Effectiveness of cognitive-behavioral stress management on psychological stress and glycemic control in gestational diabetes: a randomized controlled trial.

PubMed

Zaheri, Hamideh; Najar, Shahnaz; Abbaspoor, Zahra

2017-06-01

This study was conducted to determine the effect of cognitive-behavioral stress management (CBT) on reducing psychological stress in diabetic pregnant women. This randomized controlled trial applied through pretest and post-test with control group was conducted on 88 eligible women with gestational diabetes. Women who had a stress score more than 15, randomly assigned to intervention or control groups. Intervention group received stress management training within six two-hour sessions for three weeks. Stress and FBS were measured before intervention and two weeks after the last session. Data were analyzed using the SPSS version 19.0. Results were analyzed using chi-square, paired t test and independent sample t test. In CBT training group, stress significantly decreased two weeks after the training (p < 0.001). In the control group, the stress scores were significantly different before and after the intervention and women had a significant increase in the stress scores (p = 0.028). There was a significant difference between two groups in stress scores, two weeks after intervention (p = 0.001). Cognitive-behavioral stress management reduces stress in women with gestational diabetes and reducing stress may also improve the pregnancy outcomes, especially whose glycemic along with stress is not adequately controlled by medication.

Mediators of Treatment Effects in a Randomized Clinical Trial of Multisystemic Therapy-Health Care in Adolescents With Poorly Controlled Asthma: Disease Knowledge and Device Use Skills.

PubMed

Ellis, Deborah A; King, Pamela; Naar-King, Sylvie

2016-06-01

Determine whether Multisystemic Therapy-Health Care (MST-HC) improved asthma knowledge and controller device use skills among African-American youth with poorly controlled asthma and whether any improvements mediated changes in illness management. A randomized controlled trial was conducted with 170 adolescents with moderate to severe asthma. Families were randomized to MST-HC or attention control. Data were collected at baseline and 6 and 12 months after intervention completion. In linear mixed models, adolescents in the MST-HC group had increases in asthma knowledge; asthma knowledge was unchanged for attention control. Controller device use skills increased for adolescents in the MST-HC group, while skills declined for attention control. Both knowledge and skills mediated the relationship between intervention condition and changes in illness management. Tailored, home-based interventions that include knowledge and skills building components are one means by which illness management in African-American youth with poorly controlled asthma can be improved. © The Author 2015. Published by Oxford University Press on behalf of the Society of Pediatric Psychology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Improving Diabetes Self-Management through Acceptance, Mindfulness, and Values: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Gregg, Jennifer A.; Callaghan, Glenn M.; Hayes, Steven C.; Glenn-Lawson, June L.

2007-01-01

Patients in a low-income community health center with Type 2 diabetes (N = 81) taking a one-day education workshop as part of their diabetes medical management were randomly assigned either to education alone or to a combination of education and acceptance and commitment therapy (ACT). Both groups were taught how to manage their diabetes, but…

Biofeedback Training in Crisis Managers: A Randomized Controlled Trial.

PubMed

Janka, A; Adler, C; Brunner, B; Oppenrieder, S; Duschek, S

2017-06-01

Working in crisis environments represents a major challenge, especially for executive personnel engaged in directing disaster operations, i.e. crisis managers. Crisis management involves operating under conditions of extreme stress resulting, for instance, from high-level decision-making, principal responsibility for personnel, multitasking or working under conditions of risk and time pressure. The present study aimed to investigate the efficacy of a newly developed biofeedback training procedure based on electrodermal activity, especially designed for the target group of crisis managers. The training comprised exercises promoting acquisition of control over sympathetic arousal under resting conditions and during exposure to visual, acoustic and cognitive stressors resembling situations related to crisis management. In a randomized controlled design, 36 crisis managers were assigned to either a biofeedback training group or waiting list control group. Subjective stress was assessed using the Perceived Stress Scale. In the training group, stress level markedly decreased; the decrease remained stable at follow-up 2 months after the training. The results indicate that biofeedback training in crisis management is an effective method for stress management that may help to reduce vulnerability to stress-related performance decline and stress-related disease.

Randomized Trial of Hypnosis as a Pain and Symptom Management Strategy in Adults with Sickle Cell Disease

PubMed Central

Wallen, Gwenyth R; Middleton, Kimberly R; Ames, Nancy; Brooks, Alyssa T; Handel, Daniel

2014-01-01

Sickle cell disease (SCD) is the most common genetic disease in African-Americans, characterized by recurrent painful vaso-occlusive crises. Medical therapies for controlling or preventing crises are limited because of efficacy and/or toxicity. This is a randomized, controlled, single-crossover protocol of hypnosis for managing pain in SCD patients. Participants receive hypnosis from a trained hypnosis therapist followed by six weeks of self-hypnosis using digital media. Those in the control arm receive SCD education followed by a six-week waiting period before crossing over to the hypnosis arm of the study. Outcome measures include assessments of pain (frequency, intensity and quality), anxiety, coping strategies, sleep, depression, and health care utilization. To date, there are no published randomized, controlled trials evaluating the efficacy of hypnosis on SCD pain modulation in adults. Self-hypnosis for pain management may be helpful in modulating chronic pain, improving sleep quality, and decreasing use of narcotics in patients with SCD. TRIAL REGISTRATION ClinicalTrials.gov: NCT00393250 PMID:25520557

A Randomized trial of an Asthma Internet Self-management Intervention (RAISIN): study protocol for a randomized controlled trial.

PubMed

Morrison, Deborah; Wyke, Sally; Thomson, Neil C; McConnachie, Alex; Agur, Karolina; Saunderson, Kathryn; Chaudhuri, Rekha; Mair, Frances S

2014-05-24

The financial costs associated with asthma care continue to increase while care remains suboptimal. Promoting optimal self-management, including the use of asthma action plans, along with regular health professional review has been shown to be an effective strategy and is recommended in asthma guidelines internationally. Despite evidence of benefit, guided self-management remains underused, however the potential for online resources to promote self-management behaviors is gaining increasing recognition. The aim of this paper is to describe the protocol for a pilot evaluation of a website 'Living well with asthma' which has been developed with the aim of promoting self-management behaviors shown to improve outcomes. The study is a parallel randomized controlled trial, where adults with asthma are randomly assigned to either access to the website for 12 weeks, or usual asthma care for 12 weeks (followed by access to the website if desired). Individuals are included if they are over 16-years-old, have a diagnosis of asthma with an Asthma Control Questionnaire (ACQ) score of greater than, or equal to 1, and have access to the internet. Primary outcomes for this evaluation include recruitment and retention rates, changes at 12 weeks from baseline for both ACQ and Asthma Quality of Life Questionnaire (AQLQ) scores, and quantitative data describing website usage (number of times logged on, length of time logged on, number of times individual pages looked at, and for how long). Secondary outcomes include clinical outcomes (medication use, health services use, lung function) and patient reported outcomes (including adherence, patient activation measures, and health status). Piloting of complex interventions is considered best practice and will maximise the potential of any future large-scale randomized controlled trial to successfully recruit and be able to report on necessary outcomes. Here we will provide results across a range of outcomes which will provide estimates of efficacy to inform the design of a future full-scale randomized controlled trial of the 'Living well with asthma' website. This trial is registered with Current Controlled Trials ISRCTN78556552 on 18/06/13.

Tailored educational intervention for primary care to improve the management of dementia: the EVIDEM-ED cluster randomized controlled trial.

PubMed

Wilcock, Jane; Iliffe, Steve; Griffin, Mark; Jain, Priya; Thuné-Boyle, Ingela; Lefford, Frances; Rapp, David

2013-11-20

Early diagnosis of dementia is important because this allows those with dementia and their families to engage support and plan ahead. However, dementia remains underdetected and suboptimally managed in general practice. Our objective was to test the effect of a workplace-based tailored educational intervention developed for general practice on the clinical management of people with dementia. The tailored educational intervention was tested in an unblinded cluster randomized controlled trial with a pre/post-intervention design, with two arms: usual/normal care control versus educational intervention. The primary outcome measure was an increase in the proportion of patients with dementia who received at least two documented dementia-specific management reviews per year. Case identification was a secondary outcome measure. 23 practices in South-East England participated. A total of 1,072 patients with dementia (intervention: 512, control: 560) had information in their medical records showing the number of reviews within 12 months (or a proportion of) before intervention or randomization and within 12 months (or a proportion of) after. The mean total number of dementia management reviews after the educational intervention for people with dementia was 0.89 (SD 1.09; minimum 0; median 1; maximum 8) compared with 0.89 (SD 0.92; minimum 0; median 1; maximum 4) before intervention. In the control group prior to randomization the mean total number of dementia management reviews was 1.66 (SD 1.87; minimum 0; median 1; maximum 12) and in the period after randomization it was 1.56 (SD 1.79; minimum 0; median 1; maximum 11). Case detection rates were unaffected. The estimated incidence rate ratio for intervention versus control group was 1.03 (P = 0.927, 95% CI 0.57 to 1.86). The trial was timely, coinciding with financial incentives for dementia management in general practice (through the Quality Outcomes Framework); legal imperatives (in the form of the Mental Capacity Act 2005); policy pressure (The National Dementia Strategy 2009); and new resources (such as dementia advisors) that increased the salience of dementia for general practitioners. Despite this the intervention did not alter the documentation of clinical management of patients with dementia in volunteer practices, nor did it increase case identification. NCT00866099/Clinical Trials.

Stroke Self-Management Support Improves Survivors' Self-Efficacy and Outcome Expectation of Self-Management Behaviors.

PubMed

Lo, Suzanne H S; Chang, Anne M; Chau, Janita P C

2018-03-01

Evidence shows self-management programs are associated with improved recovery outcomes. This article reports on the effectiveness of a new nurse-led self-efficacy-based stroke self-management program. A randomized controlled trial of participants recruited from 3 acute stroke units was conducted. The intervention group received the 4-week stroke self-management program. The control group received usual care. All participants were assessed at baseline and 8 weeks after randomization. Data were analyzed using generalized estimating equations. Outcomes included self-efficacy, outcome expectation, and satisfaction with performance of self-management behaviors. One hundred twenty-eight participants were randomized with mean age, 67.46 years (SD, 11.95); 59% men; and mean duration poststroke, 45 days (SD, 26.16). At 8 weeks of follow-up in the intention-to-treat population, the intervention group improved significantly in self-efficacy (95% confidence interval, 2.55-12.45; P <0.01), outcome expectation (95% confidence interval, 5.47-14.01; P <0.01), and satisfaction with performance of self-management behaviors (95% confidence interval, 3.38-13.87; P <0.01) compared with the control. Similar results were obtained at 8 weeks of follow-up in the per-protocol population. The stroke self-management program improved survivors' self-efficacy, outcome expectation, and satisfaction with performance of self-management behaviors. URL: http://www.clinicaltrials.gov. Unique identifier: NCT02112955. © 2018 American Heart Association, Inc.

A randomized, controlled proof-of-concept trial of an Internet-based, therapist-assisted self-management treatment for posttraumatic stress disorder.

PubMed

Litz, Brett T; Engel, Charles C; Bryant, Richard A; Papa, Anthony

2007-11-01

The authors report an 8-week randomized, controlled proof-of-concept trial of a new therapist-assisted, Internet-based, self-management cognitive behavior therapy versus Internet-based supportive counseling for posttraumatic stress disorder (PTSD). Service members with PTSD from the attack on the Pentagon on September 11th or the Iraq War were randomly assigned to self-management cognitive behavior therapy (N=24) or supportive counseling (N=21). The dropout rate was similar to regular cognitive behavior therapy (30%) and unrelated to treatment arm. In the intent-to-treat group, self-management cognitive behavior therapy led to sharper declines in daily log-on ratings of PTSD symptoms and global depression. In the completer group, self-management cognitive behavior therapy led to greater reductions in PTSD, depression, and anxiety scores at 6 months. One-third of those who completed self-management cognitive behavior therapy achieved high-end state functioning at 6 months. Self-management cognitive behavior therapy may be a way of delivering effective treatment to large numbers with unmet needs and barriers to care.

A Randomized Controlled Trial to Evaluate Outcomes of a Workplace Self-Management Intervention and an Intensive Monitoring Intervention

ERIC Educational Resources Information Center

Schopp, Laura H.; Clark, Mary J.; Lamberson, William R.; Uhr, David J.; Minor, Marian A.

2017-01-01

The purpose of this study was to determine and compare outcomes of two voluntary workplace health management methods: an adapted worksite self-management (WSM) approach and an intensive health monitoring (IM) approach. Research participants were randomly assigned to either the WSM group or the IM group by a computer-generated list (n = 180; 92 WSM…

A randomized controlled trial of contingency management for psycho-stimulant use in community mental health outpatients with co-occurring serious mental illness

PubMed Central

McDonell, Michael G.; Srebnik, Debra; Angelo, Frank; McPherson, Sterling; Lowe, Jessica M.; Sugar, Andrea; Short, Robert A.; Roll, John M.; Ries, Richard K.

2014-01-01

Objective The primary objective of this study was to determine if contingency management was associated with increased stimulant drug abstinence in community mental health outpatients with serious mental illness and stimulant dependence. Secondary objectives were to determine if contingency management was associated with reductions in use of other substances, psychiatric symptoms, HIV-risk behavior, and inpatient service utilization. Method A randomized controlled design compared outcomes of 176 outpatients with serious mental illness and stimulant dependence. Participants were randomized to three months of contingency management for stimulant abstinence plus treatment-as-usual or treatment-as-usual with reinforcement for study participation only. Urine drug tests, self-report, clinician-report, and service utilization outcomes were assessed during three-month treatment and three-month follow-up periods. Results While participants in the contingency management condition were less likely to complete the treatment period (n=38; 42%) than those assigned to the control condition (n=55; 65%), X2(1)=9.8, p=0.02; those assigned to the contingency management condition were 2.4 (CI=1.9-3.0) times more likely to submit a stimulant-negative urine test during treatment. Participants assigned to contingency management experienced significantly lower levels of alcohol use, injection drug use, psychiatric symptoms, and were five times less likely than those assigned to the control condition to be admitted for psychiatric hospitalization, X2(1)=5.4, p=0.02. Contingency management participants reported significantly fewer days of stimulant drug use, relative to controls during the three-month follow-up. Conclusions When added to treatment-as-usual, contingency management is associated with large reductions in stimulant, injection drug, and alcohol use. Reductions in psychiatric symptoms and hospitalizations were important secondary benefits. PMID:23138961

Open-Label Randomized Trial of Titrated Disease Management for Patients with Hypertension: Study Design and Baseline Sample Characteristics

PubMed Central

Jackson, George L.; Weinberger, Morris; Kirshner, Miriam A.; Stechuchak, Karen M.; Melnyk, Stephanie D.; Bosworth, Hayden B.; Coffman, Cynthia J.; Neelon, Brian; Van Houtven, Courtney; Gentry, Pamela W.; Morris, Isis J.; Rose, Cynthia M.; Taylor, Jennifer P.; May, Carrie L.; Han, Byungjoo; Wainwright, Christi; Alkon, Aviel; Powell, Lesa; Edelman, David

2016-01-01

Despite the availability of efficacious treatments, only half of patients with hypertension achieve adequate blood pressure (BP) control. This paper describes the protocol and baseline subject characteristics of a 2-arm, 18-month randomized clinical trial of titrated disease management (TDM) for patients with pharmaceutically-treated hypertension for whom systolic blood pressure (SBP) is not controlled (≥140mmHg for non-diabetic or ≥130mmHg for diabetic patients). The trial is being conducted among patients of four clinic locations associated with a Veterans Affairs Medical Center. An intervention arm has a TDM strategy in which patients' hypertension control at baseline, 6, and 12 months determines the resource intensity of disease management. Intensity levels include: a low-intensity strategy utilizing a licensed practical nurse to provide bi-monthly, non-tailored behavioral support calls to patients whose SBP comes under control; medium-intensity strategy utilizing a registered nurse to provide monthly tailored behavioral support telephone calls plus home BP monitoring; and high-intensity strategy utilizing a pharmacist to provide monthly tailored behavioral support telephone calls, home BP monitoring, and pharmacist-directed medication management. Control arm patients receive the low-intensity strategy regardless of BP control. The primary outcome is SBP. There are 385 randomized (192 intervention; 193 control) veterans that are predominately older (mean age 63.5 years) men (92.5%). 61.8% are African American, and the mean baseline SBP for all subjects is 143.6mmHg. This trial will determine if a disease management program that is titrated by matching the intensity of resources to patients' BP control leads to superior outcomes compared to a low-intensity management strategy. PMID:27417982

Open-label randomized trial of titrated disease management for patients with hypertension: Study design and baseline sample characteristics.

PubMed

Jackson, George L; Weinberger, Morris; Kirshner, Miriam A; Stechuchak, Karen M; Melnyk, Stephanie D; Bosworth, Hayden B; Coffman, Cynthia J; Neelon, Brian; Van Houtven, Courtney; Gentry, Pamela W; Morris, Isis J; Rose, Cynthia M; Taylor, Jennifer P; May, Carrie L; Han, Byungjoo; Wainwright, Christi; Alkon, Aviel; Powell, Lesa; Edelman, David

2016-09-01

Despite the availability of efficacious treatments, only half of patients with hypertension achieve adequate blood pressure (BP) control. This paper describes the protocol and baseline subject characteristics of a 2-arm, 18-month randomized clinical trial of titrated disease management (TDM) for patients with pharmaceutically-treated hypertension for whom systolic blood pressure (SBP) is not controlled (≥140mmHg for non-diabetic or ≥130mmHg for diabetic patients). The trial is being conducted among patients of four clinic locations associated with a Veterans Affairs Medical Center. An intervention arm has a TDM strategy in which patients' hypertension control at baseline, 6, and 12months determines the resource intensity of disease management. Intensity levels include: a low-intensity strategy utilizing a licensed practical nurse to provide bi-monthly, non-tailored behavioral support calls to patients whose SBP comes under control; medium-intensity strategy utilizing a registered nurse to provide monthly tailored behavioral support telephone calls plus home BP monitoring; and high-intensity strategy utilizing a pharmacist to provide monthly tailored behavioral support telephone calls, home BP monitoring, and pharmacist-directed medication management. Control arm patients receive the low-intensity strategy regardless of BP control. The primary outcome is SBP. There are 385 randomized (192 intervention; 193 control) veterans that are predominately older (mean age 63.5years) men (92.5%). 61.8% are African American, and the mean baseline SBP for all subjects is 143.6mmHg. This trial will determine if a disease management program that is titrated by matching the intensity of resources to patients' BP control leads to superior outcomes compared to a low-intensity management strategy. Published by Elsevier Inc.

A randomized controlled trial of intensive care management for disabled Medicaid beneficiaries with high health care costs.

PubMed

Bell, Janice F; Krupski, Antoinette; Joesch, Jutta M; West, Imara I; Atkins, David C; Court, Beverly; Mancuso, David; Roy-Byrne, Peter

2015-06-01

To evaluate outcomes of a registered nurse-led care management intervention for disabled Medicaid beneficiaries with high health care costs. Washington State Department of Social and Health Services Client Outcomes Database, 2008-2011. In a randomized controlled trial with intent-to-treat analysis, outcomes were compared for the intervention (n = 557) and control groups (n = 563). A quasi-experimental subanalysis compared outcomes for program participants (n = 251) and propensity score-matched controls (n = 251). Administrative data were linked to describe costs and use of health services, criminal activity, homelessness, and death. In the intent-to-treat analysis, the intervention group had higher odds of outpatient mental health service use and higher prescription drug costs than controls in the postperiod. In the subanalysis, participants had fewer unplanned hospital admissions and lower associated costs; higher prescription drug costs; higher odds of long-term care service use; higher drug/alcohol treatment costs; and lower odds of homelessness. We found no health care cost savings for disabled Medicaid beneficiaries randomized to intensive care management. Among participants, care management may have the potential to increase access to needed care, slow growth in the number and therefore cost of unplanned hospitalizations, and prevent homelessness. These findings apply to start-up care management programs targeted at high-cost, high-risk Medicaid populations. © Health Research and Educational Trust.

Impact of a pharmacist-led warfarin self-management program on quality of life and anticoagulation control: a randomized trial.

PubMed

Verret, Lucie; Couturier, Justine; Rozon, Andréanne; Saudrais-Janecek, Sarah; St-Onge, Amélie; Nguyen, Angela; Basmadjian, Arsène; Tremblay, Simon; Brouillette, Denis; de Denus, Simon

2012-10-01

To evaluate the impact of a pharmacist-led warfarin patient self-management program on quality of life and anticoagulation control compared with management in a physician-led specialized anticoagulation clinic. Prospective, randomized, controlled, open-label trial. Tertiary care academic medical center. A total of 114 patients aged 18-75 years who were followed at a specialized anticoagulation clinic, had received warfarin for at least 6 months, and were expected to continue warfarin for a minimum of 4 months. All patients attended an educational session on anticoagulation provided by a pharmacist. Patients randomized to the self-management group (58 patients) also received practical training to use the CoaguChek XS device and a self-management dosing algorithm. Patients in the control group (56 patients) continued to undergo standard management at the anticoagulation clinic. Patients completed a validated quality-of-life questionnaire and the validated Oral Anticoagulation Knowledge test at the beginning and end of the study. The quality of anticoagulation control was evaluated by using the time spent in therapeutic range. After 4 months of follow-up, a significant improvement in the self-management group was observed compared with the control group in four of the five quality-of-life topics (p<0.05). Improvements in knowledge were observed in both groups after the training session and persisted after 4 months (p<0.05 for all). The time spent in the therapeutic range (80.0% in the self-management group vs 75% in the control group, p=0.79) and in the extended therapeutic range ([target international normalized ratio ± 0.3] 93.2% in the self-management group vs 91.1% in the control group, p=0.30) were similar between groups. A self-management warfarin program led by pharmacists resulted in significant improvement in the quality of life of patients receiving warfarin therapy as well as a reduction in the time required for anticoagulation monitoring, while maintaining a level of anticoagulation control similar to a high-quality specialized anticoagulation clinic. © 2012 Pharmacotherapy Publications, Inc.

Engaging women with an embodied conversational agent to deliver mindfulness and lifestyle recommendations: A feasibility randomized control trial.

PubMed

Gardiner, Paula M; McCue, Kelly D; Negash, Lily M; Cheng, Teresa; White, Laura F; Yinusa-Nyahkoon, Leanne; Jack, Brian W; Bickmore, Timothy W

2017-09-01

This randomized controlled trial evaluates the feasibility of using an Embodied Conversational Agent (ECA) to teach lifestyle modifications to urban women. Women were randomized to either 1) an ECA (content included: mindfulness, stress management, physical activity, and healthy eating) or 2) patient education sheets mirroring same content plus a meditation CD/MP3 once a day for one month. General outcome measures included: number of stress management techniques used, physical activity levels, and eating patterns. Sixty-one women ages 18 to 50 were enrolled. On average, 51% identified as white, 26% as black, 23% as other races; and 20% as Hispanic. The major stress management techniques reported at baseline were: exercise (69%), listening to music (70%), and social support (66%). After one month, women randomized to the ECA significantly decreased alcohol consumption to reduce stress (p=0.03) and increased daily fruit consumption by an average of 2 servings compared to the control (p=0.04). It is feasible to use an ECA to promote health behaviors on stress management and healthy eating among diverse urban women. Compared to patient information sheets, ECAs provide promise as a way to teach healthy lifestyle behaviors to diverse urban women. Copyright © 2017 Elsevier B.V. All rights reserved.

Effects of weight management program on postural stability and neuromuscular function among obese children: study protocol for a randomized controlled trial.

PubMed

Sun, Fenghua; Wang, Li-Juan; Wang, Lin

2015-04-10

Childhood obesity is one of the most critical public health problems in the world. It is associated with low neuromuscular function and postural deformities. Whether weight loss can improve postural stability and neuromuscular control, benefit daily activities, or prevent injury is unknown. Therefore, this study attempts to investigate the effect of a 6 month weight management program on postural stability and neuromuscular control among obese children. We will conduct a prospective, single-blind, randomized controlled trial with 120 prepubescent obese children. Participants will be randomly assigned to a weight management group or a control group. The weight management group will participate in a dietary and exercise program. The control group will receive health education. After the intervention, participants will be followed for 6 months with no active intervention. The primary and secondary outcomes will be assessed at the baseline, and after 6 months and 12 months. Primary outcome measures will include body weight, body height, body mass index, waist circumference, hip circumference, and body fat percentage. Secondary outcome measures will include three-dimensional functional biomechanics in different tasks, proprioception tests of the knee and ankle, neuromuscular response of the leg muscles, and muscle strength tests of the knee and ankle. Furthermore, adverse events will be recorded and analyzed. An intention-to-treat analysis will be performed if any participants withdraw from the trial. The important features of this trial include the randomization procedures and large sample size. This study attempts to estimate the effect of weight loss intervention on outcomes, including daily life function, postural stability, and neuromuscular control in prepubescent obese children. Therefore, our results can be useful for obese children, medical staff, and healthcare decision makers. Chinese Clinical Trial Registry ChiCTR-IOB-15005874.

Policy-into-practice for rheumatoid arthritis: randomized controlled trial and cohort study of e-learning targeting improved physiotherapy management.

PubMed

Fary, Robyn E; Slater, Helen; Chua, Jason; Ranelli, Sonia; Chan, Madelynn; Briggs, Andrew M

2015-07-01

To examine the effectiveness of a physiotherapy-specific, web-based e-learning platform, "RAP-el," in best-practice management of rheumatoid arthritis (RA) using a single-blind, randomized controlled trial (RCT) and prospective cohort study. Australian-registered physiotherapists were electronically randomized into intervention and control groups. The intervention group accessed RAP-eL over 4 weeks. Change in self-reported confidence in knowledge and skills was compared between groups at the end of the RCT using linear regression conditioned for baseline scores by a blinded assessor, using intent-to-treat analysis. Secondary outcomes included physiotherapists' satisfaction with RA management and responses to RA-relevant clinical statements and practice-relevant vignettes. Retention was evaluated in a cohort study 8 weeks after the RCT. Eighty physiotherapists were randomized into the intervention and 79 into the control groups. Fifty-six and 48, respectively, provided baseline data. Significant between-group differences were observed for change in confidence in knowledge (mean difference 8.51; 95% confidence interval [95% CI] 6.29, 10.73; effect size 1.62) and skills (mean difference 7.26; 95% CI 5.1, 9.4; effect size 1.54), with the intervention group performing better. Satisfaction in ability to manage RA, 4 of the 6 clinical statements, and responses to vignettes demonstrated significant improvement in the intervention group. Although 8-week scores showed declines in most outcomes, their clinical significance remains uncertain. RAP-eL can improve self-reported confidence, likely practice behaviors and satisfaction in physiotherapists' ability to manage people with RA, and improve their clinical knowledge in several areas of best-practice RA management in the short term. © 2015, American College of Rheumatology.

Implementation and quantitative evaluation of chronic disease self-management programme in Shanghai, China: randomized controlled trial.

PubMed Central

Fu, Dongbo; Fu, Hua; McGowan, Patrick; Shen, Yi-e; Zhu, Lizhen; Yang, Huiqin; Mao, Jianguo; Zhu, Shitai; Ding, Yongming; Wei, Zhihua

2003-01-01

OBJECTIVE: To evaluate the effectiveness of the Shanghai Chronic Disease Self-Management Program (CDSMP). METHODS: A randomized controlled trial with six-month follow-up compared patients who received treatment with those who did not receive treatment (waiting-list controls) in five urban communities in Shanghai, China. Participants in the treatment group received education from a lay-led CDSMP course and one copy of a help book immediately; those in the control group received the same education and book six months later. FINDINGS: In total, 954 volunteer patients with a medical record that confirmed a diagnosis of hypertension, heart disease, chronic lung disease, arthritis, stroke, or diabetes who lived in communities were assigned randomly to treatment (n = 526) and control (n = 428) groups. Overall, 430 (81.7%) and 349 (81.5%) patients in the treatment and control groups completed the six-month study. Patients who received treatment had significant improvements in weekly minutes of aerobic exercise, practice of cognitive symptom management, self-efficacy to manage own symptoms, and self-efficacy to manage own disease in general compared with controls. They also had significant improvements in eight indices of health status and, on average, fewer hospitalizations. CONCLUSION: When implemented in Shanghai, the CDSMP was acceptable culturally to Chinese patients. The programme improved participants' health behaviour, self-efficacy, and health status and reduced the number of hospitalizations six months after the course. The locally based delivery model was integrated into the routine of community government organizations and community health services. Chinese lay leaders taught the CDSMP courses as successfully as professionals. PMID:12764513

Effects of the TCARE® intervention on caregiver burden and depressive symptoms: preliminary findings from a randomized controlled study.

PubMed

Montgomery, Rhonda J V; Kwak, Jung; Kosloski, Karl; O'Connell Valuch, Katharine

2011-09-01

We examined the effects of a manualized care management protocol specifically designed for care managers working with caregivers, the Tailored Caregiver Assessment and Referral® (TCARE®) protocol, on caregiver identity discrepancy, burden, and depressive symptoms. Preliminary data from a longitudinal, randomized, controlled intervention study with 266 family caregivers served by 52 care managers in 4 states were analyzed using repeated measures random effects regression procedures. Caregivers in the intervention and control groups were repeatedly assessed for up to 9 months on caregiver identity discrepancy, 3 areas of caregiving burden-objective, relationship, and stress burdens; depression; and intention for nursing home placement. We found significant group by time interaction effects for caregiver identity discrepancy, relationship burden, stress burden, depression, and intention for nursing home placement. Caregivers in the intervention group experienced significant improvement on these measures, whereas caregivers in the control group worsened on these measures over time. The preliminary findings provide strong support for effectiveness of the TCARE® protocol on improving caregiver well-being and mental health outcomes.

Effects of the TCARE® Intervention on Caregiver Burden and Depressive Symptoms: Preliminary Findings From a Randomized Controlled Study

PubMed Central

Kwak, Jung; Kosloski, Karl; O’Connell Valuch, Katharine

2011-01-01

Objectives. We examined the effects of a manualized care management protocol specifically designed for care managers working with caregivers, the Tailored Caregiver Assessment and Referral® (TCARE®) protocol, on caregiver identity discrepancy, burden, and depressive symptoms. Methods. Preliminary data from a longitudinal, randomized, controlled intervention study with 266 family caregivers served by 52 care managers in 4 states were analyzed using repeated measures random effects regression procedures. Caregivers in the intervention and control groups were repeatedly assessed for up to 9 months on caregiver identity discrepancy, 3 areas of caregiving burden—objective, relationship, and stress burdens; depression; and intention for nursing home placement. Results. We found significant group by time interaction effects for caregiver identity discrepancy, relationship burden, stress burden, depression, and intention for nursing home placement. Caregivers in the intervention group experienced significant improvement on these measures, whereas caregivers in the control group worsened on these measures over time. Discussion. The preliminary findings provide strong support for effectiveness of the TCARE® protocol on improving caregiver well-being and mental health outcomes. PMID:21840840

Active management of labor

PubMed Central

Rogers, Rebecca G; Gardner, Michael O; Tool, Kevin J; Ainsley, Jeanne; Gilson, George

2000-01-01

Objective To compare the costs of a protocol of active management of labor with those of traditional labor management. Design Cost analysis of a randomized controlled trial. Methods From August 1992 to April 1996, we randomly allocated 405 women whose infants were delivered at the University of New Mexico Health Sciences Center, Albuquerque, to an active management of labor protocol that had substantially reduced the duration of labor or a control protocol. We calculated the average cost for each delivery, using both actual costs and charges. Results The average cost for women assigned to the active management protocol was $2,480.79 compared with an average cost of $2,528.61 for women in the control group (P = 0.55). For women whose infant was delivered by cesarean section, the average cost was $4,771.54 for active management of labor and $4,468.89 for the control protocol (P = 0.16). Spontaneous vaginal deliveries cost an average of $27.00 more for actively managed patients compared with the cost for the control protocol. Conclusions The reduced duration of labor by active management did not translate into significant cost savings. Overall, an average cost saving of only $47.91, or 2%, was achieved for labors that were actively managed. This reduction in cost was due to a decrease in the rate of cesarean sections in women whose labor was actively managed and not to a decreased duration of labor. PMID:10778374

Nurse case-manager vs multifaceted intervention to improve quality of osteoporosis care after wrist fracture: randomized controlled pilot study.

PubMed

Majumdar, S R; Johnson, J A; Bellerose, D; McAlister, F A; Russell, A S; Hanley, D A; Garg, S; Lier, D A; Maksymowych, W P; Morrish, D W; Rowe, B H

2011-01-01

Few outpatients with fractures are treated for osteoporosis in the years following fracture. In a randomized pilot study, we found a nurse case-manager could double rates of osteoporosis testing and treatment compared with a proven efficacious quality improvement strategy directed at patients and physicians (57% vs 28% rates of appropriate care). Few patients with fractures are treated for osteoporosis. An intervention directed at wrist fracture patients (education) and physicians (guidelines, reminders) tripled osteoporosis treatment rates compared to controls (22% vs 7% within 6 months of fracture). More effective strategies are needed. We undertook a pilot study that compared a nurse case-manager to the multifaceted intervention using a randomized trial design. The case-manager counseled patients, arranged bone mineral density (BMD) tests, and prescribed treatments. We included controls from our first trial who remained untreated for osteoporosis 1-year post-fracture. Primary outcome was bisphosphonate treatment and secondary outcomes were BMD testing, appropriate care (BMD test-treatment if bone mass low), and costs. Forty six patients untreated 1-year after wrist fracture were randomized to case-manager (n = 21) or multifaceted intervention (n = 25). Median age was 60 years and 68% were female. Six months post-randomization, 9 (43%) case-managed patients were treated with bisphosphonates compared with 3 (12%) multifaceted intervention patients (relative risk [RR] 3.6, 95% confidence intervals [CI] 1.1-11.5, p = 0.019). Case-managed patients were more likely than multifaceted intervention patients to undergo BMD tests (81% vs 52%, RR 1.6, 95%CI 1.1-2.4, p = 0.042) and receive appropriate care (57% vs 28%, RR 2.0, 95%CI 1.0-4.2, p = 0.048). Case-management cost was $44 (CDN) per patient vs $12 for the multifaceted intervention. A nurse case-manager substantially increased rates of appropriate testing and treatment for osteoporosis in patients at high-risk of future fracture when compared with a multifaceted quality improvement intervention aimed at patients and physicians. Even with case-management, nearly half of patients did not receive appropriate care. clinicaltrials.gov identifier: NCT00152321.

Improving Urban African Americans’ Blood Pressure Control through Multi-level Interventions in the Achieving Blood Pressure Control Together (ACT) Study: A Randomized Clinical Trial

PubMed Central

Ephraim, Patti L.; Hill-Briggs, Felicia; Roter, Debra; Bone, Lee; Wolff, Jennifer; Lewis-Boyer, LaPricia; Levine, David; Aboumatar, Hanan; Cooper, Lisa A; Fitzpatrick, Stephanie; Gudzune, Kimberly; Albert, Michael; Monroe, Dwyan; Simmons, Michelle; Hickman, Debra; Purnell, Leon; Fisher, Annette; Matens, Richard; Noronha, Gary; Fagan, Peter; Ramamurthi, Hema; Ameling, Jessica; Charlston, Jeanne; Sam, Tanyka; Carson, Kathryn A.; Wang, Nae-Yuh; Crews, Deidra; Greer, Raquel; Sneed, Valerie; Flynn, Sarah J.; DePasquale, Nicole; Boulware, L. Ebony

2014-01-01

Background Given their high rates of uncontrolled blood pressure, urban African Americans comprise a particularly vulnerable subgroup of persons with hypertension. Substantial evidence has demonstrated the important role of family and community support in improving patients’ management of a variety of chronic illnesses. However, studies of multilevel interventions designed specifically to improve urban African American patients’ blood pressure self-management by simultaneously leveraging patient, family, and community strengths are lacking. Methods/Design We report the protocol of the Achieving Blood Pressure Control Together (ACT) study, a randomized controlled trial designed to study the effectiveness of interventions that engage patient, family, and community-level resources to facilitate urban African American hypertensive patients’ improved hypertension self-management and subsequent hypertension control. African American patients with uncontrolled hypertension receiving health care in an urban primary care clinic will be randomly assigned to receive 1) an educational intervention led by a community health worker alone, 2) the community health worker intervention plus a patient and family communication activation intervention, or 3) the community health worker intervention plus a problem-solving intervention. All participants enrolled in the study will receive and be trained to use a digital home blood pressure machine. The primary outcome of the randomized controlled trial will be patients’ blood pressure control at 12 months. Discussion Results from the ACT study will provide needed evidence on the effectiveness of comprehensive multi-level interventions to improve urban African American patients’ hypertension control. PMID:24956323

Improving urban African Americans' blood pressure control through multi-level interventions in the Achieving Blood Pressure Control Together (ACT) study: a randomized clinical trial.

PubMed

Ephraim, Patti L; Hill-Briggs, Felicia; Roter, Debra L; Bone, Lee R; Wolff, Jennifer L; Lewis-Boyer, LaPricia; Levine, David M; Aboumatar, Hanan J; Cooper, Lisa A; Fitzpatrick, Stephanie J; Gudzune, Kimberly A; Albert, Michael C; Monroe, Dwyan; Simmons, Michelle; Hickman, Debra; Purnell, Leon; Fisher, Annette; Matens, Richard; Noronha, Gary J; Fagan, Peter J; Ramamurthi, Hema C; Ameling, Jessica M; Charlston, Jeanne; Sam, Tanyka S; Carson, Kathryn A; Wang, Nae-Yuh; Crews, Deidra C; Greer, Raquel C; Sneed, Valerie; Flynn, Sarah J; DePasquale, Nicole; Boulware, L Ebony

2014-07-01

Given their high rates of uncontrolled blood pressure, urban African Americans comprise a particularly vulnerable subgroup of persons with hypertension. Substantial evidence has demonstrated the important role of family and community support in improving patients' management of a variety of chronic illnesses. However, studies of multi-level interventions designed specifically to improve urban African American patients' blood pressure self-management by simultaneously leveraging patient, family, and community strengths are lacking. We report the protocol of the Achieving Blood Pressure Control Together (ACT) study, a randomized controlled trial designed to study the effectiveness of interventions that engage patient, family, and community-level resources to facilitate urban African American hypertensive patients' improved hypertension self-management and subsequent hypertension control. African American patients with uncontrolled hypertension receiving health care in an urban primary care clinic will be randomly assigned to receive 1) an educational intervention led by a community health worker alone, 2) the community health worker intervention plus a patient and family communication activation intervention, or 3) the community health worker intervention plus a problem-solving intervention. All participants enrolled in the study will receive and be trained to use a digital home blood pressure machine. The primary outcome of the randomized controlled trial will be patients' blood pressure control at 12months. Results from the ACT study will provide needed evidence on the effectiveness of comprehensive multi-level interventions to improve urban African American patients' hypertension control. Copyright © 2014 Elsevier Inc. All rights reserved.

The Effectiveness of a Web-Based Resource in Improving Post-Concussion Management in High Schools

PubMed Central

Glang, Ann E.; Koester, Michael C.; Chesnutt, James C.; Gioia, Gerard A.; McAvoy, Karen; Marshall, Sondra; Gau, Jeff M.

2014-01-01

BACKGROUND Because many sports concussions happen during school-sponsored sports events, most state concussion laws specifically hold schools accountable for coach training and effective concussion management practices. Brain 101: The Concussion Playbook is a web-based intervention that includes training in sports concussion for each member of the school community, presents guidelines on creating a concussion management team, and includes strategies for supporting students in the classroom. METHODS The group randomized controlled trial examined the efficacy of Brain 101 in managing sports concussion. Participating high schools (N=25) were randomly assigned to the Brain 101 intervention or control. Fall athletes and their parents completed online training, and Brain 101 school administrators were directed to create concussion management policy and procedures. RESULTS Student athletes and parents at Brain 101 schools significantly outperformed those at control schools on sports concussion knowledge, knowledge application, and behavioral intention to implement effective concussion management practices. Students who had concussions in Brain 101 schools received more varied academic accommodations than students in control schools. CONCLUSIONS Brain 101 can help schools create a comprehensive school-wide concussion management program. It requires minimal expenditures and offers engaging and effective education for teachers, coaches, parents, and students. PMID:25438964

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.

The clinical and cost-effectiveness of the BRinging Information and Guided Help Together (BRIGHT) intervention for the self-management support of people with stage 3 chronic kidney disease in primary care: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Improving the quality of care for people with vascular disease is a key priority. Chronic kidney disease (CKD) has recently been included as a target condition for general practices to add to registers of chronic conditions as part of the Quality and Outcome Framework. This paper outlines the implementation and evaluation of a self-management intervention involving an information guidebook, tailored access to local resources and telephone support for people with stage 3 chronic kidney disease. Methods/Design The study involves a multi-site, longitudinal patient-level randomized controlled trial. The study will evaluate the clinical use and cost-effectiveness of a complex self-management intervention for people with stage 3 chronic kidney disease in terms of self-management capacity, health-related quality of life and blood pressure control compared to care as usual. We describe the methods of the patient-level randomized controlled trial. Discussion The management of chronic kidney disease is a developing area of research. The BRinging Information and Guided Help Together (BRIGHT) trial aims to provide evidence that a complementary package of support for people with vascular disease that targets both clinical and social need broadens the opportunities of self-management support by addressing problems related to social disadvantage. Trial registration Trial registration reference: ISRCTN45433299 PMID:23356861

Adaptive mechanism-based congestion control for networked systems

NASA Astrophysics Data System (ADS)

Liu, Zhi; Zhang, Yun; Chen, C. L. Philip

2013-03-01

In order to assure the communication quality in network systems with heavy traffic and limited bandwidth, a new ATRED (adaptive thresholds random early detection) congestion control algorithm is proposed for the congestion avoidance and resource management of network systems. Different to the traditional AQM (active queue management) algorithms, the control parameters of ATRED are not configured statically, but dynamically adjusted by the adaptive mechanism. By integrating with the adaptive strategy, ATRED alleviates the tuning difficulty of RED (random early detection) and shows a better control on the queue management, and achieve a more robust performance than RED under varying network conditions. Furthermore, a dynamic transmission control protocol-AQM control system using ATRED controller is introduced for the systematic analysis. It is proved that the stability of the network system can be guaranteed when the adaptive mechanism is finely designed. Simulation studies show the proposed ATRED algorithm achieves a good performance in varying network environments, which is superior to the RED and Gentle-RED algorithm, and providing more reliable service under varying network conditions.

Randomized controlled trial of supervised patient self-testing of warfarin therapy using an internet-based expert system.

PubMed

Ryan, F; Byrne, S; O'Shea, S

2009-08-01

Increased frequency of prothrombin time testing, facilitated by patient self-testing (PST) of the International Normalized Ratio (INR) can improve the clinical outcomes of oral anticoagulation therapy (OAT). However, oversight of this type of management is often difficult and time-consuming for healthcare professionals. This study reports the first randomized controlled trial of an automated direct-to-patient expert system, enabling remote and effective management of patients on OAT. A prospective, randomized controlled cross-over study was performed to test the hypothesis that supervised PST using an internet-based, direct-to-patient expert system could provide improved anticoagulation control as compared with that provided by an anticoagulation management service (AMS). During the 6 months of supervised PST, patients measured their INR at home using a portable meter and entered this result, along with other information, onto the internet web page. Patients received instant feedback from the system as to what dose to take and when the next test was due. During the routine care arm, patients attended the AMS at least every 4-6 weeks and were dosed by the anticoagulation pharmacist or physician. The primary outcome variable was the difference in the time in therapeutic range (TTR) between both arms. One hundred and sixty-two patients were enrolled (male 61.6%, mean age 58.7 years), and 132 patients (81.5%) completed both arms. TTR was significantly higher during PST management than during AMS management (median TTR 74% vs 58.6%; z=5.67, P < 0.001). The use of an internet-based, direct-to-patient expert system for the management of PST improves the control of OAT as compared with AMS management.

A Randomized Controlled Trial to Evaluate an Internet-Based Self-Management Program in Systemic Sclerosis.

PubMed

Khanna, Dinesh; Serrano, Jennifer; Berrocal, Veronica J; Silver, Richard M; Cuencas, Pedro; Newbill, Sharon L; Battyany, Josephine; Maxwell, Cynthia; Alore, Mary; Dyas, Laura; Riggs, Robert; Connolly, Kerri; Kellner, Saville; Fisher, Jody J; Bush, Erica; Sachdeva, Anjali; Evnin, Luke; Raisch, Dennis W; Poole, Janet L

2018-05-09

A pilot study showed that an internet-based self-management program improves self-efficacy in systemic sclerosis (SSc). The objective of the present study was to compare the internet-based self-management program to an educational book developed for people with SSc in measures of self-efficacy and other patient-reported outcomes. A 16-week randomized, controlled trial. Of the 267 participants who completed baseline questionnaires and were randomized to the intervention (internet) or control (book) condition, 123 (93%) in the internet and 124 (94%) in the control completed the 16-week RCT. The mean (SD) age of all participants was 53.7 (11.7) years, 91% were female, and 79.4% had some college or a higher degree. The mean (SD) disease duration after diagnosis of SSc was 8.97 (8.50) years. There were no statistical differences between the 2 groups for the primary outcome measure (PROMIS Self Efficacy Managing Symptoms: mean change of 0.35 in the internet group vs. 0.94 in control group, p=0.47) and secondary outcome measures, except the EQ5D visual analog scale (p=0.05). Internet group participants agreed that the self-management modules were of importance to them, the information was presented clearly, and the website was easy to use and at an appropriate reading level. Our RCT showed that the internet-based self-management website was not statistically superior to an educational patient-focused book in improving self-efficacy and other measures. The participants were enthusiastic for the content and presentation of the self-management website. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Training pharmacy workers in recognition, management, and prevention of STDs: district-randomized controlled trial.

PubMed Central

Garcia, Patricia; Hughes, James; Carcamo, Cesar; Holmes, King K.

2003-01-01

OBJECTIVES: To determine the effectiveness of an intervention for pharmacy workers in improving their recognition and management of sexually transmitted disease (STD) syndromes. METHODS: We randomly selected 14 districts (total population nearly 4 million) from the 24 districts of low socioeconomic status in Lima, Peru. We randomly assigned paired districts to receive training and support for management and prevention of STDs or a control intervention about management of diarrhoea. The STD intervention included interactive luncheon seminars on recognition and management of four STD syndromes (urethral discharge, vaginal discharge, genital ulcers, and pelvic inflammatory disease) and STD/HIV prevention counselling; monthly pharmacy visits by "prevention salespersons" who distributed materials that included "STD/HIV prevention packets" containing information, condoms, and cards given to patients for referral of their sex partners; and workshops for physicians on managing patients with STD syndromes referred from pharmacies. Standardized simulated patients visited pharmacies in intervention and control districts at one, three, and six months after training to assess outcomes. FINDINGS: Standardized simulated patients reported significantly better recognition and management (appropriate antimicrobial regimens provided for discharge syndromes and referral to specially trained physicians for genital ulcers or pelvic inflammatory disease) by pharmacy workers of all four STD syndromes. They also reported significantly more frequent recommendations for use of condoms and treatment of partners at pharmacies in intervention districts than in control districts (by "intention-to-train" analyses, P<0.05 for 47/48 primary outcome comparisons). CONCLUSION: Training was feasible and effectively improved pharmacy workers' practices. PMID:14758407

Implementation and evaluation of an integrated computerized asthma management system in a pediatric emergency department: a randomized clinical trial.

PubMed

Dexheimer, Judith W; Abramo, Thomas J; Arnold, Donald H; Johnson, Kevin; Shyr, Yu; Ye, Fei; Fan, Kang-Hsien; Patel, Neal; Aronsky, Dominik

2014-11-01

The use of evidence-based guidelines can improve the care for asthma patients. We implemented a computerized asthma management system in a pediatric emergency department (ED) to integrate national guidelines. Our objective was to determine whether patient eligibility identification by a probabilistic disease detection system (Bayesian network) combined with an asthma management system embedded in the workflow decreases time to disposition decision. We performed a prospective, randomized controlled trial in an urban, tertiary care pediatric ED. All patients 2-18 years of age presenting to the ED between October 2010 and February 2011 were screened for inclusion by the disease detection system. Patients identified to have an asthma exacerbation were randomized to intervention or control. For intervention patients, asthma management was computer-driven and workflow-integrated including computer-based asthma scoring in triage, and time-driven display of asthma-related reminders for re-scoring on the electronic patient status board combined with guideline-compliant order sets. Control patients received standard asthma management. The primary outcome measure was the time from triage to disposition decision. The Bayesian network identified 1339 patients with asthma exacerbations, of which 788 had an asthma diagnosis determined by an ED physician-established reference standard (positive predictive value 69.9%). The median time to disposition decision did not differ among the intervention (228 min; IQR=(141, 326)) and control group (223 min; IQR=(129, 316)); (p=0.362). The hospital admission rate was unchanged between intervention (25%) and control groups (26%); (p=0.867). ED length of stay did not differ among intervention (262 min; IQR=(165, 410)) and control group (247 min; IQR=(163, 379)); (p=0.818). The control and intervention groups were similar in regards to time to disposition; the computerized management system did not add additional wait time. The time to disposition decision did not change; however the management system integrated several different information systems to support clinicians' communication. Copyright © 2014. Published by Elsevier Ireland Ltd.

Stress Management-Augmented Behavioral Weight Loss Intervention for African American Women: A Pilot, Randomized Controlled Trial

ERIC Educational Resources Information Center

Cox, Tiffany L.; Krukowski, Rebecca; Love, ShaRhonda J.; Eddings, Kenya; DiCarlo, Marisha; Chang, Jason Y.; Prewitt, T. Elaine; West, Delia Smith

2013-01-01

The relationship between chronic stress and weight management efforts may be a concern for African American (AA) women, who have a high prevalence of obesity, high stress levels, and modest response to obesity treatment. This pilot study randomly assigned 44 overweight/obese AA women with moderate to high stress levels to either a 12-week…

Teacher coaching supported by formative assessment for improving classroom practices.

PubMed

Fabiano, Gregory A; Reddy, Linda A; Dudek, Christopher M

2018-06-01

The present study is a wait-list controlled, randomized study investigating a teacher coaching approach that emphasizes formative assessment and visual performance feedback to enhance elementary school teachers' classroom practices. The coaching model targeted instructional and behavioral management practices as measured by the Classroom Strategies Assessment System (CSAS) Observer and Teacher Forms. The sample included 89 general education teachers, stratified by grade level, and randomly assigned to 1 of 2 conditions: (a) immediate coaching, or (b) waitlist control. Results indicated that, relative to the waitlist control, teachers in immediate coaching demonstrated significantly greater improvements in observations of behavior management strategy use but not for observations of instructional strategy use. Observer- and teacher-completed ratings of behavioral management strategy use at postassessment were significantly improved by both raters; ratings of instructional strategy use were significantly improved for teacher but not observer ratings. A brief coaching intervention improved teachers' use of observed behavior management strategies and self-reported use of behavior management and instructional strategies. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

A pilot randomized controlled trial of a self-management group intervention for people with early-stage dementia (The SMART study).

PubMed

Quinn, Catherine; Toms, Gill; Jones, Carys; Brand, Andrew; Edwards, Rhiannon Tudor; Sanders, Fiona; Clare, Linda

2016-05-01

Self-management equips people to manage the symptoms and lifestyle changes that occur in long-term health conditions; however, there is limited evidence about its effectiveness for people with early-stage dementia. This pilot randomized controlled trial (RCT) explored the feasibility of a self-management intervention for people with early-stage dementia. The participants were people with early-stage dementia (n = 24) and for each participant a caregiver also took part. Participants were randomly allocated to either an eight-week self-management group intervention or treatment as usual (TAU). Assessments were conducted at baseline, three months and six months post-randomization by a researcher blind to group allocation. The primary outcome measure was self-efficacy score at three months. Thirteen people with dementia were randomized to the intervention and 11 to TAU. Two groups were run, the first consisting of six people with dementia and the second of seven people with dementia. There was a small positive effect on self-efficacy with the intervention group showing gains in self-efficacy compared to the TAU group at three months (d = 0.35), and this was maintained at six months (d = 0.23). In terms of intervention acceptability, attrition was minimal, adherence was good, and satisfaction ratings were high. Feedback from participants was analyzed with content analysis. The findings suggest the positive aspects of the intervention were that it fostered independence and reciprocity, promoted social support, offered information, and provided clinician support. This study has provided preliminary evidence that self-management may be beneficial for people with early-stage dementia.

Effect of a web-based chronic disease management system on asthma control and health-related quality of life: study protocol for a randomized controlled trial

PubMed Central

2011-01-01

Background Asthma is a prevalent and costly disease resulting in reduced quality of life for a large proportion of individuals. Effective patient self-management is critical for improving health outcomes. However, key aspects of self-management such as self-monitoring of behaviours and symptoms, coupled with regular feedback from the health care team, are rarely addressed or integrated into ongoing care. Health information technology (HIT) provides unique opportunities to facilitate this by providing a means for two way communication and exchange of information between the patient and care team, and access to their health information, presented in personalized ways that can alert them when there is a need for action. The objective of this study is to evaluate the acceptability and efficacy of using a web-based self-management system, My Asthma Portal (MAP), linked to a case-management system on asthma control, and asthma health-related quality of life. Methods The trial is a parallel multi-centered 2-arm pilot randomized controlled trial. Participants are randomly assigned to one of two conditions: a) MAP and usual care; or b) usual care alone. Individuals will be included if they are between 18 and 70, have a confirmed asthma diagnosis, and their asthma is classified as not well controlled by their physician. Asthma control will be evaluated by calculating the amount of fast acting beta agonists recorded as dispensed in the provincial drug database, and asthma quality of life using the Mini Asthma Related Quality of Life Questionnaire. Power calculations indicated a needed total sample size of 80 subjects. Data are collected at baseline, 3, 6, and 9 months post randomization. Recruitment started in March 2010 and the inclusion of patients in the trial in June 2010. Discussion Self-management support from the care team is critical for improving chronic disease outcomes. Given the high volume of patients and time constraints during clinical visits, primary care physicians have limited time to teach and reinforce use of proven self-management strategies. HIT has the potential to provide clinicians and a large number of patients with tools to support health behaviour change. Trial Registration Current Controlled Trials ISRCTN34326236. PMID:22168530

Effect of a web-based chronic disease management system on asthma control and health-related quality of life: study protocol for a randomized controlled trial.

PubMed

Ahmed, Sara; Bartlett, Susan J; Ernst, Pierre; Paré, Guy; Kanter, Maria; Perreault, Robert; Grad, Roland; Taylor, Laurel; Tamblyn, Robyn

2011-12-14

Asthma is a prevalent and costly disease resulting in reduced quality of life for a large proportion of individuals. Effective patient self-management is critical for improving health outcomes. However, key aspects of self-management such as self-monitoring of behaviours and symptoms, coupled with regular feedback from the health care team, are rarely addressed or integrated into ongoing care. Health information technology (HIT) provides unique opportunities to facilitate this by providing a means for two way communication and exchange of information between the patient and care team, and access to their health information, presented in personalized ways that can alert them when there is a need for action. The objective of this study is to evaluate the acceptability and efficacy of using a web-based self-management system, My Asthma Portal (MAP), linked to a case-management system on asthma control, and asthma health-related quality of life. The trial is a parallel multi-centered 2-arm pilot randomized controlled trial. Participants are randomly assigned to one of two conditions: a) MAP and usual care; or b) usual care alone. Individuals will be included if they are between 18 and 70, have a confirmed asthma diagnosis, and their asthma is classified as not well controlled by their physician. Asthma control will be evaluated by calculating the amount of fast acting beta agonists recorded as dispensed in the provincial drug database, and asthma quality of life using the Mini Asthma Related Quality of Life Questionnaire. Power calculations indicated a needed total sample size of 80 subjects. Data are collected at baseline, 3, 6, and 9 months post randomization. Recruitment started in March 2010 and the inclusion of patients in the trial in June 2010. Self-management support from the care team is critical for improving chronic disease outcomes. Given the high volume of patients and time constraints during clinical visits, primary care physicians have limited time to teach and reinforce use of proven self-management strategies. HIT has the potential to provide clinicians and a large number of patients with tools to support health behaviour change. Current Controlled Trials ISRCTN34326236.

A pilot randomized controlled trial of a depression and disease management program delivered by phone.

PubMed

Aburizik, Arwa; Dindo, Lilian; Kaboli, Peter; Charlton, Mary; Dawn, Klein; Turvey, Carolyn

2013-11-01

Depression in medically ill patients occurs at twice the rate found in the general population. Though pharmacologic and psychotherapeutic interventions for depression are effective, response to treatment and access to care are barriers for this population. A multidimensional telehealth intervention was designed to focus on these barriers by delivering a phone based intervention that addressed managing one's illness and coping emotionally. Veterans with diabetes, hypertension, or chronic pain and depressive symptoms were randomized to one of three conditions: Usual Care (n=23), Illness Management Only (n=31), or Combined Psychotherapy and Illness Management (n=29). Those randomized to the Combined or Illness Management Only intervention group received 10 phone visits. Veterans in the Combined group received all aspects of the illness management program plus a manualized depression intervention. Subjects completed assessments at baseline, week 5, and 10 to test the main hypothesis that veterans in the Combined condition would have a greater decline in depressive symptoms. The Combined intervention yielded a significant decline in depressive symptoms when compared with Usual Care. However, the there was no significant difference between the Combined and Illness Management Only groups. This is a pilot study with a small sample size relative to a standard randomized controlled trial in psychotherapy. This telephone-based intervention succeeded in reducing depressive symptoms in veterans with chronic illness. It adds to the building evidence base for providing phone-delivered mental health services. © 2013 Elsevier B.V. All rights reserved.

Stress Prevention through a Time Management Training Intervention: An Experimental Study

ERIC Educational Resources Information Center

Häfner, Alexander; Stock, Armin; Pinneker, Lydia; Ströhle, Sabine

2014-01-01

The purpose of this study was to examine the effects of a short-term time management training programme on perceived control of time and perceived stress. The sample of 177 freshmen was randomly assigned to a time management training (n?=?89) and an active control group (CG) (n?=?88). We expected that an increase in external demands during the…

Serious games for improving knowledge and self-management in young people with chronic conditions: a systematic review and meta-analysis.

PubMed

Charlier, Nathalie; Zupancic, Nele; Fieuws, Steffen; Denhaerynck, Kris; Zaman, Bieke; Moons, Philip

2016-01-01

To conduct a systematic review and meta-analysis of randomized controlled trials assessing the effectiveness of serious games in improving knowledge and/or self-management behaviors in young people with chronic conditions. The authors searched the databases PubMed, Cochrane Library, Web of Sciences, and PsychINFO for articles published between January 1990 and January 2014. Reference lists were hand-searched to retrieve additional studies. Randomized controlled trials that compared a digital game with either standard education or no specific education in a population of children and/or adolescents with chronic conditions were included. The authors identified 9 studies in which the effectiveness of serious games in young people with chronic conditions was evaluated using a randomized controlled trials design. Six studies found a significant improvement of knowledge in the game group from pretest to posttest; 4 studies showed significantly better knowledge in the game group than in the control group after the intervention. Two studies reported significantly better self-management in the game group than in the control group after the intervention. Seven studies were included in the meta-analysis. For knowledge, pooled estimate of Hedges' gu was 0.361 (95% confidence intervals, 0.098-0.624), demonstrating that serious games improve knowledge in patients. For self-management, pooled estimate of Hedges' gu was 0.310 (95% confidence intervals, 0.122-0.497), showing that gaming improves self-management behaviors. The authors' meta-analysis shows that educational video games can be effective in improving knowledge and self-management in young people with chronic conditions. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Randomized controlled trial of contingency management for stimulant use in community mental health patients with serious mental illness.

PubMed

McDonell, Michael G; Srebnik, Debra; Angelo, Frank; McPherson, Sterling; Lowe, Jessica M; Sugar, Andrea; Short, Robert A; Roll, John M; Ries, Richard K

2013-01-01

The primary objective of this study was to determine whether contingency management was associated with increased abstinence from stimulant drug use in stimulant-dependent patients with serious mental illness treated in a community mental health center. Secondary objectives were to determine whether contingency management was associated with reductions in use of other substances, psychiatric symptoms, HIV risk behavior, and inpatient service utilization. A randomized controlled design was used to compare outcomes of 176 outpatients with serious mental illness and stimulant dependence. Participants were randomly assigned to receive 3 months of contingency management for stimulant abstinence plus treatment as usual or treatment as usual with reinforcement for study participation only. Urine drug tests and self report, clinician-report, and service utilization outcomes were assessed during the 3-month treatment period and the 3-month follow-up period. Although participants in the contingency management condition were significantly less likely to complete the treatment period than those assigned to the control condition (42% compared with 65%), they were 2.4 times (95% CI=1.9–3.0)more likely to submit a stimulant-negative urine test during treatment. Compared with participants in the control condition,they had significantly lower levels of alcohol use, injection drug use, and psychiatric symptoms and were one-fifth as likely as those assigned to the control condition to be admitted for psychiatric hospitalization during treatment. They also reported significantly fewer days of stimulant drug use during the 3-month follow-up. When added to treatment as usual, contingency management is associated with large reductions in stimulant,injection drug, and alcohol use.Reductions in psychiatric symptoms and hospitalizations are important secondary benefits.

Managing mobility outcomes in vulnerable seniors ( MMOVeS): a randomized controlled pilot study.

PubMed

Figueiredo, Sabrina; Morais, Jose A; Mayo, Nancy

2017-12-01

To estimate feasibility and potential for efficacy of an individualized, exercise-focused, self-management program (i.e. Managing Mobility Outcomes In Vulnerable Seniors ( MMOVeS)), in comparison to exercise information in improving mobility after six months among seniors recently discharged from hospital. Randomized pilot study. Two McGill University-teaching hospitals. Community dwelling seniors, aged 70 years and older, recently discharged from either participating hospitals. The physiotherapy-facilitated intervention consisted of (1) evaluation of mobility capacity, (2) setting short- and long-term goals, (3) delineation of an exercise treatment plan, (4) an educational booklet to enhance mobility self-management skills, and (5) six monthly telephone calls. Control group received a booklet with information on exercises targeting mobility limitations in seniors. Mobility, pain, and health status were assessed at baseline and at six months using multiple indicators drawn from Disabilities of the Arm, Shoulder, and Hand (DASH) Score, Lower Extremity Functional Scale (LEFS) and Short-Form (SF)-36. In all, 26 people were randomized to the intervention (mean age: 81 ± 8; 39% women), and 23 were randomized to the control (mean age: 79 ± 7; 33% women). The odds ratio for the mobility outcomes combined was 3.08 and the 95% confidence interval excluded 1 (1.65-5.77). The odds ratio for pain and health perception favored the MMOVeS group, but the 95% confidence interval included the null value. This feasibility study highlights the potential for efficacy of an individualized, exercise-focused, self-management program in comparison to exercise information in improving mobility outcome for seniors. Furthermore, a home-program combining self-management skills and exercise taught with minimal supervision prove to be feasible. Finally, data from this study can be used to estimate sample size for a confirmatory trial.

Remediating Organizational Functioning in Children with ADHD: Immediate and Long-Term Effects from a Randomized Controlled Trial

ERIC Educational Resources Information Center

Abikoff, Howard; Gallagher, Richard; Wells, Karen C.; Murray, Desiree W.; Huang, Lei; Lu, Feihan; Petkova, Eva

2013-01-01

Objective: The study compared the efficacy of 2 behavioral interventions to ameliorate organization, time management, and planning (OTMP) difficulties in 3rd- to 5th-grade children with attention-deficit/hyperactivity disorder (ADHD). Method: In a dual-site randomized controlled trial, 158 children were assigned to organizational skills training…

Randomized Controlled Trial for Behavioral Smoking and Weight Control Treatment: Effect of Concurrent Versus Sequential Intervention.

ERIC Educational Resources Information Center

Spring, Bonnie; Pagoto, Sherry; Pingitore, Regina; Doran, Neal; Schneider, Kristin; Hedeker, Don

2004-01-01

The authors compared simultaneous versus sequential approaches to multiple health behavior change in diet, exercise, and cigarette smoking. Female regular smokers (N = 315) randomized to 3 conditions received 16 weeks of behavioral smoking treatment, quit smoking at Week 5, and were followed for 9 months after quit date. Weight management was…

Factors Associated with High Use of a Workplace Web-Based Stress Management Program in a Randomized Controlled Intervention Study

ERIC Educational Resources Information Center

Hasson, H.; Brown, C.; Hasson, D.

2010-01-01

In web-based health promotion programs, large variations in participant engagement are common. The aim was to investigate determinants of high use of a worksite self-help web-based program for stress management. Two versions of the program were offered to randomly selected departments in IT and media companies. A static version of the program…

A web-based approach to managing stress and mood disorders in the workforce.

PubMed

Billings, Douglas W; Cook, Royer F; Hendrickson, April; Dove, David C

2008-08-01

To evaluate the effectiveness of a web-based multimedia health promotion program for the workplace, designed to help reduce stress and to prevent depression, anxiety, and substance abuse. Using a randomized controlled trial design, 309 working adults were randomly assigned to the web-based condition or to a wait-list control condition. All participants were assessed on multiple self-reported outcomes at pretest and posttest. Relative to controls, the web-based group reduced their stress, increased their knowledge of depression and anxiety, developed more positive attitudes toward treatment, and adopted a more healthy approach to alcohol consumption. We found that a brief and easily adaptable web-based stress management program can simultaneously reduce worker stress and address stigmatized behavioral health problems by embedding this prevention material into a more positive stress management framework.

The effectiveness of a web-based resource in improving postconcussion management in high schools.

PubMed

Glang, Ann E; Koester, Michael C; Chesnutt, James C; Gioia, Gerard A; McAvoy, Karen; Marshall, Sondra; Gau, Jeff M

2015-01-01

Because many sports concussions happen during school-sponsored sports events, most state concussion laws specifically hold schools accountable for coach training and effective concussion management practices. Brain 101: The Concussion Playbook is a Web-based intervention that includes training in sports concussion for each member of the school community, presents guidelines on creating a concussion management team, and includes strategies for supporting students in the classroom. The group randomized controlled trial examined the efficacy of Brain 101 in managing sports concussion. Participating high schools (N = 25) were randomly assigned to the Brain 101 intervention or control. Fall athletes and their parents completed online training, and Brain 101 school administrators were directed to create concussion management policy and procedures. Student athletes and parents at Brain 101 schools significantly outperformed those at control schools on sports concussion knowledge, knowledge application, and behavioral intention to implement effective concussion management practices. Students who had concussions in Brain 101 schools received more varied academic accommodations than students in control schools. Brain 101 can help schools create a comprehensive schoolwide concussion management program. It requires minimal expenditures and offers engaging and effective education for teachers, coaches, parents, and students. Copyright © 2015 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

Estimating the Standard Error of the Impact Estimator in Individually Randomized Trials with Clustering

ERIC Educational Resources Information Center

Weiss, Michael J.; Lockwood, J. R.; McCaffrey, Daniel F.

2016-01-01

In the "individually randomized group treatment" (IRGT) experimental design, individuals are first randomly assigned to a treatment arm or a control arm, but then within each arm, are grouped together (e.g., within classrooms/schools, through shared case managers, in group therapy sessions, through shared doctors, etc.) to receive…

The Comparison of the Effects of a Didactic Stress Management Program and Group Counselling on the Coping Strategies of School Counsellors

ERIC Educational Resources Information Center

Coban, Aysel Esen; Hamamci, Zeynep

2009-01-01

The aim of this study was to compare the effects of a didactic stress management program, group counselling, and a control group on school counsellors' stress coping strategies. Thirty-four school counsellors were randomly assigned to either a didactic stress management group, group counselling, or a control group. The didactic stress management…

Parental emotional management benefits family relationships: A randomized controlled trial in Hong Kong, China.

PubMed

Fabrizio, Cecilia S; Lam, Tai Hing; Hirschmann, Malia R; Pang, Irene; Yu, Nancy Xiaonan; Wang, Xin; Stewart, Sunita M

2015-08-01

There is a shortage of culturally appropriate, brief, preventive interventions designed to be sustainable and acceptable for community participants in nonwestern cultures. Parents' ability to regulate their emotions is an important factor for psychological well-being of the family. In Chinese societies, emotional regulation may be more important in light of the cultural desirability of maintaining harmonious family relationships. The objectives of our randomized controlled trial were to test the effectiveness of our Effective Parenting Programme (EPP) to increase the use of emotional management strategies (primary outcome) and enhance the parent-child relationship (secondary outcome). We utilized design characteristics that promoted recruitment, retention, and intervention sustainability. We randomized a community sample of 412 Hong Kong middle- and low-income mothers of children aged 6-8 years to the EPP or attention control group. At 3, 6 and 12- month follow up, the Effective Parent Program group reported greater increases in the use of emotion management strategies during parent-child interactions, with small to medium effect size, and lower negative affect and greater positive affect, subjective happiness, satisfaction with the parent-child relationship, and family harmony, compared to the control group, with small to medium effect size. Our results provided evidence of effectiveness for a sustainable, preventive, culturally appropriate, cognitive behaviorally-based emotion management program, in a non-clinical setting for Chinese mothers. HKCTR-1190. Copyright © 2015 Elsevier Ltd. All rights reserved.

A Mixed-Methods, Randomized, Controlled Feasibility Trial to Inform the Design of a Phase III Trial to Test the Effect of the Handheld Fan on Physical Activity and Carer Anxiety in Patients With Refractory Breathlessness.

PubMed

Johnson, Miriam J; Booth, Sara; Currow, David C; Lam, Lawrence T; Phillips, Jane L

2016-05-01

The handheld fan is an inexpensive and safe way to provide facial airflow, which may reduce the sensation of chronic refractory breathlessness, a frequently encountered symptom. To test the feasibility of developing an adequately powered, multicenter, multinational randomized controlled trial comparing the efficacy of a handheld fan and exercise advice with advice alone in increasing activity in people with chronic refractory breathlessness from a variety of medical conditions, measuring recruitment rates; data quality; and potential primary outcome measures. This was a Phase II, multisite, international, parallel, nonblinded, mixed-methods randomized controlled trial. Participants were centrally randomized to fan or control. All received breathlessness self-management/exercise advice and were followed up weekly for four weeks. Participants/carers were invited to participate in a semistructured interview at the study's conclusion. Ninety-seven people were screened, 49 randomized (mean age 68 years; 49% men), and 43 completed the study. Site recruitment varied from 0.25 to 3.3/month and screening:randomization from 1.1:1 to 8.5:1. There were few missing data except for the Chronic Obstructive Pulmonary Disease Self-Efficacy Scale (two-thirds of data missing). No harms were observed. Three interview themes included 1) a fan is a helpful self-management strategy, 2) a fan aids recovery, and 3) a symptom control trial was welcome. A definitive, multisite trial to study the use of the handheld fan as part of self-management of chronic refractory breathlessness is feasible. Participants found the fan useful. However, the value of information for changing practice or policy is unlikely to justify the expense of such a trial, given perceived benefits, the minimal costs, and an absence of harms demonstrated in this study. Copyright © 2016 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Development of an e-supported illness management and recovery programme for consumers with severe mental illness using intervention mapping, and design of an early cluster randomized controlled trial.

PubMed

Beentjes, Titus A A; van Gaal, Betsie G I; Goossens, Peter J J; Schoonhoven, Lisette

2016-01-19

E-mental health is a promising medium to keep mental health affordable and accessible. For consumers with severe mental illness the evidence of the effectiveness of e-health is limited. A number of difficulties and barriers have to be addressed concerning e-health for consumers with severe mental illness. One possible solution might be to blend e-health with face-to-face delivery of a recovery-oriented treatment, like the Illness Management & Recovery (IMR) programme. This paper describes the development of an e-health application for the IMR programme and the design of an early clustered randomized controlled trial. We developed the e-IMR intervention according to the six-step protocol of Intervention Mapping. Consumers joined the development group to address important and relevant issues for the target group. Decisions during the six-step development process were based on qualitative evaluations of the Illness Management & Recovery programme, structured interviews, discussion in the development group, and literature reviews on qualitative papers concerning consumers with severe mental illness, theoretical models, behavioural change techniques, and telemedicine for consumers with severe mental illness. The aim of the e-IMR intervention is to help consumers with severe mental illness to involve others, manage achieving goals, and prevent relapse. The e-IMR intervention consists of face-to-face delivery of the Illness Management & Recovery programme and an e-health application containing peer-testimonials on videos, follow up on goals and coping strategies, monitoring symptoms, solving problems, and communication opportunities. We designed an early cluster randomized controlled trial that will evaluate the e-IMR intervention. In the control condition the Illness Management & Recovery programme is provided. The main effect-study parameters are: illness management, recovery, psychiatric symptoms severity, self-management, quality of life, and general health. The process of the IMR program will be evaluated on fidelity and feasibility in semi-structured interviews with participants and trainers. Intervention Mapping provided a systematic procedure for the development of this e-health intervention for consumers with severe mental illness and the preparation of an early randomized controlled trial. The trial is registered in the Dutch Trial Register: NTR4772 .

Effects of self-management health information technology on glycaemic control for patients with diabetes: a meta-analysis of randomized controlled trials.

PubMed

Tao, Da; Or, Calvin Kl

2013-04-01

We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) which had evaluated self-management health information technology (SMHIT) for glycaemic control in patients with diabetes. A total of 43 RCTs was identified, which reported on 52 control-intervention comparisons. The glycosylated haemoglobin (HbA 1c ) data were pooled using a random effects meta-analysis method, followed by a meta-regression and subgroup analyses to examine the effects of a set of moderators. The meta-analysis showed that use of SMHITs was associated with a significant reduction in HbA 1c compared to usual care, with a pooled standardized mean difference of -0.30% (95% CI -0.39 to -0.21, P < 0.001). Sample size, age, study setting, type of application and method of data entry significantly moderated the effects of SMHIT use. The review supports the use of SMHITs as a self-management approach to improve glycaemic control. The effect of SMHIT use is significantly greater when the technology is a web-based application, when a mechanism for patients' health data entry is provided (manual or automatic) and when the technology is operated in the home or without location restrictions. Integrating these variables into the design of SMHITs may augment the effectiveness of the interventions. © SAGE Publications Ltd, 2013.

Outcomes of a Telehealth Intervention for Homebound Older Adults with Heart or Chronic Respiratory Failure: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Gellis, Zvi D.; Kenaley, Bonnie; McGinty, Jean; Bardelli, Ellen; Davitt, Joan; Ten Have, Thomas

2012-01-01

Purpose: Telehealth care is emerging as a viable intervention model to treat complex chronic conditions, such as heart failure (HF) and chronic obstructive pulmonary disease (COPD), and to engage older adults in self-care disease management. Design and Methods: We report on a randomized controlled trial examining the impact of a multifaceted…

Randomized Clinical Trial of the Effectiveness of a Home-Based Advanced Practice Psychiatric Nurse Intervention: Outcomes for Individuals with Serious Mental Illness and HIV

PubMed Central

Hanrahan, Nancy P.; Wu, Evan; Kelly, Deena; Aiken, Linda H.; Blank, Michael B.

2011-01-01

Individuals with serious mental illness have greater risk for contracting HIV, multiple morbidities, and die 25 years younger than the general population. This high need and high cost subgroup face unique barriers to accessing required health care in the current health care system. The effectiveness of an advanced practice nurse model of care management was assessed in a four-year random controlled trial. Results are reported in this paper. In a four-year random controlled trial, a total of 238 community-dwelling individuals with HIV and serious mental illness (SMI) were randomly assigned to an intervention group (n=128) or to a control group (n=110). Over 12 months, the intervention group received care management from advanced practice psychiatric nurse, and the control group received usual care. The intervention group showed significant improvement in depression (P=.012) and the physical component of health-related quality of life (P=.03) from baseline to 12 months. The advanced practice psychiatric nurse intervention is a model of care that holds promise for a higher quality of care and outcomes for this vulnerable population. PMID:21935499

Theory-based self-management educational interventions on patients with type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials.

PubMed

Zhao, Fang-Fang; Suhonen, Riitta; Koskinen, Sanna; Leino-Kilpi, Helena

2017-04-01

To synthesize the effects of theory-based self-management educational interventions on patients with type 2 diabetes (T2DM) in randomized controlled trials. Type 2 diabetes is a common chronic disease causing complications that put a heavy burden on society and reduce the quality of life of patients. Good self-management of diabetes can prevent complications and improve the quality of life of T2DM patients. Systematic review with meta-analysis of randomized controlled trials following Cochrane methods. A literature search was carried out in the MEDLINE, EMBASE, CINAHL, PSYCINFO, and Web of Science databases (1980-April 2015). The risk of bias of these eligible studies was assessed independently by two authors using the Cochrane Collaboration's tool. The Publication bias of the main outcomes was examined. Statistical heterogeneity and random-effects model were used for meta-analysis. Twenty studies with 5802 participants met the inclusion criteria. The interventions in the studies were based on one or more theories which mostly belong to mid-range theories. The pooled main outcomes by random-effects model showed significant improvements in HbA1c, self-efficacy, and diabetes knowledge, but not in BMI. As for quality of life, no conclusions can be drawn as the pooled outcome became the opposite with reduced heterogeneity after one study was excluded. No significant publication bias was found in the main outcomes. To get theory-based interventions to produce more effects, the role of patients should be more involved and stronger and the education team should be trained beyond the primary preparation for the self-management education program. © 2016 John Wiley & Sons Ltd.

A randomised group comparison controlled trial of 'preschoolers with autism': a parent education and skills training intervention for young children with autistic disorder.

PubMed

Tonge, Bruce; Brereton, Avril; Kiomall, Melissa; Mackinnon, Andrew; Rinehart, Nicole J

2014-02-01

To determine the effect of parent education on adaptive behaviour, autism symptoms and cognitive/language skills of young children with autistic disorder. A randomised group comparison design involving a parent education and counselling intervention and a parent education and behaviour management intervention to control for parent skills training and a control sample. Two rural and two metropolitan regions were randomly allocated to intervention groups (n = 70) or control (n = 35). Parents from autism assessment services in the intervention regions were randomly allocated to parent education and behaviour management (n = 35) or parent education and counselling (n = 35). Parent education and behaviour management resulted in significant improvement in adaptive behaviour and autism symptoms at 6 months follow-up for children with greater delays in adaptive behaviour. Parent education and behaviour management was superior to parent education and counselling. We conclude that a 20-week parent education programme including skills training for parents of young children with autistic disorder provides significant improvements in child adaptive behaviour and symptoms of autism for low-functioning children.

