ringer, Robert J.; Federman, Daniel G.; Richards, Lorie G.; Haselkorn, Jodie K.; Wittenberg, George F.; Volpe, Bruce T.; Bever, Christopher T.; Duncan, Pamela W.; Siroka, Andrew; Guarino, Peter D.

2015-01-01

Background and Purpose Stroke is a leading cause of disability. Rehabilitation robotics have been developed to aid in recovery after a stroke. This study determined the additional cost of robot-assisted therapy and tested its cost-effectiveness. Methods We estimated the intervention costs and tracked participants' healthcare costs. We collected quality of life using the Stroke Impact Scale and the Health Utilities Index. We analyzed the cost data at 36 weeks postrandomization using multivariate regression models controlling for site, presence of a prior stroke, and Veterans Affairs costs in the year before randomization. Results A total of 127 participants were randomized to usual care plus robot therapy (n=49), usual care plus intensive comparison therapy (n=50), or usual care alone (n=28). The average cost of delivering robot therapy and intensive comparison therapy was $5152 and $7382, respectively (P<0.001), and both were significantly more expensive than usual care alone (no additional intervention costs). At 36 weeks postrandomization, the total costs were comparable for the 3 groups ($17 831 for robot therapy, $19 746 for intensive comparison therapy, and $19 098 for usual care). Changes in quality of life were modest and not statistically different. Conclusions The added cost of delivering robot or intensive comparison therapy was recuperated by lower healthcare use costs compared with those in the usual care group. However, uncertainty remains about the cost-effectiveness of robotic-assisted rehabilitation compared with traditional rehabilitation. Clinical Trial Registration URL: http://clinicaltrials.gov. Unique identifier: NCT00372411. PMID:21757677

Specialist mental health consultation for depression in Australian aged care residents with dementia: a cluster randomized trial.

PubMed

McSweeney, Kate; Jeffreys, Aimee; Griffith, Joanne; Plakiotis, Chris; Kharsas, Renee; O'Connor, Daniel W

2012-11-01

This cluster randomized controlled trial sought to determine whether multidisciplinary specialist mental health consultation was more effective than care as usual in treating the depression of aged care residents with dementia. Three hundred and eighty nine aged care residents were screened for dementia and major depression. Forty four were ultimately included in the intervention sample, selected from 20 aged care facilities located in Melbourne, Australia. Facilities were randomly allocated to an intervention condition involving the provision of multidisciplinary specialist consultation regarding the best-practice management of depression in dementia, or to a care as usual condition. Consultations involved individually tailored medical and psychosocial recommendations provided to care staff and general practitioners. All residents participated in a comprehensive pre-intervention diagnostic assessment, including the administration of the Cornell Scale for Depression in Dementia. This assessment was repeated approximately 15 weeks post-intervention by a rater blind to study condition. Multidisciplinary specialist mental health consultation was significantly more effective than care as usual in treating the clinical depression of aged care residents with dementia (p < 0.05, partial η(2)  = 0.16). At follow-up, the mean Cornell Scale for Depression in Dementia score for the intervention group was 9.47, compared with 14.23 for the control group. In addition, 77% of the intervention group no longer met criteria for major depression. The results of this study suggest that the psychosocial and medical management of depressed aged care residents can be improved by increasing access to specialist mental health consultation. Copyright © 2012 John Wiley & Sons, Ltd.

Maintain levels of nicotine but reduce other smoke constituents: a formula for ''less-hazardous'' cigarettes

DOE Office of Scientific and Technical Information (OSTI.GOV)

Robinson, J.C.; Young, J.C.; Rickert, W.S.

Twenty-two volunteers who smoked more than 20 cigarettes with ''high'' nicotine yields (0.8 to 1.2 mg) per day participated in an 8-week study designed to test the hypothesis that smoking cigarettes with a constant level of nicotine but reduced deliveries of tar, carbon monoxide, and hydrogen cyanide leads to a decrease in smoke absorption. All subjects smoked their usual high-nicotine brand for the first 3 weeks (P1), and the absorption of smoke constituents was determined from levels of thiocyanate and cotinine in saliva and serum, levels of carbon monoxide in expired air, and levels of carboxyhemoglobin in the blood. Duringmore » the final 5 weeks (P2), the treatment group (16 subjects) switched to the ''light'' version of their usual brands (similar yields of nicotine but with reduced yields of tar, carbon monoxide, and hydrogen cyanide); the control group (6 subjects) smoked their usual brands for the duration of the study. Average levels of cotinine for the subjects who switched during P2 were not significantly different from those of the control group as was expected. Slight reductions were noted in average expired-air carbon monoxide levels, blood carboxyhemoglobin, and saliva thiocyanate, but these reductions were smaller than anticipated based on brand characteristics. The results suggest that the ratio of smoke constituents is different when individuals, rather than machines, smoke cigarettes. Yields determined under subject-defined conditions are necessary in order to properly evaluate the role of nicotine in the design of ''less-hazardous'' cigarettes.« less

Economic evaluation of an implementation strategy for the management of low back pain in general practice.

PubMed

Jensen, Cathrine Elgaard; Riis, Allan; Petersen, Karin Dam; Jensen, Martin Bach; Pedersen, Kjeld Møller

2017-05-01

In connection with the publication of a clinical practice guideline on the management of low back pain (LBP) in general practice in Denmark, a cluster randomised controlled trial was conducted. In this trial, a multifaceted guideline implementation strategy to improve general practitioners' treatment of patients with LBP was compared with a usual implementation strategy. The aim was to determine whether the multifaceted strategy was cost effective, as compared with the usual implementation strategy. The economic evaluation was conducted as a cost-utility analysis where cost collected from a societal perspective and quality-adjusted life years were used as outcome measures. The analysis was conducted as a within-trial analysis with a 12-month time horizon consistent with the follow-up period of the clinical trial. To adjust for a priori selected covariates, generalised linear models with a gamma family were used to estimate incremental costs and quality-adjusted life years. Furthermore, both deterministic and probabilistic sensitivity analyses were conducted. Results showed that costs associated with primary health care were higher, whereas secondary health care costs were lower for the intervention group when compared with the control group. When adjusting for covariates, the intervention was less costly, and there was no significant difference in effect between the 2 groups. Sensitivity analyses showed that results were sensitive to uncertainty. In conclusion, the multifaceted implementation strategy was cost saving when compared with the usual strategy for implementing LBP clinical practice guidelines in general practice. Furthermore, there was no significant difference in effect, and the estimate was sensitive to uncertainty.

A randomized controlled trial of the effect of intrapartum intravenous fluid management on breastfed newborn weight loss.

PubMed

Watson, Jo; Hodnett, Ellen; Armson, B Anthony; Davies, Barbara; Watt-Watson, Judy

2012-01-01

To determine the effect of conservative versus usual intrapartum intravenous (IV) fluid management for low-risk women receiving epidural analgesia on weight loss in breastfed newborns. A randomized controlled trial. A tertiary perinatal center in a large urban setting. Women experiencing uncomplicated pregnancies who planned to have epidural analgesia and to breastfeed. Healthy pregnant women were randomized to receive an IV epidural preload volume of <500 mLs continuing at an hourly rate of 75-100 mL/h (conservative care) or an epidural preload volume of ≥500 mLs and an hourly rate >125 mL/h (usual care). The primary study outcome was breastfed newborn weight loss >7% prior to hospital discharge. Secondary study outcomes included breastfeeding exclusivity, referral to outpatient breastfeeding clinic support, and delayed discharge. Other outcomes were admission to the neonatal intensive care unit and cord blood pH <7.25. Two hundred women participated (100 in the conservative care and 100 in the usual care groups). Forty-eight of 100 infants in the usual care group and 44 of the 100 infants in the conservative care group lost >7% of their birth weight prior to discharge, p < 0.52 RR 0.92 [0.68-1.24]. A policy of restricted IV fluids did not affect newborn weight loss. Women and their care providers should be reassured that the volumes of IV fluid <2500 mLs are unlikely to have a clinically meaningful effect on breastfed newborn weight loss >7%. Exploratory analyses suggest that breastfed newborn weight loss increases when intrapartum volumes infused are >2500 mLs. Care providers are encouraged to consider volumes of IV fluid infused intrapartum as a factor that may have contributed to early newborn weight loss in the first 48 h of life. © 2012 AWHONN, the Association of Women's Health, Obstetric and Neonatal Nurses.

The benefits and tolerance of exercise in myasthenia gravis (MGEX): study protocol for a randomised controlled trial.

PubMed

Birnbaum, Simone; Hogrel, Jean-Yves; Porcher, Raphael; Portero, Pierre; Clair, Bernard; Eymard, Bruno; Demeret, Sophie; Bassez, Guillaume; Gargiulo, Marcela; Louët, Estelle; Berrih-Aknin, Sonia; Jobic, Asmaa; Aegerter, Philippe; Thoumie, Philippe; Sharshar, Tarek

2018-01-18

Research exploring the effects of physical exercise in auto-immune myasthenia gravis (MG) is scarce. The few existing studies present methodological shortcomings limiting the conclusions and generalisability of results. It is hypothesised that exercise could have positive physical, psychological as well as immunomodulatory effects and may be a beneficial addition to current pharmacological management of this chronic disease. The aim of this study is to evaluate the benefits on perceived quality of life (QOL) and physical fitness of a home-based physical exercise program compared to usual care, for patients with stabilised, generalised auto-immune MG. MGEX is a multi-centre, interventional, randomised, single-blind, two-arm parallel group, controlled trial. Forty-two patients will be recruited, aged 18-70 years. Following a three-month observation period, patients will be randomised into a control or experimental group. The experimental group will undertake a 40-min home-based physical exercise program using a rowing machine, three times a week for three months, as an add-on to usual care. The control group will receive usual care with no additional treatment. All patients will be followed up for a further three months. The primary outcome is the mean change in MGQOL-15-F score between three and six months (i.e. pre-intervention and immediately post-intervention periods). The MGQOL-15-F is an MG-specific patient-reported QOL questionnaire. Secondary outcomes include the evaluation of deficits and functional limitations via MG-specific clinical scores (Myasthenia Muscle Score and MG-Activities of Daily Living scale), muscle force and fatigue, respiratory function, free-living physical activity as well as evaluations of anxiety, depression, self-esteem and overall QOL with the WHO-QOL BREF questionnaire. Exercise workload will be assessed as well as multiple safety measures (ECG, biological markers, medication type and dosage and any disease exacerbation or crisis). This is the largest randomised controlled trial to date evaluating the benefits and tolerance of physical exercise in this patient population. The comprehensive evaluations using standardised outcome measures should provide much awaited information for both patients and the scientific community. This study is ongoing. ClinicalTrials.gov, NCT02066519 . Registered on 13 January 2014.

Effect on Insulin, Glucose and Lipids in Overweight/Obese Australian Adults of 12 Months Consumption of Two Different Fibre Supplements in a Randomised Trial

PubMed Central

Pal, Sebely; Ho, Suleen; Gahler, Roland J.; Wood, Simon

2017-01-01

Higher fibre intakes are associated with risk reduction for chronic diseases. This study investigated the effects of supplementation with PolyGlycopleX® (PGX), a complexed polysaccharide, on insulin, glucose and lipids in overweight and obese individuals. In this double-blind 12 months study, participants were randomised into three groups: control (rice flour); PGX or psyllium (PSY). Participants followed their usual lifestyle and diet but consumed 5 g of their supplement before meals. Insulin was significantly lower in the PGX and PSY groups compared to control at 3 and 6 months and in the PSY group compared to control at 12 months. Serum glucose was significantly lower in the PGX group at 3 months compared to control. Total cholesterol was significantly lower in the PGX and PSY groups compared to control at 3 and 6 months. High density lipoprotein (HDL) cholesterol was significantly increased in the PGX group compared to control at 12 months. low density lipoprotein (LDL) cholesterol was significantly lower in the PGX group at 3 and 6 months compared to control and in the PSY group at 3 months compared to control. A simple strategy of fibre supplementation may offer an effective solution to glucose, insulin and lipid management without the need for other nutrient modification. PMID:28146065

Clinical and cost effectiveness of computer treatment for aphasia post stroke (Big CACTUS): study protocol for a randomised controlled trial.

PubMed

Palmer, Rebecca; Cooper, Cindy; Enderby, Pam; Brady, Marian; Julious, Steven; Bowen, Audrey; Latimer, Nicholas

2015-01-27

Aphasia affects the ability to speak, comprehend spoken language, read and write. One third of stroke survivors experience aphasia. Evidence suggests that aphasia can continue to improve after the first few months with intensive speech and language therapy, which is frequently beyond what resources allow. The development of computer software for language practice provides an opportunity for self-managed therapy. This pragmatic randomised controlled trial will investigate the clinical and cost effectiveness of a computerised approach to long-term aphasia therapy post stroke. A total of 285 adults with aphasia at least four months post stroke will be randomly allocated to either usual care, computerised intervention in addition to usual care or attention and activity control in addition to usual care. Those in the intervention group will receive six months of self-managed word finding practice on their home computer with monthly face-to-face support from a volunteer/assistant. Those in the attention control group will receive puzzle activities, supplemented by monthly telephone calls. Study delivery will be coordinated by 20 speech and language therapy departments across the United Kingdom. Outcome measures will be made at baseline, six, nine and 12 months after randomisation by blinded speech and language therapist assessors. Primary outcomes are the change in number of words (of personal relevance) named correctly at six months and improvement in functional conversation. Primary outcomes will be analysed using a Hochberg testing procedure. Significance will be declared if differences in both word retrieval and functional conversation at six months are significant at the 5% level, or if either comparison is significant at 2.5%. A cost utility analysis will be undertaken from the NHS and personal social service perspective. Differences between costs and quality-adjusted life years in the three groups will be described and the incremental cost effectiveness ratio will be calculated. Treatment fidelity will be monitored. This is the first fully powered trial of the clinical and cost effectiveness of computerised aphasia therapy. Specific challenges in designing the protocol are considered. Registered with Current Controlled Trials ISRCTN68798818 on 18 February 2014.

Educational intervention improves anticoagulation control in atrial fibrillation patients: the TREAT randomised trial.

PubMed

Clarkesmith, Danielle E; Pattison, Helen M; Lip, Gregory Y H; Lane, Deirdre A

2013-01-01

Stroke prevention in atrial fibrillation (AF), most commonly with warfarin, requires maintenance of a narrow therapeutic target (INR 2.0 to 3.0) and is often poorly controlled in practice. Poor patient-understanding surrounding AF and its treatment may contribute to the patient's willingness to adhere to recommendations. A theory-driven intervention, developed using patient interviews and focus groups, consisting of a one-off group session (1-6 patients) utilising an "expert-patient" focussed DVD, educational booklet, self-monitoring diary and worksheet, was compared in a randomised controlled trial (ISRCTN93952605) against usual care, with patient postal follow-ups at 1, 2, 6, and 12-months. Ninety-seven warfarin-naïve AF patients were randomised to intervention (n=46, mean age (SD) 72.0 (8.2), 67.4% men), or usual care (n=51, mean age (SD) 73.7 (8.1), 62.7% men), stratified by age, sex, and recruitment centre. Primary endpoint was time within therapeutic range (TTR); secondary endpoints included knowledge, quality of life, anxiety/depression, beliefs about medication, and illness perceptions. Intervention patients had significantly higher TTR than usual care at 6-months (76.2% vs. 71.3%; p=0.035); at 12-months these differences were not significant (76.0% vs. 70.0%; p=0.44). Knowledge increased significantly across time (F (3, 47) = 6.4; p<0.01), but there were no differences between groups (F (1, 47) = 3.3; p = 0.07). At 6-months, knowledge scores predicted TTR (r=0.245; p=0.04). Patients' scores on subscales representing their perception of the general harm and overuse of medication, as well as the perceived necessity of their AF specific medications predicted TTR at 6- and 12-months. A theory-driven educational intervention significantly improves TTR in AF patients initiating warfarin during the first 6-months. Adverse clinical outcomes may potentially be reduced by improving patients' understanding of the necessity of warfarin and reducing their perception of treatment harm. Improving education provision for AF patients is essential to ensure efficacious and safe treatment. The trial is registered with Current Controlled Trials, ISRCTN93952605, and details are available at www.controlled-trials.com/ISRCTN93952605.

A randomized controlled trial to increase information, motivation, and behavioral skills in Ugandan adolescents

PubMed Central

Ybarra, Michele L.; Korchmaros, Josephine D.; Prescott, Tonya L.; Birungi, Ruth

2015-01-01

Background One in twenty-five Ugandan adolescents is HIV positive. Purpose Examine the impact of an Internet-based HIV prevention program on Information-Motivation-Behavior Skills Model-related constructs. Methods Three hundred and sixty-six sexually experienced and inexperienced students 12-18+ years-old in Mbarara, Uganda were randomly assigned to: the five-lesson CyberSenga program or treatment-as-usual. Half of the intervention participants were further randomized to a booster session. Assessments were collected at three and six months post-baseline. Results Participants’ HIV-related information improved over time at a greater rate for the intervention groups compared to the control group. Motivation for condom use changed to a greater degree over time for the intervention group – especially those in the intervention+booster group - compared to the control group. Behavioral skills for condom use, and motivation and behavioral skills for abstinence were statistically similar over time for both groups. Conclusions CyberSenga improves HIV preventive information and motivation to use condoms. PMID:25633626

Therapeutic conversation to improve mood in nursing home residents with Alzheimer's disease.

PubMed

Tappen, Ruth M; Williams, Christine L

2009-10-01

Few studies have tested strategies to address the mental health needs of individuals with Alzheimer's disease (AD). To test a newly developed, empirically based modified counseling approach, 30 nursing home residents with AD were randomly assigned to a modified counseling (Therapeutic Conversation) treatment group or usual care control group. Mini-Mental State Examination mean scores were 10.60 (SD = 6.99) for the treatment group and 12.26 (SD = 7.43) for the control group. Individual treatment was provided three times per week for 16 weeks. On the posttest, treatment group participants evidenced significantly less negative mood than the control group on the Montgomery-Asberg Depression Rating Scale and the Sadness and Apathy subscales of the Alzheimer's Disease and Related Disorders Mood Scale. The differences approached significance on the Dementia Mood Assessment Scale. Results suggest that a therapeutic counseling approach can be effective in treating the dysphoria commonly found in individuals with AD. Copyright 2009, SLACK Incorporated.

Effectiveness of a Multi-Component Intervention for Overweight and Obese Children (Nereu Program): A Randomized Controlled Trial

PubMed Central

Serra-Paya, Noemi; Ensenyat, Assumpta; Castro-Viñuales, Iván; Real, Jordi; Sinfreu-Bergués, Xènia; Zapata, Amalia; Mur, Jose María; Galindo-Ortego, Gisela; Solé-Mir, Eduard; Teixido, Concepció

2015-01-01

Introduction Treatment of childhood obesity is a complex challenge for primary health care professionals. Objectives To evaluate the effectiveness of the Nereu Program in improving anthropometric parameters, physical activity and sedentary behaviours, and dietary intake. Methods Randomized, controlled, multicentre clinical trial comparing Nereu Program and usual counselling group interventions in primary care settings. The 8-month study recruited 113 children aged 6 to 12 years with overweight/obesity. Before recruitment, eligible participants were randomly allocated to an intensive, family-based multi-component behavioural intervention (Nereu Program group) or usual advice from their paediatrician on healthy eating and physical activity. Anthropometric parameters, objectively measured sedentary and physical activity behaviours, and dietary intake were evaluated pre- and post-intervention. Results At the end of the study period, both groups achieved a similar decrease in body mass index (BMIsd) compared to baseline. Nereu Program participants (n = 54) showed greater increases in moderate-intense physical activity (+6.27% vs. -0.61%, p<0.001) and daily fruit servings (+0.62 vs. +0.13, p<0.026), and decreased daily soft drinks consumption (-0.26 vs. -0.02, p<0.047), respectively, compared to the counselling group (n = 59). Conclusions At the end of the 8-month intervention, participants in the Nereu Program group showed improvement in physical activity and dietary behaviours, compared to the counselling group. Trial Registration ClinicalTrials.gov NCT01878994 PMID:26658988

Medication therapy management and complex patients with disability: a randomized controlled trial.

PubMed

Chrischilles, Elizabeth A; Doucette, William; Farris, Karen; Lindgren, Scott; Gryzlak, Brian; Rubenstein, Linda; Youland, Kelly; Wallace, Robert B

2014-02-01

Drug therapy problems, adverse drug events (ADEs), and symptom burden are high among adults with disabilities. To compare the effects of a modified medication therapy management (MTM) program within a self-efficacy workshop versus the workshop alone or usual care on symptom burden among adults with activity limitations. Three-group randomized controlled trial among adults (age 40 and older) with self-reported activity limitations in community practice. 8 weekly Living Well With a Disability (LWD) 2-hour workshop sessions with and without a collaborative medication management (CMM) module. mean number of moderate to very severe symptoms from a list of 11 physical and mental symptoms. Process measures: changes in medication regimens and self-reported ADEs. general linear mixed models (continuous outcomes) and generalized estimating equations (categorical outcomes). Participants had high symptom burden, low physical health, and took many medications. There was a significant increase in ADE reporting in the LWD + CMM group relative to the other 2 groups (Study group × Time P = .014), and there were significantly more changes in medication regimens in the LWD + CMM group (P = .013 LWD only vs LWD + CMM). The oldest third of participants had significantly fewer mean symptoms but received more intense CMM. There was no difference between the LWD-only, LWD + CMM, and usual care groups in symptom burden over time. Pharmacist MTM practices and MTM guidelines may need to be modified to affect symptom burden in a population with physical activity limitations.

Strength Training Following Hematopoietic Stem Cell Transplantation

PubMed Central

Hacker, Eileen Danaher; Larson, Janet; Kujath, Amber; Peace, David; Rondelli, Damiano; Gaston, Lisa

2010-01-01

Background Patients receiving high-dose chemotherapy and hematopoietic stem cell transplantation (HSCT) experience considerable reductions in physical activity and deterioration of their health status. Objective The purpose of this pilot study was to test the effects of strength training compared to usual activity on physical activity, muscle strength, fatigue, health status perceptions, and quality of life following HSCT. Interventions/Methods Nineteen subjects were randomized to the exercise or control group. Moderate intensity strength training began following discharge from the hospital. Dependent variables included physical activity, muscle strength, fatigue, health status perceptions and quality of life. Variables were measured prior to admission to the hospital for HSCT, day 8 following HSCT, and six weeks following discharge from the hospital. Results Significant time effects were noted for many variables with anticipated declines in physical activity, muscle strength, fatigue, and health status perceptions immediately after HSCT with subsequent improvements six weeks following hospital discharge. One group effect was noted with subjects in the exercise group reporting less fatigue than subjects in the control group. Although no significant interactions were detected, the trends suggest that the exercise group may be more physically active following the intervention compared to the usual activity group. Conclusions This study demonstrates the potential positive effects of strength training on physical activity, fatigue, and quality of life in people receiving high-dose chemotherapy and HSCT. Implications for Practice Preliminary evidence is provided for using strength training to enhance early recovery following HSCT. Elastic resistance bands are easy to use and relatively inexpensive. PMID:21116175

[The development and effects of an integrated symptom management program for prevention of recurrent cardiac events after percutaneous coronary intervention].

PubMed

Son, Youn-Jung

2008-04-01

This study was conducted to develop and to determine the effects of an integrated symptom management program for prevention of recurrent cardiac events after percutaneous coronary intervention. Subjects consisted of 58 CAD patients (experimental group: 30, control group: 28). The experimental group participated in an integrated symptom management program for 6 months which was composed of tailored education, stress management, exercise, diet, deep breathing, music therapy, periodical telephone monitoring and a daily log. The control group received the usual care. The experimental group significantly decreased symptom experiences and the level of LDL compared to the control group. The experimental group significantly increased self care activity and quality of life compared to the control group. Although no significant difference was found in cardiac recurrence, the experimental group had fewer recurrences. These results suggest that an integrated symptom management program for prevention of recurrent cardiac events after percutaneous coronary intervention can improve symptom aggravation, recurrent rate, self care activity and quality of life. Nursing interventions are needed to maintain and further enhance the quality of life of these patients and the interventions should be implemented in the overall transition period.

Comparison of the caries-protective effect of fluoride varnish with treatment as usual in nursery school attendees receiving preventive oral health support through the Childsmile oral health improvement programme - the Protecting Teeth@3 Study: a randomised controlled trial.

PubMed

Wright, William; Turner, Stephen; Anopa, Yulia; McIntosh, Emma; Wu, Olivia; Conway, David I; Macpherson, Lorna M D; McMahon, Alex D

2015-12-18

The Scottish Government set out its policy on addressing the poor oral health of Scottish children in 2005. This led to the establishment of Childsmile, a national programme designed to improve the oral health of children in Scotland. One element of the programme promotes daily tooth brushing in all nurseries in Scotland (Childsmile Core). A second targeted component (Childsmile Nursery) offers twice-yearly application of fluoride varnish to children attending nurseries in deprived areas. Studies suggest that fluoride varnish application can reduce caries in both adult and child populations. This trial aims to explore the effectiveness and cost-effectiveness of additional preventive value fluoride varnish application compared to Childsmile Core. The Protecting Teeth@3 Study is an ongoing 2 year parallel group randomised treatment as usual controlled trial. Three-year-old children attending the ante pre-school year are randomised (1:1) to the intervention arm (fluoride varnish & treatment as usual) or the control arm (treatment as usual). Children in the intervention arm will have Duraphat® fluoride varnish painted on the primary tooth surfaces and will continue to receive treatment as usual: the core Childsmile Nursery intervention. Children in the treatment as usual arm will receive the same series of contacts, without the application of varnish and will also continue with the Childsmile Core intervention. Interventions are undertaken by Childsmile trained extended duty dental nurses at six-monthly intervals. Participants receive a baseline dental inspection in nursery and an endpoint inspection in Primary 1 at the age of 5 years old. We will use primary and secondary outcome measures to compare the effectiveness of Duraphat® fluoride varnish plus treatment as usual with treatment as usual only in preventing any further dental decay. We will also undertake a full economic evaluation of the trial. This study is registered at ClinicalTrials.gov. Number: NCT01674933 (24 August 2012).

Long-term efficacy of a rural community-based integrated intervention for prevention and management of chronic obstructive pulmonary disease: a cluster randomized controlled trial in China's rural areas.

PubMed

Yuan, X; Tao, Y; Zhao, J P; Liu, X S; Xiong, W N; Xie, J G; Ni, W; Xu, Y J; Liu, H G

2015-11-01

This study aimed to assess the efficacy of a rural community-based integrated intervention for early prevention and management of chronic obstructive pulmonary disease (COPD) in China. This 18-year cluster-randomized controlled trial encompassing 15 villages included 1008 patients (454 men and 40 women in the intervention group [mean age, 54 ± 10 years]; 482 men and 32 women in the control group [mean age, 53 ± 10 years]) with confirmed COPD or at risk for COPD. Villages were randomly assigned to the intervention or the control group, and study participants residing within the villages received treatment accordingly. Intervention group patients took part in a program that included systematic health education, smoking cessation counseling, and education on management of COPD. Control group patients received usual care. The groups were compared after 18 years regarding the incidence of COPD, decline in lung function, and mortality of COPD. COPD incidence was lower in the intervention group than in the control group (10% vs 16%, <0.05). A decline in lung function was also significantly delayed in the intervention group compared to the control group of COPD and high-risk patients. The intervention group showed significant improvement in smoking cessation compared with the control group, and smokers in the intervention group had lower smoking indices than in the control group (350 vs 450, <0.05). The intervention group also had a significantly lower cumulative COPD-related death rate than the control group (37% vs 47%, <0.05). A rural community-based integrated intervention is effective in reducing the incidence of COPD among those at risk, delaying a decline in lung function in COPD patients and those at risk, and reducing mortality of COPD.