The Role of Thoracic Medial Branch Blocks in Managing Chronic Mid and Upper Back Pain: A Randomized, Double-Blind, Active-Control Trial with a 2-Year Followup

PubMed Central

Manchikanti, Laxmaiah; Singh, Vijay; Falco, Frank J. E.; Cash, Kimberly A.; Pampati, Vidyasagar; Fellows, Bert

2012-01-01

Study Design. A randomized, double-blind, active-control trial. Objective. To determine the clinical effectiveness of therapeutic thoracic facet joint nerve blocks with or without steroids in managing chronic mid back and upper back pain. Summary of Background Data. The prevalence of thoracic facet joint pain has been established as 34% to 42%. Multiple therapeutic techniques utilized in managing chronic thoracic pain of facet joint origin include medial branch blocks, radiofrequency neurotomy, and intraarticular injections. Methods. This randomized double-blind active controlled trial was performed in 100 patients with 50 patients in each group who received medial branch blocks with local anesthetic alone or local anesthetic and steroids. Outcome measures included the numeric rating scale (NRS), Oswestry Disability Index (ODI), opioid intake, and work status, at baseline, 3, 6, 12, 18, and 24 months. Results. Significant improvement with significant pain relief and functional status improvement of 50% or more were observed in 80% of the patients in Group I and 84% of the patients in Group II at 2-year followup. Conclusions. Therapeutic medial branch blocks of thoracic facets with or without steroids may provide a management option for chronic function-limiting thoracic pain of facet joint origin. PMID:22851967

Comparing the effectiveness of the BPMAP (Blood Pressure Management Application) and usual care in self-management of primary hypertension and adherence to treatment in patients aged 30-60 years: study protocol for a randomized controlled trial.

PubMed

Ashoorkhani, Mahnaz; Bozorgi, Ali; Majdzadeh, Reza; Hosseini, Hamed; Yoonessi, Ali; Ramezankhani, Ali; Eftekhar, Hassan

2016-10-21

Hypertension is one of the most important and well-known risk factors for cardiovascular diseases. Unfortunately, in spite of effective treatments, adherence to the regular use of drugs and other nondrug treatments, such as lifestyle improvement, is often poor. This study evaluates the effectiveness of an educational, supportive intervention - in the form of a Blood Pressure Management Application (BPMAP) - on self-management in patients with primary hypertension on controlling the determinant factors of hypertension, and on adherence to treatment. A two-arm, parallel-design randomized controlled clinical trial will be conducted on 30 to 60 year-old patients with primary hypertension who are attending the Tehran Heart Center. One hundred and thirty-two (132) patients will be randomly assigned to the intervention and control (usual method) groups. The most important inclusion criteria are, having primary hypertension and being pharmacologically treated for it, and not having developed the complications of hypertension, such as myocardial infarction, cerebral stroke and cardiac insufficiency. The participants should be able to read Persian and be able to use the application. The most important outcomes of the study include adherence to treatment, weight control, and regular monitoring of blood pressure which are assessed in the primary assessment (baseline data questionnaire) and again at the 8 th and 24 th weeks. The intervention is a mobile application that has capabilities such as reminders and scientific and supportive information. This application has been programmed to reduce many of the nonadherence factors of hypertension treatment. Therefore, the findings may contribute to a rise in adherence to treatment. If proven to have an appropriate impact, it may be extended for use in the national hypertension control plan. This study was registered in the Iran Randomized Clinical Trial Center under the number IRCT2015111712211N2 on 1 January 2016.

Effectiveness of disease-management programs for improving diabetes care: a meta-analysis.

PubMed

Pimouguet, Clément; Le Goff, Mélanie; Thiébaut, Rodolphe; Dartigues, Jean François; Helmer, Catherine

2011-02-08

We conducted a meta-analysis of randomized controlled trials to assess the effectiveness of disease-management programs for improving glycemic control in adults with diabetes mellitus and to study which components of programs are associated with their effectiveness. We searched several databases for studies published up to December 2009. We included randomized controlled trials involving adults with type 1 or 2 diabetes that evaluated the effect of disease-management programs on glycated hemoglobin (hemoglobin A₁(C)) concentrations. We performed a meta-regression analysis to determine the effective components of the programs. We included 41 randomized controlled trials in our review. Across these trials, disease-management programs resulted in a significant reduction in hemoglobin A₁(C) levels (pooled standardized mean difference between intervention and control groups -0.38 [95% confidence interval -0.47 to -0.29], which corresponds to an absolute mean difference of 0.51%). The finding was robust in the sensitivity analyses based on quality assessment. Programs in which the disease manager was able to start or modify treatment with or without prior approval from the primary care physician resulted in a greater improvement in hemoglobin A₁(C) levels (standardized mean difference -0.60 v. -0.28 in trials with no approval to do so; p < 0.001). Programs with a moderate or high frequency of contact reported a significant reduction in hemoglobin A₁(C) levels compared with usual care; nevertheless, only programs with a high frequency of contact led to a significantly greater reduction compared with low-frequency contact programs (standardized mean difference -0.56 v. -0.30, p = 0.03). Disease-management programs had a clinically moderate but significant impact on hemoglobin A₁(C) levels among adults with diabetes. Effective components of programs were a high frequency of patient contact and the ability for disease managers to adjust treatment with or without prior physician approval.

Effectiveness of disease-management programs for improving diabetes care: a meta-analysis

PubMed Central

Pimouguet, Clément; Le Goff, Mélanie; Thiébaut, Rodolphe; Dartigues, Jean François; Helmer, Catherine

2011-01-01

Background We conducted a meta-analysis of randomized controlled trials to assess the effectiveness of disease-management programs for improving glycemic control in adults with diabetes mellitus and to study which components of programs are associated with their effectiveness. Methods We searched several databases for studies published up to December 2009. We included randomized controlled trials involving adults with type 1 or 2 diabetes that evaluated the effect of disease-management programs on glycated hemoglobin (hemoglobin A1C) concentrations. We performed a meta-regression analysis to determine the effective components of the programs. Results We included 41 randomized controlled trials in our review. Across these trials, disease-management programs resulted in a significant reduction in hemoglobin A1C levels (pooled standardized mean difference between intervention and control groups −0.38 [95% confidence interval −0.47 to −0.29], which corresponds to an absolute mean difference of 0.51%). The finding was robust in the sensitivity analyses based on quality assessment. Programs in which the disease manager was able to start or modify treatment with or without prior approval from the primary care physician resulted in a greater improvement in hemoglobin A1C levels (standardized mean difference −0.60 v. −0.28 in trials with no approval to do so; p < 0.001). Programs with a moderate or high frequency of contact reported a significant reduction in hemoglobin A1C levels compared with usual care; nevertheless, only programs with a high frequency of contact led to a significantly greater reduction compared with low-frequency contact programs (standardized mean difference −0.56 v. −0.30, p = 0.03). Interpretation Disease-management programs had a clinically moderate but significant impact on hemoglobin A1C levels among adults with diabetes. Effective components of programs were a high frequency of patient contact and the ability for disease managers to adjust treatment with or without prior physician approval. PMID:21149524

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

Design of a randomized, controlled, comparative-effectiveness trial testing a Family Model of Diabetes Self-Management Education (DSME) vs. Standard DSME for Marshallese in the United States.

PubMed

Kim Yeary, Karen Hye-Cheon; Long, Christopher R; Bursac, Zoran; McElfish, Pearl Anna

2017-06-01

Type 2 diabetes (T2D) is a significant public health problem, with U.S. Pacific Islander communities-such as the Marshallese-bearing a disproportionate burden. Using a community-based participatory approach (CBPR) that engages the strong family-based social infrastructure characteristic of Marshallese communities is a promising way to manage T2D. Led by a collaborative community-academic partnership, the Family Model of Diabetes Self-Management Education (DSME) aimed to change diabetes management behaviors to improve glycemic control in Marshallese adults with T2D by engaging the entire family. To test the Family Model of DSME, a randomized, controlled, comparative effectiveness trial with 240 primary participants was implemented. Half of the primary participants were randomly assigned to the Standard DSME and half were randomly assigned to the Family Model DSME. Both arms received ten hours of content comprised of 6-8 sessions delivered over a 6-8 week period. The Family Model DSME was a cultural adaptation of DSME, whereby the intervention focused on engaging family support for the primary participant with T2D. The Standard DSME was delivered to the primary participant in a community-based group format. Primary participants and participating family members were assessed at baseline and immediate post-intervention, and will also be assessed at 6 and 12 months. The Family Model of DSME aimed to improve glycemic control in Marshallese with T2D. The utilization of a CBPR approach that involves the local stakeholders and the engagement of the family-based social infrastructure of Marshallese communities increase potential for the intervention's success and sustainability.

Manage at work: a randomized, controlled trial of a self-management group intervention to overcome workplace challenges associated with chronic physical health conditions.

PubMed

Shaw, William S; Besen, Elyssa; Pransky, Glenn; Boot, Cécile R L; Nicholas, Michael K; McLellan, Robert K; Tveito, Torill H

2014-05-28

The percentage of older and chronically ill workers is increasing rapidly in the US and in many other countries, but few interventions are available to help employees overcome the workplace challenges of chronic pain and other physical health conditions. While most workers are eligible for job accommodation and disability compensation benefits, other workplace strategies might improve individual-level coping and problem solving to prevent work disability. In this study, we hypothesize that an employer-sponsored group intervention program employing self-management principles may improve worker engagement and reduce functional limitation associated with chronic disorders. In a randomized controlled trial (RCT), workers participating in an employer-sponsored self-management group intervention will be compared with a no-treatment (wait list) control condition. Volunteer employees (n = 300) will be recruited from five participating employers and randomly assigned to intervention or control. Participants in the intervention arm will attend facilitated group workshop sessions at work (10 hours total) to explore methods for improving comfort, adjusting work habits, communicating needs effectively, applying systematic problem solving, and dealing with negative thoughts and emotions about work. Work engagement and work limitation are the principal outcomes. Secondary outcomes include fatigue, job satisfaction, self-efficacy, turnover intention, sickness absence, and health care utilization. Measurements will be taken at baseline, 6-, and 12-month follow-up. A process evaluation will be performed alongside the randomized trial. This study will be most relevant for organizations and occupational settings where some degree of job flexibility, leeway, and decision-making autonomy can be afforded to affected workers. The study design will provide initial assessment of a novel workplace approach and to understand factors affecting its feasibility and effectiveness. Clinicaltrials.gov: NCT01978392 (Issued November 6, 2013).

Nurse Case Management and Housing Interventions Reduce Allergen Exposures: The Milwaukee Randomized Controlled Trial

PubMed Central

Breysse, Jill; Wendt, Jean; Dixon, Sherry; Murphy, Amy; Wilson, Jonathan; Meurer, John; Cohn, Jennifer; Jacobs, David E.

2011-01-01

Objective We examined the impact of a combination of home environmental interventions and nurse case management services on total settled dust loadings and on allergen concentrations in the homes of asthmatic children. Methods Using a randomized longitudinal controlled trial study design, we randomly assigned homes of asthmatic children in Milwaukee to either a control (n=64) or an intervention (n=57) group. Control group homes received a visual assessment, education, bed/pillow dust mite encasings, and treatment of lead-based paint hazards. The intervention group received these same services plus nurse case management that included tailored, individual asthma action plans, provision of minor home repairs, home cleaning using special vacuuming and wet washing, and integrated pest management. Dust vacuum samples were collected from measured surface areas of floors in the TV room, kitchen, and child's bedroom at baseline and at three-, six-, and 12-month follow-up visits. Dust loading (mass per surface area) is a means of measuring total dust and the total amount of allergen present. Results For the intervention group, geometric mean dust loadings declined significantly from baseline (39 milligrams per square foot [mg/ft2]) to post-intervention (11 mg/ft2) (p<0.001). Baseline dust loading, treatment group, visit, and season were significant predictors of follow-up dust loadings. Mean post-intervention dust loadings were 72% higher in the control group. The total amount of allergen in settled house dust declined significantly following the intervention because total dust loading declined; the concentration of allergens in settled dust did not change significantly. Conclusion The combination of nurse case management and home environmental interventions promotes collaboration between health and housing professionals and is effective in reducing exposures to allergens in settled dust. PMID:21563716

Wordless intervention for epilepsy in learning disabilities (WIELD): study protocol for a randomized controlled feasibility trial.

PubMed

Durand, Marie-Anne; Gates, Bob; Parkes, Georgina; Zia, Asif; Friedli, Karin; Barton, Garry; Ring, Howard; Oostendorp, Linda; Wellsted, David

2014-11-20

Epilepsy is the most common neurological problem that affects people with learning disabilities. The high seizure frequency, resistance to treatments, associated skills deficit and co-morbidities make the management of epilepsy particularly challenging for people with learning disabilities. The Books Beyond Words booklet for epilepsy uses images to help people with learning disabilities manage their condition and improve quality of life. Our aim is to conduct a randomized controlled feasibility trial exploring key methodological, design and acceptability issues, in order to subsequently undertake a large-scale randomized controlled trial of the Books Beyond Words booklet for epilepsy. We will use a two-arm, single-centre randomized controlled feasibility design, over a 20-month period, across five epilepsy clinics in Hertfordshire, United Kingdom. We will recruit 40 eligible adults with learning disabilities and a confirmed diagnosis of epilepsy and will randomize them to use either the Books Beyond Words booklet plus usual care (intervention group) or to receive routine information and services (control group). We will collect quantitative data about the number of eligible participants, number of recruited participants, demographic data, discontinuation rates, variability of the primary outcome measure (quality of life: Epilepsy and Learning Disabilities Quality of Life scale), seizure severity, seizure control, intervention's patterns of use, use of other epilepsy-related information, resource use and the EQ-5D-5L health questionnaire. We will also gather qualitative data about the feasibility and acceptability of the study procedures and the Books Beyond Words booklet. Ethical approval for this study was granted on 28 April 2014, by the Wales Research Ethics Committee 5. Recruitment began on 1 July 2014. The outcomes of this feasibility study will be used to inform the design and methodology of a definitive study, adequately powered to determine the impact of the Books Beyond Words intervention to improve the management of epilepsy in people with learning disabilities. http://ISRCTN80067039 (Date of ISRCTN assignation: 23 April 2014).

Pain Management After Outpatient Shoulder Arthroscopy: A Systematic Review of Randomized Controlled Trials.

PubMed

Warrender, William J; Syed, Usman Ali M; Hammoud, Sommer; Emper, William; Ciccotti, Michael G; Abboud, Joseph A; Freedman, Kevin B

2017-06-01

Effective postoperative pain management after shoulder arthroscopy is a critical component to recovery, rehabilitation, and patient satisfaction. This systematic review provides a comprehensive overview of level 1 and level 2 evidence regarding postoperative pain management for outpatient arthroscopic shoulder surgery. Systematic review. We performed a systematic review of the various modalities reported in the literature for postoperative pain control after outpatient shoulder arthroscopy and analyzed their outcomes. Analgesic regimens reviewed include regional nerve blocks/infusions, subacromial/intra-articular injections or infusions, cryotherapy, and oral medications. Only randomized control trials with level 1 or level 2 evidence that compared 2 or more pain management modalities or placebo were included. We excluded studies without objective measures to quantify postoperative pain within the first postoperative month, subjective pain scale measurements, or narcotic consumption as outcome measures. A combined total of 40 randomized control trials met our inclusion criteria. Of the 40 included studies, 15 examined nerve blocks, 4 studied oral medication regimens, 12 studied subacromial infusion, 8 compared multiple modalities, and 1 evaluated cryotherapy. Interscalene nerve blocks (ISBs) were found to be the most effective method to control postoperative pain after shoulder arthroscopy. Increasing concentrations, continuous infusions, and patient-controlled methods can be effective for more aggressively controlling pain. Dexamethasone, clonidine, intrabursal oxycodone, and magnesium have all been shown to successfully improve the duration and adequacy of ISBs when used as adjuvants. Oral pregabalin and etoricoxib administered preoperatively have evidence supporting decreased postoperative pain and increased patient satisfaction. On the basis of the evidence in this review, we recommend the use of ISBs as the most effective analgesic for outpatient arthroscopic shoulder surgery.

Effectiveness of multimodal pain management after bipolar hemiarthroplasty for hip fracture: a randomized, controlled study.

PubMed

Kang, Hyun; Ha, Yong-Chan; Kim, Jin-Yun; Woo, Young-Cheol; Lee, Jae-Sung; Jang, Eui-Chan

2013-02-20

Appropriate pain management affects outcome after hip fracture surgery. Although multimodal pain management is commonly used for pain control for patients undergoing elective surgery, few studies have evaluated its use in those undergoing hip fracture surgery. This prospective randomized study was designed to determine the clinical value of multimodal pain management with preemptive pain medication and intraoperative periarticular multimodal drug injections in patients undergoing bipolar hip hemiarthroplasty. Of eighty-two cognitively intact elderly patients about to undergo bipolar hemiarthroplasty after a hip fracture, forty-three were randomly assigned to receive preemptive pain medication and intraoperative periarticular injections (Group I) and thirty-nine were assigned to not receive preemptive medication and injections (Group II). These two groups were compared with regard to the pain level on postoperative days one, four, and seven; at discharge; and when they started walking and standing exercises. Total amounts of fentanyl used, the frequency of use of patient-controlled analgesia, patient satisfaction at discharge, and perioperative complications were recorded. Group I had a lower pain level than Group II on postoperative days one and four, but no intergroup difference in pain level was observed on postoperative day seven. The total amount of fentanyl used and the frequency of use of patient-controlled analgesia were also lower in Group I. Patient satisfaction at discharge was higher in Group I. No significant intergroup differences were found in the times until the patients walked or performed standing exercises or in the complications. Multimodal pain management provides additional pain relief until the fourth postoperative day, improves patient satisfaction at discharge, and reduces total narcotic consumption for postoperative pain management after hip hemiarthroplasty for hip fractures.

The Effects of a Cluster Randomized Controlled Workplace Intervention on Sleep and Work-Family Conflict Outcomes in an Extended Care Setting.

PubMed

Marino, Miguel; Killerby, Marie; Lee, Soomi; Klein, Laura Cousino; Moen, Phyllis; Olson, Ryan; Kossek, Ellen Ernst; King, Rosalind; Erickson, Leslie; Berkman, Lisa F; Buxton, Orfeu M

2016-12-01

To evaluate the effects of a workplace-based intervention on actigraphic and self-reported sleep outcomes in an extended care setting. Cluster randomized trial. Extended-care (nursing) facilities. US employees and managers at nursing homes. Nursing homes were randomly selected to intervention or control settings. The Work, Family and Health Study developed an intervention aimed at reducing work-family conflict within a 4-month work-family organizational change process. Employees participated in interactive sessions with facilitated discussions, role-playing, and games designed to increase control over work processes and work time. Managers completed training in family-supportive supervision. Primary actigraphic outcomes included: total sleep duration, wake after sleep onset, nighttime sleep, variation in nighttime sleep, nap duration, and number of naps. Secondary survey outcomes included work-to-family conflict, sleep insufficiency, insomnia symptoms and sleep quality. Measures were obtained at baseline, 6-months and 12-months post-intervention. A total of 1,522 employees and 184 managers provided survey data at baseline. Managers and employees in the intervention arm showed no significant difference in sleep outcomes over time compared to control participants. Sleep outcomes were not moderated by work-to-family conflict or presence of children in the household for managers or employees. Age significantly moderated an intervention effect on nighttime sleep among employees (p=0.040), where younger employees benefited more from the intervention. In the context of an extended-care nursing home workplace, the intervention did not significantly alter sleep outcomes in either managers or employees. Moderating effects of age were identified where younger employees' sleep outcomes benefited more from the intervention.

The Effects of a Cluster Randomized Controlled Workplace Intervention on Sleep and Work-Family Conflict Outcomes in an Extended Care Setting

PubMed Central

Marino, Miguel; Killerby, Marie; Lee, Soomi; Klein, Laura Cousino; Moen, Phyllis; Olson, Ryan; Kossek, Ellen Ernst; King, Rosalind; Erickson, Leslie; Berkman, Lisa F.; Buxton, Orfeu M.

2016-01-01

Objectives To evaluate the effects of a workplace-based intervention on actigraphic and self-reported sleep outcomes in an extended care setting. Design Cluster randomized trial. Setting Extended-care (nursing) facilities. Participants US employees and managers at nursing homes. Nursing homes were randomly selected to intervention or control settings. Intervention The Work, Family and Health Study developed an intervention aimed at reducing work-family conflict within a 4-month work-family organizational change process. Employees participated in interactive sessions with facilitated discussions, role-playing, and games designed to increase control over work processes and work time. Managers completed training in family-supportive supervision. Measurements Primary actigraphic outcomes included: total sleep duration, wake after sleep onset, nighttime sleep, variation in nighttime sleep, nap duration, and number of naps. Secondary survey outcomes included work-to-family conflict, sleep insufficiency, insomnia symptoms and sleep quality. Measures were obtained at baseline, 6-months and 12-months post-intervention. Results A total of 1,522 employees and 184 managers provided survey data at baseline. Managers and employees in the intervention arm showed no significant difference in sleep outcomes over time compared to control participants. Sleep outcomes were not moderated by work-to-family conflict or presence of children in the household for managers or employees. Age significantly moderated an intervention effect on nighttime sleep among employees (p=0.040), where younger employees benefited more from the intervention. Conclusion In the context of an extended-care nursing home workplace, the intervention did not significantly alter sleep outcomes in either managers or employees. Moderating effects of age were identified where younger employees’ sleep outcomes benefited more from the intervention. PMID:28239635

Design of a Randomized Placebo-Controlled Trial to Assess Dabigatran and Omeprazole in Patients with Myocardial Injury after Noncardiac Surgery (MANAGE).

PubMed

Duceppe, Emmanuelle; Yusuf, Salim; Tandon, Vikas; Rodseth, Reitze; Biccard, Bruce M; Xavier, Denis; Szczeklik, Wojciech; Meyhoff, Christian S; Franzosi, Maria Grazia; Vincent, Jessica; Srinathan, Sadeesh K; Parlow, Joel; Magloire, Patrick; Neary, John; Rao, Mangala; Chaudhry, Navneet K; Mayosi, Bongani; de Nadal, Miriam; Popova, Ekaterine; Villar, Juan Carlos; Botto, Fernando; Berwanger, Otavio; Guyatt, Gordon; Eikelboom, John W; Sessler, Daniel I; Kearon, Clive; Pettit, Shirley; Connolly, Stuart J; Sharma, Mukul; Bangdiwala, Shrikant I; Devereaux, P J

2018-03-01

Worldwide approximately 200 million adults undergo major surgery annually, of whom 8 million are estimated to suffer a myocardial injury after noncardiac surgery (MINS). There is currently no trial data informing the management of MINS. Antithrombotic agents such as direct oral anticoagulants might prevent major vascular complications in patients with MINS. The Management of Myocardial Injury After Noncardiac Surgery (MANAGE) trial is a large international blinded randomized controlled trial of dabigatran vs placebo in patients who suffered MINS. We used a partial factorial design to also determine the effect of omeprazole vs placebo in reducing upper gastrointestinal bleeding and complications. Both study drugs were initiated in eligible patients within 35 days of suffering MINS and continued for a maximum of 2 years. The primary outcome is a composite of major vascular complications for the dabigatran trial and a composite of upper gastrointestinal complications for the omeprazole trial. We present the rationale and design of the trial and baseline characteristics of enrolled patients. The trial randomized 1754 patients between January 2013 and July 2017. Patients' mean age was 69.9 years, 51.1% were male, 14.3% had a history of peripheral artery disease, 6.6% had a history of stroke or transient ischemic attack, 12.9% had a previous myocardial infarction, and 26.0% had diabetes. The diagnosis of MINS was on the basis of an isolated ischemic troponin elevation in 80.4% of participants. MANAGE is the first randomized controlled trial to evaluate a potential treatment of patients who suffered MINS. Copyright © 2018 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

Effectiveness of a Mobile Phone App for Adults That Uses Physical Activity as a Tool to Manage Cigarette Craving After Smoking Cessation: A Study Protocol for a Randomized Controlled Trial.

PubMed

Hassandra, Mary; Lintunen, Taru; Kettunen, Tarja; Vanhala, Mauno; Toivonen, Hanna-Mari; Kinnunen, Kimmo; Heikkinen, Risto

2015-10-22

Results from studies on the effects of exercise on smoking-related variables have provided strong evidence that physical activity acutely reduces cigarette cravings. Mobile technology may provide some valuable tools to move from explanatory randomized controlled trials to pragmatic randomized controlled trials by testing the acute effectiveness of exercise on quitters under real-life conditions. An mHealth app was developed to be used as a support tool for quitters to manage their cigarette cravings. The primary aim of this paper is to present the protocol of a study examining the effectiveness of the Physical over smoking app (Ph.o.S) by comparing the point prevalence abstinence rate of a group of users to a comparator group during a 6-month follow-up period. After initial Web-based screening, eligible participants are recruited to attend a smoking cessation program for 3 weeks to set a quit smoking date. Fifty participants who succeed in quitting will be randomly allocated to the comparator and experimental groups. Both groups will separately have 1 more counseling session on how to manage cravings. In this fourth session, the only difference in treatment between the groups is that the experimental group will have an extra 10-15 minutes of guidance on how to use the fully automated Ph.o.S app to manage cravings during the follow-up period. Data will be collected at baseline, as well as before and after the quit day, and follow-up Web-based measures will be collected for a period of 6 months. The primary efficacy outcome is the 7-day point prevalence abstinence rate, and secondary efficacy outcomes are number of relapses and cravings, self-efficacy of being aware of craving experience, self-efficacy in managing cravings, and power of control in managing cravings. Recruitment for this project commenced in December 2014, and proceeded until May 2015. Follow-up data collection has commenced and will be completed by the end of December 2015. If the Ph.o.S app is shown to be effective, the study will provide evidence for the use of the app as a support tool for people who are trying to manage cravings during smoking cessation programs. It is anticipated that the results of the study will provide knowledge of how physical activity affects cigarette craving in real-life situations and inform the development and delivery of relapse prevention in smoking cessation treatment. International Standard Randomized Controlled Trial Number (ISRCTN): ISRCTN55259451; http://www.controlled-trials.com/ISRCTN55259451 (Archived by WebCite at http://www.webcitation.org/6cKF2mzEI).

Systematic review of the effects of chronic disease management on quality-of-life in people with chronic obstructive pulmonary disease.

PubMed

Niesink, A; Trappenburg, J C A; de Weert-van Oene, G H; Lammers, J W J; Verheij, T J M; Schrijvers, A J P

2007-11-01

Chronic disease management for patients with chronic obstructive pulmonary disease (COPD) may improve quality, outcomes and access to care. To investigate effectiveness of chronic disease management programmes on the quality-of-life of people with COPD. Medline and Embase (1995-2005) were searched for relevant articles, and reference lists and abstracts were searched for controlled trials of chronic disease management programmes for patients with COPD. Quality-of-life was assessed as an outcome parameter. Two reviewers independently reviewed each paper for methodological quality and extracted the data. We found 10 randomized-controlled trials comparing chronic disease management with routine care. Patient populations, health-care professionals, intensity, and content of the intervention were heterogeneous. Different instruments were used to assess quality of life. Five out of 10 studies showed statistically significant positive outcomes on one or more domains of the quality of life instruments. Three studies, partly located in primary care, showed positive results. All chronic disease management projects for people with COPD involving primary care improved quality of life. In most of the studies, aspects of chronic disease management were applied to a limited extent. Quality of randomized-controlled trials was not optimal. More research is needed on chronic disease management programmes in patients with COPD across primary and secondary care.

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.

A randomized controlled trial of ethyl glucuronide-based contingency management for outpatients with co-occurring alcohol use disorders and serious mental illness

PubMed Central

McDonell, Michael G.; Leickly, Emily; McPherson, Sterling; Skalisky, Jordan; Srebnik, Debra; Angelo, Frank; Vilardaga, Roger; Nepom, Jenny R.; Roll, John M.; Ries, Richard K.

2017-01-01

Objective To determine if a contingency management intervention using the ethyl glucuronide (EtG) alcohol biomarker resulted in increased alcohol abstinence in outpatients with co-occurring serious mental illnesses. Secondary objectives were to determine if contingency management was associated with changes in heavy drinking, treatment attendance, drug use, cigarette smoking, psychiatric symptoms, and HIV-risk behavior. Method Seventy-nine (37% female, 44% non-white) outpatients with serious mental illness and alcohol dependence receiving treatment as usual completed a 4-week observation period and were randomized to 12-weeks of contingency management for EtG-negative urine samples and addiction treatment attendance, or reinforcement only for study participation. Contingency management included the variable magnitude of reinforcement “prize draw” procedure contingent on EtG-negative samples (<150 ng/mL) three times a week and weekly gift cards for outpatient treatment attendance. Urine EtG, drug test, and self-report outcomes were assessed during the 12-week intervention and 3-month follow-up periods. Results Contingency management participants were 3.1 times (95% CI: 2.2, 4.5) more likely to submit an EtG-negative urine test during the 12-week intervention period, attaining nearly 1.5 weeks of additional abstinence relative to controls. Contingency management participants had significantly lower mean EtG levels, reported less drinking and fewer heavy drinking episodes, and were more likely to submit stimulant-negative urine and smoking-negative breath samples, relative to controls. Differences in self-reported alcohol use were maintained at the 3-month follow-up. Conclusions This is the first randomized trial utilizing an accurate and validated biomarker (EtG) to demonstrate the efficacy of contingency management for alcohol dependence in outpatients with serious mental illness. PMID:28135843

A Randomized Controlled Trial of Ethyl Glucuronide-Based Contingency Management for Outpatients With Co-Occurring Alcohol Use Disorders and Serious Mental Illness.

PubMed

McDonell, Michael G; Leickly, Emily; McPherson, Sterling; Skalisky, Jordan; Srebnik, Debra; Angelo, Frank; Vilardaga, Roger; Nepom, Jenny R; Roll, John M; Ries, Richard K

2017-04-01

The authors examined whether a contingency management intervention using the ethyl glucuronide (EtG) alcohol biomarker resulted in increased alcohol abstinence in outpatients with co-occurring serious mental illnesses. Secondary objectives were to determine whether contingency management was associated with changes in heavy drinking, treatment attendance, drug use, cigarette smoking, psychiatric symptoms, and HIV-risk behavior. Seventy-nine (37% female, 44% nonwhite) outpatients with serious mental illness and alcohol dependence receiving treatment as usual completed a 4-week observation period and were randomly assigned to 12 weeks of contingency management for EtG-negative urine samples and addiction treatment attendance, or reinforcement only for study participation. Contingency management included the variable magnitude of reinforcement "prize draw" procedure contingent on EtG-negative samples (<150 ng/mL) three times a week and weekly gift cards for outpatient treatment attendance. Urine EtG, drug test, and self-report outcomes were assessed during the 12-week intervention and 3-month follow-up periods. Contingency management participants were 3.1 times (95% CI=2.2-4.5) more likely to submit an EtG-negative urine test during the 12-week intervention period, attaining nearly 1.5 weeks of additional alcohol abstinence compared with controls. Contingency management participants had significantly lower mean EtG levels, reported less drinking and fewer heavy drinking episodes, and were more likely to submit stimulant-negative urine and smoking-negative breath samples, compared with controls. Differences in self-reported alcohol use were maintained at the 3-month follow-up. This is the first randomized trial utilizing an accurate and validated biomarker (EtG) to demonstrate the efficacy of contingency management for alcohol dependence in outpatients with serious mental illness.

Current Evidence on Auricular Therapy for Chemotherapy-Induced Nausea and Vomiting in Cancer Patients: A Systematic Review of Randomized Controlled Trials

PubMed Central

Molassiotis, Alexander; Wang, Tao; Suen, Lorna K. P.

2014-01-01

Auricular therapy (AT) has been historically viewed as a convenient approach adjunct to pharmacological therapy for cancer patients with chemotherapy-induced nausea and vomiting (CINV). The aim of this study was to assess the evidence of the therapeutic effect of AT for CINV management in cancer patients. Relevant randomized controlled trials were retrieved from 12 electronic databases without language restrictions. Meanwhile, manual search was conducted for Chinese journals on complementary medicine published within the last five years, and the reference lists of included studies were also checked to identify any possible eligible studies. Twenty-one studies with 1713 participants were included. The effect rate of AT for managing acute CINV ranged from 44.44% to 93.33% in the intervention groups and 15% to 91.67% in the control groups. For delayed CINV, it was 62.96% to 100% and 25% to 100%, respectively. AT seems to be a promising approach in managing CINV. However, the level of evidence was low and the definite effect cannot be concluded as there were significant methodological flaws identified in the analyzed studies. The implications drawn from the 21 studies put some clues for future practice in this area including the need to conduct more rigorously designed randomized controlled trials. PMID:25525445

Effects on Parental Mental Health of an Education and Skills Training Program for Parents of Young Children with Autism: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Tonge, Bruce; Brereton, Avril; Kiomall, Melissa; MacKinnon, Andrew; King, Neville; Rinehart, Nicole

2006-01-01

Objective: To determine the impact of a parent education and behavior management intervention (PEBM) on the mental health and adjustment of parents with preschool children with autism. Method: A randomized, group-comparison design involving a parent education and counseling intervention to control for nonspecific therapist effects and a control…

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.

The Effectiveness of Cognitive Behavioral Therapy versus Psychoeducation in the Management of Depression among Patients Undergoing Haemodialysis.

PubMed

Al Saraireh, Faris A; Aloush, Sami M; Al Azzam, Manar; Al Bashtawy, Mohammed

2018-01-25

The aim of this randomized controlled trial was to compare the effectiveness of psychoeducation versus cognitive behavioral therapy (CBT) in the management of depression among renal dialysis patients. A sample of 130 dialysis patients participated in the study and they were assigned at random to one of two therapies: psychoeducation (N = 65) or CBT (N = 65). Hamilton depression rating scale was completed by the participants in both groups prior to the therapies and after completion. Both therapies were effective in the management of depression, although psychoeducation was superior. Psychoeducation is recommended over CBT in the management of depression among renal dialysis patients.

Effectiveness and cost-effectiveness of a group-based pain self-management intervention for patients undergoing total hip replacement: feasibility study for a randomized controlled trial.

PubMed

Wylde, Vikki; Marques, Elsa; Artz, Neil; Blom, Ashley; Gooberman-Hill, Rachael

2014-05-20

Total hip replacement (THR) is a common elective surgical procedure and can be effective for reducing chronic pain. However, waiting times can be considerable. A pain self-management intervention may provide patients with skills to more effectively manage their pain and its impact during their wait for surgery. This study aimed to evaluate the feasibility of conducting a randomized controlled trial to assess the effectiveness and cost-effectiveness of a group-based pain self-management course for patients undergoing THR. Patients listed for a THR at one orthopedic center were posted a study invitation pack. Participants were randomized to attend a pain self-management course plus standard care or standard care only. The lay-led course was delivered by Arthritis Care and consisted of two half-day sessions prior to surgery and one full-day session after surgery. Participants provided outcome and resource-use data using a diary and postal questionnaires prior to surgery and one month, three months and six months after surgery. Brief telephone interviews were conducted with non-participants to explore barriers to participation. Invitations were sent to 385 eligible patients and 88 patients (23%) consented to participate. Interviews with 57 non-participants revealed the most common reasons for non-participation were views about the course and transport difficulties. Of the 43 patients randomized to the intervention group, 28 attended the pre-operative pain self-management sessions and 11 attended the post-operative sessions. Participant satisfaction with the course was high, and feedback highlighted that patients enjoyed the group format. Retention of participants was acceptable (83% of recruited patients completed follow-up) and questionnaire return rates were high (72% to 93%), with the exception of the pre-operative resource-use diary (35% return rate). Resource-use completion rates allowed for an economic evaluation from the health and social care payer perspective. This study highlights the importance of feasibility work prior to a randomized controlled trial to assess recruitment methods and rates, barriers to participation, logistics of scheduling group-based interventions, acceptability of the intervention and piloting resource use questionnaires to improve data available for economic evaluations. This information is of value to researchers and funders in the design and commissioning of future research. Current Controlled Trials ISRCTN52305381.

Total Quality Management Guide. Volume 2. A Guide to Implementation

DTIC Science & Technology

1990-02-15

Kaoru . Guide to Quality Control. Asian Productivity Organization. 1984. Ishikawa , Kaoru . What is Total Quality Control? The Japanese Way. Englewood...of the new Systems Age. The theories of Deming, Juran, Ishikawa , and other management methods that still predominate are pioneers of Systems Age...Feigenbaum, Armand V. Total Quality Control. New York: McGraw-Hill Book Company. 1983. bnai, Masaaki. Kaizen. New York: Random House. 1986. Ishikawa

Comprehensive, Individualized, Person-Centered Management of Community-Residing Persons with Moderate-to-Severe Alzheimer Disease: A Randomized Controlled Trial.

PubMed

Reisberg, Barry; Shao, Yongzhao; Golomb, James; Monteiro, Isabel; Torossian, Carol; Boksay, Istvan; Shulman, Melanie; Heller, Sloane; Zhu, Zhaoyin; Atif, Ayesha; Sidhu, Jaskirat; Vedvyas, Alok; Kenowsky, Sunnie

2017-01-01

The aim was to examine added benefits of a Comprehensive, Individualized, Person-Centered Management (CI-PCM) program to memantine treatment. This was a 28-week, clinician-blinded, randomized, controlled, parallel-group study, with a similar study population, similar eligibility criteria, and a similar design to the memantine pivotal trial of Reisberg et al. [N Engl J Med 2003;348:1333-1341]. Twenty eligible community-residing Alzheimer disease (AD) subject-caregiver dyads were randomized to the CI-PCM program (n = 10) or to usual community care (n = 10). Primary outcomes were the New York University Clinician's Interview-Based Impression of Change Plus Caregiver Input (NYU-CIBIC-Plus), assessed by one clinician set, and an activities of daily living inventory, assessed by a separate clinician set at baseline and at weeks 4, 12, and 28. Primary outcomes showed significant benefits of the CI-PCM program at all post-baseline evaluations. Improvement on the NYU-CIBIC-Plus in the management group at 28 weeks was 2.9 points over the comparator group. The memantine 2003 trial showed an improvement of 0.3 points on this global measure in memantine-treated versus placebo-randomized subjects at 28 weeks. Hence, globally, the management program intervention benefits were 967% greater than memantine treatment alone. These results are approximately 10 times those usually observed with both nonpharmacological and pharmacological treatments and indicate substantial benefits with the management program for advanced AD persons. © 2017 S. Karger AG, Basel.

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

Advisor-Teller Money Manager (ATM) therapy for substance use disorders.

PubMed

Rosen, Marc I; Rounsaville, Bruce J; Ablondi, Karen; Black, Anne C; Rosenheck, Robert A

2010-07-01

Patients with concomitant psychiatric and substance use disorders are commonly assigned representative payees or case managers to help manage their funds, but money management has not been conceptualized as a theory-based treatment. This randomized clinical trial was conducted to determine the effect of a money management-based therapy, advisor-teller money manager (ATM), on substance abuse or dependence. Ninety patients at a community mental health center who had a history of cocaine or alcohol abuse or dependence were assessed after random assignment to 36 weeks of ATM (N=47) or a control condition in which use of a financial workbook was reviewed (N=43). Patients assigned to ATM were encouraged to deposit their funds into a third-party account, plan weekly expenditures, and negotiate monthly budgets. Substance use calendars and urine toxicology tests were collected every other week for 36 weeks and again 52 weeks after randomization. Patients assigned to ATM had significantly more negative toxicologies for cocaine metabolite over time than patients in the control group, and treating clinicians rated ATM patients as significantly more likely to be abstinent from illicit drugs. Self-reported abstinence from alcohol did not significantly differ between groups. Unexpectedly, patients assigned to ATM were more likely to be assigned a representative payee or a conservator than control participants during the follow-up period (ten of 47 versus two of 43). One patient in ATM assaulted the therapist when his check had not arrived. ATM is an efficacious therapy for the treatment of cocaine abuse or dependence among people with concomitant psychiatric illness but requires protection of patient autonomy and staff safety.

Effectiveness of a mood management component as an adjunct to a telephone counselling smoking cessation intervention for smokers with a past major depression: a pragmatic randomized controlled trial.

PubMed

van der Meer, Regina M; Willemsen, Marc C; Smit, Filip; Cuijpers, Pim; Schippers, Gerard M

2010-11-01

To assess whether the addition of a mood management component to telephone counselling produces higher abstinence rates in smokers with past major depression and helps to prevent recurrence of depressive symptoms. Pragmatic randomized controlled trial with two conditions, with follow-up at 6 and 12 months. The control intervention consisted of eight sessions of proactive telephone counselling. The mood management intervention was an integration of the control intervention with a mood management component. This component consisted of a self-help mood management manual, two more preparatory proactive telephone counselling sessions and supplementary homework assignments and advice. Dutch national smoking cessation quitline. A total of 485 daily smokers with past major depression, according to the DSM-IV. The primary outcome measure was prolonged abstinence and secondary outcome measures were 7-day point prevalence abstinence and depressive symptoms. The mood management intervention resulted in significantly higher prolonged abstinence rates at 6- and 12-month follow-up (30.5% and 23.9% in experimental condition, 22.3% and 14.0% in the control condition). The odds ratios were 1.60 (95% CI 1.06-2.42) and 1.96 (95% CI 1.22-3.14) for both follow-ups. The mood management intervention did not seem to prevent recurrence of depressive symptoms. Adding a mood management component to telephone counselling for smoking cessation in smokers with a past major depression increases cessation rates without necessarily reducing depressive symptoms. © 2010 The Authors, Addiction © 2010 Society for the Study of Addiction.

Debate Regarding Oseltamivir Use for Seasonal and Pandemic Influenza

PubMed Central

Kelly, Heath

2016-01-01

A debate about the market-leading influenza antiviral medication, oseltamivir, which initially focused on treatment for generally mild illness, has been expanded to question the wisdom of stockpiling for use in future influenza pandemics. Although randomized controlled trial evidence confirms that oseltamivir will reduce symptom duration by 17–25 hours among otherwise healthy adolescents and adults with community-managed disease, no randomized controlled trials have examined the effectiveness of oseltamivir against more serious outcomes. Observational studies, although criticized on methodologic grounds, suggest that oseltamivir given early can reduce the risk for death by half among persons hospitalized with confirmed infection caused by influenza A(H1N1)pdm09 and influenza A(H5N1) viruses. However, available randomized controlled trial data may not be able to capture the effect of oseltamivir use among hospitalized patients with severe disease. We assert that data on outpatients with relatively mild disease should not form the basis for policies on the management of more severe disease. PMID:27191818

The Effects of the Bali Yoga Program for Breast Cancer Patients on Chemotherapy-Induced Nausea and Vomiting: Results of a Partially Randomized and Blinded Controlled Trial.

PubMed

Anestin, Annélie S; Dupuis, Gilles; Lanctôt, Dominique; Bali, Madan

2017-10-01

Complementary and alternative medicine has been shown to be beneficial in reducing chemotherapy-induced nausea and vomiting. However, conclusive results are lacking in order to confirm its usefulness. The purpose of this study was to determine whether a standardized yoga intervention could reduce these adverse symptoms. This was a partially randomized and blinded controlled trial comparing a standardized yoga intervention with standard care. Eligible patients were adults diagnosed with stages I to III breast cancer receiving chemotherapy. Patients randomized to the experimental group participated in an 8-week yoga program. There was no significant difference between the experimental and control groups on chemotherapy-induced nausea and vomiting after 8 weeks. Results suggest the yoga program is not beneficial in managing these adverse symptoms. However, considering preliminary evidence suggesting yoga's beneficial impact in cancer symptom management, methodological limitations should be explored and additional studies should be conducted.

Home-based interventions for black patients with uncontrolled hypertension: a cluster randomized controlled trial

PubMed Central

Feldman, Penny H; McDonald, Margaret V; Barrón, Yolanda; Gerber, Linda M; Peng, Timothy R

2016-01-01

Aim: Assess the comparative effectiveness of two blood pressure (BP) control interventions for black patients with uncontrolled hypertension. Patients & methods: A total of 845 patients were enrolled in a three-arm cluster randomized trial. On admission of an eligible patient, field nurses were randomized to usual care, a basic or augmented intervention. Results: Across study arms there were no significant 12 months differences in BP control rates (primary outcome) (25% usual care, 26% basic intervention, 22% augmented intervention); systolic BP (143.8 millimeters of mercury [mmHg], 146.9 mmHG, 143.9 mmHG, respectively); medication intensification (47, 43, 54%, respectively); or self-management score (18.7, 18.7, 17.9, respectively). Adjusted systolic BP dropped more than 10 mmHg from baseline to 12 months (155.5–145.4 mmHg) among all study participants. Conclusion: Neither the augmented nor basic intervention was more effective than usual care in improving BP control, systolic BP, medication intensification or patient self-management. Usual home care yielded substantial improvements, creating a high comparative effectiveness threshold. Clinical Trial Registration: NCT00139490. PMID:26946952

Assessing the effect of culturally specific audiovisual educational interventions on attaining self-management skills for chronic obstructive pulmonary disease in Mandarin- and Cantonese-speaking patients: a randomized controlled trial.

PubMed

Poureslami, Iraj; Kwan, Susan; Lam, Stephen; Khan, Nadia A; FitzGerald, John Mark

2016-01-01

Patient education is a key component in the management of chronic obstructive pulmonary disease (COPD). Delivering effective education to ethnic groups with COPD is a challenge. The objective of this study was to develop and assess the effectiveness of culturally and linguistically specific audiovisual educational materials in supporting self-management practices in Mandarin- and Cantonese-speaking patients. Educational materials were developed using participatory approach (patients involved in the development and pilot test of educational materials), followed by a randomized controlled trial that assigned 91 patients to three intervention groups with audiovisual educational interventions and one control group (pamphlet). The patients were recruited from outpatient clinics. The primary outcomes were improved inhaler technique and perceived self-efficacy to manage COPD. The secondary outcome was improved patient understanding of pulmonary rehabilitation procedures. Subjects in all three intervention groups, compared with control subjects, demonstrated postintervention improvements in inhaler technique (P<0.001), preparedness to manage a COPD exacerbation (P<0.01), ability to achieve goals in managing COPD (P<0.01), and understanding pulmonary rehabilitation procedures (P<0.05). Culturally appropriate educational interventions designed specifically to meet the needs of Mandarin and Cantonese COPD patients are associated with significantly better understanding of self-management practices. Self-management education led to improved proper use of medications, ability to manage COPD exacerbations, and ability to achieve goals in managing COPD. A relatively simple culturally appropriate disease management education intervention improved inhaler techniques and self-management practices. Further research is needed to assess the effectiveness of self-management education on behavioral change and patient empowerment strategies.

Assessing the effect of culturally specific audiovisual educational interventions on attaining self-management skills for chronic obstructive pulmonary disease in Mandarin- and Cantonese-speaking patients: a randomized controlled trial

PubMed Central

Poureslami, Iraj; Kwan, Susan; Lam, Stephen; Khan, Nadia A; FitzGerald, John Mark

2016-01-01

Background Patient education is a key component in the management of chronic obstructive pulmonary disease (COPD). Delivering effective education to ethnic groups with COPD is a challenge. The objective of this study was to develop and assess the effectiveness of culturally and linguistically specific audiovisual educational materials in supporting self-management practices in Mandarin- and Cantonese-speaking patients. Methods Educational materials were developed using participatory approach (patients involved in the development and pilot test of educational materials), followed by a randomized controlled trial that assigned 91 patients to three intervention groups with audiovisual educational interventions and one control group (pamphlet). The patients were recruited from outpatient clinics. The primary outcomes were improved inhaler technique and perceived self-efficacy to manage COPD. The secondary outcome was improved patient understanding of pulmonary rehabilitation procedures. Results Subjects in all three intervention groups, compared with control subjects, demonstrated postintervention improvements in inhaler technique (P<0.001), preparedness to manage a COPD exacerbation (P<0.01), ability to achieve goals in managing COPD (P<0.01), and understanding pulmonary rehabilitation procedures (P<0.05). Conclusion Culturally appropriate educational interventions designed specifically to meet the needs of Mandarin and Cantonese COPD patients are associated with significantly better understanding of self-management practices. Self-management education led to improved proper use of medications, ability to manage COPD exacerbations, and ability to achieve goals in managing COPD. Clinical implication A relatively simple culturally appropriate disease management education intervention improved inhaler techniques and self-management practices. Further research is needed to assess the effectiveness of self-management education on behavioral change and patient empowerment strategies. PMID:27536093

Does telemedicine improve treatment outcomes for diabetes? A meta-analysis of results from 55 randomized controlled trials.

PubMed

Su, Dejun; Zhou, Junmin; Kelley, Megan S; Michaud, Tzeyu L; Siahpush, Mohammad; Kim, Jungyoon; Wilson, Fernando; Stimpson, Jim P; Pagán, José A

2016-06-01

To assess the overall effect of telemedicine on diabetes management and to identify features of telemedicine interventions that are associated with better diabetes management outcomes. Hedges's g was estimated as the summary measure of mean difference in HbA1c between patients with diabetes who went through telemedicine care and those who went through conventional, non-telemedicine care using a random-effects model. Q statistics were calculated to assess if the effect of telemedicine on diabetes management differs by types of diabetes, age groups of patients, duration of intervention, and primary telemedicine approaches used. The analysis included 55 randomized controlled trials with a total of 9258 patients with diabetes, out of which 4607 were randomized to telemedicine groups and 4651 to conventional, non-telemedicine care groups. The results favored telemedicine over conventional care (Hedges's g=-0.48, p<0.001) in diabetes management. The beneficial effect of telemedicine were more pronounced among patients with type 2 diabetes (Hedges's g=-0.63, p<0.001) than among those with type 1 diabetes (Hedges's g=-0.27, p=0.027) (Q=4.25, p=0.04). Compared to conventional care, telemedicine is more effective in improving treatment outcomes for diabetes patients, especially for those with type 2 diabetes. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Intensive gestational glycemic management and childhood obesity: a systematic review and meta-analysis.

PubMed

Guillemette, L; Durksen, A; Rabbani, R; Zarychanski, R; Abou-Setta, A M; Duhamel, T A; McGavock, J M; Wicklow, B

2017-07-01

Hyperglycemia in pregnancy is associated with increased risk of offspring childhood obesity. Treatment reduces macrosomia; however, it is unclear if this effect translates into a reduced risk of childhood obesity. We performed a systematic review and meta-analysis of randomized controlled trials to evaluate the efficacy and safety of intensive glycemic management in pregnancy in preventing childhood obesity. We searched MEDLINE, EMBASE, CENTRAL and ClinicalTrials.gov up to February 2016 and conference abstracts from 2010 to 2015. Two reviewers independently identified randomized controlled trials evaluating intensive glycemic management interventions for hyperglycemia in pregnancy and included four of the 383 citations initially identified. Two reviewers independently extracted study data and evaluated internal validity of the studies using the Cochrane Collaboration's Risk of Bias tool. Data were pooled using random-effects models. Statistical heterogeneity was quantified using the I 2 test. The primary outcome was age- and sex-adjusted childhood obesity. Secondary outcomes included childhood weight and waist circumference and maternal hypoglycemia during the trial (safety outcome). The four eligible trials (n=767 children) similarly used lifestyle and insulin to manage gestational hyperglycemia, but only two measured offspring obesity and waist circumference and could be pooled for these outcomes. We found no association between intensive gestational glucose management and childhood obesity at 7-10 years of age (relative risk 0.89, 95% confidence interval (CI) 0.65 to 1.22; two trials; n=568 children). Waist circumference also did not differ between treatment and control arms (mean difference, -2.68 cm; 95% CI, -8.17 to 2.81 cm; two trials; n=568 children). Intensive gestational glycemic management is not associated with reduced childhood obesity in offspring, but randomized data is scarce. Long-term follow-up of trials should be prioritized and comprehensive measures of childhood metabolic risk should be considered as outcomes in future trials.

Recruiting seniors with chronic low back pain for a randomized controlled trial of a self-management program.

PubMed

Groupp, Elyse; Haas, Mitchell; Fairweather, Alisa; Ganger, Bonnie; Attwood, Michael

2005-02-01

To identify recruitment challenges and elucidate specific strategies that enabled recruitment of seniors for a randomized trial on low back pain comparing the Chronic Disease Self-management Program of the Stanford University to a 6-month wait-list control group. Recruitment for a randomized controlled trial. Community-based program offered at 12 locations. Community-dwelling seniors 60 years and older with chronic low back pain of mechanical origin. Passive recruitment strategies included advertisement in local and senior newspapers, in senior e-mail newsletters and listservs, in local community centers and businesses. Active strategies included meeting seniors at health fairs, lectures to the public and organizational meetings, and the help of trusted professionals in the community. A total of 100 white and 20 African American seniors were recruited. The program seemed to have the most appeal to white, middle-class older adults, educated through high school level. Advertisement failed to attract any participants to the program. Successful strategies included interaction with seniors at health fairs and lectures on health care, especially when the program was endorsed by a trusted community professional. Generating interest in the self-management program required keen communication skills because the idea of "self-management" was met with a myriad of responses, ranging from disinterest to disbelief. Generating interest also required active participation within the communities. Initial contacts had to be established with trusted professionals, whose endorsement enabled the project managers to present the concept of self-management to the seniors. More complex recruitment strategies were required for this study involving the self-management approach to back pain than for studies involving treatment.

Evaluation of a self-management patient education program for patients with fibromyalgia syndrome: study protocol of a cluster randomized controlled trial.

PubMed

Musekamp, Gunda; Gerlich, Christian; Ehlebracht-König, Inge; Faller, Hermann; Reusch, Andrea

2016-02-03

Fibromyalgia syndrome (FMS) is a complex chronic condition that makes high demands on patients' self-management skills. Thus, patient education is considered an important component of multimodal therapy, although evidence regarding its effectiveness is scarce. The main objective of this study is to assess the effectiveness of an advanced self-management patient education program for patients with FMS as compared to usual care in the context of inpatient rehabilitation. We conducted a multicenter cluster randomized controlled trial in 3 rehabilitation clinics. Clusters are groups of patients with FMS consecutively recruited within one week after admission. Patients of the intervention group receive the advanced multidisciplinary self-management patient education program (considering new knowledge on FMS, with a focus on transfer into everyday life), whereas patients in the control group receive standard patient education programs including information on FMS and coping with pain. A total of 566 patients are assessed at admission, at discharge and after 6 and 12 months, using patient reported questionnaires. Primary outcomes are patients' disease- and treatment-specific knowledge at discharge and self-management skills after 6 months. Secondary outcomes include satisfaction, attitudes and coping competences, health-promoting behavior, psychological distress, health impairment and participation. Treatment effects between groups are evaluated using multilevel regression analysis adjusting for baseline values. The study evaluates the effectiveness of a self-management patient education program for patients with FMS in the context of inpatient rehabilitation in a cluster randomized trial. Study results will show whether self-management patient education is beneficial for this group of patients. German Clinical Trials Register, DRKS00008782 , Registered 8 July 2015.

Effect of a stress management program on subjects with neck pain: A pilot randomized controlled trial.

PubMed

Metikaridis, T Damianos; Hadjipavlou, Alexander; Artemiadis, Artemios; Chrousos, George; Darviri, Christina

2016-05-20

Studies have shown that stress is implicated in the cause of neck pain (NP). The purpose of this study is to examine the effect of a simple, zero cost stress management program on patients suffering from NP. This study is a parallel-type randomized clinical study. People suffering from chronic non-specific NP were chosen randomly to participate in an eight week duration program of stress management (N= 28) (including diaphragmatic breathing, progressive muscle relaxation) or in a no intervention control condition (N= 25). Self-report measures were used for the evaluation of various variables at the beginning and at the end of the eight-week monitoring period. Descriptive and inferential statistic methods were used for the statistical analysis. At the end of the monitoring period, the intervention group showed a statistically significant reduction of stress and anxiety (p= 0.03, p= 0.01), report of stress related symptoms (p= 0.003), percentage of disability due to NP (p= 0.000) and NP intensity (p= 0.002). At the same time, daily routine satisfaction levels were elevated (p= 0.019). No statistically significant difference was observed in cortisol measurements. Stress management has positive effects on NP patients.

Making Self-Help More Helpful: A Randomized Controlled Trial of the Impact of Augmenting Self-Help Materials with Implementation Intentions on Promoting the Effective Self-Management of Anxiety Symptoms

ERIC Educational Resources Information Center

Varley, Rachel; Webb, Thomas L.; Sheeran, Paschal

2011-01-01

Objective: The effectiveness of self-help materials may be constrained by failures to undertake recommended exercises or to deploy the techniques that one has learned at the critical moment. The present randomized controlled trial investigated whether augmenting self-help materials with if-then plans (or implementation intentions) could overcome…

Implementation and evaluation of the 5As framework of obesity management in primary care: design of the 5As Team (5AsT) randomized control trial

PubMed Central

2014-01-01

Background Obesity is a pressing public health concern, which frequently presents in primary care. With the explosive obesity epidemic, there is an urgent need to maximize effective management in primary care. The 5As of Obesity Management™ (5As) are a collection of knowledge tools developed by the Canadian Obesity Network. Low rates of obesity management visits in primary care suggest provider behaviour may be an important variable. The goal of the present study is to increase frequency and quality of obesity management in primary care using the 5As Team (5AsT) intervention to change provider behaviour. Methods/design The 5AsT trial is a theoretically informed, pragmatic randomized controlled trial with mixed methods evaluation. Clinic-based multidisciplinary teams (RN/NP, mental health, dietitians) will be randomized to control or the 5AsT intervention group, to participate in biweekly learning collaborative sessions supported by internal and external practice facilitation. The learning collaborative content addresses provider-identified barriers to effective obesity management in primary care. Evidence-based shared decision making tools will be co-developed and iteratively tested by practitioners. Evaluation will be informed by the RE-AIM framework. The primary outcome measure, to which participants are blinded, is number of weight management visits/full-time equivalent (FTE) position. Patient-level outcomes will also be assessed, through a longitudinal cohort study of patients from randomized practices. Patient outcomes include clinical (e.g., body mass index [BMI], blood pressure), health-related quality of life (SF-12, EQ5D), and satisfaction with care. Qualitative data collected from providers and patients will be evaluated using thematic analysis to understand the context, implementation and effectiveness of the 5AsT program. Discussion The 5AsT trial will provide a wide range of insights into current practices, knowledge gaps and barriers that limit obesity management in primary practice. The use of existing resources, collaborative design, practice facilitation, and integrated feedback loops cultivate an applicable, adaptable and sustainable approach to increasing the quantity and quality of weight management visits in primary care. Trial registration NCT01967797. PMID:24947045

Implementation and evaluation of the 5As framework of obesity management in primary care: design of the 5As Team (5AsT) randomized control trial.

PubMed

Campbell-Scherer, Denise L; Asselin, Jodie; Osunlana, Adedayo M; Fielding, Sheri; Anderson, Robin; Rueda-Clausen, Christian F; Johnson, Jeffrey A; Ogunleye, Ayodele A; Cave, Andrew; Manca, Donna; Sharma, Arya M

2014-06-19

Obesity is a pressing public health concern, which frequently presents in primary care. With the explosive obesity epidemic, there is an urgent need to maximize effective management in primary care. The 5As of Obesity Management™ (5As) are a collection of knowledge tools developed by the Canadian Obesity Network. Low rates of obesity management visits in primary care suggest provider behaviour may be an important variable. The goal of the present study is to increase frequency and quality of obesity management in primary care using the 5As Team (5AsT) intervention to change provider behaviour. The 5AsT trial is a theoretically informed, pragmatic randomized controlled trial with mixed methods evaluation. Clinic-based multidisciplinary teams (RN/NP, mental health, dietitians) will be randomized to control or the 5AsT intervention group, to participate in biweekly learning collaborative sessions supported by internal and external practice facilitation. The learning collaborative content addresses provider-identified barriers to effective obesity management in primary care. Evidence-based shared decision making tools will be co-developed and iteratively tested by practitioners. Evaluation will be informed by the RE-AIM framework. The primary outcome measure, to which participants are blinded, is number of weight management visits/full-time equivalent (FTE) position. Patient-level outcomes will also be assessed, through a longitudinal cohort study of patients from randomized practices. Patient outcomes include clinical (e.g., body mass index [BMI], blood pressure), health-related quality of life (SF-12, EQ5D), and satisfaction with care. Qualitative data collected from providers and patients will be evaluated using thematic analysis to understand the context, implementation and effectiveness of the 5AsT program. The 5AsT trial will provide a wide range of insights into current practices, knowledge gaps and barriers that limit obesity management in primary practice. The use of existing resources, collaborative design, practice facilitation, and integrated feedback loops cultivate an applicable, adaptable and sustainable approach to increasing the quantity and quality of weight management visits in primary care. NCT01967797.

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.

Randomized, Controlled Trial of CBT Training for PTSD Providers

DTIC Science & Technology

2013-10-01

Statistician and Co- Investigator), Michelle Pucillo, MPH (Project Manager ), Gayatri Ranganathan , MS (Statistician), Julia Coleman (Research Associate...Journal of Consulting and Clinical Psychology, 74, 898-907. Ruzek, J. I., Friedman, M. J., & Murray, S. (2005). Toward a knowledge management system...result in superior CBT skills than wait-list control. Secondary Aim #1: To compare improvements in knowledge and attitudes following internet- based

Group antenatal intervention to reduce perinatal stress and depressive symptoms related to intergenerational conflicts: a randomized controlled trial.

PubMed

Leung, Sharron S K; Lam, T H

2012-11-01

Intergenerational conflicts are a major source of stress, which might lead to depression in new mothers. The conflict is heightened when grandparents are involved in childcare. To examine the effectiveness of an interpersonal psychotherapy oriented group intervention to reduce stress and depressive symptoms in new mothers and enhance happiness and self-efficacy in managing intergenerational conflict in childcare. This study is one of the intervention projects of FAMILY: A Jockey Club Initiative for a Harmonious Society, funded by The Hong Kong Jockey Club Charities Trust. Multisite randomized controlled trial with two arms: an intervention group attended an additional 4-week program and a control group who received usual care only. Six Maternal and Child Health Centres in Hong Kong From September 2009 to January 2010, 156 pregnant women who would have grandparents involved in childcare were recruited at their 14-32 weeks' gestation. Participants were randomized to groups using computer generated random sequences by blinded recruitment staff. Primary outcomes were stress and depressive symptoms immediately after the intervention and 6-8 weeks after delivery. Secondary outcomes were happiness and self-efficacy in managing conflict. After screening 2870 pregnant women, 156 eligible participants were randomized. Intention-to-treat analysis showed that the intervention group (n=78) had significantly lower perceived stress (p=0.017; Cohen d=0.38) and greater happiness (p=0.004; Cohen d=0.41) than the control group (n=78) immediately after the intervention. However, the effects were not sustained at postnatal follow-up. Subgroup analysis showed that participants with depressive symptoms (EPDS>12) at baseline reported significantly lower stress, greater happiness (p=0.035 and 0.037, respectively; both Cohen d=0.61), greater self-efficacy in managing conflict (p=0.012; Cohen d=0.76) than the control group after the intervention. Also, after delivery, they had significantly greater self-efficacy in managing conflict (p=0.025; Cohen d=0.61) and more able to cooperate with grandparents in childcare (p=0.046; Cohen d=0.59) than the control group. The intervention was effective in reducing stress and enhancing happiness among new mothers, particularly those with higher EPDS scores. Postnatal follow-up contacts as booster interventions may be needed to achieve lasting effects of the intervention. Copyright © 2012 Elsevier Ltd. All rights reserved.

Peer Support for Achieving Independence in Diabetes (Peer-AID): design, methods and baseline characteristics of a randomized controlled trial of community health worker assisted diabetes self-management support.

PubMed

Nelson, Karin; Drain, Nathan; Robinson, June; Kapp, Janet; Hebert, Paul; Taylor, Leslie; Silverman, Julie; Kiefer, Meghan; Lessler, Dan; Krieger, James

2014-07-01

Community health workers (CHWs) may be an important mechanism to provide diabetes self-management to disadvantaged populations. We describe the design and baseline results of a trial evaluating a home-based CHW intervention. Peer Support for Achieving Independence in Diabetes (Peer-AID) is a randomized, controlled trial evaluating a home-based CHW-delivered diabetes self-management intervention versus usual care. The study recruited participants from 3 health systems. Change in A1c measured at 12 months is the primary outcome. Changes in blood pressure, lipids, health care utilization, health-related quality of life, self-efficacy and diabetes self-management behaviors at 12 months are secondary outcomes. A total of 1438 patients were identified by a medical record review as potentially eligible, 445 patients were screened by telephone for eligibility and 287 were randomized. Groups were comparable at baseline on socio-demographic and clinical characteristics. All participants were low-income and were from diverse racial and ethnic backgrounds. The mean A1c was 8.9%, mean BMI was above the obese range, and non-adherence to diabetes medications was high. The cohort had high rates of co-morbid disease and low self-reported health status. Although one-third reported no health insurance, the mean number of visits to a physician in the past year was 5.7. Trial results are pending. Peer-AID recruited and enrolled a diverse group of low income participants with poorly controlled type 2 diabetes and delivered a home-based diabetes self-management program. If effective, replication of the Peer-AID intervention in community based settings could contribute to improved control of diabetes in vulnerable populations. Published by Elsevier Inc.

A randomized controlled trial of a nurse-led case management programme for hospital-discharged older adults with co-morbidities

PubMed Central

Chow, Susan Ka Yee; Wong, Frances Kam Yuet

2014-01-01

Aim To examine the effects of a nurse-led case management programme for hospital-discharged older adults with co-morbidities. Background The most significant chronic conditions today involve diseases of the cardiovascular, respiratory, endocrine and renal systems. Previous studies have suggested that a nurse-led case management approach using either telephone follow-ups or home visits was able to improve clinical and patient outcomes for patients having a single, chronic disease, while the effects for older patients having at least two long-term conditions are unknown. A self-help programme using motivation and empowerment approaches is the framework of care in the study. Design Randomized controlled trial. Method The study was conducted from 2010–2012. Older patients having at least two chronic diseases were included for analysis. The participants were randomized into three arms: two study groups and one control group. Data were collected at baseline and at 4 and 12 weeks later. Results Two hundred and eighty-one patients completed the study. The interventions demonstrated significant differences in hospital readmission rates within 84 days post discharge. The two intervention groups had lower readmission rates than the control group. Patients in the two study arms had significantly better self-rated health and self-efficacy. There was significant difference between the groups in the physical composite score, but no significant difference in mental component score in SF-36 scale. Conclusion The postdischarge interventions led by the nurse case managers on self-management of disease using the empowerment approach were able to provide effective clinical and patient outcomes for older patients having co-morbidities. PMID:24617755

Peer Support for Achieving Independence in Diabetes (Peer-AID): Design, methods and baseline characteristics of a randomized controlled trial of community health worker assisted diabetes self-management support

PubMed Central

Nelson, Karin; Drain, Nathan; Robinson, June; Kapp, Janet; Hebert, Paul; Taylor, Leslie; Silverman, Julie; Kiefer, Meghan; Lessler, Dan; Krieger, James

2014-01-01

Background & Objectives Community health workers (CHWs) may be an important mechanism to provide diabetes self-management to disadvantaged populations. We describe the design and baseline results of a trial evaluating a home-based CHW intervention. Methods & Research Design Peer Support for Achieving Independence in Diabetes (Peer-AID) is a randomized, controlled trial evaluating a home-based CHW-delivered diabetes self-management intervention versus usual care. The study recruited participants from 3 health systems. Change in A1c measured at 12 months is the primary outcome. Change in blood pressure, lipids, health care utilization, health-related quality of life, self-efficacy and diabetes self-management behaviors at 12 months are secondary outcomes. Results A total of 1,438 patients were identified by medical record review as potentially eligible, 445 patients were screened by telephone for eligibility and 287 were randomized. Groups were comparable at baseline on socio-demographic and clinical characteristics. All participants were low-income and were from diverse racial and ethnic backgrounds. The mean A1c was 8.9%, mean BMI was above the obese range, and non-adherence to diabetes medications was high. The cohort had high rates of co-morbid disease and low self-reported health status. Although one-third reported no health insurance, the mean number of visits to a physician in the past year was 5.7. Trial results are pending. Conclusions Peer-AID recruited and enrolled a diverse group of low income participants with poorly controlled type 2 diabetes and delivered a home-based diabetes self-management program. If effective, replication of the Peer-AID intervention in community based settings could contribute to improved control of diabetes in vulnerable populations. PMID:24956324

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.

Sticker Shock: Management Professors' Perspectives on the Rising Costs of College Textbooks

ERIC Educational Resources Information Center

Williamson, Stan; Stevens, Robert E.; Silver, Lawrence S.; Clow, Kenneth E.

2011-01-01

This study uses Internet survey methodology to target management instructors' views on the cost of textbooks and the strategies that might be exercised by universities, publishers, and legislatures to control cost increases. From a random sample of 2,893 management professors selected, using university websites, from universities throughout the…

Predicting changes in hypertension control using electronic health records from a chronic disease management program

PubMed Central

Sun, Jimeng; McNaughton, Candace D; Zhang, Ping; Perer, Adam; Gkoulalas-Divanis, Aris; Denny, Joshua C; Kirby, Jacqueline; Lasko, Thomas; Saip, Alexander; Malin, Bradley A

2014-01-01

Objective Common chronic diseases such as hypertension are costly and difficult to manage. Our ultimate goal is to use data from electronic health records to predict the risk and timing of deterioration in hypertension control. Towards this goal, this work predicts the transition points at which hypertension is brought into, as well as pushed out of, control. Method In a cohort of 1294 patients with hypertension enrolled in a chronic disease management program at the Vanderbilt University Medical Center, patients are modeled as an array of features derived from the clinical domain over time, which are distilled into a core set using an information gain criteria regarding their predictive performance. A model for transition point prediction was then computed using a random forest classifier. Results The most predictive features for transitions in hypertension control status included hypertension assessment patterns, comorbid diagnoses, procedures and medication history. The final random forest model achieved a c-statistic of 0.836 (95% CI 0.830 to 0.842) and an accuracy of 0.773 (95% CI 0.766 to 0.780). Conclusions This study achieved accurate prediction of transition points of hypertension control status, an important first step in the long-term goal of developing personalized hypertension management plans. PMID:24045907

Predicting changes in hypertension control using electronic health records from a chronic disease management program.

PubMed

Sun, Jimeng; McNaughton, Candace D; Zhang, Ping; Perer, Adam; Gkoulalas-Divanis, Aris; Denny, Joshua C; Kirby, Jacqueline; Lasko, Thomas; Saip, Alexander; Malin, Bradley A

2014-01-01

Common chronic diseases such as hypertension are costly and difficult to manage. Our ultimate goal is to use data from electronic health records to predict the risk and timing of deterioration in hypertension control. Towards this goal, this work predicts the transition points at which hypertension is brought into, as well as pushed out of, control. In a cohort of 1294 patients with hypertension enrolled in a chronic disease management program at the Vanderbilt University Medical Center, patients are modeled as an array of features derived from the clinical domain over time, which are distilled into a core set using an information gain criteria regarding their predictive performance. A model for transition point prediction was then computed using a random forest classifier. The most predictive features for transitions in hypertension control status included hypertension assessment patterns, comorbid diagnoses, procedures and medication history. The final random forest model achieved a c-statistic of 0.836 (95% CI 0.830 to 0.842) and an accuracy of 0.773 (95% CI 0.766 to 0.780). This study achieved accurate prediction of transition points of hypertension control status, an important first step in the long-term goal of developing personalized hypertension management plans.

Reduced mortality: the unexpected impact of a telephone-based care management intervention for older adults in managed care.

PubMed

Alkema, Gretchen E; Wilber, Kathleen H; Shannon, George R; Allen, Douglas

2007-08-01

This analysis evaluated mortality over 24 months for Medicare managed care members who participated in the Care Advocate Program (CA Program) designed to link those with high health care utilization to home- and community-based services. Secondary data from the CA Program, part of the California HealthCare Foundation's Elders in Managed Care Initiative. Randomized-control trial in which participants (N=781) were randomly assigned to intent-to-treat (ITT) and control groups. ITT group received telephonic social care management and 12 months of follow-up. Various multivariate analyses were used to evaluate mortality risk throughout multiple study periods controlling for sociodemographic characteristics, health status, and health care utilization. Older adults (65+) enrolled in a Medicare managed care plan who had high health care utilization in the previous year. ITT group had a significantly lower odds of mortality throughout the study (OR=0.55; p=.005) and during the care management intervention (OR=0.45; p=.006), whereas differential risk in the postintervention period was not statistically significant. Other significant predictors of mortality were age, gender, three chronic conditions (cancer, heart disease, and kidney disease), and emergency room utilization. Findings suggest that the care advocate model of social care management affected mortality while the program was in progress, but not after completion of the intervention phase. Key model elements accounted for the findings, which include individualized targeting, assessment, and monitoring; consumer choice, control, and participant self-management; and bridging medical and social service delivery systems through direct linkages and communication.

Active management of the third stage of labor with and without controlled cord traction: a systematic review and meta-analysis of randomized controlled trials.

PubMed

Du, Yongming; Ye, Man; Zheng, Feiyun

2014-07-01

To determine the specific effect of controlled cord traction in the third stage of labor in the prevention of postpartum hemorrhage. We searched PubMed, Scopus and Web of Science (inception to 30 October 2013). Randomized controlled trials comparing controlled cord traction with hands-off management in the third stage of labor were included. Five randomized controlled trials involving a total of 30 532 participants were eligible. No significant difference was found between controlled cord traction and hands-off management groups with respect to the incidence of severe postpartum hemorrhage (relative risk 0.91, 95% confidence interval 0.77-1.08), need for blood transfusion (relative risk 0.96, 95% confidence interval 0.69-1.33) or therapeutic uterotonics (relative risk 0.94, 95% confidence interval 0.88-1.01). However, controlled cord traction reduced the incidence of postpartum hemorrhage in general (relative risk 0.93, 95% confidence interval 0.87-0.99; number-needed-to-treat 111, 95% confidence interval 61-666), as well manual removal of the placenta (relative risk 0.70, 95% confidence interval 0.58-0.84) and duration of the third stage of labor (mean difference -3.20, 95% confidence interval -3.21 to -3.19). Controlled cord traction appears to reduce the risk of any postpartum hemorrhage in a general sense, as well as manual removal of the placenta and the duration of the third stage of labor. However, the reduction in the occurrence of severe postpartum hemorrhage, need for additional uterotonics and blood transfusion is not statistically significant. © 2014 Nordic Federation of Societies of Obstetrics and Gynecology.

Dissonance and Healthy Weight Eating Disorder Prevention Programs: A Randomized Efficacy Trial

ERIC Educational Resources Information Center

Stice, Eric; Shaw, Heather; Burton, Emily; Wade, Emily

2006-01-01

In this trial, adolescent girls with body dissatisfaction (N = 481, M age = 17 years) were randomized to an eating disorder prevention program involving dissonance-inducing activities that reduce thin-ideal internalization, a prevention program promoting healthy weight management, an expressive writing control condition, or an assessment-only…

A telephonic mindfulness-based intervention for persons with sickle cell disease: study protocol for a randomized controlled trial.

PubMed

Williams, Hants; Silva, Susan; Simmons, Leigh Ann; Tanabe, Paula

2017-05-15

One of the most difficult symptoms for persons with sickle cell disease (SCD) to manage is chronic pain. Chronic pain impacts approximately one-third of persons with SCD and is associated with increased pain intensity, pain behavior, and frequency and duration of hospital visits. A promising category of nonpharmacological interventions for managing both physical and affective components of pain are mindfulness-based interventions (MBIs). The primary aim of this study is to conduct a randomized controlled study to evaluate the acceptability and feasibility, as well as to determine the preliminary efficacy, of a telephonic MBI for adults with SCD who have chronic pain. We will enroll 60 adult patients with SCD and chronic pain at an outpatient comprehensive SCD center in the southeastern United States. Patients will be randomized to either an MBI or a wait-listed control group. The MBI group will complete a six-session (60 minutes), telephonically delivered, group-based MBI program. The feasibility, acceptability, and efficacy of the MBI regarding pain catastrophizing will be assessed by administering questionnaires at baseline and weeks 1, 3, and 6. In addition, ten randomly selected MBI participants will complete semistructured interviews to help determine intervention acceptability. In this study protocol, we report detailed methods of the randomized controlled trial. Findings of this study will be useful to determine the acceptability, feasibility, and efficacy of an MBI for persons with SCD and chronic pain. ClinicalTrials.gov identifier: NCT02394587 . Registered on 9 February 2015.

Heart disease management by women: does intervention format matter?

PubMed

Clark, Noreen M; Janz, Nancy K; Dodge, Julia A; Lin, Xihong; Trabert, Britton L; Kaciroti, Niko; Mosca, Lori; Wheeler, John R; Keteyian, Steven

2014-10-01

A randomized controlled trial of two formats of a program (Women Take PRIDE) to enhance management of heart disease by patients was conducted. Older women (N = 575) were randomly assigned to a group or self-directed format or to a control group. Data regarding symptoms, functional health status, and weight were collected at baseline and at 4, 12, and 18 months. The formats produced different outcomes. At 18 months, the self-directed format was better than the control in reducing the number (p ≤ .02), frequency (p ≤ .03), and bothersomeness (p ≤ .02) of cardiac symptoms. The self-directed format was also better than the group format in reducing symptom frequency of all types (p ≤ .04). The group format improved ambulation at 12 months (p ≤ .04) and weight loss at 18 months (p ≤ .03), and group participants were more likely to complete the program (p ≤ .05). The availability of different learning formats could enhance management of cardiovascular disease by patients. © 2014 Society for Public Health Education.

Heart disease management by women: does intervention format matter?

PubMed

Clark, Noreen M; Janz, Nancy K; Dodge, Julia A; Lin, Xihong; Trabert, Britton L; Kaciroti, Niko; Mosca, Lori; Wheeler, John R; Keteyian, Steven

2009-04-01

A randomized controlled trial of two formats of a program (Women Take PRIDE) to enhance management of heart disease by patients was conducted. Older women (N = 575) were randomly assigned to a group or self-directed format or to a control group. Data regarding symptoms, functional health status, and weight were collected at baseline and at 4, 12, and 18 months. The formats produced different outcomes. At 18 months, the self-directed format was better than the control in reducing the number (p < or = .02), frequency (p < or = .03), and bothersomeness (p < or = .02) of cardiac symptoms. The self-directed format was also better than the group format in reducing symptom frequency of all types (p < or = .04). The group format improved ambulation at 12 months (p < or = .04) and weight loss at 18 months (p < or = .03), and group participants were more likely to complete the program ( p < or = .05). The availability of different learning formats could enhance management of cardiovascular disease by patients.

Parent involvement in pain management for NICU infants: a randomized controlled trial.

PubMed

Franck, Linda S; Oulton, Kate; Nderitu, Sue; Lim, Magdalene; Fang, Swee; Kaiser, Anthony

2011-09-01

To demonstrate feasibility and estimate the effect of an intervention to increase parental involvement in infant pain management in the NICU on parents' stress and postdischarge parenting competence and confidence. The study involved a randomized controlled trial. Parents recruited from 4 NICUs were randomly assigned by site to receive (1) a pain information booklet and instruction on infant comforting techniques (n = 84 intervention) in addition to a generic NICU care booklet or (2) the generic NICU care booklet alone (n = 85 control). The primary outcome was postintervention Parent Stressor Scale: NICU (PSS:NICU) scores. Secondary outcomes included parent attitudes about infant pain, nursing pain assessment, and parenting competence and role attainment after discharge. No differences were found between groups in PSS:NICU scores. Significant differences favoring the intervention group were found for satisfaction with pain information, parents shown infant pain cues and comforting techniques, nursing pain assessment, and parent preference for involvement during painful procedures. Role attainment after discharge was higher for the intervention group than for the control group. Both the intervention and control groups highly valued attention to infant pain and wanted information and involvement. These results provide no evidence of a reduction in NICU-related stress for parents who receive an intervention to increase their understanding and involvement in infant pain management. However, parents in the intervention group were better prepared to take an active role in infant pain care and had more positive views about their role attainment in the postdischarge period.

Community-based peer-led diabetes self-management: a randomized trial.

PubMed

Lorig, Kate; Ritter, Philip L; Villa, Frank J; Armas, Jean

2009-01-01

The purpose of this study is to determine the effectiveness of a community-based diabetes self-management program comparing treatment participants to a randomized usual-care control group at 6 months. A total of 345 adults with type 2 diabetes but no criteria for high A1C were randomized to a usual-care control group or 6-week community-based, peer-led diabetes self-management program (DSMP). Randomized participants were compared at 6 months. The DSMP intervention participants were followed for an additional 6 months (12 months total). A1C and body mass index were measured at baseline, 6 months, and 12 months. All other data were collected by self-administered questionnaires. At 6 months, DSMP participants did not demonstrate improvements in A1C as compared with controls. Baseline A1C was much lower than in similar trials. Participants did have significant improvements in depression, symptoms of hypoglycemia, communication with physicians, healthy eating, and reading food labels (P < .01). They also had significant improvements in patient activation and self-efficacy. At 12 months, DSMP intervention participants continued to demonstrate improvements in depression, communication with physicians, healthy eating, patient activation, and self-efficacy (P < .01). There were no significant changes in utilization measures. These findings suggest that people with diabetes without elevated A1C can benefit from a community-based, peer-led diabetes program. Given the large number of people with diabetes and lack of low-cost diabetes education, the DSMP deserves consideration for implementation.

Effect of tight control management on Crohn's disease (CALM): a multicentre, randomised, controlled phase 3 trial.

PubMed

Colombel, Jean-Frederic; Panaccione, Remo; Bossuyt, Peter; Lukas, Milan; Baert, Filip; Vaňásek, Tomas; Danalioglu, Ahmet; Novacek, Gottfried; Armuzzi, Alessandro; Hébuterne, Xavier; Travis, Simon; Danese, Silvio; Reinisch, Walter; Sandborn, William J; Rutgeerts, Paul; Hommes, Daniel; Schreiber, Stefan; Neimark, Ezequiel; Huang, Bidan; Zhou, Qian; Mendez, Paloma; Petersson, Joel; Wallace, Kori; Robinson, Anne M; Thakkar, Roopal B; D'Haens, Geert

2018-12-23

Biomarkers of intestinal inflammation, such as faecal calprotectin and C-reactive protein, have been recommended for monitoring patients with Crohn's disease, but whether their use in treatment decisions improves outcomes is unknown. We aimed to compare endoscopic and clinical outcomes in patients with moderate to severe Crohn's disease who were managed with a tight control algorithm, using clinical symptoms and biomarkers, versus patients managed with a clinical management algorithm. CALM was an open-label, randomised, controlled phase 3 study, done in 22 countries at 74 hospitals and outpatient centres, which evaluated adult patients (aged 18-75 years) with active endoscopic Crohn's disease (Crohn's Disease Endoscopic Index of Severity [CDEIS] >6; sum of CDEIS subscores of >6 in one or more segments with ulcers), a Crohn's Disease Activity Index (CDAI) of 150-450 depending on dose of prednisone at baseline, and no previous use of immunomodulators or biologics. Patients were randomly assigned at a 1:1 ratio to tight control or clinical management groups, stratified by smoking status (yes or no), weight (<70 kg or ≥70 kg), and disease duration (≤2 years or >2 years) after 8 weeks of prednisone induction therapy, or earlier if they had active disease. In both groups, treatment was escalated in a stepwise manner, from no treatment, to adalimumab induction followed by adalimumab every other week, adalimumab every week, and lastly to both weekly adalimumab and daily azathioprine. This escalation was based on meeting treatment failure criteria, which differed between groups (tight control group before and after random assignment: faecal calprotectin ≥250 μg/g, C-reactive protein ≥5mg/L, CDAI ≥150, or prednisone use in the previous week; clinical management group before random assignment: CDAI decrease of <70 points compared with baseline or CDAI >200; clinical management group after random assignment: CDAI decrease of <100 points compared with baseline or CDAI ≥200, or prednisone use in the previous week). De-escalation was possible for patients receiving weekly adalimumab and azathioprine or weekly adalimumab alone if failure criteria were not met. The primary endpoint was mucosal healing (CDEIS <4) with absence of deep ulcers 48 weeks after randomisation. Primary and safety analyses were done in the intention-to-treat population. This trial has been completed, and is registered with ClinicalTrials.gov, number NCT01235689. Between Feb 11, 2011, and Nov 3, 2016, 244 patients (mean disease duration: clinical management group, 0·9 years [SD 1·7]; tight control group, 1·0 year [2·3]) were randomly assigned to monitoring groups (n=122 per group). 29 (24%) patients in the clinical management group and 32 (26%) patients in the tight control group discontinued the study, mostly because of adverse events. A significantly higher proportion of patients in the tight control group achieved the primary endpoint at week 48 (56 [46%] of 122 patients) than in the clinical management group (37 [30%] of 122 patients), with a Cochran-Mantel-Haenszel test-adjusted risk difference of 16·1% (95% CI 3·9-28·3; p=0·010). 105 (86%) of 122 patients in the tight control group and 100 (82%) of 122 patients in the clinical management group reported treatment-emergent adverse events; no treatment-related deaths occurred. The most common adverse events were nausea (21 [17%] of 122 patients), nasopharyngitis (18 [15%]), and headache (18 [15%]) in the tight control group, and worsening Crohn's disease (35 [29%] of 122 patients), arthralgia (19 [16%]), and nasopharyngitis (18 [15%]) in the clinical management group. CALM is the first study to show that timely escalation with an anti-tumour necrosis factor therapy on the basis of clinical symptoms combined with biomarkers in patients with early Crohn's disease results in better clinical and endoscopic outcomes than symptom-driven decisions alone. Future studies should assess the effects of such a strategy on long-term outcomes such as bowel damage, surgeries, hospital admissions, and disability. AbbVie. Copyright © 2017 Elsevier Ltd. All rights reserved.

Feasibility and Efficacy of an mHealth Game for Managing Anxiety: "Flowy" Randomized Controlled Pilot Trial and Design Evaluation.

PubMed

Pham, Quynh; Khatib, Yasmin; Stansfeld, Stephen; Fox, Simon; Green, Tobias

2016-02-01

Meeting the complex needs of patients with chronic common mental health disorders (CMHDs) may be the greatest challenge facing organized medical practice. On the basis of a well-established and proven theoretical foundation for controlled respiration as a behavioral intervention for CMHDs, as well as preliminary evidence that gamification can improve health outcomes through increasing patient engagement, this randomized controlled pilot study evaluated the feasibility and clinical efficacy of a mobile health game called "Flowy" ( www.flowygame.com ) that digitally delivered breathing retraining exercises for anxiety, panic, and hyperventilation symptom management. We designed an unblinded, Web-based, parallel-group randomized controlled trial focusing on feasibility, clinical efficacy, and design proof of concept. In the intervention condition (n = 31), participants received free access to "Flowy" for 4 weeks. In the control condition (n = 32), participants were placed on a waitlist for 4 weeks before being offered free access to "Flowy." Online measurements using psychological self-report questionnaires were made at 2 and 4 weeks post-baseline. At trial conclusion, participants found "Flowy" acceptable as an anxiety management intervention. "Flowy" engaged participants sufficiently to endorse proactive gameplay. Intent-to-treat analysis revealed a reduction in anxiety, panic, and self-report hyperventilation scores in both trial arms, with the intervention arm experiencing greater quality of life. Participants perceived "Flowy" as a fun and useful intervention, proactively used "Flowy" as part of their care, and would recommend "Flowy" to family and friends. Our results suggest that a digital delivery of breathing retraining exercises through a mobile health game can manage anxiety, panic, and hyperventilation symptoms associated with CMHDs.

Effectiveness of a self-management program for dual sensory impaired seniors in aged care settings: study protocol for a cluster randomized controlled trial.

PubMed

Roets-Merken, Lieve M; Graff, Maud J L; Zuidema, Sytse U; Hermsen, Pieter G J M; Teerenstra, Steven; Kempen, Gertrudis I J M; Vernooij-Dassen, Myrra J F J

2013-10-07

Five to 25 percent of residents in aged care settings have a combined hearing and visual sensory impairment. Usual care is generally restricted to single sensory impairment, neglecting the consequences of dual sensory impairment on social participation and autonomy. The aim of this study is to evaluate the effectiveness of a self-management program for seniors who acquired dual sensory impairment at old age. In a cluster randomized, single-blind controlled trial, with aged care settings as the unit of randomization, the effectiveness of a self-management program will be compared to usual care. A minimum of 14 and maximum of 20 settings will be randomized to either the intervention cluster or the control cluster, aiming to include a total of 132 seniors with dual sensory impairment. Each senior will be linked to a licensed practical nurse working at the setting. During a five to six month intervention period, nurses at the intervention clusters will be trained in a self-management program to support and empower seniors to use self-management strategies. In two separate diaries, nurses keep track of the interviews with the seniors and their reflections on their own learning process. Nurses of the control clusters offer care as usual. At senior level, the primary outcome is the social participation of the seniors measured using the Hearing Handicap Questionnaire and the Activity Card Sort, and secondary outcomes are mood, autonomy and quality of life. At nurse level, the outcome is job satisfaction. Effectiveness will be evaluated using linear mixed model analysis. The results of this study will provide evidence for the effectiveness of the Self-Management Program for seniors with dual sensory impairment living in aged care settings. The findings are expected to contribute to the knowledge on the program's potential to enhance social participation and autonomy of the seniors, as well as increasing the job satisfaction of the licensed practical nurses. Furthermore, an extensive process evaluation will take place which will offer insight in the quality and feasibility of the sampling and intervention process. If it is shown to be effective and feasible, this Self-Management Program could be widely disseminated. ClinicalTrials.gov, NCT01217502.

Effectiveness of a self-management program for dual sensory impaired seniors in aged care settings: study protocol for a cluster randomized controlled trial

PubMed Central

2013-01-01

Background Five to 25 percent of residents in aged care settings have a combined hearing and visual sensory impairment. Usual care is generally restricted to single sensory impairment, neglecting the consequences of dual sensory impairment on social participation and autonomy. The aim of this study is to evaluate the effectiveness of a self-management program for seniors who acquired dual sensory impairment at old age. Methods/Design In a cluster randomized, single-blind controlled trial, with aged care settings as the unit of randomization, the effectiveness of a self-management program will be compared to usual care. A minimum of 14 and maximum of 20 settings will be randomized to either the intervention cluster or the control cluster, aiming to include a total of 132 seniors with dual sensory impairment. Each senior will be linked to a licensed practical nurse working at the setting. During a five to six month intervention period, nurses at the intervention clusters will be trained in a self-management program to support and empower seniors to use self-management strategies. In two separate diaries, nurses keep track of the interviews with the seniors and their reflections on their own learning process. Nurses of the control clusters offer care as usual. At senior level, the primary outcome is the social participation of the seniors measured using the Hearing Handicap Questionnaire and the Activity Card Sort, and secondary outcomes are mood, autonomy and quality of life. At nurse level, the outcome is job satisfaction. Effectiveness will be evaluated using linear mixed model analysis. Discussion The results of this study will provide evidence for the effectiveness of the Self-Management Program for seniors with dual sensory impairment living in aged care settings. The findings are expected to contribute to the knowledge on the program’s potential to enhance social participation and autonomy of the seniors, as well as increasing the job satisfaction of the licensed practical nurses. Furthermore, an extensive process evaluation will take place which will offer insight in the quality and feasibility of the sampling and intervention process. If it is shown to be effective and feasible, this Self-Management Program could be widely disseminated. Clinical trials registration ClinicalTrials.gov, NCT01217502. PMID:24099315

A comparative study of entrepreneurs and managers: stress, burnout, locus of control, and social support.

PubMed

Rahim, M A

1995-01-01

This study investigated the relationships of job stress to job burnout, of locus of control and social support to stress and burnout, and the moderating effects of locus of control and social support on the stress-burnout relationship. These relationships were tested with questionnaire data collected from a random sample of entrepreneurs (N = 238) and managers (N = 288). Results showed that entrepreneurs reported that they had higher internal locus of control, received less social support, and had less job burnout than managers. Hierarchical regression analyses found support for eight of the ten main effects and one of the four moderating effects.

Effects of family treatment on parenting beliefs among caregivers of youth with poorly controlled asthma.

PubMed

Ellis, Deborah A; King, Pamela; Naar-King, Sylvie; Lam, Phebe; Cunningham, Phillippe B; Secord, Elizabeth

2014-10-01

Caregiver involvement is critical in ensuring optimal adolescent asthma management. The study investigated whether multisystemic therapy (MST), an intensive home-based family therapy, was superior to family support for changing beliefs regarding asthma-related positive parenting among caregivers of African-American youth with poorly controlled asthma. The relationship between parenting beliefs and asthma management at the conclusion of the intervention was also assessed. A randomized controlled trial was conducted with 167 adolescents with moderate-to-severe, persistent, poorly controlled asthma and their primary caregivers. Families were randomly assigned to MST or family support (FS), a home-based family support condition. Data were collected at baseline and 7-month posttest. Changes in caregiver ratings of importance and confidence for engaging in asthma-related positive parenting were assessed through questionnaire. Illness management was assessed by the Family Asthma Management System Scale. Participation in MST was associated with more change in caregiver beliefs as compared with FS for both importance (t = 2.39, p = .02) and confidence (t = 2.04, p = .04). Caregiver beliefs were also significantly related to youth controller medication adherence at the conclusion of treatment (importance: r = .21, p = .01; confidence: r = .23, p = .004). Results support the effectiveness of MST for increasing parental beliefs in the value of asthma-related positive parenting behaviors and parental self-efficacy for these behaviors among families of minority adolescents with poorly controlled asthma.

Application of implantable hemodynamic monitoring in the management of patients with diastolic heart failure: a subgroup analysis of the COMPASS-HF trial.

PubMed

Zile, Michael R; Bourge, Robert C; Bennett, Tom D; Stevenson, Lynne Warner; Cho, Yong K; Adamson, Philip B; Aaron, Mark F; Aranda, Juan M; Abraham, William T; Smart, Frank W; Kueffer, Fred J

2008-12-01

Nearly half of all patients with chronic heart failure (HF) have a normal ejection fraction (EF), and abnormal diastolic function (ie, diastolic heart failure [DHF]). However, appropriate management of DHF patients remains a difficult and uncertain challenge. The Chronicle Offers Management to Patients with Advanced Signs and Symptoms of Heart Failure (COMPASS-HF) trial was designed to evaluate whether an implantable hemodynamic monitor (IHM) was safe and effective in reducing the number of heart failure-related events (HFRE) in patients with chronic HF. The current study presents data on a prespecified and planned subgroup analysis from the COMPASS-HF trial: 70 patients with an EF > or =50% (ie, DHF). As such, this represents a subgroup analysis of the COMPASS-HF Trial. DHF patients were randomized to IHM-guided care (treatment) vs. standard care (control) for 6 months. All 70 patients received optimal medical therapy, but the hemodynamic information from the IHM was used to guide patient management only in the treatment group. The HFRE rate in DHF patients randomized to treatment was 0.58 events/6 months compared with DHF patients randomized to control, which was 0.73 events/6 months; this represented a 20% nonsignificant reduction in the overall HFRE rate in the treatment group (95% CI = -46, 56, P = .66). There was a 29% nonsignificant reduction in the relative risk of a HF hospitalization in the DHF patients randomized to treatment compared with DHF patients randomized to control (95% CI = -69, 70, P = .43). The IHM was shown to be safe and was associated with a very low system-related and procedure-related complication rate in DHF patients. However, in this subgroup analysis limited to 70 DHF patients, the addition IHM-guided care did not significantly lower the rate of HFR events. The results of this subgroup analysis in DHF patients, for whom there are currently no proven, effective management strategies, will be used to design future studies defining the effects of IHM-guided care in patients with DHF.

Cloud-based BP system integrated with CPOE improves self-management of the hypertensive patients: A randomized controlled trial.

PubMed

Lee, Peisan; Liu, Ju-Chi; Hsieh, Ming-Hsiung; Hao, Wen-Rui; Tseng, Yuan-Teng; Liu, Shuen-Hsin; Lin, Yung-Kuo; Sung, Li-Chin; Huang, Jen-Hung; Yang, Hung-Yu; Ye, Jong-Shiuan; Zheng, He-Shun; Hsu, Min-Huei; Syed-Abdul, Shabbir; Lu, Richard; Nguyen, Phung-Anh; Iqbal, Usman; Huang, Chih-Wei; Jian, Wen-Shan; Li, Yu-Chuan Jack

2016-08-01

Less than 50% of patients with hypertensive disease manage to maintain their blood pressure (BP) within normal levels. The aim of this study is to evaluate whether cloud BP system integrated with computerized physician order entry (CPOE) can improve BP management as compared with traditional care. A randomized controlled trial done on a random sample of 382 adults recruited from 786 patients who had been diagnosed with hypertension and receiving treatment for hypertension in two district hospitals in the north of Taiwan. Physicians had access to cloud BP data from CPOE. Neither patients nor physicians were blinded to group assignment. The study was conducted over a period of seven months. At baseline, the enrollees were 50% male with a mean (SD) age of 58.18 (10.83) years. The mean sitting BP of both arms was no different. The proportion of patients with BP control at two, four and six months was significantly greater in the intervention group than in the control group. The average capture rates of blood pressure in the intervention group were also significantly higher than the control group in all three check-points. Cloud-based BP system integrated with CPOE at the point of care achieved better BP control compared to traditional care. This system does not require any technical skills and is therefore suitable for every age group. The praise and assurance to the patients from the physicians after reviewing the Cloud BP records positively reinforced both BP measuring and medication adherence behaviors. Copyright © 2016. Published by Elsevier Ireland Ltd.

Time management training and perceived control of time at work.

PubMed

Häfner, Alexander; Stock, Armin

2010-01-01

The purpose of the present study was to examine the effects of time management training, which was based on psychological theory and research, on perceived control of time, perceived stress, and performance at work. The authors randomly assigned 71 employees to a training group (n = 35) or a waiting-list control group (n = 36). As hypothesized, time management training led to an increase in perceived control of time and a decrease in perceived stress. Time management training had no impact on different performance indicators. In particular, the authors explored the use and the perceived usefulness of the techniques taught. Participants judged the taught techniques as useful, but there were large differences concerning the actual use of the various techniques.

Evaluation of a train-the-trainer program for stable coronary artery disease management in community settings: A pilot study.

PubMed

Shen, Zhiyun; Jiang, Changying; Chen, Liqun

2018-02-01

To evaluate the feasibility and effectiveness of conducting a train-the-trainer (TTT) program for stable coronary artery disease (SCAD) management in community settings. The study involved two steps: (1) tutors trained community nurses as trainers and (2) the community nurses trained patients. 51 community nurses attended a 2-day TTT program and completed questionnaires assessing knowledge, self-efficacy, and satisfaction. By a feasibility and non-randomized control study, 120 SCAD patients were assigned either to intervention group (which received interventions from trained nurses) or control group (which received routine management). Pre- and post-intervention, patients' self-management behaviors and satisfaction were assessed to determine the program's overall impact. Community nurses' knowledge and self-efficacy improved (P<0.001), as did intervention group patients' self-management behaviors (P<0.001). The satisfaction of community nurses and patients was all very positive after training. The TTT program for SCAD management in community settings in China was generally feasible and effective, but many obstacles remain including patients' noncompliance, nurses' busy work schedules, and lack of policy supports. Finding ways to enhance the motivation of community nurses and patients with SCAD are important in implementing community-based TTT programs for SCAD management; further multicenter and randomized control trials are needed. Copyright © 2017 Elsevier B.V. All rights reserved.

Effectiveness of energy conservation management on fatigue and participation in multiple sclerosis: A randomized controlled trial.

PubMed

Blikman, Lyan Jm; van Meeteren, Jetty; Twisk, Jos Wr; de Laat, Fred Aj; de Groot, Vincent; Beckerman, Heleen; Stam, Henk J; Bussmann, Johannes Bj

2017-10-01

Fatigue is a frequently reported and disabling symptom in multiple sclerosis (MS). To investigate the effectiveness of an individual energy conservation management (ECM) intervention on fatigue and participation in persons with primary MS-related fatigue. A total of 86 severely fatigued and ambulatory adults with a definite diagnosis of MS were randomized in a single-blind, two-parallel-arm randomized clinical trial to the ECM group or the information-only control group in outpatient rehabilitation departments. Blinded assessments were carried out at baseline and at 8, 16, 26 and 52 weeks after randomization. Primary outcomes were fatigue (fatigue subscale of Checklist Individual Strength - CIS20r) and participation (Impact on Participation and Autonomy scale - IPA). Modified intention-to-treat analysis was based on 76 randomized patients (ECM, n = 36; MS nurse, n=40). No significant ECM effects were found for fatigue (overall difference CIS20r between the groups = -0.81; 95% confidence interval (CI), -3.71 to 2.11) or for four out of five IPA domains. An overall unfavourable effect was found in the ECM group for the IPA domain social relations (difference between the groups = 0.19; 95% CI, 0.03 to 0.35). The individual ECM format used in this study did not reduce MS-related fatigue and restrictions in participation more than an information-only control condition.

Manage at work: a randomized, controlled trial of a self-management group intervention to overcome workplace challenges associated with chronic physical health conditions

PubMed Central

2014-01-01

Background The percentage of older and chronically ill workers is increasing rapidly in the US and in many other countries, but few interventions are available to help employees overcome the workplace challenges of chronic pain and other physical health conditions. While most workers are eligible for job accommodation and disability compensation benefits, other workplace strategies might improve individual-level coping and problem solving to prevent work disability. In this study, we hypothesize that an employer-sponsored group intervention program employing self-management principles may improve worker engagement and reduce functional limitation associated with chronic disorders. Methods In a randomized controlled trial (RCT), workers participating in an employer-sponsored self-management group intervention will be compared with a no-treatment (wait list) control condition. Volunteer employees (n = 300) will be recruited from five participating employers and randomly assigned to intervention or control. Participants in the intervention arm will attend facilitated group workshop sessions at work (10 hours total) to explore methods for improving comfort, adjusting work habits, communicating needs effectively, applying systematic problem solving, and dealing with negative thoughts and emotions about work. Work engagement and work limitation are the principal outcomes. Secondary outcomes include fatigue, job satisfaction, self-efficacy, turnover intention, sickness absence, and health care utilization. Measurements will be taken at baseline, 6-, and 12-month follow-up. A process evaluation will be performed alongside the randomized trial. Discussion This study will be most relevant for organizations and occupational settings where some degree of job flexibility, leeway, and decision-making autonomy can be afforded to affected workers. The study design will provide initial assessment of a novel workplace approach and to understand factors affecting its feasibility and effectiveness. Trial registration Clinicaltrials.gov: NCT01978392 (Issued November 6, 2013) PMID:24885844

Stress management and mind-body medicine: a randomized controlled longitudinal evaluation of students' health and effects of a behavioral group intervention at a middle-size German university (SM-MESH).

PubMed

Esch, Tobias; Sonntag, Ulrike; Esch, Sonja Maren; Thees, Stefanie

2013-01-01

Student life can be stressful. Hence, we started a regular mind-body medical stress management program in 2006. By today, more than 500 students took part and evaluations showed significant results, especially with regard to a reduction of stress warning signals. For further analysis, we now decided to run a randomized controlled longitudinal trial. Participating students at Coburg University were randomized into an intervention (n = 24) or a waitlist control group (n = 19). The intervention group completed 3 sets (pre/post/follow-up) and the control group 2 sets (pre/post) of self-administered questionnaires. The questionnaires included: SF-12 Health Survey, Perceived Stress Scale (PSS), Sense of Coherence (SOC-L9), Visual Analogue Scale (VAS) concerning stress, and the Stress Warning Signs (SWS) scale. Randomly selected participants of the intervention group were also queried in qualitative interviews. The intervention consisted of an 8 week stress management group program (mind-body medical stress reduction - MBMSR). Follow-up measures were taken after 6 months. Virtually, no drop-out occurred. Our study showed significant effects in the intervention group concerning SF-12 Mental Component Scale (p = 0.05), SF-12 Physical Component Scale (p = 0.001), VAS (in general, p = 0.001) and SWS (emotional reactions, p <0.001), underlined by qualitative results, which showed a higher quality of life. The effectiveness of an MBMSR program in a group of supposedly healthy students could be demonstrated. Findings suggest that stress management might be given importance at universities that care for the performance, the quality of life, and stress-health status of their students, acknowledging and accounting for the challenging circumstances of university life, as well as the specific needs of the modern student population. Copyright © 2013 S. Karger AG, Basel.

A Meta-Analysis of the Effects of Classroom Management Strategies and Classroom Management Programs on Students' Academic, Behavioral, Emotional, and Motivational Outcomes

ERIC Educational Resources Information Center

Korpershoek, Hanke; Harms, Truus; de Boer, Hester; van Kuijk, Mechteld; Doolaard, Simone

2016-01-01

This meta-analysis examined which classroom management strategies and programs enhanced students' academic, behavioral, social-emotional, and motivational outcomes in primary education. The analysis included 54 random and nonrandom controlled intervention studies published in the past decade (2003-2013). Results showed small but significant…

Effective Strategy Formation Models for Inventory Management under the Conditions of Uncertainty

ERIC Educational Resources Information Center

Kosorukov, Oleg Anatolyevich; Sviridova, Olga Alexandrovna

2015-01-01

The article deals with the problem of modeling the commodity flows management of a trading company under the conditions of uncertain demand and long supply. The Author presents an analysis of modifications of diversified inventory management system with random demand, for which one can find the optimal inventory control strategies, including those…

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.

[Random Variable Read Me File

NASA Technical Reports Server (NTRS)

Teubert, Christopher; Sankararaman, Shankar; Cullo, Aiden

2017-01-01

Readme for the Random Variable Toolbox usable manner. is a Web-based Git version control repository hosting service. It is mostly used for computer code. It offers all of the distributed version control and source code management (SCM) functionality of Git as well as adding its own features. It provides access control and several collaboration features such as bug tracking, feature requests, task management, and wikis for every project.[3] GitHub offers both plans for private and free repositories on the same account[4] which are commonly used to host open-source software projects.[5] As of April 2017, GitHub reports having almost 20 million users and 57 million repositories,[6] making it the largest host of source code in the world.[7] GitHub has a mascot called Octocat, a cat with five tentacles and a human-like face

Passage Meditation Reduces Perceived Stress in Health Professionals: A Randomized, Controlled Trial

ERIC Educational Resources Information Center

Oman, Doug; Hedberg, John; Thoresen, Carl E.

2006-01-01

The authors evaluated an 8-week, 2-hr per week training for physicians, nurses, chaplains, and other health professionals using nonsectarian, spiritually based self-management tools based on passage meditation (E. Easwaran, 1978/1991). Participants were randomized to intervention (n = 27) or waiting list (n = 31). Pretest, posttest, and 8-and…

Hospitalization Cost Offset of a Hostility Intervention for Coronary Heart Disease Patients

ERIC Educational Resources Information Center

Davidson, Karina W.; Gidron, Yori; Mostofsky, Elizabeth; Trudeau, Kimberlee J.

2007-01-01

The authors evaluated hospitalization cost offset of hostility management group therapy for patients with coronary heart disease (CHD) from a previously published randomized controlled trial (Y. Gidron, K. Davidson, & I. Bata, 1999). Twenty-six male patients with myocardial infarction or unstable angina were randomized to either 2 months of…

Effects of Assertiveness Training and Expressive Writing on Acculturative Stress in International Students: A Randomized Trial

ERIC Educational Resources Information Center

Tavakoli, Shedeh; Lumley, Mark A.; Hijazi, Alaa M.; Slavin-Spenny, Olga M.; Parris, George P.

2009-01-01

International university students often experience acculturative stress, and culturally appropriate techniques to manage stress are needed. This randomized trial tested the effects of group assertiveness training, private expressive writing, their combination, and a wait-list control on the acculturative stress, affect, and health of 118…

The efficacy of cetirizine hydrochloride on the pruritus of cats with atopic dermatitis: a randomized, double-blind, placebo-controlled, crossover study.

PubMed

Wildermuth, Kerstin; Zabel, Sonja; Rosychuk, Rod A W

2013-12-01

Various antihistamines have been used in the management of feline atopic dermatitis, with variable reported benefit. To date, there have been no randomized, double-blind, placebo-controlled, crossover clinical trials on the use of this drug class in cats. To evaluate the clinical efficacy of cetirizine hydrochloride for the control of pruritus and dermatitis in cats diagnosed with atopic dermatitis. In this randomized, double-blind, placebo-controlled crossover clinical trial, 21 client-owned cats diagnosed with mild to moderate nonseasonal atopic dermatitis were randomly assigned to two groups. Cats in each group received either 1 mg/kg cetirizine hydrochloride or placebo once daily per os for 28 days followed by a 14 day wash-out period. Treatments were then crossed over, and cats received placebo or cetirizine hydrochloride for another 28 days. Owners marked a pruritus severity scale before inclusion in the study and weekly throughout the entire study period. Lesions were scored by the clinician using a Canine Atopic Dermatitis Extent and Severity Index (CADESI)-03 modified for the cat before enrolment and at day 28 of each treatment. Nineteen cats completed the study. There were no statistically significant differences between treatment with cetirizine hydrochloride and placebo for modified CADESI-03 or pruritus scores. This study suggests that cetirizine hydrochloride cannot be recommended for the management of feline atopic dermatitis. © 2013 ESVD and ACVD.

One-year postpartum outcomes following a weight management intervention in pregnant women with obesity

PubMed Central

Vesco, Kimberly K.; Leo, Michael C.; Karanja, Njeri; Gillman, Matthew W.; McEvoy, Cindy T.; King, Janet C.; Eckhardt, Cara L.; Smith, K. Sabina; Perrin, Nancy; Stevens, Victor J.

2016-01-01

Objective This analysis focuses on 1-year maternal and infant follow-up of a randomized trial that tested a weight management intervention conducted during pregnancy. Methods We randomly assigned 114 women with obesity (mean BMI 36.7 kg/m2) at a mean of 15 weeks’ gestation to a weight management intervention or usual care control condition. The intervention ended at delivery and resulted in less gestational weight gain and a lower proportion of large-for-gestational age newborns among intervention compared to control participants. The primary outcome at 12 months postpartum was maternal weight. Secondary outcomes included infant weight-for-age and weight-for-length z-scores. Results At 1 year, mothers in the intervention group weighed 96.3±18.6 kg, and in the control group, 99.7±19.2 kg. There was no significant difference between groups in change in weight from randomization to 1-year postpartum (b=-0.47, 95% CI [-4.03, 3.08]. There was a significant main effect of group for infant weight-for-age z-score (b=-0.40, 95% CI [-0.75,-0.05]) but not infant weight-for-length z-scores (b=-0.20, 95% CI [-0.59,0.20]. Conclusions A gestational weight management intervention did not influence maternal weight or infant weight-for-length at 1-year postpartum. Future studies may be warranted to determine if extending prenatal interventions into the postpartum period would be beneficial for maternal and infant outcomes. PMID:27670399

Can stories influence African-American patients' intentions to change hypertension management behaviors? A randomized control trial.

PubMed

Bokhour, Barbara G; Fix, Gemmae M; Gordon, Howard S; Long, Judith A; DeLaughter, Kathryn; Orner, Michelle B; Pope, Charlene; Houston, Thomas K

2016-09-01

Information-only interventions for hypertension management have limited effectiveness, particularly among disadvantaged populations. We assessed the impact of viewing African-American patients' stories of successfully controlling hypertension on intention to change hypertension management behaviors and engagement with educational materials. In a three-site randomized trial, 618 African-American Veterans with uncontrolled hypertension viewed an information-only DVD about hypertension (control) or a DVD adding videos of African-American Veterans telling stories about successful hypertension management (intervention). After viewing, patients were asked about their engagement with the DVD, and their intentions to change behavior. Mean scores were compared with two-sided t-tests. Results favored the Stories intervention, with significantly higher emotional engagement versus control (4.3 vs. 2.2 p<0.0001). Intervention patients reported significantly greater intentions to become more physically active (4.6 vs. 4.4, p=0.018), use salt substitutes (3.9 vs. 3.4, p=0.006), talk openly with their doctor about hypertension (4.6 vs. 4.5, p=0.049), and remember to take hypertension medication (4.8 vs. 4.6, p=0.04). Patients were more emotionally engaged and reported intentions to change behavior when watching real patient hypertension management success stories. Stories may be more influential than information alone, and represent a scalable approach to modifying behavioral intention. Published by Elsevier Ireland Ltd.

Effects of a case management program on patients with oral precancerous lesions: a randomized controlled trial.

PubMed

Lin, Hsiu-Ying; Chen, Shu-Ching; Peng, Hsi-Ling; Chen, Mu-Kuan

2016-01-01

The aim of this study is to identify the effects of a case management program on knowledge about oral cancer, preventive behavior for oral cancer, and level of uncertainty for patients with oral precancerous lesions. A randomized controlled trial was conducted with two groups, using a pre- and posttest design. The experimental group received a case management program and telephone follow-up sessions; the control group received routine care. Patients were assessed at three time points: first visit to the otolaryngology clinic for biopsy examination (T0), and then at 2 weeks (T1) and 4 weeks (T2) after the biopsy examination. Patients in both groups had significantly higher levels of knowledge about oral cancer, preventive behavior for oral cancer, and lower level of uncertainty at T2 compared to T0. At T2, participants in the experimental group had significantly greater knowledge about oral cancer, more preventive behavior for oral cancer, and less uncertainty compared to those in the control group. The case management program with telephone counseling effectively improved knowledge about oral cancer, preventive behavior for oral cancer, and uncertainty levels in patients with oral precancerous lesions in the four weeks after receiving a biopsy examination. The case management program can be applied with positive results to patients receiving different types of cancer screening, including colorectal, breast, and cervical screening.

Improving detection and initial management of gestational diabetes through the primary level of care in Morocco: protocol for a cluster randomized controlled trial.

PubMed

Utz, Bettina; Assarag, Bouchra; Essolbi, Amina; Barkat, Amina; El Ansari, Nawal; Fakhir, Bouchra; Delamou, Alexandre; De Brouwere, Vincent

2017-06-19

Morocco is facing a growing prevalence of diabetes and according to latest figures of the World Health Organization, already 12.4% of the population are affected. A similar prevalence has been reported for gestational diabetes (GDM) and although it is not yet high on the national agenda, immediate and long-term complications threaten the health of mothers and future generations. A situational analysis on GDM conducted in 2015 revealed difficulties in access to screening and delays in receiving appropriate care. This implementation study has as objective to evaluate a decentralized GDM detection and management approach through the primary level of care and assess its potential for scaling up. We will conduct a hybrid effectiveness-implementation research using a cluster randomized controlled trial design in two districts of Morocco. Using the health center as unit of randomization we randomly selected 20 health centers with 10 serving as intervention and 10 as control facilities. In the intervention arm, providers will screen pregnant women attending antenatal care for GDM by capillary glucose testing during antenatal care. Women tested positive will receive nutritional counselling and will be followed up through the health center. In the control facilities, screening and initial management of GDM will follow standard practice. Primary outcome will be birthweight with weight gain during pregnancy, average glucose levels and pregnancy outcomes including mode of delivery, presence or absence of obstetric or newborn complications and the prevalence of GDM at health center level as secondary outcomes. Furthermore we will assess the quality of life /care experienced by the women in both arms. Qualitative methods will be applied to evaluate the feasibility of the intervention at primary level and its adoption by the health care providers. In Morocco, gestational diabetes screening and its initial management is fragmented and coupled with difficulties in access and treatment delays. Implementation of a strategy that enables detection, management and follow-up of affected women at primary health care level is expected to positively impact on access to care and medical outcomes. The trial has been registered on clininicaltrials.gov ; identifier NCT02979756 ; retrospectively registered 22 November 2016.

Intravenous Acetaminophen in Multimodal Pain Management for Patients Undergoing Total Knee Arthroplasty: A Randomized, Double-Blind, Placebo-Controlled Trial.

PubMed

Murata-Ooiwa, Minako; Tsukada, Sachiyuki; Wakui, Motohiro

2017-10-01

Although multimodal pain management including periarticular multidrug injection can provide excellent pain relief in the early postoperative period after total knee arthroplasty (TKA), rebounding pain remains an important challenge. A randomized, double-blind, placebo-controlled trial was performed to investigate the efficacy of adding intravenous acetaminophen to multimodal pain management for TKA. We enrolled 67 patients scheduled for unilateral TKA. Patients were randomly assigned to receive either 1000 mg of intravenous acetaminophen at 6-hour intervals or normal saline at the same intervals. All patients were treated with intraoperative periarticular multidrug injection and intravenous and oral nonsteroidal anti-inflammatory drugs. The primary outcome was the postoperative 100-mm visual analog pain scale at the time of administration of study drugs. In the intention-to-treat analysis, the pain score was significantly better in the intravenous acetaminophen group than the placebo group at 17:00 one day after TKA (15.3 ± 17.0 mm vs 26.8 ± 19.0 mm; P = .013). There were no significant differences in terms of the rate of complications between groups. Even in the setting of multimodal pain management including periarticular multidrug injection, intravenous acetaminophen provided better pain relief for patients undergoing unilateral TKA. Copyright © 2017 Elsevier Inc. All rights reserved.

Active Intervention Can Decrease Burnout In Ed Nurses.

PubMed

Wei, Rong; Ji, Hong; Li, Jianxin; Zhang, Liyao

2017-03-01

The aim of this study was to evaluate whether active intervention can decrease job burnout and improve performance among ED nurses. This study was carried out in the emergency departments of 3 hospitals randomly selected from 8 comprehensive high-level hospitals in Jinan, China. A total of 102 nurses were enrolled and randomly divided into control and intervention groups. For 6 months, nurses in intervention groups were treated with ordinary treatment plus comprehensive management, whereas nurses in the control group were treated with ordinary management, respectively. Questionnaires were sent and collected at baseline and at the end of the study. The Student t test was used to evaluate the effect of comprehensive management in decreasing burnout. All ED nurses showed symptoms of job burnout at different levels. Our data indicated that comprehensive management significantly decreased emotional exhaustion and depersonalization (P < .01). The findings suggest that active intervention with comprehensive management may effectively reduce job burnout in ED nurses and contribute to relieving work-related stress and may further protect against potential mental health problems. Copyright © 2016 Emergency Nurses Association. Published by Elsevier Inc. All rights reserved.

An international randomized study of a home-based self-management program for severe COPD: the COMET.

PubMed

Bourbeau, Jean; Casan, Pere; Tognella, Silvia; Haidl, Peter; Texereau, Joëlle B; Kessler, Romain

2016-01-01

Most hospitalizations and costs related to COPD are due to exacerbations and insufficient disease management. The COPD patient Management European Trial (COMET) is investigating a home-based multicomponent COPD self-management program designed to reduce exacerbations and hospital admissions. Multicenter parallel randomized controlled, open-label superiority trial. Thirty-three hospitals in four European countries. A total of 345 patients with Global initiative for chronic Obstructive Lung Disease III/IV COPD. The program includes extensive patient coaching by health care professionals to improve self-management (eg, develop skills to better manage their disease), an e-health platform for reporting frequent health status updates, rapid intervention when necessary, and oxygen therapy monitoring. Comparator is the usual management as per the center's routine practice. Yearly number of hospital days for acute care, exacerbation number, quality of life, deaths, and costs.

Medium-term effectiveness of online behavioral training in migraine self-management: A randomized trial controlled over 10 months.

PubMed

Sorbi, M J; Kleiboer, A M; van Silfhout, H G; Vink, G; Passchier, J

2015-06-01

This randomized, controlled trial examined the medium-term effectiveness of online behavioral training in migraine self-management (oBT; N = 195) versus waitlist control (WLC; N = 173) on attack frequency, indicators of self-management (primary outcomes), headache top intensity, use of rescue medications, quality of life and disability (secondary outcomes). An online headache diary following the ICHD-II and questionnaires were completed at baseline (T0), post-training (T1) and six months later (T2). Missing data (T1: 24%; T2: 37%) were handled by multiple imputation. We established effect sizes (ES) and tested between-group differences over time with linear mixed modelling techniques based on the intention-to-treat principle. At T2, attack frequency had improved significantly in oBT (-23%, ES = 0.66) but also in WLC (-19%; ES = 0.52). Self-efficacy, internal and external control in migraine management--and triptan use--improved only in oBT, however. This indicates different processes in both groups and could signify (the start of) active self-management in oBT. Also, only oBT improved migraine-specific quality of life to a sizable extent. oBT produced self-management gains but could not account for improved attack frequency, because WLC improved as well. The perspective that BT effects develop gradually, and that online delivery will boost BT outreach, justifies further research. © International Headache Society 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

Effects of consumer-oriented health information technologies in diabetes management over time: a systematic review and meta-analysis of randomized controlled trials.

PubMed

Tao, Da; Wang, Tieyan; Wang, Tieshan; Liu, Shuang; Qu, Xingda

2017-09-01

To reveal the effects of consumer-oriented health information technologies (CHITs) on patient outcomes in diabetes management over time through systematic review and meta-analysis. We searched 5 electronic databases (from database inception to July 2016) for studies that reported on randomized controlled trials examining the effects of CHITs on glycemic control and other patient outcomes in diabetes management. Data were analyzed using either meta-analysis or a narrative synthesis approach. Eighty randomized controlled trial studies, representing 87 individual trials, were identified and included for analysis. Overall, the meta-analysis showed that the use of CHITs resulted in significant improvement in glycemic control compared to usual care (standardized mean difference = -0.31%, 95% confidence interval -0.38 to -0.23, P  < .001) in patients with diabetes. Specifically, improvement in glycemic control was significant at intervention durations of 3, 6, 8, 9, 12, 15, 30, and 60 months, while no significant differences were found at other time points reported. The narrative synthesis provided mixed effects of CHITs on other clinical, psychosocial, behavioral, and knowledge outcomes. The use of CHITs appears to be more effective than usual care in improving glycemic control for patients with diabetes. However, their effectiveness did not remain consistent over time and in other patient outcomes. Further efforts are required to examine long-term effects of CHITs and to explore factors that can moderate the effects over time. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Efficacy of a church-based lifestyle intervention programme to control high normal blood pressure and/or high normal blood glucose in church members: a randomized controlled trial in Pretoria, South Africa.

PubMed

Pengpid, Supa; Peltzer, Karl; Skaal, Linda

2014-06-06

In persons 15 years and above in South Africa the prevalence of pre-diabetes and diabetes has been estimated at 9.1% and 9.6%, respectively, and the prevalence of systolic prehypertension and hypertension, 38.2% and 24.6%, respectively. Elevated blood glucose and elevated blood pressure are prototype of preventable chronic cardiovascular disease risk factors.Lifestyle interventions have been shown to control high normal blood pressure and/or high normal blood glucose. This study proposes to evaluate the efficacy of a community (church)-based lifestyle intervention programme to control high normal blood pressure and/or high normal blood glucose in church members in a randomized controlled trial in Gauteng, South Africa. The objectives are to: (1) measure non-communicable diseases profile, including hypertension and diabetes, health behaviours, weight management and psychological distress of church members; (2) measure the reduction of blood glucose and blood pressure levels after the intervention; (3) prevent the development of impaired glucose tolerance; (4) compare health behaviours, weight management and psychological distress, blood glucose and blood pressure levels between intervention and control groups, and within group during 6, 12, 24 and 36 months during and post intervention. The study will use a group-randomized design, recruiting 300 church members from 12 churches. Churches will be randomly assigned to experimental and control conditions. Lifestyle interventions may prevent from the development of high blood pressure and/or diabetes. The findings will impact public health and will enable the health ministry to formulate policy related to lifestyle interventions to control blood pressure and glucose. PACTR201105000297151.

Balloon dilation of the eustachian tube for dilatory dysfunction: A randomized controlled trial.

PubMed

Poe, Dennis; Anand, Vijay; Dean, Marc; Roberts, William H; Stolovitzky, Jose Pablo; Hoffmann, Karen; Nachlas, Nathan E; Light, Joshua P; Widick, Mark H; Sugrue, John P; Elliott, C Layton; Rosenberg, Seth I; Guillory, Paul; Brown, Neil; Syms, Charles A; Hilton, Christopher W; McElveen, John T; Singh, Ameet; Weiss, Raymond L; Arriaga, Moises A; Leopold, John P

2018-05-01

To assess balloon dilation of the Eustachian tube with Eustachian tube balloon catheter in conjunction with medical management as treatment for Eustachian tube dilatory dysfunction. In this prospective, multicenter, randomized, controlled trial, we assigned, in a 2:1 ratio, patients age 22 years and older with Eustachian tube dilatory dysfunction refractory to medical therapy to undergo balloon dilation of the Eustachian tube with balloon catheter in conjunction with medical management or medical management alone. The primary endpoint was normalization of tympanogram at 6 weeks. Additional endpoints were normalization of Eustachian Tube Dysfunction Questionaire-7 symptom scores, positive Valsalva maneuver, mucosal inflammation, and safety. Primary efficacy results demonstrated superiority of balloon dilation of the Eustachian tube with balloon catheter + medical management compared to medical management alone. Tympanogram normalization at 6-week follow-up was observed in 51.8% (72/139) of investigational patients versus 13.9% (10/72) of controls (P < .0001). Tympanogram normalization in the treatment group was 62.2% after 24 weeks. Normalization of Eustachian Tube Dysfunction Questionaire-7 Symptom scores at 6-week follow-up was observed in 56.2% (77/137) of investigational patients versus 8.5% (6/71) controls (P < .001). The investigational group also demonstrated substantial improvement in both mucosal inflammation and Valsalva maneuver at 6-week follow-up compared to controls. No device- or procedure-related serious adverse events were reported for those who underwent balloon dilation of the Eustachian tube. This study demonstrated superiority of balloon dilation of the Eustachian tube with balloon catheter + medical management compared to medical management alone to treat Eustachian tube dilatory dysfunction in adults. 1b. Laryngoscope, 128:1200-1206, 2018. © 2017 The American Laryngological, Rhinological and Otological Society, Inc.

Randomized Controlled Trial Comparing Collagen/Oxidized Regenerated Cellulose/Silver to Standard of Care in the Management of Venous Leg Ulcers.

PubMed

Cullen, Breda M; Serena, Thomas E; Gibson, Molly C; Snyder, Robert J; Hanft, Jason R; Yaakov, Raphael A

2017-10-01

To assess healing outcomes in venous leg ulcers (VLUs) treated with a combination of collagen, oxidized regenerated cellulose, and silver in conjunction with standard of care (SOC; intervention group) compared with SOC alone (control group). Standard of care included ADAPTIC nonadhering dressing (Acelity, San Antonio, Texas) and compression. Randomized controlled trial that followed patients in 3 US facilities for 12 weeks or until complete healing. Forty-nine patients with VLUs were randomized to either the intervention group (n = 22) or the control group (n = 27). Wound healing over 12 weeks. Intent-to-treat analysis showed a mean percentage wound area reduction at 12 weeks of 85.6% (SD, 28.6%) for the intervention group and 72.5% (SD, 77.8%) for the control group. There was a higher healing rate in the intervention group compared with patients who received SOC only at both week 4 (23% vs 11%) and week 12 (64% vs 59%). There were no adverse events related to the study therapy. Although the results were not significant, there was a trend toward faster healing in the intervention group. The results of this study indicate that collagen/oxidized regenerated cellulose/silver is a suitable and safe adjunctive intervention for use with SOC to manage VLUs.

Effects of gut-directed hypnotherapy on IBS in different clinical settings-results from two randomized, controlled trials.

PubMed

Lindfors, Perjohan; Unge, Peter; Arvidsson, Patrik; Nyhlin, Henry; Björnsson, Einar; Abrahamsson, Hasse; Simrén, Magnus

2012-02-01

Gut-directed hypnotherapy has been found to be effective in irritable bowel syndrome (IBS). However, randomized, controlled studies are rare and few have been performed outside highly specialized research centers. The objective of this study was to study the effect of gut-directed hypnotherapy in IBS in different clinical settings outside the traditional research units. The study population included IBS patients refractory to standard management. In study 1, patients were randomized to receive gut-directed hypnotherapy (12 sessions, 1 h/week) in psychology private practices or supportive therapy, whereas patients were randomized to receive gut-directed hypnotherapy in a small county hospital or to serve as waiting list controls in study 2. Gastrointestinal symptom severity and quality of life were evaluated at baseline, at 3 months follow-up and after 1 year. We randomized 138 IBS patients refractory to standard management, 90 in study 1 and 48 in study 2. In both the studies, IBS-related symptoms were improved at 3 months in the gut-directed hypnotherapy groups (P<0.05), but not in the control groups (ns). In study 1, a significantly greater improvement of IBS-related symptom severity could be detected in the gut-directed hypnotherapy group than in the control group (P<0.05), and a trend in the same direction was seen in study 2 (P=0.17). The results seen at 3 months were sustained up to 1 year. Gut-directed hypnotherapy is an effective treatment alternative for patients with refractory IBS, but the effectiveness is lower when the therapy is given outside the highly specialized research centers.

Nitrous oxide for pain management of first trimester surgical abortion -- a randomized controlled pilot study.

PubMed

Singh, Rameet H; Espey, Eve; Carr, Shannon; Pereda, Brenda; Ogburn, Tony; Leeman, Lawrence

2015-02-01

The objective was to determine feasibility of a study comparing mean pain scores between women randomized to nitrous oxide/oxygen (NO) versus oxygen+oral analgesics for trimester surgical abortion. Pilot randomized controlled trial comparing NO (n=10) versus oxygen+oral analgesics (n=10). Feasibility of subject recruitment, and pain and satisfaction scores on a visual analog scale were evaluated. Fifty-seven percent of eligible women participated. Mean pain scores were similar between groups, and mean satisfaction scores were higher for the NO group (77.5 vs. 46.7, P=.048). The majority of eligible women agreed to participate in this study evaluating an uncommon pain control intervention. Copyright © 2015 Elsevier Inc. All rights reserved.

Facilitators and Barriers to the Achievement of Healthy Lifestyle Goals: Qualitative Findings From Australian Parents Enrolled in the PEACH Child Weight Management Program.

PubMed

Perry, Rebecca Anne; Daniels, Lynne Anne; Bell, Lucinda; Magarey, Anthea Margaret

2017-01-01

To describe the qualitative research methods used in the Parenting Eating and Activity for Child Health (PEACH) randomized controlled trial and to examine parent-reported facilitators and barriers to the achievement of program goals. Qualitative study using semistructured interviews. Parents enrolled in the Australian PEACH randomized controlled trial, a family-focused child weight management program conducted blinded for review. A total of 95 parents of overweight children aged 5-10 years participated in face-to-face semistructured interviews. Factors external to the PEACH intervention that facilitated or inhibited their success. Interviews were recorded, transcribed, and analyzed using thematic analysis techniques. Three facilitator themes were identified: (1) internal locus of parental control, (2) external locus of parental control, and (3) child factors. Six barrier themes were identified: (1) internal locus of parental control, (2) external locus of parental control, and (3) child factors; (4) maintenance and managing special occasions; (5) time management challenges; and (6) inconsistencies or lack of support. The social and environmental barriers and time pressures identified by parents are a common feature of Western family life such that many parents are raising families in stressful situations. Insights provided by this qualitative research provide an important understanding of these experiences. Consideration of such issues in the design and implementation of future child weight management interventions may help to increase the acceptability and effectiveness of such programs. Copyright © 2016 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

Web-based proactive system to improve breast cancer screening: a randomized controlled trial.

PubMed

Chaudhry, Rajeev; Scheitel, Sidna M; McMurtry, Erin K; Leutink, Dorinda J; Cabanela, Rosa L; Naessens, James M; Rahman, Ahmed S; Davis, Lynn A; Stroebel, Robert J

2007-03-26

Screening mammography is recommended for early detection of breast cancer but screening rates remain suboptimal. A primary care portal for a large academic primary practice was developed for all preventive services. Another Web-based system (PRECARES [PREventive CAre REminder System]) was developed for appointment secretaries to manage proactive breast cancer screening. Female patients aged 40 to 75 years were randomly assigned to a control group (usual care) and an intervention group. For the intervention group, 2 monthly letters inviting patients to undergo mammography were sent starting 3 months before they were due for annual screening, followed by a telephone call to nonresponding patients. A subgroup of women employees was further randomized to receive a reminder by either US mail or e-mail. Of the total eligible population of 6665 women identified as having consented to participate in research, 3339 were randomly assigned to the control group and 3326 to the intervention group. The screening rate for annual mammography was 64.3% for the intervention group and 55.3% for the control group (P <.001). There were no significant differences between the 2 groups for any of the other adult preventive services. For the employee subgroup, the screening rate was 57.5% for the control group, 68.1% for the US mail group, and 72.2% for the e-mail group (intervention vs control, P <.001; e-mail vs US mail; P = .24). The breast cancer screening rate improved significantly with the practice redesign of having appointment secretaries proactively manage breast cancer screening needs.

Associations among comorbid anxiety, psychiatric symptomatology, and diabetic control in a population with serious mental illness and diabetes: Findings from an interventional randomized controlled trial.

PubMed

Aftab, Awais; Bhat, Chetan; Gunzler, Douglas; Cassidy, Kristin; Thomas, Charles; McCormick, Richard; Dawson, Neal V; Sajatovic, Martha

2018-05-01

Objective Serious mental illness and type II diabetes mellitus have a high comorbidity, and both have a higher prevalence of anxiety disorders compared to the general population. Targeted Training in Illness Management is a group-based self-management training approach which targets serious mental illness and type II diabetes mellitus concurrently. This analysis examines data from a randomized controlled trial of Targeted Training in Illness Management intervention to examine the impact of comorbid anxiety on baseline psychiatric symptomatology and diabetic control, and on longitudinal treatment outcomes. Methods We conducted secondary analyses on data from a prospective, 60-week, randomized controlled trial testing Targeted Training in Illness Management versus treatment as usual in 200 individuals with serious mental illness and diabetes. Primary outcomes included measures related to serious mental illness symptoms, functional status, general health status, and diabetes control. Measures were compared between those participants with anxiety disorders versus those without anxiety at baseline as well as over time using linear mixed effects analyses. Results Forty seven percent of the participants had one or more anxiety disorders. At baseline, those with an anxiety diagnosis had higher illness severity, depressive, and other psychiatric symptomatology and disability. Diabetic control (HbA1c) was not significantly different at baseline. In the longitudinal analyses, no significant mean slope differences over time (group-by-time interaction effect) between those with anxiety diagnoses and those without in treatment as usual group were found for primary outcomes. Within the Targeted Training in Illness Management arm, those with anxiety disorders had significantly greater improvement in mental health functioning. Those with anxiety comorbidity in the Targeted Training in Illness Management group demonstrated significantly lower HbA1c levels compared to no anxiety comorbidity and also demonstrated a greater improvement in HbA1c over the first 30 weeks compared to those without anxiety comorbidity. Conclusion Comorbid anxiety in serious mental illness and type II diabetes mellitus population is associated with increased psychiatric symptomatology and greater disability. Individuals from this population appear to experience greater improvement in functioning from baseline with the Targeted Training in Illness Management intervention. Anxiety comorbidity in the serious mental illness and type II diabetes mellitus population does not appear to have a negative impact on diabetic control. These complex relationships need further study. Clinical Trials Registration ClinicalTrials.gov: Improving outcomes for individuals with serious mental illness and diabetes (NCT01410357).

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.

Internet-based self-management plus education compared with usual care in asthma: a randomized trial.

PubMed

van der Meer, Victor; Bakker, Moira J; van den Hout, Wilbert B; Rabe, Klaus F; Sterk, Peter J; Kievit, Job; Assendelft, Willem J J; Sont, Jacob K

2009-07-21

The Internet may support patient self-management of chronic conditions, such as asthma. To evaluate the effectiveness of Internet-based asthma self-management. Randomized, controlled trial. 37 general practices and 1 academic outpatient department in the Netherlands. 200 adults with asthma who were treated with inhaled corticosteroids for 3 months or more during the previous year and had access to the Internet. Asthma-related quality of life at 12 months (minimal clinically significant difference of 0.5 on the 7-point scale), asthma control, symptom-free days, lung function, and exacerbations. Participants were randomly assigned by using a computer-generated permuted block scheme to Internet-based self-management (n = 101) or usual care (n = 99). The Internet-based self-management program included weekly asthma control monitoring and treatment advice, online and group education, and remote Web communications. Asthma-related quality of life improved by 0.56 and 0.18 points in the Internet and usual care groups, respectively (adjusted between-group difference, 0.38 [95% CI, 0.20 to 0.56]). An improvement of 0.5 point or more occurred in 54% and 27% of Internet and usual care patients, respectively (adjusted relative risk, 2.00 [CI, 1.38 to 3.04]). Asthma control improved more in the Internet group than in the usual care group (adjusted difference, -0.47 [CI, -0.64 to -0.30]). At 12 months, 63% of Internet patients and 52% of usual care patients reported symptom-free days in the previous 2 weeks (adjusted absolute difference, 10.9% [CI, 0.05% to 21.3%]). Prebronchodilator FEV1 changed with 0.24 L and -0.01 L for Internet and usual care patients, respectively (adjusted difference, 0.25 L [CI, 0.03 to 0.46 L]). Exacerbations did not differ between groups. The study was unblinded and lasted only 12 months. Internet-based self-management resulted in improvements in asthma control and lung function but did not reduce exacerbations, and improvement in asthma-related quality of life was slightly less than clinically significant. Netherlands Organization for Health Research and Development, ZonMw, and Netherlands Asthma Foundation.

A randomized trial of a primary care-based disease management program to improve cardiovascular risk factors and glycated hemoglobin levels in patients with diabetes.

PubMed

Rothman, Russell L; Malone, Robb; Bryant, Betsy; Shintani, Ayumi K; Crigler, Britton; Dewalt, Darren A; Dittus, Robert S; Weinberger, Morris; Pignone, Michael P

2005-03-01

To assess the efficacy of a pharmacist-led, primary care-based, disease management program to improve cardiovascular risk factors and glycated hemoglobin (A(1C)) levels in vulnerable patients with poorly controlled diabetes. A randomized controlled trial of 217 patients with type 2 diabetes and poor glycemic control (A(1C) level >or=8.0%) was conducted at an academic general medicine practice from February 2001 to April 2003. Intervention patients received intensive management from clinical pharmacists, as well as from a diabetes care coordinator who provided diabetes education, applied algorithms for managing glucose control and decreasing cardiovascular risk factors, and addressed barriers to care. Control patients received a one-time management session from a pharmacist followed by usual care from their primary care provider. Outcomes were recorded at baseline and at 6 and 12 months. Primary outcomes included blood pressure, A(1C) level, cholesterol level, and aspirin use. Secondary outcomes included diabetes knowledge, satisfaction, use of clinical services, and adverse events. For the 194 patients (89%) with 12-month data, the intervention group had significantly greater improvement than did the control group for systolic blood pressure (-9 mm Hg; 95% confidence interval [CI]: -16 to -3 mm Hg) and A(1C) level (-0.8%; 95% CI: -1.7% to 0%). Change in total cholesterol level was not significant. At 12 months, aspirin use was 91% in the intervention group versus 58% among controls (P <0.0001). Intervention patients had greater improvements in diabetes knowledge and satisfaction than did control patients. There were no significant differences in use of clinical services or adverse events. Our comprehensive disease management program reduced cardiovascular risk factors and A(1C) levels among vulnerable patients with type 2 diabetes and poor glycemic control.

An interactive health communication application for supporting parents managing childhood long-term conditions: outcomes of a randomized controlled feasibility trial.

PubMed

Swallow, Veronica M; Knafl, Kathleen; Santacroce, Sheila; Campbell, Malcolm; Hall, Andrew G; Smith, Trish; Carolan, Ian

2014-12-03

Families living with chronic or long-term conditions such as chronic kidney disease (CKD), stages 3-5, face multiple challenges and respond to these challenges in various ways. Some families adapt well while others struggle, and family response to a condition is closely related to outcome. With families and professionals, we developed a novel condition-specific interactive health communication app to improve parents' management ability-the online parent information and support (OPIS) program. OPIS consists of a comprehensive mix of clinical caregiving and psychosocial information and support. The purpose of this study was to (1) assess feasibility of a future full-scale randomized controlled trial (RCT) of OPIS in terms of recruitment and retention, data collection procedures, and psychometric performance of the study measures in the target population, and (2) investigate trends in change in outcome measures in a small-scale RCT in parents of children with CKD stages 3-5. Parents were recruited from a pediatric nephrology clinic and randomly assigned to one of two treatment groups: usual support for home-based clinical caregiving (control) or usual support plus password-protected access to OPIS for 20 weeks (intervention). Both groups completed study measures at study entry and exit. We assessed feasibility descriptively in terms of recruitment and retention rates overall; assessed recruitment, retention, and uptake of the intervention between groups; and compared family condition management, empowerment to deliver care, and fathers' involvement between groups. We recruited 55 parents of 39 children (42% of eligible families). Of those, about three-quarters of intervention group parents (19/26, 73%) and control group parents (22/29, 76%) were retained through completion of 20-week data collection. The overall retention rate was 41/55 (75%). The 41 parents completing the trial were asked to respond to the same 10 questionnaire scales at both baseline and 20 weeks later; 10 scores were missing at baseline and nine were missing at 20 weeks. Site user statistics provided evidence that all intervention group parents accessed OPIS. Analysis found that intervention group parents showed a greater improvement in perceived competence to manage their child's condition compared to control group parents: adjusted mean Family Management Measure (FaMM) Condition Management Ability Scale intervention group 44.5 versus control group 41.9, difference 2.6, 95% CI -1.6 to 6.7. Differences between the groups in the FaMM Family Life Difficulty Scale (39.9 vs 36.3, difference 3.7, 95% CI -4.9 to 12.2) appeared to agree with a qualitative observation that OPIS helped parents achieve understanding and maintain awareness of the impact of their child's condition. A full-scale RCT of the effectiveness of OPIS is feasible. OPIS has the potential to beneficially affect self-reported outcomes, including parents' perceived competence to manage home-based clinical care for children with CKD stage 3-5. Our design and methodology can be transferred to the management of other childhood conditions. International Standard Randomized Controlled Trial Number (ISRCTN): 84283190; http://www.controlled-trials.com/ISRCTN84283190 (Archived by WebCite at http://www.webcitation.org/6TuPdrXTF).

A randomized controlled trial of a Return-to-Work Coordinator model of care in a general hospital to facilitate return to work of injured workers.

PubMed

Tan, Heidi Siew Khoon; Yeo, Doreen Sai Ching; Giam, Joanna Yu Ting; Cheong, Florence Wai Fong; Chan, Kay Fei

2016-04-07

Return-to-work (RTW) programmes for injured workers have been prevalent in Western countries with established work injury management policies for decades. In recent years, more Asian countries have started to develop RTW programmes in the absence of work injury management policies. However, few studies have evaluated the effectiveness of RTW programmes in Asia. Return-to-work coordination has been found to be an important facilitator in RTW programmes. This study seeks to determine the effectiveness of a Return-to-work coordinator (RTWC) model of care in facilitating early RTW for injured workers in Singapore. A randomized controlled trial was used. 160 injured workers in a general hospital were randomly allocated to either control (receive usual hospital standard care) or intervention (assigned a RTWC) group. The RTWC closely supported RTW arrangements and proactively liaised with employers and healthcare professionals on RTW solutions for the injured workers. At three months post injury, workers in the intervention group RTW 10 days earlier than the control group, with a higher proportion of workers in the intervention group returning to modified jobs. There were no significant differences in the quality of life measures between the two groups. The addition of a RTWC into the hospital model of care is effective in facilitating early RTW for injured workers. This could be a potential model of care for injured workers in Asian countries where work injury management policies are not yet established.

Distance education and diabetes empowerment: A single-blind randomized control trial.

PubMed

Zamanzadeh, Vahid; Zirak, Mohammad; Hemmati Maslakpak, Masomeh; Parizad, Naser

2017-11-01

Diabetes is one of the biggest problems in healthcare systems and kills many people every year. Diabetes management is impossible when only utilizing medication. So, patients must be educated to manage their diabetes. This study aims to assess the effect of education by telephone and short message service on empowering patients with type 2 diabetes (primary outcome). A single-blind randomized controlled trial was conducted in the Urmia diabetes association in Iran. Sixty six participants with definitive diagnosis of type 2 diabetes entered into the study. Patients with secondary health problems were excluded. Patients were selected by simple random sampling then allocated into intervention (n=33) and control (n=33) groups. The intervention group received an educational text message daily and instructive phone calls three days a week for three months along with usual care. The Diabetes Empowerment Scale (DES) with confirmed validity and reliability was used for collecting data. Data was analyzed using SPSS V6.1. Independent t-test, paired t-test and chi-square were used to analyze the data. The empowerment of the intervention group compared with the control group significantly improved after three months of distance education (p<0.00, EF=1. 16). The study findings show that the distance education has a significant effect on empowering patients with type 2 diabetes. Therefore, using distance education along with other diabetes management intervention is highly effective and should be part of the care in diabetes treatment. Copyright © 2016 Diabetes India. Published by Elsevier Ltd. All rights reserved.

Pilot trial of osteopathic manipulative therapy for patients with frequent episodic tension-type headache.

PubMed

Rolle, Guido; Tremolizzo, Lucio; Somalvico, Francesco; Ferrarese, Carlo; Bressan, Livio C

2014-09-01

Osteopathic manipulative therapy (OMTh; manipulative care provided by foreign-trained osteopaths) may be used for managing headache pain and related disability, but there is a need for high-quality randomized controlled trials to assess the effectiveness of this intervention. To explore the efficacy of OMTh for pain management in frequent episodic tension-type headache (TTH). Single-blind randomized placebo-controlled pilot study. Patients were recruited from 5 primary care settings. Forty-four patients who were affected by frequent episodic TTH and not taking any drugs for prophylactic management of episodic TTH were recruited. Patients were randomly allocated to an experimental or control group. The experimental group received corrective OMTh techniques, tailored for each patient; the control group received assessment of the cranial rhythmic impulse (sham therapy). The study included a 1-month baseline period, a 1-month treatment period, and a 3-month follow-up period. The primary outcome was the change in patient-reported headache frequency, and secondary outcomes included changes in headache pain intensity (discrete score, 1 [lowest perceived pain] to 5 [worst perceived pain]), over-the-counter medication use, and Headache Disability Inventory score. Forty patients completed the study (OMTh, n=21; control, n=19). The OMTh group had a significant reduction in headache frequency over time that persisted 1 month (approximate reduction, 40%; P<.001) and 3 months (approximate reduction, 50%; P<.001) after the end of treatment. Moreover, there was an absolute difference between the 2 treatment groups at the end of the study, with a 33% lower frequency of headache in the OMTh group (P<.001). This feasibility study demonstrated the efficacy of OMTh in the management of frequent episodic TTH, compared with sham therapy in a control group. Osteopathic manipulative therapy may be preferred over other treatment modalities and may benefit patients who have adverse effects to medications or who have difficulty complying with pharmacologic regimens. This protocol may serve as a model for future studies. © 2014 The American Osteopathic Association.

Effectiveness of self-management training in type 2 diabetes: a systematic review of randomized controlled trials.

PubMed

Norris, S L; Engelgau, M M; Narayan, K M

2001-03-01

To systematically review the effectiveness of self-management training in type 2 diabetes. MEDLINE, Educational Resources Information Center (ERIC), and Nursing and Allied Health databases were searched for English-language articles published between 1980 and 1999. Studies were original articles reporting the results of randomized controlled trials of the effectiveness of self-management training in people with type 2 diabetes. Relevant data on study design, population demographics, interventions, outcomes, methodological quality, and external validity were tabulated. Interventions were categorized based on educational focus (information, lifestyle behaviors, mechanical skills, and coping skills), and outcomes were classified as knowledge, attitudes, and self-care skills; lifestyle behaviors, psychological outcomes, and quality of life; glycemic control; cardiovascular disease risk factors; and economic measures and health service utilization. A total of 72 studies described in 84 articles were identified for this review. Positive effects of self-management training on knowledge, frequency and accuracy of self-monitoring of blood glucose, self-reported dietary habits, and glycemic control were demonstrated in studies with short follow-up (<6 months). Effects of interventions on lipids, physical activity, weight, and blood pressure were variable. With longer follow-up, interventions that used regular reinforcement throughout follow-up were sometimes effective in improving glycemic control. Educational interventions that involved patient collaboration may be more effective than didactic interventions in improving glycemic control, weight, and lipid profiles. No studies demonstrated the effectiveness of self-management training on cardiovascular disease-related events or mortality; no economic analyses included indirect costs; few studies examined health-care utilization. Performance, selection, attrition, and detection bias were common in studies reviewed, and external generalizability was often limited. Evidence supports the effectiveness of self-management training in type 2 diabetes, particularly in the short term. Further research is needed to assess the effectiveness of self-management interventions on sustained glycemic control, cardiovascular disease risk factors, and ultimately, microvascular and cardiovascular disease and quality of life.

School Programs Targeting Stress Management in Children and Adolescents: A Meta-Analysis

ERIC Educational Resources Information Center

Kraag, Gerda; Zeegers, Maurice P.; Kok, Gerjo; Hosman, Clemens; Abu-Saad, Huda Huijer

2006-01-01

Introduction: This meta-analysis evaluates the effect of school programs targeting stress management or coping skills in school children. Methods: Articles were selected through a systematic literature search. Only randomized controlled trials or quasi-experimental studies were included. The standardized mean differences (SMDs) between baseline…

Improvement of Rural Children's Asthma Self-Management by Lay Health Educators

ERIC Educational Resources Information Center

Horner, Sharon D.; Fouladi, Rachel T.

2008-01-01

Background: The purpose of the present analysis is to examine changes in rural children's asthma self-management after they received lay health educator (LHE)-delivered classes. Methods: Elementary schools were randomly assigned to the treatment or attention-control condition and their participating students received either asthma education or…

A Randomized Controlled Trial of Consensus-Based Child Abuse Case Management

ERIC Educational Resources Information Center

Goldbeck, L.; Laib-Koehnemund, A.; Fegert, J. M.

2007-01-01

Objective: This study evaluates the effects of expert-assisted child abuse and neglect case management in the German child welfare and healthcare system as perceived by the case workers themselves. Methods: Case workers with different professions (social workers, counselors, clinic-based and office-based psychotherapists, and physicians)…

Structural Dynamics of Management Zones for the Site-Specific Control of Tarnished Plant Bugs in Cotton

USDA-ARS?s Scientific Manuscript database

Precision-based agricultural application of insecticide relies on a non-random distribution of pests; tarnished plant bugs (Lygus lineolaris) are known to prefer vigorously growing patches of cotton. Management zones for various crops have been readily defined using NDVI (Normalized Difference Vege...

Can Chronic Disease Management Programs for Patients with Type 2 Diabetes Reduce Productivity-Related Indirect Costs of the Disease? Evidence from a Randomized Controlled Trial

PubMed Central

Bolin, Jane N.; Ohsfeldt, Robert L.; Phillips, Charles D.; Zhao, Hongwei; Ory, Marcia G.; Forjuoh, Samuel N.

2014-01-01

Abstract The objective was to assess the impacts of diabetes self-management programs on productivity-related indirect costs of the disease. Using an employer's perspective, this study estimated the productivity losses associated with: (1) employee absence on the job, (2) diabetes-related disability, (3) employee presence on the job, and (4) early mortality. Data were obtained from electronic medical records and survey responses of 376 adults aged ≥18 years who were enrolled in a randomized controlled trial of type 2 diabetes self-management programs. All study participants had uncontrolled diabetes and were randomized into one of 4 study arms: personal digital assistant (PDA), chronic disease self-management program (CDSMP), combined PDA and CDSMP, and usual care (UC). The human-capital approach was used to estimate lost productivity resulting from 1, 2, 3, and 4 above, which are summed to obtain total productivity loss. Using robust regression, total productivity loss was modeled as a function of the diabetes self-management programs and other identified demographic and clinical characteristics. Compared to subjects in the UC arm, there were no statistically significant differences in productivity losses among persons undergoing any of the 3 diabetes management interventions. Males were associated with higher productivity losses (+$708/year; P<0.001) and persons with greater than high school education were associated with additional productivity losses (+$758/year; P<0.001). Persons with more than 1 comorbid condition were marginally associated with lower productivity losses (-$326/year; P=0.055). No evidence was found that the chronic disease management programs examined in this trial affect indirect productivity losses. (Population Health Management 2014;17:112–120) PMID:24152055

Short-term outcomes of local infiltration anaesthetic in total knee arthroplasty: a randomized controlled double-blinded controlled trial.

PubMed

Mulford, Jonathan S; Watson, Anna; Broe, David; Solomon, Michael; Loefler, Andreas; Harris, Ian

2016-03-01

The primary objective of the study was to determine if local infiltration anaesthetic (LIA) reduced total length of hospital stay in total knee arthroplasty (TKA) patients. The study also examined whether LIA improves early pain management, patient satisfaction and range of motion in TKA patients. We conducted a randomized controlled double-blinded study. Fifty patients undergoing TKA were randomized to receive either placebo or LIA at the time of surgery and on the first day post-operatively. Pain scores, level of satisfaction and range of motion were recorded preoperatively and post-operatively. There was no statistical difference between the groups for length of stay, post-operative pain scores, satisfaction scores or range of motion 6 weeks post-operatively. This randomized double-blinded trial did not demonstrate a decrease in pain or reduction of length of stay due to local infiltration analgesia. © 2015 Royal Australasian College of Surgeons.

Effect of health information technology interventions on lipid management in clinical practice: a systematic review of randomized controlled trials.

PubMed

Aspry, Karen E; Furman, Roy; Karalis, Dean G; Jacobson, Terry A; Zhang, Audrey M; Liptak, Gregory S; Cohen, Jerome D

2013-01-01

Large gaps in lipid treatment and medication adherence persist in high-risk outpatients in the United States. Health information technology (HIT) is being applied to close quality gaps in chronic illness care, but its utility for lipid management has not been widely studied. To perform a qualitative review of the impact of HIT interventions on lipid management processes of care (screening or testing; drug initiation, titration or adherence; or referrals) or clinical outcomes (percent at low density lipoprotein cholesterol goal; absolute lipid levels; absolute risk scores; or cardiac hospitalizations) in outpatients with coronary heart disease or at increased risk. PubMed and Google Scholar databases were searched using Medical Subject Headings related to clinical informatics and cholesterol or lipid management. English language articles that described a randomized controlled design, tested at least one HIT tool in high risk outpatients, and reported at least 1 lipid management process measure or clinical outcome, were included. Thirty-four studies that enrolled 87,874 persons were identified. Study ratings, outcomes, and magnitude of effects varied widely. Twenty-three trials reported a significant positive effect from a HIT tool on lipid management, but only 14 showed evidence that HIT interventions improve clinical outcomes. There was mixed evidence that provider-level computerized decision support improves outcomes. There was more evidence in support of patient-level tools that provide connectivity to the healthcare system, as well as system-level interventions that involve database monitoring and outreach by centralized care teams. Randomized controlled trials show wide variability in the effects of HIT on lipid management outcomes. Evidence suggests that multilevel HIT approaches that target not only providers but include patients and systems approaches will be needed to improve lipid treatment, adherence and quality. Copyright © 2013 National Lipid Association. Published by Elsevier Inc. All rights reserved.

Lesson Study to Scale up Research-Based Knowledge: A Randomized, Controlled Trial of Fractions Learning

ERIC Educational Resources Information Center

Lewis, Catherine; Perry, Rebecca

2017-01-01

An understanding of fractions eludes many U.S. students, and research-based knowledge about fraction, such as the utility of linear representations, has not broadly influenced instruction. This randomized trial of lesson study supported by mathematical resources assigned 39 educator teams across the United States to locally managed lesson study…

Weight Management in Adults with Intellectual and Developmental Disabilities: A Randomized Controlled Trial of Two Dietary Approaches

ERIC Educational Resources Information Center

Ptomey, Lauren T.; Saunders, Richard R.; Saunders, Muriel; Washburn, Richard A.; Mayo, Matthew S.; Sullivan, Debra K.; Gibson, Cheryl A.; Goetz, Jeannine R.; Honas, Jeff J.; Willis, Erik A.; Danon, Jessica C.; Krebill, Ron; Donnelly, Joseph E.

2018-01-01

Background: The prevalence of obesity among individuals with intellectual and developmental disabilities (IDD) is equal to or greater than the general population. Methods: Overweight/obese adults (BMI =25 kg/m2) with mild-to-moderate intellectual and developmental disabilities were randomized to an enhanced stop light diet…

Advisor-Teller Money Manager (ATM) Therapy for Substance Use Disorders

PubMed Central

Rosen, Marc I.; Rounsaville, Bruce J.; Ablondi, Karen; Black, Anne C.; Rosenheck, Robert A.

2011-01-01

Objective Patients with concomitant psychiatric and substance use disorders are commonly assigned representative payees or case managers to help manage their funds, but money management has not been conceptualized as a theory-based treatment. This randomized clinical trial was conducted to determine the effect of a money management–based therapy, advisor-teller money manager (ATM), on substance abuse or dependence. Methods Ninety patients at a community mental health center who had a history of cocaine or alcohol abuse or dependence were assessed after random assignment to 36 weeks of ATM (N=47) or a control condition in which use of a financial workbook was reviewed (N=43). Patients assigned to ATM were encouraged to deposit their funds into a third-party account, plan weekly expenditures, and negotiate monthly budgets. Substance use calendars and urine toxicology tests were collected every other week for 36 weeks and again 52 weeks after randomization. Results Patients assigned to ATM had significantly more negative toxicologies for cocaine metabolite over time than patients in the control group, and treating clinicians rated ATM patients as significantly more likely to be abstinent from illicit drugs. Self-reported abstinence from alcohol did not significantly differ between groups. Unexpectedly, patients assigned to ATM were more likely to be assigned a representative payee or a conservator than control participants during the follow-up period (ten of 47 versus two of 43). One patient in ATM assaulted the therapist when his check had not arrived. Conclusions ATM is an efficacious therapy for the treatment of cocaine abuse or dependence among people with concomitant psychiatric illness but requires protection of patient autonomy and staff safety. PMID:20592006

Evaluation of a nurse-led disease management programme for chronic kidney disease: a randomized controlled trial.