Wacky Wednesday: use of distraction through humor to reduce preoperative anxiety in children and their parents.

PubMed

Berger, Jill; Wilson, Darlena; Potts, Linda; Polivka, Barbara

2014-08-01

The purpose of this study was to determine the effect of distraction through humor on anxiety among children having outpatient surgery, and their parents. Quasi-experimental design using a nonrandomized control group. The study assessed preoperative anxiety in child-parent dyads. The control group received usual care. The intervention group received the "Wacky Wednesday" (WW) intervention in which they entered an environment where employees were dressed in "wacky" attire and children and parents were provided with gifts and costume items. Anxiety scores, heart rate, and blood pressure were collected from patients and parents in both groups on admission and just before transfer to surgery. Children who arrived for surgery on WW had significantly lower anxiety scores on admission than children in the control group. In addition, children and parents who received the WW intervention had significantly lower anxiety scores just before surgery than those in the control group. Humor and distraction are effective with children and parents in relieving preoperative anxiety. Copyright © 2014 American Society of PeriAnesthesia Nurses. Published by Elsevier Inc. All rights reserved.

The effect of telehealth, telephone support or usual care on quality of life, mortality and healthcare utilization in elderly high-risk patients with multiple chronic conditions. A prospective study.

PubMed

Valdivieso, Bernardo; García-Sempere, Anibal; Sanfélix-Gimeno, Gabriel; Faubel, Raquel; Librero, Julian; Soriano, Elisa; Peiró, Salvador

2018-04-25

To assess the effect of home based telehealth or structured telephone support interventions with respect to usual care on quality of life, mortality and healthcare utilization in elderly high-risk multiple chronic condition patients. 472 elderly high-risk patients with plurimorbidity in the region of Valencia (Spain) were recruited between June 2012 and May 2013, and followed for 12 months from recruitment. Patients were allocated to either: (a) a structured telephone intervention, a nurse-led case management program with telephone follow up every 15 days; (b) telehealth, which adds technology for remote self-management and the exchange of clinical data; or (c) usual care. Main outcome measures was quality of life measured by the EuroQol (EQ-5D) instrument, cognitive impairment, functional status, mortality and healthcare resource use. Inadequate randomization process led us to used propensity scores for adjusted analyses to control for imbalances between groups at baseline. EQ-5D score was significantly higher in the telehealth group compared to usual care (diff: 0.19, 0.08-0.30), but was not different to telephone support (diff: 0.04, -0.05 to 0.14). In adjusted analyses, inclusion in the telehealth group was associated with an additional 0.18 points in the EQ-5D score compared to usual care at 12 months (p<0.001), and with a gain of 0.13 points for the telephone support group (p<0.001). No differences in mortality or utilization were found, except for a borderline significant increase in General Practitioner visits. Telehealth was associated with better quality of life. Important limitations of the study and similarity of effects to telephone intervention call for careful endorsement of telemedicine. Clinicaltrials.gov (identifier: NCT02447562). Copyright © 2018 Elsevier España, S.L.U. All rights reserved.

Design of a multicentre randomized controlled trial to evaluate the effectiveness of a tailored clinical support intervention to enhance return to work for gastrointestinal cancer patients.

PubMed

Zaman, AnneClaire G N M; Tytgat, Kristien M A J; Klinkenbijl, Jean H G; Frings-Dresen, Monique H W; de Boer, Angela G E M

2016-05-10

Gastrointestinal (GI) cancer is frequently diagnosed in people of working age, and many GI cancer patients experience work-related problems. Although these patients often experience difficulties returning to work, supportive work-related interventions are lacking. We have therefore developed a tailored work-related support intervention for GI cancer patients, and we aim to evaluate its cost-effectiveness compared with the usual care provided. If this intervention proves effective, it can be implemented in practice to support GI cancer patients after diagnosis and to help them return to work. We designed a multicentre randomized controlled trial with a follow-up of twelve months. The study population (N = 310) will include individuals aged 18-63 years diagnosed with a primary GI cancer and employed at the time of diagnosis. The participants will be randomized to the intervention or to usual care. 'Usual care' is defined as psychosocial care in which work-related issues are not discussed. The intervention group will receive tailored work-related support consisting of three face-to-face meetings of approximately 30 min each. Based on the severity of their work-related problems, the intervention group will be divided into groups receiving three types of support (A, B or C). A different supportive healthcare professional will be available for each group: an oncological nurse (A), an oncological occupational physician (B) and a multidisciplinary team (C) that includes an oncological nurse, oncological occupational physician and treating oncologist/physician. The primary outcome measure is return to work (RTW), defined as the time to a partial or full RTW. The secondary outcomes are work ability, work limitations, quality of life, and direct and indirect costs. The hypothesis is that tailored work-related support for GI cancer patients is more effective than usual care in terms of the RTW. The intervention is innovative in that it combines oncological and occupational care in a clinical setting, early in the cancer treatment process. METC protocol number NL51444.018.14/Netherlands Trial Register number NTR5022 . Registered 6 March 2015.

Effects of a renal rehabilitation exercise program in patients with CKD: a randomized, controlled trial.

PubMed

Rossi, Ana P; Burris, Debra D; Lucas, F Leslie; Crocker, Gail A; Wasserman, James C

2014-12-05

Patients with CKD have a high prevalence of cardiovascular disease associated with or exacerbated by inactivity. This randomized, controlled study investigated whether a renal rehabilitation exercise program for patients with stages 3 or 4 CKD would improve their physical function and quality of life. In total, 119 adults with CKD stages 3 and 4 were randomized, and 107 of these patients proceeded to usual care or the renal rehabilitation exercise intervention consisting of usual care plus guided exercise two times per week for 12 weeks (24 sessions). Physical function was determined by three well established performance-based tests: 6-minute walk test, sit-to-stand test, and gait-speed test. Health-related quality of life was assessed by the RAND 36-Item Short Form Health Survey. At baseline, no differences in self-reported level of activity, 6-minute walk test, and sit-to-stand test scores were observed between the usual care (n=48) and renal rehabilitation exercise (n=59) groups, although baseline gait-speed test score was higher in the renal rehabilitation exercise group (P<0.001). At follow-up, the renal rehabilitation exercise group but not the usual care group showed significant improvements in the 6-minute walk test (+210.4±266.0 ft [19% improvement] versus -10±219.9 ft; P<0.001), the sit-to-stand test (+26.9±27% of age prediction [29% improvement] versus +0.7±12.1% of age prediction; P<0.001), and the RAND-36 physical measures of role functioning (P<0.01), physical functioning (P<0.01), energy/fatigue levels (P=0.01), and general health (P=0.03) and mental measure of pain scale (P=0.04). The renal rehabilitation exercise regimen was generally well tolerated. A 12-week/24-session renal rehabilitation exercise program improved physical capacity and quality of life in patients with CKD stages 3 and 4. Longer follow-up is needed to determine if these findings will translate into decreased mortality rates. Copyright © 2014 by the American Society of Nephrology.

Clinical Research Methodology 2: Observational Clinical Research.

PubMed

Sessler, Daniel I; Imrey, Peter B

2015-10-01

Case-control and cohort studies are invaluable research tools and provide the strongest feasible research designs for addressing some questions. Case-control studies usually involve retrospective data collection. Cohort studies can involve retrospective, ambidirectional, or prospective data collection. Observational studies are subject to errors attributable to selection bias, confounding, measurement bias, and reverse causation-in addition to errors of chance. Confounding can be statistically controlled to the extent that potential factors are known and accurately measured, but, in practice, bias and unknown confounders usually remain additional potential sources of error, often of unknown magnitude and clinical impact. Causality-the most clinically useful relation between exposure and outcome-can rarely be definitively determined from observational studies because intentional, controlled manipulations of exposures are not involved. In this article, we review several types of observational clinical research: case series, comparative case-control and cohort studies, and hybrid designs in which case-control analyses are performed on selected members of cohorts. We also discuss the analytic issues that arise when groups to be compared in an observational study, such as patients receiving different therapies, are not comparable in other respects.

Cost-effectiveness of cognitive-behavioural therapy as an adjunct to pharmacotherapy for treatment-resistant depression in primary care: economic evaluation of the CoBalT Trial.

PubMed

Hollinghurst, Sandra; Carroll, Fran E; Abel, Anna; Campbell, John; Garland, Anne; Jerrom, Bill; Kessler, David; Kuyken, Willem; Morrison, Jill; Ridgway, Nicola; Thomas, Laura; Turner, Katrina; Williams, Chris; Peters, Tim J; Lewis, Glyn; Wiles, Nicola

2014-01-01

Depression is expensive to treat, but providing ineffective treatment is more expensive. Such is the case for many patients who do not respond to antidepressant medication. To assess the cost-effectiveness of cognitive-behavioural therapy (CBT) plus usual care for primary care patients with treatment-resistant depression compared with usual care alone. Economic evaluation at 12 months alongside a randomised controlled trial. Cost-effectiveness assessed using a cost-consequences framework comparing cost to the health and social care provider, patients and society, with a range of outcomes. Cost-utility analysis comparing health and social care costs with quality-adjusted life-years (QALYs). The mean cost of CBT per participant was £910. The difference in QALY gain between the groups was 0.057, equivalent to 21 days a year of good health. The incremental cost-effectiveness ratio was £14 911 (representing a 74% probability of the intervention being cost-effective at the National Institute of Health and Care Excellence threshold of £20 000 per QALY). Loss of earnings and productivity costs were substantial but there was no evidence of a difference between intervention and control groups. The addition of CBT to usual care is cost-effective in patients who have not responded to antidepressants. Primary care physicians should therefore be encouraged to refer such individuals for CBT.

Effects of a guided web-based smoking cessation program with telephone counseling: a cluster randomized controlled trial.

PubMed

Mehring, Michael; Haag, Max; Linde, Klaus; Wagenpfeil, Stefan; Schneider, Antonius

2014-09-24

Preliminary findings suggest that Web-based interventions may be effective in achieving significant smoking cessation. To date, very few findings are available for primary care patients, and especially for the involvement of general practitioners. Our goal was to examine the short-term effectiveness of a fully automated Web-based coaching program in combination with accompanied telephone counseling in smoking cessation in a primary care setting. The study was an unblinded cluster-randomized trial with an observation period of 12 weeks. Individuals recruited by general practitioners randomized to the intervention group participated in a Web-based coaching program based on education, motivation, exercise guidance, daily short message service (SMS) reminding, weekly feedback through Internet, and active monitoring by general practitioners. All components of the program are fully automated. Participants in the control group received usual care and advice from their practitioner without the Web-based coaching program. The main outcome was the biochemically confirmed smoking status after 12 weeks. We recruited 168 participants (86 intervention group, 82 control group) into the study. For 51 participants from the intervention group and 70 participants from the control group, follow-up data were available both at baseline and 12 weeks. Very few patients (9.8%, 5/51) from the intervention group and from the control group (8.6%, 6/70) successfully managed smoking cessation (OR 0.86, 95% CI 0.25-3.0; P=.816). Similar results were found within the intent-to-treat analysis: 5.8% (5/86) of the intervention group and 7.3% (6/82) of the control group (OR 1.28, 95% CI 0.38-4.36; P=.694). The number of smoked cigarettes per day decreased on average by 9.3 in the intervention group and by 6.6 in the control group (2.7 mean difference; 95% CI -5.33 to -0.58; P=.045). After adjustment for the baseline value, age, gender, and height, this significance decreases (mean difference 2.2; 95% CI -4.7 to 0.3; P=.080). This trial did not show that the tested Web-based intervention was effective for achieving smoking cessation compared to usual care. The limited statistical power and the high drop-out rate may have reduced the study's ability to detect significant differences between the groups. Further randomized controlled trials are needed in larger populations and to investigate the long-term outcome. German Register for Clinical Trials, registration number DRKS00003067; http://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ ID=DRKS00003067 (Archived by WebCite at http://www.webcitation.org/6Sff1YZpx).

Substitution of Usual Perioperative Care by eHealth to Enhance Postoperative Recovery in Patients Undergoing General Surgical or Gynecological Procedures: Study Protocol of a Randomized Controlled Trial

PubMed Central

Huirne, Judith AF; Bouwsma, Esther VA; van Dongen, Johanna M; Terwee, Caroline B; van de Ven, Peter M; den Bakker, Chantal M; van der Meij, Suzan; van Baal, W Marchien; Leclercq, Wouter KG; Geomini, Peggy MAJ; Consten, Esther CJ; Schraffordt Koops, Steven E; van Kesteren, Paul JM; Stockmann, Hein BAC; ten Cate, A Dorien; Davids, Paul HP; Scholten, Petrus C; van den Heuvel, Baukje; Schaafsma, Frederieke G; Meijerink, Wilhelmus JHJ; Bonjer, H Jaap; Anema, Johannes R

2016-01-01

Background Due to the strong reduction in the length of hospital stays in the last decade, the period of in-hospital postoperative care is limited. After discharge from the hospital, guidance and monitoring on recovery and resumption of (work) activities are usually not provided. As a consequence, return to normal activities and work after surgery is hampered, leading to a lower quality of life and higher costs due to productivity loss and increased health care consumption. Objective With this study we aim to evaluate whether an eHealth care program can improve perioperative health care in patients undergoing commonly applied abdominal surgical procedures, leading to accelerated recovery and to a reduction in costs in comparison to usual care. Methods This is a multicenter randomized, single-blinded, controlled trial. At least 308 patients between 18 and 75 years old who are on the waiting list for a laparoscopic cholecystectomy, inguinal hernia surgery, or laparoscopic adnexal surgery for a benign indication will be included. Patients will be randomized to an intervention or control group. The intervention group will have access to an innovative, perioperative eHealth care program. This intervention program consists of a website, mobile phone app, and activity tracker. It aims to improve patient self-management and empowerment by providing guidance to patients in the weeks before and after surgery. The control group will receive usual care and will have access to a nonintervention (standard) website consisting of the digital information brochure about the surgical procedure being performed. Patients are asked to complete questionnaires at 5 moments during the first 6 months after surgery. The primary outcome measure is time to return to normal activities based on a patient-specific set of 8 activities selected from the Patient-Reported Outcomes Measurement Information System (PROMIS) physical functioning item bank version 1.2. Secondary outcomes include social participation, self-rated health, duration of return to work, physical activity, length of recovery, pain intensity, and patient satisfaction. In addition, an economic evaluation alongside this randomized controlled trial will be performed from the societal and health care perspective. All statistical analyses will be conducted according to the intention-to-treat principle. Results The enrollment of patients started in September 2015. The follow-up period will be completed in February 2017. Data cleaning and analyses have not begun as of the time this article was submitted. Conclusions We hypothesize that patients receiving the intervention program will resume their normal activities sooner than patients in the control group and costs will be lower. ClinicalTrial Netherlands Trial Registry NTC4699; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4699 (Archived by WebCite at http://www.webcitation.org/6mcCBZmwy) PMID:28003177

[Infants' attachment security in a vulnerable French sample].

PubMed

Tereno, S; Guedeney, N; Dugravier, R; Greacen, T; Saïas, T; Tubach, F; Ulgen, S; Matos, I; Guédeney, A

2017-04-01

Attachment is a long lasting emotional link established between infants and their caregivers. The quality of early relationships allows infants to safely explore their environment and contribute to the establishment of a broad range of social skills. Several intervention programs targeting infant attachment have been implemented in different contexts, showing diverse degrees of efficacy. The present paper describes, for the first time, children's attachment quality distributions in a French multi-risk population, with a preventive intervention, usual or reinforced. In the CAPEDP study (Parenting and Attachment in Early Childhood: reducing mental health disorder risks and promoting resilience), a sub-sample of 117 women was recruited to assess the effects of this home-visiting program on children's attachment security. With that intent, the Strange Situation Paradigm was used when infants were between 12 and 16 months of age. In the intervention group, 63% (n=41) of the infants were coded as secure, while 15% (n=10) of them were coded as insecure-avoidant and 22% (n=14) as insecure-ambivalent/resistant. 56% (n=29) of control group infants (usual care) were coded as secure, while 27% (n=14) were coded as insecure-avoidant and 17% (n=9) as insecure-ambivalent/resistant. Even if the percentage of children with a secure attachment in the reinforced intervention group was higher than that of the control group, this difference did not reach the threshold of significance [Chi 2 (2)=2.40, P=0.30]. Intervention group distributions were closer to normative samples, and these distributions show the clinical impact of our program. In general, preventive interventions focused on attachment quality have moderate effects but, in our case, several factors might have contributed to lower the statistical impact of the program. Firstly, the control group cannot be considered has having received zero intervention for two reasons: (a) the French usual perinatal health system (Maternal and Infant Protection System) is particularly generous and (b) the effect of this usual system might have been increased by the project intensive assessment protocol (6 visits during 28 months). Secondly, it is possible that the full effect of the intervention had not yet been detected because, when a child's attachment was assessed, only two thirds of the intervention visits had been performed (29 of 44 visits). A "sleeper effect" is still possible: we hope that a more clear result will be seen when children are assessed again, at 48 months, in our follow-up study (CAPEDP-A II). By clarifying the mechanisms involved in the development of a secure attachment, our study aims to contribute and refine the development of early preventive intervention strategies in high perinatal and psychosocial vulnerability contexts. Copyright © 2016 L’Encéphale, Paris. Published by Elsevier Masson SAS. All rights reserved.

The Risk Factors and Clinical Course of Asthma with Fixed Airflow Limitation.

PubMed

Pothirat, Chaicharn; Chaiwong, Warawut; Liwsrisakun, Chalerm; Bumroongkit, Chaiwat; Deesomchok, Athavudh; Theerakittikul, Theerakorn; Limsukon, Atikun; Phetsuk, Nittaya

2016-07-01

To identify risk factors and clinical course of asthma with fixed airflow limitation. A retrospective case-control study of asthma patients was conducted over a 15-month period. Asthma with fixed airflow limitation patients were defined as chronic asthmatics who had both post-bronchodilator (BD) and on-treatment ratio of forced expiratory in first second (FEV1)/forced vital capacity (FVC) persistently less than 0.7, whereas usual chronic asthma patients had post-BD and/or on-treatment ratio of FEV1/FVC more than 0.7. Serial asthma control tests (ACT), medication used, exacerbations were assessed. The risk factors were analyzed using logistic regression. Clinical characteristics between groups were compared using Student’s t-test and Fisher’s exact test. One hundred twenty from 142 eligible subjects were enrolled. They had asthma with fixed airflow limitation (n = 40) and usual chronic asthma (n = 80). Potential risk factors of asthma with fixed airflow limitation included early disease onset (age <15 years) [(adjusted odd ratio (OR) = 3.9, 95% confidence interval (CI) 1.9-8.3)] with longer disease duration (adjusted OR = 8.4, 95% CI 4.6-15.4 for >30 years). Asthma with fixed airflow limitation patients had lower ACT scores (p<0.001), lower level of asthma control (p<0.001), required more asthma medications (p = 0.002), and higher rates of hospitalization (p = 0.001) than usual chronic asthma. The potential risk factors of asthma with fixed airflow limitation were earlier disease onset and longer disease duration. They had poorer asthma control, more medications needed, and higher rates of exacerbation than usual chronic asthma.

Separate and Combined Effects of Very Low Nicotine Cigarettes and Nicotine Replacement in Smokers with Schizophrenia and Controls

PubMed Central

Rohsenow, Damaris J.; Kaplan, Gary B.; Swift, Robert M.; AhnAllen, Christopher G.

2013-01-01

Introduction: The prevalence of smoking among people with schizophrenia in the United States is about 3 times that of the general population. Novel approaches are needed to reduce rates of smoking-related morbidity and mortality among these smokers. Methods: This study used a within-subjects design to investigate the separate and combined effects of sensorimotor replacement for smoking (very low nicotine content [VLNC] cigarettes vs. no cigarettes) and transdermal nicotine replacement (42 mg nicotine [NIC] vs. placebo [PLA] patches) in smokers with schizophrenia (SS; n = 30) and control smokers without psychiatric illness (CS; n = 26). Each session contained a 5-hr controlled administration period in which participants underwent the following conditions, in counterbalanced order: VLNC + NIC, VLNC + PLA, no cigarettes + NIC, no cigarettes + PLA, usual-brand cigarettes + no patches. Next, participants completed measures of cigarette craving, nicotine withdrawal, smoking habit withdrawal, and cigarette subjective effects, followed by a 90-min period of ad libitum usual-brand smoking. Results: Smoking VLNC cigarettes during the controlled administration periods reduced cigarette craving, nicotine withdrawal symptoms, habit withdrawal symptoms, and usual-brand smoking in SS and CS relative to the no cigarette conditions. VLNC cigarettes were well accepted by both groups and did not affect psychiatric symptom levels in SS. Transdermal nicotine significantly reduced cigarette craving but did not affect usual-brand smoking. Conclusions: These findings suggest that reducing the nicotine content of cigarettes to nonaddictive levels may be a promising approach for reducing nicotine dependence among people with schizophrenia. PMID:22517190

The effect of donepezil on the cognitive ability early in the course of recovery from traumatic brain injury.

PubMed

Campbell, Kelsey A; Kennedy, Richard E; Brunner, Robert C; Hollis, Sean D; Lumsden, Ross A; Novack, Thomas A

2018-05-08

To investigate the effect of donepezil on cognitive ability in patients who have sustained a traumatic brain injury (TBI). We hypothesized that donepezil, an acetylcholinesterase inhibitor, would enhance cognitive recovery beyond that of usual care in an acute rehabilitation facility. This retrospective, longitudinal analysis included 55 patients who were non-randomly prescribed donepezil during acute care and compared them to 74 patients who received usual rehabilitation treatment. All 129 patients completed neuropsychological assessment at two time points. Donepezil was increased from 5 to 10 mg 7-10 days after initiation and maintained until follow-up cognitive assessment. Primary cognitive abilities of interest included processing speed, attention and memory. Cognitive and functional abilities were assessed by a standard neuropsychological battery for TBI. Propensity scores were used to adjust for differences between groups. Mixed effect model analysis showed no significant differences between treatment and control groups on all neuropsychological subtests over time. Acute administration of donepezil did not significantly improve measures of cognitive or functional ability beyond that of treatment as usual in patients with moderate-to-severe TBI.

Empiric auto-titrating CPAP in people with suspected obstructive sleep apnea.

PubMed

Drummond, Fitzgerald; Doelken, Peter; Ahmed, Qanta A; Gilbert, Gregory E; Strange, Charlie; Herpel, Laura; Frye, Michael D

2010-04-15

Efficient diagnosis and treatment of obstructive sleep apnea (OSA) can be difficult because of time delays imposed by clinic visits and serial overnight polysomnography. In some cases, it may be desirable to initiate treatment for suspected OSA prior to polysomnography. Our objective was to compare the improvement of daytime sleepiness and sleep-related quality of life of patients with high clinical likelihood of having OSA who were randomly assigned to receive empiric auto-titrating continuous positive airway pressure (CPAP) while awaiting polysomnogram versus current usual care. Serial patients referred for overnight polysomnography who had high clinical likelihood of having OSA were randomly assigned to usual care or immediate initiation of auto-titrating CPAP. Epworth Sleepiness Scale (ESS) scores and the Functional Outcomes of Sleep Questionnaire (FOSQ) scores were obtained at baseline, 1 month after randomization, and again after initiation of fixed CPAP in control subjects and after the sleep study in auto-CPAP patients. One hundred nine patients were randomized. Baseline demographics, daytime sleepiness, and sleep-related quality of life scores were similar between groups. One-month ESS and FOSQ scores were improved in the group empirically treated with auto-titrating CPAP. ESS scores improved in the first month by a mean of -3.2 (confidence interval -1.6 to -4.8, p < 0.001) and FOSQ scores improved by a mean of 1.5, (confidence interval 0.5 to 2.7, p = 0.02), whereas scores in the usual-care group did not change (p = NS). Following therapy directed by overnight polysomnography in the control group, there were no differences in ESS or FOSQ between the groups. No adverse events were observed. Empiric auto-CPAP resulted in symptomatic improvement of daytime sleepiness and sleep-related quality of life in a cohort of patients awaiting polysomnography who had a high pretest probability of having OSA. Additional studies are needed to evaluate the applicability of empiric treatment to other populations.

Oral administration of Chinese herbal medicine during gestation period for preventing hemolytic disease of the newborn due to ABO incompatibility: A systematic review of randomized controlled trials.

PubMed

Cao, Huijuan; Wu, Ruohan; Han, Mei; Caldwell, Patrina Ha Yuen; Liu, Jian-Ping

2017-01-01

About 85.3% of hemolytic disease of the newborn (HDN) is caused by maternal-fetal ABO blood group incompatibility. However, there is currently no recommended "best" therapy for ABO incompatibility during pregnancy. To systematically assess the safety and effectiveness of oral Chinese herbal medicine (CHM) for preventing HDN due to ABO incompatibility. The protocol of this review was registered on the PROSPERO website (No. CRD42016038637).Six databases were searched from inception to April 2016. Randomized controlled trials (RCTs) of CHM for maternal-fetal ABO incompatibility were included. The primary outcome was incidence of HDN. The Cochrane risk of bias tool was used to assess the methodological quality of included trials. Risk ratios (RR) and mean differences with 95% confidence interval were used as effect measures. Meta-analyses using Revman 5.3 software were conducted if there were sufficient trials without obvious clinical or statistical heterogeneity available. Totally 28 RCTs involving3413 women were included in the review. The majority of the trials had unclear or high risk of bias. Our study found that the rate of HDN and the incidence of neonatal jaundice might be 70% lower in the herbal medicine group compared with the usual care group (RR from 0.25 to 0.30).After treatment with herbal medicine, women were twice as likely to have antibody titers lower than 1:64 compared with women who received usual care(RR from 2.15 to 3.14) and the umbilical cord blood bilirubin level in the herbal medicine group was 4umol/L lower than in those receiving usual care. There was no difference in Apgar scores or birthweights between the two groups. This review found very low-quality evidence that CHM prevented HDN caused by maternal-fetal ABO incompatibility. No firm conclusions can be drawn regarding the effectiveness or safety of CHM for this condition.

Oral administration of Chinese herbal medicine during gestation period for preventing hemolytic disease of the newborn due to ABO incompatibility: A systematic review of randomized controlled trials

PubMed Central

Cao, Huijuan; Wu, Ruohan; Han, Mei; Caldwell, Patrina Ha Yuen

2017-01-01

Background About 85.3% of hemolytic disease of the newborn (HDN) is caused by maternal-fetal ABO blood group incompatibility. However, there is currently no recommended “best” therapy for ABO incompatibility during pregnancy. Objectives To systematically assess the safety and effectiveness of oral Chinese herbal medicine (CHM) for preventing HDN due to ABO incompatibility. Methods The protocol of this review was registered on the PROSPERO website (No. CRD42016038637).Six databases were searched from inception to April 2016. Randomized controlled trials (RCTs) of CHM for maternal-fetal ABO incompatibility were included. The primary outcome was incidence of HDN. The Cochrane risk of bias tool was used to assess the methodological quality of included trials. Risk ratios (RR) and mean differences with 95% confidence interval were used as effect measures. Meta-analyses using Revman 5.3 software were conducted if there were sufficient trials without obvious clinical or statistical heterogeneity available. Results Totally 28 RCTs involving3413 women were included in the review. The majority of the trials had unclear or high risk of bias. Our study found that the rate of HDN and the incidence of neonatal jaundice might be 70% lower in the herbal medicine group compared with the usual care group (RR from 0.25 to 0.30).After treatment with herbal medicine, women were twice as likely to have antibody titers lower than 1:64 compared with women who received usual care(RR from 2.15 to 3.14) and the umbilical cord blood bilirubin level in the herbal medicine group was 4umol/L lower than in those receiving usual care. There was no difference in Apgar scores or birthweights between the two groups. Conclusions This review found very low-quality evidence that CHM prevented HDN caused by maternal-fetal ABO incompatibility. No firm conclusions can be drawn regarding the effectiveness or safety of CHM for this condition. PMID:28719639

A randomized trial of exercise therapy in patients with acute low back pain. Efficacy on sickness absence.

PubMed

Faas, A; van Eijk, J T; Chavannes, A W; Gubbels, J W

1995-04-15

A randomized, placebo-controlled trial in which patients received either usual care by a general practitioner (information and analgesics), or placebo physiotherapy given by a physiotherapist, or exercise therapy given by a physiotherapist. To assess the efficacy of exercise therapy on sickness absence from work in patients with acute low back pain. Exercise therapy during the nonchronic phase of back pain is considered to reduce sickness absence, but this opinion is controversial. Patients with acute nonspecific low back pain and a paid job were included for analysis. Sickness absence (number of days) was checked monthly during the 1-year follow-up period and compliance was also assessed. From 40 general practices 363 patients who were gainfully employed were included. In the exercise therapy group the percentage of patients with sickness absence was higher and the duration of absence was longer than in the placebo and usual care groups, but these differences were not significant. Indications of more absence in the exercise therapy group appeared to be based largely on a greater number of patients with absences during the first 3 months. Patients in the exercise group who had not reported sick at entry had more sickness absences during the follow-up year than patients in the usual care and placebo group. Good compliance did not affect the results. Exercise therapy for patients with acute low back pain does not reduce sickness absence.

Effectiveness of the Assessment of Burden of COPD (ABC) tool on health-related quality of life in patients with COPD: a cluster randomised controlled trial in primary and hospital care

PubMed Central

Slok, Annerika H M; Kotz, Daniel; van Breukelen, Gerard; Chavannes, Niels H; Rutten-van Mölken, Maureen P M H; Kerstjens, Huib A M; van der Molen, Thys; Asijee, Guus M; Dekhuijzen, P N Richard; Holverda, Sebastiaan; Salomé, Philippe L; Goossens, Lucas M A; Twellaar, Mascha; in ‘t Veen, Johannes C C M; van Schayck, Onno C P

2016-01-01

Objective Assessing the effectiveness of the Assessment of Burden of COPD (ABC) tool on disease-specific quality of life in patients with chronic obstructive pulmonary disease (COPD) measured with the St. George's Respiratory Questionnaire (SGRQ), compared with usual care. Methods A pragmatic cluster randomised controlled trial, in 39 Dutch primary care practices and 17 hospitals, with 357 patients with COPD (postbronchodilator FEV1/FVC ratio <0.7) aged ≥40 years, who could understand and read the Dutch language. Healthcare providers were randomly assigned to the intervention or control group. The intervention group applied the ABC tool, which consists of a short validated questionnaire assessing the experienced burden of COPD, objective COPD parameter (eg, lung function) and a treatment algorithm including a visual display and treatment advice. The control group provided usual care. Researchers were blinded to group allocation during analyses. Primary outcome was the number of patients with a clinically relevant improvement in SGRQ score between baseline and 18-month follow-up. Secondary outcomes were the COPD Assessment Test (CAT) and the Patient Assessment of Chronic Illness Care (PACIC; a measurement of perceived quality of care). Results At 18-month follow-up, 34% of the 146 patients from 27 healthcare providers in the intervention group showed a clinically relevant improvement in the SGRQ, compared with 22% of the 148 patients from 29 healthcare providers in the control group (OR 1.85, 95% CI 1.08 to 3.16). No difference was found on the CAT (−0.26 points (scores ranging from 0 to 40); 95% CI −1.52 to 0.99). The PACIC showed a higher improvement in the intervention group (0.32 points (scores ranging from 1 to 5); 95% CI 0.14 to 0.50). Conclusions This study showed that use of the ABC tool may increase quality of life and perceived quality of care. Trial registration number NTR3788; Results. PMID:27401361

Impact of a preoperative conversational hypnotic session on propofol consumption using closed-loop anesthetic induction guided by the bispectral index

PubMed Central

Bataille, Aurélien; Besset, Sébastien; Szekely, Barbara; Michel-Cherqui, Mireille; Dumans, Virginie; Liu, Ngai; Chazot, Thierry; Fischler, Marc; Le Guen, Morgan

2017-01-01

Abstract Objective: The automated administration of propofol in a closed loop could be used to objectively evaluate the nonpharmacological anesthetic action of hypnotherapy. The objective of this study was to evaluate the impact of a conversational hypnosis session on the consumption of propofol for anesthetic induction. Design: A randomized, usual care-controlled, single-center, patient-blind trial. Setting: Tertiary care center in France from November 2012 to December 2013. Participants: Adult patients scheduled for a surgical procedure under general anesthesia. Interventions: Before surgery, patients were randomized with a computer-generated random list for a preoperative conversational hypnosis session or for usual care. The conversational hypnosis session was conducted and individualized by the therapist with an academic degree in hypnosis in a quiet environment. Anesthetic induction was automatically performed by propofol without opioids and was assisted by the bispectral index in a closed loop. Outcome: Primary endpoint was the propofol dose required for anesthesia induction, defined as a Bispectral index less than 60 for at least 30 seconds. Results: The study included 48 patients in the hypnosis group and 49 patients in the control group. No difference in propofol consumption to obtain anesthesia induction was observed between the groups (total dose: 138.6 [67.5] and 130 [47.9] mg, P = .47; adjusted dose: 2.15 [1.09] and 1.95 [0.66] mg/kg, P = .28, for the hypnosis and control groups, respectively). Hetero-evaluation of arm movement during propofol injection (no reaction: 98% and 74%; P = .004, in the hypnosis and control groups, respectively) and face reaction at venous access placement (no reaction 59% and 30%; P = .017, in the hypnosis and control groups, respectively) were lower in the hypnosis group. No adverse event was reported. Conclusions: No difference in propofol consumption was observed in this study designed to evaluate the effect of a hypnotic conversational session on anesthesia induction using an automated tool for propofol administration. PMID:28489735

Randomized controlled trial of web-based multimodal therapy for children with acquired brain injury to improve gross motor capacity and performance.

PubMed

Baque, Emmah; Barber, Lee; Sakzewski, Leanne; Boyd, Roslyn N

2017-06-01

To compare efficacy of a web-based multimodal training programme, 'Move it to improve it' (Mitii TM ), to usual care on gross motor capacity and performance for children with an acquired brain injury. Randomized waitlist controlled trial. Home environment. A total of 60 independently ambulant children (30 in each group), minimum 12 months post-acquired brain injury were recruited and randomly allocated to receive either 20 weeks of Mitii TM training (30 minutes/day, six days/week, total 60 hours) immediately, or waitlisted (usual care control group) for 20 weeks. A total of 58 children completed baseline assessments (32 males; age 11 years 11 months ± 2 years 6 months; Gross Motor Function Classification System equivalent I = 29, II = 29). The Mitii TM program comprised of gross motor, upper limb and visual perception/cognitive activities. The primary outcome was 30-second, repetition maximum functional strength tests for the lower limb (sit-to-stand, step-ups, half-kneel to stand). Secondary outcomes were the 6-minute walk test, High-level Mobility Assessment Tool, Timed Up and Go Test and habitual physical activity as captured by four-day accelerometry. Groups were equivalent at baseline on demographic and clinical measures. The Mitii TM group demonstrated significantly greater improvements on combined score of functional strength tests (mean difference 10.19 repetitions; 95% confidence interval, 3.26-17.11; p = 0.006) compared with the control group. There were no other between-group differences on secondary outcomes. Although the Mitii TM programme demonstrated statistically significant improvements in the functional strength tests of the lower limb, results did not exceed the minimum detectable change and cannot be considered clinically relevant for children with an acquired brain injury. Australian New Zealand Clinical Trials Registration Number, ANZCTR12613000403730.

[Amnioinfusion: techniques, indications, and controlled retrospective study of 55 cases].

PubMed

Gramellini, D; Fieni, S; Piantelli, G; Faiola, S; Kaihura, C; Verrotti, C; Cavallotti, D; Viola, P; Bacchini, G; Vadora, E

2000-01-01

Amnioinfusion is a relatively recent procedure introduced among fetal medicine techniques. Its applications focus on two different methods: transcervical and transabdominal. The first procedure usually is carried out during "intrapartum amnioinfusion" to prevent or treat fetal heart rate (FHR) decelerations related to oligohydramnios or to dilute thick meconium staining of the amniotic fluid. The latter method used during "antepartum amnioinfusion" is usually indicated for severe oligohydramnios in order to avoid the complications related such as pulmonary hypoplasia, deforming effects of oligohydramnios, variable FHR decelerations and intraventricular hemorrhages. Antepartum amnioinfusion, also used to improve ultrasound visualisation in presence of oligohydramnios, is less employed as compared to intrapartum amnioinfusion, therefore its risks are not well established. In order to study possible adverse effects on the mother or foetus, fifty five patients affected by oligohydramnios at 17th-34th week of gestational age were submitted to antepartum amnioinfusion (1-5 procedures) and were matched retrospectively with forty seven women with the same characteristics treated with the conservative and expectant management. The trend of pregnancy was the same for both groups in relation to maternal fever > 38 degrees (10.9% in the amnioinfused group vs 17.0% in control group ns), leukocyte count > 18,000/mm3 (25.5% vs 21.3%, ns), C-reactive protein > 10 ng/ml (10.9% vs 6.4%, ns). The latency period between admission and delivery was significantly longer in the amnioinfused group than in the control one [21 (range 1-98) vs 9 days (range 0-72); p < 0.001] and the frequency of Apgar score < 7 at the 5th min was less represented in the amnioinfused group than in the control group (32.3% vs 66.6%; p < 0.001). In conclusion, it was interesting to note that antepartum amnioinfusion seems to increase the latency period between premature rupture of membranes and delivery, but it remains to clarify if this procedure is as much safe for the fetus as for the mother.

Effectiveness of integrated disease management for primary care chronic obstructive pulmonary disease patients: results of cluster randomised trial.

PubMed

Kruis, Annemarije L; Boland, Melinde R S; Assendelft, Willem J J; Gussekloo, Jacobijn; Tsiachristas, Apostolos; Stijnen, Theo; Blom, Coert; Sont, Jacob K; Rutten-van Mölken, Maureen P H M; Chavannes, Niels H

2014-09-10

To investigate the long term effectiveness of integrated disease management delivered in primary care on quality of life in patients with chronic obstructive pulmonary disease (COPD) compared with usual care. 24 month, multicentre, pragmatic cluster randomised controlled trial 40 general practices in the western part of the Netherlands Patients with COPD according to GOLD (Global Initiative for COPD) criteria. Exclusion criteria were terminal illness, cognitive impairment, alcohol or drug misuse, and inability to fill in Dutch questionnaires. Practices were included if they were willing to create a multidisciplinary COPD team. General practitioners, practice nurses, and specialised physiotherapists in the intervention group received a two day training course on incorporating integrated disease management in practice, including early recognition of exacerbations and self management, smoking cessation, physiotherapeutic reactivation, optimal diagnosis, and drug adherence. Additionally, the course served as a network platform and collaborating healthcare providers designed an individual practice plan to integrate integrated disease management into daily practice. The control group continued usual care (based on international guidelines). The primary outcome was difference in health status at 12 months, measured by the Clinical COPD Questionnaire (CCQ); quality of life, Medical Research Council dyspnoea, exacerbation related outcomes, self management, physical activity, and level of integrated care (PACIC) were also assessed as secondary outcomes. Of a total of 1086 patients from 40 clusters, 20 practices (554 patients) were randomly assigned to the intervention group and 20 clusters (532 patients) to the usual care group. No difference was seen between groups in the CCQ at 12 months (mean difference -0.01, 95% confidence interval -0.10 to 0.08; P=0.8). After 12 months, no differences were seen in secondary outcomes between groups, except for the PACIC domain "follow-up/coordination" (indicating improved integration of care) and proportion of physically active patients. Exacerbation rates as well as number of days in hospital did not differ between groups. After 24 months, no differences were seen in outcomes, except for the PACIC follow-up/coordination domain. In this pragmatic study, an integrated disease management approach delivered in primary care showed no additional benefit compared with usual care, except improved level of integrated care and a self reported higher degree of daily activities. The contradictory findings to earlier positive studies could be explained by differences between interventions (provider versus patient targeted), selective reporting of positive trials, or little room for improvement in the already well developed Dutch healthcare system. Netherlands Trial Register NTR2268. © Kruis et al 2014.

Cost of opioid-treated chronic low back pain: Findings from a pilot randomized controlled trial of mindfulness meditation-based intervention.

PubMed

Zgierska, Aleksandra E; Ircink, James; Burzinski, Cindy A; Mundt, Marlon P

Opioid-treated chronic low back pain (CLBP) is debilitating, costly, and often refractory to existing treatments. This secondary analysis aims to pilot-test the hypothesis that mindfulness meditation (MM) can reduce economic burden related to opioid-treated CLBP. Twenty-six-week unblinded pilot randomized controlled trial, comparing MM, adjunctive to usual-care, to usual care alone. Outpatient. Thirty-five adults with opioid-treated CLBP (≥30 morphine-equivalent mg/day) for 3 + months enrolled; none withdrew. Eight weekly therapist-led MM sessions and at-home practice. Costs related to self-reported healthcare utilization, medication use (direct costs), lost productivity (indirect costs), and total costs (direct + indirect costs) were calculated for 6-month pre-enrollment and postenrollment periods and compared within and between the groups. Participants (21 MM; 14 control) were 20 percent men, age 51.8 ± 9.7 years, with severe disability, opioid dose of 148.3 ± 129.2 morphine-equivalent mg/d, and individual annual income of $18,291 ± $19,345. At baseline, total costs were estimated at $15,497 ± 13,677 (direct: $10,635 ± 9,897; indirect: $4,862 ± 7,298) per participant. Although MM group participants, compared to controls, reduced their pain severity ratings and pain sensitivity to heat stimuli (p < 0.05), no statistically significant within-group changes or between-group differences in direct and indirect costs were noted. Adults with opioid-treated CLBP experience a high burden of disability despite the high costs of treatment. Although this pilot study did not show a statistically significant impact of MM on costs related to opioid-treated CLBP, MM can improve clinical outcomes and should be assessed in a larger trial with long-term follow-up.

Reproductive health choices for young adults with sickle cell disease or trait: randomized controlled trial immediate posttest effects.

PubMed

Wilkie, Diana J; Gallo, Agatha M; Yao, Yingwei; Molokie, Robert E; Stahl, Christine; Hershberger, Patricia E; Zhao, Zhongsheng; Suarez, Marie L; Labotka, Robert J; Johnson, Bonnye; Angulo, Rigo; Angulo, Veronica; Carrasco, Jesus; Shuey, David; Pelligra, Stephanie; Wang, Edward; Rogers, Dennie T; Thompson, Alexis A

2013-01-01

People with sickle cell disease (SCD) or sickle cell trait (SCT) may not have information about genetic inheritance needed for making informed reproductive health decisions. CHOICES is a Web-based, multimedia educational intervention that provides information about reproductive options and consequences to help those with SCD or SCT identify and implement an informed parenting plan. Efficacy of CHOICES compared with usual care must be evaluated. The purpose was to compare immediate posttest effects of CHOICES versus an attention-control usual care intervention (e-Book) on SCD-/SCT-related reproductive health knowledge, intention, and behavior. In a randomized controlled study, we recruited subjects with SCD/SCT from clinics, community settings, and online networks with data collected at sites convenient to the 234 subjects with SCD (n = 136) or SCT (n = 98). Their ages ranged from 18 to 35 years; 65% were women, and 94% were African American. Subjects completed a measure of sickle cell reproductive knowledge, intention, and behavior before and immediately after the intervention. Compared with the e-Book group, the CHOICES group had significantly higher average knowledge scores and probability of reporting a parenting plan to avoid SCD or SCD and SCT when pretest scores were controlled. Effects on intention and planned behavior were not significant. The CHOICES group showed significant change in their intention and planned behavior, whereas the e-Book group did not show significant change in their intention, but their planned behavior differed significantly. Initial efficacy findings are encouraging but warrant planned booster sessions and outcome follow-ups to determine sustained intervention efficacy on reproductive health knowledge, intention, and actual behavior of persons with SCD/SCT.

Reducing intrusive traumatic memories after emergency caesarean section: A proof-of-principle randomized controlled study.

PubMed

Horsch, Antje; Vial, Yvan; Favrod, Céline; Harari, Mathilde Morisod; Blackwell, Simon E; Watson, Peter; Iyadurai, Lalitha; Bonsall, Michael B; Holmes, Emily A

2017-07-01

Preventative psychological interventions to aid women after traumatic childbirth are needed. This proof-of-principle randomized controlled study evaluated whether the number of intrusive traumatic memories mothers experience after emergency caesarean section (ECS) could be reduced by a brief cognitive intervention. 56 women after ECS were randomized to one of two parallel groups in a 1:1 ratio: intervention (usual care plus cognitive task procedure) or control (usual care). The intervention group engaged in a visuospatial task (computer-game 'Tetris' via a handheld gaming device) for 15 min within six hours following their ECS. The primary outcome was the number of intrusive traumatic memories related to the ECS recorded in a diary for the week post-ECS. As predicted, compared with controls, the intervention group reported fewer intrusive traumatic memories (M = 4.77, SD = 10.71 vs. M = 9.22, SD = 10.69, d = 0.647 [95% CI: 0.106, 1.182]) over 1 week (intention-to-treat analyses, primary outcome). There was a trend towards reduced acute stress re-experiencing symptoms (d = 0.503 [95% CI: -0.032, 1.033]) after 1 week (intention-to-treat analyses). Times series analysis on daily intrusions data confirmed the predicted difference between groups. 72% of women rated the intervention "rather" to "extremely" acceptable. This represents a first step in the development of an early (and potentially universal) intervention to prevent postnatal posttraumatic stress symptoms that may benefit both mother and child. ClinicalTrials.gov, www.clinicaltrials.gov, NCT02502513. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Reproductive Health CHOICES for Young Adults with Sickle Cell Disease or Trait: Randomized Controlled Trial Immediate Posttest Effects

PubMed Central

Wilkie, Diana J; Gallo, Agatha M.; Yao, Yingwei; Molokie, Robert E.; Stahl, Christine; Hershberger, Patricia E.; Zhao, Zhongsheng; Suarez, Marie L.; Labotka, Robert J.; Johnson, Bonnye; Angulo, Rigo; Angulo, Veronica; Carrasco, Jesus; Shuey, David; Pelligra, Stephanie; Wang, Edward; Rogers, Dennie T.; Thompson, Alexis A.

2013-01-01

Background People with sickle cell disease (SCD) or sickle cell trait (SCT) may not have information about genetic inheritance needed for making informed reproductive health decisions. CHOICES is a web-based, multimedia educational intervention that provides information about reproductive options and consequences to help those with SCD or SCT identify and implement an informed parenting plan. Efficacy of CHOICES compared with usual care must be evaluated. Objective The purpose was to compare immediate posttest effects of CHOICES versus an attention control usual care intervention (e-Book) on SCD/SCT-related reproductive health knowledge, intention, and behavior. Methods In a randomized controlled study, we recruited subjects with SCD/SCT from clinics, community settings, and online networks with data collected at sites convenient to the 234 subjects with SCD (n = 136) or SCT (n = 98) (age ranged from18-35 years, 65% were female, and 94% were African American). Subjects completed a measure of sickle cell reproductive knowledge, intention, and behavior before and immediately after the intervention. Results Compared to the e-Book group, the CHOICES group had significantly higher average knowledge scores and probability of reporting a parenting plan to avoid SCD or SCD and SCT when pretest scores were controlled. Effects on intention and planned behavior were not significant. The CHOICES group showed significant change in their intention and planned behavior; the e-Book group did not show significant change in their intention, but their planned behavior differed significantly. Discussion Initial efficacy findings are encouraging but warrant planned booster sessions and outcome follow-ups to determine sustained intervention efficacy on reproductive health knowledge, intention, and actual behavior of persons with SCD/SCT. PMID:23995469

The effectiveness of a tobacco prevention program with adolescents living in a tobacco-producing region.

PubMed Central

Noland, M P; Kryscio, R J; Riggs, R S; Linville, L H; Ford, V Y; Tucker, T C

1998-01-01

OBJECTIVES: This study investigated the efficacy of a social-influences tobacco prevention program conducted with adolescents living in a high tobacco production area. METHODS: Students in 10 experimental schools completed the tobacco prevention program and a booster intervention. Control students received health education as usual. RESULTS: After 2 years of treatment, smoking rates in the treatment group (vs the control group) were lower for 30-day, 7-day, and 24-hour smoking. The intervention had more of an impact on those who were involved in raising tobacco than it did on those not involved in raising tobacco. CONCLUSIONS: Although modest, effects were achieved with minimal intervention time in a high-risk group, indicating that social-influences prevention programs may be effective in such groups. PMID:9842390

Organ donation video messaging in motor vehicle offices: results of a randomized trial.

PubMed

Rodrigue, James R; Fleishman, Aaron; Fitzpatrick, Sean; Boger, Matthew

2015-12-01

Since nearly all registered organ donors in the United States signed up via a driver's license transaction, motor vehicle (MV) offices represent an important venue for organ donation education. To evaluate the impact of organ donation video messaging in MV offices. A 2-group (usual care vs usual care+video messaging) randomized trial with baseline, intervention, and follow-up assessment phases. Twenty-eight MV offices in Massachusetts. Usual care comprised education of MV clerks, display of organ donation print materials (ie, posters, brochures, signing mats), and a volunteer ambassador program. The intervention included video messaging with silent (subtitled) segments highlighting individuals affected by donation, playing on a recursive loop on monitors in MV waiting rooms. Aggregate monthly donor designation rates at MV offices (primary) and percentage of MV customers who registered as donors after viewing the video (secondary). Controlling for baseline donor designation rate, analysis of covariance showed a significant group effect for intervention phase (F=7.3, P=.01). The usual-care group had a significantly higher aggregate monthly donor designation rate than the intervention group had. In the logistic regression model of customer surveys (n=912), prior donor designation (β=-1.29, odds ratio [OR]=0.27 [95% CI=0.20-0.37], P<.001), white race (β=0.57 OR=1.77 [95% CI=1.23-2.54], P=.002), and viewing the intervention video (β=0.73, OR=1.54 [95% CI=1.24-2.60], P=.01) were statistically significant predictors of donor registration on the day of the survey. The relatively low uptake of the video intervention by customers most likely contributed to the negative trial finding.

Usual medical treatments or levonorgestrel-IUS for women with heavy menstrual bleeding: long-term randomised pragmatic trial in primary care.

PubMed

Kai, Joe; Middleton, Lee; Daniels, Jane; Pattison, Helen; Tryposkiadis, Konstantinos; Gupta, Janesh

2016-12-01

Heavy menstrual bleeding (HMB) is a common, chronic problem affecting women and health services. However, long-term evidence on treatment in primary care is lacking. To assess the effectiveness of commencing the levonorgestrel-releasing intrauterine system (LNG-IUS) or usual medical treatments for women presenting with HMB in general practice. A pragmatic, multicentre, parallel, open-label, long term, randomised controlled trial in 63 primary care practices across the English Midlands. In total, 571 women aged 25-50 years, with HMB were randomised to LNG-IUS or usual medical treatment (tranexamic/mefenamic acid, combined oestrogen-progestogen, or progesterone alone). The primary outcome was the patient reported Menorrhagia Multi-Attribute Scale (MMAS, measuring effect of HMB on practical difficulties, social life, psychological and physical health, and work and family life; scores from 0 to 100). Secondary outcomes included surgical intervention (endometrial ablation/hysterectomy), general quality of life, sexual activity, and safety. At 5 years post-randomisation, 424 (74%) women provided data. While the difference between LNG-IUS and usual treatment groups was not significant (3.9 points; 95% confidence interval = -0.6 to 8.3; P = 0.09), MMAS scores improved significantly in both groups from baseline (mean increase, 44.9 and 43.4 points, respectively; P<0.001 for both comparisons). Rates of surgical intervention were low in both groups (surgery-free survival was 80% and 77%; hazard ratio 0.90; 95% CI = 0.62 to 1.31; P = 0.6). There was no difference in generic quality of life, sexual activity scores, or serious adverse events. Large improvements in symptom relief across both groups show treatment for HMB can be successfully initiated with long-term benefit and with only modest need for surgery. © British Journal of General Practice 2016.

Design of a randomized controlled trial to assess the comparative effectiveness of a multifaceted intervention to improve adherence to colorectal cancer screening among patients cared for in a community health center.

PubMed

Baker, David W; Brown, Tiffany; Buchanan, David R; Weil, Jordan; Cameron, Kenzie A; Ranalli, Lauren; Ferreira, M Rosario; Stephens, Quinn; Balsley, Kate; Goldman, Shira N; Wolf, Michael S

2013-04-29

Colorectal cancer (CRC) is common and leads to significant morbidity and mortality. Although screening with fecal occult blood testing (FOBT) or endoscopy has been shown to decrease CRC mortality, screening rates remain suboptimal. Screening rates are particularly low for people with low incomes and members of underrepresented minority groups. FOBT should be done annually to detect CRC early and to reduce CRC mortality, but this often does not occur. This paper describes the design of a multifaceted intervention to increase long-term adherence to FOBT among poor, predominantly Latino patients, and the design of a randomized controlled trial (RCT) to test the efficacy of this intervention compared to usual care. In this RCT, patients who are due for repeat FOBT are identified in the electronic health record (EHR) and randomized to receive either usual care or a multifaceted intervention. The usual care group includes multiple point-of-care interventions (e.g., standing orders, EHR reminders), performance measurement, and financial incentives to improve CRC screening rates. The intervention augments usual care through mailed CRC screening test kits, low literacy patient education materials, automated phone and text message reminders, in-person follow up calls from a CRC Screening Coordinator, and communication of results to patients along with a reminder card highlighting when the patient is next due for screening. The primary outcome is completion of FOBT within 6 months of becoming due. The main goal of the study is to determine the comparative effectiveness of the intervention compared to usual care. Additionally, we want to assess whether or not it is possible to achieve high rates of adherence to CRC screening with annual FOBT, which is necessary for reducing CRC mortality. The intervention relies on technology that is increasingly widespread and declining in cost, including EHR systems, automated phone and text messaging, and FOBTs for CRC screening. We took this approach to ensure generalizability and allow us to rapidly disseminate the intervention through networks of community health centers (CHCs) if the RCT shows the intervention to be superior to usual care. ClinicalTrials.gov NCT01453894.