PubMed

Wong, Frances Kam Yuet; Chow, Susan Ka Yee; Chan, Tony Moon Fai

2010-03-01

Patients with end stage renal failure require dialysis and strict adherence to treatment plans to sustain life. However, non-adherence is a common and serious problem among patients with chronic kidney disease. There is a scarcity of studies in examining the effects of disease management programmes on patients with chronic kidney disease. This paper examines whether the study group receiving the disease management programme have better improvement than the control group, comparing outcomes at baseline (O1), at 7 weeks at the completion of the programme (O2) and at 13 weeks (O3). This is a randomized controlled trial. The outcome measures were non-adherence in diet, fluid, dialysis and medication, quality of life, satisfaction, symptom control, complication control and health service utilisation. There was no significant difference between the control and study group for the baseline measures, except for sleep. Significant differences (p<0.05) were found between the control and study group at O2 in the outcome measures of diet degree non-adherence, sleep, symptom, staff encouragement, overall health and satisfaction. Sustained effects at O3 were noted in the outcome measures of continuous ambulatory peritoneal dialysis (CAPD) non-adherence degree, sleep, symptom, and effect of kidney disease. Many studies exploring chronic disease management have neglected the group with end stage renal failure and this study fills this gap. This study has employed an innovative model of skill mix using specialist and general nurses and demonstrated patient improvement in diet non-adherence, CAPD non-adherence, aspects of quality of life and satisfaction with care. Redesigning chronic disease management programmes helps to optimize the use of different levels of skills and resources to bring about positive outcomes. Copyright 2009 Elsevier Ltd. All rights reserved.

Implementation of Treat-to-Target in Rheumatoid Arthritis Through a Learning Collaborative: Results of a Randomized Controlled Trial.

PubMed

Solomon, Daniel H; Losina, Elena; Lu, Bing; Zak, Agnes; Corrigan, Cassandra; Lee, Sara B; Agosti, Jenifer; Bitton, Asaf; Harrold, Leslie R; Pincus, Theodore; Radner, Helga; Yu, Zhi; Smolen, Josef S; Fraenkel, Liana; Katz, Jeffrey N

2017-07-01

Treat-to-target (TTT) is an accepted paradigm for the management of rheumatoid arthritis (RA), but some evidence suggests poor adherence. The purpose of this study was to test the effects of a group-based multisite improvement learning collaborative on adherence to TTT. We conducted a cluster-randomized quality-improvement trial with waitlist control across 11 rheumatology sites in the US. The intervention entailed a 9-month group-based learning collaborative that incorporated rapid-cycle improvement methods. A composite TTT implementation score was calculated as the percentage of 4 required items documented in the visit notes for each patient at 2 time points, as evaluated by trained staff. The mean change in the implementation score for TTT across all patients for the intervention sites was compared with that for the control sites after accounting for intracluster correlation using linear mixed models. Five sites with a total of 23 participating rheumatology providers were randomized to intervention and 6 sites with 23 participating rheumatology providers were randomized to the waitlist control. The intervention included 320 patients, and the control included 321 patients. At baseline, the mean TTT implementation score was 11% in both arms; after the 9-month intervention, the mean TTT implementation score was 57% in the intervention group and 25% in the control group (change in score of 46% for intervention and 14% for control; P = 0.004). We did not observe excessive use of resources or excessive occurrence of adverse events in the intervention arm. A learning collaborative resulted in substantial improvements in adherence to TTT for the management of RA. This study supports the use of an educational collaborative to improve quality. © 2017, American College of Rheumatology.

The steps to health employee weight management randomized control trial: rationale, design and baseline characteristics.

PubMed

Østbye, Truls; Stroo, Marissa; Brouwer, Rebecca J N; Peterson, Bercedis L; Eisenstein, Eric L; Fuemmeler, Bernard F; Joyner, Julie; Gulley, Libby; Dement, John M

2013-07-01

The workplace can be an important setting for addressing obesity. An increasing number of employers offer weight management programs. Present the design, rationale and baseline characteristics of the Steps to Health study (STH), a randomized trial to evaluate the effectiveness of two preexisting employee weight management programs offered at Duke University and Medical Center. 550 obese (BMI ≥30) employee volunteers were randomized 1:1 to two programs. Baseline data, collected between January 2011 and July 2012, included height/weight, accelerometry, workplace injuries, health care utilization, and questionnaires querying socio-cognitive factors, perceptions of health climate, physical activity, and dietary intake. In secondary analyses participants in the two programs will also be compared to a non-randomized observational control group of obese employees. At baseline, the mean age was 45 years, 83% were female, 41% white, and 53% black. Mean BMI was 37.2. Participants consumed a mean of 2.37 servings of fruits and vegetables per day (in the past week), participated in 11.5 min of moderate-to-vigorous physical activity, and spent 620 min being sedentary. STH addresses the need for evaluation of worksite interventions to promote healthy weight. In addition to having direct positive effects on workers' health, worksite programs have the potential to increase productivity and reduce health care costs. Copyright © 2013 Elsevier Inc. All rights reserved.

Steps to Health employee weight management randomized control trial: short-term follow-up results.

PubMed

Østbye, Truls; Stroo, Marissa; Brouwer, Rebecca J N; Peterson, Bercedis L; Eisenstein, Eric L; Fuemmeler, Bernard F; Joyner, Julie; Gulley, Libby; Dement, John M

2015-02-01

To present the short-term follow-up findings of the Steps to Health study, a randomized trial to evaluate the effectiveness of two employee weight management programs offered within Duke University and the Health System. A total of 550 obese (body mass index, ≥30 kg/m2) employees were randomized 1:1 between January 2011 and June 2012 to the education-based Weight Management (WM) or the WM+ arm, which focused on behavior modification. Employees were contacted to complete a follow-up visit approximately 14 months after baseline. There were no clinically, or statistically, meaningful differences between arms, but there were modest reductions in body mass index, and positive, meaningful changes in diet and physical activity for both arms. The modest positive effects observed in this study may suggest that to achieve weight loss through the workplace more intensive interventions may be required.

Design of the Lifestyle Improvement through Food and Exercise (LIFE) study: a randomized controlled trial of self-management of type 2 diabetes among African American patients from safety net health centers.

PubMed

Lynch, Elizabeth B; Liebman, Rebecca; Ventrelle, Jennifer; Keim, Kathryn; Appelhans, Bradley M; Avery, Elizabeth F; Tahsin, Bettina; Li, Hong; Shapera, Merle; Fogelfeld, Leon

2014-11-01

The Lifestyle Improvement through Food and Exercise (LIFE) study is a community-based randomized-controlled trial to measure the effectiveness of a lifestyle intervention to improve glycemic control among African Americans with type 2 diabetes attending safety net clinics. The study enrolled African American adults with a diagnosis of type 2 diabetes and HbA1c ≥ 7.0 who had attended specific safety net community clinics in the prior year. 210 patients will be enrolled and randomized to either the LIFE intervention or a standard of care control group, which consists of two dietitian-led diabetes self-management classes. The LIFE intervention was delivered in 28 group sessions over 12 months and focused on improving diet through dietitian-led culturally-tailored nutrition education, increasing physical activity through self-monitoring using an accelerometer, increasing ability to manage blood sugar through modifications to lifestyle, and providing social support for behavior change. In addition to the group sessions, peer supporters made regular telephone calls to participants to monitor progress toward behavioral goals and provide social support. The 12-month intervention phase was followed by a six-month maintenance phase consisting of two group sessions. The primary outcome of the study is change in A1C from baseline to 12 months, and an additional follow-up will occur at 18 months. The hypothesis of the study is that the participants in the LIFE intervention will show a greater improvement in glycemic control over 12 months than participants in the control group. Copyright © 2014 Elsevier Inc. All rights reserved.

The efficacy of anticonvulsants on orofacial pain: a systematic review.

PubMed

Martin, Wilhelmus J J M; Forouzanfar, Tymour

2011-05-01

Controversy exists about the effectiveness of anticonvulsants for the management of orofacial pain disorders. To ascertain appropriate therapies, a systematic review was conducted of existing randomized controlled trials. Trials were identified from PubMed, Cochrane, and Ovid Medline databases from 1962 through March 2010, from references in retrieved reports, and from references in review articles. Eight useful trials were identified for this review. Six studies were randomized placebo-controlled trials and 2 studies were randomized active-controlled. Two independent investigators reviewed these articles by using a 15-item checklist. Four studies were classified as "high quality." However, heterogeneity of the trials and the small sample sizes precluded the drawing of firm conclusions about the efficacy of the interventions studied on orofacial pain patients. There is limited to moderate evidence supporting the efficacy of commonly used anticonvulsants for treatment of patients with orofacial pain disorders. More randomized controlled trials are needed on the efficacy of anticonvulsants. Copyright © 2011 Mosby, Inc. All rights reserved.

Effects of far-infrared irradiation on myofascial neck pain: a randomized, double-blind, placebo-controlled pilot study.

PubMed

Lai, Chien-Hung; Leung, Ting-Kai; Peng, Chih-Wei; Chang, Kwang-Hwa; Lai, Ming-Jun; Lai, Wen-Fu; Chen, Shih-Ching

2014-02-01

The objective of this study was to determine the relative efficacy of irradiation using a device containing a far-infrared emitting ceramic powder (cFIR) for the management of chronic myofascial neck pain compared with a control treatment. This was a randomized, double-blind, placebo-controlled pilot study. The study comprised 48 patients with chronic, myofascial neck pain. Patients were randomly assigned to the experimental group or the control (sham-treatment) group. The patients in the experimental group wore a cFIR neck device for 1 week, and the control group wore an inert neck device for 1 week. Quantitative measurements based on a visual analogue scale (VAS) scoring of pain, a sleep quality assessment, pressure-pain threshold (PPT) testing, muscle tone and compliance analysis, and skin temperature analysis were obtained. Both the experimental and control groups demonstrated significant improvement in pain scores. However, no statistically significant difference in the pain scores was observed between the experimental and control groups. Significant decreases in muscle stiffness in the upper regions of the trapezius muscles were reported in the experimental group after 1 week of treatment. Short-term treatment using the cFIR neck device partly reduced muscle stiffness. Although the differences in the VAS and PPT scores for the experimental and control groups were not statistically significant, the improvement in muscle stiffness in the experimental group warrants further investigation of the long-term effects of cFIR treatment for pain management.

HIMALAIA (Hypertension Induction in the Management of AneurysmaL subArachnoid haemorrhage with secondary IschaemiA): a randomized single-blind controlled trial of induced hypertension vs. no induced hypertension in the treatment of delayed cerebral ischemia after subarachnoid hemorrhage.

PubMed

Gathier, C S; van den Bergh, W M; Slooter, A J C

2014-04-01

Delayed cerebral ischemia (DCI) is a major complication after aneurysmal subarachnoid hemorrhage (SAH). One option to treat delayed cerebral ischemia is to use induced hypertension, but its efficacy on the eventual outcome has not been proven in a randomized clinical trial. This article describes the design of the HIMALAIA trial (Hypertension Induction in the Management of AneurysmaL subArachnoid haemorrhage with secondary IschaemiA), designed to assess the effectiveness of induced hypertension on neurological outcome in patients with DCI after SAH. To investigate whether induced hypertension improves the functional outcome in patients with delayed cerebral ischemia after SAH. The HIMALAIA trial is a multicenter, singe-blinded, randomized controlled trial in patients with DCI after a recent SAH. Eligible patients will be randomized to either induced hypertension (n = 120) or to no induced hypertension (n = 120). In selected centers, the efficacy of induced hypertension in augmenting cerebral blood flow will be measured by means of cerebral perfusion computerized tomography scanning. Follow-up assessments will be performed at 3 and 12 months after randomization by trial nurses who are blinded to the treatment allocation and management. We will include patients during five years. The primary outcome is the proportion of subarachnoid hemorrhage patients with delayed cerebral ischemia with poor outcome three-months after randomization, defined as a modified Rankin scale of more than 3. Secondary outcome measures are related to treatment failure, functional outcome, adverse events, and cerebral hemodynamics. The HIMALAIA trial is registered at clinicaltrials.gov under identifier NCT01613235. © 2013 The Authors. International Journal of Stroke © 2013 World Stroke Organization.

Effects of computer-based stress management training on psychological well-being and work performance in japanese employees: a cluster randomized controlled trial.

PubMed

Umanodan, Rino; Shimazu, Akihito; Minami, Masahide; Kawakami, Norito

2014-01-01

This study evaluated the effectiveness of a computer-based stress management training (SMT) program in improving employees' psychological well-being and work performance. A total of 12 work units (N=263) were randomly assigned to either an intervention group (8 work units, n=142) or to a wait-list control group (4 work units, n=121). All participants were requested to answer online questionnaires assessing psychological well-being as a primary outcome, and coping style, social support, and knowledge about stress management as secondary outcomes at baseline (T0), immediately after the intervention (T1), and 2 months after the intervention (T2). The group × time interaction was tested using a mixed-model repeated measures ANOVA. Results showed a group × time interaction for "knowledge about stress management" in the entire sample. Among participants who had more than 3 d of training, a significant group × time interaction was observed for "problem-solving" and "avoidance and suppression" as well as "knowledge about stress management." Our computer-based stress management program was effective for improving knowledge about stress management. It was also effective for improving coping skills in instances where participants had enough time (at least 3 d) to complete all sessions.

Effectiveness of self-management promotion educational program among diabetic patients based on health belief model

PubMed Central

Jalilian, Farzad; Motlagh, Fazel Zinat; Solhi, Mahnaz; Gharibnavaz, Hasan

2014-01-01

Introduction: Diabetes is a chronic disease; it can cause serious complications. Diabetes self-management is essential for prevention of disease complications. This study was conducted to evaluate self-management promotion educational program intervention efficiency among diabetic patients in Iran and health belief model (HBM) was applied as a theoretical framework. Materials and Methods: Overall, 120 Type 2 diabetic patients referred to rural health centers in Gachsaran, Iran participated in this study as randomly divided into intervention and control group. This was a longitudinal randomized pre- and post-test series control group design panel study to implement a behavior modification based intervention to promotion self-management among diabetic patients. Cross-tabulation and t-test by using SPSS statistical package, version 16 was used for the statistical analysis. Results: Mean age was 55.07 years (SD = 9.94, range: 30-70). Our result shows significant improvements in average response for susceptibility, severity, benefit and self-management among intervention group. Additionally, after intervention, average response of the barrier to self-management was decreased among intervention group. Conclusion: Our result showed education program based on HBM was improve of self-management and seems implementing these programs can be effective in the and prevention of diabetes complications. PMID:24741654

Improving communication in cancer pain management nursing: a randomized controlled study assessing the efficacy of a communication skills training program.

PubMed

Canivet, Delphine; Delvaux, Nicole; Gibon, Anne-Sophie; Brancart, Cyrielle; Slachmuylder, Jean-Louis; Razavi, Darius

2014-12-01

Effective communication is needed for optimal cancer pain management. This study assessed the efficacy of a general communication skills training program for oncology nurses on communication about pain management. A total of 115 nurses were randomly assigned to a training group (TG) or control group (CG). The assessment included the recording of interviews with a simulated cancer patient at baseline for both groups and after training (TG) or 3 months after baseline (CG). Two psychologists rated the content of interview transcripts to assess cancer pain management communication. Group-by-time effects were measured using a generalized estimating equation. Trained nurses asked the simulated patient more questions about emotions associated with pain (relative rate [RR] = 4.28, p = 0.049) and cognitions associated with pain treatment (RR = 3.23, p < 0.001) and used less paternalistic statements about cancer pain management (RR = 0.40, p = 0.006) compared with untrained nurses. The general communication skills training program improved only a few of the communication strategies needed for optimal cancer pain management in nursing. General communication skills training programs should be consolidated using specific modules focusing on communication skills related to cancer pain management.

A Mood Management Intervention in an Internet Stop Smoking Randomized Controlled Trial Does Not Prevent Depression: A Cautionary Tale

PubMed Central

Schueller, Stephen M.; Pérez-Stable, Eliseo J.; Muñoz, Ricardo F.

2014-01-01

Smoking and depression are related, and mood management interventions included in smoking cessation interventions can increase smoking abstinence rates. Could a mood management intervention embedded in an Internet-based smoking cessation intervention prevent major depressive episodes? Spanish- and English-speaking smokers (N = 17,430) from 191 countries were randomized to one of four online self-help intervention conditions (two with mood management). We analyzed preventive effects among those participants without a major depressive episode at baseline. The mood management intervention did not reduce the incidence of major depressive episodes in the following 12 months. However, we found a mood management by depression risk interaction (OR = 1.77, p = .004), such that high-risk participants who received the mood management intervention had an increased occurrence of major depressive episodes (32.8% vs. 26.6%), but not low-risk participants (11.6% vs. 10.8%). Further research on whether mood management interventions may have deleterious effects on subsets of smokers appears warranted. PMID:25525565

MIOTIC study: a prospective, multicenter, randomized study to evaluate the long-term efficacy of mobile phone-based Internet of Things in the management of patients with stable COPD.

PubMed

Zhang, Jing; Song, Yuan-Lin; Bai, Chun-Xue

2013-01-01

Chronic obstructive pulmonary disease (COPD) is a common disease that leads to huge economic and social burden. Efficient and effective management of stable COPD is essential to improve quality of life and reduce medical expenditure. The Internet of Things (IoT), a recent breakthrough in communication technology, seems promising in improving health care delivery, but its potential strengths in COPD management remain poorly understood. We have developed a mobile phone-based IoT (mIoT) platform and initiated a randomized, multicenter, controlled trial entitled the 'MIOTIC study' to investigate the influence of mIoT among stable COPD patients. In the MIOTIC study, at least 600 patients with stable GOLD group C or D COPD and with a history of at least two moderate-to-severe exacerbations within the previous year will be randomly allocated to the control group, which receives routine follow-up, or the intervention group, which receives mIoT management. Endpoints of the study include (1) frequency and severity of acute exacerbation; (2) symptomatic evaluation; (3) pre- and post-bronchodilator forced expiratory volume in 1 second (FEV1) and FEV1/forced vital capacity (FVC) measurement; (4) exercise capacity; and (5) direct medical cost per year. Results from this study should provide direct evidence for the suitability of mIoT in stable COPD patient management.

MIOTIC study: a prospective, multicenter, randomized study to evaluate the long-term efficacy of mobile phone-based Internet of Things in the management of patients with stable COPD

PubMed Central

Zhang, Jing; Song, Yuan-lin; Bai, Chun-xue

2013-01-01

Chronic obstructive pulmonary disease (COPD) is a common disease that leads to huge economic and social burden. Efficient and effective management of stable COPD is essential to improve quality of life and reduce medical expenditure. The Internet of Things (IoT), a recent breakthrough in communication technology, seems promising in improving health care delivery, but its potential strengths in COPD management remain poorly understood. We have developed a mobile phone-based IoT (mIoT) platform and initiated a randomized, multicenter, controlled trial entitled the ‘MIOTIC study’ to investigate the influence of mIoT among stable COPD patients. In the MIOTIC study, at least 600 patients with stable GOLD group C or D COPD and with a history of at least two moderate-to-severe exacerbations within the previous year will be randomly allocated to the control group, which receives routine follow-up, or the intervention group, which receives mIoT management. Endpoints of the study include (1) frequency and severity of acute exacerbation; (2) symptomatic evaluation; (3) pre- and post-bronchodilator forced expiratory volume in 1 second (FEV1) and FEV1/forced vital capacity (FVC) measurement; (4) exercise capacity; and (5) direct medical cost per year. Results from this study should provide direct evidence for the suitability of mIoT in stable COPD patient management. PMID:24082784

A randomized comparison of online- and telephone-based care management with internet training alone in adult patients with poorly controlled type 2 diabetes.

PubMed

McMahon, Graham T; Fonda, Stephanie J; Gomes, Helen E; Alexis, George; Conlin, Paul R

2012-11-01

Care management may improve the quality of diabetes care by enhancing contact between high-risk patients and their providers. This prospective, longitudinal, randomized trial sought to investigate whether telephone or online care management improves diabetes-related outcomes over time compared with usual care supplemented with Internet access and training. One hundred fifty-one adult subjects with type 2 diabetes mellitus and an elevated hemoglobin A1c (A1c) level (≥8.5%) were randomly assigned to online care management (n=51), telephone-based care management (n=51), or Web training (n=49) groups. Online and telephone participants interacted with a care manager through a diabetes education and care management Web site and by telephone, respectively. The Web training group was provided with online diabetes self-management resources but no care management support. The primary outcome measure was A1c measured every 3 months for a year. A1c declined significantly and substantially in all groups over 12 months. A1c declined linearly at a rate of 0.32% (P<0.0001) per quarter for the online group, 0.36% (P<0.0001) for the telephone group, and 0.41% for the Web training group (P<0.0001). The rate of change over time did not differ significantly among groups. The groups converged at 12 months with average absolute A1c difference of -1.5%. The number of interactions with care providers was not significantly associated with the change in A1c. Blood pressure, weight, lipid levels, and diabetes distress did not differ among groups over time. Online, telephone-based care management, and Web training for diabetes patients with elevated A1c were each associated with a substantial improvement in A1c over a 1-year period. Internet access and training alone may be as effective as care management in patients with poorly controlled diabetes.

Clinical inertia in the pharmacological management of hypertension: A systematic review and meta-analysis.

PubMed

Milman, Tal; Joundi, Raed A; Alotaibi, Naif M; Saposnik, Gustavo

2018-06-01

Clinical Inertia is defined as "failure of health care providers to initiate or intensify therapy according to current guidelines". This phenomenon is gaining increasing attention as a major cause of clinicians' failure to adequately manage hypertension, thus leading to an increased incidence of cardiovascular events. We performed a systematic review and meta-analysis of randomized controlled trials to determine whether interventions aimed at reducing clinical inertia in the pharmacological treatment of hypertension improve blood pressure (BP) control. MEDLINE, Embase, and Cochrane Database of Systematic Reviews were searched from the start of their database until October 3, 2017 for the MESH terms "Hypertension" or "Blood Pressure", their subheadings, and the keywords "Therapeutic Inertia" or "Clinical Inertia". Studies were included if they addressed pharmacologic hypertension management, clinical inertia, were randomized controlled trials, reported an outcome describing prescriber behavior, and were available in English. Data for the included studies was extracted by two independent observers. Quality of studies was analyzed using the Cochrane Risk of Bias Assessment. Data was pooled for statistical analysis using both fixed- and random-effects models. The primary study outcome was the percentage of patients achieving blood pressure control as defined by the Joint National Committee guidelines or study authors. Of 474 citations identified, ten met inclusion criteria comprising a total of 26,871 patients, and eight were selected for meta-analysis. Interventions included Physician Education, Physician Reminders, Patient Education, Patient Reminders, Ambulatory BP Monitoring, Digital Medication Offerings, Physician Peer Visits, and Pharmacist-led Counselling. Pooled event rates revealed more patients with controlled BP in the intervention group versus control (55%, 95% CI 46-63% versus 45%, 95% CI 37-53%) and interventions significantly improved the odds of BP control (OR = 1.19, 95% CI = 1.12-1.27, P < .001). Heterogeneity in the quantitative analysis was moderate. Addressing clinical inertia through physician reminders, ambulatory BP monitoring, and educational interventions for primary care providers was associated with an improvement in blood pressure control. Our findings encourage further research to investigate strategies at reducing clinical inertia in the management of hypertension.

Case management to increase quality of life after cancer treatment: a randomized controlled trial.

PubMed

Scherz, Nathalie; Bachmann-Mettler, Irène; Chmiel, Corinne; Senn, Oliver; Boss, Nathalie; Bardheci, Katarina; Rosemann, Thomas

2017-03-28

Case management has been shown to be beneficial in phases of cancer screening and treatment. After treatment is completed, patients experience a loss of support due to reduced contact with medical professionals. Case management has the potential to offer continuity of care and ease re-entry to normal life. We therefore aim to investigate the effect of case management on quality of life in early cancer survivors. Between 06/2010 and 07/2012, we randomized 95 patients who had just completed cancer treatment in 11 cancer centres in the canton of Zurich, Switzerland. Patients in the case management group met with a case manager at least three times over 12 months. Patient-reported outcomes were assessed after 3, 6 and 12 months using the Functional Assessment of Cancer Therapy (FACT-G) scale, the Patient Assessment of Chronic Illness Care (PACIC) and the Self-Efficacy scale. The change in FACT-G over 12 months was significantly greater in the case management group than in the control group (16.2 (SE 2.0) vs. 9.2 (SE 1.5) points, P = 0.006). The PACIC score increased by 0.20 (SE 0.14) in the case management group and decreased by 0.29 (SE 0.12) points in the control group (P = 0.009). Self-Efficacy increased by 3.1 points (SE 0.9) in the case management group and by 0.7 (SE 0.8) points in the control group (P = 0.049). Case management has the potential to improve quality of life, to ease re-entry to normal life and to address needs for continuity of care in early cancer survivors. The study has been submitted to the ISRCTN register under the name "Case Management in Oncology Rehabilitation" on the 12th of October 2010 and retrospectively registered under the number ISRCTN41474586 on the 24th of November 2010.

Rheumatoid Arthritis and Cardiovascular Disease: Update on Treatment Issues

PubMed Central

Barbhaiya, Medha; Solomon, Daniel H.

2016-01-01

Purpose of review This review examines thresholds for treatment of traditional cardiovascular disease (CVD) risk factors among RA patients and whether RA-specific treatment modulates cardiovascular risk. Recent findings There are substantial data demonstrating an increased CVD risk among patients with RA. Both traditional CVD risk factors and inflammation contribute to this risk. Recent epidemiologic studies strengthen the case that aggressive immunosuppression with biologic DMARDs, such as TNF antagonists, is associated with a reduced risk of CVD events. However, to data, there are no randomized controlled trials published regarding the management of CVD in RA. Summary Epidemiologic evidence continues to accumulate regarding the relationship between the effects of traditional CVD risk factors and RA-specific treatments on CV outcomes in RA. The field needs randomized controlled trials to better guide management. PMID:23466960

Cutaneous lichen planus: A systematic review of treatments.

PubMed

Fazel, Nasim

2015-06-01

Various treatment modalities are available for cutaneous lichen planus. Pubmed, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Database of Abstracts of Reviews of Effects, and Health Technology Assessment Database were searched for all the systematic reviews and randomized controlled trials related to cutaneous lichen planus. Two systematic reviews and nine relevant randomized controlled trials were identified. Acitretin, griseofulvin, hydroxychloroquine and narrow band ultraviolet B are demonstrated to be effective in the treatment of cutaneous lichen planus. Sulfasalazine is effective, but has an unfavorable safety profile. KH1060, a vitamin D analogue, is not beneficial in the management of cutaneous lichen planus. Evidence from large scale randomized trials demonstrating the safety and efficacy for many other treatment modalities used to treat cutaneous lichen planus is simply not available.

A health economic outcome evaluation of an internet-based mobile-supported stress management intervention for employees.

PubMed

Ebert, David Daniel; Kählke, Fanny; Buntrock, Claudia; Berking, Matthias; Smit, Filip; Heber, Elena; Baumeister, Harald; Funk, Burkhardt; Riper, Heleen; Lehr, Dirk

2018-03-01

Objective This study aimed to estimate and evaluate the cost-effectiveness and cost-benefit of a guided internet- and mobile-supported occupational stress-management intervention (iSMI) for employees from the employer's perspective alongside a randomized controlled trial. Methods A sample of 264 employees with elevated symptoms of perceived stress (Perceived Stress Scale, PSS-10 ≥22) was randomly assigned either to the iSMI or a waitlist control (WLC) group with unrestricted access to treatment as usual. The iSMI consisted of seven sessions of problem-solving and emotion-regulation techniques and one booster session. Self-report data on symptoms of perceived stress and economic data were assessed at baseline, and at six months following randomization. A cost-benefit analysis (CBA) and a cost-effectiveness analysis (CEA) with symptom-free status as the main outcome from the employer's perspective was carried out. Statistical uncertainty was estimated using bootstrapping (N=5000). Results The CBA yielded a net-benefit of EUR181 [95% confidence interval (CI) -6043-1042] per participant within the first six months following randomization. CEA showed that at a willingness-to-pay ceiling of EUR0, EUR1000, EUR2000 for one additional symptom free employee yielded a 67%, 90%, and 98% probability, respectively, of the intervention being cost-effective compared to the WLC. Conclusion The iSMI was cost-effective when compared to WLC and even lead to cost savings within the first six months after randomization. Offering stress-management interventions can present good value for money in occupational healthcare.

Improved self-management skills in Chinese diabetes patients through a comprehensive health literacy strategy: study protocol of a cluster randomized controlled trial.

PubMed

Xu, Wang Hong; Rothman, Russell L; Li, Rui; Chen, Yingyao; Xia, Qinghua; Fang, Hong; Gao, Junling; Yan, Yujie; Zhou, Peng; Jiang, Yu; Liu, Yinan; Zhou, Fangjia; Wang, Wei; Chen, Minling; Liu, Xiao Yu; Liu, Xiao Na

2014-12-20

Diabetes self-management often involves the interpretation and application of oral, written, or quantitative information. Numerous diabetes patients in China have limited health literacy, which likely leads to poorer clinical outcomes. This study is designed to examine the efficacy and cost-effectiveness of addressing health literacy to improve self-management skills and glycemic control in Chinese diabetes patients. This is a cluster randomized controlled trial (RCT) conducted in 20 community healthcare sites in Shanghai, China. Overall, 800 diabetes patients will be randomized into intervention and control arms and will have a baseline hemoglobin A1c (HbA1c) assay and undergo a baseline survey which includes measures of health literacy and diabetes numeracy using revised Chinese versions of the Health Literacy Management Scale and Diabetes Numeracy Test Scale. During the 1-year period of intervention, while the control group will receive usual care, the intervention group will be supplemented with a comprehensive health literacy strategy which includes i) training healthcare providers in effective health communication skills that address issues related to low literacy, and ii) use of an interactive Diabetes Education Toolkit to improve patient understanding and behaviors. Assessments will be conducted at both patient and healthcare provider levels, and will take place upon admission and after 3, 6, 12, and 24 months of intervention. The primary outcome will be the improvement in HbA1c between Intervention group and Control group patients. Secondary outcomes at the patient level will include improvement in i) clinical outcomes (blood pressure, fasting lipids, body mass index, weight, smoking status), ii) patient reported self-management behaviors, and iii) patient-reported self-efficacy. Outcomes at the provider level will include: i) provider satisfaction and ii) intensity and type of care provided. The effects of the intervention will be examined in multivariable general linear models. Both cost-effectiveness and cost-utility analyses will be performed. The main strengths of this study are its large sample size and RCT design, involvement of both patients and healthcare providers, and the long term follow-up (24-months). This project will help to demonstrate the value of addressing health literacy and health communication to improve self-management and clinical outcomes among Chinese diabetes patients. ISRCTN76130594, Registration date: Sept 22, 2014.

Effectiveness of a partnership-based self-management programme for patients with mild and moderate chronic obstructive pulmonary disease: a pragmatic randomized controlled trial.

PubMed

Jonsdottir, Helga; Amundadottir, Olof R; Gudmundsson, Gunnar; Halldorsdottir, Bryndis S; Hrafnkelsson, Birgir; Ingadottir, Thorbjorg Soley; Jonsdottir, Rosa; Jonsson, Jon Steinar; Sigurjonsdottir, Ellen D; Stefansdottir, Ingibjorg K

2015-11-01

To evaluate the effectiveness of a 6-month, partnership-based self-management programme for patients with mild and moderate chronic obstructive pulmonary disease. Self-management is a widely valued concept used to address contemporary issues of chronic health problems. Findings of self-management programmes for people with chronic obstructive pulmonary disease are inconclusive. Pragmatic randomized control trial. Patients, 45-65 years old, with mild and moderate chronic obstructive pulmonary disease were invited with a family member. Experimental group (n = 48) participated in a 6-month, partnership-based self-management programme consisting of: (a) three to four conversations between nurse and patient-family member; (b) 6 months of smoking cessation; and (c) interdisciplinary team-patient-family member group meeting. Control group (n = 52) received usual care. Data were collected at months zero, six and 12. The trial lasted from June 2009-March 2013. Patients with mild and moderate chronic obstructive pulmonary disease who participated in the partnership-based self-management programme perceived less intrusiveness of the disease and its treatment than patients in the control group. Patients in the experimental group did not have better health-related quality of life, less anxiety or depression, increased physical activity, fewer exacerbations or better smoking status than patients in the control group. Patients in both groups found participation in the research useful and important. The partnership-based self-management programme had benefits concerning perception of the intrusiveness of chronic obstructive pulmonary disease and its treatment on lifestyles, activities and interests for young patients with the disease in its early stages. High satisfaction in control group, low family attendance and the relatively short treatment period may explain the less than expected benefits of the programme. © 2015 John Wiley & Sons Ltd.

Building a Tailored, Patient-Guided, Web-Based Self-Management Intervention 'ReumaUitgedaagd!' for Adults With a Rheumatic Disease: Results of a Usability Study and Design for a Randomized Control Trail.

PubMed

Ammerlaan, Judy W; Mulder, Olga K; de Boer-Nijhof, Nienke C; Maat, Bertha; Kruize, Aike A; van Laar, Jaap; van Os-Medendorp, Harmieke; Geenen, Rinie

2016-06-23

The chronic nature of rheumatic diseases imposes daily challenges upon those affected and causes patients to make daily decisions about the way they self-manage their illness. Although there is attention to self-management and evidence for the desirability of tailored interventions to support people with a rheumatic disease, interventions based on individual needs and preferences are scarce. To provide a systematic and comprehensive description of the theoretical considerations for building a Web-based, expert, patient-guided, and tailored intervention for adult patients with a rheumatic disease. Also, to present the results of a usability study on the feasibility of this intervention, and its study design in order to measure the effectiveness. To fit the intervention closely to the autonomy, needs, and preferences of the individual patient, a research team comprising patient representatives, health professionals, Web technicians, and communication experts was formed. The research team followed the new guidance by the Medical Research Council (MRC) for developing and evaluating complex interventions as a guide for the design of the intervention. Considerations from self-determination theory and a comprehensive assessment of preferences and needs in patients with a rheumatic disease guided the development of the Web-based intervention. The usability study showed that the intervention was useful, easy to use, and accepted and appreciated by the target group of patients. The planned randomized controlled trial is designed to be conducted among 120 adults with a rheumatic disease, who are assigned to the self-management intervention or a self-help control group. Both groups will be asked to formulate personal goals they want to achieve concerning their self-management. Progress toward the personal goal is the primary outcome measure of this study. Self-reported Web-based measures will be assessed before randomization at baseline, and 3 and 6 months after randomization. Also, feasibility and adherence to the Web-based self-management intervention as process outcomes will be evaluated. By identifying the individual goals at the beginning of the intervention and customizing the intervention to the individual patient, we aim to improve the usefulness and effectiveness of the Web-based self-management intervention. If proven effective, ReumaUitgedaagd! Online will be implemented in the Netherlands.

Uncertainty, learning, and the optimal management of wildlife

USGS Publications Warehouse

Williams, B.K.

2001-01-01

Wildlife management is limited by uncontrolled and often unrecognized environmental variation, by limited capabilities to observe and control animal populations, and by a lack of understanding about the biological processes driving population dynamics. In this paper I describe a comprehensive framework for management that includes multiple models and likelihood values to account for structural uncertainty, along with stochastic factors to account for environmental variation, random sampling, and partial controllability. Adaptive optimization is developed in terms of the optimal control of incompletely understood populations, with the expected value of perfect information measuring the potential for improving control through learning. The framework for optimal adaptive control is generalized by including partial observability and non-adaptive, sample-based updating of model likelihoods. Passive adaptive management is derived as a special case of constrained adaptive optimization, representing a potentially efficient suboptimal alternative that nonetheless accounts for structural uncertainty.

A standardized crisis management model for self-harming and suicidal individuals with three or more diagnostic criteria of borderline personality disorder: The Brief Admission Skåne randomized controlled trial protocol (BASRCT).

PubMed

Liljedahl, Sophie I; Helleman, Marjolein; Daukantaité, Daiva; Westrin, Åsa; Westling, Sofie

2017-06-15

Brief Admission is a crisis and risk management strategy in which self-harming and suicidal individuals with three or more diagnostic criteria of borderline personality disorder self-admit to hospital at times of increasing risk when other efforts to stay safe are failing. Standardized in the current randomized controlled trial, the intensity of Brief Admission Skåne is implemented in durations of three days, with a maximum frequency of three times a month. Brief Admission is integrated into existing treatment plans in advance of crises to prevent reliance on general psychiatric admissions for risk management, as these may be lengthy, unstructured, and of uncertain therapeutic value. The overall objective of the Brief Admission Skåne randomized controlled trial is to determine if Brief Admission can replace general psychiatric admission for self-harming and suicidal individuals with complex mental illness at times of escalating risk. Other objectives of the study are to evaluate whether Brief Admission increases daily functioning and enhances coping, reduces psychiatric symptoms including frequency and severity of self-harm and suicidal behaviours. A final objective is to determine if Brief Admission is an effective crisis management model for this population. Participants are randomized at an individual level to either Brief Admission Skåne plus Treatment as Usual or Treatment As Usual. Based on a priori power analyses, N = 124 participants will be recruited to the study. Data collection is in progress, and will continue until June 2018. All participant data are single-blinded and will be handled with intention-to-treat analysis. Based on the combined clinical experience of our international research group, the Brief Admission Skåne randomized controlled trial upon which the current protocol is based represents the first initiative to standardize, implement and evaluate Brief Admission amongst self-harming and suicidal individuals, including those with borderline traits. Objectively measuring protocol fidelity and developing English-language Brief Admission study protocols and training materials are implementation and dissemination targets developed in order to facilitate adherent international export of Brief Admission Skåne. NCT02985047 . Registered November 25, 2016. Retrospectively registered.

Can chronic disease management programs for patients with type 2 diabetes reduce productivity-related indirect costs of the disease? Evidence from a randomized controlled trial.

PubMed

Adepoju, Omolola E; Bolin, Jane N; Ohsfeldt, Robert L; Phillips, Charles D; Zhao, Hongwei; Ory, Marcia G; Forjuoh, Samuel N

2014-04-01

The objective was to assess the impacts of diabetes self-management programs on productivity-related indirect costs of the disease. Using an employer's perspective, this study estimated the productivity losses associated with: (1) employee absence on the job, (2) diabetes-related disability, (3) employee presence on the job, and (4) early mortality. Data were obtained from electronic medical records and survey responses of 376 adults aged ≥18 years who were enrolled in a randomized controlled trial of type 2 diabetes self-management programs. All study participants had uncontrolled diabetes and were randomized into one of 4 study arms: personal digital assistant (PDA), chronic disease self-management program (CDSMP), combined PDA and CDSMP, and usual care (UC). The human-capital approach was used to estimate lost productivity resulting from 1, 2, 3, and 4 above, which are summed to obtain total productivity loss. Using robust regression, total productivity loss was modeled as a function of the diabetes self-management programs and other identified demographic and clinical characteristics. Compared to subjects in the UC arm, there were no statistically significant differences in productivity losses among persons undergoing any of the 3 diabetes management interventions. Males were associated with higher productivity losses (+$708/year; P<0.001) and persons with greater than high school education were associated with additional productivity losses (+$758/year; P<0.001). Persons with more than 1 comorbid condition were marginally associated with lower productivity losses (-$326/year; P=0.055). No evidence was found that the chronic disease management programs examined in this trial affect indirect productivity losses.

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).

Does the use of consumer health information technology improve outcomes in the patient self-management of diabetes? A meta-analysis and narrative review of randomized controlled trials.

PubMed

Or, Calvin K L; Tao, Da

2014-05-01

To assess whether the use of consumer health information technologies (CHITs) improves outcomes in the patient self-management of diabetes. The evidence from randomized controlled trials (RCTs) on the effects of CHITs on patient outcomes was analyzed using either meta-analysis or a narrative synthesis approach. A systematic search of seven electronic databases was conducted to identify relevant reports of RCTs for the analysis. In the meta-analyses, standardized mean differences in patient outcomes were calculated and random-effects models were applied in cases where the heterogeneity of the results was moderate or high, otherwise fixed-effects models were used. Sixty-two studies, representing 67 RCTs, met the inclusion criteria. The results of the meta-analyses showed that the use of CHITs was associated with significant reductions in HbA1c, blood pressure, total cholesterol, and triglycerides levels when compared with the usual care. The findings from the narrative synthesis indicated that only a small proportion of the trials reported positive effects of CHITs on patient outcomes. The use of CHITs in supporting diabetes self-management appears to have potential benefits for patients' self-management of diabetes. However, the effectiveness of the technologies in improving patient outcomes still awaits confirmation in future studies. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Informed consent in research to improve the number and quality of deceased donor organs.

PubMed

Rey, Michael M; Ware, Lorraine B; Matthay, Michael A; Bernard, Gordon R; McGuire, Amy L; Caplan, Arthur L; Halpern, Scott D

2011-02-01

Improving the management of potential organ donors in the intensive care unit could meet an important public health goal by increasing the number and quality of transplantable organs. However, randomized clinical trials are needed to quantify the extent to which specific interventions might enhance organ recovery and outcomes among transplant recipients. Among several barriers to conducting such studies are the absence of guidelines for obtaining informed consent for such studies and the fact that deceased organ donors are not covered by extant federal regulations governing oversight of research with human subjects. This article explores the underexamined ethical issues that arise in the context of donor management studies and provides ethical guidelines and suggested regulatory oversight mechanisms to enable such studies to be conducted ethically. We conclude that both the respect that is traditionally accorded to the prior wishes of the dead and the possibility of postmortem harm support a role for surrogate consent of donors in such randomized controlled trials. Furthermore, although recipients will often be considered human subjects under federal regulations, several ethical arguments support waiving requirements for recipient consent in donor management randomized controlled trials. Finally, we suggest that new regulatory mechanisms, perhaps linked to existing regional and national organ donation and transplantation infrastructures, must be established to protect patients in donor management studies while limiting unnecessary barriers to the conduct of this important research.

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.

The Effects of Reduced Cigarette Smoking on Discounting Future Rewards: An Initial Evaluation

ERIC Educational Resources Information Center

Yi, Richard; Johnson, Matthew W.; Giordano, Louis A.; Landes, Reid D.; Badger, Gary J.; Bickel, Warren K.

2008-01-01

To determine whether reduction of smoking via contingency management in dependent smokers would decrease the discounting of delayed reinforcers compared with smokers who did not reduce their smoking, moderate to heavy cigarette smokers were randomly assigned to one of two conditions: a contingency management condition and a control condition. In…

A randomized controlled trial of laparoscopic Nissen fundoplication versus proton pump inhibitors for the treatment of patients with chronic gastroesophageal reflux disease (GERD): 3-year outcomes.

PubMed

Anvari, Mehran; Allen, Christopher; Marshall, John; Armstrong, David; Goeree, Ron; Ungar, Wendy; Goldsmith, Charles

2011-08-01

A randomized controlled trial (RCT) investigated patients with gastroesophageal reflux disease (GERD) who were stable and symptomatically controlled with long-term medical therapy to compare ongoing optimized medical therapy with laparoscopic Nissen fundoplication (LNF). Of the 180 patients eligible for randomization, 104 gave informed consent, and 3 withdrew from the study immediately after randomization. The patients randomized to medical therapy received optimized treatment with proton pump inhibitors (PPIs) using a standardized management protocol based on best evidence and published guidelines. The surgical patients underwent LNF by one of four surgeons using a previously published technique. The patients underwent symptom evaluation using the GERD symptom scale (GERSS) and the global visual analog scale (VAS) for overall symptom control. They had 24-h esophageal pH monitoring at baseline and after 3 years. The medical patients were evaluated receiving PPI, and the surgical patients were evaluated not receiving PPI. For the 3-year follow-up assessment, 93 patients were available. At 3 years, surgery was associated with more heartburn-free days, showing a mean difference of -1.35 days per week (p = 0.0077) and a lower VAS score (p = 0.0093) than medical management. Surgical patients reported improved quality of life on the general health subscore of the Medical Outcomes Survey Short Form 36 (SF-36) at 3 years, with a mean difference of -12.19 (p = 0.0124). The groups did not differ significantly in terms of GERSS or acid exposure on 24-h esophageal pH monitoring at 3 years. There were six treatment failures (11.8%) in the surgical group and eight treatment failures (16%) in the medical group by 3 years. For patients whose GERD symptoms are stable and controlled with PPI, continuing medical therapy and laparoscopic antireflux surgery are equally effective, although surgery may result in better symptom control and quality of life.

Randomized controlled trial of internal and external targeted temperature management methods in post- cardiac arrest patients.

PubMed

Look, Xinqi; Li, Huihua; Ng, Mingwei; Lim, Eric Tien Siang; Pothiawala, Sohil; Tan, Kenneth Boon Kiat; Sewa, Duu Wen; Shahidah, Nur; Pek, Pin Pin; Ong, Marcus Eng Hock

2018-01-01

Targeted temperature management post-cardiac arrest is currently implemented using various methods, broadly categorized as internal and external. This study aimed to evaluate survival-to-hospital discharge and neurological outcomes (Glasgow-Pittsburgh Score) of post-cardiac arrest patients undergoing internal cooling verses external cooling. A randomized controlled trial of post-resuscitation cardiac arrest patients was conducted from October 2008-September 2014. Patients were randomized to either internal or external cooling methods. Historical controls were selected matched by age and gender. Analysis using SPSS version 21.0 presented descriptive statistics and frequencies while univariate logistic regression was done using R 3.1.3. 23 patients were randomized to internal cooling and 22 patients to external cooling and 42 matched controls were selected. No significant difference was seen between internal and external cooling in terms of survival, neurological outcomes and complications. However in the internal cooling arm, there was lower risk of developing overcooling (p=0.01) and rebound hyperthermia (p=0.02). Compared to normothermia, internal cooling had higher survival (OR=3.36, 95% CI=(1.130, 10.412), and lower risk of developing cardiac arrhythmias (OR=0.18, 95% CI=(0.04, 0.63)). Subgroup analysis showed those with cardiac cause of arrest (OR=4.29, 95% CI=(1.26, 15.80)) and sustained ROSC (OR=5.50, 95% CI=(1.64, 20.39)) had better survival with internal cooling compared to normothermia. Cooling curves showed tighter temperature control for internal compared to external cooling. Internal cooling showed tighter temperature control compared to external cooling. Internal cooling can potentially provide better survival-to-hospital discharge outcomes and reduce cardiac arrhythmia complications in carefully selected patients as compared to normothermia. Copyright © 2017. Published by Elsevier Inc.

The Beliefs, Attitudes and Views of University Students about Anger and the Effects of Cognitive Behavioral Therapy-Oriented Anger Control and Anxiety Management Programs on Their Anger Management Skill Levels

ERIC Educational Resources Information Center

Karahan, T. Fikret; Yalçin, B. Murat; Erbas, Melda M.

2014-01-01

This study was designed as a qualitative focus group using a randomized controlled trail with a mixed methodology. The study has dual aims. First we searched the beliefs, attitudes and views of 176 university students on how to deal with anger using eight focus discussion groups. The anxiety and anger levels of these students were investigated…

Long-Term Effectiveness of a Stress Management Intervention at Work: A 9-Year Follow-Up Study Based on a Randomized Wait-List Controlled Trial in Male Managers.

PubMed

Li, Jian; Riedel, Natalie; Barrech, Amira; Herr, Raphael M; Aust, Birgit; Mörtl, Kathrin; Siegrist, Johannes; Gündel, Harald; Angerer, Peter

2017-01-01

Short- and medium-term effectiveness (up to 3 years) of individual level stress management interventions (SMI) at work were demonstrated, yet long-term effectiveness remains unexplored. We therefore aimed to address this research gap. 94 male middle managers participated in a randomized wait-list controlled trial between 2006 and 2008 and in a post-trial-follow-up survey in 2015. During the first two years, all received an 18-hour psychotherapeutic SMI intervention which was based on the Effort-Reward Imbalance (ERI) model: tackling stressor on mismatch between effort and reward and promoting recovery on overcommitment. Work stress (i.e., ERI indicators) was the primary outcome, and the secondary outcome was depressive symptoms. The long-term effectiveness of the SMI was examined by mixed modeling, using an external control group ( n = 94). Effort and reward were substantially improved with significant intervention ⁎ time interaction effects ( p < 0.001) compared to the external control group; effects on overcommitment and depressive symptoms were also significant ( p < 0.05 and p < 0.01, resp.), though their trajectories in the intervention group were less sustainable. The effectiveness of this psychotherapeutic SMI at work based on the ERI model was observed over a 9-year period, particularly on the effort-reward ratio.

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.

Self-management education for rehabilitation inpatients suffering from inflammatory bowel disease: a cluster-randomized controlled trial.

PubMed

Reusch, A; Weiland, R; Gerlich, C; Dreger, K; Derra, C; Mainos, D; Tuschhoff, T; Berding, A; Witte, C; Kaltz, B; Faller, H

2016-12-01

Although inflammatory bowel disease (IBD) affects patients' psychological well-being, previous educational programs have failed to demonstrate effects on psychosocial outcomes and quality of life. Therefore, we developed a group-based psychoeducational program that combined provision of both medical information and psychological self-management skills, delivered in an interactive manner, and evaluated it in a large, cluster-randomized trial. We assigned 540 rehabilitation inpatients suffering from IBD (mean age 43 years, 66% female) to either the new intervention or a control group comprising the same overall intensity and the same medical information, but only general psychosocial information. The primary outcome was patient-reported IBD-related concerns. Secondary outcomes included disease knowledge, coping, self-management skills, fear of progression, anxiety, depression and quality of life. Assessments took place at baseline, end of rehabilitation and after 3 and 12 months.The psychoeducational self-management program did not prove superior to the control group regarding primary and secondary outcomes. However, positive changes over time occurred in both groups regarding most outcomes. The superior effectiveness of the newly developed psychoeducational program could not be demonstrated. Since the intervention and control groups may have been too similar, this trial may have been too conservative to produce between-group effects. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Skin penetration operators' knowledge and attitudes towards infection control.

PubMed

Oberdorfer, Aurmporn; Wiggers, John H; Considine, Robyn J; Bowman, Jenny; Cockburn, Jill

2003-01-01

To assess the knowledge and attitudes of owners/managers of commercial skin-penetration premises regarding infection control. A telephone survey was conducted with a randomly selected sample of 874 owners/managers. Participants appeared to lack knowledge of essential infection-control practices. Less than 39% correctly identified recommended disinfection procedures, and between 12% to 67% were not aware of inappropriate sterlization procedures. Almost all participants accepted the need for guidelines. Half acknowledged a need to improve their infection-control compliance, and most accepted having their premises regularly checked by the councils. There is a considerable opportunity to increase infection-control compliance among skin-penetration operators.

Achieving cannabis cessation -- evaluating N-acetylcysteine treatment (ACCENT): design and implementation of a multi-site, randomized controlled study in the National Institute on Drug Abuse Clinical Trials Network.

PubMed

McClure, Erin A; Sonne, Susan C; Winhusen, Theresa; Carroll, Kathleen M; Ghitza, Udi E; McRae-Clark, Aimee L; Matthews, Abigail G; Sharma, Gaurav; Van Veldhuisen, Paul; Vandrey, Ryan G; Levin, Frances R; Weiss, Roger D; Lindblad, Robert; Allen, Colleen; Mooney, Larissa J; Haynes, Louise; Brigham, Gregory S; Sparenborg, Steve; Hasson, Albert L; Gray, Kevin M

2014-11-01

Despite recent advances in behavioral interventions for cannabis use disorders, effect sizes remain modest, and few individuals achieve long-term abstinence. One strategy to enhance outcomes is the addition of pharmacotherapy to complement behavioral treatment, but to date no efficacious medications targeting cannabis use disorders in adults through large, randomized controlled trials have been identified. The National Institute on Drug Abuse Clinical Trials Network (NIDA CTN) is currently conducting a study to test the efficacy of N-acetylcysteine (NAC) versus placebo (PBO), added to contingency management, for cannabis cessation in adults (ages 18-50). This study was designed to replicate positive findings from a study in cannabis-dependent adolescents that found greater odds of abstinence with NAC compared to PBO. This paper describes the design and implementation of an ongoing 12-week, intent-to-treat, double-blind, randomized, placebo-controlled study with one follow-up visit four weeks post-treatment. Approximately 300 treatment-seeking cannabis-dependent adults will be randomized to NAC or PBO across six study sites in the United States. The primary objective of this 12-week study is to evaluate the efficacy of twice-daily orally-administered NAC (1200 mg) versus matched PBO, added to contingency management, on cannabis abstinence. NAC is among the first medications to demonstrate increased odds of abstinence in a randomized controlled study among cannabis users in any age group. The current study will assess the cannabis cessation efficacy of NAC combined with a behavioral intervention in adults, providing a novel and timely contribution to the evidence base for the treatment of cannabis use disorders. Copyright © 2014 Elsevier Inc. All rights reserved.

Achieving Cannabis Cessation - Evaluating N-acetylcysteine Treatment (ACCENT): Design and implementation of a multi-site, randomized controlled study in the National Institute on Drug Abuse Clinical Trials Network

PubMed Central

McClure, Erin A.; Sonne, Susan C.; Winhusen, Theresa; Carroll, Kathleen M.; Ghitza, Udi E.; McRae-Clark, Aimee L.; Matthews, Abigail G.; Sharma, Gaurav; Van Veldhuisen, Paul; Vandrey, Ryan G.; Levin, Frances R.; Weiss, Roger D.; Lindblad, Robert; Allen, Colleen; Mooney, Larissa J.; Haynes, Louise; Brigham, Gregory S.; Sparenborg, Steve; Hasson, Albert L.; Gray, Kevin M.

2014-01-01

Despite recent advances in behavioral interventions for cannabis use disorders, effect sizes remain modest, and few individuals achieve long-term abstinence. One strategy to enhance outcomes is the addition of pharmacotherapy to complement behavioral treatment, but to date no efficacious medications targeting cannabis use disorders in adults through large, randomized controlled trials have been identified. The National Institute on Drug Abuse Clinical Trials Network (NIDA CTN) is currently conducting a study to test the efficacy of N-acetylcysteine (NAC) versus placebo (PBO), added to contingency management, for cannabis cessation in adults (ages 18–50). This study was designed to replicate positive findings from a study in cannabis-dependent adolescents that found greater odds of abstinence with NAC compared to PBO. This paper describes the design and implementation of an ongoing 12-week, intent-to-treat, double-blind, randomized, placebo-controlled study with one follow-up visit four weeks post-treatment. Approximately 300 treatment-seeking cannabis-dependent adults will be randomized to NAC or PBO across six study sites in the United States. The primary objective of this 12-week study is to evaluate the efficacy of twice-daily orally-administered NAC (1200 mg) versus matched PBO, added to contingency management, on cannabis abstinence. NAC is among the first medications to demonstrate increased odds of abstinence in a randomized controlled study among cannabis users in any age group. The current study will assess the cannabis cessation efficacy of NAC combined with a behavioral intervention in adults, providing a novel and timely contribution to the evidence base for the treatment of cannabis use disorders. PMID:25179587

Online distribution channel increases article usage on Mendeley: a randomized controlled trial.

PubMed

Kudlow, Paul; Cockerill, Matthew; Toccalino, Danielle; Dziadyk, Devin Bissky; Rutledge, Alan; Shachak, Aviv; McIntyre, Roger S; Ravindran, Arun; Eysenbach, Gunther

2017-01-01

Prior research shows that article reader counts (i.e. saves) on the online reference manager, Mendeley, correlate to future citations. There are currently no evidenced-based distribution strategies that have been shown to increase article saves on Mendeley. We conducted a 4-week randomized controlled trial to examine how promotion of article links in a novel online cross-publisher distribution channel (TrendMD) affect article saves on Mendeley. Four hundred articles published in the Journal of Medical Internet Research were randomized to either the TrendMD arm ( n  = 200) or the control arm ( n  = 200) of the study. Our primary outcome compares the 4-week mean Mendeley saves of articles randomized to TrendMD versus control. Articles randomized to TrendMD showed a 77% increase in article saves on Mendeley relative to control. The difference in mean Mendeley saves for TrendMD articles versus control was 2.7, 95% CI (2.63, 2.77), and statistically significant ( p  < 0.01). There was a positive correlation between pageviews driven by TrendMD and article saves on Mendeley (Spearman's rho r  = 0.60). This is the first randomized controlled trial to show how an online cross-publisher distribution channel (TrendMD) enhances article saves on Mendeley. While replication and further study are needed, these data suggest that cross-publisher article recommendations via TrendMD may enhance citations of scholarly articles.

Mathematical model of blasting schemes management in mining operations in presence of random disturbances

NASA Astrophysics Data System (ADS)

Kazakova, E. I.; Medvedev, A. N.; Kolomytseva, A. O.; Demina, M. I.

2017-11-01

The paper presents a mathematical model of blasting schemes management in presence of random disturbances. Based on the lemmas and theorems proved, a control functional is formulated, which is stable. A universal classification of blasting schemes is developed. The main classification attributes are suggested: the orientation in plan the charging wells rows relatively the block of rocks; the presence of cuts in the blasting schemes; the separation of the wells series onto elements; the sequence of the blasting. The periodic regularity of transition from one Short-delayed scheme of blasting to another is proved.

Mindfulness Meditation Versus Physical Exercise in the Management of Depression Among Nursing Students.

PubMed

Alsaraireh, Faris Abdelkarim; Aloush, Sami Mohammad

2017-10-01

Depression among nursing students is an ongoing problem. Several psychotherapies have been suggested as alternatives to antidepressants in the management of depression. The aim of this randomized controlled study was to compare the effectiveness of mindfulness meditation versus physical exercise in the management of depression among nursing students. A sample of 181 soon-to-graduate nursing students participated in the study and were assigned at random to one of two therapies: physical exercise (n = 90) or mindfulness meditation (n = 91). The Center for Epidemiologic Studies Depression Scale was completed by the participants in both groups prior to the therapies and after completion. The findings indicated that both therapies were effective in the management of depression. However, mindfulness meditation is more effective than physical exercise. Mindfulness meditation is recommended over physical exercise in the management of depression among undergraduate nursing students. [J Nurs Educ. 2017;56(10):599-604.]. Copyright 2017, SLACK Incorporated.

The effects of combining Web-based eHealth with telephone nurse case management for pediatric asthma control: a randomized controlled trial.

PubMed

Gustafson, David; Wise, Meg; Bhattacharya, Abhik; Pulvermacher, Alice; Shanovich, Kathleen; Phillips, Brenda; Lehman, Erik; Chinchilli, Vernon; Hawkins, Robert; Kim, Jee-Seon

2012-07-26

Asthma is the most common pediatric illness in the United States, burdening low-income and minority families disproportionately and contributing to high health care costs. Clinic-based asthma education and telephone case management have had mixed results on asthma control, as have eHealth programs and online games. To test the effects of (1) CHESS+CM, a system for parents and children ages 4-12 years with poorly controlled asthma, on asthma control and medication adherence, and (2) competence, self-efficacy, and social support as mediators. CHESS+CM included a fully automated eHealth component (Comprehensive Health Enhancement Support System [CHESS]) plus monthly nurse case management (CM) via phone. CHESS, based on self-determination theory, was designed to improve competence, social support, and intrinsic motivation of parents and children. We identified eligible parent-child dyads from files of managed care organizations in Madison and Milwaukee, Wisconsin, USA, sent them recruitment letters, and randomly assigned them (unblinded) to a control group of treatment as usual plus asthma information or to CHESS+CM. Asthma control was measured by the Asthma Control Questionnaire (ACQ) and self-reported symptom-free days. Medication adherence was a composite of pharmacy refill data and medication taking. Social support, information competence, and self-efficacy were self-assessed in questionnaires. All data were collected at 0, 3, 6, 9, and 12 months. Asthma diaries kept during a 3-week run-in period before randomization provided baseline data. Of 305 parent-child dyads enrolled, 301 were randomly assigned, 153 to the control group and 148 to CHESS+CM. Most parents were female (283/301, 94%), African American (150/301, 49.8%), and had a low income as indicated by child's Medicaid status (154/301, 51.2%); 146 (48.5%) were single and 96 of 301 (31.9%) had a high school education or less. Completion rates were 127 of 153 control group dyads (83.0%) and 132 of 148 CHESS+CM group dyads (89.2%). CHESS+CM group children had significantly better asthma control on the ACQ (d = -0.31, 95% confidence limits [CL] -0.56, -0.06, P = .011), but not as measured by symptom-free days (d = 0.18, 95% CL -0.88, 1.60, P = 1.00). The composite adherence scores did not differ significantly between groups (d = 1.48%, 95% CL -8.15, 11.11, P = .76). Social support was a significant mediator for CHESS+CM's effect on asthma control (alpha = .200, P = .01; beta = .210, P = .03). Self-efficacy was not significant (alpha = .080, P = .14; beta = .476, P = .01); neither was information competence (alpha = .079, P = .09; beta = .063, P = .64). Integrating telephone case management with eHealth benefited pediatric asthma control, though not medication adherence. Improved methods of measuring medication adherence are needed. Social support appears to be more effective than information in improving pediatric asthma control. Clinicaltrials.gov NCT00214383; http://clinicaltrials.gov/ct2/show/NCT00214383 (Archived by WebCite at http://www.webcitation.org/68OVwqMPz).

Effects of a resistance training program on balance and fatigue perception in patients with Parkinson's disease: A randomized controlled trial.

PubMed

Ortiz-Rubio, Araceli; Cabrera-Martos, Irene; Torres-Sánchez, Irene; Casilda-López, Jesús; López-López, Laura; Valenza, Marie Carmen

2017-11-22

Fatigue and balance impairment leads to a loss of independence and are important to adequately manage. The objective of this study was to examine the effects of a resistance training program on dynamic balance and fatigue in patients with Parkinson's disease (PD). Randomized controlled trial. Forty-six patients with PD were randomly allocated to an intervention group receiving a 8-week resistance training program focused on lower limbs or to a control group. Balance was assessed using the Mini-BESTest and fatigue was assessed by the Piper Fatigue Scale. Patients in the intervention group improved significantly (p<0.05) on dynamic balance (reactive postural control and total values) and perceived fatigue. An 8-week resistance training program was found to be effective at improving dynamic balance and fatigue in patients with PD. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

Study protocol on comparative effectiveness of mindfulness meditation and qigong on psychophysiological outcomes for patients with colorectal cancer: a randomized controlled trial.

PubMed

Ho, Rainbow T H; Wan, Adrian H Y; Chan, Jessie S M; Ng, S M; Chung, K F; Chan, Cecilia L W

2017-08-08

Colorectal cancer imposes threats to patients' well-being. Although most physical symptoms can be managed by medication, psychosocial stressors may complicate survival and hamper quality of life. Mindfulness and Qigong, two kinds of mind-body exercise rooted in Eastern health philosophy, has been found effective in symptoms management, improving mental health, and reducing stress. With these potential benefits, a randomized controlled trial (RCT) is planned to investigate the comparative effectiveness of mindfulness and Baduanjin intervention on the bio-psychosocial wellbeing of people with colorectal cancer. A 3-arm RCT with waitlist control design will be used in this study. One hundred eighty-nine participants will be randomized into (i) Mindfulness, (ii) Baduanjin, or (iii) waitlist control groups. Participants in both the Baduanjin and mindfulness groups will receive 8-weeks of specific intervention. All three groups will undergo four assessment phases: (i) at baseline, (ii) at 4-week, (iii) at 8-week (post-intervention), and 6-month post-intervention (maintenance). All participants will be assessed in terms of cancer-related symptoms and symptom distress, mental health status, quality of life, stress level based on physiological marker. Based on prior research studies, participants in both the mindfulness and Baduanjn intervention group are expected to have better symptoms management, lower stress level, better mental health, and higher level of quality of life than the control group. This study contributes to better understanding on the common and unique effectiveness of mindfulness and Baduanjin qigong, as such patients and qualified healthcare professionals can select or provide practices which will produce maximum benefits, satisfaction, adherence, and sustainability. The trial has been registered in the Clinical Trials Centre of the University of Hong Kong ( HKCTR-2198 ) on 08 March 2017.

Supporting stress management for women undergoing the early stages of fertility treatment: a cluster-randomized controlled trial.

PubMed

Mori, Akiko

2009-06-01

The purpose of this study was to determine the effects of a support program for the stress management of women undergoing fertility treatment to reduce stress related to infertility and treatment. We randomly assigned seven institutions into an experimental group (four institutions, n = 96) and a control group (three institutions, n = 44) using cluster randomization. The women in the experimental group were asked to continue stress management homework for 3 months. A nurse provided feedback on the homework every month. Those in the control group were given only the booklet. The primary outcomes were the risk ratios of "depression" and "anxiety" according to the Hospital Anxiety and Depression Scale. The secondary outcomes were "health status" from the Medical Outcomes Study Short-Form 36-item Health Survey (SF-36) v2 and "satisfaction" from the Visual Analogue Scale. We excluded 15 women who became pregnant and performed an intention-to-treat analysis of 125 women. There were no differences in the incidence of depression and anxiety between the experimental and control groups. There were significant interaction effects between the program and time in the scores of the two subscales of SF-36 and the summary. There was no difference in satisfaction. The use of ovulation-enhancing agents showed that the scores of "role functioning physical" and "physical component summary" in the non-use subgroup were higher at 2 and 3 months in the experimental group, compared to the control group. Positive effects of the support program were observed on two subscales of the SF-36 in the subgroup that did not use ovulation-enhancing agents.

Efficacy of Auriculotherapy for Constipation in Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

PubMed Central

Yang, Li-Hua; Du, Shi-Zheng; Sun, Jin-Fang; Mei, Si-Juan; Wang, Xiao-Qing; Zhang, Yuan-Yuan

2014-01-01

Abstract Objectives: To assess the clinical evidence of auriculotherapy for constipation treatment and to identify the efficacy of groups using Semen vaccariae or magnetic pellets as taped objects in managing constipation. Methods: Databases were searched, including five English-language databases (the Cochrane Library, PubMed, Embase, CINAHL, and AMED) and four Chinese medical databases. Only randomized controlled trials were included in the review process. Critical appraisal was conducted using the Cochrane risk of bias tool. Results: Seventeen randomized, controlled trials (RCTs) met the inclusion criteria, of which 2 had low risk of bias. The primary outcome measures were the improvement rate and total effective rate. A meta-analysis of 15 RCTs showed a moderate, significant effect of auriculotherapy in managing constipation compared with controls (relative risk [RR], 2.06; 95% confidence interval [CI], 1.52– 2.79; p<0.00001). The 15 RCTs also showed a moderate, significant effect of auriculotherapy in relieving constipation (RR, 1.28; 95% CI, 1.13–1.44; p<0.0001). For other symptoms associated with constipation, such as abdominal distension or anorexia, results of the meta-analyses showed no statistical significance. Subgroup analysis revealed that use of S. vaccariae and use of magnetic pellets were both statistically favored over the control in relieving constipation. Conclusions: Current evidence illustrated that auriculotherapy, a relatively safe strategy, is probably beneficial in managing constipation. However, most of the eligible RCTs had a high risk of bias, and all were conducted in China. No definitive conclusion can be made because of cultural and geographic differences. Further rigorous RCTs from around the world are warranted to confirm the effect and safety of auriculotherapy for constipation. PMID:25020089

The Effects of Aromatherapy Massage and Reflexology on Pain and Fatigue in Patients with Rheumatoid Arthritis: A Randomized Controlled Trial.

PubMed

Gok Metin, Zehra; Ozdemir, Leyla

2016-04-01

Nonpharmacologic interventions for symptom management in patients with rheumatoid arthritis are underinvestigated. Limited data suggest that aromatherapy massage and reflexology may help to reduce pain and fatigue in patients with rheumatoid arthritis. The aim of this study was to examine and compare the effects of aromatherapy massage and reflexology on pain and fatigue in patients with rheumatoid arthritis. The study sample was randomly assigned to either an aromatherapy massage (n = 17), reflexology (n = 17) or the control group (n = 17). Aromatherapy massage was applied to both knees of subjects in the first intervention group for 30 minutes. Reflexology was administered to both feet of subjects in the second intervention group for 40 minutes during weekly home visits. Control group subjects received no intervention. Fifty-one subjects with rheumatoid arthritis were recruited from a university hospital rheumatology clinic in Turkey between July 2014 and January 2015 for this randomized controlled trial. Data were collected by personal information form, DAS28 index, Visual Analog Scale and Fatigue Severity Scale. Pain and fatigue scores were measured at baseline and within an hour after each intervention for 6 weeks. Pain and fatigue scores significantly decreased in the aromatherapy massage and reflexology groups compared with the control group (p < .05). The reflexology intervention started to decrease mean pain and fatigue scores earlier than aromatherapy massage (week 1 vs week 2 for pain, week 1 vs week 4 for fatigue) (p < .05). Aromatherapy massage and reflexology are simple and effective nonpharmacologic nursing interventions that can be used to help manage pain and fatigue in patients with rheumatoid arthritis. Copyright © 2016 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

Efficacy of auriculotherapy for constipation in adults: a systematic review and meta-analysis of randomized controlled trials.

PubMed

Yang, Li-Hua; Duan, Pei-Bei; Du, Shi-Zheng; Sun, Jin-Fang; Mei, Si-Juan; Wang, Xiao-Qing; Zhang, Yuan-Yuan

2014-08-01

To assess the clinical evidence of auriculotherapy for constipation treatment and to identify the efficacy of groups using Semen vaccariae or magnetic pellets as taped objects in managing constipation. Databases were searched, including five English-language databases (the Cochrane Library, PubMed, Embase, CINAHL, and AMED) and four Chinese medical databases. Only randomized controlled trials were included in the review process. Critical appraisal was conducted using the Cochrane risk of bias tool. Seventeen randomized, controlled trials (RCTs) met the inclusion criteria, of which 2 had low risk of bias. The primary outcome measures were the improvement rate and total effective rate. A meta-analysis of 15 RCTs showed a moderate, significant effect of auriculotherapy in managing constipation compared with controls (relative risk [RR], 2.06; 95% confidence interval [CI], 1.52- 2.79; p<0.00001). The 15 RCTs also showed a moderate, significant effect of auriculotherapy in relieving constipation (RR, 1.28; 95% CI, 1.13-1.44; p<0.0001). For other symptoms associated with constipation, such as abdominal distension or anorexia, results of the meta-analyses showed no statistical significance. Subgroup analysis revealed that use of S. vaccariae and use of magnetic pellets were both statistically favored over the control in relieving constipation. Current evidence illustrated that auriculotherapy, a relatively safe strategy, is probably beneficial in managing constipation. However, most of the eligible RCTs had a high risk of bias, and all were conducted in China. No definitive conclusion can be made because of cultural and geographic differences. Further rigorous RCTs from around the world are warranted to confirm the effect and safety of auriculotherapy for constipation.

Financial Incentives for Chronic Disease Management: Results and Limitations of 2 Randomized Clinical Trials With New York Medicaid Patients.

PubMed

VanEpps, Eric M; Troxel, Andrea B; Villamil, Elizabeth; Saulsgiver, Kathryn A; Zhu, Jingsan; Chin, Jo-Yu; Matson, Jacqueline; Anarella, Joseph; Roohan, Patrick; Gesten, Foster; Volpp, Kevin G

2018-01-01

To identify whether financial incentives promote improved disease management in Medicaid recipients diagnosed with hypertension or diabetes, respectively. Four-group, multicenter, randomized clinical trials. Between 2013 and 2016, New York State Medicaid managed care members diagnosed with hypertension (N = 920) or with diabetes (N = 959). Participants in each 6-month trial were randomly assigned to 1 of 4 arms: (1) process incentives-earned by attending primary care visits and/or receiving prescription medication refills, (2) outcome incentives-earned by reducing systolic blood pressure (hypertension) or hemoglobin A 1c (HbA 1c ; diabetes) levels, (3) combined process and outcome incentives, and (4) control (no incentives). Systolic blood pressure (hypertension) and HbA 1c (diabetes) levels, primary care visits, and medication prescription refills. Analysis and Results: At 6 months, there were no statistically significant differences between intervention arms and the control arm in the change in systolic blood pressure, P = .531. Similarly, there were no significant differences in blood glucose control (HbA 1c ) between the intervention arms and control after 6 months, P = .939. The majority of participants had acceptable systolic blood pressure (<140 mm Hg) or blood glucose (<8.0%) levels at baseline and throughout the study. Financial incentives-regardless of whether they were delivered based on disease-relevant outcomes, process activities, or a combination of the two-have a negligible impact on health outcomes for Medicaid recipients diagnosed with either hypertension or diabetes in 2 studies in which, among other design and operational limitations, the majority of recipients had relatively well-controlled diseases at the time of enrollment.

Effects of Heart Rate Variability Biofeedback on EEG Alpha Asymmetry and Anxiety Symptoms in Male Athletes: A Pilot Study.

PubMed

Dziembowska, Inga; Izdebski, Paweł; Rasmus, Anna; Brudny, Janina; Grzelczak, Marta; Cysewski, Piotr

2016-06-01

Heart rate variability biofeedback (HRV-BFB) has been shown as useful tool to manage stress in various populations. The present study was designed to investigate whether the biofeedback-based stress management tool consisting of rhythmic breathing, actively self-generated positive emotions and a portable biofeedback device induce changes in athletes' HRV, EEG patterns, and self-reported anxiety and self-esteem. The study involved 41 healthy male athletes, aged 16-21 (mean 18.34 ± 1.36) years. Participants were randomly divided into two groups: biofeedback and control. Athletes in the biofeedback group received HRV biofeedback training, athletes in the control group didn't receive any intervention. During the randomized controlled trial (days 0-21), the mean anxiety score declined significantly for the intervention group (change-4 p < 0.001) but not for the control group (p = 0.817). In addition, as compared to the control, athletes in biofeedback group showed substantial and statistically significant improvement in heart rate variability indices and changes in power spectra of both theta and alpha brain waves, and alpha asymmetry. These changes suggest better self-control in the central nervous system and better flexibility of the autonomic nervous system in the group that received biofeedback training. A HRV biofeedback-based stress management tool may be beneficial for stress reduction for young male athletes.

Pilot study evaluating a brief mindfulness intervention for those with chronic pain: study protocol for a randomized controlled trial.

PubMed

Howarth, Ana; Perkins-Porras, Linda; Smith, Jared G; Subramaniam, Jeevakan; Copland, Claire; Hurley, Mike; Beith, Iain; Riaz, Muhammad; Ussher, Michael

2016-06-02

The burden of chronic pain is a major challenge, impacting the quality of life of patients. Intensive programmes of mindfulness-based therapy can help patients to cope with chronic pain but can be time consuming and require a trained specialist to implement. The self-management model of care is now integral to the care of patients with chronic pain; home-based interventions can be very acceptable, making a compelling argument for investigating brief, self-management interventions. The aim of this study is two-fold: to assess the immediate effects of a brief self-help mindfulness intervention for coping with chronic pain and to assess the feasibility of conducting a definitive randomized controlled trial to determine the effectiveness of such an intervention. A randomized controlled pilot study will be conducted to evaluate a brief mindfulness intervention for those with chronic pain. Ninety chronic pain patients who attend hospital outpatient clinics will be recruited and allocated randomly to either the control or treatment group on a 1:1 basis using the computer-generated list of random numbers. The treatment group receives mindfulness audios and the control group receives audios of readings from a non-fiction book, all of which are 15 minutes in length. Immediate effects of the intervention are assessed with brief psychological measures immediately before and after audio use. Mindfulness, mood, health-related quality of life, pain catastrophizing and experience of the intervention are assessed with standardized measures, brief ratings and brief telephone follow-ups, at baseline and after one week and one month. Feasibility is assessed by estimation of effect sizes for outcomes, patient adherence and experience, and appraisal of resource allocation in provision of the intervention. This trial will assess whether a brief mindfulness-based intervention is effective for immediately reducing perceived distress and pain with the side effect of increasing relaxation in chronic pain patients and will determine the feasibility of conducting a definitive randomized controlled trial. Patient recruitment began in January 2015 and is due to be completed in June 2016. ISRCTN61538090 Registered 20 April 2015.

Design and rationale of the medical students learning weight management counseling skills (MSWeight) group randomized controlled trial.

PubMed

Ockene, Judith K; Ashe, Karen M; Hayes, Rashelle B; Churchill, Linda C; Crawford, Sybil L; Geller, Alan C; Jolicoeur, Denise; Olendzki, Barbara C; Basco, Maria Theresa; Pendharkar, Jyothi A; Ferguson, Kristi J; Guck, Thomas P; Margo, Katherine L; Okuliar, Catherine A; Shaw, Monica A; Soleymani, Taraneh; Stadler, Diane D; Warrier, Sarita S; Pbert, Lori

2018-01-01

Physicians have an important role addressing the obesity epidemic. Lack of adequate teaching to provide weight management counseling (WMC) is cited as a reason for limited treatment. National guidelines have not been translated into an evidence-supported, competency-based curriculum in medical schools. Weight Management Counseling in Medical Schools: A Randomized Controlled Trial (MSWeight) is designed to determine if a multi-modal theoretically-guided WMC educational intervention improves observed counseling skills and secondarily improve perceived skills and self-efficacy among medical students compared to traditional education (TE). Eight U.S. medical schools were pair-matched and randomized in a group randomized controlled trial to evaluate whether a multi-modal education (MME) intervention compared to traditional education (TE) improves observed WMC skills. The MME intervention includes innovative components in years 1-3: a structured web-course; a role play exercise, WebPatientEncounter, and an enhanced outpatient internal medicine or family medicine clerkship. This evidence-supported curriculum uses the 5As framework to guide treatment and incorporates patient-centered counseling to engage the patient. The primary outcome is a comparison of scores on an Objective Structured Clinical Examination (OSCE) WMC case among third year medical students. The secondary outcome compares changes in scores of medical students from their first to third year on an assessment of perceived WMC skills and self-efficacy. MSWeight is the first RCT in medical schools to evaluate whether interventions integrated into the curriculum improve medical students' WMC skills. If this educational approach for teaching WMC is effective, feasible and acceptable it can affect how medical schools integrate WMC teaching into their curriculum. Copyright © 2017 Elsevier Inc. All rights reserved.

Effects of a novel method for enteral nutrition infusion involving a viscosity-regulating pectin solution: A multicenter randomized controlled trial.

PubMed

Tabei, Isao; Tsuchida, Shigeru; Akashi, Tetsuro; Ookubo, Katsuichiro; Hosoda, Satoru; Furukawa, Yoshiyuki; Tanabe, Yoshiaki; Tamura, Yoshiko

2018-02-01

The initial complications associated with infusion of enteral nutrition (EN) for clinical and nutritional care are vomiting, aspiration pneumonia, and diarrhea. There are many recommendations to prevent these complications. A novel method involving a viscosity-regulating pectin solution has been demonstrated. In Japan, this method along with the other so-called "semi-solid EN" approaches has been widely used in practice. However, there has been no randomized clinical trial to prove the efficiency and safety of a viscosity-regulating pectin solution in EN management. Therefore, we planned and initiated a multicenter randomized controlled trial to determine the efficiency and safety. This study included 34 patients from 7 medical institutions who participated. Institutional review board (IRB) approval was obtained from all participating institutions. Patients who required EN management were enrolled and randomly assigned to the viscosity regulation of enteral feeding (VREF) group and control group. The VREF group (n = 15) was managed with the addition of a viscosity-regulating pectin solution. The control group (n = 12) was managed with conventional EN administration, usually in a gradual step-up method. Daily clinical symptoms of pneumonia, fever, vomiting, and diarrhea; defecation frequency; and stool form were observed in the 2 week trial period. The dose of EN and duration of infusion were also examined. A favorable trend for clinical symptoms was noticed in the VREF group. No significant differences were observed in episodes of pneumonia, fever, vomiting, and diarrhea between the 2 groups. An apparent reduction in infusion duration and hardening of stool form were noted in the VREF group. The novel method involving a viscosity-regulating pectin solution with EN administration can be clinically performed safely and efficiently, similar to the conventional method. Moreover, there were benefits, such as improvement in stool form, a short time for EN infusion, and a reduction in vomiting episodes, with the use of the novel method. This indicates some potential advantages in the quality of life among patients receiving this novel method. Copyright © 2017 European Society for Clinical Nutrition and Metabolism. Published by Elsevier Ltd. All rights reserved.

A randomized controlled trial of an educational intervention on Hellenic nursing staff's knowledge and attitudes on cancer pain management.

PubMed

Patiraki, Elisabeth I; Papathanassoglou, Elizabeth D E; Tafas, Cheryl; Akarepi, Vasiliki; Katsaragakis, Stelios G; Kampitsi, Anjuleta; Lemonidou, Chrysoula

2006-12-01

The purpose of this randomized controlled study was to explore the effectiveness of an educational intervention on nurses' attitudes and knowledge regarding pain management and to explore associations with nurses' characteristics. A four Solomon group experimental design was employed to assess the effect of the intervention and potential effects of pre-intervention testing. One hundred and twelve nurses were randomized to two intervention and two control groups. The intervention was based on viewing a series of educational videotapes and case scenarios. The Validated Hellenic version of the Nurses Knowledge and Attitudes Survey Regarding Pain (GV-NKASRP) was used. Pre-intervention scores revealed various limitations in regard to pain assessment and management. At the pre-test, the average number of correct answers was 17.58+/-7.58 (45.1%+/-19.3% of total questions). Pre-intervention scores differed significantly among participants with different educational backgrounds (P < 0.0001). A significant effect of pain education on total knowledge scores as well as regarding specific questions was detected. Intervention group participants provided 6.11+/-5.55 additional correct answers (15.66%+/-14.23% improvement, P < 0.0001), and they exhibited significantly improved post-test scores compared to controls (26.49+/-5.24 vs. 18.75+/-4.48; P < 0.0001). A potential negative effect of pre-test on knowledge gain for specific items and for total scores was detected. These findings suggest low pre-test knowledge scores among Hellenic oncology nurses and a significant effect of the intervention.

A randomized controlled trial of the effect of participatory ergonomic low back pain training on workplace improvement

PubMed Central

Kajiki, Shigeyuki; Izumi, Hiroyuki; Hayashida, Kenshi; Kusumoto, Akira; Nagata, Tomohisa; Mori, Koji

2017-01-01

Objectives: This study aimed to determine the effects of participatory workplace improvement (PWI) -based provision of ergonomic training and ergonomic action checklists (ACLs) to on-site managers on workplace improvement activities for low back pain (LBP). Methods: A randomized controlled trial (RCT) was conducted at a manufacturing company in Japan. Teams entered in the study were randomly assigned to a control and an intervention group. A total of three interventional training sessions on methods of ergonomics were provided to on-site managers in the intervention group, with 1-month intervals between sessions. Ergonomic ACLs were provided at the same time. After completion of the training sessions, each team then provided a report of improvements each month for the next 10 months. Two people in charge of safety and health chose two major objectives of the implemented activities from the five categories. The reported number of improvements was analyzed using a Poisson regression model. Results: In the intervention group, although the incident rate ratio (IRR) of PWIs in countermeasures for the LBP category was significantly elevated after the training sessions, the IRR of improvements decreased over time during the 10-month follow-up period. No significant difference was observed in the IRR of total PWIs in either the control or intervention group. Conclusions: PWI-based provision of ergonomic training sessions and ergonomics ACLs to on-site managers was shown to be effective for workplace improvement activities targeted at LBP. However, because the effects decrease over time, efforts should be made to maintain the effects through regular interventions. PMID:28320978

A randomized controlled trial of the effect of participatory ergonomic low back pain training on workplace improvement.

PubMed

Kajiki, Shigeyuki; Izumi, Hiroyuki; Hayashida, Kenshi; Kusumoto, Akira; Nagata, Tomohisa; Mori, Koji

2017-05-25

This study aimed to determine the effects of participatory workplace improvement (PWI) -based provision of ergonomic training and ergonomic action checklists (ACLs) to on-site managers on workplace improvement activities for low back pain (LBP). A randomized controlled trial (RCT) was conducted at a manufacturing company in Japan. Teams entered in the study were randomly assigned to a control and an intervention group. A total of three interventional training sessions on methods of ergonomics were provided to on-site managers in the intervention group, with 1-month intervals between sessions. Ergonomic ACLs were provided at the same time. After completion of the training sessions, each team then provided a report of improvements each month for the next 10 months. Two people in charge of safety and health chose two major objectives of the implemented activities from the five categories. The reported number of improvements was analyzed using a Poisson regression model. In the intervention group, although the incident rate ratio (IRR) of PWIs in countermeasures for the LBP category was significantly elevated after the training sessions, the IRR of improvements decreased over time during the 10-month follow-up period. No significant difference was observed in the IRR of total PWIs in either the control or intervention group. PWI-based provision of ergonomic training sessions and ergonomics ACLs to on-site managers was shown to be effective for workplace improvement activities targeted at LBP. However, because the effects decrease over time, efforts should be made to maintain the effects through regular interventions.

Age differences in coping and locus of control: a study of managerial stress in Hong Kong.

PubMed

Siu, O; Cooper, C L; Spector, P E; Donald, I

2001-12-01

The present study involved data collection from 3 samples of Hong Kong managers to examine mechanisms by which age would relate to work well-being. A total of 634 managers was drawn by random sampling and purposive sampling methods. The results showed that age was positively related to well-being (job satisfaction and mental well-being). Furthermore, older managers reported fewer sources of stress, better coping, and a more internal locus of control. Multiple regression analyses suggested that the relations of age with 2 well-being indicators can be attributed to various combinations of coping, work locus of control, sources of stress, managerial level, and organizational tenure.

Effectiveness of Stress Management Skill Training on the Depression, Anxiety and Stress Levels in Drug Addicts after Drug Withdrawal

PubMed Central

Habibi, Zahra; Tourani, Somayeh; Sadeghi, Hasan; Abolghasemi, Abbass

2013-01-01

Background Stressful life events may cause initiation of drug use among people. The main purpose of this study was to evaluate the effectiveness of stress management skill training on depression, anxiety and stress levels in drug addicts after withdrawal. Objectives The population included all drug addicts after withdrawal in 2012 in Alborz province. Materials and Methods The study was quasi-experimental with pretest-posttest design with a control group. Levels of emotional reactions (depression, anxiety and stress) in all referrals to a counseling center for drug withdrawal in 2012 using the Depression, Anxiety, Stress (DASS-21) questionnaire was assessed. The study population included drug addicts after withdrawal. The sampling method was available sampling and random assignment. Thirty people who had higher emotional reactions were randomly selected and divided into two test (n = 15) and control (n = 15) groups. For the test group, a stress management skill training course was held in twelve 90-minute sessions, but the control group received no intervention. The obtained data were analyzed using SPSS-19 software with analysis of covariance. Results The results showed that stress management skill training has a significant effect on reducing emotional reactions (P < 0.01). It was noted that after 2 months test group follow-up, stress management training has retained its effect. Conclusion Apparently, training addicts about life skills, particularly stress management seems to be a good idea. PMID:24971280

Effects of a 3-year nurse-based case management in aged patients with acute myocardial infarction on rehospitalisation, mortality, risk factors, physical functioning and mental health. a secondary analysis of the randomized controlled KORINNA study.

PubMed

Kirchberger, Inge; Hunger, Matthias; Stollenwerk, Björn; Seidl, Hildegard; Burkhardt, Katrin; Kuch, Bernhard; Meisinger, Christa; Holle, Rolf

2015-01-01

Home-based secondary prevention programs led by nurses have been proposed to facilitate patients' adjustment to acute myocardial infarction (AMI). The objective of this study was to conduct secondary analyses of the three-year follow-up of a nurse-based case management for elderly patients discharged from hospital after an AMI. In a single-centre randomized two-armed parallel group trial of hospitalized patients with AMI ≥65 years, patients hospitalized between September 2008 and May 2010 in the Hospital of Augsburg, Germany, were randomly assigned to case management or usual care. The case-management intervention consisted of a nurse-based follow-up for three years including home visits and telephone calls. Study endpoints were time to first unplanned readmission or death, clinical parameters, functional status, depressive symptoms and malnutrition risk. Persons who assessed three-year outcomes and validated readmission data were blinded. The intention-to-treat approach was applied to the statistical analyses which included Cox Proportional Hazards models. Three hundred forty patients were allocated to receive case-management (n = 168) or usual care (n = 172). During three years, in the intervention group there were 80 first unplanned readmissions and 6 deaths, while the control group had 111first unplanned readmissions and 3 deaths. The intervention did not significantly affect time to first unplanned readmission or death (Hazard Ratio 0.89, 95% confidence interval (CI) 0.67-1.19; p = 0.439), blood pressure, cholesterol level, instrumental activities of daily life (IADL) (only for men), and depressive symptoms. However, patients in the intervention group had a significantly better functional status, as assessed by the HAQ Disability Index, IADL (only for women), and hand grip strength, and better SCREEN-II malnutrition risk scores than patients in the control group. A nurse-based management among elderly patients with AMI did not significantly affect time to unplanned readmissions or death during a three-year follow-up. However, the results indicate that functional status and malnutrition risk can be improved. Current Controlled Trials ISRCTN02893746.

Village doctor-assisted case management of rural patients with schizophrenia: protocol for a cluster randomized control trial.

PubMed

Gong, Wenjie; Xu, Dong; Zhou, Liang; Brown, Henry Shelton; Smith, Kirk L; Xiao, Shuiyuan

2014-01-16

Strict compliance with prescribed medication is the key to reducing relapses in schizophrenia. As villagers in China lack regular access to psychiatrists to supervise compliance, we propose to train village 'doctors' (i.e., villagers with basic medical training and currently operating in villages across China delivering basic clinical and preventive care) to manage rural patients with schizophrenia with respect to compliance and monitoring symptoms. We hypothesize that with the necessary training and proper oversight, village doctors can significantly improve drug compliance of villagers with schizophrenia. We will conduct a cluster randomized controlled trial in 40 villages in Liuyang, Hunan Province, China, home to approximately 400 patients with schizophrenia. Half of the villages will be randomized into the treatment group (village doctor, or VD model) wherein village doctors who have received training in a schizophrenia case management protocol will manage case records, supervise drug taking, educate patients and families on schizophrenia and its treatment, and monitor patients for signs of relapse in order to arrange prompt referral. The other 20 villages will be assigned to the control group (case as usual, or CAU model) wherein patients will be visited by psychiatrists every two months and receive free antipsychotic medications under an on-going government program, Project 686. These control patients will receive no other management or follow up from health workers. A baseline survey will be conducted before the intervention to gather data on patient's socio-economic status, drug compliance history, and clinical and health outcome measures. Data will be re-collected 6 and 12 months into the intervention. A difference-in-difference regression model will be used to detect the program effect on drug compliance and other outcome measures. A cost-effectiveness analysis will also be conducted to compare the value of the VD model to that of the CAU group. Lack of specialists is a common problem in resource-scarce areas in China and other developing countries. The results of this experiment will provide high level evidence on the role of health workers with relatively limited medical training in managing severe psychiatric disease and other chronic conditions in developing countries. ChiCTR-TRC-13003263.

A randomized controlled trial of the Arctic Sun Temperature Management System versus conventional methods for preventing hypothermia during off-pump cardiac surgery.

PubMed

Grocott, Hilary P; Mathew, Joseph P; Carver, Elizabeth H; Phillips-Bute, Barbara; Landolfo, Kevin P; Newman, Mark F

2004-02-01

In this trial we compared the hypothermia avoidance abilities of the Arctic Sun Temperature Management System (a servo-regulated system that circulates temperature-controlled water through unique energy transfer pads adherent to the patient's body) with conventional temperature control methods. Patients undergoing off-pump coronary artery bypass (OPCAB) surgery were randomized to either the Arctic Sun System alone (AS group) or conventional methods (control group; increased room temperature, heated IV fluids, convective forced air warming system) for the prevention of hypothermia (defined by a temperature <36 degrees C). The AS group had nasopharyngeal temperature servo-regulated to a target of 36.8 degrees C. Temperature was recorded throughout the operative period and comparisons were made between groups for both the time and area under the curve (AUC) for a temperature <36 degrees C (AUC<36 degrees C). Twenty-nine patients (AS group = 14, control group = 15) were studied. The AS group had significantly less hypothermia than the control group, both for duration of time <36 degrees C (2.5 [0-22] min, median [interquartile range] AS group versus 118 [49-192] min, control group; P = 0.0008) as well as for AUC<36 degrees C (0.3 [0-2.2] degrees C x min, AS group versus 17.1 [3.6-173.4] degrees C x min, control group; P = 0.002). The Arctic Sun Temperature Management System significantly reduced intraoperative hypothermia during OPCAB surgery. Importantly, this was achieved in the absence of any other temperature modulating techniques, including the use of IV fluid warming or increases in the ambient operating room temperature. The Arctic Sun Temperature Management System was more effective than conventional methods in preventing hypothermia during off-pump coronary artery bypass graft surgery.

Post-fracture care: do we need to educate patients rather than doctors? The PREVOST randomized controlled trial.

PubMed

Merle, B; Chapurlat, R; Vignot, E; Thomas, T; Haesebaert, J; Schott, A-M

2017-05-01

We conducted a multicenter, randomized controlled trial to evaluate the impact of a population-based patient-centered post-fracture care program with a dedicated case manager, PREVention of OSTeoporosis (PREVOST), on appropriate post-fracture osteoporosis management. We showed that, compared to usual care, BMD investigation post-fracture was significantly improved (+20%) by our intervention program. Our study aims to evaluate the impact of a population-based patient-centered post-fracture care program, PREVOST, on appropriate post-fracture care. Multicenter, randomized controlled trial enrolling 436 women aged 50 to 85 years and attending a French hospital, for a low-energy fracture of the wrist or humerus. Randomization was stratified by age, hospital department, and site of fracture. The intervention was performed by a trained case manager who interacted only with the patients, with repeated oral and written information about fragility fractures and osteoporosis management, and prompting them to visit their primary care physicians. Control group received usual care. The primary outcome was the initiation of an appropriate post-fracture care defined by Bone Mineral Density (BMD) and/or anti-osteoporotic treatment prescription at 6 months. At 6 months, 53% of women in intervention group initiated a post-fracture care versus 33% for usual care (adjOR 2.35, 95%CI [1.58-3.50], p < 0.001). Post-fracture care was more frequent after wrist than humerus fracture (adjOR 1.93, 95%CI [1.14-3.30], p = 0.015) and decreased with age (adjOR for 10 years increase 0.76, 95%CI [0.61-0.96], p = 0.02). The intervention resulted in BMD prescription in 50% of patients (adjOR 2.10, 95%CI [1.41-3.11], p < 0.001) and in BMD performance in 41% of patients (adjOR 2.12, 95%CI [1.40-3.20], p < 0.001) versus 33 and 25% for usual care, respectively. Having performed a BMD increased treatment prescription; however, only 46% of women with a low BMD requiring a treatment according to the French guidelines received a prescription. A patient-centered care program with a dedicated case manager can significantly improve post-fracture BMD investigation.

A robust and high-performance queue management controller for large round trip time networks

NASA Astrophysics Data System (ADS)

Khoshnevisan, Ladan; Salmasi, Farzad R.

2016-05-01

Congestion management for transmission control protocol is of utmost importance to prevent packet loss within a network. This necessitates strategies for active queue management. The most applied active queue management strategies have their inherent disadvantages which lead to suboptimal performance and even instability in the case of large round trip time and/or external disturbance. This paper presents an internal model control robust queue management scheme with two degrees of freedom in order to restrict the undesired effects of large and small round trip time and parameter variations in the queue management. Conventional approaches such as proportional integral and random early detection procedures lead to unstable behaviour due to large delay. Moreover, internal model control-Smith scheme suffers from large oscillations due to the large round trip time. On the other hand, other schemes such as internal model control-proportional integral and derivative show excessive sluggish performance for small round trip time values. To overcome these shortcomings, we introduce a system entailing two individual controllers for queue management and disturbance rejection, simultaneously. Simulation results based on Matlab/Simulink and also Network Simulator 2 (NS2) demonstrate the effectiveness of the procedure and verify the analytical approach.

Efficacy and cost-effectiveness of a web-based and mobile stress-management intervention for employees: design of a randomized controlled trial.

PubMed

Heber, Elena; Ebert, David Daniel; Lehr, Dirk; Nobis, Stephanie; Berking, Matthias; Riper, Heleen

2013-07-15

Work-related stress is associated with a variety of mental and emotional problems and can lead to substantial economic costs due to lost productivity, absenteeism or the inability to work. There is a considerable amount of evidence on the effectiveness of traditional face-to-face stress-management interventions for employees; however, they are often costly, time-consuming, and characterized by a high access threshold. Web-based interventions may overcome some of these problems yet the evidence in this field is scarce. This paper describes the protocol for a study that will examine the efficacy and cost-effectiveness of a web-based guided stress-management training which is based on problem solving and emotion regulation and aimed at reducing stress in adult employees. The study will target stressed employees aged 18 and older. A randomized controlled trial (RCT) design will be applied. Based on a power calculation of d=.35 (1-β of 80%, α = .05), 264 participants will be recruited and randomly assigned to either the intervention group or a six-month waitlist control group. Inclusion criteria include an elevated stress level (Cohen's Perceived Stress Scale-10 ≥ 22) and current employment. Exclusion criteria include risk of suicide or previously diagnosed psychosis or dissociative symptoms. The primary outcome will be perceived stress, and secondary outcomes include depression and anxiety. Data will be collected at baseline and seven weeks and six months after randomization. An extended follow up at 12 months is planned for the intervention group. Moreover, a cost-effectiveness analysis will be conducted from a societal perspective and will include both direct and indirect health care costs. Data will be analyzed on an intention-to-treat basis and per protocol. The substantial negative consequences of work-related stress emphasize the necessity for effective stress-management trainings. If the proposed internet intervention proves to be (cost-) effective, a preventative, economical stress-management tool will be conceivable. The strengths and limitations of the present study are discussed. German Register of Clinical Studies (DRKS): DRKS00004749.

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

Impact of different dietary approaches on glycemic control and cardiovascular risk factors in patients with type 2 diabetes: a protocol for a systematic review and network meta-analysis.

PubMed

Schwingshackl, Lukas; Chaimani, Anna; Hoffmann, Georg; Schwedhelm, Carolina; Boeing, Heiner

2017-03-20

Dietary advice is one of the cornerstones in the management of type 2 diabetes mellitus. The American Diabetes Association recommended a hypocaloric diet for overweight or obese adults with type 2 diabetes in order to induce weight loss. However, there is limited evidence on the optimal approaches to control hyperglycemia in type 2 diabetes patients. The aim of the present study is to assess the comparative efficacy of different dietary approaches on glycemic control and blood lipids in patients with type 2 diabetes mellitus in a systematic review including a standard pairwise and network meta-analysis of randomized trials. We will conduct searches in Cochrane Central Register of Controlled Trials (CENTRAL) on the Cochrane Library, PubMed (from 1966), and Google Scholar. Citations, abstracts, and relevant papers will be screened for eligibility by two reviewers independently. Randomized controlled trials (with a control group or randomized trials with at least two intervention groups) will be included if they meet the following criteria: (1) include type 2 diabetes mellitus, (2) include patients aged ≥18 years, (3) include dietary intervention (different type of diets: e.g., Mediterranean dietary pattern, low-carbohydrate diet, low-fat diet, vegetarian diet, high protein diet); either hypo, iso-caloric, or ad libitum diets, (4) minimum intervention period of 12 weeks. For each outcome measure of interest, random effects pairwise and network meta-analyses will be performed in order to determine the pooled relative effect of each intervention relative to every other intervention in terms of the post-intervention values (or mean differences between the changes from baseline value scores). Subgroup analyses are planned for study length, sample size, age, and sex. This systematic review will synthesize the available evidence on the comparative efficacy of different dietary approaches in the management of glycosylated hemoglobin (primary outcome), fasting glucose, and cardiovascular risk factors in type 2 diabetes mellitus patients. The results of the present network meta-analysis will influence evidence-based treatment decisions since it will be fundamental for based recommendations in the management of type 2 diabetes. PROSPERO 42016047464.

The Preliminary Effects of Massage and Inhalation Aromatherapy on Chemotherapy-Induced Acute Nausea and Vomiting: A Quasi-Randomized Controlled Pilot Trial.

PubMed

Zorba, Pinar; Ozdemir, Leyla

2017-04-20

Despite pharmacological treatment, chemotherapy-induced nausea and vomiting (CINV) are observed in patients. This quasi-randomized controlled pilot study evaluated the feasibility and preliminary effects of massage and inhalation aromatherapies on chemotherapy-induced acute nausea/vomiting. Seventy-five patients with breast cancer were randomly grouped into 1 of 3 groups: massage (n = 25), inhalation (n = 25), and control (n = 25). The patients in the massage group received 20-minute aromatherapy foot massage, whereas those in the inhalation group received 3-minute inhalation aromatherapy before their second, third, and fourth chemotherapy cycles. The control group underwent only the routine treatment. A nausea, vomiting, and retching patient follow-up form was used to evaluate nausea severity by visual analog scale and frequency of vomiting and retching. The incidence of nausea and retching was significantly higher in the control group than in the other groups in the third and fourth chemotherapy cycles (P < .001). Furthermore, in these 2 cycles, the incidence of nausea and retching was significantly lower in the massage group than in the inhalation group (P < .001). Nausea severity was significantly lower among patients in the massage and inhalation groups than in the control group in all 3 cycles (P < .001). Nausea severity was significantly lower in the massage and inhalation aromatherapy groups than in the control group. Nausea and retching incidence was reduced in the aromatherapy groups compared with that in the control group. Nonpharmacological approaches are recommended for managing CINV. Massage and inhalation aromatherapy seems promising regarding the management of CINV.

Disease management program for chronic obstructive pulmonary disease: a randomized controlled trial.

PubMed

Rice, Kathryn L; Dewan, Naresh; Bloomfield, Hanna E; Grill, Joseph; Schult, Tamara M; Nelson, David B; Kumari, Sarita; Thomas, Mel; Geist, Lois J; Beaner, Caroline; Caldwell, Michael; Niewoehner, Dennis E

2010-10-01

The effect of disease management for chronic obstructive pulmonary disease (COPD) is not well established. To determine whether a simplified disease management program reduces hospital admissions and emergency department (ED) visits due to COPD. We performed a randomized, adjudicator-blinded, controlled, 1-year trial at five Veterans Affairs medical centers of 743 patients with severe COPD and one or more of the following during the previous year: hospital admission or ED visit for COPD, chronic home oxygen use, or course of systemic corticosteroids for COPD. Control group patients received usual care. Intervention group patients received a single 1- to 1.5-hour education session, an action plan for self-treatment of exacerbations, and monthly follow-up calls from a case manager. We determined the combined number of COPD-related hospitalizations and ED visits per patient. Secondary outcomes included hospitalizations and ED visits for all causes, respiratory medication use, mortality, and change in Saint George's Respiratory Questionnaire. After 1 year, the mean cumulative frequency of COPD-related hospitalizations and ED visits was 0.82 per patient in usual care and 0.48 per patient in disease management (difference, 0.34; 95% confidence interval, 0.15-0.52; P < 0.001). Disease management reduced hospitalizations for cardiac or pulmonary conditions other than COPD by 49%, hospitalizations for all causes by 28%, and ED visits for all causes by 27% (P < 0.05 for all). A relatively simple disease management program reduced hospitalizations and ED visits for COPD. Clinical trial registered with www.clinicaltrials.gov (NCT00126776).

Adapting Hypertension Self-Management Interventions to Enhance their Sustained Effectiveness among Urban African Americans

PubMed Central

Ameling, Jessica M.; Ephraim, Patti L.; Bone, Lee R.; Levine, David M.; Roter, Debra L.; Wolff, Jennifer L.; Hill-Briggs, Felicia; Fitzpatrick, Stephanie L.; Noronha, Gary J.; Fagan, Peter J.; Lewis-Boyer, LaPricia; Hickman, Debra; Simmons, Michelle; Purnell, Leon; Fisher, Annette; Cooper, Lisa A.; Aboumatar, Hanan J.; Albert, Michael C.; Flynn, Sarah J.; Boulware, L. Ebony

2014-01-01

African Americans suffer disproportionately poor hypertension control despite the availability of efficacious interventions. Using principles of community-based participatory research and implementation science, we adapted established hypertension self-management interventions to enhance interventions’ cultural relevance and potential for sustained effectiveness among urban African Americans. We obtained input from patients and their family members, their health care providers, and community members. The process required substantial time and resources, and the adapted interventions will be tested in a randomized controlled trial. PMID:24569158

Adapting hypertension self-management interventions to enhance their sustained effectiveness among urban African Americans.

PubMed

Ameling, Jessica M; Ephraim, Patti L; Bone, Lee R; Levine, David M; Roter, Debra L; Wolff, Jennifer L; Hill-Briggs, Felicia; Fitzpatrick, Stephanie L; Noronha, Gary J; Fagan, Peter J; Lewis-Boyer, LaPricia; Hickman, Debra; Simmons, Michelle; Purnell, Leon; Fisher, Annette; Cooper, Lisa A; Aboumatar, Hanan J; Albert, Michael C; Flynn, Sarah J; Boulware, L Ebony

2014-01-01

African Americans suffer disproportionately poor hypertension control despite the availability of efficacious interventions. Using principles of community-based participatory research and implementation science, we adapted established hypertension self-management interventions to enhance interventions' cultural relevance and potential for sustained effectiveness among urban African Americans. We obtained input from patients and their family members, their health care providers, and community members. The process required substantial time and resources, and the adapted interventions will be tested in a randomized controlled trial.

Multidisciplinary COPD disease management program: impact on clinical outcomes.

PubMed

Morganroth, Melvin; Pape, Ginger; Rozenfeld, Yelena; Heffner, John E

2016-01-01

We hypothesized performance improvement interventions would improve COPD guideline-recommended care and decrease COPD exacerbations in primary care clinic practices. We initiated a performance improvement project in 12 clinics to improve COPD outcomes incorporating physician education, case management, web-based decision support (CareManager(TM)), and performance feedback. We collected baseline and one-year follow up data on 242 patients who had COPD with acute exacerbations. We analyzed data by two methods. First, the 12 clinics were cluster randomized to 4 intervention (117 patients) and 8 control (125 patients) clinics which all had access to CareManager(TM) but only intervention clinic physicians received case management, academic detailing, and decision support assistance. Exacerbation rates and guideline adherence were compared. Second, data from all 12 clinics were pooled in a quasi-experimental design comparing baseline and post-implementation of CareManager(TM) to determine the value of system-wide performance improvement during the study period. In the randomized analysis, baseline demographics were similar. No differences (p = 0.79) occurred in exacerbation rates between intervention and control clinics although both groups had decreased numbers of exacerbations from baseline to follow up (p < 0.05). The pooled data from all 12 clinics demonstrated a reduction (p < 0.05) in mean exacerbations/patient from 2.3 (CI 2.0-2.6) during baseline to 1.4 (CI 1.1-1.7) at one-year follow up. Emergency department visits and hospitalizations/patient decreased (p = 0.003). Patients naïve at study start to depression screening, pneumococcal vaccination, inhaled control medications or smoking cessation had fewer (p < 0.05) exacerbations after these interventions. We observed no difference in exacerbation rates between clinics receiving case management, academic detailing, and ongoing assistance with decision support and controls. Implementation of a web-based disease management system (CareManager(TM)) along with health system-wide COPD performance improvement efforts was associated with fewer COPD exacerbations and increased adherence to guideline recommendations.

Use of a low-literacy written action plan to improve parent understanding of pediatric asthma management: A randomized controlled study.

PubMed

Yin, Hsiang Shonna; Gupta, Ruchi S; Mendelsohn, Alan L; Dreyer, Benard; van Schaick, Linda; Brown, Christina R; Encalada, Karen; Sanchez, Dayana C; Warren, Christopher M; Tomopoulos, Suzy

2017-11-01

The objective of the study was to determine whether parents who use a low-literacy, pictogram- and photograph-based written asthma action plan (WAAP) have a better understanding of child asthma management compared to parents using a standard plan. A randomized controlled study was carried out in 2 urban pediatric outpatient clinics. Inclusion criteria were English- and Spanish-speaking parents of 2- to 12-year-old asthmatic children. Parents were randomized to receive a low-literacy or standard asthma action plan (American Academy of Allergy, Asthma and Immunology) for a hypothetical patient on controller and rescue medications. A structured questionnaire was used to assess whether there was an error in knowledge of (1) medications to give everyday and when sick, (2) need for spacer use, and (3) appropriate emergency response to give albuterol and seek medical help. Multiple logistic regression analyses were performed, adjusting for parent age, health literacy (Newest Vital Sign); child asthma severity, medications; and site. 217 parents were randomized (109 intervention and 108 control). Parents who received the low-literacy plan were (1) less likely to make an error in knowledge of medications to take everyday and when sick compared to parents who received the standard plan (63.0 vs. 77.3%, p = 0.03; adjusted odds ratio [AOR] = 0.5[95% confidence interval: 0.2-0.9]) and (2) less likely to make an error regarding spacer use (14.0 vs. 51.1%, p < 0.001; AOR = 0.1 [0.06-0.3]). No difference in error in appropriate emergency response was seen (43.1 vs. 48.1%, p = 0.5). Use of a low-literacy WAAP was associated with better parent understanding of asthma management. Further study is needed to assess whether the use of this action plan improves child asthma outcomes.

The Effect of a "Mindful Restaurant Eating" Intervention on Weight Management in Women

ERIC Educational Resources Information Center

Timmerman, Gayle M.; Brown, Adama

2012-01-01

Objective: To evaluate the effect of a "Mindful Restaurant Eating" intervention on weight management. Design: Randomized control trial. Setting: Greater metropolitan area of Austin, Texas. Participants: Women (n = 35) 40-59 years old who eat out at least 3 times per week. Intervention: The intervention, using 6 weekly 2-hour, small group…

Impact of parental weight status on a school-based weight management programme designed for Mexican-American children

USDA-ARS?s Scientific Manuscript database

While overweight and obese children are more likely to have overweight or obese parents, less is known about the effect of parental weight status on children's success in weight management programmes. This study was a secondary data analysis of a randomized controlled trial and investigated the impa...

Resource Contention Management in Parallel Systems

DTIC Science & Technology

1989-04-01

technical competence include communications, command and control, battle management, information processing, surveillance sensors, intelligence data ...two-simulation approach since they require only a single simulation run. More importantly, since they involve only observed data , they may also be...we use the original, unobservable RAC of Section 2 and handle un- observable transitions by generating artifcial events, when required, using a random

Parent Stress Management Training for Attention-Deficit/Hyperactivity Disorder

ERIC Educational Resources Information Center

Treacy, Lee; Tripp, Gail; Baird, Amanda

2005-01-01

This study assessed the effectiveness of a targeted 9-week parent stress management program (PSM) on the parenting stress, mood, family functioning, parenting style, locus of control, and perceived social support of parents of children diagnosed with DSM-IV ADHD. Sixty-three parents from 42 families were randomly assigned to 1 of 2 conditions:…

Randomized, Controlled Trial of CBT Training for PTSD Providers

DTIC Science & Technology

2015-10-01

Wilkinson (Project Manager ), Gayatri Ranganathan , MS (Statistician), Bernet Kato (Statistician), Julia Coleman (Research Associate), Julia Dwyer...I., Friedman, M. J., & Murray, S. (2005). Toward a knowledge management system for posttraumatic stress disorder treatment in veterans healthcare...Secondary Aim #1: To compare improvements in knowledge and attitudes following internet- based training with or without web-centered supervision and

Shunting for normal pressure hydrocephalus (NPH).

PubMed

Esmonde, T; Cooke, S

2002-01-01

Since the condition was first described in 1965, the syndrome of normal pressure hydrocephalus (NPH) has conventionally been managed by placement of a cerebrospinal fluid (CSF) shunt. To determine the effectiveness of shunting procedures in promoting stability or improvement in the neurological symptoms and signs of NPH. The trials were identified from a search of the Specialized Register of the Cochrane Dementia and Cognitive Improvement Group on 26 June 2001 using the terms 'shunt*' and 'normal pressure hydrocephalus'. Studies included for analysis were those involving the placement of a CSF shunt for the treatment of NPH as part of a randomized controlled trial. No data matching the selection criteria were found. No randomized controlled trials of shunt placement versus no shunt were found. There is no evidence to indicate whether placement of a shunt is effective in the management of NPH.

Care management for low-risk patients with heart failure: a randomized, controlled trial.

PubMed

DeBusk, Robert Frank; Miller, Nancy Houston; Parker, Kathleen Marie; Bandura, Albert; Kraemer, Helena Chmura; Cher, Daniel Joseph; West, Jeffrey Alan; Fowler, Michael Bruce; Greenwald, George

2004-10-19

Nurse care management programs for patients with chronic illness have been shown to be safe and effective. To determine whether a telephone-mediated nurse care management program for heart failure reduced the rate of rehospitalization for heart failure and for all causes over a 1-year period. Randomized, controlled trial of usual care with nurse management versus usual care alone in patients hospitalized for heart failure from May 1998 through October 2001. 5 northern California hospitals in a large health maintenance organization. Of 2786 patients screened, 462 met clinical criteria for heart failure and were randomly assigned (228 to intervention and 234 to usual care). Nurse care management provided structured telephone surveillance and treatment for heart failure and coordination of patients' care with primary care physicians. Time to first rehospitalization for heart failure or for any cause and time to a combined end point of first rehospitalization, emergency department visit, or death. At 1 year, half of the patients had been rehospitalized at least once and 11% had died. Only one third of rehospitalizations were for heart failure. The rate of first rehospitalization for heart failure was similar in both groups (proportional hazard, 0.85 [95% CI, 0.46 to 1.57]). The rate of all-cause rehospitalization was similar (proportional hazard, 0.98 [CI, 0.76 to 1.27]). The findings of this study, conducted in a single health care system, may not be generalizable to other health care systems. The overall effect of the intervention was minor. Among patients with heart failure at low risk on the basis of sociodemographic and medical attributes, nurse care management did not statistically significantly reduce rehospitalizations for heart failure or for any cause. Such programs may be less effective for patients at low risk than those at high risk.

Evaluating an Organizational-Level Occupational Health Intervention in a Combined Regression Discontinuity and Randomized Control Design.

PubMed

Sørensen, By Ole H

2016-10-01

Organizational-level occupational health interventions have great potential to improve employees' health and well-being. However, they often compare unfavourably to individual-level interventions. This calls for improving methods for designing, implementing and evaluating organizational interventions. This paper presents and discusses the regression discontinuity design because, like the randomized control trial, it is a strong summative experimental design, but it typically fits organizational-level interventions better. The paper explores advantages and disadvantages of a regression discontinuity design with an embedded randomized control trial. It provides an example from an intervention study focusing on reducing sickness absence in 196 preschools. The paper demonstrates that such a design fits the organizational context, because it allows management to focus on organizations or workgroups with the most salient problems. In addition, organizations may accept an embedded randomized design because the organizations or groups with most salient needs receive obligatory treatment as part of the regression discontinuity design. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Distance management of inflammatory bowel disease: Systematic review and meta-analysis

PubMed Central

Huang, Vivian W; Reich, Krista M; Fedorak, Richard N

2014-01-01

AIM: To review the effectiveness of distance management methods in the management of adult inflammatory bowel disease (IBD) patients. METHODS: A systematic review and meta-analysis of randomized controlled trials comparing distance management and standard clinic follow-up in the management of adult IBD patients. Distance management intervention was defined as any remote management method in which there is a patient self-management component whereby the patient interacts remotely via a self-guided management program, electronic interface, or self-directs open access to clinic follow up. The search strategy included electronic databases (Medline, PubMed, CINAHL, The Cochrane Central Register of Controlled Trials, EMBASE, KTPlus, Web of Science, and SCOPUS), conference proceedings, and internet search for web publications. The primary outcome was the mean difference in quality of life, and the secondary outcomes included mean difference in relapse rate, clinic visit rate, and hospital admission rate. Study selection, data extraction, and risk of bias assessment were completed by two independent reviewers. RESULTS: The search strategy identified a total of 4061 articles, but only 6 randomized controlled trials met the inclusion and exclusion criteria for the systematic review and meta-analysis. Three trials involved telemanagement, and three trials involved directed patient self-management and open access clinics. The total sample size was 1463 patients. There was a trend towards improved quality of life in distance management patients with an end IBDQ quality of life score being 7.28 (95%CI: -3.25-17.81) points higher than standard clinic follow-up. There was a significant decrease in the clinic visit rate among distance management patients mean difference -1.08 (95%CI: -1.60--0.55), but no significant change in relapse rate or hospital admission rate. CONCLUSION: Distance management of IBD significantly decreases clinic visit utilization, but does not significantly affect relapse rates or hospital admission rates. PMID:24574756

Long-term outcomes of internet-based self-management support in adults with asthma: randomized controlled trial.

PubMed

van Gaalen, Johanna L; Beerthuizen, Thijs; van der Meer, Victor; van Reisen, Patricia; Redelijkheid, Geertje W; Snoeck-Stroband, Jiska B; Sont, Jacob K

2013-09-12

Long-term asthma management falls short of the goals set by international guidelines. The Internet is proposed as an attractive medium to support guided self-management in asthma. Recently, in a multicenter, pragmatic randomized controlled parallel trial with a follow-up period of 1 year, patients were allocated Internet-based self-management (IBSM) support (Internet group [IG]) or usual care (UC) alone. IBSM support was automatically terminated after 12 months of follow-up. In this study, IBSM support has been demonstrated to improve asthma-related quality of life, asthma control, lung function, and the number of symptom-free days as compared to UC. IBSM support was based on known key components for effective self-management and included weekly asthma control monitoring and treatment advice, online and group education, and communication (both online and offline) with a respiratory nurse. The objective of the study was to assess the long-term effects of providing patients 1 year of IBSM support as compared to UC alone. Two hundred adults with physician-diagnosed asthma (3 or more months of inhaled corticosteroids prescribed in the past year) from 37 general practices and 1 academic outpatient department who previously participated were invited by letter for additional follow-up at 1.5 years after finishing the study. The Asthma Control Questionnaire (ACQ) and the Asthma Quality of Life Questionnaire (AQLQ) were completed by 107 participants (60 UC participants and 47 IG participants). A minimal clinical important difference in both questionnaires is 0.5 on a 7-point scale. At 30 months after baseline, a sustained and significant difference in terms of asthma-related quality of life of 0.29 (95% CI 0.01-0.57) and asthma control of -0.33 (95% CI -0.61 to -0.05) was found in favor of the IBSM group. No such differences were found for inhaled corticosteroid dosage or for lung function, measured as forced expiratory volume in 1 second. Improvements in asthma-related quality of life and asthma control were sustained in patients who received IBSM support for 1 year, even up to 1.5 years after terminating support. Future research should be focused on implementation of IBSM on a wider scale within routine asthma care. International Standard Randomized Controlled Trial Number (ISRCTN): 79864465; http://www.controlled-trials.com/ISRCTN79864465 (Archived by WebCite at http://www.webcitation.org/6J4VHhPk4).

Economic evaluation of a randomized controlled trial of pharmacist-supervized patient self-testing of warfarin therapy.

PubMed

Gallagher, J; Mc Carthy, S; Woods, N; Ryan, F; O' Shea, S; Byrne, S

2015-02-01

The increase in numbers of patients requiring oral anti-coagulation testing in outpatient clinics has focused attention on alternative flexible systems of anti-coagulation management. One option is pharmacist led patient self-testing (PST) of international normalised ratio (INR) levels. PST has demonstrated improvements in anti-coagulation control, but its cost-effectiveness is inconclusive. This study reports the first cost-effectiveness evaluation of a randomized controlled trial of an automated direct-to-patient expert system, enabling remote and effective management of patients on oral anti-coagulation therapy. We conducted an economic evaluation alongside a randomised controlled trial investigating a pharmacist led PST method. The primary outcome was to determine the cost effectiveness of PST in comparison with usual care (management in a hospital based anti-coagulation clinic). Long term anti-coagulation patients were recruited to a 6 month cross over study between PST and routine care in an anti-coagulation clinic. Economic evaluation was from the healthcare payer perspective. On a per patient basis over a 6 month period, PST resulted in an incremental cost of €59.08 in comparison with routine care. Patients achieved a significantly higher time in therapeutic range (TTR) during the PST arm in comparison with routine care, (72 ± 19.7% vs. 59 ± 13.5%). Overall cost of managing a patient through pharmacist supervised PST for a 6 month period is €226.45. Additional analysis of strategies from a societal perspective indicated that PST was the dominant strategy. Pharmacist led patient self-testing is a viable method of management. It provides significant increases in anti-coagulation control for a minimal increase in cost. © 2014 John Wiley & Sons Ltd.

The Bilirubin Albumin Ratio in the Management of Hyperbilirubinemia in Preterm Infants to Improve Neurodevelopmental Outcome: A Randomized Controlled Trial – BARTrial

PubMed Central

van Imhoff, Deirdre E.; Bos, Arend F.; Lopriore, Enrico; Offringa, Martin; Ruiter, Selma A. J.; van Braeckel, Koen N. J. A.; Krabbe, Paul F. M.; Quik, Elise H.; van Toledo-Eppinga, Letty; Nuytemans, Debbie H. G. M.; van Wassenaer-Leemhuis, Aleid G.; Benders, Manon J. N.; Korbeeck-van Hof, Karen K. M.; van Lingen, Richard A.; Groot Jebbink, Liesbeth J. M.; Liem, Djien; Mansvelt, Petri; Buijs, Jan; Govaert, Paul; van Vliet, Ineke; Mulder, Twan L. M.; Wolfs, Cecile; Fetter, Willem P. F.; Laarman, Celeste

2014-01-01

Background and Objective High bilirubin/albumin (B/A) ratios increase the risk of bilirubin neurotoxicity. The B/A ratio may be a valuable measure, in addition to the total serum bilirubin (TSB), in the management of hyperbilirubinemia. We aimed to assess whether the additional use of B/A ratios in the management of hyperbilirubinemia in preterm infants improved neurodevelopmental outcome. Methods In a prospective, randomized controlled trial, 615 preterm infants of 32 weeks' gestation or less were randomly assigned to treatment based on either B/A ratio and TSB thresholds (consensus-based), whichever threshold was crossed first, or on the TSB thresholds only. The primary outcome was neurodevelopment at 18 to 24 months' corrected age as assessed with the Bayley Scales of Infant Development III by investigators unaware of treatment allocation. Secondary outcomes included complications of preterm birth and death. Results Composite motor (100±13 vs. 101±12) and cognitive (101±12 vs. 101±11) scores did not differ between the B/A ratio and TSB groups. Demographic characteristics, maximal TSB levels, B/A ratios, and other secondary outcomes were similar. The rates of death and/or severe neurodevelopmental impairment for the B/A ratio versus TSB groups were 15.4% versus 15.5% (P = 1.0) and 2.8% versus 1.4% (P = 0.62) for birth weights ≤1000 g and 1.8% versus 5.8% (P = 0.03) and 4.1% versus 2.0% (P = 0.26) for birth weights of >1000 g. Conclusions The additional use of B/A ratio in the management of hyperbilirubinemia in preterm infants did not improve their neurodevelopmental outcome. Trial Registration Controlled-Trials.com ISRCTN74465643 PMID:24927259

Abstinence Reinforcement Therapy (ART) for Rural Veterans: Methodology for an mHealth Smoking Cessation Intervention

PubMed Central

Wilson, Sarah M.; Hair, Lauren P.; Hertzberg, Jeffrey S.; Kirby, Angela C.; Olsen, Maren K.; Lindquist, Jennifer H.; Maciejewski, Matthew L.; Beckham, Jean C.; Calhoun, Patrick S.

2016-01-01

Introduction Smoking is the most preventable cause of morbidity and mortality in U.S. veterans. Rural veterans in particular have elevated risk for smoking and smoking-related illness. However, these veterans underutilize smoking cessation treatment, which suggests that interventions for rural veterans should optimize efficacy and reach. Objective The primary goal of the current study is to evaluate the effectiveness of an intervention that combines evidenced based treatment for smoking cessation with smart-phone based, portable contingency management on smoking rates compared to a contact control intervention in a randomized controlled trial among rural Veteran smokers. Specifically, Veterans will be randomized to receive Abstinence Reinforcement Therapy (ART) which combines evidenced based cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for access to nicotine replacement (NRT), and mobile contingency management (mCM) or a control condition (i.e., TC and NRT alone) that will provide controls for therapist, medication, time and attention effects. Methods Smokers were identified using VHA electronic medical records and recruited proactively via telephone. Participants (N = 310) are randomized to either ART or a best practice control consisting of telephone counseling and telemedicine. Participating patients will be surveyed at 3-months, 6-months and 12-months post-randomization. The primary outcome measure is self-reported and biochemically validated prolonged abstinence at 6-month follow-up. Discussion This trial is designed to test the relative effectiveness of ART compared to a telehealth-only comparison group. Dissemination of this mHealth intervention for veterans in a variety of settings would be warranted if ART improves smoking outcomes for rural veterans and is cost-effective. PMID:27521811

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.

Recombinant factor VIIa analog in the management of hemophilia with inhibitors: results from a multicenter, randomized, controlled trial of vatreptacog alfa.

PubMed

Lentz, S R; Ehrenforth, S; Karim, F Abdul; Matsushita, T; Weldingh, K N; Windyga, J; Mahlangu, J N

2014-08-01

Vatreptacog alfa, a recombinant factor VIIa (rFVIIa) analog with three amino acid substitutions and 99% identity to native FVIIa, was developed to improve the treatment of hemophilic patients with inhibitors. To confirm the safety and assess the efficacy of vatreptacog alfa in treating bleeding episodes in hemophilic patients with inhibitors. In this international, multicenter, randomized, double-blind, active-controlled, crossover, confirmatory phase III trial (adept(™) 2) in patients with hemophilia A or B and inhibitors, bleeds were randomized 3 : 2 to treatment with vatreptacog alfa (one to three doses at 80 μg kg(-1) ) or rFVIIa (one to three doses at 90 μg kg(-1) ). Treatment failures after three doses of trial product (TP) were managed according to the local standard of care. In the 72 patients enrolled, 567 bleeds were treated with TP. Both vatreptacog alfa and rFVIIa gave 93% effective bleeding control at 12 h. Vatreptacog alfa was superior to rFVIIa in secondary efficacy outcomes, including the number of doses used to treat a bleed and sustained bleeding control 24-48 h after the first dose. Eight patients (11%) developed antibodies against vatreptacog alfa, including four with cross-reactivity against rFVIIa and one with an in vitro neutralizing effect to vatreptacog alfa. This large randomized controlled trial confirmed the well-established efficacy and safety profile of rFVIIa, and showed that vatreptacog alfa had similar or better efficacy than rFVIIa. However, because of the development of anti-drug antibodies, a positive benefit-risk profile is unlikely to be achieved with vatreptacog alfa. © 2014 The Authors. Journal of Thrombosis and Haemostasis published by Wiley Periodicals, Inc. on behalf of International Society on Thrombosis and Haemostasis.

Acute and long-term management of food allergy: systematic review.

PubMed

de Silva, D; Geromi, M; Panesar, S S; Muraro, A; Werfel, T; Hoffmann-Sommergruber, K; Roberts, G; Cardona, V; Dubois, A E J; Halken, S; Host, A; Poulsen, L K; Van Ree, R; Vlieg-Boerstra, B J; Agache, I; Sheikh, A

2014-02-01

Allergic reactions to food can have serious consequences. This systematic review summarizes evidence about the immediate management of reactions and longer-term approaches to minimize adverse impacts. Seven bibliographic databases were searched from their inception to September 30, 2012, for systematic reviews, randomized controlled trials, quasi-randomized controlled trials, controlled clinical trials, controlled before-and-after and interrupted time series studies. Experts were consulted for additional studies. There was no language or geographic restrictions. Two reviewers critically appraised the studies using the appropriate tools. Data were not suitable for meta-analysis due to heterogeneity so were narratively synthesized. Eighty-four studies were included, but two-thirds were at high risk of potential bias. There was little evidence about acute management for non-life-threatening reactions. H1-antihistamines may be of benefit, but this evidence was in part derived from studies on those with cross-reactive birch pollen allergy. Regarding long-term management, avoiding the allergenic food or substituting an alternative was commonly recommended, but apart from for infants with cow's milk allergy, there was little high-quality research on this management approach. To reduce symptoms in children with cow's milk allergy, there was evidence to recommend alternatives such as extensively hydrolyzed formula. Supplements such as probiotics have not proved helpful, but allergen-specific immunotherapy may be disease modifying and therefore warrants further exploration. Food allergy can be debilitating and affects a significant number of people. However, the evidence base about acute and longer-term management is weak and needs to be strengthened as a matter of priority. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

A randomized controlled open trial of population-based disease and case management in a Medicare Plus Choice health maintenance organization.

PubMed

Martin, David C; Berger, Marc L; Anstatt, David T; Wofford, Jonathan; Warfel, DeAnn; Turpin, Robin S; Cannuscio, Carolyn C; Teutsch, Steven M; Mansheim, Bernard J

2004-10-01

The object of this study was to examine the effect of population-based disease management and case management on resource use, self-reported health status, and member satisfaction with and retention in a Medicare Plus Choice health maintenance organization (HMO). Study design consisted of a prospective, randomized controlled open trial of 18 months' duration. Participants were 8504 Medicare beneficiaries aged 65 and older who had been continuously enrolled for at least 12 months in a network model Medicare Plus Choice HMO serving a contiguous nine-county metropolitan area. Members were care managed with an expert clinical information system and frequent telephone contact. Main outcomes included self-reported health status measured by the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), resource use measured by admission rates and bed-days per thousand per year, member satisfaction, and costs measured by paid claims. More favorable outcomes occurred in the intervention group for satisfaction with the health plan (P < .01) and the social function domain as measured by SF-36 (P = .04). There was no difference in member retention or mortality between groups. Use of skilled nursing home services was significantly lower in the intervention group than in the control (616 vs 747 days per thousand members per year, P = .02). This reduction, however, did not lead to lower mean total expenditures in the intervention group compared with the control (6828 dollars per member for 18 months vs 7001 dollars, P = .61). Population-based disease management and case management led to improved self-reported satisfaction and social function but not to a global net decrease in resource use or improved member retention.

Effects of herbaceous and woody plant control on longleaf pine growth and understory plant cover

Treesearch

James D. Haywood

2013-01-01

To determine if either herbaceous or woody plants are more competitive with longleaf pine (Pinus palustris Mill.) trees, four vegetation management treatments— check, herbaceous plant control (HPC), woody plant control (WPC), and HPC+WPC—were applied in newly established longleaf pine plantings in a randomized complete block design in two studies....

Androgen Deprivation Therapy and maintenance of intimacy: a randomized controlled pilot study of an educational intervention for patients and their partners.

PubMed

Walker, Lauren M; Hampton, Amy J; Wassersug, Richard J; Thomas, Bejoy C; Robinson, John W

2013-03-01

Androgen Deprivation Therapy (ADT) for prostate cancer is associated with many treatment side effects that tend to erode couples' intimacy. We piloted a randomized controlled trial to investigate the effect of an educational intervention designed to preserve couples' intimacy in the face of ADT. Couples were recruited at the time the patient was first prescribed ADT and were randomized to a treatment or control group. Those in the treatment group were asked to read an educational guide and participate in an educational session designed to inform couples about possible ADT side effects and management strategies. To assess changes in the couples' relationships, they were administered the Dyadic Adjustment Scale and the Personal Assessment of Intimacy in Relationships questionnaire prior to randomization and again at 6 months. While results were not statistically significant, trends and effect sizes suggest that the educational intervention helped attenuate declines in intimacy for patients, but not for their partners. Couples who participated in the intervention were more successful at maintaining sexual activity than were couples in the control group. ADT places considerable strain on intimate relationships, particularly for the partners. It appears that patients who receive help in anticipating and managing ADT related changes report better dyadic adjustment and closer intimacy. More efforts are needed to develop interventions to benefit patients' partners. We conclude that the intervention holds promise and that a full-scale evaluation of the intervention is both feasible and warranted. Copyright © 2012 Elsevier Inc. All rights reserved.

The Evidence for the Role of Nutraceuticals in the Management of Pediatric Migraine: a Review.

PubMed

Orr, Serena L

2018-04-04

Nutraceuticals are a form of complementary and alternative medicine that is commonly used by children and adolescents with migraine. In this review, observational studies, randomized controlled trials, systematic reviews, and meta-analyses on the efficacy and safety of single compound nutraceuticals for the management of migraine in children and adolescents were identified through a literature search of MEDLINE, Embase, and EBM Reviews-Cochrane Central Register of Controlled Trials. Twenty-one studies were reviewed, of which 11 were observational studies, 7 were randomized controlled trials, and 3 were systematic reviews. Six different nutraceuticals were included in the review: vitamin D, riboflavin, coenzyme Q10, magnesium, butterbur, and polyunsaturated fatty acids. All but three of the studies assessed the role of nutraceuticals in migraine prevention, while three studies evaluated the role of intravenous magnesium for acute migraine management. Overall, the quality and size of the studies were limited. Due to low quality evidence and limited studies, no definite conclusions can be drawn on the efficacy of nutraceuticals for the treatment of pediatric migraine. Future studies are warranted in order to establish evidence upon which to define the role of nutraceuticals in this patient population.

Nuevo Amanecer: results of a randomized controlled trial of a community-based, peer-delivered stress management intervention to improve quality of life in Latinas with breast cancer.

PubMed

Nápoles, Anna María; Ortíz, Carmen; Santoyo-Olsson, Jasmine; Stewart, Anita L; Gregorich, Steven; Lee, Howard E; Durón, Ysabel; McGuire, Peggy; Luce, Judith

2015-07-01

We evaluated a community-based, translational stress management program to improve health-related quality of life in Spanish-speaking Latinas with breast cancer. We adapted a cognitive-behavioral stress management program integrating evidence-based and community best practices to address the needs of Latinas with breast cancer. Spanish-speaking Latinas with breast cancer were randomly assigned to an intervention or usual-care control group. Trained peers delivered the 8-week intervention between February 2011 and February 2014. Primary outcomes were breast cancer-specific quality of life and distress, and general symptoms of distress. Of 151 participants, 95% were retained at 6 months (between May 2011 and May 2014). Improvements in quality of life from baseline to 6 months were greater for the intervention than the control group on physical well-being, emotional well-being, breast cancer concerns, and overall quality of life. Decreases from baseline to 6 months were greater for the intervention group on depression and somatization. Results suggest that translation of evidence-based programs can reduce psychosocial health disparities in Latinas with breast cancer. Integration of this program into community-based organizations enhances its dissemination potential.

Teaching ergonomics to nursing facility managers using computer-based instruction.

PubMed

Harrington, Susan S; Walker, Bonnie L

2006-01-01

This study offers evidence that computer-based training is an effective tool for teaching nursing facility managers about ergonomics and increasing their awareness of potential problems. Study participants (N = 45) were randomly assigned into a treatment or control group. The treatment group completed the ergonomics training and a pre- and posttest. The control group completed the pre- and posttests without training. Treatment group participants improved significantly from 67% on the pretest to 91% on the posttest, a gain of 24%. Differences between mean scores for the control group were not significant for the total score or for any of the subtests.

A randomized controlled trial of a leg orthosis versus traditional treatment for soldiers with shin splints: a pilot study.

PubMed

Johnston, Ember; Flynn, Timothy; Bean, Michael; Breton, Matthew; Scherer, Matthew; Dreitzler, Gail; Thomas, Dennis

2006-01-01

Diagnosis and management strategies for shin splints in active duty military populations closely resemble those in civilian athletic populations. There is a paucity of evidence supporting the use of many of these interventions. The purpose of this study was to present data on the Shin Saver orthosis as a treatment for shin splints in an active duty military population and to review current condition management. Twenty-five subjects diagnosed with shin splints by a U.S. Army physical therapist were randomly assigned to a shin orthosis treatment group or a control group. There was no significant difference between treatment and control groups in days to finish a 0.5-mile run pain free. Visual analog scales for pain at intake versus after 1 week of relative rest revealed no significant improvement in symptoms in either group. Current best-practice guidelines support a treatment program of rest, cryotherapy, and a graduated walk-to-run program.

Comparison of virtual patient simulation with mannequin-based simulation for improving clinical performances in assessing and managing clinical deterioration: randomized controlled trial.

PubMed

Liaw, Sok Ying; Chan, Sally Wai-Chi; Chen, Fun-Gee; Hooi, Shing Chuan; Siau, Chiang

2014-09-17

Virtual patient simulation has grown substantially in health care education. A virtual patient simulation was developed as a refresher training course to reinforce nursing clinical performance in assessing and managing deteriorating patients. The objective of this study was to describe the development of the virtual patient simulation and evaluate its efficacy, by comparing with a conventional mannequin-based simulation, for improving the nursing students' performances in assessing and managing patients with clinical deterioration. A randomized controlled study was conducted with 57 third-year nursing students who were recruited through email. After a baseline evaluation of all participants' clinical performance in a simulated environment, the experimental group received a 2-hour fully automated virtual patient simulation while the control group received 2-hour facilitator-led mannequin-based simulation training. All participants were then re-tested one day (first posttest) and 2.5 months (second posttest) after the intervention. The participants from the experimental group completed a survey to evaluate their learning experiences with the newly developed virtual patient simulation. Compared to their baseline scores, both experimental and control groups demonstrated significant improvements (P<.001) in first and second post-test scores. While the experimental group had significantly lower (P<.05) second post-test scores compared with the first post-test scores, no significant difference (P=.94) was found between these two scores for the control group. The scores between groups did not differ significantly over time (P=.17). The virtual patient simulation was rated positively. A virtual patient simulation for a refreshing training course on assessing and managing clinical deterioration was developed. Although the randomized controlled study did not show that the virtual patient simulation was superior to mannequin-based simulation, both simulations have demonstrated to be effective refresher learning strategies for improving nursing students' clinical performance. Given the greater resource requirements of mannequin-based simulation, the virtual patient simulation provides a more promising alternative learning strategy to mitigate the decay of clinical performance over time.

The NKF-NUS hemodialysis trial protocol - a randomized controlled trial to determine the effectiveness of a self management intervention for hemodialysis patients

PubMed Central

2011-01-01

Background Poor adherence to treatment is common in patients on hemodialysis which may increase risk for poor clinical outcomes and mortality. Self management interventions have been shown to be effective in improving compliance in other chronic populations. The aim of this trial is to evaluate the effectiveness of a recently developed group based self management intervention for hemodialysis patients compared to standard care. Methods/Design This is a multicentre parallel arm block randomized controlled trial (RCT) of a four session group self management intervention for hemodialysis patients delivered by health care professionals compared to standard care. A total of 176 consenting adults maintained on hemodialysis for a minimum of 6 months will be randomized to receive the self management intervention or standard care. Primary outcomes are biochemical markers of clinical status and adherence. Secondary outcomes include general health related quality of life, disease-specific quality of life, mood, self efficacy and self-reported adherence. Outcomes will be measured at baseline, immediately post-intervention and at 3 and 9 months post-intervention by an independent assessor and analysed on intention to treat principles with linear mixed-effects models across all time points. A qualitative component will examine which aspects of program participants found particularly useful and any barriers to change. Discussion The NKF-NUS intervention builds upon previous research emphasizing the importance of empowering patients in taking control of their treatment management. The trial design addresses weaknesses of previous research by use of an adequate sample size to detect clinically significant changes in biochemical markers, recruitment of a sufficiently large representative sample, a theory based intervention and careful assessment of both clinical and psychological endpoints at various follow up points. Inclusion of multiple dependent variables allows us to assess the broader impact on the intervention including both hard end points as well as patient reported outcomes. This program, if found to be effective, has the potential to be implemented within the existing renal services delivery model in Singapore, particularly as this is being delivered by health care professionals already working with hemodialysis patients in these settings who are specifically trained in facilitating self management in renal patients. Trial registration Current Controlled Trials ISRTN31434033 PMID:21272382

Distractive Auditory Stimuli in the Form of Music in Individuals With COPD: A Systematic Review.

PubMed

Lee, Annemarie L; Desveaux, Laura; Goldstein, Roger S; Brooks, Dina

2015-08-01

Music has been used as a distractive auditory stimulus (DAS) in patients with COPD, but its effects are unclear. This systematic review aimed to establish the effect of DAS on exercise capacity, symptoms, and health-related quality of life (HRQOL) under three conditions: (1) during exercise training, (2) during exercise testing, and (3) for symptom management at rest. Randomized controlled or crossover trials as well as cohort studies of DAS during exercise training, during formal exercise testing, and for symptom management among individuals with COPD were identified from a search of seven databases. Two reviewers independently assessed study quality. Weighted mean differences (WMDs) with 95% CIs were calculated using a random-effects model. Thirteen studies (12 of which were randomized controlled or crossover trials) in 415 participants were included. DAS increased exercise capacity when applied over at least 2 months of exercise training (WMD, 98 m; 95% CI, 47-150 m). HRQOL improved only after a training duration of 3 months. Less dyspnea was noted with DAS during exercise training, but this was not consistently observed in short-term exercise testing or as a symptom management strategy at rest. DAS appears to reduce symptoms of dyspnea and fatigue when used during exercise training, with benefits observed in exercise capacity and HRQOL. When applied during exercise testing, the effects on exercise capacity and symptoms and as a strategy for symptom management at rest are inconsistent.

Effectiveness and cost-effectiveness of a self-management training for patients with chronic and treatment resistant anxiety or depressive disorders: design of a multicenter randomized controlled trial.

PubMed

Zoun, Maringa H H; Koekkoek, Bauke; Sinnema, Henny; Muntingh, Anna D T; van Balkom, Anton J L M; Schene, Aart H; Smit, Filip; Spijker, Jan

2016-07-07

Many patients with anxiety or depressive disorders achieve no remission of their symptoms after evidence-based treatment algorithms. They develop a chronic course of the disorder. Current care for these patients usually consists of long-term supportive contacts with a community psychiatric nurse and pharmacological management by a psychiatrist. Data on the effectiveness of these treatments is lacking. A psychosocial rehabilitation approach, where self-management is an increasingly important part, could be more suitable. It focuses on the restoration of functioning and enhancement of patients' autonomy and responsibility. Treatment with this focus, followed by referral to primary care, may be more (cost-)effective. A multicenter randomized controlled trial is designed for twelve participating specialized outpatient mental health services in the Netherlands. Patients with chronic and treatment resistant anxiety or depressive disorders, currently receiving supportive care in specialized outpatient mental health care, are asked to participate. After inclusion, patients receive the baseline questionnaire and are randomized to the intervention group or the usual care control group. The intervention focuses on rehabilitation and self-management and is provided by a trained community psychiatric nurse, followed by referral to primary care. Measurements take place at 6, 12, and 18 months after baseline. This study evaluates both the effectiveness (on quality of life, symptom severity, and empowerment), and cost-effectiveness of the intervention compared to usual care. In addition, a questionnaire is designed to get insight in which self-management strategies patients use to manage their disorder, and in the experiences of patients with the change of care setting. In this study we evaluate the effectiveness and cost-effectiveness of a self-management intervention for patients with chronic and treatment resistant anxiety or depressive disorders in specialized outpatient mental health care. The results of this study may provide a first 'proof-of-concept' in this under-researched but important field, and might be relevant for a large group of patients in the context of a transition of the Dutch health care system. Netherlands Trial Register: NTR3335 , registered 7 March 2012.

The NKF-NUS hemodialysis trial protocol - a randomized controlled trial to determine the effectiveness of a self management intervention for hemodialysis patients.

PubMed

Griva, Konstadina; Mooppil, Nandakumar; Seet, Penny; Krishnan, Deby Sarojiuy Pala; James, Hayley; Newman, Stanton P

2011-01-28

Poor adherence to treatment is common in patients on hemodialysis which may increase risk for poor clinical outcomes and mortality. Self management interventions have been shown to be effective in improving compliance in other chronic populations. The aim of this trial is to evaluate the effectiveness of a recently developed group based self management intervention for hemodialysis patients compared to standard care. This is a multicentre parallel arm block randomized controlled trial (RCT) of a four session group self management intervention for hemodialysis patients delivered by health care professionals compared to standard care. A total of 176 consenting adults maintained on hemodialysis for a minimum of 6 months will be randomized to receive the self management intervention or standard care. Primary outcomes are biochemical markers of clinical status and adherence. Secondary outcomes include general health related quality of life, disease-specific quality of life, mood, self efficacy and self-reported adherence. Outcomes will be measured at baseline, immediately post-intervention and at 3 and 9 months post-intervention by an independent assessor and analysed on intention to treat principles with linear mixed-effects models across all time points. A qualitative component will examine which aspects of program participants found particularly useful and any barriers to change. The NKF-NUS intervention builds upon previous research emphasizing the importance of empowering patients in taking control of their treatment management. The trial design addresses weaknesses of previous research by use of an adequate sample size to detect clinically significant changes in biochemical markers, recruitment of a sufficiently large representative sample, a theory based intervention and careful assessment of both clinical and psychological endpoints at various follow up points. Inclusion of multiple dependent variables allows us to assess the broader impact on the intervention including both hard end points as well as patient reported outcomes. This program, if found to be effective, has the potential to be implemented within the existing renal services delivery model in Singapore, particularly as this is being delivered by health care professionals already working with hemodialysis patients in these settings who are specifically trained in facilitating self management in renal patients.

Nurse leader mindfulness meditation program for stress management: a randomized controlled trial.

PubMed

Pipe, Teri Britt; Bortz, Jennifer J; Dueck, Amylou; Pendergast, Debra; Buchda, Vicki; Summers, Jay

2009-03-01

The aim of this study was to rigorously evaluate a brief stress management intervention for nurse leaders. Despite the nursing shortage, evidence-based workplace approaches addressing nurse stress have not been well studied. Nurse leaders (n = 33) were randomly assigned to brief mindfulness meditation course (MMC) or leadership course (control). Self-report measures of stress were administered at baseline and within 1 week of course completion. Among MMC participants, change scores (from baseline to postintervention) on several subscales of the Symptom Checklist 90-Revised showed significantly more improvement in self-reported stress symptoms relative to controls. Mindfulness meditation course participants had significantly more improvement in Positive Symptom Distress Index (P = 0.010; confidence interval [CI] = -0.483 to -0.073) and Global Severity Index (P = 0.019; CI = -0.475 to -0.046) and nearly significantly more improvement in Positive Symptom Total (P = 0.066; CI = -16.66 to 0.581) compared with controls. Results support preliminary effectiveness of a 4-week MMC in reducing self-reported stress symptoms among nursing leaders.

Nitrous oxide for pain management during in-office hysteroscopic sterilization: a randomized controlled trial.

PubMed

Schneider, Emily N; Riley, Regan; Espey, Eve; Mishra, Shiraz I; Singh, Rameet H

2017-03-01

To evaluate whether inhaled nitrous oxide with oxygen (N 2 O/O 2 ) is associated with less pain compared to oral sedation for pain management during in-office hysteroscopic sterilization. This double blinded randomized controlled trial enrolled women undergoing in-office hysteroscopic sterilization. All participants received pre-procedure intramuscular ketorolac and a standardized paracervical block. The intervention group also received N 2 O/O 2 via a nasal mask titrated to a maximum 70%:30% mixture by a nurse during the procedure and placebo pills pre-procedure and the active control group received inhaled O 2 during the procedure and 5/325 mg hydrocodone/acetaminophen and 1 mg lorazepam pre-procedure. The primary outcome was maximum procedure pain on a 100 mm Visual Analog Scale (VAS with anchors at 0=no pain and 100=worst imaginable pain) assessed 3-5 min post procedure. Thirty women per treatment arm were required to detect a clinically significant pain difference of 20 mm. Seventy-two women, 36 per study arm, were randomized. Mean age of participants was 34.1±5.7 years and mean BMI was 30.1±6.6kg/m 2 . Mean maximum procedure pain scores were 22.8±27.6 mm and 54.5±32.7 mm for intervention and control groups, respectively (p<.001). Most study participants (97%) stated N 2 O/O 2 should be offered for gynecologic office procedures and 86% would pay for it if not a covered benefit. N 2 O/O 2 decreased pain with in-office hysteroscopic sterilization compared to oral sedation and is an effective pain management option for this procedure. Given its safety and favorable side effect profile, N 2 O/O 2 can be used for pain management for in-office hysteroscopic sterilization and adds a safe, easily administered option to currently available strategies. Copyright © 2016 Elsevier Inc. All rights reserved.

Effectiveness of myofascial release in the management of plantar heel pain: a randomized controlled trial.

PubMed

Ajimsha, M S; Binsu, D; Chithra, S

2014-06-01

Previous studies have reported that stretching of the calf musculature and the plantar fascia are effective management strategies for plantar heel pain (PHP). However, it is unclear whether myofascial release (MFR) can improve the outcomes in this population. To investigate whether myofascial release (MFR) reduces the pain and functional disability associated with plantar heel pain (PHP) in comparison with a control group receiving sham ultrasound therapy (SUST). Randomized, controlled, double blinded trial. Nonprofit research foundation clinic in India. Sixty-six patients, 17 men and 49 women with a clinical diagnosis of PHP were randomly assigned into MFR or a control group and given 12 sessions of treatment per client over 4 weeks. The Foot Function Index (FFI) scale was used to assess pain severity and functional disability. The primary outcome measure was the difference in FFI scale scores between week 1 (pretest score), week 4 (posttest score), and follow-up at week 12 after randomization. Additionally, pressure pain thresholds (PPT) were assessed over the affected gastrocnemii and soleus muscles, and over the calcaneus, by an assessor blinded to the treatment allocation. The simple main effects analysis showed that the MFR group performed better than the control group in weeks 4 and 12 (P<0.001). Patients in the MFR and control groups reported a 72.4% and 7.4% reduction, respectively, in their pain and functional disability in week 4 compared with that in week 1, which persisted as 60.6% in the follow-up at week 12 in the MFR group compared to the baseline. The mixed ANOVA also revealed significant group-by-time interactions for changes in PPT over the gastrocnemii and soleus muscles, and the calcaneus (P<0.05). This study provides evidence that MFR is more effective than a control intervention for PHP. Copyright © 2014 Elsevier Ltd. All rights reserved.

Job retention vocational rehabilitation for employed people with inflammatory arthritis (WORK-IA): a feasibility randomized controlled trial.

PubMed

Hammond, Alison; O'Brien, Rachel; Woodbridge, Sarah; Bradshaw, Lucy; Prior, Yeliz; Radford, Kate; Culley, June; Whitham, Diane; Ruth Pulikottil-Jacob

2017-07-21

Inflammatory arthritis leads to work disability, absenteeism and presenteeism (i.e. at-work productivity loss) at high cost to individuals, employers and society. A trial of job retention vocational rehabilitation (VR) in the United States identified this helped people keep working. The effectiveness of this VR in countries with different socioeconomic policies and conditions, and its impact on absenteeism, presenteeism and health, are unknown. This feasibility study tested the acceptability of this VR, modified for the United Kingdom, compared to written advice about managing work problems. To help plan a randomized controlled trial, we tested screening, recruitment, intervention delivery, response rates, applicability of the control intervention and identified the relevant primary outcome. A feasibility randomized controlled trial with rheumatoid, psoriatic or inflammatory arthritis patients randomized to receive either job retention VR or written information only (the WORK-IA trial). Following three days VR training, rheumatology occupational therapists provided individualised VR on a one to one basis. VR included work assessment, activity diaries and action planning, and (as applicable) arthritis self-management in the workplace, ergonomics, fatigue and stress management, orthoses, employment rights and support services, assistive technology, work modifications, psychological and disclosure support, workplace visits and employer liaison. Fifty five (10%) people were recruited from 539 screened. Follow-up response rates were acceptable at 80%. VR was delivered with fidelity. VR was more acceptable than written advice only (7.8 versus 6.7). VR took on average 4 h at a cost of £135 per person. Outcome assessment indicated VR was better than written advice in reducing presenteeism (Work Limitations Questionnaire (WLQ) change score mean: VR = -12.4 (SD 13.2); control = -2.5 (SD 15.9), absenteeism, perceived risk of job loss and improving pain and health status, indicating proof of concept. The preferred primary outcome measure was the WLQ, a presenteeism measure. This brief job retention VR is a credible and acceptable intervention for people with inflammatory arthritis with concerns about continuing to work due to arthritis. ISRCTN 76777720 . Registered 21.9.12.

The effects of intervention based on supportive leadership behaviour on Iranian nursing leadership performance: a randomized controlled trial.

PubMed

Shirazi, Mandana; Emami, Amir Hossein; Mirmoosavi, Seyed Jamal; Alavinia, Seyed Mohammad; Zamanian, Hadi; Fathollahbeigi, Faezeh; Masiello, Italo

2016-04-01

To assess the effects of a workshop on supportive leadership behaviour (SLB) on the performance of head nurses, using a randomized controlled trial design. The effect of transformational leadership on SLB in nursing management is emphasised. A total of 110 head nurses working at university hospitals were included randomly in two control and intervention groups. The head nurses in the intervention group participated in supportive leadership training, but the control group did not. Performance in supportive leadership was assessed with a validated instrument, which six subordinates used to assess their head nurse (n = 731). There was a significant difference in SLB scores from baseline to the 3 month follow-up (P < 0.0001). Moreover, the post-intervention scores were significantly higher in the intervention group, compared with the control group (P < 0.0001). The results showed that in the intervention group, the effect sizes were greater for males (50%) than for females (36%) and greater for married participants (42%) than for single participants (37%). The workshop on supportive leadership behaviour, particularly the interactive multifaceted training, improved the leadership performance of the head nurses who participated in this study. Health policy decision makers should apply SLB, which is a significant leadership style, to improve the outcomes in other groups of health-care management, such as physicians. Future studies are needed to investigate the effects of such workshops in longer periods of follow up. © 2015 John Wiley & Sons Ltd.

Effects of honey use on the management of radio/chemotherapy-induced mucositis: a meta-analysis of randomized controlled trials.

PubMed

Xu, J-L; Xia, R; Sun, Z-H; Sun, L; Min, X; Liu, C; Zhang, H; Zhu, Y-M

2016-12-01

This meta-analysis aimed to assess the prophylactic effects of honey use on the management of radio/chemotherapy-induced mucositis. PubMed, Cochrane Library, Science Direct, China National Knowledge Infrastructure (CNKI), VIP (Chinese scientific journal database), and China Biology Medicine (CBM) were searched for relevant articles without language restriction. Two reviewers searched and evaluated the related studies independently. Statistical analyses were performed using Stata 11.0, calculating the pooled risk ratio (RR) with the corresponding 95% confidence interval (CI). Begg's funnel plot was used together with Egger's test to detect publication bias. A total of seven randomized controlled trials were finally included. Quality assessment showed one article to have a low risk of bias, two to have a moderate risk, and four to have a high risk. Meta-analysis showed that, compared with blank control, honey treatment could reduce the incidence of oral mucositis after radio/chemotherapy (RR 0.35, 95% CI 0.18-0.70, P=0.003). No meta-analysis was applied for honey vs. lidocaine or honey vs. golden syrup. The sensitivity analysis showed no significant change when any one study was excluded. No obvious publication bias (honey vs. blank control) was detected. In conclusion, honey can effectively reduce the incidence of radio/chemotherapy-induced oral mucositis; however, further multi-centre randomized controlled trials are needed to support the current evidence. Copyright © 2016 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Impact of Volume Management on Volume Overload and Rehospitalization in CAPD Patients.

PubMed

Xu, Yi; Yang, Shen-Min; Wang, Xiao-Hua; Wang, Hai-Fang; Niu, Mei-E; Yang, Yi-Qun; Lu, Guo-Yuan; Pang, Jian-Hong; Wang, Fei; Li, Lin

2018-05-01

Heart failure due to volume overload is a major reason for rehospitalization in continuous ambulatory peritoneal dialysis patients. Strict volume control provides better cardiac functions and blood pressure in this population. Volume management, which is a volume control strategy, may decrease volume overload and related complications. Using a quasi-experimental design, 66 continuous ambulatory peritoneal dialysis patients were randomly assigned to the intervention group ( n = 34) and control group ( n = 32). The patients were followed up for 6 months with scheduled clinic and/or telephone visits; the intervention group adopted volume management strategy, while the control group adopted conventional care. Volume overload and cardiac function were compared between the two groups at the baseline and at 6 months. At Month 6, the intervention group resulted in significant improvement in volume overloaded status, cardiac function, and volume-overload-related rehospitalization. Volume management strategy allows for better control of volume overload and is associated with fewer volume-related readmissions.

Heart failure disease management: implementation and outcomes.