Cognitive behaviour therapy to prevent harmful compliance with command hallucinations (COMMAND): a randomised controlled trial.

PubMed

Birchwood, Max; Michail, Maria; Meaden, Alan; Tarrier, Nicholas; Lewis, Shon; Wykes, Til; Davies, Linda; Dunn, Graham; Peters, Emmanuelle

2014-06-01

Acting on command hallucinations in psychosis can have serious consequences for the individual and for other people and is a major cause of clinical and public concern. No evidence-based treatments are available to reduce this risk behaviour. We therefore tested our new cognitive therapy to challenge the perceived power of voices to inflict harm on the voice hearer if commands are not followed, thereby reducing the hearer's motivation to comply. In COMMAND, a single-blind, randomised controlled trial, eligible participants from three centres in the UK who had command hallucinations for at least 6 months leading to major episodes of harm to themselves or other people were assigned in a 1: 1 ratio to cognitive therapy for command hallucinations + treatment as usual versus just treatment as usual for 9 months. Only the raters were masked to treatment assignment. The primary outcome was harmful compliance. Analysis was by intention to treat. The trial is registered, number ISRCTN62304114. 98 (50%) of 197 participants were assigned to cognitive therapy for command hallucinations + treatment as usual and 99 (50%) to treatment as usual. At 18 months, 39 (46%) of 85 participants in the treatment as usual group fully complied with the voices compared with 22 (28%) of 79 in the cognitive therapy for command hallucinations + treatment as usual group (odds ratio 0·45, 95% CI 0·23-0·88, p=0·021). At 9 months the treatment effect was not significant (0·74, 0·40-1·39, p=0·353). However, the treatment by follow-up interaction was not significant and the treatment effect common to both follow-up points was 0·57 (0·33-0·98, p=0·042). This is the first trial to show a clinically meaningful reduction in risk behaviour associated with commanding voices. We will next determine if change in power was the mediator of change. Further more complex trials are needed to identify the most influential components of the treatment in reducing power and compliance. UK Medical Research Council and the National Institute for Health Research. Copyright © 2014 Elsevier Ltd. All rights reserved.

[Effects of TeenSTAR, an abstinence only sexual education program, on adolescent sexual behavior].

PubMed

Vigil, Pilar; Riquelme, Rosa; Rivadeneira, Rosario; Aranda, Waldo

2005-10-01

Urgent measures are required to stop the increase in the frequency of pregnancies and sexually transmitted diseases among teenagers. A means of facing this problem is promoting sexual abstinence among youngsters. There are studies that confirm the efficacy of this approach. To show the results of the application of a holistic sexuality program (TeenSTAR) among Chilean teenagers. Students attending basic or high school were divided into a control or study group. The control group (342 students) received the usual education on sexuality given by their schools and the study group (398 students) participated in twelve TeenSTAR sessions lasting 1.5 hours each, given by a trained professor. Assessment of achievements was made using an anonymous questionnaire answered at the start and end of the program. The rates of sexual initiation among control and study groups were 15 and 6.5%, respectively. Among sexually active students, 20% of those in the study group and 9% of those in the control group discontinued sexual activity. A higher proportion of students in the TeenSTAR program retarded their sexual initiation or discontinued sexual activity and found more reasons to maintain sexual abstinence than control students.

Evaluation of the effectiveness and cost-effectiveness of lightweight fibreglass heel casts in the management of ulcers of the heel in diabetes: a randomised controlled trial.

PubMed Central

Jeffcoate, William; Game, Frances; Turtle-Savage, Vivienne; Musgrove, Alison; Price, Patricia; Tan, Wei; Bradshaw, Lucy; Montgomery, Alan; Fitzsimmons, Deborah; Farr, Angela; Winfield, Thomas; Phillips, Ceri

2017-01-01

BACKGROUND Ulcers of the foot in people with diabetes mellitus are slow to heal and result in considerable cost and patient suffering. The prognosis is worst for ulcers of the heel. OBJECTIVE To assess both the clinical effectiveness and the cost-effectiveness of lightweight fibreglass casts in the management of heel ulcers. DESIGN A pragmatic, multicentre, parallel, observer-blinded randomised controlled trial. A central randomisation centre used a computer-generated random number sequence to allocate participants to groups. SETTING Thirty-five specialist diabetic foot secondary care centres in the UK. Those recruited were aged ≥ 18 years and had diabetes mellitus complicated by ulcers of the heel of grades 2-4 on the National Pressure Ulcer Advisory Panel and European Pressure Ulcer Advisory Panel scale. PARTICIPANTS In total, 509 participants [68% male, 15% with type 1 diabetes mellitus, mean age 67.5 years (standard deviation 12.4 years)] were randomised 1 : 1 to the intervention (n = 256) or the control (n = 253) arm. The primary outcome data were available for 425 participants (212 from the intervention arm and 213 from the control arm) and exceeded the total required; attrition was 16.5%. The median ulcer area at baseline was 275 mm(2) [interquartile range (IQR) 104-683 mm(2)] in the intervention group and 206 mm(2) (IQR 77-649 mm(2)) in the control group. There were no differences between the two groups at baseline in any parameter, neither in relation to the participant nor in relation to their ulcer. INTERVENTIONS The intervention group received usual care supplemented by the addition of an individually moulded, lightweight, fibreglass heel cast. The control group received usual care alone. The intervention phase continued either until the participant's ulcer had healed (maintained for 28 days) or for 24 weeks, whichever occurred first. During this intervention phase, the participants were reviewed every 2 weeks, and the fibreglass casts were replaced when they were no longer usable. MAIN OUTCOME MEASURES The primary outcome measure was ulcer healing (confirmed by a blinded observer and maintained for 4 weeks) within 24 weeks. Other outcome measures included the time taken for the ulcer to heal, the percentage reduction in the cross-sectional area, the reduction in local pain, amputation, survival and health economic analysis. The study was powered to define a difference in healing of 15% (55% intervention vs. 40% control). RESULTS Forty-four per cent (n = 94) of the intervention group healed within 24 weeks, compared with 37% (n = 80) of the control participants (odds ratio 1.42, 95% confidence interval 0.95 to 2.14; p = 0.088), using an intention-to-treat analysis. No differences were observed between the two groups for any secondary outcome. LIMITATIONS Although the component items of care were standardised, because this was a pragmatic trial, usual care was not uniform. There was some evidence of a small excess of adverse events in the intervention group; however, non-blinded observers documented these events. There was no excess of adverse device effects. CONCLUSIONS There may be a small increase in healing with the use of a heel cast, but the estimate was not sufficiently precise to provide strong evidence of an effect. There was no evidence of any subgroup in which the intervention appeared to be particularly effective. A health economic analysis suggested that it is unlikely that the intervention represents good value for money. The provision of a lightweight heel cast may be of benefit to some individuals, but we have found no evidence to justify the routine adoption of this in clinical practice. FUTURE WORK It is unlikely that further study of this intervention will have an impact on usual clinical care, and so future efforts should be directed towards other interventions designed to improve the healing of ulcers in this population. TRIAL REGISTRATION Current Controlled Trials ISRCTN62524796. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 34. See the NIHR Journals Library website for further project information. PMID:28644115

Trial Protocol: randomised controlled trial of the effects of very low calorie diet, modest dietary restriction, and sequential behavioural programme on hunger, urges to smoke, abstinence and weight gain in overweight smokers stopping smoking.

PubMed

Lycett, Deborah; Hajek, Peter; Aveyard, Paul

2010-10-07

Weight gain accompanies smoking cessation, but dieting during quitting is controversial as hunger may increase urges to smoke. This is a feasibility trial for the investigation of a very low calorie diet (VLCD), individual modest energy restriction, and usual advice on hunger, ketosis, urges to smoke, abstinence and weight gain in overweight smokers trying to quit. This is a 3 armed, unblinded, randomized controlled trial in overweight (BMI > 25 kg/m2), daily smokers (CO > 10 ppm); with at least 30 participants in each group. Each group receives identical behavioural support and NRT patches (25 mg(8 weeks),15 mg(2 weeks),10 mg(2 weeks)). The VLCD group receive a 429-559 kcal/day liquid formula beginning 1 week before quitting and continuing for 4 weeks afterwards. The modest energy restricted group (termed individual dietary and activity planning(IDAP)) engage in goal-setting and receive an energy prescription based on individual basal metabolic rate(BMR) aiming for daily reduction of 600 kcal. The control group receive usual dietary advice that accompanies smoking cessation i.e. avoiding feeling hungry but eating healthy snacks. After this, the VLCD participants receive IDAP to provide support for changing eating habits in the longer term; the IDAP group continues receiving this support. The control group receive IDAP 8 weeks after quitting. This allows us to compare IDAP following a successful quit attempt with dieting concurrently during quitting. It also aims to prevent attrition in the unblinded, control group by meeting their need for weight management. Follow-up occurs at 6 and 12 months.Outcome measures include participant acceptability, measured qualitatively by semi-structured interviewing and quantitatively by recruitment and attrition rates. Feasibility of running the trial within primary care is measured by interview and questionnaire of the treatment providers. Adherence to the VLCD is verified by the presence of urinary ketones measured weekly. Daily urges to smoke, hunger and withdrawal are measured using the Mood and Physical Symptoms Scale-Combined (MPSS-C) and a Hunger Craving Score (HCS). 24 hour, 7 day point prevalence and 4-week prolonged abstinence (Russell Standard) is confirmed by CO < 10 ppm. Weight, waist and hip circumference and percentage body fat are measured at each visit. Current controlled trials ISRCTN83865809.

First Graders' Literacy and Self-Regulation Gains: The Effect of Individualizing Student Instruction

ERIC Educational Resources Information Center

Connor, Carol McDonald; Ponitz, Claire Cameron; Phillips, Beth M.; Travis, Q. Monet; Glasney, Stephanie; Morrison, Frederick J.

2010-01-01

We examined the effect of individualizing student instruction (ISI; N = 445 students, 46 classrooms) on first graders' self-regulation gains compared to a business-as-usual control group. Self-regulation, conceptualized as a constellation of executive skills, was positively associated with academic development. We hypothesized that the ISI…

Creating healthful home food environments: Results of a study with participants in the Expanded Food and Nutrition Education Program

USDA-ARS?s Scientific Manuscript database

Our objective was to evaluate a modified curriculum for the 6-session Texas Expanded Food and Nutrition Education Program (EFNEP), promoting healthful home food environments and parenting skills related to obesity prevention. We used a two-group randomized control trial: intervention versus usual EF...

The Effects of Family Therapies for Adolescent Delinquency and Substance Abuse: A Meta-Analysis

ERIC Educational Resources Information Center

Baldwin, Scott A.; Christian, Sarah; Berkeljon, Arjan; Shadish, William R.

2012-01-01

This meta-analysis summarizes results from k = 24 studies comparing either Brief Strategic Family Therapy, Functional Family Therapy, Multidimensional Family Therapy, or Multisystemic Therapy to either treatment-as-usual, an alternative therapy, or a control group in the treatment of adolescent substance abuse and delinquency. Additionally, the…

Does Working Memory Moderate the Effects of Fraction Intervention? An Aptitude-Treatment Interaction

ERIC Educational Resources Information Center

Fuchs, Lynn S.; Schumacher, Robin F.; Sterba, Sonya K.; Long, Jessica; Namkung, Jessica; Malone, Amelia; Hamlett, Carol L.; Jordan, Nancy C.; Gersten, Russell; Siegler, Robert S.; Changas, Paul

2014-01-01

This study investigated whether individual differences in working memory (WM) moderate effects of 2 variations of intervention designed to improve at-risk 4th graders' fraction knowledge. We also examined the effects of each intervention condition against a business-as-usual control group and assessed whether children's measurement interpretation…

Linking clinic and home: a randomized, controlled clinical effectiveness trial of real-time, wireless blood pressure monitoring for older patients with kidney disease and hypertension.

PubMed

Rifkin, Dena E; Abdelmalek, Joseph A; Miracle, Cynthia M; Low, Chai; Barsotti, Ryan; Rios, Phil; Stepnowsky, Carl; Agha, Zia

2013-02-01

Older adults with chronic kidney disease have a high rate of uncontrolled hypertension. Home monitoring of blood pressure (BP) is an integral part of management, but requires that patients bring records to clinic visits. Telemonitoring interventions, however, have not targeted older, less technologically-skilled populations. Veterans with stage 3 or greater chronic kidney disease and uncontrolled hypertension were randomized to a novel telemonitoring device pairing a Bluetooth-enabled BP cuff with an Internet-enabled hub, which wirelessly transmitted readings (n=28), or usual care (n=15). Home recordings were reviewed weekly and telemonitoring participants were contacted if BP was above goal. The prespecified primary endpoints were improved data exchange and device acceptability. Secondary endpoint was BP change. Forty-three participants (average age 68 years, 75% white) completed the 6-month study. Average start-of-study BP was 147/78 mmHg. Those in the intervention arm had a median of 29 (IQR 22, 53) transmitted BP readings per month, with 78% continuing to use the device regularly, whereas only 20% of those in the usual care group brought readings to in-person visits. The median number of telephone contacts triggered by the wireless monitoring was 2 (IQR 1, 4) per patient. Both groups had a significant improvement in systolic BP (P<0.05, for both changes); systolic BP fell a median of 13 mmHg in monitored participants compared with 8.5 mmHg in usual care participants (P for comparison 0.31). This low-cost wireless monitoring strategy led to greater sharing of data between patients and clinic and produced a trend toward improvements in BP control over usual care at 6 months.

Effect of a peer support service on breast-feeding continuation in the UK: a randomised controlled trial.

PubMed

Jolly, Kate; Ingram, Lucy; Freemantle, Nick; Khan, Khalid; Chambers, Jacky; Hamburger, Ros; Brown, Julia; Dennis, Cindy-Lee; Macarthur, Christine

2012-12-01

to assess the effectiveness of a peer support worker (PSW) service on breast-feeding continuation. cluster randomised controlled trial (ISRCTN16126175). Primary Care Trust, UK serving a multi-ethnic, socio-economically disadvantaged population. 2,724 women giving birth following antenatal care from 66 clinics: 33 clinics (1,267 women) randomised to the PSW service and 33 clinics (1,457 women) to usual care. 848 women consented to additional follow-up by questionnaire at 6 months. PSW service provided in the antenatal and postnatal period. any and exclusive breast feeding at 10-14 days obtained from routine computerised records and at 6 weeks and 6 months from a questionnaire. follow-up: 94% at 10-14 days, 67.5% at 6 months. There was no difference in any breast feeding at 10-14 days between intervention and usual care, odds ratio (OR) 1.07 (95% CI 0.87-1.31, p=0.54). Proportion of women reporting any breast feeding in the intervention group at 6 weeks was 62.7% and 64.5% in the usual care group OR 0.93 (95% CI 0.64-1.35); and at 6 months was 34.3% and 38.9%, respectively, OR 1.06 (95% CI 0.71-1.58). universal antenatal peer support and postnatal peer support for women who initiated breast feeding did not improve breast-feeding rates up to 6 months in this UK population. with high levels of professional support part of usual maternity care it may not be possible for low intensity peer support to produce additional benefit. More intensive or targeted programmes might be effective, but should have concurrent high quality evaluation. Copyright © 2011 Elsevier Ltd. All rights reserved.

Circuit class therapy and 7-day-week therapy increase physiotherapy time, but not patient activity: early results from the CIRCIT trial.

PubMed

English, Coralie; Bernhardt, Julie; Hillier, Susan

2014-10-01

The optimum model of physiotherapy service delivery for maximizing active task practice during rehabilitation after stroke is unknown. The purpose of the study was to examine the relative effectiveness of 2 alternative models of physiotherapy service delivery against a usual care control with regard to increasing patient activity. Substudy within a large 3-armed randomized controlled trial, which compared 3 different models of physiotherapy service delivery, was provided for 4 weeks during subacute, inpatient rehabilitation (n=283). The duration of all physiotherapy sessions was recorded. In addition, 32 participants were observed at 10-minute intervals for 1 weekday and 1 weekend day between 8:00 am and 4:30 pm. At each observation, we recorded physical activity, location, and people present. Participants receiving 7-day-week and circuit class therapy received an additional 3 hours and 22 hours of physiotherapy time, respectively, when compared with usual care. Participants were standing or walking for a median of 8.2% of observations. On weekdays, circuit class therapy participants spent more time in therapy-related activity (10.2% of observations) when compared with usual care participants (6.1% of observations). On weekends, 7-day therapy participants spent more time in therapy-related activity (4.2% of observations) when compared with both usual care and circuit class therapy participants (0% of observations for both groups). Activity levels outside of therapy sessions did not differ between groups. A greater dosage of physiotherapy time did not translate into meaningful increases in physical activity across the day. http://www.anzctr.org.au/. Unique identifier: ACTRN12610000096055. © 2014 American Heart Association, Inc.

Randomised controlled feasibility trial of a web-based weight management intervention with nurse support for obese patients in primary care

PubMed Central

2014-01-01

Background There is a need for cost-effective weight management interventions that primary care can deliver to reduce the morbidity caused by obesity. Automated web-based interventions might provide a solution, but evidence suggests that they may be ineffective without additional human support. The main aim of this study was to carry out a feasibility trial of a web-based weight management intervention in primary care, comparing different levels of nurse support, to determine the optimal combination of web-based and personal support to be tested in a full trial. Methods This was an individually randomised four arm parallel non-blinded trial, recruiting obese patients in primary care. Following online registration, patients were randomly allocated by the automated intervention to either usual care, the web-based intervention only, or the web-based intervention with either basic nurse support (3 sessions in 3 months) or regular nurse support (7 sessions in 6 months). The main outcome measure (intended as the primary outcome for the main trial) was weight loss in kg at 12 months. As this was a feasibility trial no statistical analyses were carried out, but we present means, confidence intervals and effect sizes for weight loss in each group, uptake and retention, and completion of intervention components and outcome measures. Results All randomised patients were included in the weight loss analyses (using Last Observation Carried Forward). At 12 months mean weight loss was: usual care group (n = 43) 2.44 kg; web-based only group (n = 45) 2.30 kg; basic nurse support group (n = 44) 4.31 kg; regular nurse support group (n = 47) 2.50 kg. Intervention effect sizes compared with usual care were: d = 0.01 web-based; d = 0.34 basic nurse support; d = 0.02 regular nurse support. Two practices deviated from protocol by providing considerable weight management support to their usual care patients. Conclusions This study demonstrated the feasibility of delivering a web-based weight management intervention supported by practice nurses in primary care, and suggests that the combination of the web-based intervention with basic nurse support could provide an effective solution to weight management support in a primary care context. Trial registration Current Controlled Trials ISRCTN31685626. PMID:24886516

Spa therapy adjunct to pharmacotherapy is beneficial in rheumatoid arthritis: a crossover randomized controlled trial

NASA Astrophysics Data System (ADS)

Karagülle, Mine; Kardeş, Sinan; Dişçi, Rian; Karagülle, Müfit Zeki

2018-02-01

This study aims to investigate whether 2-week spa therapy, as an adjunct to usual pharmacological therapy, has any beneficial effect in patients with rheumatoid arthritis (RA). In this single-blind crossover study, 50 patients were randomly assigned in a 1:1 manner to receive usual pharmacological therapy plus 2-week spa therapy or usual pharmacological therapy alone (period 1.6 months); after a 9-month washout, patients were crossed over to the opposite assignment (period 2.6 months). Spa therapy program included a daily saline balneotherapy session at 36-37 °C for 20 min except Sundays. The clinical outcomes were evaluated at baseline, after spa therapy (2 weeks) and 3 and 6 months after the spa therapy in both period and were pain (Visual Analogue Scale (VAS)), patient and physician global assessments (VAS), Health Assessment Questionnaire (HAQ), and Disease Activity Score (DAS28). Spa therapy was superior to control therapy in improving all the assessed clinical outcomes at the end of the spa therapy. This superiority persisted significantly in physician global assessment ( p = 0.010) and with a trend in favor of spa group in patient global assessment ( p = 0.058), function ( p = 0.092), and disease activity ( p = 0.098) at 3 months. Statistically significant improvements were found in spa therapy compared to control in disease activity ( p = 0.006) and patient ( p = 0.020) and physician global ( p = 0.011) assessments, and a trend toward improvements in pain ( p = 0.069) and swollen joints ( p = 0.070) at 6 months. A 2-week spa therapy adjunct to usual pharmacological therapy provided beneficial clinical effects compared to usual pharmacological therapy alone, in RA patients treated with traditional disease-modifying antirheumatic drugs. These beneficial effects may last for 6 months.

An economic evaluation of the ketogenic diet versus care as usual in children and adolescents with intractable epilepsy: An interim analysis.

PubMed

de Kinderen, Reina J A; Lambrechts, Danielle A J E; Wijnen, Ben F M; Postulart, Debby; Aldenkamp, Albert P; Majoie, Marian H J M; Evers, Silvia M A A

2016-01-01

To gain insight into the cost-effectiveness of the ketogenic (KD) diet compared with care as usual (CAU) in children and adolescents with intractable epilepsy, we conducted an economic evaluation from a societal perspective, alongside a randomized controlled trial. Participants from a tertiary epilepsy center were randomized into KD (intervention) group or CAU (control) group. Seizure frequency, quality adjusted life years (QALYs), health care costs, production losses of parents and patient, and family costs were assessed at baseline and during a 4-month study period and compared between the intervention and control groups. The incremental cost-effectiveness ratios (ICERs) (i.e., cost per QALY and cost per responder), and cost-effectiveness acceptability curves (CEACs) were calculated and presented. In total, 48 children were included in the analyses of this study (26 KD group). At 4 months, 50% of the participants in the KD group had a seizure reduction ≥50% from baseline, compared with 18.2 of the participants in the CAU group. The mean costs per patient in the CAU group were €15,245 compared to €20,986 per patient in the KD group, resulting in an ICER of €18,044 per responder. We failed, however, to measure any benefits in terms of QALYs and therefore, the cost per QALY rise high above any acceptable ceiling ratio. It might be that the quality of life instruments used in this study were not sufficiently sensitive to detect changes, or it might be that being a clinical responder is not sufficient to improve a patient's quality of life. Univariate and multivariate sensitivity analyses and nonparametric bootstrapping were performed and demonstrated the robustness of our results. The results show that the KD reduces seizure frequency. The study did not find any improvements in quality of life and, therefore, unfavorable cost per QALY ratio's resulted. Wiley Periodicals, Inc. © 2015 International League Against Epilepsy.

The efficacy of SMART Arm training early after stroke for stroke survivors with severe upper limb disability: a protocol for a randomised controlled trial.

PubMed

Brauer, Sandra G; Hayward, Kathryn S; Carson, Richard G; Cresswell, Andrew G; Barker, Ruth N

2013-07-02

Recovery of upper limb function after stroke is poor. The acute to subacute phase after stroke is the optimal time window to promote the recovery of upper limb function. The dose and content of training provided conventionally during this phase is however, unlikely to be adequate to drive functional recovery, especially in the presence of severe motor disability. The current study concerns an approach to address this shortcoming, through evaluation of the SMART Arm, a non-robotic device that enables intensive and repetitive practice of reaching by stroke survivors with severe upper limb disability, with the aim of improving upper limb function. The outcomes of SMART Arm training with or without outcome-triggered electrical stimulation (OT-stim) to augment movement and usual therapy will be compared to usual therapy alone. A prospective, assessor-blinded parallel, three-group randomised controlled trial is being conducted. Seventy-five participants with a first-ever unilateral stroke less than 4 months previously, who present with severe arm disability (three or fewer out of a possible six points on the Motor Assessment Scale [MAS] Item 6), will be recruited from inpatient rehabilitation facilities. Participants will be randomly allocated to one of three dose-matched groups: SMART Arm training with OT-stim and usual therapy; SMART Arm training without OT-stim and usual therapy; or usual therapy alone. All participants will receive 20 hours of upper limb training over four weeks. Blinded assessors will conduct four assessments: pre intervention (0-weeks), post intervention (4-weeks), 26 weeks and 52 weeks follow-up. The primary outcome measure is MAS item 6. All analyses will be based on an intention-to-treat principle. By enabling intensive and repetitive practice of a functional upper limb task during inpatient rehabilitation, SMART Arm training with or without OT-stim in combination with usual therapy, has the potential to improve recovery of upper limb function in those with severe motor disability. The immediate and long-term effects of SMART Arm training on upper limb impairment, activity and participation will be explored, in addition to the benefit of training with or without OT-stim to augment movement when compared to usual therapy alone. ACTRN12608000457347.

Immediate interruption of sedation compared with usual sedation care in critically ill postoperative patients (SOS-Ventilation): a randomised, parallel-group clinical trial.

PubMed

Chanques, Gerald; Conseil, Matthieu; Roger, Claire; Constantin, Jean-Michel; Prades, Albert; Carr, Julie; Muller, Laurent; Jung, Boris; Belafia, Fouad; Cissé, Moussa; Delay, Jean-Marc; de Jong, Audrey; Lefrant, Jean-Yves; Futier, Emmanuel; Mercier, Grégoire; Molinari, Nicolas; Jaber, Samir

2017-10-01

Avoidance of excessive sedation and subsequent prolonged mechanical ventilation in intensive care units (ICUs) is recommended, but no data are available for critically ill postoperative patients. We hypothesised that in such patients stopping sedation immediately after admission to the ICU could reduce unnecessary sedation and improve patient outcomes. We did a randomised, parallel-group, clinical trial at three ICUs in France. Stratified randomisation with minimisation (1:1 via a restricted web platform) was used to assign eligible patients (aged ≥18 years, admitted to an ICU after abdominal surgery, and expected to require at least 12 h of mechanical ventilation because of a critical illness defined by a Sequential Organ Failure Assessment score >1 for any organ, but without severe acute respiratory distress syndrome or brain injury) to usual sedation care provided according to recommended practices (control group) or to immediate interruption of sedation (intervention group). The primary outcome was the time to successful extubation (defined as the time from randomisation to the time of extubation [or tracheotomy mask] for at least 48 h). All patients who underwent randomisation (except for those who were excluded after randomisation) were included in the intention-to-treat analysis. This study is registered with ClinicalTrials.gov, number NCT01486121. Between Dec 2, 2011, and Feb 27, 2014, 137 patients were randomly assigned to the control (n=68) or intervention groups (n=69). In the intention-to-treat analysis, time to successful extubation was significantly lower in the intervention group than in the control group (median 8 h [IQR 4-36] vs 50 h [29-93], group difference -33·6 h [95% CI -44·9 to -22·4]; p<0·0001). The adjusted hazard ratio was 5·2 (95% CI 3·1-8·8, p<0·0001). Immediate interruption of sedation in critically ill postoperative patients with organ dysfunction who were admitted to the ICU after abdominal surgery improved outcomes compared with usual sedation care. These findings support interruption of sedation in these patients following transfer from the operating room. Délégation à la Recherche Clinique et à l'Innovation du Groupement de Coopération Sanitaire de la Mission d'Enseignement, de Recherche, de Référence et d'Innovation (DRCI-GCS-MERRI) de Montpellier-Nîmes. Copyright © 2017 Elsevier Ltd. All rights reserved.