PubMed

Whellan, David J

2005-01-01

Millions of dollars are being spent to identify new therapies to improve mortality and morbidity for the growing epidemic of patients sustaining heart failure. However, in clinical practice, these therapies are currently underused. To bridge the gap between proven therapies and clinical practice, the medical community has turned to disease management. Heart failure disease management interventions vary from vital-sign monitoring to multidisciplinary approaches involving a pharmacist, nutritionist, nurse practitioner, and physician. This review attempts to categorize these inventions based on location. We compared the published results from randomized, controlled trials of the following types of heart failure disease management interventions: inpatient, clinic visits, home visits, and telephone follow up. Although research shows an improvement in the quality of care and a decrease in hospitalizations for patients sustaining heart failure, the economic impact of disease management is still unclear. The current reimbursement structure is a disincentive to providers wanting to offer disease management services to patients sustaining heart failure. Additionally, the cost of providing disease management services such as additional clinical visits, patient education materials, or additional personnel time has not been well documented. Most heart failure disease management studies do confirm the concept that providing increased access to healthcare providers for an at-risk group of patients sustaining heart failure does improve outcomes. However, a large-scale randomized, controlled clinical trial based in the United States is needed to prove that this concept can be implemented beyond a single center and to determine how much it will cost patients, providers, healthcare systems, and payers.

Effects of a Rubric-Driven Assessment on Teacher Performance with Regard to Behavioral Management Skills

ERIC Educational Resources Information Center

Simmons, Kevin R.

2010-01-01

The purpose of this researcher was to evaluate the efficacy of an in-service training program in the use of a rubric-driven assessment system for classroom behavior management. Thirty randomly assigned teachers received in-service training and 30 teachers served as a control group. The use of a rubric-driven assessment provided both teachers and…

Comparison of a Mindful Eating Intervention to a Diabetes Self-Management Intervention among Adults with Type 2 Diabetes: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Miller, Carla K.; Kristeller, Jean L.; Headings, Amy; Nagaraja, Haikady

2014-01-01

Mindful eating may be an effective intervention for increasing awareness of hunger and satiety cues, improving eating regulation and dietary patterns, reducing symptoms of depression and anxiety, and promoting weight loss. Diabetes self-management education (DSME), which addresses knowledge, self-efficacy, and outcome expectations for improving…

Parents' Opinions about an Intervention to Manage Repetitive Behaviours in Young Children with Autism Spectrum Disorder: A Qualitative Study

ERIC Educational Resources Information Center

Hodgson, Anna R.; Grahame, Victoria; Garland, Deborah; Gaultier, Fiona; Lecouturier, Jan; Le Couteur, Ann

2018-01-01

Background: Early intervention for autism spectrum disorder (ASD) tends to focus on enhancing social communication skills. We report data collected via focus group discussions as part of a feasibility and acceptability pilot randomized controlled trial (RCT) about a new parent group intervention to manage restricted and repetitive behaviours (RRB)…

Exploring telemonitoring and self-management by patients with chronic obstructive pulmonary disease: a qualitative study embedded in a randomized controlled trial.

PubMed

Fairbrother, Peter; Pinnock, Hilary; Hanley, Janet; McCloughan, Lucy; Sheikh, Aziz; Pagliari, Claudia; McKinstry, Brian

2013-12-01

To explore patient and professional views on self-management in the context of telemonitoring in chronic obstructive pulmonary disease (COPD). Semi-structured interviews with patients with COPD and healthcare professionals participating in a randomized controlled trial of telemonitoring in Lothian, Scotland, explored experiences of using telemonitoring, and dynamics in patient-practitioner relationships. Transcribed data were analyzed using the Framework approach. 38 patients (mean age 67.5 years) and 32 professionals provided 70 interviews. Patients considered that telemonitoring empowered self-management by enhancing their understanding of COPD and providing additional justification for their decisions to adjust treatment or seek professional advice. Professionals discussed telemonitoring as promoting compliance with medical advice and encouraged patients to exercise personal responsibility within clinical parameters, but expressed concerns about promoting the sick role and creating dependence on telemonitoring. Telemonitoring assisted many patients to embrace greater responsibility for their health but the model of service provision remained clinician-centered. A medical model of 'compliant self-management' may paradoxically have promoted dependence on professionals. Patients and professionals shared responsibility for meeting the central objective of prompt management of exacerbations of COPD. Care is needed, however, to minimize the risk in some patients, of telemonitoring increasing dependence on practitioner support. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

The effects of a nurse case manager and a community health worker team on diabetic control, emergency department visits, and hospitalizations among urban African Americans with type 2 diabetes mellitus: a randomized controlled trial.

PubMed

Gary, Tiffany L; Batts-Turner, Marian; Yeh, Hsin-Chieh; Hill-Briggs, Felicia; Bone, Lee R; Wang, Nae-Yuh; Levine, David M; Powe, Neil R; Saudek, Christopher D; Hill, Martha N; McGuire, Maura; Brancati, Frederick L

2009-10-26

Although African American adults bear a disproportionate burden from diabetes mellitus (DM), few randomized controlled trials have tested culturally appropriate interventions to improve DM care. We randomly assigned 542 African Americans with type 2 DM enrolled in an urban managed care organization to either an intensive or minimal intervention group. The intensive intervention group consisted of all components of the minimal intervention plus individualized, culturally tailored care provided by a nurse case manager (NCM) and a community health worker (CHW), using evidence-based clinical algorithms with feedback to primary care providers (eg, physicians, nurse practitioners, or physician assistants). The minimal intervention consisted of mailings and telephone calls every 6 months to remind participants about preventive screenings. Data on diabetic control were collected at baseline and at 24 months by blind observers; data emergency department (ER) visits and hospitalizations were assessed using administrative data. At baseline, participants had a mean age of 58 years, 73% were women, and 50% were living in poverty. At 24 months, compared with the minimal intervention group, those in the intensive intervention group were 23% less likely to have ER visits (rate difference [RD], -14.5; adjusted rate ratio [RR], 0.77; 95% confidence interval [CI], 0.59-1.00). In on-treatment analyses, the rate reduction was strongest for patients who received the most NCM and CHW visits (RD, -31.0; adjusted RR, 0.66; 95% CI, 0.43-1.00; rate reduction downward arrow 34%). These data suggest that a culturally tailored intervention conducted by an NCM/CHW team reduced ER visits in urban African Americans with type 2 DM. clinicaltrials.gov Identifier: NCT00022750.

Effectiveness of chemotherapy counselling on self-esteem and psychological affects among cancer patients in Malaysia: Randomized controlled trial.

PubMed

Mohd-Sidik, Sherina; Akhtari-Zavare, Mehrnoosh; Periasamy, Ummavathy; Rampal, Lekhraj; Fadhilah, Siti Irma; Mahmud, Rozi

2018-05-01

The aim of this study was to implement and evaluate the outcomes of chemotherapy counselling based on the "Managing Patients on Chemotherapy" module on self-esteem and psychological affect (anxiety, depression) of cancer patients by pharmacists in ten selected government hospitals in Peninsular Malaysia. A randomized control trial was conducted among 2120 cancer patients from April 2016 to January 2017 in ten selected government hospitals in Peninsular Malaysia. Cancer patients were randomly assigned to intervention and control groups. The intervention group received chemotherapy counselling by pharmacists based on the "Managing Patients on Chemotherapy" module. The outcomes were assessed at baseline, 1st, 2nd and 3rd follow-ups after counselling. In the course of data analysis; independent sample t-test, chi-square and two-way repeated measures ANOVA were conducted. Mean scores of self-esteem in the intervention group had significant difference in comparison with those of the control group in the 1st, 2nd and 3rd follow-ups after counselling (P < 0.0001). Also, among those with depression and anxiety at baseline, there was reduction in depression and anxiety scores after the 1st, 2nd and 3rd follow-ups after counselling (p < 0.05). Repetitive counselling by pharmacists based on the "Managing Patients on Chemotherapy" module had positive effect on improving self-esteem and psychological affect of cancer patients undergoing chemotherapy in Peninsular Malaysia. This module can be used for all Malaysian cancer patients undergoing chemotherapy to improving self-esteem and psychological affect. Copyright © 2018 The Authors. Published by Elsevier B.V. All rights reserved.

Electronic communications and home blood pressure monitoring (e-BP) study: design, delivery, and evaluation framework.

PubMed

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

2008-05-01

Randomized controlled trials have provided unequivocal evidence that treatment of hypertension decreases mortality and major disability from cardiovascular disease; however, blood pressure remains inadequately treated in most affected individuals. This large gap continues despite the facts that more than 90% of adults with hypertension have health insurance, and hypertension is the leading cause of visits to the doctor. New approaches are needed to improve hypertension care. The Electronic Communications and Home Blood Pressure Monitoring (e-BP) study is a three-arm randomized controlled trial designed to determine whether care based on the Chronic Care Model and delivered over the Internet improves hypertension care. The primary study outcomes are systolic, diastolic, and blood pressure control; secondary outcomes are medication adherence, patient self-efficacy, satisfaction and quality of life, and healthcare utilization and costs. Hypertensive patients receiving care at Group Health medical centers are eligible if they have uncontrolled blood pressure on two screening visits and access to the Web and an e-mail address. Study participants are randomly assigned to three intervention groups: (a) usual care; (b) home blood pressure monitoring receipt and proficiency training on its use and the Group Health secure patient website (with secure e-mail access to their healthcare provider, access to a shared medical record, prescription refill and other services); or (c) this plus pharmacist care management (collaborative care management between the patient, the pharmacist, and the patient's physician via a secure patient website and the electronic medical record). We will determine whether a new model of patient-centered care that leverages Web communications, self-monitoring, and collaborative care management improves hypertension control. If this model proves successful and cost-effective, similar interventions could be used to improve the care of large numbers of patients with uncontrolled hypertension.

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.

Randomized, double-blinded, placebo-controlled trial comparing two multimodal opioid-minimizing pain management regimens following transsphenoidal surgery.

PubMed

Shepherd, Deborah M; Jahnke, Heidi; White, William L; Little, Andrew S

2018-02-01

OBJECTIVE Pain control is an important clinical consideration and quality-of-care metric. No studies have examined postoperative pain control following transsphenoidal surgery for pituitary lesions. The study goals were to 1) report postoperative pain scores following transsphenoidal surgery, 2) determine if multimodal opioid-minimizing pain regimens yielded satisfactory postoperative pain control, and 3) determine if intravenous (IV) ibuprofen improved postoperative pain scores and reduced opioid use compared with placebo. METHODS This study was a single-center, randomized, double-blinded, placebo-controlled intervention trial involving adult patients with planned transsphenoidal surgery for pituitary tumors randomized into 2 groups. Group 1 patients were treated with scheduled IV ibuprofen, scheduled oral acetaminophen, and rescue opioids. Group 2 patients were treated with IV placebo, scheduled oral acetaminophen, and rescue opioids. The primary end point was patient pain scores (visual analog scale [VAS], rated 0-10) for 48 hours after surgery. The secondary end point was opioid use as estimated by oral morphine equivalents (OMEs). RESULTS Of 136 patients screened, 62 were enrolled (28 in Group 1, 34 in Group 2). The study was terminated early because the primary and secondary end points were reached. Baseline characteristics between groups were well matched except for age (Group 1, 59.3 ± 14.4 years; Group 2, 49.8 ± 16.2 years; p = 0.02). Mean VAS pain scores were significantly different, with a 43% reduction in Group 1 (1.7 ± 2.2) compared with Group 2 (3.0 ± 2.8; p < 0.0001). Opioid use was significantly different, with a 58% reduction in Group 1 (26.3 ± 28.7 mg OME) compared with Group 2 (62.5 ± 63.8 mg OME; p < 0.0001). CONCLUSIONS Multimodal opioid-minimizing pain-management protocols resulted in acceptable pain control following transsphenoidal surgery. IV ibuprofen resulted in significantly improved pain scores and significantly decreased opioid use compared with placebo. Postoperative multimodal pain management, including a nonsteroidal antiinflammatory medication, should be considered after surgery to improve patient comfort and to limit opioid use. Clinical trial registration no.: NCT02351700 (clinicaltrials.gov) ■ CLASSIFICATION OF EVIDENCE Type of question: therapeutic; study design: randomized, controlled trial; evidence: Class III.

Randomized controlled trial of the Valencia model of waking hypnosis plus CBT for pain, fatigue, and sleep management in patients with cancer and cancer survivors.

PubMed

Mendoza, M E; Capafons, A; Gralow, J R; Syrjala, K L; Suárez-Rodríguez, J M; Fann, J R; Jensen, M P

2017-11-01

This study evaluated the efficacy of an intervention combining the Valencia model of waking hypnosis with cognitive-behavioral therapy (VMWH-CBT) in managing cancer-related pain, fatigue, and sleep problems in individuals with active cancer or who were post-treatment survivors. We hypothesized that four sessions of VMWH-CBT would result in greater improvement in participants' symptoms than four sessions of an education control intervention. Additionally, we examined the effects on several secondary outcome domains that are associated with increases in these symptoms (depression, pain interference, pain catastrophizing, and cancer treatment distress). The study design was a randomized controlled crossover clinical trial comparing the VMWH-CBT intervention with education control. Participants (N = 44) received four sessions of both treatments, in a counterbalanced order (n = 22 per order condition). Participants were 89% female (N = 39) with mean age of 61 years (SD = 12.2). They reported significantly greater improvement after receiving the active treatment relative to the control condition in all the outcome measures. Treatment gains were maintained at 3-month follow-up. This study supports the beneficial effects of the VMWH-CBT intervention relative to a control condition and that treatment gains remain stable. VMWH-CBT-trained clinicians should be accessible for managing symptoms both during and after cancer treatment, though the findings need to be replicated in larger samples of cancer survivors. Copyright © 2016 John Wiley & Sons, Ltd.

Probiotic capsules and xylitol chewing gum to manage symptoms of pharyngitis: a randomized controlled factorial trial

PubMed Central

Little, Paul; Stuart, Beth; Wingrove, Zoe; Mullee, Mark; Thomas, Tammy; Johnson, Sophie; Leydon, Gerry; Richards-Hall, Samantha; Williamson, Ian; Yao, Lily; Zhu, Shihua; Moore, Michael

2017-01-01

BACKGROUND: Reducing the use of antibiotics for upper respiratory tract infections is needed to limit the global threat of antibiotic resistance. We estimated the effectiveness of probiotics and xylitol for the management of pharyngitis. METHODS: In this parallel-group factorial randomized controlled trial, participants in primary care (aged 3 years or older) with pharyngitis underwent randomization by nurses who provided sequential intervention packs. Pack contents for 3 kinds of material and advice were previously determined by computer-generated random numbers: no chewing gum, xylitol-based chewing gum (15% xylitol; 5 pieces daily) and sorbitol gum (5 pieces daily). Half of each group were also randomly assigned to receive either probiotic capsules (containing 24 × 109 colony-forming units of lactobacilli and bifidobacteria) or placebo. The primary outcome was mean self-reported severity of sore throat and difficulty swallowing (scale 0–6) in the first 3 days. We used multiple imputation to avoid the assumption that data were missing completely at random. RESULTS: A total of 1009 individuals consented, 934 completed the baseline assessment, and 689 provided complete data for the primary outcome. Probiotics were not effective in reducing the severity of symptoms: mean severity scores 2.75 with no probiotic and 2.78 with probiotic (adjusted difference −0.001, 95% confidence interval [CI] −0.24 to 0.24). Chewing gum was also ineffective: mean severity scores 2.73 without gum, 2.72 with sorbitol gum (adjusted difference 0.07, 95% CI −0.23 to 0.37) and 2.73 with xylitol gum (adjusted difference 0.01, 95% CI −0.29 to 0.30). None of the secondary outcomes differed significantly between groups, and no harms were reported. INTERPRETATION: Neither probiotics nor advice to chew xylitol-based chewing gum was effective for managing pharyngitis. Trial registration: ISRCTN, no. ISRCTN51472596 PMID:29255098

Probiotic capsules and xylitol chewing gum to manage symptoms of pharyngitis: a randomized controlled factorial trial.

PubMed

Little, Paul; Stuart, Beth; Wingrove, Zoe; Mullee, Mark; Thomas, Tammy; Johnson, Sophie; Leydon, Gerry; Richards-Hall, Samantha; Williamson, Ian; Yao, Lily; Zhu, Shihua; Moore, Michael

2017-12-18

Reducing the use of antibiotics for upper respiratory tract infections is needed to limit the global threat of antibiotic resistance. We estimated the effectiveness of probiotics and xylitol for the management of pharyngitis. In this parallel-group factorial randomized controlled trial, participants in primary care (aged 3 years or older) with pharyngitis underwent randomization by nurses who provided sequential intervention packs. Pack contents for 3 kinds of material and advice were previously determined by computer-generated random numbers: no chewing gum, xylitol-based chewing gum (15% xylitol; 5 pieces daily) and sorbitol gum (5 pieces daily). Half of each group were also randomly assigned to receive either probiotic capsules (containing 24 × 10 9 colony-forming units of lactobacilli and bifidobacteria) or placebo. The primary outcome was mean self-reported severity of sore throat and difficulty swallowing (scale 0-6) in the first 3 days. We used multiple imputation to avoid the assumption that data were missing completely at random. A total of 1009 individuals consented, 934 completed the baseline assessment, and 689 provided complete data for the primary outcome. Probiotics were not effective in reducing the severity of symptoms: mean severity scores 2.75 with no probiotic and 2.78 with probiotic (adjusted difference -0.001, 95% confidence interval [CI] -0.24 to 0.24). Chewing gum was also ineffective: mean severity scores 2.73 without gum, 2.72 with sorbitol gum (adjusted difference 0.07, 95% CI -0.23 to 0.37) and 2.73 with xylitol gum (adjusted difference 0.01, 95% CI -0.29 to 0.30). None of the secondary outcomes differed significantly between groups, and no harms were reported. Neither probiotics nor advice to chew xylitol-based chewing gum was effective for managing pharyngitis. Trial registration: ISRCTN, no. ISRCTN51472596. © 2017 Joule Inc. or its licensors.

Systematic review and meta-analyses of randomized controlled trials examining tinnitus management

PubMed Central

Hoare, Derek J; Kowalkowski, Victoria L; Kang, Sujin; Hall, Deborah A

2011-01-01

Objectives/Hypothesis To evaluate the existing level of evidence for tinnitus management strategies identified in the UK Department of Health's Good Practice Guideline. Study Design Systematic review of peer-reviewed literature and meta-analyses. Methods Searches were conducted in PubMed, Cambridge Scientific Abstracts, Web of Science, and EMBASE (earliest to August 2010), supplemented by hand searches in October 2010. Only randomized controlled trials that used validated questionnaire measures of symptoms (i.e., measures of tinnitus distress, anxiety, depression) were included. Results Twenty-eight randomized controlled trials met our inclusion criteria, most of which provide moderate levels of evidence for the effects they reported. Levels of evidence were generally limited by the lack of blinding, lack of power calculations, and incomplete data reporting in these studies. Only studies examining cognitive behavioral therapy were numerous and similar enough to perform meta-analysis, from which the efficacy of cognitive behavioral therapy (moderate effect size) appears to be reasonably established. Antidepressants were the only drug class to show any evidence of potential benefit. Conclusions The efficacy of most interventions for tinnitus benefit remains to be demonstrated conclusively. In particular, high-level assessment of the benefit derived from those interventions most commonly used in practice, namely hearing aids, maskers, and tinnitus retraining therapy needs to be performed. PMID:21671234

A controlled trial of web-based diabetes disease management: the MGH diabetes primary care improvement project.

PubMed

Meigs, James B; Cagliero, Enrico; Dubey, Anil; Murphy-Sheehy, Patricia; Gildesgame, Catharyn; Chueh, Henry; Barry, Michael J; Singer, Daniel E; Nathan, David M

2003-03-01

To test effects of a web-based decision support tool, the diabetes Disease Management Application (DMA), developed to improve evidence-based management of type 2 diabetes. We conducted a group randomized controlled trial of 12 intervention and 14 control staff providers and 307 intervention and 291 control patients with type 2 diabetes in a hospital-based internal medicine clinic. Providers were randomly assigned from May 1998 through April 1999 to have access to the DMA (intervention) or not to have access (control). The DMA displays interactive patient-specific clinical data, treatment advice, and links to other web-based care resources. We compared patients in the intervention and control groups for changes in processes and outcomes of care from the year preceding the study through the year of the study by intention-to-treat analysis. The DMA was used for 42% of scheduled patient visits. The number of HbA(1c) tests obtained per year increased significantly in the intervention group (+0.3 tests/year) compared with the control group (-0.04 tests/year, P = 0.008), as did the number of LDL cholesterol tests (intervention, +0.2 tests/year; control, +0.01 tests/year; P = 0.02) and the proportions of patients undergoing at least one foot examination per year (intervention, +9.8%; control, -0.7%; P = 0.003). Levels of HbA(1c) decreased by 0.2 in the intervention group and increased by 0.1 in the control group (P = 0.09); proportions of patients with LDL cholesterol levels <130 mg/dl increased by 20.3% in the intervention group and 10.5% in the control group (P = 0.5). Web-based patient-specific decision support has the potential to improve evidence-based parameters of diabetes care.

Internet Telehealth for Pediatric Asthma Case Management: Integrating Computerized and Case Manager Features for Tailoring a Web-Based Asthma Education Program

PubMed Central

Wise, Meg; Gustafson, David H.; Sorkness, Christine A.; Molfenter, Todd; Staresinic, Anthony; Meis, Tracy; Hawkins, Robert P.; Shanovich, Kathleen Kelly; Walker, Nola P.

2008-01-01

This article reports on the development of a personalized, Web-based asthma-education program for parents whose 4- to 12-year-old children have moderate to severe asthma. Personalization includes computer-based tailored messages and a human coach to build asthma self-management skills. Computerized features include the Asthma Manager, My Calendar/Reminder, My Goals, and a tailored home page. These are integrated with monthly asthma-education phone calls from an asthmanurse case manager. The authors discuss the development process and issues and describe the current randomized evaluation study to test whether the yearlong integrated intervention can improve adherence to a daily asthma controller medication, asthma control, and parent quality of life to reduce asthma-related healthcare utilization. Implications for health education for chronic disease management are raised. PMID:16928987

Effectiveness of Parent-Child Mediation in Improving Family Functioning and Reducing Adolescent Problem Behavior: Results from a Pilot Randomized Controlled Trial.

PubMed

Tucker, Joan S; Edelen, Maria Orlando; Huang, Wenjing

2017-03-01

Parent-child mediation programs are intended to resolve or manage disputes and improve family functioning, but rigorous evaluations of their effectiveness are lacking. Families referred to a community-based mediation program (N = 111) were randomized to an intervention or wait-list control group, and completed three surveys over a 12-week period. With the exception of parent-reported child delinquency (which decreased more in the intervention group), this evaluation provides little support for the short-term effectiveness of parent-child mediation for improving family functioning and reducing child problem behaviors in general. Given that this is the first randomized controlled trial of a parent-child mediation program, additional evaluations involving larger samples and longer follow-ups are needed before firm conclusions can be drawn about the effectiveness of this intervention.

Effectiveness of Parent-Child Mediation in Improving Family Functioning and Reducing Adolescent Problem Behavior: Results from a Pilot Randomized Controlled Trial

PubMed Central

Tucker, Joan S.; Edelen, Maria Orlando; Huang, Wenjing

2016-01-01

Parent-child mediation programs are intended to resolve or manage disputes and improve family functioning, but rigorous evaluations of their effectiveness are lacking. Families referred to a community-based mediation program (N=111) were randomized to an intervention or wait-list control group, and completed three surveys over a 12-week period. With the exception of parent-reported child delinquency (which decreased more in the intervention group), this evaluation provides little support for the short-term effectiveness of parent-child mediation for improving family functioning and reducing child problem behaviors in general. Given that this is the first randomized controlled trial of a parent-child mediation program, additional evaluations involving larger samples and longer follow-ups are needed before firm conclusions can be drawn about the effectiveness of this intervention. PMID:26762375

Surgical versus expectant management in women with an incomplete evacuation of the uterus after treatment with misoprostol for miscarriage: the MisoREST trial

PubMed Central

2013-01-01

Background Medical treatment with misoprostol is a non-invasive and inexpensive treatment option in first trimester miscarriage. However, about 30% of women treated with misoprostol have incomplete evacuation of the uterus. Despite being relatively asymptomatic in most cases, this finding often leads to additional surgical treatment (curettage). A comparison of effectiveness and cost-effectiveness of surgical management versus expectant management is lacking in women with incomplete miscarriage after misoprostol. Methods/Design The proposed study is a multicentre randomized controlled trial that assesses the costs and effects of curettage versus expectant management in women with incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage. Eligible women will be randomized, after informed consent, within 24 hours after identification of incomplete evacuation of the uterus by ultrasound scanning. Women are randomly allocated to surgical or expectant management. Curettage is performed within three days after randomization. Primary outcome is the sonographic finding of an empty uterus (maximal diameter of any contents of the uterine cavity < 10 millimeters) six weeks after study entry. Secondary outcomes are patients’ quality of life, surgical outcome parameters, the type and number of re-interventions during the first three months and pregnancy rates and outcome 12 months after study entry. Discussion This trial will provide evidence for the (cost) effectiveness of surgical versus expectant management in women with incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage. Trial registration Dutch Trial Register: NTR3110 PMID:23638956

A prospective randomized trial examining health care utilization in individuals using multiple smartphone-enabled biosensors.

PubMed

Bloss, Cinnamon S; Wineinger, Nathan E; Peters, Melissa; Boeldt, Debra L; Ariniello, Lauren; Kim, Ju Young; Sheard, Judith; Komatireddy, Ravi; Barrett, Paddy; Topol, Eric J

2016-01-01

Background. Mobile health and digital medicine technologies are becoming increasingly used by individuals with common, chronic diseases to monitor their health. Numerous devices, sensors, and apps are available to patients and consumers-some of which have been shown to lead to improved health management and health outcomes. However, no randomized controlled trials have been conducted which examine health care costs, and most have failed to provide study participants with a truly comprehensive monitoring system. Methods. We conducted a prospective randomized controlled trial of adults who had submitted a 2012 health insurance claim associated with hypertension, diabetes, and/or cardiac arrhythmia. The intervention involved receipt of one or more mobile devices that corresponded to their condition(s) (hypertension: Withings Blood Pressure Monitor; diabetes: Sanofi iBGStar Blood Glucose Meter; arrhythmia: AliveCor Mobile ECG) and an iPhone with linked tracking applications for a period of 6 months; the control group received a standard disease management program. Moreover, intervention study participants received access to an online health management system which provided participants detailed device tracking information over the course of the study. This was a monitoring system designed by leveraging collaborations with device manufacturers, a connected health leader, health care provider, and employee wellness program-making it both unique and inclusive. We hypothesized that health resource utilization with respect to health insurance claims may be influenced by the monitoring intervention. We also examined health-self management. Results & Conclusions. There was little evidence of differences in health care costs or utilization as a result of the intervention. Furthermore, we found evidence that the control and intervention groups were equivalent with respect to most health care utilization outcomes. This result suggests there are not large short-term increases or decreases in health care costs or utilization associated with monitoring chronic health conditions using mobile health or digital medicine technologies. Among secondary outcomes there was some evidence of improvement in health self-management which was characterized by a decrease in the propensity to view health status as due to chance factors in the intervention group.

A prospective randomized trial examining health care utilization in individuals using multiple smartphone-enabled biosensors

PubMed Central

Peters, Melissa; Boeldt, Debra L.; Ariniello, Lauren; Kim, Ju Young; Sheard, Judith; Komatireddy, Ravi; Barrett, Paddy

2016-01-01

Background. Mobile health and digital medicine technologies are becoming increasingly used by individuals with common, chronic diseases to monitor their health. Numerous devices, sensors, and apps are available to patients and consumers–some of which have been shown to lead to improved health management and health outcomes. However, no randomized controlled trials have been conducted which examine health care costs, and most have failed to provide study participants with a truly comprehensive monitoring system. Methods. We conducted a prospective randomized controlled trial of adults who had submitted a 2012 health insurance claim associated with hypertension, diabetes, and/or cardiac arrhythmia. The intervention involved receipt of one or more mobile devices that corresponded to their condition(s) (hypertension: Withings Blood Pressure Monitor; diabetes: Sanofi iBGStar Blood Glucose Meter; arrhythmia: AliveCor Mobile ECG) and an iPhone with linked tracking applications for a period of 6 months; the control group received a standard disease management program. Moreover, intervention study participants received access to an online health management system which provided participants detailed device tracking information over the course of the study. This was a monitoring system designed by leveraging collaborations with device manufacturers, a connected health leader, health care provider, and employee wellness program–making it both unique and inclusive. We hypothesized that health resource utilization with respect to health insurance claims may be influenced by the monitoring intervention. We also examined health-self management. Results & Conclusions. There was little evidence of differences in health care costs or utilization as a result of the intervention. Furthermore, we found evidence that the control and intervention groups were equivalent with respect to most health care utilization outcomes. This result suggests there are not large short-term increases or decreases in health care costs or utilization associated with monitoring chronic health conditions using mobile health or digital medicine technologies. Among secondary outcomes there was some evidence of improvement in health self-management which was characterized by a decrease in the propensity to view health status as due to chance factors in the intervention group. PMID:26788432

Effects of herbaceous and woody plant control on Pinus palustris growth and foliar nutrients through six growing seasons

Treesearch

James D. Haywood

2005-01-01

To determine if either herbaceous or woody plants are more competitive with longleaf pine (Pinuspalustris P. Mill.) seedlings, two vegetation management treatments-herbaceous plant control (HPC, No or Yes) and woody plant control (WPC, No or Yes) were applied in newly established longleaf pine plantings in a randomized complete block 2 x 2 factorial...

Reflexology in the management of chemotherapy induced peripheral neuropathy: A pilot randomized controlled trial.

PubMed

Kurt, Seda; Can, Gulbeyaz

2018-02-01

The current experimental study aimed to evaluate the effectiveness of reflexology on the management of symptoms and functions of chemotherapy-induced peripheral neuropathy (CIPN) in cancer patients. This study was conducted as a randomized controlled trial in 60 patients (30 experimental and 30 control patients) who had chemotherapy-induced Grade II-IV peripheral neuropathy complaints from July 2013 to November 2015. Data were collected using the patient identification form, European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy (EORTC-CIPN-20) form, and BPI (used for related chemotherapy-induced peripheral neuropathy symptoms). The majority of the patients were being treated for gastrointestinal or breast cancer and were primarily receiving Eloxatine- or taxane-based treatment. It was found that reflexology applications did not lead to differences in either group in terms of peripheral neuropathy severity and incidence (p > 0.05) and only led to improvement in sensory functions in the experimental group (p < 0.05). It was determined that reflexology is not an effective method in the management of patients' activity levels, walking ability etc. and motor, autonomic functions related CIPN, but reflexology is effective method in the management of patients' sensory functions related CIPN. Key Words: Peripheral neuropathy, reflexology, chemotherapy, EORTC QLQ-CIPN-20, BPI. Copyright © 2017 Elsevier Ltd. All rights reserved.

Conservative management of tendinopathy: an evidence-based approach

PubMed Central

Loppini, Mattia; Maffulli, Nicola

2011-01-01

Summary Tendinopathy is one of the most frequent overuse injuries associated with sport. It is a failure of a chronic healing response associated with both chronic overloaded and unloaded states. Although several conservative therapeutic options have been proposed, very few of them are supported by randomized controlled trials. Eccentric exercises provide excellent clinical results both in athletic and sedentary patients, with no reported adverse effects. Combining eccentric loading and low-energy shock wave therapy produces higher success rates compared with eccentric training alone or shock wave therapy alone. High-volume injection of normal saline solution, corticosteroids, or anesthetics can reduce pain and improve long-term function in patients with Achilles or patellar tendinopathy. The use of injectable substances such as platelet-rich plasma, autologous blood, polidocanol, and corticosteroids in and around tendons is not support by strong clinical evidence. Further randomized controlled trials are necessary to define the best conservative management of tendinopathy. PMID:23738261

Testing the Model: A Phase 1/2 Randomized Double Blind Placebo Control Trial of Targeted Therapeutics: Liposomal Glutathione and Curcumin

DTIC Science & Technology

2016-10-01

Syndrome, P. Goodnik and N.G. Klimas, eds., American Psychiatric Press, Washington, D.C., 1993. 4 2. Clinical Management of Chronic...Klimas, N. and Fletcher, M.A. Stress Management Interventions and psychosocial predictors of progression in HIV-1 infection. in K.Goodkin, ed...Fletcher, M.A. Psychoimmunology and Stress Management in HIV-1 Infection. in Update in Psychoneuroimmunology, Gorman, J.M. and Kertzner, R.M., eds

Results of the Medicare Health Support disease-management pilot program.

PubMed

McCall, Nancy; Cromwell, Jerry

2011-11-03

In the Medicare Modernization Act of 2003, Congress required the Centers for Medicare and Medicaid Services to test the commercial disease-management model in the Medicare fee-for-service program. The Medicare Health Support Pilot Program was a large, randomized study of eight commercial programs for disease management that used nurse-based call centers. We randomly assigned patients with heart failure, diabetes, or both to the intervention or to usual care (control) and compared them with the use of a difference-in-differences method to evaluate the effects of the commercial programs on the quality of clinical care, acute care utilization, and Medicare expenditures for Medicare fee-for-service beneficiaries. The study included 242,417 patients (163,107 in the intervention group and 79,310 in the control group). The eight commercial disease-management programs did not reduce hospital admissions or emergency room visits, as compared with usual care. We observed only 14 significant improvements in process-of-care measures out of 40 comparisons. These modest improvements came at substantial cost to the Medicare program in fees paid to the disease-management companies ($400 million), with no demonstrable savings in Medicare expenditures. In this large study, commercial disease-management programs using nurse-based call centers achieved only modest improvements in quality-of-care measures, with no demonstrable reduction in the utilization of acute care or the costs of care.

A goal management intervention for polyarthritis patients: rationale and design of a randomized controlled trial.

PubMed

Arends, Roos Y; Bode, Christina; Taal, Erik; Van de Laar, Mart A F J

2013-08-13

A health promotion intervention was developed for inflammatory arthritis patients, based on goal management. Elevated levels of depression and anxiety symptoms, which indicate maladjustment, are found in such patients. Other indicators of adaptation to chronic disease are positive affect, purpose in life and social participation. The new intervention focuses on to improving adaptation by increasing psychological and social well-being and decreasing symptoms of affective disorders. Content includes how patients can cope with activities and life goals that are threatened or have become impossible to attain due to arthritis. The four goal management strategies used are: goal maintenance, goal adjustment, goal disengagement and reengagement. Ability to use various goal management strategies, coping versatility and self-efficacy are hypothesized to mediate the intervention's effect on primary and secondary outcomes. The primary outcome is depressive symptoms. Secondary outcomes are anxiety symptoms, positive affect, purpose in life, social participation, pain, fatigue and physical functioning. A cost-effectiveness analysis and stakeholders' analysis are planned. The protocol-based psycho-educational program consists of six group-based meetings and homework assignments, led by a trained nurse. Participants are introduced to goal management strategies and learn to use these strategies to cope with threatened personal goals. Four general hospitals participate in a randomized controlled trial with one intervention group and a waiting list control condition. The purpose of this study is to evaluate the effectiveness of a goal management intervention. The study has a holistic focus as both the absence of psychological distress and presence of well-being are assessed. In the intervention, applicable goal management competencies are learned that assist people in their choice of behaviors to sustain and enhance their quality of life. Nederlands Trial Register = NTR3606, registration date 11-09-2012.

Effects of Natural Sounds on Pain: A Randomized Controlled Trial with Patients Receiving Mechanical Ventilation Support.

PubMed

Saadatmand, Vahid; Rejeh, Nahid; Heravi-Karimooi, Majideh; Tadrisi, Sayed Davood; Vaismoradi, Mojtaba; Jordan, Sue

2015-08-01

Nonpharmacologic pain management in patients receiving mechanical ventilation support in critical care units is under investigated. Natural sounds may help reduce the potentially harmful effects of anxiety and pain in hospitalized patients. The aim of this study was to examine the effect of pleasant, natural sounds on self-reported pain in patients receiving mechanical ventilation support, using a pragmatic parallel-arm, randomized controlled trial. The study was conducted in a general adult intensive care unit of a high-turnover teaching hospital, in Tehran, Iran. Between October 2011 and June 2012, we recruited 60 patients receiving mechanical ventilation support to the intervention (n = 30) and control arms (n = 30) of a pragmatic parallel-group, randomized controlled trial. Participants in both arms wore headphones for 90 minutes. Those in the intervention arm heard pleasant, natural sounds, whereas those in the control arm heard nothing. Outcome measures included the self-reported visual analog scale for pain at baseline; 30, 60, and 90 minutes into the intervention; and 30 minutes post-intervention. All patients approached agreed to participate. The trial arms were similar at baseline. Pain scores in the intervention arm fell and were significantly lower than in the control arm at each time point (p < .05). Administration of pleasant, natural sounds via headphones is a simple, safe, nonpharmacologic nursing intervention that may be used to allay pain for up to 120 minutes in patients receiving mechanical ventilation support. Copyright © 2015 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

Implantable Hemodynamic Monitoring for Heart Failure Patients.

PubMed

Abraham, William T; Perl, Leor

2017-07-18

Rates of heart failure hospitalization remain unacceptably high. Such hospitalizations are associated with substantial patient, caregiver, and economic costs. Randomized controlled trials of noninvasive telemedical systems have failed to demonstrate reduced rates of hospitalization. The failure of these technologies may be due to the limitations of the signals measured. Intracardiac and pulmonary artery pressure-guided management has become a focus of hospitalization reduction in heart failure. Early studies using implantable hemodynamic monitors demonstrated the potential of pressure-based heart failure management, whereas subsequent studies confirmed the clinical utility of this approach. One large pivotal trial proved the safety and efficacy of pulmonary artery pressure-guided heart failure management, showing a marked reduction in heart failure hospitalizations in patients randomized to active pressure-guided management. "Next-generation" implantable hemodynamic monitors are in development, and novel approaches for the use of this data promise to expand the use of pressure-guided heart failure management. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Web-based self-management for patients with multiple sclerosis: a practical, randomized trial.

PubMed

Miller, Deborah M; Moore, Shirley M; Fox, Robert J; Atreja, Ashish; Fu, Alex Z; Lee, Jar-Chi; Saupe, Welf; Stadtler, Maria; Chakraborty, Swati; Harris, C M; Rudick, Richard A

2011-01-01

No studies have addressed the use of electronic personal health records (e-PHRs) for self-management in complex neurological disorders. We assessed and tested an Internet-based self-management system that utilized the e-PHR and determined its impact on self-assessed well-being, clinician-assessed well-being, and healthcare utilization in patients with multiple sclerosis (MS). Subjects were randomized to usual care (a secure Web-based messaging system) or active intervention, which included secure messaging, self-monitoring, self-management of MS symptoms, and communication about upcoming clinic visits. Computers and Internet access were provided. Subjects were included if they had MS, lived within the county or region surrounding our MS center, had at least two appointments at our center in the previous 12 months, and demonstrated basic typing and computer skills. Study duration was 12 months. Of 220 subjects completing informed consent, 206 met the inclusion criteria. At the study's end, 83 subjects remained in the usual care group and 84 in the enhanced care group. Both groups used the available system components. The groups did not significantly differ on the primary endpoints or healthcare utilization. Self-management support is an emerging aspect of chronic care management. We established the feasibility of conducting a randomized, controlled trial using e-PHRs for patient self-management. We did not find that e-PHR-enabled self-management augmented multidisciplinary MS center-based care, possibly because the differences between interventions were not great enough.

A Mobile Health Intervention for Self-Management and Lifestyle Change for Persons With Type 2 Diabetes, Part 2: One-Year Results From the Norwegian Randomized Controlled Trial RENEWING HEALTH

PubMed Central

Torbjørnsen, Astrid; Wahl, Astrid Klopstad; Jenum, Anne Karen; Småstuen, Milada Cvancarova; Årsand, Eirik; Ribu, Lis

2014-01-01

Background Self-management is crucial in the daily management of type 2 diabetes. It has been suggested that mHealth may be an important method for enhancing self-management when delivered in combination with health counseling. Objective The objective of this study was to test whether the use of a mobile phone–based self-management system used for 1 year, with or without telephone health counseling by a diabetes specialist nurse for the first 4 months, could improve glycated hemoglobin A1c (HbA1c) level, self-management, and health-related quality of life compared with usual care. Methods We conducted a 3-arm prospective randomized controlled trial involving 2 intervention groups and 1 control group. Eligible participants were persons with type 2 diabetes with an HbA1c level ≥7.1% (≥54.1 mmol/mol) and aged ≥18 years. Both intervention groups received the mobile phone–based self-management system Few Touch Application (FTA). The FTA consisted of a blood glucose–measuring system with automatic wireless data transfer, diet manual, physical activity registration, and management of personal goals, all recorded and operated using a diabetes diary app on the mobile phone. In addition, one intervention group received health counseling based on behavior change theory and delivered by a diabetes specialist nurse for the first 4 months after randomization. All groups received usual care by their general practitioner. The primary outcome was HbA1c level. Secondary outcomes were self-management (heiQ), health-related quality of life (SF-36), depressive symptoms (CES-D), and lifestyle changes (dietary habits and physical activity). Data were analyzed using univariate methods (t test, ANOVA) and multivariate linear and logistic regression. Results A total of 151 participants were randomized: 51 to the FTA group, 50 to the FTA-health counseling (FTA-HC) group, and 50 to the control group. Follow-up data after 1 year were available for 120 participants (79%). HbA1c level decreased in all groups, but did not differ between groups after 1 year. The mean change in the heiQ domain skills and technique acquisition was significantly greater in the FTA-HC group after adjusting for age, gender, and education (P=.04). Other secondary outcomes did not differ between groups after 1 year. In the FTA group, 39% were substantial users of the app; 34% of the FTA-HC group were substantial users. Those aged ≥63 years used the app more than their younger counterparts did (OR 2.7; 95% CI 1.02-7.12; P=.045). Conclusions The change in HbA1c level did not differ between groups after the 1-year intervention. Secondary outcomes did not differ between groups except for an increase in the self-management domain of skill and technique acquisition in the FTA-HC group. Older participants used the app more than the younger participants did. PMID:25499872

Randomized, double-blind, placebo-controlled trial of oral docusate in the management of constipation in hospice patients.

PubMed

Tarumi, Yoko; Wilson, Mitchell P; Szafran, Olga; Spooner, G Richard

2013-01-01

The stool softener docusate is widely used in the management of constipation in hospice patients. There is little experimental evidence to support this practice, and no randomized trials have been conducted in the hospice setting. To assess the efficacy of docusate in hospice patients. This was a 10-day, prospective, randomized, double-blind, placebo-controlled trial of docusate and sennosides vs. placebo and sennosides in hospice patients in Edmonton, Alberta. Patients were included if they were age 18 years or older, able to take oral medications, did not have a gastrointestinal stoma, and had a Palliative Performance Scale score of 20% or more. The primary outcome measures were stool frequency, volume, and consistency. Secondary outcomes were patient perceptions of bowel movements (difficulty and completeness of evacuation) and bowel-related interventions. A total of 74 patients were randomized into the study (35 to the docusate group and 39 to the placebo group). There were neither significant differences between the groups in stool frequency, volume, or consistency, nor in difficulty or completeness of evacuation. On the Bristol Stool Form Scale, more patients in the placebo group had Type 4 (smooth and soft) and Type 5 (soft blobs) stool, whereas in the docusate group, more had Type 3 (sausage like) and Type 6 (mushy) stool (P=0.01). There was no significant benefit of docusate plus sennosides compared with placebo plus sennosides in managing constipation in hospice patients. Docusate use should be considered on an individual basis. Copyright © 2013 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.

Periarticular Injection of Liposomal Bupivacaine Offers No Benefit Over Standard Bupivacaine in Total Knee Arthroplasty: A Prospective, Randomized, Controlled Trial.

PubMed

Alijanipour, Pouya; Tan, Timothy L; Matthews, Christopher N; Viola, Jessica R; Purtill, James J; Rothman, Richard H; Parvizi, Javad; Austin, Matthew S

2017-02-01

Periarticular injection of liposomal bupivacaine has been adopted as part of multimodal pain management after total knee arthroplasty (TKA). In this prospective, randomized clinical trial, we enrolled 162 patients undergoing primary TKA in a single institution between January 2014 and May 2015. Eighty-seven patients were randomized to liposomal bupivacaine (experimental group), and 75 patients were randomized to free bupivacaine (control group). All patients received spinal anesthesia and otherwise identical surgical approaches, pain management, and rehabilitation protocols. Outcomes evaluated include the patient-reported visual analog pain scores, narcotic consumption, and narcotic-related side effects (Brief Pain Inventory) within 96 hours after surgery as well as functional outcomes using the Knee Society Score and the Short-Form 12 measured preoperatively and at 4-6 weeks after surgery. There were no statistically significant differences between the groups in terms of postoperative daily pain scores, narcotic consumption (by-day and overall), or narcotic-related side effects. There were no statistically significant differences between the groups in terms of surgical (P = .76) and medical complications or length of hospital stay (P = .35). There were no statistically significant differences in satisfaction between the groups (P = .56) or between the groups in postoperative Knee Society Score (P = .53) and the Short-Form 12 at 4-6 weeks (P = .82, P = .66). As part of multimodal pain management protocol, periarticular injection of liposomal bupivacaine compared with bupivacaine HCl did not result in any clinically or statistically significant improvement of the measured outcomes following TKA. Copyright © 2016 Elsevier Inc. All rights reserved.

Diarrhea and dengue control in rural primary schools in Colombia: study protocol for a randomized controlled trial

PubMed Central

2012-01-01

Background Diarrheal diseases and dengue fever are major global health problems. Where provision of clean water is inadequate, water storage is crucial. Fecal contamination of stored water is a common source of diarrheal illness, but stored water also provides breeding sites for dengue vector mosquitoes. Poor household water management and sanitation are therefore potential determinants of both diseases. Little is known of the role of stored water for the combined risk of diarrhea and dengue, yet a joint role would be important for developing integrated control and management efforts. Even less is known of the effect of integrating control of these diseases in school settings. The objective of this trial was to investigate whether interventions against diarrhea and dengue will significantly reduce diarrheal disease and dengue entomological risk factors in rural primary schools. Methods/design This is a 2×2 factorial cluster randomized controlled trial. Eligible schools were rural primary schools in La Mesa and Anapoima municipalities, Cundinamarca, Colombia. Eligible pupils were school children in grades 0 to 5. Schools were randomized to one of four study arms: diarrhea interventions (DIA); dengue interventions (DEN); combined diarrhea and dengue interventions (DIADEN); and control (C). Schools were allocated publicly in each municipality (strata) at the start of the trial, obviating the need for allocation concealment. The primary outcome for diarrhea is incidence rate of diarrhea in school children and for dengue it is density of adult female Aedes aegypti per school. Approximately 800 pupils from 34 schools were enrolled in the trial with eight schools in the DIA arm, nine in the DEN, eight in the DIADEN, and nine in the control arms. The trial status as of June 2012 was: completed baseline data collections; enrollment, randomization, and allocation of schools. The trial was funded by the Research Council of Norway and the Lazos de Calandaima Foundation. Discussion This is the first trial investigating the effect of a set of integrated interventions to control both dengue and diarrhea. This is also the first trial to study the combination of diarrhea-dengue disease control in school settings. Trial registration Current Controlled Trials ISRCTN40195031 PMID:23034084

Diarrhea and dengue control in rural primary schools in Colombia: study protocol for a randomized controlled trial.

PubMed

Overgaard, Hans J; Alexander, Neal; Mátiz, Maria Ines; Jaramillo, Juan Felipe; Olano, Victor Alberto; Vargas, Sandra; Sarmiento, Diana; Lenhart, Audrey; Seidu, Razak; Stenström, Thor Axel

2012-10-03

Diarrheal diseases and dengue fever are major global health problems. Where provision of clean water is inadequate, water storage is crucial. Fecal contamination of stored water is a common source of diarrheal illness, but stored water also provides breeding sites for dengue vector mosquitoes. Poor household water management and sanitation are therefore potential determinants of both diseases. Little is known of the role of stored water for the combined risk of diarrhea and dengue, yet a joint role would be important for developing integrated control and management efforts. Even less is known of the effect of integrating control of these diseases in school settings. The objective of this trial was to investigate whether interventions against diarrhea and dengue will significantly reduce diarrheal disease and dengue entomological risk factors in rural primary schools. This is a 2×2 factorial cluster randomized controlled trial. Eligible schools were rural primary schools in La Mesa and Anapoima municipalities, Cundinamarca, Colombia. Eligible pupils were school children in grades 0 to 5. Schools were randomized to one of four study arms: diarrhea interventions (DIA); dengue interventions (DEN); combined diarrhea and dengue interventions (DIADEN); and control (C). Schools were allocated publicly in each municipality (strata) at the start of the trial, obviating the need for allocation concealment. The primary outcome for diarrhea is incidence rate of diarrhea in school children and for dengue it is density of adult female Aedes aegypti per school. Approximately 800 pupils from 34 schools were enrolled in the trial with eight schools in the DIA arm, nine in the DEN, eight in the DIADEN, and nine in the control arms. The trial status as of June 2012 was: completed baseline data collections; enrollment, randomization, and allocation of schools. The trial was funded by the Research Council of Norway and the Lazos de Calandaima Foundation. This is the first trial investigating the effect of a set of integrated interventions to control both dengue and diarrhea. This is also the first trial to study the combination of diarrhea-dengue disease control in school settings. Current Controlled Trials ISRCTN40195031.

A Randomized, Controlled Trial of Meditation Compared to Exposure Therapy and Education Control on PTSD in Veterans

DTIC Science & Technology

2014-10-01

alternative therapy for PTSD. Our collaborative group (Maharishi University of Management Research Institute, VA San Diego Healthcare System, University of...Prolonged Exposure, and PTSD Health Education, and are supervised by the research team for quality control . No study-related adverse events have...by the research team for quality control . For home practice, over 70% of subjects have indicated compliance with their home practice program (at

Comparing the effects of education using telephone follow-up and smartphone-based social networking follow-up on self-management behaviors among patients with hypertension.

PubMed

Najafi Ghezeljeh, Tahereh; Sharifian, Sanaz; Nasr Isfahani, Mehdi; Haghani, Hamid

2018-03-05

Little is known about the benefits of social networks in the management of patients. The aim of this study was to compare the effects of self-management (SM) education using telephone follow-up and mobile phone-based social networking on SM behaviors among patients with hypertension. This randomized clinical trial was conducted with 100 patients. They were randomly allocated to four groups: (i) control, (ii) SM training without follow-up, (iii) telephone follow-up and (iv) smartphone-based social networking follow-up. The hypertension SM behavior questionnaire was used for data collection before and six weeks after the study. Those patients who underwent SM education training (with and without follow-up) had statistically significant differences from those in the control group in terms of SM behaviors (p < .001). There was no statistically significant difference between different types of follow-up. SM education using telephone follow-up and/or smartphone-based social networking follow-up influenced SM behaviors among patients with hypertension.

Effects of a Worksite Tobacco Control Intervention in India: The Mumbai Worksite Tobacco Control Study, a Cluster Randomized Trial

PubMed Central

Sorensen, Glorian; Pednekar, Mangesh; Cordeira, Laura Shulman; Pawar, Pratibha; Nagler, Eve; Stoddard, Anne M.; Kim, Hae-Young; Gupta, Prakash C.

2016-01-01

Objectives We assessed a worksite intervention designed to promote tobacco control among manufacturing workers in Greater Mumbai, India. Methods We used a cluster-randomized design to test an integrated health promotion/health protection intervention, which addressed changes at the management and worker levels. Between July 2012 and July 2013, we recruited 20 worksites on a rolling basis and randomly assigned them to intervention or delayed-intervention control conditions. The follow-up survey was conducted between December 2013 and November 2014. Results The difference in 30-day quit rates between intervention and control conditions was statistically significant for production workers (OR=2.25, P=0.03), although not for the overall sample (OR=1.70; P=0.12). The intervention resulted in a doubling of the 6-month cessation rates among workers in the intervention worksites compared to those in the control, for production workers (OR=2.29; P=0.07) and for the overall sample (OR=1.81; P=0.13), but the difference did not reach statistical significance. Conclusions These findings demonstrate the potential impact of a tobacco control intervention that combined tobacco control and health protection programming within Indian manufacturing worksites. PMID:26883793

Empowered Diabetes Management: Life Coaching and Pharmacist Counseling for Employed Adults with Diabetes

ERIC Educational Resources Information Center

Nishita, Christy; Cardazone, Gina; Uehara, Denise Lea; Tom, Tammy

2013-01-01

The Hawai'i Demonstration to Maintain Independence and Employment was a randomized controlled trial examining the effect of a participant-driven, multicomponent intervention on 190 employed adults with diabetes, 36% of whom were Asian and 35% of whom were Native Hawaiian or Pacific Islander. A no treatment concurrent control group was used, and…

Design of the Violence and Stress Assessment (ViStA) study: a randomized controlled trial of care management for PTSD among predominantly Latino patients in safety net health centers.

PubMed

Meredith, Lisa S; Eisenman, David P; Green, Bonnie L; Kaltman, Stacey; Wong, Eunice C; Han, Bing; Cassells, Andrea; Tobin, Jonathan N

2014-07-01

Posttraumatic stress disorder (PTSD) is a common problem in primary care. Although effective treatments are available, little is known about whether such treatments are effective within the context of Federally Qualified Health Centers (FQHCs) that serve as national "safety nets" for providing primary care for low income and underinsured patients. The Violence and Stress Assessment (ViStA) study is the first randomized controlled trial (RCT) to test the impact of a care management intervention for treating PTSD in FQHCs. To develop a PTSD management intervention appropriate for lower resource FQHCs and the predominantly Latino patients they serve, formative work was conducted through a collaborative effort between researchers and an FQHC practice-based research network. This article describes how FQHC stakeholders were convened to review, assess, and prioritize evidence-based strategies for addressing patient, clinician, and system-level barriers to care. This multi-component care management intervention incorporates diagnosis with feedback, patient education and activation; navigation and linkage to community resources; clinician education and medication guidance; and structured cross-disciplinary communication and continuity of care, all facilitated by care managers with FQHC experience. We also describe the evaluation design of this five-year RCT and the characteristics of the 404 English or Spanish speaking patients enrolled in the study and randomized to either the intervention or to usual care. Patients are assessed at baseline, six months, and 12 months to examine intervention effectiveness on PTSD, other mental health symptoms, health-related quality-of-life, health care service use; and perceived barriers to care and satisfaction with care. Copyright © 2014 Elsevier Inc. All rights reserved.

Effectiveness of personalized written asthma action plans in the management of children with partly controlled asthma in Trinidad: a randomized controlled trial.

PubMed

Khan, Raveed; Maharaj, Rohan; Seerattan, Natasha; Babwah, Feaz

2014-02-01

The provision of written asthma action plans (WAAPs) is regarded by regional and international guidelines as an essential component of patient education and self-management. However, the evidence for this practice in children is deficient. To evaluate the effectiveness of adding a personalized WAAP in the treatment of children with partly controlled asthma. Children with partly controlled asthma were randomized to receive a personalized WAAP or no plan, in addition to standard care including education. They were followed up with serial measurement of outcome variables. The primary outcome measured was the number of emergency room (ER) revisits. Ninety-one children participated, 45 in the intervention group and 46 in the control group. Comparison with pretrial data revealed significantly improved outcomes with respect to the numbers of ER visits ( p = 0.005 and 0.0002) and acute asthmatic attacks ( p = 0.0064 and 0.0006) in both arms of the study. Children in receipt of a personalized WAAP had fewer ER visits ( p = 0.78), asthma attacks ( p = 0.84), missed school days ( p = 0.28), night-time awakenings ( p = 0.48) and unscheduled doctor visits ( p = 0.69) than those who did not receive a plan. The results of this study suggest that the provision of personalized WAAPs may play a useful role in the management of children with partly controlled asthma but is no better than standard care. Asthma education is a critical component in the prevention of exacerbations in children with partly controlled asthma.

Testing the Replicability of a Successful Care Management Program: Results from a Randomized Trial and Likely Explanations for Why Impacts Did Not Replicate.

PubMed

Peterson, G Greg; Zurovac, Jelena; Brown, Randall S; Coburn, Kenneth D; Markovich, Patricia A; Marcantonio, Sherry A; Clark, William D; Mutti, Anne; Stepanczuk, Cara

2016-12-01

To test whether a care management program could replicate its success in an earlier trial and determine likely explanations for why it did not. Medicare claims and nurse contact data for Medicare fee-for-service beneficiaries with chronic illnesses enrolled in the trial in eastern Pennsylvania (N = 483). A randomized trial with half of enrollees receiving intensive care management services and half receiving usual care. We developed and tested hypotheses for why impacts declined. All outcomes and covariates were derived from claims and the nurse contact data. From 2010 to 2014, the program did not reduce hospitalizations or generate Medicare savings to offset program fees that averaged $260 per beneficiary per month. These estimates are statistically different (p < .05) from the large reductions in hospitalizations and spending in the first trial (2002-2010). The treatment-control differences in the second trial disappeared because the control group's risk-adjusted hospitalization rate improved, not because the treatment group's outcomes worsened. Even if demonstrated in a randomized trial, successful results from one test may not replicate in other settings or time periods. Assessing whether gaps in care that the original program filled exist in other settings can help identify where earlier success is likely to replicate. © Health Research and Educational Trust.

Patient satisfaction and psychological well-being after internet-based cognitive behavioral stress management (IB-CBSM) for women with preterm labor: A randomized controlled trial.

PubMed

Scherer, S; Alder, J; Gaab, J; Berger, T; Ihde, K; Urech, C

2016-01-01

Despite its value for the management of psychological burden, little is known about the efficacy of and patient satisfaction with internet-based cognitive behavioral stress management (IB-CBSM) for women with preterm labor. The present study sets out to analyze stress/anxiety reduction, patient satisfaction and patient's working alliance in a group of 58 women with preterm labor participating in an online psychological stress management project. As part of the project, women were randomly assigned to online stress management or a control condition. Levels of stress and anxiety decreased significantly in both conditions from pre- to post-treatment measure. Participants in IB-CBSM reported significant higher working alliance inventory (WAI) scores in the task and goal subscale (p<.001; p<.05) than women in the control condition. In Addition the IB-CBSM group showed significant correlations of the WAI subscale task and goal and the stress/anxiety outcome. Regarding patient satisfaction, women in the IB-CBSM reported significantly higher satisfaction scores (p<.001) than women in the control condition. WAI explained nearly 40% of the variance in patient satisfaction. Furthermore, WAI mediates, at least in part, the relationship between group condition and patient satisfaction. The current analysis indicated that participants in IB-CBSM had higher WAI scores and were more satisfied with the program. In addition only the IB-CBSM group showed significant correlations of the WAI with the stress/anxiety reduction outcome. Based on these findings, it can be presumed that measures of agreement with working alliance parameters, especially task and goal components, are substantially important for more effective and satisfactory therapeutic interventions. Copyright © 2015 Elsevier Inc. All rights reserved.

Enhancing Asthma Self-Management in Rural School-Aged Children: A Randomized Controlled Trial.

PubMed

Horner, Sharon D; Brown, Adama; Brown, Sharon A; Rew, D Lynn

2016-06-01

To test the effects of 2 modes of delivering an asthma educational intervention on health outcomes and asthma self-management in school-aged children who live in rural areas. Longitudinal design with data collected 4 times over 12 months. The target sample was composed of children in grades 2-5 who had a provider diagnosis of asthma. Elementary schools were stratified into high or low socioeconomic status based on student enrollment in the free or reduced-cost lunch program. Schools were then randomly assigned to 1 of 3 treatment arms: in-school asthma class, asthma day camp, or the attention-control group. Sample retention was good (87.7%) and equally distributed by study arm. Improvements in emergency department visits and office visits were related to attending either the asthma class or asthma day camp. Asthma severity significantly decreased in both asthma treatment groups. Other factors such as hospitalizations, parent asthma management, and child asthma management improved for all groups. Both asthma class and asthma day camp yielded significant reductions in asthma severity. There were reductions in the emergency department and office visits for the 2 asthma arms, and hospitalizations declined significantly for all groups. Asthma self-management also improved in all groups, while it was somewhat higher in the asthma arms. This may be due to the attention being drawn to asthma management by study participation and the action of completing questionnaires about asthma management, asthma symptoms, and health outcomes. © 2015 National Rural Health Association.

Pharmacologic intervention for retained placenta: a systematic review and meta-analysis.

PubMed

Duffy, James M N; Mylan, Sophie; Showell, Marian; Wilson, Matthew J A; Khan, Khalid S

2015-03-01

To assess the effectiveness and safety of pharmacologic interventions for the treatment of retained placenta (when the placenta remains undelivered after 30 minutes of active management of the third stage of labor). We searched: 1) Cochrane Central Register of Controlled Trials (CENTRAL), 2) Cochrane Pregnancy and Childbirth Group's Trials Register, 3) EMBASE, and 4) MEDLINE from inception to June 2014. Randomized controlled trials comparing a pharmacologic intervention(s) with a placebo for the treatment of retained placenta were included. Sixteen randomized controlled trials, including 1,683 participants, were included. Study characteristics and quality were recorded. The meta-analysis was based on random-effects methods for pooled data. There were no statistically significant differences in the requirement to perform manual removal of a placenta in patients treated with oxytocin (55% compared with 60%; relative risk [RR] 0.86, 95% confidence interval [CI] 0.73-1.02; 10 randomized controlled trials [RCTs]), prostaglandins (44% compared with 55%; RR 0.82, 95% CI 0.58-1.15; four RCTs), nitroglycerin (85% compared with 80%; RR 1.06, 95% CI 0.80-1.41; one RCT), or oxytocin and nitroglycerin (52% compared with 79%; RR 0.23, 95% CI 0.01-8.48; two RCTs) compared with placebo. There was limited reporting of secondary outcomes. As opposed to the use of oxytocin as part of the active management of the third stage of labor that has been shown to diminish bleeding in the third stage, once the diagnosis of retained placenta has been made, no pharmacologic treatment has been shown to be effective. When retained placenta is diagnosed, immediate manual removal of the placenta should be considered. PROSPERO International Prospective Register of Systematic Reviews, http://www.crd.york.ac.uk/PROSPERO/, CRD42014010641.

Milrinone therapy for enterovirus 71-induced pulmonary edema and/or neurogenic shock in children: a randomized controlled trial.

PubMed

Chi, Chia-Yu; Khanh, Truong Huu; Thoa, Le Phan Kim; Tseng, Fan-Chen; Wang, Shih-Min; Thinh, Le Quoc; Lin, Chia-Chun; Wu, Han-Chieh; Wang, Jen-Ren; Hung, Nguyen Thanh; Thuong, Tang Chi; Chang, Chung-Ming; Su, Ih-Jen; Liu, Ching-Chuan

2013-07-01

Enterovirus 71-induced brainstem encephalitis with pulmonary edema and/or neurogenic shock (stage 3B) is associated with rapid mortality in children. In a small pilot study, we found that milrinone reduced early mortality compared with historical controls. This prospective, randomized control trial was designed to provide more definitive evidence of the ability of milrinone to reduce the 1-week mortality of stage 3B enterovirus 71 infections. Prospective, unicenter, open-label, randomized, controlled study. Inpatient ward of a large tertiary teaching hospital in Ho Chi Minh City, Vietnam. Children (≤ 18 yr old) admitted with proven enterovirus 71-induced pulmonary edema and/or neurogenic shock. Patients were randomly assigned to receive intravenous milrinone (0.5 μg/kg/min) (n = 22) or conventional management (n = 19). Both groups received dopamine or dobutamine and intravenous immunoglobulin. The primary endpoint was 1-week mortality. The secondary endpoints included length of ventilator dependence and hospital stay and adverse events. The median age was 2 years with a predominance of boys in both groups. The 1-week mortality was significantly lower, 18.2% (4/22) in the milrinone compared with 57.9% (11/19) in the conventional management group (relative risk = 0.314 [95% CI, 0.12-0.83], p = 0.01). The median duration of ventilator-free days was longer in the milrinone treatment group (p = 0.01). There was no apparent neurologic sequela in the survivors in either group, and no drug-related adverse events were documented. Milrinone significantly reduced the 1-week mortality of enterovirus 71-induced pulmonary edema and/or neurogenic shock without adverse effects. Further studies are needed to determine whether milrinone might be useful to prevent progression of earlier stages of brainstem encephalitis.

Hemodialysis Self-management Intervention Randomized Trial (HED-SMART): A Practical Low-Intensity Intervention to Improve Adherence and Clinical Markers in Patients Receiving Hemodialysis.

PubMed

Griva, Konstadina; Nandakumar, Mooppil; Ng, Jo-An H; Lam, Kevin F Y; McBain, Hayley; Newman, Stanton P

2018-03-01

Poor adherence to treatment is common in hemodialysis patients. However, effective interventions for adherence in this population are lacking. Small studies of behavioral interventions have yielded improvements, but clinical effectiveness and long-term effects are unclear. Multicenter parallel (1:1) design, blinded cluster-randomized controlled trial. Patients undergoing maintenance hemodialysis enrolled in 14 dialysis centers. Dialysis shifts of eligible patients were randomly assigned to either an interactive and targeted self-management training program (HED-SMART; intervention; n=134) or usual care (control; n=101). HED-SMART, developed using the principles of problem solving and social learning theory, was delivered in a group format by health care professionals over 4 sessions. Serum potassium and phosphate concentrations, interdialytic weight gains (IDWGs), self-reported adherence, and self-management skills at 1 week, 3 months, and 9 months postintervention. 235 participants were enrolled in the study (response rate, 44.2%), and 82.1% completed the protocol. IDWG was significantly lowered across all 3 assessments relative to baseline (P<0.001) among patients randomly assigned to HED-SMART. In contrast, IDWG in controls showed no change except at 3 months, when it worsened significantly. Improvements in mineral markers were noted in the HED-SMART arm at 3 months (P<0.001) and in potassium concentrations (P<0.001) at 9 months. Phosphate concentrations improved in HED-SMART at 3 months (P=0.03), but these effects were not maintained at 9 months postintervention. Significant differences between the arms were found for the secondary outcomes of self-reported adherence, self-management skills, and self-efficacy at all time points. Low proportion of patients with diabetes. HED-SMART provides an effective and practical model for improving health in hemodialysis patients. The observed improvements in clinical markers and self-report adherence, if maintained at the longer follow-up, could significantly reduce end-stage renal disease-related complications. Given the feasibility of this kind of program, it has strong potential for supplementing usual care. Registered at ISRCTN with study number ISRCTN31434033. Copyright © 2017 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Protocol of an ongoing randomized controlled trial of care management for comorbid depression and hypertension: the Chinese Older Adult Collaborations in Health (COACH) study.

PubMed

Chen, Shulin; Conwell, Yeates; Xue, Jiang; Li, Lydia W; Tang, Wan; Bogner, Hillary R; Dong, Hengjin

2018-05-29

Depression and hypertension are common, costly, and destructive conditions among the rapidly aging population of China. The two disorders commonly coexist and are poorly recognized and inadequately treated, especially in rural areas. The Chinese Older Adult Collaborations in Health (COACH) Study is a cluster randomized controlled trial (RCT) designed to test the hypotheses that the COACH intervention, designed to manage comorbid depression and hypertension in older adult, rural Chinese primary care patients, will result in better treatment adherence and greater improvement in depressive symptoms and blood pressure control, and better quality of life, than enhanced Care-as-Usual (eCAU). Based on chronic disease management and collaborative care principles, the COACH model integrates the care provided by the older person's primary care provider (PCP) with that delivered by an Aging Worker (AW) from the village's Aging Association, supervised by a psychiatrist consultant. One hundred sixty villages, each of which is served by one PCP, will be randomly selected from two counties in Zhejiang Province and assigned to deliver eCAU or the COACH intervention. Approximately 2400 older adult residents from the selected villages who have both clinically significant depressive symptoms and a diagnosis of hypertension will be recruited into the study, randomized by the villages in which they live and receive primary care. After giving informed consent, they will undergo a baseline research evaluation; receive treatment for 12 months with the approach to which their village was assigned; and be re-evaluated at 3, 6, 9, and 12 months after entry. Depression and HTN control are the primary outcomes. Treatment received, health care utilization, and cost data will be obtained from the subjects' electronic medical records (EMR) and used to assess adherence to care recommendations and, in a preliminary manner, to establish cost and cost effectiveness of the intervention. The COACH intervention is designed to serve as a model for primary care-based management of common mental disorders that occur in tandem with common chronic conditions of later life. It leverages existing resources in rural settings, integrates social interventions with the medical model, and is consistent with the cultural context of rural life. ClinicalTrials.gov ID: NCT01938963 ; First posted: September 10, 2013.

Testing the feasibility of a knowledge translation intervention designed to improve chiropractic care for adults with neck pain disorders: study protocol for a pilot cluster-randomized controlled trial.

PubMed

Dhopte, Prakash; Ahmed, Sara; Mayo, Nancy; French, Simon; Quon, Jeffrey A; Bussières, André

2016-01-01

Neck pain in adults is common and a leading cause of physical disability. Recently, a guideline was developed for the management of non-specific neck pain (NSNP) with an aim to improve the quality of the delivery of chiropractic care. One key guideline recommendation is to undertake multimodal care for patients with NSNP. The aim of this pilot study is to determine the feasibility of implementing a multifaceted knowledge translation intervention by promoting the use of multimodal care by chiropractors managing patients with NSNP. The design is a cluster-randomized controlled pilot and feasibility trial. Chiropractors in private practice in Canada will be approached to participate in the study. Thirty consenting chiropractors will be randomized to receive either a theory-based educational intervention in the experimental group or simply a printed copy of the guideline in the control group. Each chiropractor will recruit five neck pain patients (a total of 150 patients) into the study. Development of the multifaceted intervention was informed by the results of a related qualitative study based on the Theoretical Domains Framework and consists of a series of three webinars, two online case scenarios, a self-management video on Brief Action Planning, and a printed copy of the practice guideline. Primary feasibility outcomes for both chiropractors and patients include rates of (1) recruitment, (2) retention, and (3) adherence to the intervention. A checklist of proxy measures embedded within patient encounter forms will be used to assess chiropractors' compliance with guideline recommendations (e.g. exercise and self-care prescriptions) at study onset and at 3 months. Secondary outcomes include scores of behavioural constructs (level of knowledge and self-efficacy) for recommended multimodal care. Clinical outcomes include pain intensity and neck pain-specific disability. Analyses from this study will focus on generating point estimates and corresponding 95 % confidence intervals for parameters of a priori interest (recruitment, retention, adherence, pain intensity, Neck Disability Index). Results of this study will inform the design of a larger cluster-randomized controlled trial aimed at evaluating the effectiveness of the theory-based tailored intervention and increasing the use of multimodal care by chiropractors managing patients with NSNP. https://clinicaltrials.gov/, NCT02483091.

Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain.

PubMed

Khadilkar, A; Milne, S; Brosseau, L; Robinson, V; Saginur, M; Shea, B; Tugwell, P; Wells, G

2005-07-20

Chronic low-back pain (LBP) affects a significant proportion of the population. Transcutaneous electrical nerve stimulation (TENS) was introduced more than 30 years ago as an adjunct to the pharmacological management of pain. However, despite its widespread use, the usefulness of TENS in chronic LBP is still controversial. The aim of this systematic review was to determine the effectiveness of TENS in the management of chronic LBP. We searched the Cochrane Central Register of Controlled Trials (Issue 2, 2005), MEDLINE, EMBASE and PEDro up to April 1, 2005. Only randomized controlled clinical trials (RCTs) evaluating the effect of TENS on chronic LBP were included. Abstracts were excluded unless further data could be obtained from the authors. Two reviewers independently selected trials and extracted data using predetermined forms. Heterogeneity was tested with Cochrane's Q test. A fixed effect model was used throughout for calculating continuous variables, except where heterogeneity existed, in which case, a random effects model was used. Results are presented as weighted mean differences (WMD) with 95% confidence intervals (95% CI), where the difference between the treated and control groups was weighted by the inverse of the variance. Standardized mean differences (SMD) were calculated by dividing the difference between the treated and control by the baseline variance. SMD were used when different scales were used to measure the same concept. Dichotomous outcomes were analyzed with odds ratios. The only two RCTs (175 patients) meeting eligibility criteria differed in study design, methodological quality, inclusion and exclusion criteria, type and method of TENS application, treatment schedule, co-interventions and final outcomes. In one RCT, TENS produced significantly greater pain relief than the placebo control. However, in the other RCT, no statistically significant differences between treatment and control groups were shown for multiple outcome measures. Pre-planned subgroup analyses, intended to examine the impact of different stimulation parameters, sites of TENS application, treatment durations and baseline patient characteristics were not possible due to the small number of included trials. There is inconsistent evidence to support the use of TENS as a single treatment in the management of chronic LBP. Larger, multi-center, randomized controlled trials are needed to better assess the true effectiveness of TENS. Special attention should be given to the risks and benefits of long-term use, which more appropriately addresses the realities of managing chronic low-back pain.

Urban-Rural Differences in the Effect of a Medicare Health Promotion and Disease Self-Management Program on Physical Function and Health Care Expenditures

ERIC Educational Resources Information Center

Meng, Hongdao; Wamsley, Brenda; Liebel, Diane; Dixon, Denise; Eggert, Gerald; Van Nostrand, Joan

2009-01-01

Purpose: To evaluate the impact of a multicomponent health promotion and disease self-management intervention on physical function and health care expenditures among Medicare beneficiaries. To determine if these outcomes vary by urban or rural residence. Design and Methods: We analyzed data from a 22-month randomized controlled trial of a health…

Effects of a Brief Mindfulness-Based Intervention Program for Stress Management among Medical Students: The Mindful-Gym Randomized Controlled Study

ERIC Educational Resources Information Center

Phang, Cheng Kar; Mukhtar, Firdaus; Ibrahim, Normala; Keng, Shian-Ling; Sidik, Sherina Mohd.

2015-01-01

Pursuing undergraduate medical training can be very stressful and academically challenging experience. A 5-week mindfulness-based stress management (MBSM/Mindful-Gym) program was developed to help medical students cope with stress. The aim of this study was to evaluate the effectiveness of the intervention in reducing stress among students in a…

"Learn Young, Learn Fair", a Stress Management Program for Fifth and Sixth Graders: Longitudinal Results from an Experimental Study

ERIC Educational Resources Information Center

Kraag, Gerda; Van Breukelen, Gerard J. P.; Kok, Gerjo; Hosman, Clemens

2009-01-01

Background: This study examined the effects of a universal stress management program (Learn Young, Learn Fair) on stress, coping, anxiety and depression in fifth and sixth grade children. Methods: Fifty-two schools (1467 children) participated in a clustered randomized controlled trial. Data was collected in the fall of 2002, the spring of 2003,…

A Novel Mobile App and Population Management System to Manage Rheumatoid Arthritis Flares: Protocol for a Randomized Controlled Trial

PubMed Central

Wang, Penny; Luo, Dee; Lu, Fengxin; Elias, Josephine S; Landman, Adam B; Michaud, Kaleb D

2018-01-01

Background Rheumatoid arthritis flares have a profound effect on patients, causing pain and disability. However, flares often occur between regularly scheduled health care provider visits and are, therefore, difficult to monitor and manage. We sought to develop a mobile phone app combined with a population management system to help track RA flares between visits. Objective The objective of this study is to implement the mobile app plus the population management system to monitor rheumatoid arthritis disease activity between scheduled health care provider visits over a period of 6 months. Methods This is a randomized controlled trial that lasts for 6 months for each participant. We aim to recruit 190 patients, randomized 50:50 to the intervention group versus the control group. The intervention group will be assigned the mobile app and be prompted to answer daily questionnaires sent to their mobile devices. Both groups will be assigned a population manager, who will communicate with the participants via telephone at 6 weeks and 18 weeks. The population manager will also communicate with the participants in the intervention group if their responses indicate a sustained increase in rheumatoid arthritis disease activity. To assess patient satisfaction, the primary outcomes will be scores on the Treatment Satisfaction Questionnaire for Medication as well as the Perceived Efficacy in Patient-Physician Interactions questionnaire at 6 months. To determine the effect of the mobile app on rheumatoid arthritis disease activity, the primary outcome will be the Clinical Disease Activity Index at 6 months. Results The trial started in November 2016, and an estimated 2.5 years will be necessary to complete the study. Study results are expected to be published by the end of 2019. Conclusions The completion of this study will provide important data regarding the following: (1) the assessment of validated outcome measures to assess rheumatoid arthritis disease activity with a mobile app between routinely scheduled health care provider visits, (2) patient engagement in monitoring their condition, and (3) communication between patients and health care providers through the population management system. Trial Registration ClinicalTrials.gov NCT02822521, http://clinicaltrials.gov/ct2/show/NCT02822521 (Archived by WebCite at http://www.webcitation.org/6xed3kGPd) PMID:29643053

Cluster randomized controlled trial of a peer support program for people with diabetes: study protocol for the Australasian peers for progress study

PubMed Central

2012-01-01

Background Well managed diabetes requires active self-management in order to ensure optimal glycaemic control and appropriate use of available clinical services and other supports. Peer supporters can assist people with their daily diabetes self-management activities, provide emotional and social support, assist and encourage clinical care and be available when needed. Methods A national database of Australians diagnosed with type 2 diabetes is being used to invite people in pre-determined locations to participate in community-based peer support groups. Peer supporters are self-identified from these communities. All consenting participants receive diabetes self-management education and education manual prior to randomization by community to a peer support intervention or usual care. This multi-faceted intervention comprises four interconnected components for delivering support to the participants. (1) Trained supporters lead 12 monthly group meetings. Participants are assisted to set goals to improve diabetes self-management, discuss with and encourage each other to strengthen linkages with local clinical services (including allied health services) as well as provide social and emotional support. (2) Support through regular supporter-participant or participant-participant contact, between monthly sessions, is also promoted in order to maintain motivation and encourage self-improvement and confidence in diabetes self-management. (3) Participants receive a workbook containing diabetes information, resources and community support services, key diabetes management behaviors and monthly goal setting activity sheets. (4) Finally, a password protected website contains further resources for the participants. Supporters are mentored and assisted throughout the intervention by other supporters and the research team through attendance at a weekly teleconference. Data, including a self-administered lifestyle survey, anthropometric and biomedical measures are collected on all participants at baseline, 6 and 12 months. The primary outcome is change in cardiovascular disease risk using the UKPDS risk equation. Secondary outcomes include biomedical, quality of life, psychosocial functioning, and other lifestyle measures. An economic evaluation will determine whether the program is cost effective. Discussion This manuscript presents the protocol for a cluster randomized controlled trial of group-based peer support for people with type 2 diabetes in a community setting. Results from this trial will contribute evidence about the effectiveness of peer support in achieving effective self-management of diabetes. Trial registration number Australian New Zealand Clinical Trials Registry (ANZCTR); ACTRN12609000469213 PMID:23035666

Mobile Device-Based Electronic Data Capture System Used in a Clinical Randomized Controlled Trial: Advantages and Challenges.

PubMed

Zhang, Jing; Sun, Lei; Liu, Yu; Wang, Hongyi; Sun, Ningling; Zhang, Puhong

2017-03-08

Electronic data capture (EDC) systems have been widely used in clinical research, but mobile device-based electronic data capture (mEDC) system has not been well evaluated. The aim of our study was to evaluate the feasibility, advantages, and challenges of mEDC in data collection, project management, and telemonitoring in a randomized controlled trial (RCT). We developed an mEDC to support an RCT called "Telmisartan and Hydrochlorothiazide Antihypertensive Treatment (THAT)" study, which was a multicenter, double-blinded, RCT, with the purpose of comparing the efficacy of telmisartan and hydrochlorothiazide (HCTZ) monotherapy in high-sodium-intake patients with mild to moderate hypertension during a 60 days follow-up. Semistructured interviews were conducted during and after the trial to evaluate the feasibility, advantage, and challenge of mEDC. Nvivo version 9.0 (QSR International) was used to analyze records of interviews, and a thematic framework method was used to obtain outcomes. The mEDC was successfully used to support the data collection and project management in all the 14 study hospitals. A total of 1333 patients were recruited with support of mEDC, of whom 1037 successfully completed all 4 visits. Across all visits, the average time needed for 141 questions per patient was 53 min, which were acceptable to both doctors and patients. All the interviewees, including 24 doctors, 53 patients, 1 clinical research associate (CRA), 1 project manager (PM), and 1 data manager (DM), expressed their satisfaction to nearly all the functions of the innovative mEDC in randomization, data collection, project management, quality control, and remote monitoring in real time. The average satisfaction score was 9.2 (scale, 0-10). The biggest challenge came from the stability of the mobile or Wi-Fi signal although it was not a problem in THAT study. The innovative mEDC has many merits and is well acceptable in supporting data collection and project management in a timely manner in clinical trial. ©Jing Zhang, Lei Sun, Yu Liu, Hongyi Wang, Ningling Sun, Puhong Zhang. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 08.03.2017.

Massage Therapy for Pain and Function in Patients With Arthritis: A Systematic Review of Randomized Controlled Trials.

PubMed

Nelson, Nicole L; Churilla, James R

2017-09-01

Massage therapy is gaining interest as a therapeutic approach to managing osteoarthritis and rheumatoid arthritis symptoms. To date, there have been no systematic reviews investigating the effects of massage therapy on these conditions. Systematic review was used. The primary aim of this review was to critically appraise and synthesize the current evidence regarding the effects of massage therapy as a stand-alone treatment on pain and functional outcomes among those with osteoarthritis or rheumatoid arthritis. Relevant randomized controlled trials were searched using the electronic databases Google Scholar, MEDLINE, and PEDro. The PEDro scale was used to assess risk of bias, and the quality of evidence was assessed with the GRADE approach. This review found seven randomized controlled trials representing 352 participants who satisfied the inclusion criteria. Risk of bias ranged from four to seven. Our results found low- to moderate-quality evidence that massage therapy is superior to nonactive therapies in reducing pain and improving certain functional outcomes. It is unclear whether massage therapy is more effective than other forms of treatment. There is a need for large, methodologically rigorous randomized controlled trials investigating the effectiveness of massage therapy as an intervention for individuals with arthritis.

Components of effective randomized controlled trials of hydrotherapy programs for fibromyalgia syndrome: A systematic review.

PubMed

Perraton, Luke; Machotka, Zuzana; Kumar, Saravana

2009-11-30

Previous systematic reviews have found hydrotherapy to be an effective management strategy for fibromyalgia syndrome (FMS). The aim of this systematic review was to summarize the components of hydrotherapy programs used in randomized controlled trials. A systematic review of randomized controlled trials was conducted. Only trials that have reported significant FMS-related outcomes were included. Data relating to the components of hydrotherapy programs (exercise type, duration, frequency and intensity, environmental factors, and service delivery) were analyzed. Eleven randomized controlled trials were included in this review. Overall, the quality of trials was good. Aerobic exercise featured in all 11 trials and the majority of hydrotherapy programs included either a strengthening or flexibility component. Great variability was noted in both the environmental components of hydrotherapy programs and service delivery. Aerobic exercise, warm up and cool-down periods and relaxation exercises are common features of hydrotherapy programs that report significant FMS-related outcomes. Treatment duration of 60 minutes, frequency of three sessions per week and an intensity equivalent to 60%-80% maximum heart rate were the most commonly reported exercise components. Exercise appears to be the most important component of an effective hydrotherapy program for FMS, particularly when considering mental health-related outcomes.

A self-management intervention for African Americans with comorbid diabetes and hypertension: a pilot randomized controlled trial.

PubMed

Lynch, Elizabeth B; Liebman, Rebecca; Ventrelle, Jennifer; Avery, Elizabeth F; Richardson, DeJuran

2014-05-29

The objective of this pilot 6-month randomized controlled trial was to determine the effectiveness of an intensive, community-based, group intervention that focused on diet, physical activity, and peer support for reducing weight among urban-dwelling African Americans with comorbid type 2 diabetes and hypertension. Sixty-one participants were randomized into an intervention or control group. The 6-month intervention consisted of 18 group sessions led by a dietitian in a community setting and weekly telephone calls from a peer supporter. The intervention featured culturally tailored nutrition education, behavioral skills training, and social support focused on changes to diet and physical activity. The control group consisted of two 3-hour group sessions of diabetes self-management education taught by a community health worker. Outcome measures were assessed at baseline and 6 months. The primary outcome was achievement of a 5% weight reduction at 6 months. A secondary outcome was achievement of a 0.5 percentage-point reduction in hemoglobin A1c (HbA1c). Groups did not differ in achievement of the weight-loss goal. Intervention participants lost a mean of 2.8 kg (P = .01); control participants did not lose a significant amount of weight. A greater proportion of intervention (50.0%) than control (21.4%) participants reduced HbA1c by 0.5 percentage points or more at 6 months (P = .03). The intervention was more effective than usual care (short-term diabetes education) at improving glycemic control, but not weight, in low-income African Americans with comorbid diabetes and hypertension. A community-based 6-month group class with culturally tailored education, behavioral skills training, and peer support can lead to a clinically significant reduction in HbA1c.

Can Telemedicine Improve Adherence to Resuscitation Guidelines for Critically Ill Children at Community Hospitals? A Randomized Controlled Trial Using High-Fidelity Simulation.

PubMed

Yang, Chris P; Hunt, Elizabeth A; Shilkofski, Nicole; Dudas, Robert; Egbuta, Chinyere; Schwartz, Jamie M

2017-07-01

Children transferred from community hospitals lacking specialized pediatric care are more seriously ill than those presenting to pediatric centers. Pediatric consultation and adherence to management guidelines improve outcomes. The aims of the study were (1) to assess whether telemedicine consultation in critical situations is feasible and (2) to compare the impact of pediatric critical care medicine (PCCM) consultation via telemedicine versus telephone on community hospital adherence to resuscitation guidelines through a randomized controlled telemedicine trial. In situ, high-fidelity simulation scenarios of critically ill children presenting to a community hospital and progressing to cardiopulmonary arrest were performed. Scenarios were randomized to PCCM consultation via telephone (control) or telemedicine (intervention). Primary outcome measure was proportion of teams who successfully defibrillated in 180 seconds or less from presentation of pulseless ventricular tachycardia. The following 30 scenarios were completed: 15 control and 15 intervention. Only 11 (37%) of 30 teams, defibrillated in 180 seconds or less from presentation of pulseless ventricular tachycardia; control: 6 (40%) of 15 versus intervention: 5 (33%) of 15, P = 0.7. Request for or use of backboard during cardiopulmonary resuscitation occurred in 24 (80%) of 30 scenarios; control: 9 (60%) of 15 versus intervention: 15 (100%) of 15, P = 0.006. Request for or use of stepstool during cardiopulmonary resuscitation occurred in 6 (20%) of 30 scenarios; control: 1 (7%) of 15 versus intervention: 5 (33%) of 15, P = 0.07. This study demonstrates the feasibility of using telemedicine to support acute management of children who present to community hospitals. Neither study arm adhered to current resuscitation guidelines and telemedicine consultation with PCCM experts was not associated with improvement. However, further research on optimizing telemedicine impact on the quality of pediatric care at community hospitals is warranted.

Disease management produces limited quality-of-life improvements in patients with congestive heart failure: evidence from a randomized trial in community-dwelling patients.

PubMed

Smith, Brad; Forkner, Emma; Zaslow, Barbara; Krasuski, Richard A; Stajduhar, Karl; Kwan, Michael; Ellis, Robert; Galbreath, Autumn Dawn; Freeman, Gregory L

2005-11-01

Disease management programs are reported to improve clinical and quality-of-life outcomes while simultaneously lowering healthcare costs. To examine the effectiveness of disease management in improving health-related quality of life (HRQL) among patients with heart failure beyond 12 months. A total of 1069 community-dwelling patients 18 years and older in South Texas with echocardiographic evidence of congestive heart failure were randomly assigned to disease management, augmented disease management, and control groups. They were followed up 18 months. Patients in the control group received usual care. Patients in the intervention groups were assigned a registered nurse as a disease manager who performed telephonic patient education and medication management. Health-related quality-of-life data (based on the Medical Outcomes Study 36-Item Short-Form Health Survey [SF-36]) were collected 4 times, at 6-month intervals. Disease management has a limited effect on HRQL. Analysis of the SF-36 health transition measure showed a positive effect of the intervention on self-reported improvement in health at 6 months and at 12 months (P = .04 and P = .004, respectively). However, no effect of disease management was observed across any of the SF-36 components. Women and patients with diastolic heart failure had poorer HRQL scores. Participation in disease management has little effect on HRQL outcomes in congestive heart failure. Beneficial effects on the SF-36 scale scores seen at 6 and 12 months were not sustained. Therefore, it is unclear whether disease management can provide long-term improvement in HRQL for patients with congestive heart failure.

Case Management in Primary Care for Frequent Users of Health Care Services: A Mixed Methods Study.

PubMed

Hudon, Catherine; Chouinard, Maud-Christine; Dubois, Marie-France; Roberge, Pasquale; Loignon, Christine; Tchouaket, Éric; Lambert, Mireille; Hudon, Émilie; Diadiou, Fatoumata; Bouliane, Danielle

2018-05-01

This study aimed to evaluate the effects of the V1SAGES case management intervention (Vulnerable Patients in Primary Care: Nurse Case Management and Self-management Support) for frequent users of health care services with chronic disease and complex care needs on psychological distress and patient activation. We used a 2-phase sequential mixed methods design. The first phase was a pragmatic randomized controlled trial with intention-to-treat analysis that measured the effects of the intervention compared with usual care on psychological distress and patient activation before and after 6 months. The second phase had a qualitative descriptive design and entailed thematic analysis of in-depth interviews (25 patients, 6 case management nurses, 9 health managers) and focus groups (8 patients' spouses, 21 family physicians) to understand stakeholders' perceived effects of the intervention on patients. A total of 247 patients were randomized into the intervention group (n = 126) or the control group (n = 121). Compared with usual care, the intervention reduced psychological distress (odds ratio = 0.43; 95% CI, 0.19-0.95, P = .04), but did not have any significant effect on patient activation ( P = .43). Qualitative results suggested that patients and their spouses benefitted from the case management intervention, gaining a sense of security, and stakeholders noted better patient self-management of health. Together, our study's quantitative and qualitative results suggest that case management reduces psychological distress, making patients and caregivers feel more secure, whereas impact on self-management is unclear. Case management is a promising avenue to improve outcomes among frequent users of health care with complex needs. © 2018 Annals of Family Medicine, Inc.

Does teaching crisis resource management skills improve resuscitation performance in pediatric residents?*.

PubMed

Blackwood, Jaime; Duff, Jonathan P; Nettel-Aguirre, Alberto; Djogovic, Dennis; Joynt, Chloe

2014-05-01

The effect of teaching crisis resource management skills on the resuscitation performance of pediatric residents is unknown. The primary objective of this pilot study was to determine if teaching crisis resource management to residents leads to improved clinical and crisis resource management performance in simulated pediatric resuscitation scenarios. A prospective, randomized control pilot study. Simulation facility at tertiary pediatric hospital. Junior pediatric residents. Junior pediatric residents were randomized to 1 hour of crisis resource management instruction or no additional training. Time to predetermined resuscitation tasks was noted in simulated resuscitation scenarios immediately after intervention and again 3 months post intervention. Crisis resource management skills were evaluated using the Ottawa Global Rating Scale. Fifteen junior residents participated in the study, of which seven in the intervention group. The intervention crisis resource management group placed monitor leads 24.6 seconds earlier (p = 0.02), placed an IV 47.1 seconds sooner (p = 0.04), called for help 50.4 seconds faster (p = 0.03), and checked for a pulse after noticing a rhythm change 84.9 seconds quicker (p = 0.01). There was no statistically significant difference in time to initiation of cardiopulmonary resuscitation (p = 0.264). The intervention group had overall crisis resource management performance scores 1.15 points higher (Ottawa Global Rating Scale [out of 7]) (p = 0.02). Three months later, these differences between the groups persisted. A 1-hour crisis resource management teaching session improved time to critical initial steps of pediatric resuscitation and crisis resource management performance as measured by the Ottawa Global Rating Scale. The control group did not develop these crisis resource management skills over 3 months of standard training indicating that obtaining these skills requires specific education. Larger studies of crisis resource education are required.

Delivery strategies to optimize resource utilization and performance status for patients with advanced life-limiting illness: results from the "palliative care trial" [ISRCTN 81117481].

PubMed

Abernethy, Amy P; Currow, David C; Shelby-James, Tania; Rowett, Debra; May, Frank; Samsa, Gregory P; Hunt, Roger; Williams, Helena; Esterman, Adrian; Phillips, Paddy A

2013-03-01

Evidence-based approaches are needed to improve the delivery of specialized palliative care. The aim of this trial was to improve on current models of service provision. This 2×2×2 factorial cluster randomized controlled trial was conducted at an Australian community-based palliative care service, allowing three simultaneous comparative effectiveness studies. Participating patients were newly referred adults, experiencing pain, and who were expected to live >48 hours. Patients enrolled with their general practitioners (GPs) and were randomized three times: 1) individualized interdisciplinary case conference including their GP vs. control, 2) educational outreach visiting for GPs about pain management vs. control, and 3) structured educational visiting for patients/caregivers about pain management vs. control. The control condition was current palliative care. Outcomes included Australia-modified Karnofsky Performance Status (AKPS) and pain from 60 days after randomization and hospitalizations. There were 461 participants: mean age 71 years, 50% male, 91% with cancer, median survival 179 days, and median baseline AKPS 60. Only 47% of individuals randomized to the case conferencing intervention received it; based on a priori-defined analyses, 32% of participants were included in final analyses. Case conferencing reduced hospitalizations by 26% (least squares means hospitalizations per patient: case conference 1.26 [SE 0.10] vs. control 1.70 [SE 0.13], P=0.0069) and better maintained performance status (AKPS case conferences 57.3 [SE 1.5] vs. control 51.7 [SE 2.3], P=0.0368). Among patients with declining function (AKPS <70), case conferencing and patient/caregiver education better maintained performance status (AKPS case conferences 55.0 [SE 2.1] vs. control 46.5 [SE 2.9], P=0.0143; patient/caregiver education 54.7 [SE 2.8] vs. control 46.8 [SE 2.1], P=0.0206). Pain was unchanged. GP education did not change outcomes. A single case conference added to current specialized community-based palliative care reduced hospitalizations and better maintained performance status. Comparatively, patient/caregiver education was less effective; GP education was not effective. Copyright © 2013 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.

Effects of self-management intervention on health outcomes of patients with heart failure: a systematic review of randomized controlled trials

PubMed Central

Jovicic, Aleksandra; Holroyd-Leduc, Jayna M; Straus, Sharon E

2006-01-01

Background Heart failure is the most common cause of hospitalization among adults over 65. Over 60% of patients die within 10 years of first onset of symptoms. The objective of this study is to determine the effectiveness of self-management interventions on hospital readmission rates, mortality, and health-related quality of life in patients diagnosed with heart failure. Methods The study is a systematic review of randomized controlled trials. The following data sources were used: MEDLINE (1966-11/2005), EMBASE (1980-11/2005), CINAHL (1982-11/2005), the ACP Journal Club database (to 11/2005), the Cochrane Central Trial Registry and the Cochrane Database of Systematic Reviews (to 11/2005); article reference lists; and experts in the field. We included randomized controlled trials of self-management interventions that enrolled patients 18 years of age or older who were diagnosed with heart failure. The primary outcomes of interest were all-cause hospital readmissions, hospital readmissions due to heart failure, and mortality. Secondary outcomes were compliance with treatment and quality of life scores. Three reviewers independently assessed the quality of each study and abstracted the results. For each included study, we computed the pooled odds ratios (OR) for all-cause hospital readmission, hospital readmission due to heart failure, and death. We used a fixed effects model to quantitatively synthesize results. We were not able to pool effects on health-related quality of life and measures of compliance with treatment, but we summarized the findings from the relevant studies. We also summarized the reported cost savings. Results From 671 citations that were identified, 6 randomized trials with 857 patients were included in the review. Self-management decreased all-cause hospital readmissions (OR 0.59; 95% confidence interval (CI) 0.44 to 0.80, P = 0.001) and heart failure readmissions (OR 0.44; 95% CI 0.27 to 0.71, P = 0.001). The effect on mortality was not significant (OR = 0.93; 95% CI 0.57 to 1.51, P = 0.76). Adherence to prescribed medical advice improved, but there was no significant difference in functional capabilities, symptom status and quality of life. The reported savings ranged from $1300 to $7515 per patient per year. Conclusion Self-management programs targeted for patients with heart failure decrease overall hospital readmissions and readmissions for heart failure. PMID:17081306

Effect of goal attainment theory based education program on cardiovascular risks, behavioral modification, and quality of life among patients with first episode of acute myocardial infarction: Randomized study.

PubMed

Park, Moonkyoung; Song, Rhayun; Jeong, Jin-Ok

2017-06-01

Effect of goal-attainment-theory-based education program on cardiovascular risks, behavioral modification, and quality of life among patients with first episode of acute myocardial infarction: randomized study BACKGROUND: The behavioral modification strategies should be explored at the time of admission to lead the maximum effect of cardiovascular risk management. This randomized study aimed to elucidate the effects of a nurse-led theory-based education program in individuals with a first episode of acute myocardial infarction on cardiovascular risks, health behaviors, and quality of life over 6 months. The study involved a convenience sample of 64 patients with acute myocardial infarction who were randomly assigned to either the education group or the control group. The goal-attainment-based education program was designed to set the mutually agreed goals of risk management and the behavioral modification strategies for achieving those goals. Those in the control group received routine management only. The participants in both groups were contacted at 6-8 weeks and at 6 months after discharge to measure outcome variables. Repeated measure ANOVA was conducted using SPSSWIN (version 20.0) to determine the significance of differences in outcome variables over 6 months between the groups. Both groups showed significant positive changes in cardiovascular risks, health behaviors, and quality of life over 6 months. The 2-year risk of cardiovascular disease was significantly reduced in both study groups, but with no significant interaction effect (F=2.01, p=0.142). The performance and maintenance of health behaviors (F=3.75, p=0.029) and the mental component of quality of life (F=4.03, p=0.020) were significantly better in the education group than the control group. Applying a goal-oriented education program at an early stage of hospital management improved and maintained blood glucose, health behaviors, and mental component of the quality of life up to six months in individuals with a first episode of myocardial infarction. Further studies are warranted to explore the role of behavioral modification mediating between cardiovascular risk management and quality of life in this population. Copyright © 2017 Elsevier Ltd. All rights reserved.

A novel behavioral intervention in adolescents with type 1 diabetes mellitus improves glycemic control: preliminary results from a pilot randomized control trial.

PubMed

Maranda, Louise; Lau, May; Stewart, Sunita M; Gupta, Olga T

2015-04-01

The purpose of this study was to develop and pilot-test an innovative behavioral intervention in adolescents with type 1 diabetes mellitus (T1DM) incorporating structured care of a pet to improve glycemic control. Twenty-eight adolescents with A1C > 8.5% (69 mmol/mol) were randomly assigned to either the intervention group (care of a Betta splendens pet fish) or the control group (usual care). Adolescents in the intervention group were given instructions to associate daily and weekly fish care duties with diabetes self-management tasks, including blood glucose testing and parent-adolescent communication. After 3 months, the participants in the intervention group exhibited a statistically significant decrease in A1C level (-0.5%) compared with their peers in the control group, who had an increase in A1C level (0.8%) (P = .04). The younger adolescents (10-13 years of age) demonstrated a greater response to the intervention, which was statistically significant (-1.5% vs 0.6%, P = .04), compared with the older adolescents (14-17 years of age). Structured care of a pet fish can improve glycemic control in adolescents with T1DM, likely by providing cues to perform diabetes self-management behaviors. © 2015 The Author(s).

A Prospective Randomized Controlled Trial of Nonpharmacological Pain Management During Intravenous Cannulation in a Pediatric Emergency Department.

PubMed

Miller, Kate; Tan, Xianghong; Hobson, Andrew Dillon; Khan, Asaduzzaman; Ziviani, Jenny; OʼBrien, Eavan; Barua, Kim; McBride, Craig A; Kimble, Roy M

2016-07-01

Intravenous (IV) cannulation is commonly performed in pediatric emergency departments (EDs). The busy ED environment is often not conducive to conventional nonpharmacological pain management. This study assessed the use of Ditto (Diversionary Therapy Technologies, Brisbane, Australia), a handheld electronic device which provides procedural preparation and distraction, as a means of managing pain and distress during IV cannulation performed in the pediatric ED. A randomized controlled trial with 98 participants, aged 3 to 12 years, was conducted in a pediatric ED. Participants were recruited and randomized into 5 intervention groups as follows: (1) Standard Distraction, (2) PlayStation Portable Distraction, (3) Ditto Distraction, (4) Ditto Procedural Preparation, and (5) Ditto Preparation and Distraction. Children's pain and distress levels were assessed via self-reports and observational reports by caregivers and nursing staff across the following 3 time points: (1) before, (2) during, and (3) after IV cannulation. Caregivers and nursing staff reported significantly reduced pain and distress levels in children accessing the combined preparation and distraction Ditto protocol, as compared to standard distraction (P ≤ 0.01). This intervention also saw the greatest reduction in pain and distress as reported by the child. Caregiver reports indicate that using the combined Ditto protocol was most effective in reducing children's pain experiences while undergoing IV cannulation in the ED. The use of Ditto offers a promising opportunity to negotiate barriers to the provision of nonpharmacological approaches encountered in the busy ED environment, and provide nonpharmacological pain-management interventions in pediatric EDs.

Epidemiological evaluation quality of life in patients suffering from early rheumatoid arthritis: a pragmatic, prospective, randomized, blind allocation controlled of a modular program group intervention

PubMed Central

2015-01-01

OBJECTIVES: Epidemiology has taken on new roles in the management of health care services. In this study, we developed a non-pharmacological self-management modular program group intervention and evaluated its efficacy as an adjunct therapy in patients suffering from early rheumatoid arthritis (RA). METHODS: Patients were randomized to either participate in a non-equivalent intervention group along with the standard of care or only receive standard-of-care treatment at a community rheumatology center. The outcomes measured were a pain visual analog scale (VAS), patient general health (GH) on a VAS, and the Short Form 36 Health Survey version 2 scale measuring quality of life. These parameters were evaluated in the first week to obtain baseline values, and at 20, 32, 48, and 60 weeks to evaluate the efficacy of the intervention group. RESULTS: The patients were randomized, with 100 patients in the intervention group and 106 in the control group. The intervention and control groups were similar with regard to the percentage of women (86% vs. 89.6%), tobacco usage (25% vs. 19.8%), mean age (42.6±13.2 years vs. 46.6±10.9 years), and disease duration (15.3±6.7 months vs. 14.5±6.6 months). The mean outcomes were significantly different between the two groups, and post-hoc pairwise analysis demonstrated significant deterioration in the control group in contrast to improvement in the intervention group at the second, third, fourth, and fifth evaluations. Improvements were often seen as early as the 12-week and 24-week follow-up visits. CONCLUSIONS: Epidemiology contributes to the evaluation of how well specific therapies or other health interventions prevent or control health problems. The modular program group intervention implemented in this study appears to be a suitable and feasible method to facilitate much more comprehensive management of early RA in socioeconomically challenged communities. PMID:26552423

Epidemiological evaluation quality of life in patients suffering from early rheumatoid arthritis: a pragmatic, prospective, randomized, blind allocation controlled of a modular program group intervention.

PubMed

Yousefi, Hadi; Chopra, Arvind; Farrokhseresht, Reza; Sarmukaddam, Sanjeev; Noghabi, Fariba Asadi; Bedekar, Nilima; Madani, Abdolhosain

2015-01-01

Epidemiology has taken on new roles in the management of health care services. In this study, we developed a non-pharmacological self-management modular program group intervention and evaluated its efficacy as an adjunct therapy in patients suffering from early rheumatoid arthritis (RA). Patients were randomized to either participate in a non-equivalent intervention group along with the standard of care or only receive standard-of-care treatment at a community rheumatology center. The outcomes measured were a pain visual analog scale (VAS), patient general health (GH) on a VAS, and the Short Form 36 Health Survey version 2 scale measuring quality of life. These parameters were evaluated in the first week to obtain baseline values, and at 20, 32, 48, and 60 weeks to evaluate the efficacy of the intervention group. The patients were randomized, with 100 patients in the intervention group and 106 in the control group. The intervention and control groups were similar with regard to the percentage of women (86% vs. 89.6%), tobacco usage (25% vs. 19.8%), mean age (42.6±13.2 years vs. 46.6±10.9 years), and disease duration (15.3±6.7 months vs. 14.5±6.6 months). The mean outcomes were significantly different between the two groups, and post-hoc pairwise analysis demonstrated significant deterioration in the control group in contrast to improvement in the intervention group at the second, third, fourth, and fifth evaluations. Improvements were often seen as early as the 12-week and 24-week follow-up visits. Epidemiology contributes to the evaluation of how well specific therapies or other health interventions prevent or control health problems. The modular program group intervention implemented in this study appears to be a suitable and feasible method to facilitate much more comprehensive management of early RA in socioeconomically challenged communities.

Atherosclerotic renovascular disease – epidemiology, treatment and current challenges

PubMed Central

Vassallo, Diana

2017-01-01

The neutral results of recent large randomized controlled trials comparing renal revascularization with optimal medical therapy in patients with atherosclerotic renovascular disease (ARVD) have cast doubt on the role of revascularization in the management of unselected patients with this condition. However, these studies have strengthened the evidence base for the role of contemporary intensive medical vascular protection therapy and aggressive risk factor control in improving clinical outcomes in ARVD. Patients presenting with ‘high-risk’ clinical features such as uncontrolled hypertension, rapidly declining renal function or flash pulmonary oedema are underrepresented in these studies; hence these results may not be applicable to all patients with ARVD. In this ‘high-risk’ subgroup, conservative management may not be sufficient in preventing adverse events, and indeed, observational evidence suggests that this specific patient subgroup may gain benefit from timely renal revascularization. Current challenges include the development of novel diagnostic techniques to establish haemodynamic significance of a stenosis, patient risk stratification and prediction of post-revascularization outcomes to ultimately facilitate patient selection for revascularization. In this paper we describe the epidemiology of this condition and discuss treatment recommendations for this condition in light of the results of recent randomized controlled trials while highlighting important clinical unmet needs and challenges faced by clinicians managing this condition. PMID:29056991

Efficacy of Noninvasive Stellate Ganglion Blockade Performed Using Physical Agent Modalities in Patients with Sympathetic Hyperactivity-Associated Disorders: A Systematic Review and Meta-Analysis.

PubMed

Liao, Chun-De; Tsauo, Jau-Yih; Liou, Tsan-Hon; Chen, Hung-Chou; Rau, Chi-Lun

2016-01-01

Stellate ganglion blockade (SGB) is mainly used to relieve symptoms of neuropathic pain in conditions such as complex regional pain syndrome and has several potential complications. Noninvasive SGB performed using physical agent modalities (PAMs), such as light irradiation and electrical stimulation, can be clinically used as an alternative to conventional invasive SGB. However, its application protocols vary and its clinical efficacy remains controversial. This study investigated the use of noninvasive SGB for managing neuropathic pain or other disorders associated with sympathetic hyperactivity. We performed a comprehensive search of the following online databases: Medline, PubMed, Excerpta Medica Database, Cochrane Library Database, Ovid MEDLINE, Europe PubMed Central, EBSCOhost Research Databases, CINAHL, ProQuest Research Library, Physiotherapy Evidence Database, WorldWideScience, BIOSIS, and Google Scholar. We identified and included quasi-randomized or randomized controlled trials reporting the efficacy of SGB performed using therapeutic ultrasound, transcutaneous electrical nerve stimulation, light irradiation using low-level laser therapy, or xenon light or linearly polarized near-infrared light irradiation near or over the stellate ganglion region in treating complex regional pain syndrome or disorders requiring sympatholytic management. The included articles were subjected to a meta-analysis and risk of bias assessment. Nine randomized and four quasi-randomized controlled trials were included. Eleven trials had good methodological quality with a Physiotherapy Evidence Database (PEDro) score of ≥6, whereas the remaining two trials had a PEDro score of <6. The meta-analysis results revealed that the efficacy of noninvasive SGB on 100-mm visual analog pain score is higher than that of a placebo or active control (weighted mean difference, -21.59 mm; 95% CI, -34.25, -8.94; p = 0.0008). Noninvasive SGB performed using PAMs effectively relieves pain of various etiologies, making it a valuable addition to the contemporary pain management armamentarium. However, this evidence is limited by the potential risk of bias.

Randomized, controlled trial of antibiotics in the management of community-acquired skin abscesses in the pediatric patient.

PubMed

Duong, Myto; Markwell, Stephen; Peter, John; Barenkamp, Stephen

2010-05-01

Emergency department visits for skin and soft tissue infections are increasing with the discovery of community-acquired methicillin-resistant Staphylococcus aureus. Whether abscesses treated surgically also require antibiotics is controversial. There are no published pediatric randomized controlled trials evaluating the need for antibiotics in skin abscess management. We determine the benefits of antibiotics in surgically managed pediatric skin abscesses. This was a double-blind, randomized, controlled trial. Pediatric patients were randomized to receive 10 days of placebo or trimethoprim-sulfamethoxazole after incision and draining. Follow-up consisted of a visit/call at 10 to 14 days and a call at 90 days. Primary outcome was treatment failure at the 10-day follow-up. Secondary outcome was new lesion development at the 10- and 90-day follow-ups. Noninferiority of placebo relative to trimethoprim-sulfamethoxazole for primary and secondary outcomes was assessed. One hundred sixty-one patients were enrolled, with 12 lost to follow-up. The failure rates were 5.3% (n=4/76) and 4.1% (n=3/73) in the placebo and antibiotic groups, respectively, yielding a difference of 1.2%, with a 1-sided 95% confidence interval (CI) (-infinity to 6.8%). Noninferiority was established with an equivalence threshold of 7%. New lesions occurred at the 10-day follow-up: 19 on placebo (26.4%) and 9 on antibiotics (12.9%), yielding a difference of 13.5%, with 95% 1-sided CI (-infinity to 24.3%). At the 3-month follow-up, 15 of 52 (28.8%) in the placebo group and 13 of 46 (28.3%) in the antibiotic group developed new lesions. The difference was 0.5%, with 95% 1-sided CI (-infinity to 15.6%). Antibiotics are not required for pediatric skin abscess resolution. Antibiotics may help prevent new lesions in the short term, but further studies are required. Copyright 2009 American College of Emergency Physicians. Published by Mosby, Inc. All rights reserved.

Do Mobile Phone Applications Improve Glycemic Control (HbA1c) in the Self-management of Diabetes? A Systematic Review, Meta-analysis, and GRADE of 14 Randomized Trials.

PubMed

Hou, Can; Carter, Ben; Hewitt, Jonathan; Francisa, Trevor; Mayor, Sharon

2016-11-01

To investigate the effect of mobile phone applications (apps) on glycemic control (HbA 1c ) in the self-management of diabetes. Relevant studies that were published between 1 January 1996 and 1 June 2015 were searched from five databases: Medline, CINAHL, Cochrane Library, Web of Science, and Embase. Randomized controlled trials that evaluated diabetes apps were included. We conducted a systematic review with meta-analysis and GRADE (Grading of Recommendations Assessment, Development and Evaluation) of the evidence. Participants from 14 studies (n = 1,360) were included and quality assessed. Although there may have been clinical diversity, all type 2 diabetes studies reported a reduction in HbA 1c . The mean reduction in participants using an app compared with control was 0.49% (95% Cl 0.30, 0.68; I 2 = 10%), with a moderate GRADE of evidence. Subgroup analyses indicated that younger patients were more likely to benefit from the use of diabetes apps, and the effect size was enhanced with health care professional feedback. There was inadequate data to describe the effectiveness of apps for type 1 diabetes. Apps may be an effective component to help control HbA 1c and could be considered as an adjuvant intervention to the standard self-management for patients with type 2 diabetes. Given the reported clinical effect, access, and nominal cost of this technology, it is likely to be effective at the population level. The functionality and use of this technology need to be standardized, but policy and guidance are anticipated to improve diabetes self-management care. © 2016 by the American Diabetes Association.

Psychosocial behaviour management programme for home-dwelling people with dementia: A cluster-randomized controlled trial.

PubMed

Nakanishi, Miharu; Endo, Kaori; Hirooka, Kayo; Granvik, Eva; Minthon, Lennart; Nägga, Katarina; Nishida, Atsushi

2018-03-01

Little is known about the effectiveness of a psychosocial behaviour management programme on home-dwelling people with dementia. We developed a Behaviour Analytics & Support Enhancement (BASE) programme for care managers and professional caregivers of home care services in Japan. We investigated the effects of BASE on challenging behaviour of home-dwelling people with dementia. A cluster-randomized controlled trial was conducted with home care providers from 3 different districts in Tokyo. Each provider recruited persons with dementia aged 65 years or older to receive home care in the BASE programme in August 2016. An online monitoring and assessment system was introduced to the intervention group for repeated measures of challenging behaviour with a total score of the Neuropsychiatric Inventory. Care professionals in both the intervention and control groups evaluated challenging behaviour of persons with dementia at baseline (September 2016) and follow-up (February 2017). A majority of persons with dementia had Alzheimer disease (59.3%). One-hundred and forty-one persons with dementia were included in the intervention group and 142 in the control group. Multilevel modelling revealed a significant reduction in challenging behaviour in the intervention group after 6 months (mean score, 18.3 to 11.2) compared with that of the control group (11.6 to 10.8; P < .05). The implementation of the BASE programme resulted in a reduction of challenging behaviour of home-dwelling people with dementia. Future research should examine the long-term effects of behaviour management programmes on behaviour, nursing home placement, and hospital admission of home-dwelling people with dementia. Copyright © 2017 John Wiley & Sons, Ltd.

Study protocol: The Technology-Enhanced Coaching (TEC) program to improve diabetes outcomes – A randomized controlled trial

PubMed Central

Heisler, Michele; Mase, Rebecca; Brown, Brianne; Wilson, Shayla; Reeves, Pamela J.

2017-01-01

Background Racial and ethnic minority adults with diabetes living in under-resourced communities face multiple barriers to sustaining self-management behaviors necessary to improve diabetes outcomes. Peer support and decision support tools each have been associated with improved diabetes outcomes. Methods 289 primarily African American adults with poor glycemic control will be recruited from the Detroit Veteran’s Administration Hospital and randomized to Technology-Enhanced Coaching (TEC) or Peer Coaching alone. Participants in both arms will be assigned a peer coach trained in autonomy-supportive approaches. Coaches are diabetes patients with prior poor glycemic control who now have good control. All participants meet face-to-face initially with their coach to review diabetes education materials and develop an action plan. Educational materials in the TEC arm are delivered via a web-based, educational tool tailored with each participant’s personalized health data (iDecide). Over the next six months, Coaches call their assigned participants once a week to provide support for weekly action steps. Data are also collected on an Observational Control group with no contact with study staff. Changes in A1c, blood pressure, other patient-centered outcomes and mediators and moderators of intervention effects will be assessed. Discussion Tailored e-Health tools with educational content may enhance the effectiveness of peer coaching programs to better prepare patients to set self-management goals, identify action plans, and discuss treatment options with their health care providers. The study will provide insights for scalable self-management support programs for diabetes and chronic illnesses that require high levels of sustained patient self-management. PMID:28132876

Clinical Inertia in a Randomized Trial of Telemedicine-Based Chronic Disease Management: Lessons Learned.

PubMed

Barton, Anna Beth; Okorodudu, Daniel E; Bosworth, Hayden B; Crowley, Matthew J

2018-01-17

Treatment nonadherence and clinical inertia perpetuate poor cardiovascular disease (CVD) risk factor control. Telemedicine interventions may counter both treatment nonadherence and clinical inertia. We explored why a telemedicine intervention designed to reduce treatment nonadherence and clinical inertia did not improve CVD risk factor control, despite enhancing treatment adherence versus usual care. In this analysis of a randomized trial, we studied recipients of the 12-month telemedicine intervention. This intervention comprised two nurse-administered components: (1) monthly self-management education targeting improved treatment adherence; and (2) quarterly medication management facilitation designed to support treatment intensification by primary care (thereby reducing clinical inertia). For each medication management facilitation encounter, we ascertained whether patients met treatment goals, and if not, whether primary care recommended treatment intensification following the encounter. We assessed disease control associated with encounters, where intensification was/was not recommended. We examined 455 encounters across 182 intervention recipients (100% African Americans with type 2 diabetes). Even after accounting for valid reasons for deferring intensification (e.g., treatment nonadherence), intensification was not recommended in 67.5% of encounters in which hemoglobin A1c was above goal, 72.5% in which systolic blood pressure was above goal, and 73.9% in which low-density lipoprotein cholesterol was above goal. In each disease state, treatment intensification was more likely with poorer control. Despite enhancing treatment adherence, this intervention was unsuccessful in countering clinical inertia, likely explaining its lack of effect on CVD risk factors. We identify several lessons learned that may benefit investigators and healthcare systems.

Stress management and dietary counseling in hypertensive patients: a pilot study of additional effect.

PubMed

Katsarou, Alexia L; Vryonis, Marios M; Protogerou, Athanassios D; Alexopoulos, Evangelos C; Achimastos, Apostolos; Papadogiannis, Dimitrios; Chrousos, George P; Darviri, Christina

2014-01-01

In Western societies, cardiovascular (CV) disease is the primary cause of mortality, and high blood pressure (BP) is the main reversible factor leading to CV disease. Dietary habits and psychosocial stress contribute to the establishment of hypertension, while its role in the control of high BP is currently examined. In this study, we examined the effect and feasibility of a combined intervention of dietary education and stress management on the control of hypertension. A randomized, controlled pilot study was designed to evaluate the effect of combined education on stress management techniques and dietary habits (Mediterranean diet principle) on office BP after eight weeks. Of the 45 randomized subjects, 36 were included in the final analysis (control group = 20 (age: 67 ± 12 years, 31.8%, males) and intervention group = 16 (age: 62 ± 12 years, 47%, males)). CV disease risk factors (except smoking), BP, dietary habits, perceived stress and physical activity (all assessed with validated questionnaires) were similar between the two groups at baseline. After eight weeks, office BP (systolic and diastolic) and perceived stress were significantly reduced, whereas the adherence in Mediterranean diet principle was significantly increased, but only in the intervention group. A combined intervention of stress management techniques and Mediterranean diet education seems to be beneficial for BP reduction. Such interventions could possibly serve as a complementary treatment along with drug therapy or in the early treatment of high normal BP. A call to action for designing epidemiological studies and evaluating the efficacy of such non-pharmacological treatment strategies is therefore warranted.

Nurse care coordination and technology effects on health status of frail older adults via enhanced self-management of medication: randomized clinical trial to test efficacy.

PubMed

Marek, Karen Dorman; Stetzer, Frank; Ryan, Polly A; Bub, Linda Denison; Adams, Scott J; Schlidt, Andrea; Lancaster, Rachelle; O'Brien, Anne-Marie

2013-01-01

Self-management of complex medication regimens for chronic illness is challenging for many older adults. The purpose of this study was to evaluate health status outcomes of frail older adults receiving a home-based support program that emphasized self-management of medications using both care coordination and technology. This study used a randomized controlled trial with three arms and longitudinal outcome measurement. Older adults having difficulty in self-managing medications (n = 414) were recruited at discharge from three Medicare-certified home healthcare agencies in a Midwestern urban area. All participants received baseline pharmacy screens. The control group received no further intervention. A team of advanced practice nurses and registered nurses coordinated care for 12 months to two intervention groups who also received either an MD.2 medication-dispensing machine or a medplanner. Health status outcomes (the Geriatric Depression Scale, Mini Mental Status Examination, Physical Performance Test, and SF-36 Physical Component Summary and Mental Component Summary) were measured at baseline and at 3, 6, 9, and 12 months. After covariate and baseline health status adjustment, time × group interactions for the MD.2 and medplanner groups on health status outcomes were not significant. Time × group interactions were significant for the medplanner and control group comparisons. Participants with care coordination had significantly better health status outcomes over time than those in the control group, but addition of the MD.2 machine to nurse care coordination did not result in better health status outcomes.

HOME-BASED BLOOD PRESSURE INTERVENTIONS FOR AFRICAN AMERICANS

PubMed Central

Feldman, Penny H.; McDonald, Margaret V.; Mongoven, Jennifer M.; Peng, Timothy R.; Gerber, Linda M.; Pezzin, Liliana E.

2009-01-01

Background Efforts to increase blood pressure (BP) control rates in African Americans, a traditionally underserved, high risk population must address both provider practice and patient adherence issues. The Home-Based BP Intervention for African Americans study is a three-arm randomized controlled trial designed to test two strategies to improve HTN management and outcomes in a decentralized service setting serving a vulnerable and complex home care population. The primary study outcomes are systolic BP, diastolic BP, and BP control; secondary outcomes are nurse adherence to HTN management recommendations, and patient adherence to medication, healthy diet and other self-management strategies. Methods and Results Nurses (N=312) in a nonprofit Medicare-certified home health agency are randomized along with their eligible hypertensive patients (N=845). The two interventions being tested are: (i) a “basic” intervention delivering key evidence-based reminders to home care nurses and patients while the patient is receiving traditional post-acute home health care; and (ii) an “augmented” intervention that includes that same as the basic intervention, plus transition to an ongoing HTN Home Support Program that extends support for 12 months. Outcomes are measured at 3 and 12 months post baseline interview. The interventions will be assessed relative to usual care and to each other. Conclusions Systems change to improve BP management and outcomes in home health will not easily occur without new intervention models and rigorous evaluation of their impact. Results from this trial will provide important information on potential strategies to improve BP control in a low income, chronically ill patient population. PMID:20031844

Psychological Interventions for the Management of Glycemic and Psychological Outcomes of Type 2 Diabetes Mellitus in China: A Systematic Review and Meta-Analyses of Randomized Controlled Trials.

PubMed

Chapman, Anna; Liu, Shuo; Merkouris, Stephanie; Enticott, Joanne C; Yang, Hui; Browning, Colette J; Thomas, Shane A

2015-01-01

China has the largest number of type 2 diabetes mellitus (T2DM) cases globally, and T2DM management has become a critical public health issue in China. Individuals with T2DM have an increased risk of developing mental health disorders, psychological disturbances, and functional problems associated with living with their condition. Previous systematic reviews have demonstrated that, generally, psychological interventions are effective in the management of T2DM-related outcomes; however, these reviews have predominantly included studies conducted within English-speaking countries and have not determined the efficacy of the varying types of psychological interventions. As such, this paper aims to synthesize evidence and quantify the efficacy of psychological therapies for the management of glycemic and psychological outcomes of T2DM in China, relative to control conditions. A systematic search (MEDLINE, PsycINFO, CINAHL, Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, and Wangfang Data) for all years to December 2014 identified all available literature. Eligibility criteria included: peer-reviewed journal articles, randomized controlled trials (RCTs) assessing the efficacy of a psychological therapy for the management of T2DM, adult participants (≥18 years) diagnosed with T2DM or non-insulin-dependent diabetes mellitus, and Chinese speaking participants only (in mainland China). Outcome measures were glycated hemoglobin, blood glucose concentration, depression, anxiety, and quality of life. Effect sizes were pooled using a random effects model. Negative effect sizes corresponded to positive outcomes favoring the intervention. Forty-five RCTs were eligible for the meta-analyses. Cognitive behavioral therapy (CBT) and motivational interviewing (MI) were more effective than the control condition in the reduction of glycated hemoglobin [CBT: -0.97 (95% CI -1.37 to -0.57); MI: -0.71 (95% CI -1.00 to -0.43)]. CBT and client-centered therapy (CCT) were also associated with reductions in depression and blood glucose concentration, and CBT was associated with reductions in anxiety. Psychological interventions, namely, CBT, MI, and CCT are effective in improving certain T2DM-related outcomes in China. Considerable levels of heterogeneity and unclear risk of bias associated with most included RCTs suggest caution when interpreting results. In China, where the burden of T2DM is increasing significantly, psychological interventions may provide promising approaches to assist in the management of T2DM to delay the progression of T2DM related outcomes.

Cervical epidural injections in chronic discogenic neck pain without disc herniation or radiculitis: preliminary results of a randomized, double-blind, controlled trial.

PubMed

Manchikanti, Laxmaiah; Cash, Kimberly A; Pampati, Vidyasagar; Wargo, Bradley W; Malla, Yogesh

2010-01-01

Chronic neck pain is a common problem in the adult population with a typical 12-month prevalence of 30% to 50%. However, there is a lack of consensus regarding the causes and treatments of chronic neck pain. Despite limited evidence, cervical epidural injections are one of the commonly performed non-surgical interventions in the management of chronic neck pain. A randomized, double-blind, active control trial. An interventional pain management practice, a specialty referral center, a private practice setting in the United States. To evaluate the effectiveness of cervical interlaminar epidural injections with local anesthetic with or without steroids in the management of chronic neck pain with or without upper extremity pain in patients without disc herniation or radiculitis or facet joint pain. Patients without disc herniation or radiculitis and negative for facet joint pain by means of controlled diagnostic medial branch blocks were randomly assigned to one of 2 groups: injection of local anesthetic only or local anesthetic mixed with non-particulate betamethasone. Seventy patients were included in this analysis. Randomization was performed by computer-generated random allocation sequence by simple randomization. Multiple outcome measures were utilized including the Numeric Rating Scale (NRS), the Neck Disability Index (NDI), employment status, and opioid intake with assessment at 3, 6, and 12 months post-treatment. Significant pain relief or functional status was defined as a 50% or more reduction. Significant pain relief (> or = 50%) was demonstrated in 80% of patients in both groups and functional status improvement (> or = 50%) in 69% of Group I and 80% of Group II. The overall average procedures per year were 3.9 +/- 1.01 in Group I and 3.9 +/- 0.8 in Group II with an average total relief per year of 40.3 +/- 14.1 weeks in Group I and 42.1 +/- 9.9 weeks in Group II over a period of 52 weeks in the successful group. The results of this study are limited by the lack of a placebo group and a preliminary report of 70 patients, with 35 patients in each group. Cervical interlaminar epidural injections with local anesthetic with or without steroids may be effective in patients with chronic function-limiting discogenic.

Manage Your Life Online: A Web-Based Randomized Controlled Trial Evaluating the Effectiveness of a Problem-Solving Intervention in a Student Sample.

PubMed

Bird, Timothy; Mansell, Warren; Wright, Jason; Gaffney, Hannah; Tai, Sara

2018-01-25

Evidence for the efficacy of computer-based psychological interventions is growing. A number of such interventions have been found to be effective, especially for mild to moderate cases. They largely rely on psychoeducation and 'homework tasks', and are specific to certain diagnoses (e.g. depression). This paper presents the results of a web-based randomized controlled trial of Manage Your Life Online (MYLO), a program that uses artificial intelligence to engage the participant in a conversation across any problem topic. Healthy volunteers (n = 213) completed a baseline questionnaire and were randomized to the MYLO program or to an active control condition where they used the program ELIZA, which emulates a Rogerian psychotherapist. Participants completed a single session before completing post-study and 2-week follow-up measures. Analyses were per protocol with intent to follow-up. Both programs were associated with improvements in problem distress, anxiety and depression post-intervention, and again 2 weeks later, but MYLO was not found to be more effective than ELIZA. MYLO was rated as significantly more helpful than ELIZA, but there was no main effect of intervention on problem resolution. Findings are consistent with those of a previous smaller, laboratory-based trial and provide support for the acceptability and effectiveness of MYLO delivered over the internet for a non-clinical sample. The lack of a no-treatment control condition means that the effect of spontaneous recovery cannot be ruled out.

Impact of a Plant-Based Diet and Support on Mitigating Type 2 Diabetes Mellitus in Latinos Living in Medically Underserved Areas.

PubMed

Ramal, Edelweiss; Champlin, Andrea; Bahjri, Khaled

2018-03-01

To determine the impact that a high-fiber, low-fat diet, derived from mostly plant-based sources, when coupled with support has upon self-management of type 2 diabetes mellitus in Latinos from medically underserved areas (MUAs). Experimental randomized controlled community pilot study. Three community clinics in MUAs located within San Bernardino County, California. Thirty-two randomly assigned Latinos with A1 C greater than 6.4: 15 control and 17 experimental. Participants completed a 5-week education program. Researchers provided follow-up support for 17 randomly assigned experimental group participants through focus groups held at participating clinics-1, 3, and 6 months posteducation. Changes in fat and fiber consumption were measured using a modified Dietary Screener for Mexican Americans. Self-management was measured through the Self-Efficacy for Exercise Scale and Diabetes Quality of Life Measure. Baseline characteristics for both groups were analyzed using independent t tests and χ 2 tests. A 2-way repeated-measures analysis of variance was used to analyze biometric data between baseline and 6 months for both groups. Mean A1 C levels decreased from baseline to 6 months for both groups: control, μ 1 = 9.57, μ 2 = 9.49; experimental, μ 1 = 8.53, μ 2 = 7.31. The experimental group demonstrated a statistically significant reduction in mean A1 C levels ( P = .002) when compared to the control group.

Implementation of a guideline for low back pain management in primary care: a cost-effectiveness analysis.

PubMed

Becker, Annette; Held, Heiko; Redaelli, Marcus; Chenot, Jean F; Leonhardt, Corinna; Keller, Stefan; Baum, Erika; Pfingsten, Michael; Hildebrandt, Jan; Basler, Heinz-Dieter; Kochen, Michael M; Donner-Banzhoff, Norbert; Strauch, Konstantin

2012-04-15

Cost-effectiveness analysis alongside a cluster randomized controlled trial. To study the cost-effectiveness of 2 low back pain guideline implementation (GI) strategies. Several evidence-based guidelines on management of low back pain have been published. However, there is still no consensus on the effective implementation strategy. Especially studies on the economic impact of different implementation strategies are lacking. This analysis was performed alongside a cluster randomized controlled trial on the effectiveness of 2 GI strategies (physician education alone [GI] or physician education in combination with motivational counseling [MC] by practice nurses)--both compared with the postal dissemination of the guideline (control group, C). Sociodemographic data, pain characteristics, and cost data were collected by interview at baseline and after 6 and 12 months. low back pain-related health care costs were valued for 2004 from the societal perspective. For the cost analysis, 1322 patients from 126 general practices were included. Both interventions showed lower direct and indirect costs as well as better patient outcomes during follow-up compared with controls. In addition, both intervention arms showed superiority of cost-effectiveness to C. The effects attenuated when adjusting for differences of health care utilization prior to patient recruitment and for clustering of data. Trends in cost-effectiveness are visible but need to be confirmed in future studies. Researchers performing cost-evaluation studies should test for baseline imbalances of health care utilization data instead of judging on the randomization success by reviewing non-cost parameters like clinical data alone.

Effectiveness and efficiency of the two trolley system as an infection control mechanism in the operating theatre.

PubMed

Tuisawana, Viliame

2009-11-01

A good infection control manager understands the need to prevent a complete cycle of infection. The Infection Control Working Group Manual of Fiji, emphasised that the Cycle of Infection is the series of stage in which infection is spread. Operating theatres have infection control protocols. Most equipments and instruments used in operating theatre circulate within the theatre. The theatre trolleys are a main component in managing an operating theatre but the least recognised. This paper reviews the effectiveness and efficiency of the current two-trolley system as an infection control mechanism in theatre. The paper will discuss infection control using the current trolley system in relation to the layout of Labasa Hospital operating theatre, human resource, equipment standard and random swab results. The following are random swab results of theatre equipments taken by the Infection Control Nurse from 2006 to 2008. The Labasa Hospital Infection Committee have discouraged random swab sample from mid 2008 based on new guidelines on infection control. The two trolley system, in which an allocated outside trolley transports patients from the ward to a semi-sterile area in theatre. The inside trolley which transports the patient to the operating table. The two trolley system means more trolleys, extra staffs for lifting, additional handling of very sick patients, congestion and delay in taking patients to operating table in theatres should be considered. The one-trolley system in theatre greatly reduces the chances of manually lifting patients, thus reducing the risk of patient injury from fall and risk of back injuries to nurses. There are other evident based practices which can compliment the one trolley system for an effective infection control mechanism in theatres. The Fiji Infection Control Manual (2002) emphases the importance of regularly cleaning the environment and equipments in theatre but there is never a mention about using a two trolley system as an infection control mechanism for theatre.

Impact of decision support in electronic medical records on lipid management in primary care.

PubMed

Gill, James M; Chen, Ying Xia; Glutting, Joseph J; Diamond, James J; Lieberman, Michael I

2009-10-01

Electronic decision-support tools may help to improve management of hyperlipidemia and other chronic diseases. This study examined the impact of lipid management tools integrated into an electronic medical record (EMR) in primary care practices. This randomized controlled trial was conducted in a national network of physicians who use an outpatient EMR. Adult primary care physicians were randomized by office to receive an electronic form that was embedded in the EMR. The form contained prompts regarding suboptimal care based on Adult Treatment Panel-III (ATP-III) guidelines, as well as reporting tools to identify patients outside of office visits whose lipid management was suboptimal. All active patients, ages 20-79 years, whose physicians participated in the study, were categorized as high, moderate, or low cardiovascular risk, and the proportion who were tested for hyperlipidemia, at lipid goal, and on lipid-lowering medications if not at goal were measured according to ATP-III guidelines. A total of 105 physicians from 25 offices and 64,150 patients were included in the study. Outcomes improved for most measures from before to 1 year after the intervention (November 1, 2005 to October 31, 2006). However, after controlling for confounding variables and for clustering in multilevel modeling, only up-to-date lipid testing for high-risk patients was statistically better in the intervention group as compared to the control group (adjusted odds ratio 15.0, P < 0.05). This study showed few differences in quality of lipid management after implementing an EMR-based disease management intervention in primary care settings. Future studies may need to examine more comprehensive interventions that include office staff in a team approach to care.

A randomized, clinical trial of education or motivational-interviewing-based coaching compared to usual care to improve cancer pain management.

PubMed

Thomas, Mary Laudon; Elliott, Janette E; Rao, Stephen M; Fahey, Kathleen F; Paul, Steven M; Miaskowski, Christine

2012-01-01

To test the effectiveness of two interventions compared to usual care in decreasing attitudinal barriers to cancer pain management, decreasing pain intensity, and improving functional status and quality of life (QOL). Randomized clinical trial. Six outpatient oncology clinics (three Veterans Affairs [VA] facilities, one county hospital, and one community-based practice in California, and one VA clinic in New Jersey)Sample: 318 adults with various types of cancer-related pain. Patients were randomly assigned to one of three groups: control, standardized education, or coaching. Patients in the education and coaching groups viewed a video and received a pamphlet on managing cancer pain. In addition, patients in the coaching group participated in four telephone sessions with an advanced practice nurse interventionist using motivational interviewing techniques to decrease attitudinal barriers to cancer pain management. Questionnaires were completed at baseline and six weeks after the final telephone calls. Analysis of covariance was used to evaluate for differences in study outcomes among the three groups. Pain intensity, pain relief, pain interference, attitudinal barriers, functional status, and QOL. Attitudinal barrier scores did not change over time among groups. Patients randomized to the coaching group reported significant improvement in their ratings of pain-related interference with function, as well as general health, vitality, and mental health. Although additional evaluation is needed, coaching may be a useful strategy to help patients decrease attitudinal barriers toward cancer pain management and to better manage their cancer pain. By using motivational interviewing techniques, advanced practice oncology nurses can help patients develop an appropriate plan of care to decrease pain and other symptoms.

Interferential and horizontal therapies in chronic low back pain due to multiple vertebral fractures: a randomized, double blind, clinical study.

PubMed

Zambito, A; Bianchini, D; Gatti, D; Rossini, M; Adami, S; Viapiana, O

2007-11-01

Chronic low back pain due to multiple vertebral fractures is of difficult management. Electrical nerve stimulation is frequently used, but its efficacy has never been properly evaluated. In a randomized placebo-controlled clinical trial, we have shown that both interferential currents and horizontal therapy are more effective than placebo for functional. Multiple vertebral fractures almost invariably ensue in chronic low back pain that remains of difficult management. Electrical nerve stimulation is frequently used but its efficacy has never been properly evaluated. One hundred and fifteen women with chronic back pain due to previous multiple vertebral osteoporotic fractures (CBPMF) were randomly assigned to either interferential currents (IFT), horizontal therapy (HT) or sham HT administered for 30 minutes daily for 5 days per week for two weeks together with a standard exercise program. Efficacy assessment was obtained at baseline and at week 2, 6 and 14 and included a functional questionnaire (Backill), the standard visual analog scale (VAS) and the mean analgesic consumption. At week 2 a significant and similar improvement in both the VAS and Backill score was observed in the three groups. The two scores continued to improve in the two active groups with changes significantly (p < 0.001) greater than those observed in control patients at week 6 and 14. The use of analgesic medications improved only in the HT group. This randomized double-blind controlled study provides the first evidence that IFT and HT therapy are significantly effective in alleviating both pain and disability in patients with CBPMF.

Therapeutic education among adults with type 2 diabetes: effects of a three-day intervention on perceived competence, self-management behaviours and glycaemic control.

PubMed

Trouilloud, David; Regnier, Jennifer

2013-06-01

The purpose of this study was to evaluate the impact of a three-day therapeutic education programme on perceived competence, self-management behaviours (i.e. physical activity, diet and medication) and glycaemic control among adults with type 2 diabetes. A total of 120 participants were included in this randomized, wait list control group trial. The results confirm that therapeutic education may be a powerful healthcare intervention to improve lifestyle and health status of people with type 2 diabetes. We observed that the education programme used in this study generated positive changes in glycaemic control and adherence to physical activity and diet after three months follow-up. Furthermore, the intervention positively impacted participants' perceived competence towards physical activity and diet. The latter finding is of particular importance, given that perceived competence has been found to be involved in long-term adherence to self-management behaviours.

Classroom-based Interventions and Teachers' Perceived Job Stressors and Confidence: Evidence from a Randomized Trial in Head Start Settings.

PubMed

Zhai, Fuhua; Raver, C Cybele; Li-Grining, Christine

2011-09-01

Preschool teachers' job stressors have received increasing attention but have been understudied in the literature. We investigated the impacts of a classroom-based intervention, the Chicago School Readiness Project (CSRP), on teachers' perceived job stressors and confidence, as indexed by their perceptions of job control, job resources, job demands, and confidence in behavior management. Using a clustered randomized controlled trial (RCT) design, the CSRP provided multifaceted services to the treatment group, including teacher training and mental health consultation, which were accompanied by stress-reduction services and workshops. Overall, 90 teachers in 35 classrooms at 18 Head Start sites participated in the study. After adjusting for teacher and classroom factors and site fixed effects, we found that the CSRP had significant effects on the improvement of teachers' perceived job control and work-related resources. We also found that the CSRP decreased teachers' confidence in behavior management and had no statistically significant effects on job demands. Overall, we did not find significant moderation effects of teacher race/ethnicity, education, teaching experience, or teacher type. The implications for research and policy are discussed.

[Tele-medicine system for high-risk asthmatic patients].

PubMed

Kokubu, F; Suzuki, H; Sano, Y; Kihara, N; Adachi, M

1999-07-01

We have developed a tele-medicine system to monitor the airway status at home for patients with poorly controlled asthma, whereby a nurse provides instructions to individuals via the telephone to help them manage exacerbation under the supervision of their physicians. We examined the effectiveness of this system with a randomized control study. Patients with high hospitalization risk were enrolled in the study by screening patients for those with multiple previous emergency room visits and randomly assigned to either the tele-medicine or control group. After six months of participation in the program, the number of emergency room visits decreased significantly and the activities of daily living were improved in the tele-medicine group. Most of the patients in the tele-medicine group were able to continue measuring and transmitting peak expiratory flow (PEF) value successfully, and at six months had noticed an improvement in PEF. We therefore conclude that the system effectively contributes to the management of poorly controlled asthma. In addition, further consideration suggests that the reduction of emergency room visits may lead to reduction in hospitalization since we found a good correlation between number of emergency room visits and hospitalization from the studies published previously.

Total Quality Management: A Guide to Implementation

DTIC Science & Technology

1989-08-01

Kaizen. New York: Random House. 1986. Ishikawa , Kaoru . Guide to Quality Control. Asian Productivity Organization. 1984. Ishikawa , Kaoru . What is Total...with the problems and the new management principles are based on the complexities of the new Systems Age. The theories of Deming, Juran, Ishikawa , and...Progress. Jun 1985. Miller, Jeffery G. and Thomas E. Vollmann. "The Hidden Factory." Harvard Business Review. Sep-Oct 1985. Shimoyamada, Kaoru . "The

ALGOS: the development of a randomized controlled trial testing a case management algorithm designed to reduce suicide risk among suicide attempters

PubMed Central

2011-01-01

Background Suicide attempts (SA) constitute a serious clinical problem. People who attempt suicide are at high risk of further repetition. However, no interventions have been shown to be effective in reducing repetition in this group of patients. Methods/Design Multicentre randomized controlled trial. We examine the effectiveness of «ALGOS algorithm»: an intervention based in a decisional tree of contact type which aims at reducing the incidence of repeated suicide attempt during 6 months. This algorithm of case management comprises the two strategies of intervention that showed a significant reduction in the number of SA repeaters: systematic telephone contact (ineffective in first-attempters) and «Crisis card» (effective only in first-attempters). Participants who are lost from contact and those refusing healthcare, can then benefit from «short letters» or «postcards». Discussion ALGOS algorithm is easily reproducible and inexpensive intervention that will supply the guidelines for assessment and management of a population sometimes in difficulties with healthcare compliance. Furthermore, it will target some of these subgroups of patients by providing specific interventions for optimizing the benefits of case management strategy. Trial Registration The study was registered with the ClinicalTrials.gov Registry; number: NCT01123174. PMID:21194496

Predictors of Short- and Long-Term Attrition From the Parents as Agents of Change Randomized Controlled Trial for Managing Pediatric Obesity.

PubMed

Spence, Nicholas D; Newton, Amanda S; Keaschuk, Rachel A; Ambler, Kathryn A; Jetha, Mary M; Holt, Nicholas L; Rosychuk, Rhonda J; Spence, John C; Sharma, Arya M; Ball, Geoff D C

Attrition in pediatric weight management is a substantial problem. This study examined factors associated with short- and long-term attrition from a lifestyle and behavioral intervention for parents of children with overweight or obesity. Fifty-two families with children ages 6 to 12 years old and body mass index at or above the 85th percentile participated in a randomized controlled trial focused on parents, comparing parent-based cognitive behavioral therapy with parent-based psychoeducation for pediatric weight management. We examined program attrition using two clinical phases of the intervention: short-term and long-term attrition, modeled using the general linear model. Predictors included intervention type, child/parent weight status, sociodemographic factors, and health of the family system. Higher self-assessed health of the family system was associated with lower short-term attrition; higher percentage of intervention sessions attended by parents was associated with lower long-term attrition. Different variables were significant in our short- and long-term models. Attrition might best be conceptualized based on short- and long-term phases of clinical, parent-based interventions for pediatric weight management. Copyright © 2016 National Association of Pediatric Nurse Practitioners. Published by Elsevier Inc. All rights reserved.

Revisited: A Systematic Review of Therapeutic Hypothermia for Adult Patients Following Traumatic Brain Injury.

PubMed

Watson, Hannah I; Shepherd, Andrew A; Rhodes, Jonathan K J; Andrews, Peter J D

2018-06-01

Therapeutic hypothermia has been of topical interest for many years and with the publication of two international, multicenter randomized controlled trials, the evidence base now needs updating. The aim of this systematic review of randomized controlled trials is to assess the efficacy of therapeutic hypothermia in adult traumatic brain injury focusing on mortality, poor outcomes, and new pneumonia. The following databases were searched from January 1, 2011, to January 26, 2018: Cochrane Central Register of Controlled Trial, MEDLINE, PubMed, and EMBASE. Only foreign articles published in the English language were included. Only articles that were randomized controlled trials investigating adult traumatic brain injury sustained following an acute, closed head injury were included. Two authors independently assessed at each stage. Quality was assessed using the Cochrane Collaboration's tool for assessing the risk of bias. All extracted data were combined using the Mantel-Haenszel estimator for pooled risk ratio with 95% CIs. p value of less than 0.05 was considered statistically significant. All statistical analyses were conducted using RevMan 5 (Cochrane Collaboration, Version 5.3, Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014). Twenty-two studies with 2,346 patients are included. Randomized controlled trials with a low risk of bias show significantly more mortality in the therapeutic hypothermia group (risk ratio, 1.37; 95% CI, 1.04-1.79; p = 0.02), whereas randomized controlled trials with a high risk of bias show the opposite with a higher mortality in the control group (risk ratio, 0.70; 95% CI, 0.60-0.82; p < 0.00001). Overall, this review is in-keeping with the conclusions published by the most recent randomized controlled trials. High-quality studies show no significant difference in mortality, poor outcomes, or new pneumonia. In addition, this review shows a place for fever control in the management of traumatic brain injury.

Symptom-Based Controller Therapy: A New Paradigm for Asthma Management

PubMed Central

Divekar, Rohit; Ameredes, Bill T.; Calhoun, William J.

2013-01-01

Appropriate management of persistent asthma, according to US and international guidelines, requires daily use of controller medications, most generally, inhaled corticosteroids (ICS). This approach, although effective and well established, imposes burdens of treatment and side effects onto asthma patients. A growing body of evidence suggests that patients with persistent asthma need not be managed with daily ICS, but rather can use them on an intermittent basis, occasioned by the occurrence of symptoms sufficient to warrant treatment with a rescue inhaler. Large, randomized, controlled studies, over a range of asthma severity, and in a range of ages from pediatrics to adults, suggest that in well-selected patients, a symptom based approach to administering controller therapy may produce equivalent outcomes, while reducing exposure to ICS. The concept of providing anti-inflammatory treatment to the patient, at the time inflammation is developing, is termed ‘temporal personalization’. The evidence to date suggests that symptom-based controller therapy is broadly useful in selected asthma patients, and is a management approach that could be incorporated into US and international guidelines for asthma. PMID:23904098

A randomized controlled evaluation of specialist nurse education following accident and emergency department attendance for acute asthma.

PubMed

Levy, M L; Robb, M; Allen, J; Doherty, C; Bland, J M; Winter, R J

2000-09-01

We investigated whether hospital-based specialist asthma nurses improved recognition and self-treatment of asthma episodes by patients followed up after attending accident and emergency departments (A&E) for asthma exacerbations. We carried out a randomized prospective controlled trial of adult asthma self-management, following a hospital outpatient nurse consultation in two outer-London District General Hospitals (secondary care centres). The study included 211 adults, over 18 years old (mean age 40 years) who attended for asthma in two accident and emergency departments over 13 months. One hundred and eight evaluable patients were randomized into the control group who continued with their usual medical treatment and were not offered any intervention during the study period. One hundred and three evaluable patients were randomized into the intervention group. They were offered three 6-weekly outpatient appointments with one of two specialist asthma nurses for a structured asthma consultation, after attendance at the accident and emergency department. Following assessment of their asthma treatment and control, the nurses advised patients, through the use of self-management-plans, how to recognize and manage uncontrolled asthma and when to seek medical assistance. Medication and inhaler device type were altered if necessary The primary outcome was patient reported self-management of asthma exacerbations for 6 months. Secondary outcomes were assessed at baseline, 3 months and 6 months. These included home peak flow and symptom diaries, structured telephone questionnaires and audit of general practitioner records to determine utilization of services (6 months before and after A&E). Data were analysed on an intention to treat basis by multiple and logistic regression. The intervention group increased their use of inhaled topical steroids in 31/61 (51%) vs. 15/70 (21%) attacks in controls (OR 3.91 CI 1.8-8.4, P<0.001) and their use of rescue medication in 54/61 (89%) severe attacks vs. 53/70 (76%) controls (OR 2.88 CI 1.1-7.9, P<0.05). Intervention patients had significantly higher (mean 20.1 l min(-1); CI 0.4-39.7; P<0.05) and less variable PEF and significantly lower and less variable symptom scores 6 months after entry. Thirty-four percent of intervention patients vs. 42% controls had severe attacks (61 and 70 respectively, OR 0.96 CI 0.7-1.4) during the 6 months. Intervention patients had fewer days off work than controls in the first 3 months (NS) but similar days off during the 6-month period. Intervention patients had fewer episodes away from work in the first (0.34 vs. 0.54, P = 0.08) and the second 3 months (0.25 vs. 0.30, NS) than the controls. Over 80% of the patients records were audited by their general practitioners; the active group had less routine consultations with the doctor (P = 0.03) and practice nurse (P = 0.03), less consultations for uncontrolled episodes (P = 0.06) and less hospital visits (NS) than the controls. Hospital-based specialist nurses reduced asthma morbidity by improving patient self-management behaviour in acute attacks leading to reduced symptoms, improved lung function, less time off work and fewer consultations with health professionals.

Minimal intervention dentistry for early childhood caries and child dental anxiety: a randomized controlled trial.

PubMed

Arrow, P; Klobas, E

2017-06-01

To compare changes in child dental anxiety after treatment for early childhood caries (ECC) using two treatment approaches. Children with ECC were randomized to test (atraumatic restorative treatment (ART)-based approach) or control (standard care approach) groups. Children aged 3 years or older completed a dental anxiety scale at baseline and follow up. Changes in child dental anxiety from baseline to follow up were tested using the chi-squared statistic, Wilcoxon rank sum test, McNemar's test and multinomial logistic regression. Two hundred and fifty-four children were randomized (N = 127 test, N = 127 control). At baseline, 193 children completed the dental anxiety scale, 211 at follow up and 170 completed the scale on both occasions. Children who were anxious at baseline (11%) were no longer anxious at follow up, and 11% non-anxious children became anxious. Multinomial logistic regression found each increment in the number of visits increased the odds of worsening dental anxiety (odds ratio (OR), 2.2; P < 0.05), whereas each increment in the number of treatments lowered the odds of worsening anxiety (OR, 0.50; P = 0.05). The ART-based approach to managing ECC resulted in similar levels of dental anxiety to the standard treatment approach and provides a valuable alternative approach to the management of ECC in a primary dental care setting. © 2016 Australian Dental Association.

A randomized controlled trial on errorless learning in goal management training: study rationale and protocol

PubMed Central

2013-01-01

Background Many brain-injured patients referred for outpatient rehabilitation have executive deficits, notably difficulties with planning, problem-solving and goal directed behaviour. Goal Management Training (GMT) has proven to be an efficacious cognitive treatment for these problems. GMT entails learning and applying an algorithm, in which daily tasks are subdivided into multiple steps. Main aim of the present study is to examine whether using an errorless learning approach (preventing the occurrence of errors during the acquisition phase of learning) contributes to the efficacy of Goal Management Training in the performance of complex daily tasks. Methods/Design The study is a double blind randomized controlled trial, in which the efficacy of Goal Management Training with an errorless learning approach will be compared with conventional Goal Management Training, based on trial and error learning. In both conditions 32 patients with acquired brain injury of mixed etiology will be examined. Main outcome measure will be the performance on two individually chosen everyday-tasks before and after treatment, using a standardized observation scale and goal attainment scaling. Discussion This is the first study that introduces errorless learning in Goal Management Training. It is expected that the GMT-errorless learning approach will improve the execution of complex daily tasks in brain-injured patients with executive deficits. The study can contribute to a better treatment of executive deficits in cognitive rehabilitation. Trial registration (Dutch Trial Register): http://NTR3567 PMID:23786651

Increased Use of Community Medicine Distributors and Rational Use of Drugs in Children Less than Five Years of Age in Uganda Caused by Integrated Community Case Management of Fever

PubMed Central

Kalyango, Joan N.; Lindstrand, Ann; Rutebemberwa, Elizeus; Ssali, Sarah; Kadobera, Daniel; Karamagi, Charles; Peterson, Stefan; Alfven, Tobias

2012-01-01

We compared use of community medicine distributors (CMDs) and drug use under integrated community case management and home-based management strategies in children 6–59 months of age in eastern Uganda. A cross-sectional study with 1,095 children was nested in a cluster randomized trial with integrated community case management (CMDs treating malaria and pneumonia) as the intervention and home-based management (CMDs treating only malaria) as the control. Care-seeking from CMDs was higher in intervention areas (31%) than in control areas (22%; P = 0.01). Prompt and appropriate treatment of malaria was higher in intervention areas (18%) than in control areas (12%; P = 0.03) and among CMD users (37%) than other health providers (9%). The mean number of drugs among CMD users compared with other health providers was 1.6 versus 2.4 in intervention areas and 1.4 versus 2.3 in control areas. Use of CMDs was low. However, integrated community case management of childhood illnesses increased use of CMDs and rational drug use. PMID:23136276

Self discipline and obesity in Bangkok school children.

PubMed

Sirikulchayanonta, Chutima; Ratanopas, Wasoontara; Temcharoen, Paradee; Srisorrachatr, Suwat

2011-03-10

Childhood obesity has become an important public health problem in Thailand. This study aimed to determine the relationship between self discipline and obesity in Bangkok school children. A case control study was conducted. 140 cases (obese children) and 140 controls (normal weight children) were randomly chosen from grades 4-6 students in 4 Bangkok public schools. Questionnaire responses regarding general characteristics and child self-discipline were obtained from children and their parents. Self discipline in eating habits, money management and time management were reported at significantly lower levels among the obese group (p < 0.05). After controlling all other variables, it was revealed that the ranking of factors associated with obesity by adjusted odds ratio (OR) were low self-discipline in managing expenses (3.1), poor home environment (3.0,), moderate self-discipline in time management (2.9), television viewing time ≥2 hours/day (2.6), an obese father (2.2), and an obese mother (1.9). It was recommended that parents and teachers participate in child self-discipline guidance, particularly with regard to eating habits, money management and time management in a supportive environment that both facilitates prevention of obesity and simultaneously develops a child's personal control.

Self discipline and obesity in Bangkok school children

PubMed Central

2011-01-01

Background Childhood obesity has become an important public health problem in Thailand. This study aimed to determine the relationship between self discipline and obesity in Bangkok school children. Methods A case control study was conducted. 140 cases (obese children) and 140 controls (normal weight children) were randomly chosen from grades 4-6 students in 4 Bangkok public schools. Questionnaire responses regarding general characteristics and child self-discipline were obtained from children and their parents. Results Self discipline in eating habits, money management and time management were reported at significantly lower levels among the obese group (p < 0.05). After controlling all other variables, it was revealed that the ranking of factors associated with obesity by adjusted odds ratio (OR) were low self-discipline in managing expenses (3.1), poor home environment (3.0,), moderate self-discipline in time management (2.9), television viewing time ≥2 hours/day (2.6), an obese father (2.2), and an obese mother (1.9). Conclusions It was recommended that parents and teachers participate in child self-discipline guidance, particularly with regard to eating habits, money management and time management in a supportive environment that both facilitates prevention of obesity and simultaneously develops a child's personal control. PMID:21392376

Effects of structured testing versus routine testing of blood glucose in diabetes self-management: A randomized controlled trial.

PubMed

Nishimura, Akiko; Harashima, Shin-Ichi; Fujita, Yoshihito; Tanaka, Daisuke; Wang, Yu; Liu, Yanyan; Inagaki, Nobuya

2017-01-01

To compare the effects of structured and routine testing regimens used in self-monitoring of blood glucose (SMBG) on glycemic control and diabetes self-management in insulin-naïve type 2 diabetes patients. Sixty-two outpatients with insulin-naïve type 2 diabetes were randomly allocated into two less-frequent SMBG usage groups: a structured testing group (STG) and a routine testing group (RTG). Subjects in STG measured 7-points on SMBG for 3 consecutive days once every two months without daily testing; subjects in RTG measured SMBG 3 times each week before breakfast on Monday and Friday and before dinner on Wednesday. The primary endpoint was HbA1c reduction. The secondary endpoints were change in body weight, blood pressure, treatment change, and self-management performance change. HbA1c levels were significantly decreased by 0.32% (3.50mmol/mol) in STG, partly because physicians changed medications more actively. In contrast, body weight and systolic/diastolic blood pressure were significantly reduced by 0.94kg and 6.8/4.7mmHg, respectively, in RTG, possibly related to the increased diet and exercise score in RTG. Structured testing without daily testing is beneficial for glycemic control; routine testing 3 times a week is more helpful for daily self-management. In low SMBG frequency usage, these two regimens can be utilized according to individual diabetic conditions. Copyright © 2017 Elsevier Inc. All rights reserved.

Effects of diabetes self-management programs on time-to-hospitalization among patients with type 2 diabetes: a survival analysis model.

PubMed

Adepoju, Omolola E; Bolin, Jane N; Phillips, Charles D; Zhao, Hongwei; Ohsfeldt, Robert L; McMaughan, Darcy K; Helduser, Janet W; Forjuoh, Samuel N

2014-04-01

This study compared time-to-hospitalization among subjects enrolled in different diabetes self-management programs (DSMP). We sought to determine whether the interventions delayed the occurrence of any acute event necessitating hospitalization. Electronic medical records (EMR) were obtained for 376 adults enrolled in a randomized controlled trial (RCT) of Type 2 diabetes (T2DM) self-management programs. All study participants had uncontrolled diabetes and were randomized into either: personal digital assistant (PDA), Chronic Disease Self-Management Program (CDSMP), combined PDA and CDSMP (COM), or usual care (UC) groups. Subjects were followed for a maximum of two years. Time-to-hospitalization was measured as the interval between study enrollment and the occurrence of a diabetes-related hospitalization. Subjects enrolled in the CDSMP-only arm had significantly prolonged time-to-hospitalization (Hazard ratio: 0.10; p=0.002) when compared to subjects in the control arm. Subjects in the PDA-only and combined PDA and CDSMP arms showed no improvements in comparison to the control arm. CDSMP can be effective in delaying time-to-hospitalization among patients with T2DM. Reducing unnecessary healthcare utilization, particularly inpatient hospitalization is a key strategy to improving the quality of health care and lowering associated health care costs. The CDSMP offers the potential to reduce time-to-hospitalization among T2DM patients. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Carotid artery stenting vs. carotid endarterectomy in the management of carotid artery stenosis: Lessons learned from randomized controlled trials

PubMed Central

Salem, Mohamed M.; Alturki, Abdulrahman Y.; Fusco, Matthew R.; Thomas, Ajith J.; Carter, Bob S.; Chen, Clark C.; Kasper, Ekkehard M.