Quantitative Magnetic Resonance Diffusion-Weighted Imaging Evaluation of the Supratentorial Brain Regions in Patients Diagnosed with Brainstem Variant of Posterior Reversible Encephalopathy Syndrome: A Preliminary Study.

PubMed

Chen, Tai-Yuan; Wu, Te-Chang; Ko, Ching-Chung; Feng, I-Jung; Tsui, Yu-Kun; Lin, Chien-Jen; Chen, Jeon-Hor; Lin, Ching-Po

2017-07-01

Posterior reversible encephalopathy syndrome (PRES) is a clinicoradiologic entity with several causes, characterized by rapid onset of symptoms and typical neuroimaging features, which usually resolve if promptly recognized and treated. Brainstem variant of PRES presents with vasogenic edema in brainstem regions on magnetic resonance (MR) images and there is sparing of the supratentorial regions. Because PRES is usually caused by a hypertensive crisis, which would likely have a systemic effect and global manifestations on the brain tissue, we thus proposed that some microscopic abnormalities of the supratentorial regions could be detected with diffusion-weighted imaging (DWI) using apparent diffusion coefficient (ADC) analysis in brainstem variant of PRES and hypothesized that "normal-looking" supratentorial regions will increase water diffusion. We retrospectively identified patients with PRES who underwent brain magnetic resonance imaging studies. We identified 11 brainstem variants of PRES patients, who formed the study cohort, and 11 typical PRES patients and 20 normal control subjects as the comparison cohorts for this study. Nineteen regions of interest were drawn and systematically placed. The mean ADC values were measured and compared among these 3 groups. ADC values of the typical PRES group were consistently elevated compared with those in normal control subjects. ADC values of the brainstem variant group were consistently elevated compared with those in normal control subjects. ADC values of the typical PRES group and brainstem variant group did not differ significantly, except for the pons area. Quantitative MR DWI may aid in the evaluation of supratentorial microscopic abnormalities in brainstem variant of PRES patients. Copyright © 2017 National Stroke Association. Published by Elsevier Inc. All rights reserved.

A theory-based exercise intervention in patients with heart failure: A protocol for randomized, controlled trial

PubMed Central

Rajati, Fatemeh; Mostafavi, Firoozeh; Sharifirad, Gholamreza; Sadeghi, Masoomeh; Tavakol, Kamran; Feizi, Awat; Pashaei, Tahereh

2013-01-01

Background: Regular exercise has been associated with improved quality of life (QoL) in patients with heart failure (HF). However, less is known on the theoretical framework, depicting how educational intervention on psychological, social, and cognitive variables affects physical activity (PA). The purpose of this study is to assess the effectiveness of a social cognitive theory-based (SCT-based) exercise intervention in patients with HF. Materials and Methods: This is a randomized controlled trial, with measurements at baseline, immediately following the intervention, and at 1, 3, and 6 months follow-up. Sixty patients who are referred to the cardiac rehabilitation (CR) unit and meet the inclusion criteria will be randomly allocated to either an intervention group or a usual-care control group. Data will be collected using various methods (i.e., questionnaires, physical tests, paraclinical tests, patients’ interviews, and focus groups). The patients in the intervention group will receive eight face-to-face counseling sessions, two focus groups, and six educational sessions over a 2-month period. The intervention will include watching videos, using book and pamphlets, and sending short massage services to the participants. The primary outcome measures are PA and QoL. The secondary outcome measures will be the components of SCT, heart rate and blood pressure at rest, body mass index, left ventricular ejection fraction, exercise capacity, and maximum heart rate. Conclusion: The findings of this trial may assist with the development of a theoretical model for exercise intervention in CR. The intervention seems to be promising and has the potential to bridge the gap of the usually limited and incoherent provision of educational care in the CR setting. PMID:24379841

Land- and water-based exercise intervention in women with fibromyalgia: the al-Andalus physical activity randomised controlled trial.

PubMed

Carbonell-Baeza, Ana; Ruiz, Jonatan R; Aparicio, Virginia A; Ortega, Francisco B; Munguía-Izquierdo, Diego; Alvarez-Gallardo, Inmaculada C; Segura-Jiménez, Víctor; Camiletti-Moirón, Daniel; Romero, Alejandro; Estévez-López, Fernando; Samos, Blanca; Casimiro, Antonio J; Sierra, Ángela; Latorre, Pedro A; Pulido-Martos, Manuel; Femia, Pedro; Pérez-López, Isaac J; Chillón, Palma; Girela-Rejón, María J; Tercedor, Pablo; Lucía, Alejandro; Delgado-Fernández, Manuel

2012-02-15

The al-Andalus physical activity intervention study is a randomised control trial to investigate the effectiveness of a land- and water-based exercise intervention for reducing the overall impact of fibromyalgia (primary outcome), and for improving tenderness and pain-related measures, body composition, functional capacity, physical activity and sedentary behaviour, fatigue, sleep quality, health-related quality of life, and cognitive function (secondary outcomes) in women with fibromyalgia. One hundred eighty women with fibromyalgia (age range: 35-65 years) will be recruited from local associations of fibromyalgia patients in Andalucía (Southern Spain). Patients will be randomly assigned to a usual care (control) group (n = 60), a water-based exercise intervention group (n = 60) or a land-based exercise intervention group (n = 60). Participants in the usual care group will receive general physical activity guidelines and participants allocated in the intervention groups will attend three non-consecutive training sessions (60 min each) per week during 24 weeks. Both exercise interventions will consist of aerobic, muscular strength and flexibility exercises. We will also study the effect of a detraining period (i.e., 12 weeks with no exercise intervention) on the studied variables. Our study attempts to reduce the impact of fibromyalgia and improve patients' health status by implementing two types of exercise interventions. Results from this study will help to assess the efficacy of exercise interventions for the treatment of fibromyalgia. If the interventions would be effective, this study will provide low-cost and feasible alternatives for health professionals in the management of fibromyalgia. Results from the al-Andalus physical activity intervention will help to better understand the potential of regular physical activity for improving the well-being of women with fibromyalgia. ClinicalTrials.gov ID: NCT01490281.

Cost-effectiveness of a multicomponent primary care program targeting frail elderly people.

PubMed

Ruikes, Franca G H; Adang, Eddy M; Assendelft, Willem J J; Schers, Henk J; Koopmans, Raymond T C M; Zuidema, Sytse U

2018-05-16

Over the last 20 years, integrated care programs for frail elderly people aimed to prevent functional dependence and reduce hospitalization and institutionalization. However, results have been inconsistent and merely modest. To date, evidence on the cost-effectiveness of these programs is scarce. We evaluated the cost-effectiveness of the CareWell program, a multicomponent integrated care program for frail elderly people. Economic evaluation from a healthcare perspective embedded in a cluster controlled trial of 12 months in 12 general practices in (the region of) Nijmegen. Two hundred and four frail elderly from 6 general practices in the intervention group received care according to the CareWell program, consisting of multidisciplinary team meetings, proactive care planning, case management, and medication reviews; 165 frail elderly from 6 general practices in the control group received usual care. In cost-effectiveness analyses, we related costs to daily functioning (Katz-15 change score i.e. follow up score minus baseline score) and quality adjusted life years (EQ-5D-3 L). Adjusted mean costs directly related to the intervention were €456 per person. Adjusted mean total costs, i.e. intervention costs plus healthcare utilization costs, were €1583 (95% CI -4647 to 1481) higher in the intervention group than in the control group. Incremental Net Monetary Benefits did not show significant differences between groups, but on average tended to favour usual care. The CareWell primary program was not cost-effective after 12 months. From a cost-effectiveness perspective, widespread implementation of the program in its current form cannot be recommended. The study was registered in the ClinicalTrials.govProtocol Registration System: ( NCT01499797 ; December 26, 2011). Retrospectively registered.

A randomised controlled trial of sensory awareness training and additional motor practice for learning scalpel skills in podiatry students.

PubMed

Causby, Ryan S; McDonnell, Michelle N; Reed, Lloyd; Hillier, Susan L

2016-12-05

The process of using a scalpel, like all other motor activities, is dependent upon the successful integration of afferent (sensory), cognitive and efferent (motor) processes. During learning of these skills, even if motor practice is carefully monitored there is still an inherent risk involved. It is also possible that this strategy could reinforce high levels of anxiety experienced by the student and affect student self-efficacy, causing detrimental effects on motor learning. An alternative training strategy could be through targeting sensory rather than motor processes. Second year podiatry students who were about to commence learning scalpel skills were recruited. Participants were randomly allocated into sensory awareness training (Sensory), additional motor practice (Motor) or usual teaching only (Control) groups. Participants were then evaluated on psychological measures (Intrinsic Motivation Inventory) and dexterity measures (Purdue Pegboard, Grooved Pegboard Test and a grip-lift task). A total of 44 participants were included in the study. There were no baseline differences or significant differences between the three groups over time on the Perceived Competence, Effort/ Importance or Pressure/ Tension, psychological measures. All groups showed a significant increase in Perceived Competence over time (F 1,41  = 13.796, p = 0.001). Only one variable for the grip-lift task (Preload Duration for the non-dominant hand) showed a significant difference over time between the groups (F 2,41  = 3.280, p = 0.038), specifically, Motor and Control groups. The use of sensory awareness training, or additional motor practice did not provide a more effective alternative compared with usual teaching. Further research may be warranted using more engaged training, provision of supervision and greater participant numbers. Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12616001428459 . Registered 13 th October 2016. Registered Retrospectively.

Technology-Intensified Diabetes Education Study (TIDES) in African Americans with type 2 diabetes: study protocol for a randomized controlled trial.

PubMed

Williams, Joni S; Lynch, Cheryl P; Knapp, Rebecca G; Egede, Leonard E

2014-11-25

Compared to American Whites, African Americans have a higher prevalence of type 2 diabetes mellitus (T2DM), experiencing poorer metabolic control and greater risks for complications and death. Patient-level factors, such as diabetes knowledge, self-management skills, empowerment, and perceived control, account for >90% of the variance observed in outcomes between these racial groups. There is strong evidence that self-management interventions that include telephone-delivered diabetes education and skills training are effective at improving metabolic control in diabetes. Web-based home telemonitoring systems in conjunction with active care management are also effective ways to lower glycosylated hemoglobin A1c values when compared to standard care, and provide feedback to patients; however, there are no studies in African Americans with poorly controlled T2DM that examine the use of technology-based feedback to tailor or augment diabetes education and skills training. This study provides a unique opportunity to address this gap in the literature. We describe an ongoing 4-year randomized clinical trial, which will test the efficacy of a technology-intensified diabetes education and skills training (TIDES) intervention in African Americans with poorly controlled T2DM. Two hundred male and female AfricanAmerican participants, 21 years of age or older and with a glycosylated hemoglobin A1c level ≥ 8%, will be randomized into one of two groups for 12 weeks of telephone interventions: (1) TIDES intervention group or (2) a usual-care group. Participants will be followed for 12 months to ascertain the effect of the interventions on glycemic control. Our primary hypothesis is that, among African Americans with poorly controlled T2DM, patients randomized to the TIDES intervention will have significantly greater reduction in glycosylated hemoglobin A1c at 12 months of follow-up compared to the usual-care group. Results from this study will add to the current literature examining how best to deliver diabetes education and skills training and provide important insight into effective strategies to improve metabolic control and hence reduce diabetes complications and mortality rates in African Americans with poorly controlled T2DM. This study was registered with the National Institutes of Health Clinical Trials Registry on 13 March 2014 (ClinicalTrials.gov identifier# NCT02088658).

Computerised cognitive behaviour therapy (cCBT) as treatment for depression in primary care (REEACT trial): large scale pragmatic randomised controlled trial

PubMed Central

Littlewood, Elizabeth; Hewitt, Catherine; Brierley, Gwen; Tharmanathan, Puvan; Araya, Ricardo; Barkham, Michael; Bower, Peter; Cooper, Cindy; Gask, Linda; Kessler, David; Lester, Helen; Lovell, Karina; Parry, Glenys; Richards, David A; Andersen, Phil; Brabyn, Sally; Knowles, Sarah; Shepherd, Charles; Tallon, Debbie; White, David

2015-01-01

Study question How effective is supported computerised cognitive behaviour therapy (cCBT) as an adjunct to usual primary care for adults with depression? Methods This was a pragmatic, multicentre, three arm, parallel randomised controlled trial with simple randomisation. Treatment allocation was not blinded. Participants were adults with symptoms of depression (score ≥10 on nine item patient health questionnaire, PHQ-9) who were randomised to receive a commercially produced cCBT programme (“Beating the Blues”) or a free to use cCBT programme (MoodGYM) in addition to usual GP care. Participants were supported and encouraged to complete the programme via weekly telephone calls. Control participants were offered usual GP care, with no constraints on the range of treatments that could be accessed. The primary outcome was severity of depression assessed with the PHQ-9 at four months. Secondary outcomes included health related quality of life (measured by SF-36) and psychological wellbeing (measured by CORE-OM) at four, 12, and 24 months and depression at 12 and 24 months. Study answer and limitations Participants offered commercial or free to use cCBT experienced no additional improvement in depression compared with usual GP care at four months (odds ratio 1.19 (95% confidence interval 0.75 to 1.88) for Beating the Blues v usual GP care; 0.98 (0.62 to 1.56) for MoodGYM v usual GP care). There was no evidence of an overall difference between either programme compared with usual GP care (0.99 (0.57 to 1.70) and 0.68 (0.42 to 1.10), respectively) at any time point. Commercially provided cCBT conferred no additional benefit over free to use cCBT or usual GP care at any follow-up point. Uptake and use of cCBT was low, despite regular telephone support. Nearly a quarter of participants (24%) had dropped out by four months. The study did not have enough power to detect small differences so these cannot be ruled out. Findings cannot be generalised to cCBT offered with a much higher level of guidance and support. What this study adds Supported cCBT does not substantially improve depression outcomes compared with usual GP care alone. In this study, neither a commercially available nor free to use computerised CBT intervention was superior to usual GP care. Funding, competing interests, data sharing Commissioned and funded by the UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme (project No 06/43/05). The authors have no competing interests. Requests for patient level data will be considered by the REEACT trial management group Trial registration Current Controlled Trials ISRCTN91947481. PMID:26559241

Randomized controlled pilot trial of a novel dissonance-based group treatment for eating disorders.

PubMed

Stice, Eric; Rohde, Paul; Butryn, Meghan; Menke, Katharine S; Marti, C Nathan

2015-02-01

The authors conducted a pilot trial of a new dissonance-based group eating disorder treatment designed to be a cost-effective front-line transdiagnostic treatment that could be more widely disseminated than extant individual or family treatments that are more expensive and difficult to deliver. Young women with a DSM-5 eating disorder (N = 72) were randomized to an 8-week dissonance-based Counter Attitudinal Therapy group treatment or a usual care control condition, completing diagnostic interviews and questionnaires at pre, post, and 2-month follow-up. Intent-to-treat analyses revealed that intervention participants showed greater reductions in outcomes than usual care controls in a multivariate multilevel model (χ(2)[6] = 34.1, p < .001), producing large effects for thin-ideal internalization (d = .79), body dissatisfaction (d = 1.14), and blinded interview-assessed eating disorder symptoms (d = .95), and medium effects for dissonance regarding perpetuating the thin ideal (d = .65) and negative affect (d = .55). Midway through this pilot we refined engagement procedures, which was associated with increased effect sizes (e.g., the d for eating disorder symptoms increased from .51 to 2.30). This new group treatment produced large reductions in eating disorder symptoms, which is encouraging because it requires about 1/20th the therapist time necessary for extant individual and family treatments, and has the potential to provide a cost-effective and efficacious approach to reaching the majority of individuals with eating disorders who do not presently received treatment. Copyright © 2014 Elsevier Ltd. All rights reserved.

Is it possible to strengthen psychiatric nursing staff's clinical supervision? RCT of a meta-supervision intervention.

PubMed

Gonge, Henrik; Buus, Niels

2015-04-01

To test the effects of a meta-supervision intervention in terms of participation, effectiveness and benefits of clinical supervision of psychiatric nursing staff. Clinical supervision is regarded as a central component in developing mental health nursing practices, but the evidence supporting positive outcomes of clinical supervision in psychiatric nursing is not convincing. The study was designed as a randomized controlled trial. All permanently employed nursing staff members at three general psychiatric wards at a Danish university hospital (n = 83) were allocated to either an intervention group (n = 40) receiving the meta-supervision in addition to attending usual supervision or to a control group (n = 43) attending usual supervision. Self-reported questionnaire measures of clinical supervision effectiveness and benefits were collected at base line in January 2012 and at follow-up completed in February 2013. In addition, a prospective registration of clinical supervision participation was carried out over 3 months subsequent to the intervention. The main result was that it was possible to motivate staff in the intervention group to participate significantly more frequently in sessions of the ongoing supervision compared with the control group. However, more frequent participation was not reflected in the experienced effectiveness of the clinical supervision or in the general formative or restorative benefits. The intervention had a positive effect on individuals or wards already actively engaged in clinical supervision, which suggested that individuals and wards without well-established supervision practices may require more comprehensive interventions targeting individual and organizational barriers to clinical supervision. © 2014 John Wiley & Sons Ltd.

A 3-year physical activity intervention program increases the gain in bone mineral and bone width in prepubertal girls but not boys: the prospective copenhagen school child interventions study (CoSCIS).

PubMed

Hasselstrøm, H A; Karlsson, M K; Hansen, S E; Grønfeldt, V; Froberg, K; Andersen, L B

2008-10-01

The aim of this study was to evaluate the effect of increasing the amount of time spent in physical education classes on bone mineral accrual and gain in bone size in prepubertal Danish children. A total of 135 boys and 108 girls, aged 6-8 years, were included in a school-based curriculum intervention program where the usual time spent in physical education classes was doubled to four classes (180 min) per week. The control group comprised age-matched children (62 boys and 76 girls) recruited from a separate community who completed the usual Danish school curriculum of physical activity (90 min/week). Dual-energy X-ray absorptiometry was used to evaluate bone mineral content (BMC; g), bone mineral density (g/cm(2)), and bone width at the calcaneus and distal forearm before and after 3 years of intervention. Anthropometrics and Tanner stages were evaluated on the same occasions. General physical activity was measured with an accelerometer worn for 4 days. In girls, the intervention group had a 12.5% increase (P = 0.04) in distal forearm BMC and a 13.2% increase (P = 0.005) in distal forearm scanned area compared with girls in the control group. No differences were found between the intervention and control groups in boys. Increasing the frequency of physical education classes for prepubertal children is associated with a higher accrual of bone mineral and higher gain in bone size after 3 years in girls but not in boys.

The economics of dementia-care mapping in nursing homes: a cluster-randomised controlled trial.

PubMed

van de Ven, Geertje; Draskovic, Irena; van Herpen, Elke; Koopmans, Raymond T C M; Donders, Rogier; Zuidema, Sytse U; Adang, Eddy M M; Vernooij-Dassen, Myrra J F J

2014-01-01

Dementia-care mapping (DCM) is a cyclic intervention aiming at reducing neuropsychiatric symptoms in people with dementia in nursing homes. Alongside an 18-month cluster-randomized controlled trial in which we studied the effectiveness of DCM on residents and staff outcomes, we investigated differences in costs of care between DCM and usual care in nursing homes. Dementia special care units were randomly assigned to DCM or usual care. Nurses from the intervention care homes received DCM training, a DCM organizational briefing day and conducted the 4-months DCM-intervention twice during the study. A single DCM cycle consists of observation, feedback to the staff, and action plans for the residents. We measured costs related to health care consumption, falls and psychotropic drug use at the resident level and absenteeism at the staff level. Data were extracted from resident files and the nursing home records. Prizes were determined using the Dutch manual of health care cost and the cost prices delivered by a pharmacy and a nursing home. Total costs were evaluated by means of linear mixed-effect models for longitudinal data, with the unit as a random effect to correct for dependencies within units. 34 units from 11 nursing homes, including 318 residents and 376 nursing staff members participated in the cost analyses. Analyses showed no difference in total costs. However certain changes within costs could be noticed. The intervention group showed lower costs associated with outpatient hospital appointments over time (p = 0.05) than the control group. In both groups, the number of falls, costs associated with the elderly-care physician and nurse practitioner increased equally during the study (p<0.02). DCM is a cost-neutral intervention. It effectively reduces outpatient hospital appointments compared to usual care. Other considerations than costs, such as nursing homes' preferences, may determine whether they adopt the DCM method. Dutch Trials Registry NTR2314.

Evaluation of a decision aid for women with breech presentation at term: a randomised controlled trial [ISRCTN14570598

PubMed Central

Nassar, N; Roberts, CL; Raynes-Greenow, CH; Barratt, A; Peat, B

2007-01-01

Objectives To evaluate the effectiveness of a decision aid for women with a breech presentation compared with usual care. Design Randomised controlled trial. Setting Tertiary obstetric hospitals offering external cephalic version (ECV). Population Women with a singleton pregnancy were diagnosed antenatally with a breech presentation at term, and were clinically eligible for ECV. Methods Women were randomised to either receive a decision aid about the management options for breech presentation in addition to usual care or to receive usual care only with standard counselling from their usual pregnancy care provider. The decision aid comprised a 24-page booklet supplemented by a 30-minute audio-CD and worksheet that was designed for women to take home and review with a partner. Main outcome measures Decisional conflict (uncertainty), knowledge, anxiety and satisfaction with decision making, and were assessed using self-administered questionnaires. Results Compared with usual care, women reviewing the decision aid experienced significantly lower decisional conflict (mean difference −8.92; 95% CI −13.18, −4.66) and increased knowledge (mean difference 8.40; 95% CI 3.10, 13.71), were more likely to feel that they had enough information to make a decision (RR 1.30; 95% CI 1.14, 1.47), had no increase in anxiety and reported greater satisfaction with decision making and overall experience of pregnancy and childbirth. In contrast, 19% of women in the usual care group reported they would have made a different decision about their care. Conclusions A decision aid is an effective and acceptable tool for pregnant women that provides an important adjunct to standard counselling for the management of breech presentation. Please cite this paper as: Nassar N, Roberts C, Raynes-Greenow C, Barratt A, Peat B, on behalf of the Decision Aid for Breech Presentation Trial Collaborators. Evaluation of a decision aid for women with breech presentation at term: a randomised controlled trial [ISRCTN14570598]. BJOG 2007;114:325–333. PMID:17217360

The effectiveness and cost-effectiveness of a participative community singing programme as a health promotion initiative for older people: protocol for a randomised controlled trial.

PubMed

Skingley, Ann; Clift, Stephen M; Coulton, Simon P; Rodriguez, John

2011-02-28

The growth in numbers of older people represents a considerable cost to health and social care services in the United Kingdom. There is an acknowledged need to address issues of social exclusion and both the physical and mental health of this age group. In recent years there has been much interest in the potential contribution of the arts to the health of communities and individuals. There is some evidence that participative singing may be of benefit to older people, however studies to date are limited in number and have lacked rigour. There is therefore a need to build on this knowledge base to provide more quantifiable evidence of both effectiveness and cost effectiveness of singing as a health intervention for this population group. The proposed study is a pragmatic randomised controlled trial with two parallel arms. The primary hypothesis is that singing groups for older people improve both physical and mental aspects of quality of life when compared to usual activities. Potential participants will be volunteers over 60 years living in the community and recruited through publicity. Eligible and consenting participants will be randomized to either a singing group or a control group. Singing groups will take part in a twelve week planned programme of singing and control groups will continue with usual activities. The primary outcome measure will be the York SF-12, a health related quality of life measure which will be administered at baseline, three and six months after baseline. The study will evaluate both effectiveness and cost-effectiveness. This study proposes to add to the existing body of evidence on the value of singing for older people by using a rigorous methodological design, which includes a power calculation, a standardised intervention and assessment of cost-effectiveness. It should be regarded as a stage in a progressive programme of studies in this area. If group singing is found to be effective and cost-effective it may offer an alternative means to maintaining the health of people in later life. ISRCTN62404401.

The Clinical Effects of Aromatherapy Massage on Reducing Pain for the Cancer Patients: Meta-Analysis of Randomized Controlled Trials.

PubMed

Chen, Ting-Hao; Tung, Tao-Hsin; Chen, Pei-Shih; Wang, Shu-Hui; Chao, Chuang-Min; Hsiung, Nan-Hsing; Chi, Ching-Chi

2016-01-01

Purpose. Aromatherapy massage is an alternative treatment in reducing the pain of the cancer patients. This study was to investigate whether aromatherapy massage could improve the pain of the cancer patients. Methods. We searched PubMed and Cochrane Library for relevant randomized controlled trials without language limitations between 1 January 1990 and 31 July 2015 with a priori defined inclusion and exclusion criteria. The search terms included aromatherapy, essential oil, pain, ache, cancer, tumor, and carcinoma. There were 7 studies which met the selection criteria and 3 studies were eventually included among 63 eligible publications. Results. This meta-analysis included three randomized controlled trials with a total of 278 participants (135 participants in the massage with essential oil group and 143 participants in the control (usual care) group). Compared with the control group, the massage with essential oil group had nonsignificant effect on reducing the pain (standardized mean difference = 0.01; 95% CI [-0.23,0.24]). Conclusion. Aromatherapy massage does not appear to reduce pain of the cancer patients. Further rigorous studies should be conducted with more objective measures.

Expert patient self-management program versus usual care in bronchiectasis: a randomized controlled trial.

PubMed

Lavery, Katherine A; O'Neill, Brenda; Parker, Michael; Elborn, J Stuart; Bradley, Judy M

2011-08-01

To investigate the efficacy of a disease-specific Expert Patient Programme (EPP) compared with usual care in patients with bronchiectasis. Proof-of-concept randomized controlled trial. Regional respiratory center. Adult patients (N=64; age, >18y) with a primary diagnosis of bronchiectasis based on a respiratory physician's assessment including a computed tomographic scan. Patients were randomly assigned to an intervention (usual care plus EPP; n=32) or control group (usual care only; n=32). The primary outcome measure was the Chronic Disease Self-efficacy Scale (CDSS). Other outcome measures included the Revised Illness Perception Questionnaire (IPQ-R), the St Georges Respiratory Questionnaire, and standard EPP questionnaires. Data were collected at baseline, postintervention, and 3 and 6 months postintervention. This disease-specific EPP for patients with bronchiectasis significantly improved self-efficacy in 6 of 10 subscales (CDSS subscales: exercise regularly [P=.02]; get information about disease [P=.03]; obtain help from community, family, and friends [P=.06]; communicate with physician [P=.85]; manage disease in general [P=.05]; do chores [P=.04]; social/recreational activities [P=.03]; manage symptoms [P<.01]; manage shortness of breath [P=.08]; control/manage depression [P=.01]) compared with usual care. There was no improvement on IPQ-R score. Patients who received the intervention reported more symptoms and decreased quality of life between 3 and 6 months postintervention and an increase in some components of self reported health care use. Patients receiving the disease-specific EPP indicated they were satisfied with the intervention and learned new self-management techniques. There were no significant differences in lung function over time. This original study indicates that a disease-specific EPP results in short-term improvements in self-efficacy. Based on these positive preliminary findings, a larger adequately powered study is justified to investigate the efficacy of a disease-specific EPP in patients with bronchiectasis. Copyright © 2011 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

COACH trial: A randomized controlled trial of nurse practitioner/community health worker cardiovascular disease risk reduction in urban community health centers: Rationale and design

PubMed Central

Allen, Jerilyn K; Himmelfarb, Cheryl R Dennison; Szanton, Sarah L; Bone, Lee; Hill, Martha N; Levine, David M

2011-01-01

Background Despite well-publicized guidelines on the appropriate management of cardiovascular disease (CVD) and type 2 diabetes, implementation of risk-reducing practices remains poor. This paper describes the rationale and design of a randomized controlled clinical trial evaluating the effectiveness of a comprehensive program of CVD risk reduction delivered by nurse practitioner (NP)/community health worker (CHW) teams versus enhanced usual care in improving the proportion of patients in urban community health centers who achieve goal levels recommended by national guidelines for lipids, blood pressure, HbA1c and prescription of appropriate medications. Methods The COACH (Community Outreach and Cardiovascular Health) trial is a randomized controlled trial in which patients at federally-qualified community health centers were randomly assigned to one of two groups: comprehensive intensive management of CVD risk factors for one year by a NP/CHW team or an enhanced usual care control group. Results A total of 3899 patients were assessed for eligibility and 525 were randomized. Groups were comparable at baseline on sociodemographic and clinical characteristics with the exception of statistically significant differences in total cholesterol and hemoglobin A1c. Conclusions This study is a novel amalgam of multilevel interdisciplinary strategies to translate highly efficacious therapies to low-income federally-funded health centers that care for patients who carry a disproportionate burden of CVD, type 2 diabetes and uncontrolled CVD risk factors. The impact of such a community clinic-based intervention is potentially enormous. PMID:21241828

COACH trial: a randomized controlled trial of nurse practitioner/community health worker cardiovascular disease risk reduction in urban community health centers: rationale and design.

PubMed

Allen, Jerilyn K; Himmelfarb, Cheryl R Dennison; Szanton, Sarah L; Bone, Lee; Hill, Martha N; Levine, David M

2011-05-01

Despite well-publicized guidelines on the appropriate management of cardiovascular disease (CVD) and type 2 diabetes, implementation of risk-reducing practices remains poor. This paper describes the rationale and design of a randomized controlled clinical trial evaluating the effectiveness of a comprehensive program of CVD risk reduction delivered by nurse practitioner (NP)/community health worker (CHW) teams versus enhanced usual care in improving the proportion of patients in urban community health centers who achieve goal levels recommended by national guidelines for lipids, blood pressure, HbA1c and prescription of appropriate medications. The COACH (Community Outreach and Cardiovascular Health) trial is a randomized controlled trial in which patients at federally-qualified community health centers were randomly assigned to one of two groups: comprehensive intensive management of CVD risk factors for one year by a NP/CHW team or an enhanced usual care control group. A total of 3899 patients were assessed for eligibility and 525 were randomized. Groups were comparable at baseline on sociodemographic and clinical characteristics with the exception of statistically significant differences in total cholesterol and hemoglobin A1c. This study is a novel amalgam of multilevel interdisciplinary strategies to translate highly efficacious therapies to low-income federally-funded health centers that care for patients who carry a disproportionate burden of CVD, type 2 diabetes and uncontrolled CVD risk factors. The impact of such a community clinic-based intervention is potentially enormous. Copyright © 2011 Elsevier Inc. All rights reserved.

The effect of medical nutrition therapy by a registered dietitian nutritionist in patients with prediabetes participating in a randomized controlled clinical research trial.

PubMed

Parker, Anna R; Byham-Gray, Laura; Denmark, Robert; Winkle, Peter J

2014-11-01

Prior studies have provided evidence that lifestyle change prevents or delays the occurrence of type 2 diabetes mellitus. The challenge is to translate research evidence for type 2 diabetes mellitus prevention into health care settings. We investigated the effect of medical nutrition therapy (MNT) compared with usual care on fasting plasma glucose values, glycated hemoglobin (HbA1c), serum lipid levels, and Diabetes Risk Score, from baseline to the end of a 12-week intervention in overweight or obese adults with prediabetes. Prospective, randomized, parallel group study of 76 adults with impaired fasting plasma glucose or an HbA1c of 5.7% to 6.4%, recruited between April 2010 and May 2011 who completed a 12-week intervention period. The primary outcome measure was fasting plasma glucose. Secondary outcome measures were HbA1c, serum lipid levels, and Diabetes Risk Score. A factorial repeated measures analysis of variance was used to make comparisons between the two groups (the MNT and usual care groups) and two measures of time (baseline and 12 weeks postintervention). Data analysis was performed using the Statistical Package for the Social Sciences (release 19.0, 2010, SPSS Inc). There was a significant interaction for group assignment and HbA1c (P=0.01), with the MNT group experiencing significantly lower HbA1c levels than the usual care group (5.79% vs 6.01%) after the 12-week intervention. There was a significant interaction for group assignment and Diabetes Risk Score (P=0.001). Diabetes Risk Score for the MNT group decreased from 17.54±3.69 to 15.31±3.79 compared with the usual care group score, which went from 17.23±4.69 to 16.83±4.73. Regardless of group assignment, both groups experienced a reduction in total cholesterol (P=0.01) and low-density lipoprotein cholesterol (P=0.04) level. The results demonstrate that individualized MNT is effective in decreasing HbA1c level in patients diagnosed with prediabetes. Copyright © 2014 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.

Effectiveness of a standardized back school program for patients with chronic low back pain after implementation in routine rehabilitation care.

PubMed

Meng, Karin; Peters, Stefan; Faller, Hermann

2017-06-01

To evaluate the effectiveness of a standardized, patient-oriented, biopsychosocial back school after implementation in inpatient orthopedic rehabilitation. A multi-center, quasi-experimental controlled study of patients with low back pain (n=535) was conducted. Patients in the control group received the traditional back school before implementation of the new program (usual care); patients in the intervention group received the new standardized back school after implementation into routine care. Patients' illness knowledge and conduct of back exercises (primary outcomes) and secondary self-management outcomes and treatment satisfaction were obtained at admission, discharge, and 6 and 12 months after rehabilitation. We found a significant small between-group intervention effect on patients' illness knowledge in medium- to long term (6 months: η 2 =0.015; 12 months: η 2 =0.013). There were trends for effects on conduct of back exercises among men (6 and 12 months: η 2 =0.008 both). Furthermore, significant small effects were observed for treatment satisfaction at discharge and physical activity after 6 months. The standardized back school seems to be more effective in certain outcomes than a usual care program despite heterogeneous program implementation. Further dissemination within orthopedic rehabilitation may be encouraged to foster self-management outcomes. Copyright © 2017 Elsevier B.V. All rights reserved.

A controlled trial on the effect of hypnosis on dental anxiety in tooth removal patients.

PubMed

Glaesmer, Heide; Geupel, Hendrik; Haak, Rainer

2015-09-01

Empirical evidence concerning the efficacy of hypnosis to reduce anxiety in dental patients is limited. Hence we conducted a controlled trial in patients undergoing tooth removal. The study aims at assessing patient's attitude toward hypnosis and comparing the course of dental anxiety before, during and subsequent to tooth removal in patients with treatment as usual (TAU) and patients with treatment as usual and hypnosis (TAU+HYP). 102 patients in a dental practice were assigned to TAU or TAU+HYP. Dental anxiety was assessed before, during and after treatment. All patients were asked about their experiences and attitudes toward hypnosis. More than 90% of patients had positive attitudes toward hypnosis. Dental anxiety was highest before treatment, and was decreasing across the three assessment points in both groups. The TAU+HYP group reported significantly lower levels of anxiety during treatment, but not after treatment compared with TAU group. Our findings confirm that hypnosis is beneficial as an adjunct intervention to reduce anxiety in patients undergoing tooth removal, particularly with regard to its no-invasive nature. The findings underline that hypnosis is not only beneficial, but also highly accepted by the patients. Implementation of hypnosis in routine dental care should be forwarded. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

A self-management program for employees with complaints of the arm, neck, or shoulder (CANS): study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Complaints of the arm, neck, or shoulder (CANS) have a multifactorial origin and cause considerable work problems, including decreased work productivity, sickness absence, and, ultimately, job loss. There is a need for intervention programs for people with CANS. Self-management is an approach used in chronic disease care to improve self-efficacy and wellness behaviors to facilitate participants to make informed choices and carry them out. This study will evaluate the effectiveness of a self-management program (including ehealth) and compare it to usual care among employees with chronic CANS (lasting >3 months). Methods/design This is a randomized controlled trial in which 142 participants will be recruited and randomized (with pre-stratification) to either the intervention group (IG) or control group (CG). The IG will participate in a self-management program consisting of six group sessions and an ehealth module. The CG is allowed to use all usual care available. The primary outcome of the study is the self-reported disability of arm, shoulder, and hand, measured with the Disabilities of the Arm, Shoulder and Hand questionnaire (DASH). Secondary outcomes include: absenteeism, pain in the previous week, quality of life, catastrophizing pain, self-efficacy, workstyle, presenteeism, fatigue, the use of usual care, and limitations experienced on the job. Data are collected at baseline and at 3, 6, and 12 months follow-up. Discussion Following the process of intervention mapping we developed a self-management program to suit and alleviate the problems and needs of employees with CANS. A strength of the study is that our intervention is specifically tailored to match the needs of employees with CANS. The study also has some potential weaknesses (for example, use of co-interventions, combination of group sessions and ehealth, self-reporting of data and possible contamination, Hawthorne effect, and recall or information bias) which are discussed. Trial registration The trial is registered with the Dutch Trial Register (http://www.trialregister.nlNTR3816): (January 2013). The first participant was randomized in September 2012. PMID:23958154

Intervention to improve social and family support for caregivers of dependent patients: ICIAS study protocol.

PubMed

Rosell-Murphy, Magdalena; Bonet-Simó, Josep M; Baena, Esther; Prieto, Gemma; Bellerino, Eva; Solé, Francesc; Rubio, Montserrat; Krier, Ilona; Torres, Pascuala; Mimoso, Sonia

2014-03-25

Despite the existence of formal professional support services, informal support (mainly family members) continues to be the main source of eldercare, especially for those who are dependent or disabled. Professionals on the primary health care are the ideal choice to educate, provide psychological support, and help to mobilize social resources available to the informal caregiver.Controversy remains concerning the efficiency of multiple interventions, taking a holistic approach to both the patient and caregiver, and optimum utilization of the available community resources. .For this reason our goal is to assess whether an intervention designed to improve the social support for caregivers effectively decreases caregivers burden and improves their quality of life. CONTROLled, multicentre, community intervention trial, with patients and their caregivers randomized to the intervention or control group according to their assigned Primary Health Care Team (PHCT). Primary Health Care network (9 PHCTs). Primary informal caregivers of patients receiving home health care from participating PHCTs. Required sample size is 282 caregivers (141 from PHCTs randomized to the intervention group and 141 from PHCTs randomized to the control group. a) PHCT professionals: standardized training to implement caregivers intervention. b) Caregivers: 1 individualized counselling session, 1 family session, and 4 educational group sessions conducted by participating PHCT professionals; in addition to usual home health care visits, periodic telephone follow-up contact and unlimited telephone support. Caregivers and dependent patients: usual home health care, consisting of bimonthly scheduled visits, follow-up as needed, and additional attention upon request.Data analysisDependent variables: Caregiver burden (short-form Zarit test), caregivers' social support (Medical Outcomes Study), and caregivers' reported quality of life (SF-12)INDEPENDENT VARIABLES: a) Caregiver: sociodemographic data, Goldberg Scale, Apgar family questionnaire, Holmes and Rahe Psychosocial Stress Scale, number of chronic diseases. b) Dependent patient: sociodemographic data, level of dependency (Barthel Index), cognitive impairment (Pfeiffer test). If the intervention intended to improve social and family support is effective in reducing the burden on primary informal caregivers of dependent patients, this model can be readily applied throughout usual PHCT clinical practice. Clinical trials registrar: NCT02065427.

A multicentre randomised controlled trial and economic evaluation of ion-exchange water softeners for the treatment of eczema in children: the Softened Water Eczema Trial (SWET).

PubMed

Thomas, K S; Koller, K; Dean, T; O'Leary, C J; Sach, T H; Frost, A; Pallett, I; Crook, A M; Meredith, S; Nunn, A J; Burrows, N; Pollock, I; Graham-Brown, R; O'Toole, E; Potter, D; Williams, H C

2011-02-01

To determine whether installation of an ion-exchange water softener in the home could improve atopic eczema in children and, if so, to establish its likely cost and cost-effectiveness. An observer-blind, parallel-group randomised controlled trial of 12 weeks duration followed by a 4-week observational period. Eczema was assessed by research nurses blinded to intervention at baseline, 4 weeks, 12 weeks and 16 weeks. The primary outcome was analysed as intent-to-treat, using the randomised allocation rather than actual treatment received. A secondary per-protocol analysis excluded participants who failed to receive their allocated treatment and who were deemed to be protocol violators. Secondary and primary care referral centres in England (UK) serving a variety of ethnic and social groups and including children living in both urban and periurban homes. Three hundred and thirty-six children (aged 6 months to 16 years) with moderate/severe atopic eczema, living in homes in England supplied by hard water (≥ 200 mg/l calcium carbonate). Participants were randomised to either installation of an ion-exchange water softener plus usual eczema care (group A) for 12 weeks or usual eczema care alone (group B) for 12 weeks. This was followed by a 4-week observational period, during which water softeners were switched off/removed from group A homes and installed in group B homes. Standard procedure was to soften all water in the home, but to provide mains (hard) water at a faucet-style tap in the kitchen for drinking and cooking. Participants were therefore exposed to softened water for bathing and washing of clothes, but continued to drink mains (hard) water. Usual care was defined as any treatment that the child was currently using in order to control his or her eczema. New treatment regimens used during the trial period were documented. Primary outcome was the difference between group A and group B in mean change in disease severity at 12 weeks compared with baseline, as measured using the Six Area, Six Sign Atopic Dermatitis (SASSAD) score. This is an objective severity scale completed by blinded observers (research nurses) unaware of the allocated intervention. Secondary outcomes included use of topical medications, night-time movement, patient-reported eczema severity and a number of quality of life measures. A planned subgroup analysis was conducted, based on participants with at least one mutation in the gene encoding filaggrin (a protein in the skin thought to be important for normal skin barrier function). Target recruitment was achieved (n = 336). The analysed population included 323 children who had complete data. The mean change in primary outcome (SASSAD) at 12 weeks was -5.0 [standard deviation (SD) 8.8] for the water softener group (group A) and -5.7 (SD 9.8) for the usual care group (group B) [mean difference 0.66, 95% confidence interval (CI) -1.37 to 2.69, p = 0.53]. The per-protocol analysis supported the main analysis, and there was no evidence that the treatment effect varied between children with and without mutations in the filaggrin gene. No between-group differences were found in the three secondary outcomes that were assessed blindly (use of topical medications; night-time movement; proportion showing reasonable, good or excellent improvement). Small, but statistically significant, differences in favour of the water softener were found in three of the secondary outcomes that were assessed by participants [Patient-Oriented Eczema Measure (POEM); well-controlled weeks (WCWs); Dermatitis Family Index (DFI)]. The results of the economic evaluation, and the uncertainty surrounding them, suggest that ion-exchange water softeners are unlikely to be a cost-effective intervention for children with atopic eczema from an NHS perspective. Water softeners provided no additional benefit to usual care in this study population. Small, but statistically significant, differences were found in some secondary outcomes as reported by parents, but it is likely that such improvements were the result of response bias. Whether or not the wider benefits of installing a water softener in the home are sufficient to justify the purchase of a softener is something for individual householders to consider on a case-by-case basis. This trial demonstrated overwhelming demand for non-pharmacological interventions for the treatment of eczema, and this is something that should be considered when prioritising future research in the field. Current Controlled Trials ISRCTN71423189. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 15, No. 8. See the HTA programme website for further project information. Results of this trial are also published at www.plosmedicine.org.

Preventing substance misuse: study protocol for a randomised controlled trial of the Strengthening Families Programme 10–14 UK (SFP 10–14 UK)

PubMed Central

2014-01-01

Background Prevention of alcohol, drug and tobacco misuse by young people is a key public health priority. There is a need to develop the evidence base through rigorous evaluations of innovative approaches to substance misuse prevention. The Strengthening Families Programme 10–14 is a universal family-based alcohol, drugs and tobacco prevention programme, which has achieved promising results in US trials, and which now requires cross-cultural assessment. This paper therefore describes the protocol for a randomised controlled trial of the UK version of the Strengthening Families Programme 10–14 (SFP 10–14 UK). Methods/Design The trial comprises a pragmatic cluster randomised controlled effectiveness trial with families as the unit of randomisation, with embedded process and economic evaluations. Participating families will be randomised to one of two treatment groups - usual care with full access to existing services (control group), or usual care plus SFP 10–14 UK (intervention group). The trial has two primary outcomes - the number of occasions that young people report having drunk alcohol in the last 30 days, and drunkenness during the last 30 days, both dichotomised as ‘never’ and ‘1-2 times or more’. The main follow-up is at 2 years past baseline, and short-term and intermediate outcomes are also measured at 9 and 15 months. Discussion The results from this trial will provide evidence on the effectiveness and cost-effectiveness of an innovative universal family-based substance misuse prevention programme in a UK context. Trial registration Current Controlled Trials ISRCTN63550893. PMID:24438460

How effective are cognitive behavior therapies for major depression and anxiety disorders? A meta‐analytic update of the evidence

PubMed Central

Cuijpers, Pim; Cristea, Ioana A.; Karyotaki, Eirini; Reijnders, Mirjam; Huibers, Marcus J.H.

2016-01-01

We report the current best estimate of the effects of cognitive behavior therapy (CBT) in the treatment of major depression (MDD), generalized anxiety disorder (GAD), panic disorder (PAD) and social anxiety disorder (SAD), taking into account publication bias, the quality of trials, and the influence of waiting list control groups on the outcomes. In our meta‐analyses, we included randomized trials comparing CBT with a control condition (waiting list, care‐as‐usual or pill placebo) in the acute treatment of MDD, GAD, PAD or SAD, diagnosed on the basis of a structured interview. We found that the overall effects in the 144 included trials (184 comparisons) for all four disorders were large, ranging from g=0.75 for MDD to g=0.80 for GAD, g=0.81 for PAD, and g=0.88 for SAD. Publication bias mostly affected the outcomes of CBT in GAD (adjusted g=0.59) and MDD (adjusted g=0.65), but not those in PAD and SAD. Only 17.4% of the included trials were considered to be high‐quality, and this mostly affected the outcomes for PAD (g=0.61) and SAD (g=0.76). More than 80% of trials in anxiety disorders used waiting list control groups, and the few studies using other control groups pointed at much smaller effect sizes for CBT. We conclude that CBT is probably effective in the treatment of MDD, GAD, PAD and SAD; that the effects are large when the control condition is waiting list, but small to moderate when it is care‐as‐usual or pill placebo; and that, because of the small number of high‐quality trials, these effects are still uncertain and should be considered with caution. PMID:27717254

Effects of a lifestyle intervention on psychosocial well-being of severe mentally ill residential patients: ELIPS, a cluster randomized controlled pragmatic trial.

PubMed

Stiekema, Annemarie P M; Looijmans, Anne; van der Meer, Lisette; Bruggeman, Richard; Schoevers, Robert A; Corpeleijn, Eva; Jörg, Frederike

2018-03-01

Large studies investigating the psychosocial effects of lifestyle interventions in patients with a severe mental illness (SMI) are scarce, especially in residential patients. This large, randomized controlled, multicentre pragmatic trial assessed the psychosocial effects of a combined diet-and-exercise lifestyle intervention targeting the obesogenic environment of SMI residential patients. Twenty-nine sheltered and clinical care teams were randomized into intervention (n=15) or control (n=14) arm. Team tailored diet-and-exercise lifestyle plans were set up to change the obesogenic environment into a healthier setting, and team members were trained in supporting patients to make healthier choices. The control group received care-as-usual. The Calgary Depression Scale for Schizophrenia (CDSS), Positive and Negative Syndrome Scale (PANSS), Health of the Nation Outcome Scales (HoNOS) and the Manchester Short Assessment of Quality of Life (MANSA) were assessed at baseline and after three and twelve months. Data were available for 384 intervention and 386 control patients (48.6±12.5years old, 62.7% males, 73.7% psychotic disorder). Linear mixed model analysis showed no psychosocial improvements in the intervention group compared to care-as-usual; the intervention group showed a slightly reduced quality of life (overall) and a small increase in depressive symptoms (clinical care facilities) and psychotic symptoms (sheltered facilities). This may be due to difficulties with implementation, the intervention not being specifically designed for improvements in mental well-being, or the small change approach, which may take longer to reach an effect. Further research might elucidate what type of lifestyle intervention under what circumstances positively affects psychosocial outcomes in this population. Copyright © 2018 Elsevier B.V. All rights reserved.

First outline and baseline data of a randomized, controlled multicenter trial to evaluate the health economic impact of home telemonitoring in chronic heart failure - CardioBBEAT.

PubMed

Hofmann, Reiner; Völler, Heinz; Nagels, Klaus; Bindl, Dominik; Vettorazzi, Eik; Dittmar, Ronny; Wohlgemuth, Walter; Neumann, Till; Störk, Stefan; Bruder, Oliver; Wegscheider, Karl; Nagel, Eckhard; Fleck, Eckart

2015-08-11

Evidence that home telemonitoring for patients with chronic heart failure (CHF) offers clinical benefit over usual care is controversial as is evidence of a health economic advantage. Between January 2010 and June 2013, patients with a confirmed diagnosis of CHF were enrolled and randomly assigned to 2 study groups comprising usual care with and without an interactive bi-directional remote monitoring system (Motiva®). The primary endpoint in CardioBBEAT is the Incremental Cost-Effectiveness Ratio (ICER) established by the groups' difference in total cost and in the combined clinical endpoint "days alive and not in hospital nor inpatient care per potential days in study" within the follow-up of 12 months. A total of 621 predominantly male patients were enrolled, whereof 302 patients were assigned to the intervention group and 319 to the control group. Ischemic cardiomyopathy was the leading cause of heart failure. Despite randomization, subjects of the control group were more often in NYHA functional class III-IV, and exhibited peripheral edema and renal dysfunction more often. Additionally, the control and intervention groups differed in heart rhythm disorders. No differences existed regarding risk factor profile, comorbidities, echocardiographic parameters, especially left ventricular and diastolic diameter and ejection fraction, as well as functional test results, medication and quality of life. While the observed baseline differences may well be a play of chance, they are of clinical relevance. Therefore, the statistical analysis plan was extended to include adjusted analyses with respect to the baseline imbalances. CardioBBEAT provides prospective outcome data on both, clinical and health economic impact of home telemonitoring in CHF. The study differs by the use of a high evidence level randomized controlled trial (RCT) design along with actual cost data obtained from health insurance companies. Its results are conducive to informed political and economic decision-making with regard to home telemonitoring solutions as an option for health care. Overall, it contributes to developing advanced health economic evaluation instruments to be deployed within the specific context of the German Health Care System. ClinicalTrials.gov NCT02293252 ; date of registration: 10 November 2014.

Self-blood pressure monitoring in an urban, ethnically diverse population: a randomized clinical trial utilizing the electronic health record.

PubMed

Yi, Stella S; Tabaei, Bahman P; Angell, Sonia Y; Rapin, Anne; Buck, Michael D; Pagano, William G; Maselli, Frank J; Simmons, Alvaro; Chamany, Shadi

2015-03-01

Hypertension is a leading risk factor for cardiovascular disease. Although control rates have improved over time, racial/ethnic disparities in hypertension control persist. Self-blood pressure monitoring, by itself, has been shown to be an effective tool in predominantly white populations, but less studied in minority, urban communities. These types of minimally intensive approaches are important to test in all populations, especially those experiencing related health disparities, for broad implementation with limited resources. The New York City Health Department in partnership with community clinic networks implemented a randomized clinical trial (n=900, 450 per arm) to investigate the effectiveness of self-blood pressure monitoring in medically underserved and largely black and Hispanic participants. Intervention participants received a home blood pressure monitor and training on use, whereas control participants received usual care. After 9 months, systolic blood pressure decreased (intervention, 14.7 mm Hg; control, 14.1 mm Hg; P=0.70). Similar results were observed when incorporating longitudinal data and calculating a mean slope over time. Control was achieved in 38.9% of intervention and 39.1% of control participants at the end of follow-up; the time-to-event experience of achieving blood pressure control in the intervention versus control groups were not different from each other (logrank P value =0.91). Self-blood pressure monitoring was not shown to improve control over usual care in this largely minority, urban population. The patient population in this study, which included a high proportion of Hispanics and uninsured persons, is understudied. Results indicate these groups may have additional meaningful barriers to achieving blood pressure control beyond access to the monitor itself. http://clinicaltrials.gov. Unique Identifier: NCT01123577. © 2015 American Heart Association, Inc.

Efficacy of communication skills training on colorectal cancer screening by GPs: a cluster randomised controlled trial.

PubMed

Aubin-Auger, I; Laouénan, C; Le Bel, J; Mercier, A; Baruch, D; Lebeau, J P; Youssefian, A; Le Trung, T; Peremans, L; Van Royen, P

2016-01-01

Colorectal cancer (CRC) mass screening has been implemented in France since 2008. Participation rates remain too low. The objective of this study was to test if the implementation of a training course focused on communication skills among general practitioners (GP) would increase the delivery of gaiac faecal occult blood test and CRC screening participation among the target population of each participating GP. A cluster randomised controlled trial was conducted with GP's practice as a cluster unit. GPs from practices in the control group were asked to continue their usual care. GPs of the intervention group received a 4-h educational training, built with previous qualitative data on CRC screening focusing on doctor-patient communication with a follow-up of 7 months for both groups. The primary outcome measure was the patients' participation rate in the target population for each GP. Seventeen GPs (16 practices) in intervention group and 28 GPs (19 practices) in control group participated. The patients' participation rate in the intervention group were 36.7% vs. 24.5% in the control group (P = 0.03). Doctor-patient communication should be developed and appear to be one of the possible targets of improvement patients adherence and participation rate in the target population for CRC mass screening. © 2015 John Wiley & Sons Ltd.

RCT of working memory training in ADHD: long-term near-transfer effects.

PubMed

Hovik, Kjell Tore; Saunes, Brit-Kari; Aarlien, Anne Kristine; Egeland, Jens

2013-01-01

The aim of the study is to evaluate the long-term near-transfer effects of computerized working memory (WM) training on standard WM tasks in children with Attention-Deficit/Hyperactivity Disorder (ADHD). Sixty-seven children aged 10-12 years in Vestfold/Telemark counties (Norway) diagnosed with F90.0 Hyperkinetic disorder (ICD-10) were randomly assigned to training or control group. The training group participated in a 25-day training program at school, while the control group received treatment-as-usual. Participants were tested one week before intervention, immediately after and eight months later. Based on a component analysis, six measures of WM were grouped into composites representing Visual, Auditory and Manipulation WM. The training group had significant long-term differential gains compared to the control group on all outcome measures. Performance gains for the training group were significantly higher in the visual domain than in the auditory domain. The differential gain in Manipulation WM persisted after controlling for an increase in simple storage capacity. Systematic training resulted in a long-term positive gain in performance on similar tasks, indicating the viability of training interventions for children with ADHD. The results provide evidence for both domain-general and domain-specific models. Far-transfer effects were not investigated in this article. Controlled-Trials.com ISRCTN19133620.

Epidemiologic methods in clinical trials.

PubMed

Rothman, K J

1977-04-01

Epidemiologic methods developed to control confounding in non-experimental studies are equally applicable for experiments. In experiments, most confounding is usually controlled by random allocation of subjects to treatment groups, but randomization does not preclude confounding except for extremely large studies, the degree of confounding expected being inversely related to the size of the treatment groups. In experiments, as in non-experimental studies, the extent of confounding for each risk indicator should be assessed, and if sufficiently large, controlled. Confounding is properly assessed by comparing the unconfounded effect estimate to the crude effect estimate; a common error is to assess confounding by statistical tests of significance. Assessment of confounding involves its control as a prerequisite. Control is most readily and cogently achieved by stratification of the data, though with many factors to control simultaneously, multivariate analysis or a combination of multivariate analysis and stratification might be necessary.

Mindfulness-based stress reduction added to care as usual for lung cancer patients and/or their partners: A multicentre randomized controlled trial.

PubMed

Schellekens, M P J; van den Hurk, D G M; Prins, J B; Donders, A R T; Molema, J; Dekhuijzen, R; van der Drift, M A; Speckens, A E M

2017-12-01

Lung cancer patients report among the highest distress rates of all cancer patients. Partners report similar distress rates. The present study examined the effectiveness of additional mindfulness-based stress reduction (care as usual [CAU] + MBSR) versus solely CAU to reduce psychological distress in lung cancer patients and/or their partners. We performed a multicentre, parallel-group, randomized controlled trial. Mindfulness-based stress reduction is an 8-week group-based intervention, including mindfulness practice and teachings on stress. Care as usual included anticancer treatment, medical consultations, and supportive care. The primary outcome was psychological distress. Secondary outcomes included quality of life, caregiver burden, relationship satisfaction, mindfulness skills, self-compassion, rumination, and posttraumatic stress symptoms. Outcomes were assessed at baseline, post-intervention, and 3-month follow-up. Linear mixed modeling was conducted on an intention-to-treat sample. Moderation (gender, disease stage, baseline distress, participation with/without partner) and mediation analyses were performed. A total of 31 patients and 21 partners were randomized to CAU + MBSR and 32 patients and 23 partners to CAU. After CAU + MBSR patients reported significantly less psychological distress (p = .008, d = .69) than after CAU. Baseline distress moderated outcome: those with more distress benefitted most from MBSR. Additionally, after CAU + MBSR patients showed more improvements in quality of life, mindfulness skills, self-compassion, and rumination than after CAU. In partners, no differences were found between groups. Our findings suggest that psychological distress in lung cancer patients can be effectively treated with MBSR. No effect was found in partners, possibly because they were more focused on patients' well-being rather than their own. Copyright © 2017 John Wiley & Sons, Ltd.

Randomized controlled trial comparing treatment outcome of two compression bandaging systems and standard care without compression in patients with venous leg ulcers.

PubMed

Wong, I K Y; Andriessen, A; Charles, H E; Thompson, D; Lee, D T F; So, W K W; Abel, M

2012-01-01

In Hong Kong, at the time of the study, compression treatment was not considered usual care for venous leg ulcer patients. This randomized controlled trial compared quality of life (QOL) aspects in venous leg ulcer patients of over 55-years of age, of short-stretch compression (SSB), four-layer compression bandaging (4LB) and usual care (UC) (moist wound healing dressing, no compression). Study period was 24-weeks, the primary outcome was the patient functional status, disease-specific and generic health-related QOL measures and ulcer healing rates, comparing week 1 vs. week 24 (end) results. Assessments included photogrammetry, Brief Pain Inventory, SF-12 Health Survey, Charing Cross Venous Ulcer Questionnaire and Frenchay Activity Index. Data analysis was performed using, where appropriate; Kaplan Meier and log rank chi-square and the repeated measures analysis of variance test. A total of 321 patients participated in the study, 45 (14%) withdrew for various reasons. Compression bandaging in both groups significantly reduced pain (P < 0.0001) and improved functional status and QOL. Healing rate at 24 weeks for both compression groups was significant (P < 0.001); for SSB this was 72.0% (77/107) vs. 67.3% in the 4LB group (72/107) and 29.0% (31/107) with usual care. The reduction in ulcer area from weeks 12 to 24 was significant only for SSB (P < 0.047). Compression was shown to be feasible for elderly community care patients in Hong Kong and is currently implemented as part of standard venous leg ulcer treatment. © 2011 The Authors. Journal of the European Academy of Dermatology and Venereology © 2011 European Academy of Dermatology and Venereology.

An educational intervention on drug interactions and contraceptive options for epilepsy patients: a pilot randomized controlled trial.

PubMed

Mody, Sheila K; Haunschild, Carolyn; Farala, John Paul; Honerkamp-Smith, Gordon; Hur, Vivian; Kansal, Leena

2016-01-01

This pilot study investigates whether an educational handout could increase short-term information retention about drug interactions between antiepileptic drugs (AEDs) and hormonal contraceptives among female epilepsy patients of reproductive age. This is a pilot randomized controlled trial of an educational intervention among reproductive-age women with epilepsy in an academic neurology clinic. Investigators measured knowledge before and after participants received either usual care or the educational handout. The 10-question test assessed increased knowledge of which AEDs affected efficacy of certain hormonal contraceptives and was assessed by calculating the improvement in score between the pretest and posttest. The educational handout included the names of AEDs that have drug interactions with certain contraceptives and the efficacy of the contraceptives. A total of 42 epilepsy patients participated in this study. Fourteen participants were taking AEDs that are enzyme p450 inducers and 13 participants were taking Lamotrigine. Twenty women were randomized to receive the educational handout and 22 women were randomized to usual care. We found no statistical difference in the groups with regard to age, ethnicity or level of education. We found a significantly higher improvement in quiz scores in the educational handout group (3.65 point increase) compared to the usual care group (0.68 point increase) as calculated by the Student's two-sample t test (p<.001). An educational handout on drug interactions and contraceptives resulted in increased short-term information retention on this topic among reproductive-age female epilepsy patients. This pilot study highlights the need for further larger studies to evaluate the impact of educational interventions on improving patient knowledge about the drug interaction of AEDs and hormonal contraceptives. Copyright © 2016. Published by Elsevier Inc.

Effect of Structured Touch and Guided Imagery for Pain and Anxiety in Elective Joint Replacement Patients--A Randomized Controlled Trial: M-TIJRP.

PubMed

Forward, John Brent; Greuter, Nancy Elizabeth; Crisall, Santa J; Lester, Houston F

2015-01-01

Postoperative management of pain after total joint arthroplasty remains a challenge despite advancements in analgesics. Evidence shows that complementary modalities with mind-body and tactile-based approaches are valid and effective adjuncts to reduce pain and anxiety postoperatively. To investigate the effectiveness of the "M" Technique (M), a registered method of structured touch using a set sequence and number of strokes, and a consistent level of pressure on hands and feet, compared with guided imagery and usual care, for the reduction of pain and anxiety in patients undergoing elective total knee or hip replacement surgery. Randomized controlled trial: M-TIJRP (MiTechnique and guided Imagery in Joint Replacement Patients [Mighty Junior P]). At a community hospital, 225 male and female patients, aged 38 to 90 years, undergoing elective total hip or knee replacement were randomly assigned to 1 of 3 groups (75 patients in each): M, guided imagery, or usual care. They were blinded to their assignment until the intervention. Reduction of pain and anxiety postoperatively. Secondary outcomes measured use of pain medication and patient satisfaction. This study yielded positive findings for the management of pain and anxiety in patients undergoing elective joint replacement using M and guided imagery for 18 to 20 minutes compared with usual care. M showed the largest predicted decreases in both pain and anxiety between groups. There was no significant difference in narcotic pain medication use between groups. Patient satisfaction survey ratings were highest for M, followed by guided imagery. The benefit of M may be because of the specifically structured sequence of touch by competent caring, trained providers.

Effect of Structured Touch and Guided Imagery for Pain and Anxiety in Elective Joint Replacement Patients—A Randomized Controlled Trial: M-TIJRP

PubMed Central

Forward, John Brent; Greuter, Nancy Elizabeth; Crisall, Santa J; Lester, Houston F

2015-01-01

Context: Postoperative management of pain after total joint arthroplasty remains a challenge despite advancements in analgesics. Evidence shows that complementary modalities with mind-body and tactile-based approaches are valid and effective adjuncts to reduce pain and anxiety postoperatively. Objective: To investigate the effectiveness of the “M” Technique (M), a registered method of structured touch using a set sequence and number of strokes, and a consistent level of pressure on hands and feet, compared with guided imagery and usual care, for the reduction of pain and anxiety in patients undergoing elective total knee or hip replacement surgery. Methods: Randomized controlled trial: M-TIJRP (MiTechnique and guided Imagery in Joint Replacement Patients [Mighty Junior P]). At a community hospital, 225 male and female patients, aged 38 to 90 years, undergoing elective total hip or knee replacement were randomly assigned to 1 of 3 groups (75 patients in each): M, guided imagery, or usual care. They were blinded to their assignment until the intervention. Main Outcome Measures: Reduction of pain and anxiety postoperatively. Secondary outcomes measured use of pain medication and patient satisfaction. Results: This study yielded positive findings for the management of pain and anxiety in patients undergoing elective joint replacement using M and guided imagery for 18 to 20 minutes compared with usual care. M showed the largest predicted decreases in both pain and anxiety between groups. There was no significant difference in narcotic pain medication use between groups. Patient satisfaction survey ratings were highest for M, followed by guided imagery. Conclusion: The benefit of M may be because of the specifically structured sequence of touch by competent caring, trained providers. PMID:26222093

Oxidative stress in patients with type 1 diabetes mellitus: is it affected by a single bout of prolonged exercise?

PubMed

Francescato, Maria Pia; Stel, Giuliana; Geat, Mario; Cauci, Sabina

2014-01-01

Presently, no clear-cut guidelines are available to suggest the more appropriate physical activity for patients with type 1 diabetes mellitus due to paucity of experimental data obtained under patients' usual life conditions. Accordingly, we explored the oxidative stress levels associated with a prolonged moderate intensity, but fatiguing, exercise performed under usual therapy in patients with type 1 diabetes mellitus and matched healthy controls. Eight patients (4 men, 4 women; 49±11 years; Body Mass Index 25.0±3.2 kg·m(-2); HbA1c 57±10 mmol·mol(-1)) and 14 controls (8 men, 6 women; 47±11 years; Body Mass Index 24.3±3.3 kg·m(-2)) performed a 3-h walk at 30% of their heart rate reserve. Venous blood samples were obtained before and at the end of the exercise for clinical chemistry analysis and antioxidant capacity. Capillary blood samples were taken at the start and thereafter every 30 min to determine lipid peroxidation. Patients showed higher oxidative stress values as compared to controls (95.9±9.7 vs. 74.1±12.2 mg·L(-1) H2O2; p<0.001). In both groups, oxidative stress remained constant throughout the exercise (p = NS), while oxidative defence increased significantly at the end of exercise (p<0.02) from 1.16±0.13 to 1.19±0.10 mmol·L(-1) Trolox in patients and from 1.09±0.21 to 1.22±0.14 mmol·L(-1) Trolox in controls, without any significant difference between the two groups. Oxidative stress was positively correlated to HbA1c (p<0.005) and negatively related with uric acid (p<0.005). In conclusion, we were the first to evaluate the oxidative stress in patients with type 1 diabetes exercising under their usual life conditions (i.e. usual therapy and diet). Specifically, we found that the oxidative stress was not exacerbated due to a single bout of prolonged moderate intensity aerobic exercise, a condition simulating several outdoor leisure time physical activities. Oxidative defence increased in both patients and controls, suggesting beneficial effects of prolonged aerobic fatiguing exercise.

A walking programme and a supervised exercise class versus usual physiotherapy for chronic low back pain: a single-blinded randomised controlled trial. (The Supervised Walking In comparison to Fitness Training for Back Pain (SWIFT) Trial)

PubMed Central

Hurley, Deirdre A; O'Donoghue, Grainne; Tully, Mark A; Moffett, Jennifer Klaber; van Mechelen, Willem; Daly, Leslie; Boreham, Colin AG; McDonough, Suzanne M

2009-01-01

Background Chronic low back pain (CLBP) is a persistent disabling condition with rising significant healthcare, social and economic costs. Current research supports the use of exercise-based treatment approaches that encourage people with CLBP to assume a physically active role in their recovery. While international clinical guidelines and systematic reviews for CLBP support supervised group exercise as an attractive first-line option for treating large numbers of CLBP patients at low cost, barriers to their delivery include space and time restrictions in healthcare settings and poor patient attendance. The European Clinical Guidelines have identified the need for research in the use of brief/minimal contact self-activation interventions that encourage participation in physical activity for CLBP. Walking may be an ideally suited form of individualized exercise prescription as it is easy to do, requires no special skills or facilities, and is achievable by virtually all ages with little risk of injury, but its effectiveness for LBP is unproven. Methods and design This study will be an assessor-blinded randomized controlled trial that will investigate the difference in clinical effectiveness and costs of an individualized walking programme and a supervised general exercise programme compared to usual physiotherapy, which will act as the control group, in people with chronic low back pain. A sample of 246 patients will be recruited in Dublin, Ireland through acute general hospital outpatient physiotherapy departments that provide treatment for people with CLBP. Patients will be randomly allocated to one of the three groups in a concealed manner. The main outcomes will be functional disability, pain, quality of life, fear avoidance, back beliefs, physical activity, satisfaction and costs, which will be evaluated at baseline, and 3, 6 and 12 months [follow-up by pre-paid postage]. Qualitative telephone interviews and focus groups will be embedded in the research design to obtain feedback about participants' experiences of the interventions and trial participation, and to inform interpretation of the quantitative data. Planned analysis will be by intention to treat (quantitative data) and thematic analysis (qualitative data) Discussion The trial will evaluate the effectiveness of a walking programme and a supervised general exercise programme compared to usual physiotherapy in people with CLBP. Trial registration Current controlled trial ISRCTN17592092 PMID:19573247

A hitchhiker's guide to the MADS world of plants.

PubMed

Gramzow, Lydia; Theissen, Guenter

2010-01-01

Plant life critically depends on the function of MADS-box genes encoding MADS-domain transcription factors, which are present to a limited extent in nearly all major eukaryotic groups, but constitute a large gene family in land plants. There are two types of MADS-box genes, termed type I and type II, and in plants these groups are distinguished by exon-intron and domain structure, rates of evolution, developmental function and degree of functional redundancy. The type I genes are further subdivided into three groups - M alpha, M beta and M gamma - while the type II genes are subdivided into the MIKCC and MIKC* groups. The functional diversification of MIKCC genes is closely linked to the origin of developmental and morphological novelties in the sporophytic (usually diploid) generation of seed plants, most spectacularly the floral organs and fruits of angiosperms. Functional studies suggest different specializations for the different classes of genes; whereas type I genes may preferentially contribute to female gametophyte, embryo and seed development and MIKC*-group genes to male gametophyte development, the MIKCC-group genes became essential for diverse aspects of sporophyte development. Beyond the usual transcriptional regulation, including feedback and feed-forward loops, various specialized mechanisms have evolved to control the expression of MADS-box genes, such as epigenetic control and regulation by small RNAs. In future, more data from genome projects and reverse genetic studies will allow us to understand the birth, functional diversification and death of members of this dynamic and important family of transcription factors in much more detail.

Effectiveness of a training programme to improve hand hygiene compliance in primary healthcare

PubMed Central

2009-01-01

Background Hand hygiene is the most effective measure for preventing infections related to healthcare, and its impact on the reduction of these infections is estimated at 50%. Non-compliance has been highlighted in several studies in hospitals, although none have been carried out in primary healthcare. Main objective To evaluated the effect of a "Hand Hygiene for the reduction of healthcare-associated infections" training program for primary healthcare workers, measured by variation from correct hand hygiene compliance, according to regulatory and specific criteria, 6 months after the baseline, in the intervention group (group receiving a training program) and in the control group (a usual clinical practice). Secondary objectives -To describe knowledges, attitudes and behaviors as regards hand hygiene among the professionals, and their possible association with "professional burnout", stratifying the results by type of group (intervention and usual clinical practice). -To estimate the logistic regression model that best explains hand hygiene compliance. Methods/Design Experimental study of parallel groups, with a control group, and random assignment by Health Center. Area of study.- Health centers in north-eastern Madrid (Spain). Sample studied.- Healthcare workers (physicians, odontostomatologists, pediatricians, nurses, dental hygienists, midwife and nursing auxiliaries). Intervention.- A hand hygiene training program, including a theoretical-practical workshop, provision of alcohol-based solutions and a reminder strategy in the workplace. Other variables: sociodemographic and professional knowledges, attitudes, and behaviors with regard to hand hygiene. Statistical Analysis: descriptive and inferential, using multivariate methods (covariance analysis and logistic regression). Discussion This study will provide valuable information on the prevalence of hand hygiene non-compliance, and improve healthcare. PMID:20015368

Minimising impairment: Protocol for a multicentre randomised controlled trial of upper limb orthoses for children with cerebral palsy.

PubMed

Imms, Christine; Wallen, Margaret; Elliott, Catherine; Hoare, Brian; Randall, Melinda; Greaves, Susan; Adair, Brooke; Bradshaw, Elizabeth; Carter, Rob; Orsini, Francesca; Shih, Sophy T F; Reddihough, Dinah

2016-05-27

Upper limb orthoses are frequently prescribed for children with cerebral palsy (CP) who have muscle overactivity predominantly due to spasticity, with little evidence of long-term effectiveness. Clinical consensus is that orthoses help to preserve range of movement: nevertheless, they can be complex to construct, expensive, uncomfortable and require commitment from parents and children to wear. This protocol paper describes a randomised controlled trial to evaluate whether long-term use of rigid wrist/hand orthoses (WHO) in children with CP, combined with usual multidisciplinary care, can prevent or reduce musculoskeletal impairments, including muscle stiffness/tone and loss of movement range, compared to usual multidisciplinary care alone. This pragmatic, multicentre, assessor-blinded randomised controlled trial with economic analysis will recruit 194 children with CP, aged 5-15 years, who present with flexor muscle stiffness of the wrist and/or fingers/thumb (Modified Ashworth Scale score ≥1). Children, recruited from treatment centres in Victoria, New South Wales and Western Australia, will be randomised to groups (1:1 allocation) using concealed procedures. All children will receive care typically provided by their treating organisation. The treatment group will receive a custom-made serially adjustable rigid WHO, prescribed for 6 h nightly (or daily) to wear for 3 years. An application developed for mobile devices will monitor WHO wearing time and adverse events. The control group will not receive a WHO, and will cease wearing one if previously prescribed. Outcomes will be measured 6 monthly over a period of 3 years. The primary outcome is passive range of wrist extension, measured with fingers extended using a goniometer at 3 years. Secondary outcomes include muscle stiffness, spasticity, pain, grip strength and hand deformity. Activity, participation, quality of life, cost and cost-effectiveness will also be assessed. This study will provide evidence to inform clinicians, services, funding agencies and parents/carers of children with CP whether the provision of a rigid WHO to reduce upper limb impairment, in combination with usual multidisciplinary care, is worth the effort and costs. ANZ Clinical Trials Registry: U1111-1164-0572 .

Effect of a multifactorial fall-and-fracture risk assessment and management program on gait and balance performances and disability in hospitalized older adults: a controlled study.

PubMed

Trombetti, A; Hars, M; Herrmann, F; Rizzoli, R; Ferrari, S

2013-03-01

This controlled intervention study in hospitalized oldest old adults showed that a multifactorial fall-and-fracture risk assessment and management program, applied in a dedicated geriatric hospital unit, was effective in improving fall-related physical and functional performances and the level of independence in activities of daily living in high-risk patients. Hospitalization affords a major opportunity for interdisciplinary cooperation to manage fall-and-fracture risk factors in older adults. This study aimed at assessing the effects on physical performances and the level of independence in activities of daily living (ADL) of a multifactorial fall-and-fracture risk assessment and management program applied in a geriatric hospital setting. A controlled intervention study was conducted among 122 geriatric inpatients (mean ± SD age, 84 ± 7 years) admitted with a fall-related diagnosis. Among them, 92 were admitted to a dedicated unit and enrolled into a multifactorial intervention program, including intensive targeted exercise. Thirty patients who received standard usual care in a general geriatric unit formed the control group. Primary outcomes included gait and balance performances and the level of independence in ADL measured 12 ± 6 days apart. Secondary outcomes included length of stay, incidence of in-hospital falls, hospital readmission, and mortality rates. Compared to the usual care group, the intervention group had significant improvements in Timed Up and Go (adjusted mean difference [AMD] = -3.7s; 95 % CI = -6.8 to -0.7; P = 0.017), Tinetti (AMD = -1.4; 95 % CI = -2.1 to -0.8; P < 0.001), and Functional Independence Measure (AMD = 6.5; 95 %CI = 0.7-12.3; P = 0.027) test performances, as well as in several gait parameters (P < 0.05). Furthermore, this program favorably impacted adverse outcomes including hospital readmission (hazard ratio = 0.3; 95 % CI = 0.1-0.9; P = 0.02). A multifactorial fall-and-fracture risk-based intervention program, applied in a dedicated geriatric hospital unit, was effective and more beneficial than usual care in improving physical parameters related to the risk of fall and disability among high-risk oldest old patients.

Presenting risk information to people with diabetes: evaluating effects and preferences for different formats by a web-based randomised controlled trial.

PubMed

Edwards, Adrian; Thomas, Richard; Williams, Rhys; Ellner, Andrew L; Brown, Polly; Elwyn, Glyn

2006-11-01

Web-based patient information is widespread and information on the benefits and risks of treatments is often difficult to understand. We therefore evaluated different risk presentation formats - numerical, graphical and others - addressing the pros and cons of tight control versus usual treatment approaches for diabetes. Randomised controlled trial. Online. Publicity disseminated via Diabetes UK. People with diabetes or their carers. Control group information based on British Medical Journal 'Best Treatments'. Four intervention groups received enhanced information resources: (1) detailed numerical information (absolute/relative risk, numbers-needed-to-treat); (2) 'anchoring' to familiar risks or descriptions; (3) graphical (bar charts, thermometer scales, crowd figure formats); (4) combination of 1-3. Decision conflict scale (DCS, a measure of uncertainty); satisfaction with information; further free text responses for qualitative content analysis. Seven hundred and ten people visited the website and were randomised. Five hundred and eight completed the questionnaire for quantitative data. Mean DCS scores ranged from 2.12 to 2.24 for the five randomisation groups, indicating neither clear delay or vacillation about decisions (usually DCS>2.5) nor tending to make decisions (usually DCS<2.0). There were no statistically significant effects of the interventions on DCS, or satisfaction with information. Two hundred and fifty-six participants provided responses for qualitative analysis: most found graphical representations helpful, specifically bar chart formats; many found other graphic formats (thermometer style, crowd figures/smiley faces) and 'anchoring' information unhelpful, and indicated information overload. Many negative experiences with healthcare indicate a challenging context for effective information provision and decision support. Online evaluation of different risk representation formats was feasible. There was a lack of intervention effects on quantitative outcomes, perhaps reflecting already well-informed participants from the Diabetes UK patient organisation. The large qualitative dataset included many comments about what participants found helpful as formats for communicating risk information. These findings assist the design of online decision aids and the representation of risk information. The challenge is to provide more information, in appropriate and clear formats, but without risking information overload. Interactive web designs hold much promise to achieve this.

Effects of Structured Versus Usual Care on Renal Endpoint in Type 2 Diabetes: The SURE Study

PubMed Central

Chan, Juliana C.; So, Wing-Yee; Yeung, Chun-Yip; Ko, Gary T.; Lau, Ip-Tim; Tsang, Man-Wo; Lau, Kam-Piu; Siu, Sing-Chung; Li, June K.; Yeung, Vincent T.; Leung, Wilson Y.; Tong, Peter C.

2009-01-01

OBJECTIVE Multifaceted care has been shown to reduce mortality and complications in type 2 diabetes. We hypothesized that structured care would reduce renal complications in type 2 diabetes. RESEARCH DESIGN AND METHODS A total of 205 Chinese type 2 diabetic patients from nine public hospitals who had plasma creatinine levels of 150–350 μmol/l were randomly assigned to receive structured care (n = 104) or usual care (n = 101) for 2 years. The structured care group was managed according to a prespecified protocol with the following treatment goals: blood pressure <130/80 mmHg, A1C <7%, LDL cholesterol <2.6 mmol/l, triglyceride <2 mmol/l, and persistent treatment with renin-angiotensin blockers. The primary end point was death and/or renal end point (creatinine >500 μmol/l or dialysis). RESULTS Of these 205 patients (mean ± SD age 65 ± 7.2 years; disease duration 14 ± 7.9 years), the structured care group achieved better control than the usual care group (diastolic blood pressure 68 ± 12 vs. 71 ± 12 mmHg, respectively, P = 0.02; A1C 7.3 ± 1.3 vs. 8.0 ± 1.6%, P < 0.01). After adjustment for age, sex, and study sites, the structured care (23.1%, n = 24) and usual care (23.8%, n = 24; NS) groups had similar end points, but more patients in the structured care group attained ≥3 treatment goals (61%, n = 63, vs. 28%, n = 28; P < 0.001). Patients who attained ≥3 treatment targets (n = 91) had reduced risk of the primary end point (14 vs. 34; relative risk 0.43 [95% CI 0.21–0.86] compared with that of those who attained ≤2 targets (n = 114). CONCLUSIONS Attainment of multiple treatment targets reduced the renal end point and death in type 2 diabetes. In addition to protocol, audits and feedback are needed to improve outcomes. PMID:19460913

A Randomized Pilot Study of Naturopathic Medicine in Multiple Sclerosis

PubMed Central

Calabrese, Carlo; Morris, Cynthia; Yadav, Vijayshree; Griffith, Debbie; Frank, Rachel; Oken, Barry S.; Baldauf-Wagner, Sara; Bourdette, Dennis

2008-01-01

Abstract Background Complementary and alternative medicine (CAM) use is high in people with multiple sclerosis (MS), yet there are limited reports on safety and effectiveness of CAM in MS. Naturopathic medicine encompasses a broad range of CAM modalities and may improve quality of life in patients with MS. Objective To assess quality of life in MS subjects who received interventions designed to “model” the “whole practice” of naturopathy. Design A pilot, randomized, controlled study with a 6-month intervention period. Participants Participants who met criteria for clinically definite MS. Interventions The 3 intervention arms were usual care, naturopathic medicine plus usual care, and MS education plus usual care. Outcome measures The primary outcome measure was quality of life (36-item short form health survey [SF-36]). Secondary outcome measures included fatigue (Modified Fatigue Impact Scale); depression (Beck Depression Inventory); cognition battery (Stroop test and Paced Auditory Serial Addition Test 3), and neurologic impairment (Expanded Disability Status Scale [EDSS] and Multiple Sclerosis Functional Composite). Adverse event reporting and laboratory measures were used to assess safety. Results Forty-five (45) participants (15 per group) were randomized and all completed the 6-month intervention. There were no significant differences between groups on any outcome measure. There was a trend in favoring the naturopathic group in the General Health subscale of the SF-36 (p = 0.11), Timed Walk (p = 0.11), and neurologic impairment (EDSS) (p = 0.07). There was a trend favoring the Education group in the Stroop attention test (p = 0.07). There was no difference between groups in adverse events or laboratory changes. Conclusions Naturopathic medicine combined with usual care for MS showed a trend in improvement in the General Health subscale of the SF-36, Timed Walk, and neurologic impairment. Evaluation of naturopathic medicine, as a multimodality regimen, warrants further investigation. PMID:18532899

The cost of a primary care-based childhood obesity prevention intervention

PubMed Central

2014-01-01

Background United States pediatric guidelines recommend that childhood obesity counseling be conducted in the primary care setting. Primary care-based interventions can be effective in improving health behaviors, but also costly. The purpose of this study was to evaluate the cost of a primary care-based obesity prevention intervention targeting children between the ages of two and six years who are at elevated risk for obesity, measured against usual care. Methods High Five for Kids was a cluster-randomized controlled clinical trial that aimed to modify children’s nutrition and TV viewing habits through a motivational interviewing intervention. We assessed visit-related costs from a societal perspective, including provider-incurred direct medical costs, provider-incurred equipment costs, parent time costs and parent out-of-pocket costs, in 2011 dollars for the intervention (n = 253) and usual care (n = 192) groups. We conducted a net cost analysis using both societal and health plan costing perspectives and conducted one-way sensitivity and uncertainty analyses on results. Results The total costs for the intervention group and usual care groups in the first year of the intervention were $65,643 (95% CI [$64,522, $66,842]) and $12,192 (95% CI [$11,393, $13,174]). The mean costs for the intervention and usual care groups were $259 (95% CI [$255, $264]) and $63 (95% CI [$59, $69]) per child, respectively, for a incremental difference of $196 (95% CI [$191, $202]) per child. Children in the intervention group attended a mean of 2.4 of a possible 4 in-person visits and received 0.45 of a possible 2 counseling phone calls. Provider-incurred costs were the primary driver of cost estimates in sensitivity analyses. Conclusions High Five for Kids was a resource-intensive intervention. Further studies are needed to assess the cost-effectiveness of the intervention relative to other pediatric obesity interventions. Trial registration ClinicalTrials.gov Identifier: NCT00377767. PMID:24472122

The cost of a primary care-based childhood obesity prevention intervention.

PubMed

Wright, Davene R; Taveras, Elsie M; Gillman, Matthew W; Horan, Christine M; Hohman, Katherine H; Gortmaker, Steven L; Prosser, Lisa A

2014-01-29

United States pediatric guidelines recommend that childhood obesity counseling be conducted in the primary care setting. Primary care-based interventions can be effective in improving health behaviors, but also costly. The purpose of this study was to evaluate the cost of a primary care-based obesity prevention intervention targeting children between the ages of two and six years who are at elevated risk for obesity, measured against usual care. High Five for Kids was a cluster-randomized controlled clinical trial that aimed to modify children's nutrition and TV viewing habits through a motivational interviewing intervention. We assessed visit-related costs from a societal perspective, including provider-incurred direct medical costs, provider-incurred equipment costs, parent time costs and parent out-of-pocket costs, in 2011 dollars for the intervention (n = 253) and usual care (n =192) groups. We conducted a net cost analysis using both societal and health plan costing perspectives and conducted one-way sensitivity and uncertainty analyses on results. The total costs for the intervention group and usual care groups in the first year of the intervention were $65,643 (95% CI [$64,522, $66,842]) and $12,192 (95% CI [$11,393, $13,174]). The mean costs for the intervention and usual care groups were $259 (95% CI [$255, $264]) and $63 (95% CI [$59, $69]) per child, respectively, for a incremental difference of $196 (95% CI [$191, $202]) per child. Children in the intervention group attended a mean of 2.4 of a possible 4 in-person visits and received 0.45 of a possible 2 counseling phone calls. Provider-incurred costs were the primary driver of cost estimates in sensitivity analyses. High Five for Kids was a resource-intensive intervention. Further studies are needed to assess the cost-effectiveness of the intervention relative to other pediatric obesity interventions.

Effects of structured versus usual care on renal endpoint in type 2 diabetes: the SURE study: a randomized multicenter translational study.

PubMed

Chan, Juliana C; So, Wing-Yee; Yeung, Chun-Yip; Ko, Gary T; Lau, Ip-Tim; Tsang, Man-Wo; Lau, Kam-Piu; Siu, Sing-Chung; Li, June K; Yeung, Vincent T; Leung, Wilson Y; Tong, Peter C

2009-06-01

Multifaceted care has been shown to reduce mortality and complications in type 2 diabetes. We hypothesized that structured care would reduce renal complications in type 2 diabetes. A total of 205 Chinese type 2 diabetic patients from nine public hospitals who had plasma creatinine levels of 150-350 micromol/l were randomly assigned to receive structured care (n = 104) or usual care (n = 101) for 2 years. The structured care group was managed according to a prespecified protocol with the following treatment goals: blood pressure <130/80 mmHg, A1C <7%, LDL cholesterol <2.6 mmol/l, triglyceride <2 mmol/l, and persistent treatment with renin-angiotensin blockers. The primary end point was death and/or renal end point (creatinine >500 micromol/l or dialysis). Of these 205 patients (mean +/- SD age 65 +/- 7.2 years; disease duration 14 +/- 7.9 years), the structured care group achieved better control than the usual care group (diastolic blood pressure 68 +/- 12 vs. 71 +/- 12 mmHg, respectively, P = 0.02; A1C 7.3 +/- 1.3 vs. 8.0 +/- 1.6%, P < 0.01). After adjustment for age, sex, and study sites, the structured care (23.1%, n = 24) and usual care (23.8%, n = 24; NS) groups had similar end points, but more patients in the structured care group attained >or=3 treatment goals (61%, n = 63, vs. 28%, n = 28; P < 0.001). Patients who attained >or=3 treatment targets (n = 91) had reduced risk of the primary end point (14 vs. 34; relative risk 0.43 [95% CI 0.21-0.86] compared with that of those who attained

A study protocol of a randomised controlled trial incorporating a health economic analysis to investigate if additional allied health services for rehabilitation reduce length of stay without compromising patient outcomes.

PubMed

Taylor, Nicholas F; Brusco, Natasha K; Watts, Jennifer J; Shields, Nora; Peiris, Casey; Sullivan, Natalie; Kennedy, Genevieve; Teo, Cheng Kwong; Farley, Allison; Lockwood, Kylee; Radia-George, Camilla

2010-11-12

Reducing patient length of stay is a high priority for health service providers. Preliminary information suggests additional Saturday rehabilitation services could reduce the time a patient stays in hospital by three days. This large trial will examine if providing additional physiotherapy and occupational therapy services on a Saturday reduces health care costs, and improves the health of hospital inpatients receiving rehabilitation compared to the usual Monday to Friday service. We will also investigate the cost effectiveness and patient outcomes of such a service. A randomised controlled trial will evaluate the effect of providing additional physiotherapy and occupational therapy for rehabilitation. Seven hundred and twelve patients receiving inpatient rehabilitation at two metropolitan sites will be randomly allocated to the intervention group or control group. The control group will receive usual care physiotherapy and occupational therapy from Monday to Friday while the intervention group will receive the same amount of rehabilitation as the control group Monday to Friday plus a full physiotherapy and occupational therapy service on Saturday. The primary outcomes will be patient length of stay, quality of life (EuroQol questionnaire), the Functional Independence Measure (FIM), and health utilization and cost data. Secondary outcomes will assess clinical outcomes relevant to the goals of therapy: the 10 metre walk test, the timed up and go test, the Personal Care Participation Assessment and Resource Tool (PC PART), and the modified motor assessment scale. Blinded assessors will assess outcomes at admission and discharge, and follow up data on quality of life, function and health care costs will be collected at 6 and 12 months after discharge. Between group differences will be analysed with analysis of covariance using baseline measures as the covariate. A health economic analysis will be carried out alongside the randomised controlled trial. This paper outlines the study protocol for the first fully powered randomised controlled trial incorporating a health economic analysis to establish if additional Saturday allied health services for rehabilitation inpatients reduces length of stay without compromising discharge outcomes. If successful, this trial will have substantial health benefits for the patients and for organizations delivering rehabilitation services. Australian and New Zealand Clinical Trials Registry ACTRN12609000973213.

A study protocol of a randomised controlled trial incorporating a health economic analysis to investigate if additional allied health services for rehabilitation reduce length of stay without compromising patient outcomes

PubMed Central

2010-01-01

Background Reducing patient length of stay is a high priority for health service providers. Preliminary information suggests additional Saturday rehabilitation services could reduce the time a patient stays in hospital by three days. This large trial will examine if providing additional physiotherapy and occupational therapy services on a Saturday reduces health care costs, and improves the health of hospital inpatients receiving rehabilitation compared to the usual Monday to Friday service. We will also investigate the cost effectiveness and patient outcomes of such a service. Methods/Design A randomised controlled trial will evaluate the effect of providing additional physiotherapy and occupational therapy for rehabilitation. Seven hundred and twelve patients receiving inpatient rehabilitation at two metropolitan sites will be randomly allocated to the intervention group or control group. The control group will receive usual care physiotherapy and occupational therapy from Monday to Friday while the intervention group will receive the same amount of rehabilitation as the control group Monday to Friday plus a full physiotherapy and occupational therapy service on Saturday. The primary outcomes will be patient length of stay, quality of life (EuroQol questionnaire), the Functional Independence Measure (FIM), and health utilization and cost data. Secondary outcomes will assess clinical outcomes relevant to the goals of therapy: the 10 metre walk test, the timed up and go test, the Personal Care Participation Assessment and Resource Tool (PC PART), and the modified motor assessment scale. Blinded assessors will assess outcomes at admission and discharge, and follow up data on quality of life, function and health care costs will be collected at 6 and 12 months after discharge. Between group differences will be analysed with analysis of covariance using baseline measures as the covariate. A health economic analysis will be carried out alongside the randomised controlled trial. Discussion This paper outlines the study protocol for the first fully powered randomised controlled trial incorporating a health economic analysis to establish if additional Saturday allied health services for rehabilitation inpatients reduces length of stay without compromising discharge outcomes. If successful, this trial will have substantial health benefits for the patients and for organizations delivering rehabilitation services. Clinical trial registration number Australian and New Zealand Clinical Trials Registry ACTRN12609000973213 PMID:21073703

Gender-informed, psychoeducational programme for couples to prevent postnatal common mental disorders among primiparous women: cluster randomised controlled trial.

PubMed

Fisher, Jane; Rowe, Heather; Wynter, Karen; Tran, Thach; Lorgelly, Paula; Amir, Lisa H; Proimos, Jenny; Ranasinha, Sanjeeva; Hiscock, Harriet; Bayer, Jordana; Cann, Warren

2016-03-07

Interventions to prevent postpartum common mental disorders (PCMD) among unselected populations of women have had limited success. The aim was to determine whether What Were We Thinking (WWWT) a gender-informed, psychoeducational programme for couples and babies can prevent PCMD among primiparous women 6 months postpartum. Cluster-randomised controlled trial. 48 Maternal and Child Health Centres (MCHCs) from 6 Local Government Areas in Melbourne, Australia were allocated randomly to usual care (24) or usual care plus WWWT (24). English-speaking primiparous women receiving primary care at trial MCHCs were recruited to the intervention (204) and control (196) conditions. Of these, 187 (91.7%) and 177 (90.3%) provided complete data. WWWT is a manualised programme comprising primary care from a trained nurse, print materials and a face-to-face seminar. Data sources were standardised and study-specific measures collected in blinded computer-assisted telephone interviews at 6 and 26 weeks postpartum. The primary outcome was PCMD assessed by Composite International Diagnostic Interviews and Patient Health Questionnaire (PHQ) Depression and Generalised Anxiety Disorder modules. In intention-to-treat analyses the adjusted OR (AOR) of PCMD in the intervention compared to the usual care group was 0.78 (95% CI 0.38 to 1.63, ns), but mild to moderate anxiety symptoms (AOR 0.58, 95% CI 0.35 to 0.97) and poor self-rated health (AOR 0.46, 95% CI 0.22 to 0.97) were significantly lower. In a per protocol analysis, comparing the full (three component) intervention and usual care groups, the AOR of PCMD was 0.36, (95% CI 0.14 to 0.95). The WWWT seminar was appraised as salient, comprehensible and useful by >85% participants. No harms were detected. WWWT is readily integrated into primary care, enables inclusion of fathers and addresses modifiable risks for PCMD directly. The full intervention appears a promising programme for preventing PCMD, optimising family functioning, and as the first component of a stepped approach to mental healthcare. ACTRN12613000506796; Results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Functional Assessment and Intervention by Nursing Assistants in Hospice and Palliative Care Inpatient Care Settings: A Quality Improvement Pilot Study.

PubMed

Mueller, Karen; Hamilton, Gillian; Rodden, Betheny; DeHeer, Hendrick D

2016-03-01

This study assessed the impact of a nursing assistant-led functional intervention in an urban hospice. Thirty-three patients participated. A physical therapist trained 4 nursing assistants to assess 4 basic functional activities at admission and discharge and to provide daily activity training to intervention group participants. Control group participants were assessed at admission and discharge and received the usual standard of care. Both groups improved. The intervention group participants demonstrated significant improvement in the Timed up and Go test as well as their self-reported ability to achieve goals on the Patient-Specific Functional Scale. Control group participants made significant improvements in the ability to move from supine to sit in bed. These findings suggest that nursing assistants can provide activity-based assessment and intervention leading to improved function among patients in hospice. © The Author(s) 2014.

Impact of additional counselling sessions through phone calls on smoking cessation outcomes among smokers in Penang State, Malaysia

PubMed Central

2014-01-01

Background Studies all over the world reported that smoking relapses occur during the first two weeks after a quit date. The current study aimed to assess the impact of the additional phone calls counselling during the first month on the abstinence rate at 3 and 6 months after quit date among smokers in Penang, Malaysia. Methods The study was conducted at Quit Smoking Clinic of two major hospitals in Penang, Malaysia. All the eligible smokers who attended the clinics between February 1st and October 31st 2012 were invited. Participants were randomly assigned by using urn design method either to receive the usual care that followed in the clinics (control) or the usual care procedure plus extra counselling sessions through phone calls during the first month of quit attempt (intervention). Results Participants in our cohort smoked about 14 cigarettes per day on average (mean = 13.78 ± 7.0). At 3 months, control group was less likely to quit smoking compared to intervention group (36.9% vs. 46.7%, verified smoking status) but this did not reach statistical significance (OR = 0.669; 95% CI = 0.395-1.133, P = 0.86). However, at 6 months, 71.7% of the intervention group were successfully quit smoking (bio-chemically verified) compared to 48.6% of the control group (P < 0.001). The control group were significantly less likely to quit smoking (OR = 0.375; 95% CI = 0.217-0.645, P < 0.001). Conclusions Smoking cessation intervention consisting of phone calls counselling delivered during the first month of quit attempt revealed significantly higher abstinence rates compared with a standard care approach. Therefore, the additional counselling in the first few weeks after stop smoking is a promising treatment strategy that should be evaluated further. Trial registration TCTR20140504001 PMID:24886549

The effectiveness of narrative enhancement and cognitive therapy: a randomized controlled study of a self-stigma intervention.

PubMed

Hansson, Lars; Lexén, Annika; Holmén, Joacim

2017-11-01

Stigma has been proposed to be one of the most serious obstacles to successful treatment, rehabilitation and inclusion in society of people with severe mental illness. An aspect of stigma which has been increasingly discussed is self-stigma, which refers to the internalization of negative stereotypes among people with severe mental illness. The aim of the present study was to investigate the effectiveness of a group-based anti self-stigma intervention, narrative enhancement and cognitive therapy (NECT) as an add-on to treatment as usual, with regard to changes in self-stigma, self-esteem, and subjective quality of life. After screening for eligibility 106 participants were included in a randomized controlled trial using a wait-list control group, of which 87 completed the study. Assessments were made at baseline, at termination of the intervention, and at a 6-month follow-up (intervention group only). The results showed that NECT was effective in reducing self-stigma and improving self-esteem compared to treatment as usual only. No differences were shown regarding subjective quality of life. Changes shown in the intervention group at termination of intervention were stable at the 6-month follow-up. A regression analysis showed that there was a positive relationship between exposure to the intervention and reduction of self-stigma. The conclusion of the present study is that, using a sample size with adequate power, NECT seems to be an effective intervention with regard to diminishing self-stigma and improving self-esteem, and that these improvements were stable at a 6-month follow-up. There was a distinct relationship between number of sessions attended and improvements in self-stigma and self-esteem controlling for confounding factors. This puts attention to the importance of creating a group climate which facilitate and encourage participation through the various phases of the intervention.

Evaluation of a group cognitive-behavioral depression prevention program for young adolescents: a randomized effectiveness trial.

PubMed

Gillham, Jane E; Reivich, Karen J; Brunwasser, Steven M; Freres, Derek R; Chajon, Norma D; Kash-Macdonald, V Megan; Chaplin, Tara M; Abenavoli, Rachel M; Matlin, Samantha L; Gallop, Robert J; Seligman, Martin E P

2012-01-01

Depression is a common psychological problem in adolescence. Recent research suggests that group cognitive-behavioral interventions can reduce and prevent symptoms of depression in youth. Few studies have tested the effectiveness of such interventions when delivered by school teachers and counselors (as opposed to research team staff). We evaluated the effectiveness of the Penn Resiliency Program for adolescents (PRP-A), a school-based group intervention that targets cognitive behavioral risk factors for depression. We randomly assigned 408 middle school students (ages 10-15) to one of three conditions: PRP-A, PRP-AP (in which adolescents participated in PRP-A and parents were invited to attend a parent intervention component), or a school-as-usual control. Adolescents completed measures of depression and anxiety symptoms, cognitive style, and coping at baseline, immediately after the intervention, and at 6-month follow-up. PRP-A reduced depression symptoms relative to the school as usual control. Baseline levels of hopelessness moderated intervention effects. Among participants with average and high levels of hopelessness, PRP (A and AP) significantly improved depression symptoms, anxiety symptoms, hopelessness, and active coping relative to control. Among participants with low baseline hopelessness, we found no intervention effects. PRP-AP was not more effective than PRP-A alone. We found no intervention effects on clinical levels of depression or anxiety. These findings suggest that cognitive-behavioral interventions can be beneficial when delivered by school teachers and counselors. These interventions may be most helpful to students with elevated hopelessness.

Psychological treatment of post-traumatic stress disorder (PTSD).

PubMed

Bisson, J; Andrew, M

2005-04-18

Psychological interventions are widely used in the treatment of post-traumatic stress disorder (PTSD). To perform a systematic review of randomised controlled trials of all psychological treatments except eye movement desensitisation and reprocessing following the guidelines of the Cochrane Collaboration. Systematic searches of computerised databases, hand search of the Journal of Traumatic Stress, searches of reference lists, known websites and discussion fora, and personal communication with key workers. Types of studies - Any randomised controlled trial of a psychological treatment. Types of participants - Adults suffering from traumatic stress symptoms for three months or more. Types of interventions - Trauma-focused cognitive behavioural therapy/exposure therapy (TFCBT); stress management (SM); other therapies (supportive therapy, non-directive counselling, psychodynamic therapy and hypnotherapy); group cognitive behavioural therapy (group CBT). Types of outcomes - Severity of clinician rated traumatic stress symptoms. Secondary measures included self-reported traumatic stress symptoms, depressive symptoms, anxiety symptoms, adverse effects and dropouts. Data was entered using the Review Management software. Quality assessments were performed. The data were analysed for summary effects using the RevMan 4.2 programme. Twenty-nine studies were included in the review. With regards to reduction of clinician assessed PTSD symptoms TFCBT did significantly better than waitlist/usual care (standardised mean difference (SMD) = -1.36; 95% CI, -1.88 to -0.84; 13 studies; n = 609). There was no significant difference between TFCBT and SM (SMD = -0.27; 95% CI, -0.71 to 0.16; 6 studies; n = 239). TFCBT did significantly better than other therapies (SMD = -0.81; 95% CI, -1.19 to -0.42; 3 studies; n = 120). Stress management did significantly better than waitlist/usual care (SMD = -1.14; 95% CI, -1.62 to -0.67; 3 studies; n = 86) and than other therapies (SMD = -1.22; 95% CI, -2.09 to -0.35; 1 study; n = 25). There was no significant difference between other therapies and waitlist/usual care control (SMD = -0.43; 95% CI, -0.90 to 0.04; 2 studies; n = 72). Group TFCBT was significantly better than waitlist/usual care (SMD = -0.72; 95% CI, -1.14 to -0.31). There was evidence that individual TFCBT, stress management and group TFCBT are effective in the treatment of PTSD. Other non-trauma focused psychological treatments did not reduce PTSD symptoms as significantly. There was some evidence that individual TFCBT is superior to stress management in the treatment of PTSD at between 2 and 5 months following treatment, and also that TFCBT was also more effective than other therapies. There was insufficient evidence to determine whether psychological treatment is harmful. There was some evidence of greater drop-out in active treatment groups.

Culture-specific programs for children and adults from minority groups who have asthma.

PubMed

McCallum, Gabrielle B; Morris, Peter S; Brown, Ngiare; Chang, Anne B

2017-08-22

People with asthma who come from minority groups often have poorer asthma outcomes, including more acute asthma-related doctor visits for flare-ups. Various programmes used to educate and empower people with asthma have previously been shown to improve certain asthma outcomes (e.g. adherence outcomes, asthma knowledge scores in children and parents, and cost-effectiveness). Models of care for chronic diseases in minority groups usually include a focus of the cultural context of the individual, and not just the symptoms of the disease. Therefore, questions about whether tailoring asthma education programmes that are culturally specific for people from minority groups are effective at improving asthma-related outcomes, that are feasible and cost-effective need to be answered. To determine whether culture-specific asthma education programmes, in comparison to generic asthma education programmes or usual care, improve asthma-related outcomes in children and adults with asthma who belong to minority groups. We searched the Cochrane Register of Controlled Trials (CENTRAL), the Cochrane Airways Group Specialised Register, MEDLINE, Embase, review articles and reference lists of relevant articles. The latest search fully incorporated into the review was performed in June 2016. Randomised controlled trials (RCTs) comparing the use of culture-specific asthma education programmes with generic asthma education programmes, or usual care, in adults or children from minority groups with asthma. Two review authors independently selected, extracted and assessed the data for inclusion. We contacted study authors for further information if required. In this review update, an additional three studies and 220 participants were added. A total of seven RCTs (two in adults, four in children, one in both children and adults) with 837 participants (aged from one to 63 years) with asthma from ethnic minority groups were eligible for inclusion in this review. The methodological quality of studies ranged from very low to low. For our primary outcome (asthma exacerbations during follow-up), the quality of evidence was low for all outcomes. In adults, use of a culture-specific programme, compared to generic programmes or usual care did not significantly reduce the number of participants from two studies with 294 participants for: exacerbations with one or more exacerbations during follow-up (odds ratio (OR) 0.80, 95% confidence interval (CI) 0.50 to 1.26), hospitalisations over 12 months (OR 0.83, 95% CI 0.31 to 2.22) and exacerbations requiring oral corticosteroids (OR 0.97, 95% CI 0.55 to 1.73). However, use of a culture-specific programme, improved asthma quality of life scores in 280 adults from two studies (mean difference (MD) 0.26, 95% CI 0.17 to 0.36) (although the MD was less then the minimal important difference for the score). In children, use of a culture-specific programme was superior to generic programmes or usual care in reducing severe asthma exacerbations requiring hospitalisation in two studies with 305 children (rate ratio 0.48, 95% CI 0.24 to 0.95), asthma control in one study with 62 children and QoL in three studies with 213 children, but not for the number of exacerbations during follow-up (OR 1.55, 95% CI 0.66 to 3.66) or the number of exacerbations (MD 0.18, 95% CI -0.25 to 0.62) among 100 children from two studies. The available evidence showed that culture-specific education programmes for adults and children from minority groups are likely effective in improving asthma-related outcomes. This review was limited by few studies and evidence of very low to low quality. Not all asthma-related outcomes improved with culture-specific programs for both adults and children. Nevertheless, while modified culture-specific education programs are usually more time intensive, the findings of this review suggest using culture-specific asthma education programmes for children and adults from minority groups. However, more robust RCTs are needed to further strengthen the quality of evidence and determine the cost-effectiveness of culture-specific programs.

Online diabetes self-management program: a randomized study.

PubMed

Lorig, Kate; Ritter, Philip L; Laurent, Diana D; Plant, Kathryn; Green, Maurice; Jernigan, Valarie Blue Bird; Case, Siobhan

2010-06-01

We hypothesized that people with type 2 diabetes in an online diabetes self-management program, compared with usual-care control subjects, would 1) demonstrate reduced A1C at 6 and 18 months, 2) have fewer symptoms, 3) demonstrate increased exercise, and 4) have improved self-efficacy and patient activation. In addition, participants randomized to listserve reinforcement would have better 18-month outcomes than participants receiving no reinforcement. A total of 761 participants were randomized to 1) the program, 2) the program with e-mail reinforcement, or 3) were usual-care control subjects (no treatment). This sample included 110 American Indians/Alaska Natives (AI/ANs). Analyses of covariance models were used at the 6- and 18-month follow-up to compare groups. At 6 months, A1C, patient activation, and self-efficacy were improved for program participants compared with usual care control subjects (P < 0.05). There were no changes in other health or behavioral indicators. The AI/AN program participants demonstrated improvements in health distress and activity limitation compared with usual-care control subjects. The subgroup with initial A1C >7% demonstrated stronger improvement in A1C (P = 0.01). At 18 months, self-efficacy and patient activation were improved for program participants. A1C was not measured. Reinforcement showed no improvement. An online diabetes self-management program is acceptable for people with type 2 diabetes. Although the results were mixed they suggest 1) that the program may have beneficial effects in reducing A1C, 2) AI/AN populations can be engaged in and benefit from online interventions, and 3) our follow-up reinforcement appeared to have no value.