2018-01-01

Background: Carotid artery stenosis, both symptomatic and asymptomatic, has been well studied with several multicenter randomized trials. The superiority of carotid endarterectomy (CEA) to medical therapy alone in both symptomatic and asymptomatic carotid artery stenosis has been well established in previous trials in the 1990s. The consequent era of endovascular carotid artery stenting (CAS) has offered another option for treating carotid artery stenosis. A series of randomized trials have now been conducted to compare CEA and CAS in the treatment of carotid artery disease. The large number of similar trials has created some confusion due to inconsistent results. Here, the authors review the trials that compare CEA and CAS in the management of carotid artery stenosis. Methods: The PubMed database was searched systematically for randomized controlled trials published in English that compared CEA and CAS. Only human studies on adult patients were assessed. The references of identified articles were reviewed for additional manuscripts to be included if inclusion criteria were met. The following terms were used during search: carotid stenosis, endarterectomy, stenting. Retrospective or single-center studies were excluded from the review. Results: Thirteen reports of seven large-scale prospective multicenter studies, comparing both interventions for symptomatic or asymptomatic extracranial carotid artery stenosis, were identified. Conclusions: While the superiority of intervention to medical management for symptomatic patients has been well established in the literatures, careful selection of asymptomatic patients for intervention should be undertaken and only be pursued after institution of appropriate medical therapy until further reports on trials comparing medical therapy to intervention in this patient group are available. PMID:29740506

Computer Decision Support Software Safely Improves Glycemic Control in the Burn Intensive Care Unit: A Randomized Controlled Clinical Study

DTIC Science & Technology

2011-01-01

Program Jointly Managed by the USA MRMC, NIH, NASA, and the Juvenile Diabetes Research Foundation and Combat Casualty Care Division, United States Army...were performed in the CP group (p = 0.0003), and nursing staff compliance with CP recommendations was greater (p < 0.0001). Conclusions—Glycemic...enhanced consistency in practice, providing standardization among nursing staff. Keywords Glycemic control; hypoglycemia; computer decision support

A randomized study of remote monitoring and fluid monitoring for the management of patients with implanted cardiac arrhythmia devices.

PubMed

Lüthje, Lars; Vollmann, Dirk; Seegers, Joachim; Sohns, Christian; Hasenfuß, Gerd; Zabel, Markus

2015-08-01

Only limited comparative data exist on the benefits of fluid monitoring (FM) combined with remote monitoring (RM) regarding morbidity and mortality of heart failure (HF) patients. This prospective single-centre randomized pilot study aimed to estimate the influence of RM in combination with FM on HF hospitalizations as well as ventricular tachyarrhythmias and mortality. Patients with standard indication for implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy and defibrillator were implanted with devices capable of RM and FM, and were followed for 15 months. Subjects were randomly allocated to RM including OptiVol and predefined management of alerts (remote group), or standard in-office visits every 3 months (control group). A total of 176 patients (77% male; 66 ± 12 years; left ventricular ejection fraction (LVEF) 32 ± 11%; ischemic cardiomyopathy 50%; CRT device 50%; primary prevention 85%) were analysed. Cox proportional hazard analysis on the time to first HF-related hospitalization showed a hazard ratio of 1.23 [0.62-2.44] (P = 0.551) favouring the control group. In the remote group, 13 patients (15%) experienced ICD shocks vs. 10 patients (11%) in the control group (P = 0.512). The average time to first ICD shock was 212 ± 173 days in the remote arm and 212 ± 143 days in the control arm (P = 0.994). The Kaplan-Meier estimate of mortality after 1 year was 8.6% (eight deaths) in the remote group vs. 4.6% in the control group (six deaths; P = 0.502). In a single-centre randomized pilot study of RM in combination with FM, no significant influence on HF-related hospitalizations, ICD shocks, or mortality was found. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

Mexican American Trial of Community Health Workers: A Randomized Controlled Trial of a Community Health Worker Intervention for Mexican Americans With Type 2 Diabetes Mellitus

PubMed Central

Martin, Molly A.; Swider, Susan M.; Tumialán Lynas, Carmen M.; Janssen, Imke; Avery, Elizabeth F.; Powell, Lynda H.

2014-01-01

Objectives. We assessed whether community health workers (CHWs) could improve glycemic control among Mexican Americans with diabetes. Methods. We recruited 144 Mexican Americans with type 2 diabetes between January 2006 and September 2008 into the single-blinded, randomized controlled Mexican American Trial of Community Health Workers (MATCH) and followed them for 2 years. Participants were assigned to either a CHW intervention, delivering self-management training through 36 home visits over 2 years, or a bilingual control newsletter delivering the same information on the same schedule. Results. Intervention participants showed significantly lower hemoglobin A1c levels than control participants at both year 1 Δ = −0.55; P = .021) and year 2 (Δ = −0.69; P = .005). We observed no effect on blood pressure control, glucose self-monitoring, or adherence to medications or diet. Intervention participants increased physical activity from a mean of 1.63 days per week at baseline to 2.64 days per week after 2 years. Conclusions. A self-management intervention delivered by CHWs resulted in sustained improvements in glycemic control over 2 years among Mexican Americans with diabetes. MATCH adds to the growing body of evidence supporting the use of CHWs to reduce diabetes-related health disparities. PMID:23947316

Patients' Perceptions and Experiences of a mHealth Diabetes Self-management System.

PubMed

Georgsson, Mattias; Staggers, Nancy

2017-03-01

Chronic diseases, including diabetes, constitute a substantial disease burden around the world. Mobile self-management systems now play a significant and increasingly important role in patients' disease management. Yet, patients' perceptions of these systems after longer-term use are largely unexplored. A random sample of 10 diabetes patients was assessed immediately after they exited a larger, 6-month randomized controlled trial on the use of a mHealth system called Care4Life. This descriptive, exploratory study assessed patients' perceptions and experiences of mHealth using a questionnaire and semistructured interview whose development was guided by the Technology Acceptance Model. Results indicated that patients saw clear benefits in using the technology and had favorable behavioral disease outcomes after using Care4Life. Suggestions for improving the system were highly individual despite the apparent homogeneity of the patient group. The study begins to fill the gap about the longer-term use of mHealth systems in chronic disease management and reflects the significance of individual needs for mHealth systems.

Primary repair of penetrating colon injuries: a systematic review.

PubMed

Singer, Marc A; Nelson, Richard L

2002-12-01

Primary repair of penetrating colon injuries is an appealing management option; however, uncertainty about its safety persists. This study was conducted to compare the morbidity and mortality of primary repair with fecal diversion in the management of penetrating colon injuries by use of a meta-analysis of randomized, prospective trials. We searched for prospective, randomized trials in MEDLINE (1966 to November 2001), the Cochrane Library, and EMBase using the terms colon, penetrating, injury, colostomy, prospective, and randomized. Studies were included if they were randomized, controlled trials that compared the outcomes of primary repair with fecal diversion in the management of penetrating colon injuries. Five studies were included. Reviewers performed data extraction independently. Outcomes evaluated from each trial included mortality, total complications, infectious complications, intra-abdominal infections, wound complications, penetrating abdominal trauma index, and length of stay. Peto odds ratios for combined effect were calculated with a 95 percent confidence interval for each outcome. Heterogeneity was also assessed for each outcome. The penetrating abdominal trauma index of included subjects did not differ significantly between studies. Mortality was not significantly different between groups (odds ratio, 1.70; 95 percent confidence interval, 0.51-5.66). However, total complications (odds ratio, 0.28; 95 percent confidence interval, 0.18-0.42), total infectious complications (odds ratio, 0.41; 95 percent confidence interval, 0.27-0.63), abdominal infections including dehiscence (odds ratio, 0.59; 95 percent confidence interval, 0.38-0.94), abdominal infections excluding dehiscence (odds ratio, 0.52; 95 percent confidence interval, 0.31-0.86), wound complications including dehiscence (odds ratio, 0.55; 95 percent confidence interval, 0.34-0.89), and wound complications excluding dehiscence (odds ratio, 0.43; 95 percent confidence interval, 0.25-0.76) all significantly favored primary repair. Meta-analysis of currently published randomized, controlled trials favors primary repair over fecal diversion for penetrating colon injuries.

Quadrupling Inhaled Glucocorticoid Dose to Abort Asthma Exacerbations.

PubMed

McKeever, Tricia; Mortimer, Kevin; Wilson, Andrew; Walker, Samantha; Brightling, Christopher; Skeggs, Andrew; Pavord, Ian; Price, David; Duley, Lelia; Thomas, Mike; Bradshaw, Lucy; Higgins, Bernard; Haydock, Rebecca; Mitchell, Eleanor; Devereux, Graham; Harrison, Timothy

2018-03-08

Asthma exacerbations are frightening for patients and are occasionally fatal. We tested the concept that a plan for patients to manage their asthma (self-management plan), which included a temporary quadrupling of the dose of inhaled glucocorticoids when asthma control started to deteriorate, would reduce the incidence of severe asthma exacerbations among adults and adolescents with asthma. We conducted a pragmatic, unblinded, randomized trial involving adults and adolescents with asthma who were receiving inhaled glucocorticoids, with or without add-on therapy, and who had had at least one exacerbation in the previous 12 months. We compared a self-management plan that included an increase in the dose of inhaled glucocorticoids by a factor of 4 (quadrupling group) with the same plan without such an increase (non-quadrupling group), over a period of 12 months. The primary outcome was the time to a first severe asthma exacerbation, defined as treatment with systemic glucocorticoids or an unscheduled health care consultation for asthma. A total of 1922 participants underwent randomization, of whom 1871 were included in the primary analysis. The number of participants who had a severe asthma exacerbation in the year after randomization was 420 (45%) in the quadrupling group as compared with 484 (52%) in the non-quadrupling group, with an adjusted hazard ratio for the time to a first severe exacerbation of 0.81 (95% confidence interval, 0.71 to 0.92; P=0.002). The rate of adverse effects, which were related primarily to local effects of inhaled glucocorticoids, was higher in the quadrupling group than in the non-quadrupling group. In this trial involving adults and adolescents with asthma, a personalized self-management plan that included a temporary quadrupling of the dose of inhaled glucocorticoids when asthma control started to deteriorate resulted in fewer severe asthma exacerbations than a plan in which the dose was not increased. (Funded by the Health Technology Assessment Programme of the National Institute for Health Research; Current Controlled Trials number, ISRCTN15441965 .).

The relative effectiveness of self-management programs for type 2 diabetes.

PubMed

McGowan, Patrick

2015-10-01

The objectives of the study were to investigate the effectiveness of 2 types of peer-led self-management programs in bringing about improvements in subjects with type 2 diabetes mellitus and to determine whether there were differences in effectiveness between the 2 programs. The study used a 3-arm randomized controlled trial design with clinical measures taken at baseline and at 6 and 12 months post-program. In total, 405 persons completed baseline questionnaires and were randomly allocated to a diabetes self-management program (n=130), to a general self-management program (n=109) or to a control group (n=122). A 2-way factorial analyses of variance was employed as the primary statistical analysis. The findings showed that the self-management programs had affected 5 of the 30 measures: fatigue, cognitive symptom management, self-efficacy with regard to the disease in general, communication with physician, and the score on the Diabetes Empowerment Scale. In addition, 3 variables-social role limitations, total hospital nights and glycated hemoglobin levels-showed marginally significant interaction effects. The second analysis found similar results, with 4 of the 5 measures remaining statistically significant: fatigue, cognitive symptom management, communication with physician and diabetes empowerment, with neither program being more effective than the other. The major findings are that although both programs were effective in bringing about positive changes in the outcome measures, there was little difference in effectiveness between the Diabetes Self-Management Program and the Chronic Disease Self-Management Program. This finding is consistent with the principle that behaviour-change strategies using self-efficacy are key components in health education programs. Copyright © 2015 Canadian Diabetes Association. Published by Elsevier Inc. All rights reserved.

A Randomized Longitudinal Factorial Design to Assess Malaria Vector Control and Disease Management Interventions in Rural Tanzania

PubMed Central

Kramer, Randall A.; Mboera, Leonard E. G.; Senkoro, Kesheni; Lesser, Adriane; Shayo, Elizabeth H.; Paul, Christopher J.; Miranda, Marie Lynn

2014-01-01

The optimization of malaria control strategies is complicated by constraints posed by local health systems, infrastructure, limited resources, and the complex interactions between infection, disease, and treatment. The purpose of this paper is to describe the protocol of a randomized factorial study designed to address this research gap. This project will evaluate two malaria control interventions in Mvomero District, Tanzania: (1) a disease management strategy involving early detection and treatment by community health workers using rapid diagnostic technology; and (2) vector control through community-supported larviciding. Six study villages were assigned to each of four groups (control, early detection and treatment, larviciding, and early detection and treatment plus larviciding). The primary endpoint of interest was change in malaria infection prevalence across the intervention groups measured during annual longitudinal cross-sectional surveys. Recurring entomological surveying, household surveying, and focus group discussions will provide additional valuable insights. At baseline, 962 households across all 24 villages participated in a household survey; 2,884 members from 720 of these households participated in subsequent malariometric surveying. The study design will allow us to estimate the effect sizes of different intervention mixtures. Careful documentation of our study protocol may also serve other researchers designing field-based intervention trials. PMID:24840349

A randomized longitudinal factorial design to assess malaria vector control and disease management interventions in rural Tanzania.

PubMed

Kramer, Randall A; Mboera, Leonard E G; Senkoro, Kesheni; Lesser, Adriane; Shayo, Elizabeth H; Paul, Christopher J; Miranda, Marie Lynn

2014-05-16

The optimization of malaria control strategies is complicated by constraints posed by local health systems, infrastructure, limited resources, and the complex interactions between infection, disease, and treatment. The purpose of this paper is to describe the protocol of a randomized factorial study designed to address this research gap. This project will evaluate two malaria control interventions in Mvomero District, Tanzania: (1) a disease management strategy involving early detection and treatment by community health workers using rapid diagnostic technology; and (2) vector control through community-supported larviciding. Six study villages were assigned to each of four groups (control, early detection and treatment, larviciding, and early detection and treatment plus larviciding). The primary endpoint of interest was change in malaria infection prevalence across the intervention groups measured during annual longitudinal cross-sectional surveys. Recurring entomological surveying, household surveying, and focus group discussions will provide additional valuable insights. At baseline, 962 households across all 24 villages participated in a household survey; 2,884 members from 720 of these households participated in subsequent malariometric surveying. The study design will allow us to estimate the effect sizes of different intervention mixtures. Careful documentation of our study protocol may also serve other researchers designing field-based intervention trials.

Biofeedback Intervention for Stress and Anxiety among Nursing Students: A Randomized Controlled Trial

PubMed Central

Ratanasiripong, Paul; Ratanasiripong, Nop; Kathalae, Duangrat

2012-01-01

Purpose. It has been well documented that nursing students across the world experience stress and anxiety throughout their education and training. The purpose of this randomized controlled study is to investigate the impact of biofeedback intervention program on nursing students' levels of stress and anxiety during their first clinical training. Methods. Participants consisted of 60 second-year baccalaureate nursing students. The 30 participants in the biofeedback group received training on how to use the biofeedback device to assist in stress and anxiety management for 5 weeks while the 30 in the control group did not receive any training. Findings. Results indicated that the biofeedback group was able to maintain the stress level while the control group had a significant increase in the stress level over the 5-week period of clinical training. Additionally, the biofeedback group had a significant reduction in anxiety, while the control group had a moderate increase in anxiety. Conclusions. The better the nursing students can manage their stress and anxiety, the more successful they can be in their clinical training. Ultimately, the more psychologically healthy the nursing students are, the more likely they will flourish and graduate to become productive and contributing members of the nursing profession. PMID:22811932

A randomized controlled trial of long term effect of BCM guided fluid management in MHD patients (BOCOMO study): rationales and study design

PubMed Central

2012-01-01

Background Bioimpedance analysis (BIA) has been reported as helpful in identifying hypervolemia. Observation data showed that hypervolemic maintenance hemodialysis (MHD) patients identified using BIA methods have higher mortality risk. However, it is not known if BIA-guided fluid management can improve MHD patients’ survival. The objectives of the BOCOMO study are to evaluate the outcome of BIA guided fluid management compared with standard care. Methods This is a multicenter, prospective, randomized, controlled trial. More than 1300 participants from 16 clinical sites will be included in the study. The enrolment period will last 6 months, and minimum length of follow-up will be 36 months. MHD patients aged between 18 years and 80 years who have been on MHD for at least 3 months and meet eligibility criteria will be invited to participate in the study. Participants will be randomized to BIA arm or control arm in a 1:1 ratio. A portable whole body bioimpedance spectroscopy device (BCM—Fresenius Medical Care D GmbH) will be used for BIA measurement at baseline for both arms of the study. In the BIA arm, additional BCM measurements will be performed every 2 months. The primary intent-to-treat analysis will compare outcomes for a composite endpoint of death, acute myocardial infarction, stroke or incident peripheral arterial occlusive disease between groups. Secondary endpoints will include left ventricular wall thickness, blood pressure, medications, and incidence and length of hospitalization. Discussions Previous results regarding the benefit of strict fluid control are conflicting due to small sample sizes and unstable dry weight estimating methods. To our knowledge this is the first large-scale, multicentre, prospective, randomized controlled trial to assess whether BIS-guided volume management improves outcomes of MHD patients. The endpoints of the BOCOMO study are of utmost importance to health care providers. In order to obtain that aim, the study was designed with very careful important considerations related to the endpoints, sample size, inclusion criteria, exclusion criteria and so on. For example, annual mortality of Beijing MHD patients was around 10%. To reach statistical significance, the sample size will be very large. By using composite endpoint, the sample size becomes reasonable and feasible. Limiting inclusion to patients with urine volume less than 800 ml/day the day before dialysis session will limit confounding due to residual renal function effects on the measured parameters. Patients who had received BIS measurement within 3 months prior to enrolment are excluded as data from such measurements might lead to protocol violation. Although not all patients enrolled will be incident patients, we will record the vintage of dialysis in the multivariable analysis. Trial registration Current Controlled Trials NCT01509937 PMID:23006960

Health-related quality of life in a multicenter randomized controlled comparison of telephonic disease management and automated home monitoring in patients recently hospitalized with heart failure: SPAN-CHF II trial.

PubMed

Konstam, Varda; Gregory, Douglas; Chen, Jie; Weintraub, Andrew; Patel, Ayan; Levine, Daniel; Venesy, David; Perry, Kathleen; Delano, Christine; Konstam, Marvin A

2011-02-01

Although disease management programs have been shown to provide a number of clinical benefits to patients with heart failure (HF), the incremental impact of an automated home monitoring (AHM) system on health-related quality of life (HRQL) is unknown. We performed a prospective randomized investigation, examining the additive value of AHM to a previously described nurse-directed HF disease management program (SPAN-CHF), with attention to HRQL, in patients with a recent history of decompensated HF. A total of 188 patients were randomized to receive the SPAN-CHF intervention for 90 days, either with (AHM group) or without (NAHM, standard-care group) AHM, with a 1:1 randomization ratio after HF-related hospitalization. HRQL, measured by the Minnesota Living With Heart Failure Questionnaire (MLHFQ) (Physical, Emotional, and Total scores on MLHFQ) was assessed at 3 time points: baseline, 45 days, and 90 days. Although both treatments (AHM and NAHM) improved HRQL at 45 and 90 days compared with baseline with respect to Physical, Emotional, and Total domain scales, no significant difference emerged between AHM and NAHM groups. AHM and NAHM treatments demonstrated improved HRQL scores at 45 and 90 days after baseline assessment. When comparing 2 state-of the-art disease management programs regarding HRQL outcomes, our results did not support the added value of AHM. Copyright © 2011. Published by Elsevier Inc.

Providing intensive addiction/housing case management to homeless veterans enrolled in addictions treatment: A randomized controlled trial.

PubMed

Malte, Carol A; Cox, Koriann; Saxon, Andrew J

2017-05-01

This study sought to determine whether homeless veterans entering Veterans Affairs (VA) substance use treatment randomized to intensive addiction/housing case management (AHCM) had improved housing, substance use, mental health, and functional outcomes and lower acute health care utilization, compared to a housing support group (HSG) control. Homeless veterans (n = 181) entering outpatient VA substance use treatment were randomized to AHCM and HSG and received treatment for 12 months. AHCM provided individualized housing, substance use and mental health case management, life skills training, and community outreach. The control condition was a weekly drop-in housing support group. Adjusted longitudinal analyses compared groups on baseline to month 12 change in percentage of days housed and functional status, substance use, and mental health outcomes (36-Item Short-Form Health Survey; Addiction Severity Index [ASI]). Negative binomial regression models compared groups on health care utilization. Both conditions significantly increased percentage of days housed, with no differences detected between conditions. In total, 74 (81.3%) AHCM and 64 (71.1%) HSG participants entered long-term housing (odds ratio = 1.9, 95% confidence interval [0.9, 4.0], p = .088). HSG participants experienced a greater decrease in emergency department visits than AHCM (p = .037), whereas AHCM participants remained in substance use treatment 52.7 days longer (p = .005) and had greater study treatment participation (p < .001) than HSG. ASI alcohol composite scores improved more for HSG than AHCM (p = .006), and both conditions improved on ASI drug and psychiatric scores and alcohol/drug abstinence. AHCM did not demonstrate overarching benefits beyond standard VA housing and substance use care. For those veterans not entering or losing long-term housing, different approaches to outreach and ongoing intervention are required. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

A store-based intervention to increase fruit and vegetable consumption: The El Valor de Nuestra Salud cluster randomized controlled trial

PubMed Central

Ayala, Guadalupe X.; Baquero, Barbara; Pickrel, Julie L.; Mayer, Joni; Belch, George; Rock, Cheryl L.; Linnan, Laura; Gittelsohn, Joel; Sanchez-Flack, Jennifer; Elder, John P.

2015-01-01

Introduction Most evidence-based interventions to improve fruit and vegetable (FV) consumption target individual behaviors and family systems; however, these changes are difficult to sustain without environmental support. This paper describes an innovative social and structural food store-based intervention to increase availability and accessibility of FVs in tiendas (small-to medium-sized Latino food stores) and purchasing and consumption of FVs among tienda customers. Methods Using a cluster randomized controlled trial with 16 tiendas pair-matched and randomized to an intervention or wait-list control condition, this study will evaluate a 2-month intervention directed at tiendas, managers, and employees followed by a 4-month customer-directed food marketing campaign. The intervention involves social (e.g., employee trainings) and structural (e.g., infrastructure) environmental changes. Three hundred sixty-nine customers (approximately 23 per tienda) serve on an evaluation cohort and complete assessments (interviews and measurements of weight) at 3 time points: baseline, 6-months post-baseline, and 12-months post-baseline. The primary study outcome is customer-reported daily consumption of FVs. Manager interviews and monthly tienda audits and collection of sales data will provide evidence of tienda-level intervention effects, our secondary outcomes. Process evaluation methods assess dose delivered, dose received, and fidelity. Results Recruitment of tiendas, managers, employees, and customers is complete. Demographic data shows that 30% of the customers are males, thus providing a unique opportunity to examine the effects of a tienda-based intervention on Latino men. Conclusions Determining whether a tienda-based intervention can improve customers’ FV purchasing and consumption will provide key evidence for how to create healthier consumer food environments. PMID:25924592

A store-based intervention to increase fruit and vegetable consumption: The El Valor de Nuestra Salud cluster randomized controlled trial.

PubMed

Ayala, Guadalupe X; Baquero, Barbara; Pickrel, Julie L; Mayer, Joni; Belch, George; Rock, Cheryl L; Linnan, Laura; Gittelsohn, Joel; Sanchez-Flack, Jennifer; Elder, John P

2015-05-01

Most evidence-based interventions to improve fruit and vegetable (FV) consumption target individual behaviors and family systems; however, these changes are difficult to sustain without environmental support. This paper describes an innovative social and structural food store-based intervention to increase availability and accessibility of FVs in tiendas (small- to medium-sized Latino food stores) and purchasing and consumption of FVs among tienda customers. Using a cluster randomized controlled trial with 16 tiendas pair-matched and randomized to an intervention or wait-list control condition, this study will evaluate a 2-month intervention directed at tiendas, managers, and employees followed by a 4-month customer-directed food marketing campaign. The intervention involves social (e.g., employee trainings) and structural (e.g., infrastructure) environmental changes. Three hundred sixty-nine customers (approximately 23 per tienda) serve on an evaluation cohort and complete assessments (interviews and measurements of weight) at 3 time points: baseline, 6-months post-baseline, and 12-months post-baseline. The primary study outcome is customer-reported daily consumption of FVs. Manager interviews and monthly tienda audits and collection of sales data will provide evidence of tienda-level intervention effects, our secondary outcomes. Process evaluation methods assess dose delivered, dose received, and fidelity. Recruitment of tiendas, managers, employees, and customers is complete. Demographic data shows that 30% of the customers are males, thus providing a unique opportunity to examine the effects of a tienda-based intervention on Latino men. Determining whether a tienda-based intervention can improve customers' FV purchasing and consumption will provide key evidence for how to create healthier consumer food environments. Copyright © 2015 Elsevier Inc. All rights reserved.

Rationale and design of the Staying Positive with Arthritis (SPA) Study: A randomized controlled trial testing the impact of a positive psychology intervention on racial disparities in pain.

PubMed

Hausmann, Leslie R M; Ibrahim, Said A; Kwoh, C Kent; Youk, Ada; Obrosky, D Scott; Weiner, Debra K; Vina, Ernest; Gallagher, Rollin M; Mauro, Genna T; Parks, Acacia

2018-01-01

Knee osteoarthritis is a painful, disabling condition that disproportionately affects African Americans. Existing arthritis treatments yield small to moderate improvements in pain and have not been effective at reducing racial disparities in the management of pain. The biopsychosocial model of pain and evidence from the positive psychology literature suggest that increasing positive psychological skills (e.g., gratitude, kindness) could improve pain and functioning and reduce disparities in osteoarthritis pain management. Activities to cultivate positive psychological skills have been developed and validated; however, they have not been tested in patients with osteoarthritis, their effects on racial differences in health outcomes have not been examined, and evidence of their effects on health outcomes in patients with other chronic illnesses is of limited quality. In this article we describe the rationale and design of Staying Positive with Arthritis (SPA) study, a randomized controlled trial in which 180 African American and 180 White primary care patients with chronic pain from knee osteoarthritis will be randomized to a 6-week program of either positive skill-building activities or neutral control activities. The primary outcomes will be self-reported pain and functioning as measured by the WOMAC Osteoarthritis Index. We will assess these primary outcomes and potential, exploratory psychosocial mediating variables at an in-person baseline visit and by telephone at 1, 3, and 6months following completion of the assigned program. If effective, the SPA program would be a novel, theoretically-informed psychosocial intervention to improve quality and equity of care in the management of chronic pain from osteoarthritis. Published by Elsevier Inc.

A study protocol for a single-blind, randomized controlled trial of adjunctive transcranial direct current stimulation (tDCS) for chronic pain among patients receiving specialized, inpatient multimodal pain management.

PubMed

Janice Jimenez-Torres, G; Weinstein, Benjamin L; Walker, Cory R; Christopher Fowler, J; Ashford, Philippa; Borckardt, Jeffrey J; Madan, Alok

2017-03-01

Available treatments for chronic pain (CP) are modestly effective or associated with iatrogenic harm. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that may be an effective, adjunctive treatment to non-opioid therapies. In this randomized control trial (RCT), we compare adjunctive active versus sham tDCS among patients in a multimodal inpatient pain management program. The primary objectives of the RCT are to improve pain tolerance and subjective pain experience. Patients admitted to the Pain Management Program at The Menninger Clinic in Houston, Texas are eligible for this trial. Eighty-four participants will be randomized (1:1) into a single-blind, 2×12 (group×time) controlled trial. A battery-powered direct and constant current stimulator (Soterix Medical Inc. 2014) delivers anodal stimulation over the left dorsolateral prefrontal cortex (DLPFC) and cathodal stimulation over the right DLPFC. Active tDCS is applied by supplying a 2mA current for 20min/session over 10 sessions. Participants complete self-report and performance-based assessments on a weekly basis just prior to brain stimulation. Self-report assessments are collected via Chronic Pain Tracker version 3.6, an iPad interfaced application. The performance-based pain tolerance task is completed through the cold presser task. Interventions with cross-symptomatic therapeutic potential are absolutely essential in the context of CP, in which psychiatric comorbidity is the norm. Modalities that can be used in tandem with evidence-based, non-opioid therapies have the potential to have a synergistic effect, resulting in increased effectiveness of what have been modestly effective treatments to date. Copyright © 2017 Elsevier Inc. All rights reserved.

Parent Involvement Intervention in Developing Weight Management Skills for both Parents and Overweight/Obese Children.

PubMed

Kim, Hee Soon; Park, Jiyoung; Park, Kye-Yeong; Lee, Myung-Nam; Ham, Ok Kyung

2016-03-01

The purpose of the study was to evaluate a parent involvement intervention for childhood obesity intended to increase parents' skills in managing children's weight-related behavior and to improve child-parent relationships. Many studies reported on parental influence on childhood obesity, emphasizing parent involvement in prevention and management of childhood obesity. A randomized controlled trial was conducted. Forty-two parents of overweight/obese children were recruited from four cities and randomized to the experimental group or control group. The parental intervention was provided only to parents in the experimental group and consisted of weekly newsletters and text messages for a period of 5 weeks. Exercise classes and nutrition education were provided to all children. Lifestyle Behaviour Checklist and the Child-Parent Relationship Scale (CPRS) were used for measurement of parent outcome. For the child outcome, dietary self-efficacy, exercise frequency, and body mass index were measured. A mixed-design analysis of variance was performed with city location entered as a random effect. After the intervention, CPRS of parents and dietary self-efficacy of children showed an increase in the experimental group (p < .05). Intervention effects differed significantly according to the city location regarding the control efficacy of parents and dietary self-efficacy of children (p < .05). The results support the effectiveness of the parent involvement intervention in promoting child-parent relationship and dietary self-efficacy of children. However, a 5-week parent involvement intervention was not sufficient to produce significant changes in children's body mass index. Further research is needed to investigate effects of parent involvement intervention with long-term evaluation. Copyright © 2016. Published by Elsevier B.V.

Advancing current approaches to disease management evaluation: capitalizing on heterogeneity to understand what works and for whom.

PubMed

Elissen, Arianne M J; Adams, John L; Spreeuwenberg, Marieke; Duimel-Peeters, Inge G P; Spreeuwenberg, Cor; Linden, Ariel; Vrijhoef, Hubertus J M

2013-03-14

Evaluating large-scale disease management interventions implemented in actual health care settings is a complex undertaking for which universally accepted methods do not exist. Fundamental issues, such as a lack of control patients and limited generalizability, hamper the use of the 'gold-standard' randomized controlled trial, while methodological shortcomings restrict the value of observational designs. Advancing methods for disease management evaluation in practice is pivotal to learn more about the impact of population-wide approaches. Methods must account for the presence of heterogeneity in effects, which necessitates a more granular assessment of outcomes. This paper introduces multilevel regression methods as valuable techniques to evaluate 'real-world' disease management approaches in a manner that produces meaningful findings for everyday practice. In a worked example, these methods are applied to retrospectively gathered routine health care data covering a cohort of 105,056 diabetes patients who receive disease management for type 2 diabetes mellitus in the Netherlands. Multivariable, multilevel regression models are fitted to identify trends in clinical outcomes and correct for differences in characteristics of patients (age, disease duration, health status, diabetes complications, smoking status) and the intervention (measurement frequency and range, length of follow-up). After a median one year follow-up, the Dutch disease management approach was associated with small average improvements in systolic blood pressure and low-density lipoprotein, while a slight deterioration occurred in glycated hemoglobin. Differential findings suggest that patients with poorly controlled diabetes tend to benefit most from disease management in terms of improved clinical measures. Additionally, a greater measurement frequency was associated with better outcomes, while longer length of follow-up was accompanied by less positive results. Despite concerted efforts to adjust for potential sources of confounding and bias, there ultimately are limits to the validity and reliability of findings from uncontrolled research based on routine intervention data. While our findings are supported by previous randomized research in other settings, the trends in outcome measures presented here may have alternative explanations. Further practice-based research, perhaps using historical data to retrospectively construct a control group, is necessary to confirm results and learn more about the impact of population-wide disease management.

"Why Didn't it Work?" Lessons From a Randomized Controlled Trial of a Web-based Personally Controlled Health Management System for Adults with Asthma.

PubMed

Lau, Annie Y S; Arguel, Amaël; Dennis, Sarah; Liaw, Siaw-Teng; Coiera, Enrico

2015-12-15

Personally controlled health management systems (PCHMS), which may include a personal health record (PHR), health management tools, and information resources, have been advocated as a next-generation technology to improve health behaviors and outcomes. There have been successful trials of PCHMS in various health settings. However, there is mixed evidence for whether consumers will use these systems over the long term and whether they ultimately lead to improved health outcomes and behaviors. The aim was to test whether use of a PCHMS by consumers can increase the uptake or updating of a written asthma action plan (AAP) among adults with asthma. A 12-month parallel 2-group randomized controlled trial was conducted. Participants living with asthma were recruited nationally in Australia between April and August 2013, and randomized 1:1 to either the PCHMS group or control group (online static educational content). The primary outcome measure was possession of an up-to-date written AAP poststudy. Secondary measures included (1) utilizing the AAP; (2) planned or unplanned visits to a health care professional for asthma-related concerns; (3) severe asthma exacerbation, inadequately controlled asthma, or worsening of asthma that required a change in treatment; and (4) number of days lost from work or study due to asthma. Ancillary analyses examined reasons for adoption or nonadoption of the intervention. Outcome measures were collected by online questionnaire prestudy, monthly, and poststudy. A total of 330 eligible participants were randomized into 1 of 2 arms (intervention: n=154; control: n=176). Access to the PCHMS was not associated with a significant difference in any of the primary or secondary outcomes. Most participants (80.5%, 124/154) did not access the intervention or accessed it only once. Despite the intervention being effective in other preventive care settings, system use was negligible and outcome changes were not seen as a result. Consumers must perceive the need for assistance with a task and assign priority to the task supported by the eHealth intervention. Additionally, the cost of adopting the intervention (eg, additional effort, time spent learning the new system) must be lower than the benefit. Otherwise, there is high risk consumers will not adopt the eHealth intervention. Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12612000716864; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=362714 (Archived by WebCite® at http://www.webcitation.org/6dMV6hg4A).

Application of a sub-specialties management model improves quality control in a central sterile supply department.

PubMed

Wang, Li; Cai, Xuejiao; Cheng, Ping

2018-05-30

The management of medical devices is crucial to safe, high-quality surgical care, but has received little attention in the medical literature. This study explored the effect of a sub-specialties management model in the Central Sterile Supply Department (CSSD). A traditional routine management model (control) was applied from September 2015 through April 2016, and a newly developed sub-specialties management model (observation) was applied from July 2016 through February 2017. Health personnel from various clinical departments were randomly selected to participate as the control (n = 86) and observation (n = 90) groups, respectively. The groups were compared for rates of personnel satisfaction, complaints regarding device errors, and damage of medical devices. The satisfaction score of the observation group (95.8 ± 1.2) was significantly higher than that of the control (90.2 ± 2.3; P = 0.000). The rate of complaints of the observation group (3.3%) was significantly lower than that of the control (11.6%; P = 0.035). The quality control regarding recycle and packing was significantly higher during the observation period than the control period, which favorably influenced the scores for satisfaction. The rate of damage to specialist medical devices during the observation period (0.40%) was lower than during the control period (0.61%; P = 0.003). The theoretical knowledge and practical skills of the CSSD professionals improved after application of the sub-specialties management model. A management model that considers the requirements of specialist medical devices can improve quality control in the CSSD.

Health and loyalty promotion visits for new enrollees: results of a randomized controlled trial.

PubMed

Thompson, M; Gee, S; Larson, P; Kotz, K; Northrop, L

2001-01-01

Managed care needs effective and efficient ways to orient new members, enhance trust and loyalty, and offer prevention and self-care education and services. Recent adult enrollees of Kaiser Permanente (Northern California) were randomly assigned to one of three intervention conditions (n = 286) (individual visit with a physician, physician visit plus a visit with a health educator, a group visit of eight new members led by a physician and health educator) or a random control group (n = 278). Outcomes were gauged via pre- and post-visit questionnaires and a 20-min telephone survey at baseline and at a 6-month follow-up. Compared to controls, attendees of the three interventions had higher satisfaction, self-rated prevention knowledge, acceptance of health plan guidelines, and were more likely to plan to remain in the health plan. Group visit attendees stood out as experiencing the greatest benefits and were especially likely to report saving a telephone call or visit to their doctor by using a self-care handbook.

Effective behavioral intervention strategies using mobile health applications for chronic disease management: a systematic review.

PubMed

Lee, Jung-Ah; Choi, Mona; Lee, Sang A; Jiang, Natalie

2018-02-20

Mobile health (mHealth) has continuously been used as a method in behavioral research to improve self-management in patients with chronic diseases. However, the evidence of its effectiveness in chronic disease management in the adult population is still lacking. We conducted a systematic review to examine the effectiveness of mHealth interventions on process measures as well as health outcomes in randomized controlled trials (RCTs) to improve chronic disease management. Relevant randomized controlled studies that were published between January 2005 and March 2016 were searched in six databases: PubMed, CINAHL, EMBASE, the Cochrane Library, PsycINFO, and Web of Science. The inclusion criteria were RCTs that conducted an intervention using mobile devices such as smartphones or tablets for adult patients with chronic diseases to examine disease management or health promotion. Of the 12 RCTs reviewed, 10 of the mHealth interventions demonstrated statistically significant improvement in some health outcomes. The most common features of mHealth systems used in the reviewed RCTs were real-time or regular basis symptom assessments, pre-programed reminders, or feedbacks tailored specifically to the data provided by participants via mHealth devices. Most studies developed their own mHealth systems including mobile apps. Training of mHealth systems was provided to participants in person or through paper-based instructions. None of the studies reported the relationship between health outcomes and patient engagement levels on the mHealth system. Findings from mHealth intervention studies for chronic disease management have shown promising aspects, particularly in improving self-management and some health outcomes.

Dose Adjustment for Normal Eating: A Role for the Expert Patient?

PubMed Central

2014-01-01

The Dose Adjustment for Normal Eating (DAFNE) programme of intensive insulin therapy for type 1 diabetes provides a structured educational intervention to improve glycemic control, reduce hypoglycemia and improve quality of life. Enhancement of self-management skills is a key element of DAFNE and patients acquire detailed skills in insulin dose adjustment. Following DAFNE training, patients report improved confidence in their ability to manage their own insulin dosing, but generally still seek and require the assistance of health professionals when making substantial changes to their insulin regimens. Some DAFNE trained patients may be able to assist their peers in aspects of diabetes management within a group environment, but widespread introduction of the expert patient/peer educator role in the self-management of type 1 diabetes, in particular related to insulin dose management, would require formal and detailed evaluation, preferably in randomized controlled clinical trials, before being introduced into routine clinical practice. PMID:24851201

Current role of modern radiotherapy techniques in the management of breast cancer

PubMed Central

Ozyigit, Gokhan; Gultekin, Melis

2014-01-01

Breast cancer is the most common type of malignancy in females. Advances in systemic therapies and radiotherapy (RT) provided long survival rates in breast cancer patients. RT has a major role in the management of breast cancer. During the past 15 years several developments took place in the field of imaging and irradiation techniques, intensity modulated RT, hypofractionation and partial-breast irradiation. Currently, improvements in the RT technology allow us a subsequent decrease in the treatment-related complications such as fibrosis and long-term cardiac toxicity while improving the loco-regional control rates and cosmetic results. Thus, it is crucial that modern radiotherapy techniques should be carried out with maximum care and efficiency. Several randomized trials provided evidence for the feasibility of modern radiotherapy techniques in the management of breast cancer. However, the role of modern radiotherapy techniques in the management of breast cancer will continue to be defined by the mature results of randomized trials. Current review will provide an up-to-date evidence based data on the role of modern radiotherapy techniques in the management of breast cancer. PMID:25114857

Impact of Targeted Preoperative Optimization on Clinical Outcome in Emergency Abdominal Surgeries: A Prospective Randomized Trial.

PubMed

Sethi, Ashish; Debbarma, Miltan; Narang, Neeraj; Saxena, Anudeep; Mahobia, Mamta; Tomar, Gaurav Singh

2018-01-01

Perforation peritonitis continues to be one of the most common surgical emergencies that need a surgical intervention most of the times. Anesthesiologists are invariably involved in managing such cases efficiently in perioperative period. The assessment and evaluation of Acute Physiology and Chronic Health Evaluation II (APACHE II) score at presentation and 24 h after goal-directed optimization, administration of empirical broad-spectrum antibiotics, and definitive source control postoperatively. Outcome assessment in terms of duration of hospital stay and mortality in with or without optimization was also measured. It is a prospective, randomized, double-blind controlled study in hospital setting. One hundred and one patients aged ≥18 years, of the American Society of Anesthesiologists physical Status I and II (E) with clinical diagnosis of perforation peritonitis posted for surgery were enrolled. Enrolled patients were randomly divided into two groups. Group A is optimized by goal-directed optimization protocol in the preoperative holding room by anesthesiology residents whereas in Group S, managed by surgery residents in the surgical wards without any fixed algorithm. The assessment of APACHE II score was done as a first step on admission and 24 h postoperatively. Duration of hospital stay and mortality in both the groups were also measured and compared. Categorical data are presented as frequency counts (percent) and compared using the Chi-square or Fisher's exact test. The statistical significance for categorical variables was determined by Chi-square analysis. For continuous variables, a two-sample t -test was applied. The mean APACHE II score on admission in case and control groups was comparable. Significant lowering of serial scores in case group was observed as compared to control group ( P = 0.02). There was a significant lowering of mean duration of hospital stay seen in case group (9.8 ± 1.7 days) as compared to control group ( P = 0.007). Furthermore, a significant decline in death rate was noted in case group as compared to control group ( P = 0.03). Goal-directed optimized patients with perforation peritonitis were discharged early as compared to control group with significantly lesser mortality as compared with randomly optimized patients in the perioperative period.

Primary Definitive Procedure versus Conventional Three-staged Procedure for the Management of Low-type Anorectal Malformation in Females: A Randomized Controlled Trial.

PubMed

Gupta, Alisha; Agarwala, Sandeep; Sreenivas, Vishnubhatla; Srinivas, Madhur; Bhatnagar, Veereshwar

2017-01-01

Females with Krickenbeck low-type anorectal malformations - vestibular fistula (VF) and perineal fistula (PF) - are managed either by a primary definitive or conventional three-staged approach. Ultimate outcome in these children may be affected by wound dehiscence leading to healing by fibrosis. Most of the literature favors one approach over other based on retrospective analysis of their outcomes. Whether a statistically significant difference in wound dehiscence rates between these approaches exists needed to be seen. A randomized controlled trial for girls <14 years with VF or PF was done. Random tables were used to randomize 33 children to Group I (primary procedure) and 31 to Group II (three-staged procedure). Statistical analysis was done for significance of difference ( P < 0.05) in the primary outcome (wound dehiscence) and secondary outcomes (immediate and early postoperative complications). Of the 64 children randomized, 54 (84%) had VF. Both groups were comparable in demography, clinical profile and age at surgery. The incidence of wound dehiscence (39.4% vs. 18.2%; P = 0.04), immediate postoperative complications (51.5% vs. 12.9%; P = 0.001), and early postoperative complications (42.4% vs. 12.9%; P = 0.01) was significantly higher in Group I as compared to Group II. Six of 13 children (46.2%) with dehiscence in Group I required a diverting colostomy to be made. Females with VF or PF undergoing primary definitive procedure have a significantly higher incidence of wound dehiscence ( P = 0.04), immediate ( P = 0.001) and early postoperative complications ( P = 0.01).

Evaluation of a smartphone application for self-care performance of patients with chronic hepatitis B: A randomized controlled trial.

PubMed

Jeon, Jae Hee

2016-11-01

To verify the usefulness of a smartphone application (App) for facilitating self-care in patients with chronic hepatitis B (CHB). CHB is a global health problem, and patients with CHB need to routinely perform self-care. Health-related smartphone apps could help users self-manage their disease. Fifty-three CHB patients were assessed in this randomized controlled before-and-after experimental study. The patients were randomly and equally assigned to groups that did (n=26) or did not (n=27) use the smartphone app for 12weeks. The experimental and control groups were analyzed for differences in disease knowledge, self-efficacy, and self-care before and after use of the smartphone app. After intervention, patients who used the app displayed significantly increased disease knowledge compared with the control group (p=.015). Self-efficacy and self-care also significantly increased in the experimental group (p=0.006 and 0.001, respectively). The smartphone app can be useful for increasing self-care in CHB patients. App: application, CHB: chronic hepatitis B, CVI: content validity. Copyright © 2016 Elsevier Inc. All rights reserved.

Effects of yoga on chronic neck pain: a systematic review of randomized controlled trials

PubMed Central

Kim, Sang-Dol

2016-01-01

[Purpose] The aim of this study was to investigate the effectiveness of yoga in the management of chronic neck pain. [Subjects and Methods] Five electronic databases were searched to identify randomized controlled trials (RCTs) of yoga intervention on chronic neck pain. The trials were published in the English language between January 1966 and December 2015. The Cochrane Risk of Bias Tool was used to assess the quality of the trials. [Results] Three trials were identified and included in this review. A critical appraisal was performed on the trials, and the result indicated a high risk of bias. A narrative description was processed because of the small number of RCTs. Neck pain intensity and functional disability were significantly lower in the yoga groups than in the control groups. [Conclusion] Evidence from the 3 randomly controlled trials shows that yoga may be beneficial for chronic neck pain. The low-quality result of the critical appraisal and the small number of trials suggest that high-quality RCTs are required to examine further the effects of yoga intervention on chronic neck pain relief. PMID:27512290

Effect of PTSD diagnosis and contingency management procedures on cocaine use in dually cocaine and opioid-dependent individuals maintained on LAAM: A retrospective analysis

PubMed Central

Mancino, M.; McGaugh, J.; Feldman, Z.; Poling, J.; Oliveto, A.

2012-01-01

This randomized clinical trial retrospectively examined the effect of Post Traumatic Stress Disorder (PTSD) and contingency management (CM) on cocaine use in opioid and cocaine dependent individuals maintained on high or low-dose LAAM randomly assigned to CM or a yoked-control condition. Cocaine-positive urines decreased more rapidly over time in those without PTSD versus those with PTSD in the non-contingency condition. In participants with PTSD, CM resulted in fewer cocaine positive urines compared to the non-contingent condition. This suggests that CM may help improve the potentially worse outcomes in opioid-and cocaine dependent individuals with PTSD compared to those without PTSD. PMID:20163389

Multimedia educational aids for improving consumer knowledge about illness management and treatment decisions: a review of randomized controlled trials.

PubMed

Jeste, Dilip V; Dunn, Laura B; Folsom, David P; Zisook, Dan

2008-01-01

Psychiatric practice is becoming increasingly more complex in terms of the available treatment options, use of new technologies for assessments, and a need for psychiatric patients and their caregivers to be familiar with general medical procedures. This trend will only intensify in the years to come. Routine methods of providing information relevant to clinical decision making about healthcare evaluations or management are often suboptimal. Relatively little research has been done on enhancing the capacity of psychiatric patients and the caregivers to make truly informed decisions about management. In this paper, we review studies that compared the effects of multimedia (video- or computer-based) educational aids with those of routine procedures to inform healthcare consumers about medical evaluations or management. Although most of these investigations were conducted in non-psychiatric patients, the results should be relevant for psychiatric practice of tomorrow. We searched MEDLINE, PsycINFO, and CINAHL bibliographic databases. Randomized controlled trials that used objective measures of knowledge or understanding of the information provided were selected. Studies were rated as positive if the multimedia educational aid resulted in a greater improvement in knowledge or understanding than the control condition. The quality of each study was also rated using a newly developed Scale for Assessing Scientific Quality of Investigations (SASQI). A total of 37 randomized controlled trials were identified. Nearly two-thirds of the studies (23/37) in diverse patient populations and for varied medical assessments and treatments reported that multimedia educational aids produced better understanding of information compared to routine methods. SASQI scores for the positive and negative studies were comparable, suggesting that lower quality was not related to positive findings. In conclusion, multimedia educational aids hold promise for improving the provision of complex medical information to patients and caregivers. It is likely that as psychiatric patients and their treating clinicians face increasingly complex choices regarding mental health treatment, multimedia decisional aids could become an effective supplement to the clinician patient interaction in near future.

Web-Based and Mobile Stress Management Intervention for Employees: A Randomized Controlled Trial.

PubMed

Heber, Elena; Lehr, Dirk; Ebert, David Daniel; Berking, Matthias; Riper, Heleen

2016-01-27

Work-related stress is highly prevalent among employees and is associated with adverse mental health consequences. Web-based interventions offer the opportunity to deliver effective solutions on a large scale; however, the evidence is limited and the results conflicting. This randomized controlled trial evaluated the efficacy of guided Web- and mobile-based stress management training for employees. A total of 264 employees with elevated symptoms of stress (Perceived Stress Scale-10, PSS-10≥22) were recruited from the general working population and randomly assigned to an Internet-based stress management intervention (iSMI) or waitlist control group. The intervention (GET.ON Stress) was based on Lazarus's transactional model of stress, consisted of seven sessions, and applied both well-established problem solving and more recently developed emotion regulation strategies. Participants also had the opportunity to request automatic text messages on their mobile phone along with the iSMI. Participants received written feedback on every completed session from an e-coach. The primary outcome was perceived stress (PSS-10). Web-based self-report assessments for both groups were scheduled at baseline, 7 weeks, and 6 months. At 12 months, an extended follow-up was carried out for the iSMI group only. An intention-to-treat analysis of covariance revealed significantly large effect differences between iSMI and waitlist control groups for perceived stress at posttest (F1,261=58.08, P<.001; Cohen's d=0.83) and at the 6-month follow-up (F1,261=80.17, P<.001; Cohen's d=1.02). The effects in the iSMI group were maintained at 12-month follow-up. This Web- and mobile-based intervention has proven effective in reducing stress in employees in the long term. Internet-based stress management interventions should be further pursued as a valuable alternative to face-to-face interventions. German Clinical Trials Register (DRKS): 00004749; http://drks-neu.uniklinik-freiburg.de/ drks_web/setLocale_EN.do (Archived by WebCite at http://www.webcitation.org/6e8rl98nl).

A Family-Based Randomized Controlled Trial of Pain Intervention for Adolescents with Sickle Cell Disease

PubMed Central

Barakat, Lamia P.; Schwartz, Lisa A.; Salamon, Katherine S.; Radcliffe, Jerilynn

2010-01-01

The study had two aims--to determine the efficacy of a family-based cognitive-behavioral pain management intervention for adolescents with sickle cell disease (SCD) in (1) reducing pain and improving health-related variables and (2) improving psychosocial outcomes. Each adolescent and a family support person were randomly assigned to receive a brief pain intervention (PAIN) (n = 27) or a disease education attention control intervention (DISEASE ED) (n = 26) delivered at home. Assessment of primary pain and health-related variables (health service use, pain coping, pain-related hindrance of goals) and secondary psychosocial outcomes (disease knowledge, disease self-efficacy, and family communication) occurred at baseline (prior to randomization), post-intervention, and one-year follow-up. Change on outcomes did not differ significantly by group at either time point. When groups were combined in exploratory analyses, there was evidence of small to medium effects of intervention on health-related and psychosocial variables. Efforts to address barriers to participation and improve feasibility of psychosocial interventions for pediatric SCD are critical to advancing development of effective treatments for pain. Sample size was insufficient to adequately test efficacy, and analyses did not support this focused cognitive-behavioral pain management intervention in this sample of adolescents with SCD. Exploratory analyses suggest that comprehensive interventions, that address a broad range of skills related to disease management and adolescent health concerns, may be more effective in supporting teens during healthcare transition. PMID:20686425

POLICY IMPLICATIONS OF ADJUSTING RANDOMIZED TRIAL DATA FOR ECONOMIC EVALUATIONS: A DEMONSTRATION FROM THE ASCUS-LSIL TRIAGE STUDY

PubMed Central

Campos, Nicole G.; Castle, Philip E.; Schiffman, Mark; Kim, Jane J.

2013-01-01

Background Although the randomized controlled trial (RCT) is widely considered the most reliable method for evaluation of health care interventions, challenges to both internal and external validity exist. Thus, the efficacy of an intervention in a trial setting does not necessarily represent the real-world performance that decision makers seek to inform comparative effectiveness studies and economic evaluations. Methods Using data from the ASCUS-LSIL Triage Study (ALTS), we performed a simplified economic evaluation of age-based management strategies to detect cervical intraepithelial neoplasia grade 3 (CIN3) among women who were referred to the study with low-grade squamous intraepithelial lesions (LSIL). We used data from the trial itself to adjust for 1) potential lead time bias and random error that led to variation in the observed prevalence of CIN3 by study arm, and 2) potential ascertainment bias among providers in the most aggressive management arm. Results We found that using unadjusted RCT data may result in counterintuitive cost-effectiveness results when random error and/or bias are present. Following adjustment, the rank order of management strategies changed for two of the three age groups we considered. Conclusion Decision analysts need to examine study design, available trial data and cost-effectiveness results closely in order to detect evidence of potential bias. Adjustment for random error and bias in RCTs may yield different policy conclusions relative to unadjusted trial data. PMID:22147881

Comparing the Efficacy of a Mobile Phone-Based Blood Glucose Management System With Standard Clinic Care in Women With Gestational Diabetes: Randomized Controlled Trial.

PubMed

Mackillop, Lucy; Hirst, Jane Elizabeth; Bartlett, Katy Jane; Birks, Jacqueline Susan; Clifton, Lei; Farmer, Andrew J; Gibson, Oliver; Kenworthy, Yvonne; Levy, Jonathan Cummings; Loerup, Lise; Rivero-Arias, Oliver; Ming, Wai-Kit; Velardo, Carmelo; Tarassenko, Lionel

2018-03-20

Treatment of hyperglycemia in women with gestational diabetes mellitus (GDM) is associated with improved maternal and neonatal outcomes and requires intensive clinical input. This is currently achieved by hospital clinic attendance every 2 to 4 weeks with limited opportunity for intervention between these visits. We conducted a randomized controlled trial to determine whether the use of a mobile phone-based real-time blood glucose management system to manage women with GDM remotely was as effective in controlling blood glucose as standard care through clinic attendance. Women with an abnormal oral glucose tolerance test before 34 completed weeks of gestation were individually randomized to a mobile phone-based blood glucose management solution (GDm-health, the intervention) or routine clinic care. The primary outcome was change in mean blood glucose in each group from recruitment to delivery, calculated with adjustments made for number of blood glucose measurements, proportion of preprandial and postprandial readings, baseline characteristics, and length of time in the study. A total of 203 women were randomized. Blood glucose data were available for 98 intervention and 85 control women. There was no significant difference in rate of change of blood glucose (-0.16 mmol/L in the intervention and -0.14 mmol/L in the control group per 28 days, P=.78). Women using the intervention had higher satisfaction with care (P=.049). Preterm birth was less common in the intervention group (5/101, 5.0% vs 13/102, 12.7%; OR 0.36, 95% CI 0.12-1.01). There were fewer cesarean deliveries compared with vaginal deliveries in the intervention group (27/101, 26.7% vs 47/102, 46.1%, P=.005). Other glycemic, maternal, and neonatal outcomes were similar in both groups. The median time from recruitment to delivery was similar (intervention: 54 days; control: 49 days; P=.23). However, there were significantly more blood glucose readings in the intervention group (mean 3.80 [SD 1.80] and mean 2.63 [SD 1.71] readings per day in the intervention and control groups, respectively; P<.001). There was no significant difference in direct health care costs between the two groups, with a mean cost difference of the intervention group compared to control of -£1044 (95% CI -£2186 to £99). There were no unexpected adverse outcomes. Remote blood glucocse monitoring in women with GDM is safe. We demonstrated superior data capture using GDm-health. Although glycemic control and maternal and neonatal outcomes were similar, women preferred this model of care. Further studies are required to explore whether digital health solutions can promote desired self-management lifestyle behaviors and dietetic adherence, and influence maternal and neonatal outcomes. Digital blood glucose monitoring may provide a scalable, practical method to address the growing burden of GDM around the world. ClinicalTrials.gov NCT01916694; https://clinicaltrials.gov/ct2/show/NCT01916694 (Archived by WebCite at http://www.webcitation.org/6y3lh2BOQ). ©Lucy Mackillop, Jane Elizabeth Hirst, Katy Jane Bartlett, Jacqueline Susan Birks, Lei Clifton, Andrew J Farmer, Oliver Gibson, Yvonne Kenworthy, Jonathan Cummings Levy, Lise Loerup, Oliver Rivero-Arias, Wai-Kit Ming, Carmelo Velardo, Lionel Tarassenko. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 20.03.2018.

Knowledge translation interventions for critically ill patients: a systematic review*.

PubMed

Sinuff, Tasnim; Muscedere, John; Adhikari, Neill K J; Stelfox, Henry T; Dodek, Peter; Heyland, Daren K; Rubenfeld, Gordon D; Cook, Deborah J; Pinto, Ruxandra; Manoharan, Venika; Currie, Jan; Cahill, Naomi; Friedrich, Jan O; Amaral, Andre; Piquette, Dominique; Scales, Damon C; Dhanani, Sonny; Garland, Allan

2013-11-01

We systematically reviewed ICU-based knowledge translation studies to assess the impact of knowledge translation interventions on processes and outcomes of care. We searched electronic databases (to July, 2010) without language restrictions and hand-searched reference lists of relevant studies and reviews. Two reviewers independently identified randomized controlled trials and observational studies comparing any ICU-based knowledge translation intervention (e.g., protocols, guidelines, and audit and feedback) to management without a knowledge translation intervention. We focused on clinical topics that were addressed in greater than or equal to five studies. Pairs of reviewers abstracted data on the clinical topic, knowledge translation intervention(s), process of care measures, and patient outcomes. For each individual or combination of knowledge translation intervention(s) addressed in greater than or equal to three studies, we summarized each study using median risk ratio for dichotomous and standardized mean difference for continuous process measures. We used random-effects models. Anticipating a small number of randomized controlled trials, our primary meta-analyses included randomized controlled trials and observational studies. In separate sensitivity analyses, we excluded randomized controlled trials and collapsed protocols, guidelines, and bundles into one category of intervention. We conducted meta-analyses for clinical outcomes (ICU and hospital mortality, ventilator-associated pneumonia, duration of mechanical ventilation, and ICU length of stay) related to interventions that were associated with improvements in processes of care. From 11,742 publications, we included 119 investigations (seven randomized controlled trials, 112 observational studies) on nine clinical topics. Interventions that included protocols with or without education improved continuous process measures (seven observational studies and one randomized controlled trial; standardized mean difference [95% CI]: 0.26 [0.1, 0.42]; p = 0.001 and four observational studies and one randomized controlled trial; 0.83 [0.37, 1.29]; p = 0.0004, respectively). Heterogeneity among studies within topics ranged from low to extreme. The exclusion of randomized controlled trials did not change our results. Single-intervention and lower-quality studies had higher standardized mean differences compared to multiple-intervention and higher-quality studies (p = 0.013 and 0.016, respectively). There were no associated improvements in clinical outcomes. Knowledge translation interventions in the ICU that include protocols with or without education are associated with the greatest improvements in processes of critical care.

Integration of chronic disease prevention and management services into primary care: a pragmatic randomized controlled trial (PR1MaC).

PubMed

Fortin, Martin; Chouinard, Maud-Christine; Dubois, Marie-France; Bélanger, Martin; Almirall, José; Bouhali, Tarek; Sasseville, Maxime

2016-01-01

Chronic disease prevention and management programs are usually single-disease oriented. Our objective was to evaluate an intervention that targeted multiple chronic conditions and risk factors. We conducted a pragmatic randomized controlled trial involving patients aged 18-75 years with at least 1 of the targeted chronic conditions or risk factors from 8 primary care practices in the Saguenay region of Quebec, Canada, to evaluate an intervention that included self-management support and patient-centred motivational approaches. Self-management (primary outcome) was evaluated using the Health Education Impact Questionnaire (heiQ). Secondary outcomes included self-efficacy, health-related quality of life, psychological distress and health behaviours. Three hundred thirty-two patients were recruited and randomly assigned ( n = 166 for both intervention and control groups) and evaluated after 3 months. The intervention group showed improvement in 6 of the 8 heiQ domains: health-directed behaviour (relative risk [RR] 1.71, 95% confidence interval [CI] 1.13 to 2.59), emotional well-being (RR 1.73, 95% CI 1.07 to 2.79), self-monitoring and insight (RR 2.40, 95% CI 1.19 to 4.86), constructive attitudes and approaches (RR 2.40, 95% CI 1.37 to 4.21), skill and technique acquisition (RR 1.70, 95% CI 1.14 to 2.53), and health service navigation (RR 1.93, 95% CI 1.08 to 3.47). Improvement was also observed in the Physical Component Summary ( p = 0.017) and the Single Index ( p = 0.041) of the 12-Item Short Form Health Survey (version 2). The intervention group improved in fruit and vegetable consumption (odds ratio [OR] 2.36, 95% CI 1.41 to 3.95) and physical activity (OR 3.81, 95% CI 1.65 to 8.76). One-year improvement was maintained in the intervention group for several outcomes. It is possible to implement an intervention integrating chronic disease prevention and management services into primary care settings. We obtained positive and promising results using this intervention. Trial registration: ClinicalTrials.gov, no.: NCT01319656.

Variability in Postarrest Targeted Temperature Management Practice: Implications of the 2015 Guidelines.

PubMed

Leary, Marion; Blewer, Audrey L; Delfin, Gail; Abella, Benjamin S

2015-12-01

In 2002 postarrest care was significantly altered when multiple randomized controlled trials found that therapeutic hypothermia at a goal temperature of 32-34°C significantly improved survival and neurologic outcomes. In 2013, targeted temperature management (TTM) was reexamined via a randomized controlled trial between 33°C and 36°C in post-cardiac arrest patients and found similar outcomes in both cohorts. Before the release of the 2015 American Heart Association (AHA) Guidelines, our group found that across hospitals in the United States, and even within the same institution, TTM protocol variability existed. After the 2013 TTM trial, it was anticipated that the 2015 Guidelines would clarify which target temperature should be used during postarrest care. The AHA released their updates for post-cardiac arrest TTM recently and, based on the literature available, have recommended the use of TTM at a goal temperature between 32°C and 36°C. Whether this variability has an effect on TTM implementation or patient outcomes is unknown.

Ameliorating Patient Stigma Amongst Staff Working With Personality Disorder: Randomized Controlled Trial of Self-Management Versus Skills Training.

PubMed

Clarke, Sue; Taylor, Georgina; Bolderston, Helen; Lancaster, Joanna; Remington, Bob

2015-11-01

Patients diagnosed with a personality disorder (PD) are often stigmatized by the healthcare staff who treat them. This study aimed to compare the impact on front-line staff of a self-management Acceptance and Commitment Therapy-based training intervention (ACTr) with a knowledge- and skills-based Dialectical Behaviour Training intervention (DBTr). A service-based randomized controlled trial was conducted comparing the effects of 2-day ACTr (N = 53) and DBTr (N = 47) staff workshops over 6 months. Primary outcome measures were staff attitudes towards patients and staff-patient relationships. For both interventions, staff attitudes, therapeutic relationship, and social distancing all improved pre- to postintervention, and these changes were maintained at 6-month follow-up. Although offering different resources to staff, both ACTr and DBTr were associated with an improved disposition towards PD patients. Future research could evaluate a combined approach, both for staff working with PD patients and those working with other stigmatized groups.

Activity Pacing Self-Management in Chronic Fatigue Syndrome: A Randomized Controlled Trial

PubMed Central

van Eupen, Inge; Meirte, Jill; Van Cauwenbergh, Deborah; Moorkens, Greta; Meeus, Mira; Nijs, Jo

2015-01-01

OBJECTIVE. The objective of this study was to evaluate the effectiveness of an activity pacing self-management (APSM) intervention in improving performance of daily life activities in women with chronic fatigue syndrome (CFS). METHOD. A total of 33 women with CFS (age 41.1 ± 11.2 yr) were randomly allocated to APSM (experimental group; n = 16) or relaxation (control group; n = 17). Main outcome measures included the Canadian Occupational Performance Measure (COPM; primary) and Checklist Individual Strength (CIS). RESULTS. COPM scores changed significantly over time in both groups (p = .03). The change in Satisfaction scores showed a significant difference in favor only of APSM (effect size = 0.74 [0.11, 1.4]). CIS scores decreased significantly in the experimental group only (p < .01). CONCLUSION. APSM was found to be feasible and effective in optimizing participation in desired daily life activities in women with CFS. Replication in a larger sample with long-term follow-up is required. PMID:26356665

Total Quality Management (TQM) Awareness Seminar. Revision 8

DTIC Science & Technology

1990-04-18

in the United States and abroad, including Dr. W. Edwards Deming, Dr. Joseph Juran, Philip Crosby, Genichi Taguchi, Kaoru Ishikawa , and Armand...Hall, Inc., Englewood Cliffs, NJ 07022. 1985 Ishikawa , Kaoru , Guide to Quality Control, Tokyo; Asian Productivity Organization, 1976 (Available from...Random House Business Division, 201 East 50th Street, New York, NY 10022. � Ishikawa , Karou, What is Total Quality Control?: The Japanese Way, Prentice

The effectiveness of peer health coaching in improving glycemic control among low-income patients with diabetes: protocol for a randomized controlled trial.

PubMed

Ghorob, Amireh; Vivas, Maria Mercedes; De Vore, Diana; Ngo, Victoria; Bodenheimer, Thomas; Chen, Ellen; Thom, David H

2011-04-01

Although self-management support improves diabetes outcomes, it is not consistently provided in health care settings strained for time and resources. One proposed solution to personnel and funding shortages is to utilize peer coaches, patients trained to provide diabetes education and support to other patients. Coaches share similar experiences about living with diabetes and are able to reach patients within and beyond the health care setting. Given the limited body of evidence that demonstrates peer coaching significantly improves chronic disease care, this present study examines the impact of peer coaching delivered in a primary care setting on diabetes outcomes. The aim of this multicenter, randomized control trial is to evaluate the effectiveness of utilizing peer coaches to improve clinical outcomes and self-management skills in low-income patients with poorly controlled diabetes. A total of 400 patients from six primary health centers based in San Francisco that serve primarily low-income populations will be randomized to receive peer coaching (n = 200) or usual care (n = 200) over 6 months. Patients in the peer coach group receive coaching from patients with diabetes who are trained and mentored as peer coaches. The primary outcome is change in HbA1c. Secondary outcomes include change in: systolic blood pressure, body mass index (BMI), LDL cholesterol, diabetes self-care activities, medication adherence, diabetes-related quality of life, diabetes self-efficacy, and depression. Clinical values (HbA1c, LDL cholesterol and blood pressure) and self-reported diabetes self-efficacy and self-care activities are measured at baseline and after 6 months for patients and coaches. Peer coaches are also assessed at 12 months. Patients with diabetes, who are trained as peer health coaches, are uniquely poised to provide diabetes self management support and education to patients. This study is designed to investigate the impact of peer health coaching in patients with poorly controlled diabetes. Additionally, we will assess disease outcomes in patients with well controlled diabetes who are trained and work as peer health coaches. ClinicalTrials.gov identifier: NCT01040806.

Effect of case management on glycemic control and behavioral outcomes for chinese people with type 2 diabetes: A 2-year study.

PubMed

Yuan, Xiaodan; Wang, Fengmei; Fish, Anne Folta; Xue, Cunyi; Chen, Tao; Liu, Chao; Lou, Qingqing

2016-08-01

To examine the effect of case management on glycemic control and behavioral outcomes in adults with Type 2 diabetes in China. Participants were randomly assigned to a 1-year case management (CM) group (n=60) or control group (n=60). Monthly case management visits included identifying individuals' diabetes-related problems, setting goals, planning self-care, and evaluating progress. During a 1-year follow-up, all participants attended visits every 3 months without intervention. In the CM vs. the control group, HbA1c was reduced at 6 months compared to baseline (P=0.034), with trends at 12 and 24 months, and empowerment ability improved (P<0.05). Also in the CM vs. controls, total self-care behaviors, the frequency of exercise, blood glucose testing, and foot care were higher (P<0.001) at 12 months, and the percentage of individuals with HbA1c ≤7.0% was higher (P=0.035) at 24 months. The case management intervention in China was effective at 6 months and, based on trends in HbA1c at 12 and 24 months and results for behavioral outcomes, the intervention shows promise and warrants more research. A case management approach can enhance behavior change and glycemic control in Chinese with diabetes. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Components of effective randomized controlled trials of hydrotherapy programs for fibromyalgia syndrome: A systematic review

PubMed Central

Perraton, Luke; Machotka, Zuzana; Kumar, Saravana

2009-01-01

Aim Previous systematic reviews have found hydrotherapy to be an effective management strategy for fibromyalgia syndrome (FMS). The aim of this systematic review was to summarize the components of hydrotherapy programs used in randomized controlled trials. Method A systematic review of randomized controlled trials was conducted. Only trials that have reported significant FMS-related outcomes were included. Data relating to the components of hydrotherapy programs (exercise type, duration, frequency and intensity, environmental factors, and service delivery) were analyzed. Results Eleven randomized controlled trials were included in this review. Overall, the quality of trials was good. Aerobic exercise featured in all 11 trials and the majority of hydrotherapy programs included either a strengthening or flexibility component. Great variability was noted in both the environmental components of hydrotherapy programs and service delivery. Conclusions Aerobic exercise, warm up and cool-down periods and relaxation exercises are common features of hydrotherapy programs that report significant FMS-related outcomes. Treatment duration of 60 minutes, frequency of three sessions per week and an intensity equivalent to 60%–80% maximum heart rate were the most commonly reported exercise components. Exercise appears to be the most important component of an effective hydrotherapy program for FMS, particularly when considering mental health-related outcomes. PMID:21197303

Assessing the value of disease management: impact of 2 disease management strategies in an underserved asthma population.

PubMed

Galbreath, Autumn Dawn; Smith, Brad; Wood, Pamela R; Inscore, Stephen; Forkner, Emma; Vazquez, Marilu; Fallot, Andre; Ellis, Robert; Peters, Jay I

2008-12-01

The goal of disease management (DM) is to improve health outcomes and reduce cost through decreasing health care utilization. Although some studies have shown that DM improves asthma outcomes, these interventions have not been examined in a large randomized controlled trial. To compare the effectiveness of 2 previously successful DM programs with that of traditional care. Nine hundred two individuals with asthma (429 adults; 473 children) were randomly assigned to telephonic DM, augmented DM (ADM; DM plus in-home visits by a respiratory therapist), or traditional care. Data were collected at enrollment and at 6 and 12 months. Primary outcomes were time to first asthma-related event, quality of life (QOL), and rates of asthma-related health care utilization. Secondary outcomes included rate of controller medication initiation, number of oral corticosteroid bursts, asthma symptom scores, and number of school days missed. There were no significant differences between groups in time to first asthma-related event or health care utilization. Adult participants in the ADM group had greater improvement in QOL (P = .04) and a decrease in asthma symptoms (P = .001) compared with other groups. Of children not receiving controller medications at enrollment (13%), those in the intervention groups were more likely to have controller medications initiated than the control group (P = .01). Otherwise, there were no differences in outcomes. Overall, participation in asthma DM did not result in significant differences in utilization or clinical outcomes. The only significant impact was a higher rate of controllermedication initiation in children and improvement in asthma symptoms and QOL in adults who received ADM.

Myocardial perfusion 320-row multidetector computed tomography-guided treatment strategy for the clinical management of patients with recent acute-onset chest pain: Design of the CArdiac cT in the treatment of acute CHest pain (CATCH)-2 randomized controlled trial.

PubMed

Sørgaard, Mathias; Linde, Jesper J; Hove, Jens D; Petersen, Jan R; Jørgensen, Tem B S; Abdulla, Jawdat; Heitmann, Merete; Kragelund, Charlotte; Hansen, Thomas Fritz; Udholm, Patricia M; Pihl, Christian; Kühl, J Tobias; Engstrøm, Thomas; Jensen, Jan Skov; Høfsten, Dan E; Kelbæk, Henning; Kofoed, Klaus F

2016-09-01

Patients admitted with chest pain are a diagnostic challenge because the majority does not have coronary artery disease (CAD). Assessment of CAD with coronary computed tomography angiography (CCTA) is safe, cost-effective, and accurate, albeit with a modest specificity. Stress myocardial computed tomography perfusion (CTP) has been shown to increase the specificity when added to CCTA, without lowering the sensitivity. This article describes the design of a randomized controlled trial, CATCH-2, comparing a clinical diagnostic management strategy of CCTA alone against CCTA in combination with CTP. Patients with acute-onset chest pain older than 50 years and with at least one cardiovascular risk factor for CAD are being prospectively enrolled to this study from 6 different clinical sites since October 2013. A total of 600 patients will be included. Patients are randomized 1:1 to clinical management based on CCTA or on CCTA in combination with CTP, determining the need for further testing with invasive coronary angiography including measurement of the fractional flow reserve in vessels with coronary artery lesions. Patients are scanned with a 320-row multidetector computed tomography scanner. Decisions to revascularize the patients are taken by the invasive cardiologist independently of the study allocation. The primary end point is the frequency of revascularization. Secondary end points of clinical outcome are also recorded. The CATCH-2 will determine whether CCTA in combination with CTP is diagnostically superior to CCTA alone in the management of patients with acute-onset chest pain. Copyright © 2015 Elsevier Inc. All rights reserved.

Tailored chemotherapy information faxed to general practitioners improves confidence in managing adverse effects and satisfaction with shared care: results from a randomized controlled trial.

PubMed

Jefford, Michael; Baravelli, Carl; Dudgeon, Paul; Dabscheck, Adrian; Evans, Melanie; Moloney, Michael; Schofield, Penelope

2008-05-10

General practitioners (GPs) play a critical role in the treatment of patients with cancer; yet often lack information for optimal care. We developed standardized information for GPs about chemotherapy (CT). In a randomized controlled trial we assessed the impact of sending, by fax, information tailored to the particular patient's CT regimen. Primary end points were: confidence treating patients who were receiving CT (confidence), knowledge of adverse effects and reasons to refer the patient to the treatment center (knowledge), and satisfaction with information and shared care of patients (satisfaction). Focus group work informed the development of the CT information which focused on potential adverse effects and recommended management strategies. GPs of patients due to commence CT were randomly assigned to receive usual correspondence with or without the faxed patient/regimen-specific information. Telephone questionnaire at baseline and 1 week postintervention assessed knowledge, confidence, and satisfaction. Ninety-seven GPs managed 97 patients receiving 23 types of CT. Eighty-one (83.5%) completed the follow-up questionnaire. GPs in the intervention group demonstrated a significantly greater increase in confidence (mean difference, 0.28; 95% CI, 0.10 to 0.47) and satisfaction (mean difference, 0.57; 95% CI, 0.27 to 0.88) compared with usual care, reflecting a 7.1% and 10.5% difference in score, respectively. No differences were detected for knowledge. GPs receiving the CT sheet found correspondence significantly more useful (P < .001) and instructive (P < .001) than GPs who received standard correspondence alone. Information about CT faxed to GPs is a simple, inexpensive intervention that increases confidence managing CT adverse effects and satisfaction with shared care. This intervention could have widespread application.

Reduced knee joint loading with lateral and medial wedge insoles for management of knee osteoarthritis: a protocol for a randomized controlled trial.

PubMed

Lewinson, Ryan T; Collins, Kelsey H; Vallerand, Isabelle A; Wiley, J Preston; Woodhouse, Linda J; Reimer, Raylene A; Worobets, Jay T; Herzog, Walter; Stefanyshyn, Darren J

2014-12-03

Knee osteoarthritis (OA) progression has been linked to increased peak external knee adduction moments (KAMs). Although some trials have attempted to reduce pain and improve function in OA by reducing KAMs with a wedged footwear insole intervention, KAM reduction has not been specifically controlled for in trial designs, potentially explaining the mixed results seen in the literature. Therefore, the primary purpose of this trial is to identify the effects of reduced KAMs on knee OA pain and function. Forty-six patients with radiographically confirmed diagnosis medial knee OA will be recruited for this 3 month randomized controlled trial. Recruitment will be from Alberta and surrounding areas. Eligibility criteria include being between the ages of 40 and 85 years, have knee OA primarily localized to the medial tibiofemoral compartment, based on the American College of Rheumatology diagnostic criteria and be classified as having a Kellgren-Lawrence grade of 1 to 3. Patients will visit the laboratory at baseline for testing that includes dual x-ray absorptiometry, biomechanical testing, and surveys (KOOS, PASE activity scale, UCLA activity scale, comfort visual analog scale). At baseline, patients will be randomized to either a wedged insole group to reduce KAMs, or a waitlist control group where no intervention is provided. The survey tests will be repeated at 3 months, and response to wedged insoles over 3 months will be evaluated. This study represents the first step in systematically evaluating the effects of reduced KAMs on knee OA management by using a patient-specific wedged insole prescription procedure rather than providing the same insole to all patients. The results of this trial will provide indications as to whether reduced KAMs are an effective strategy for knee OA management, and whether a personalized approach to footwear insole prescription is warranted. NCT02067208.

On-Site Construction Productivity Improvement Through Total Quality Management

DTIC Science & Technology

1991-12-01

morale of the work force. i Kaoru Ishikawa , Guide to Ouality Control, (2d ed; New York: Asian Productivity Organization, 1982), p. 45. ’"Ibid. 34...Curve Kaoru Ishikawa , Guide to Quality Control, (2d ed; New York: Asian Productivity Organization, 1982), p. 62. 54 For any normal distribution, 99.73...KAIZEN The Key to Japan’s Comoetitive Success. New York: Random House Business Division, 1986. Ishikawa , Kaoru , Guide to Ouality Control. 2d ed; New

Methodology for Knowledge Synthesis of the Management of Vaccination Pain and Needle Fear.

PubMed

Taddio, Anna; McMurtry, C Meghan; Shah, Vibhuti; Yoon, Eugene W; Uleryk, Elizabeth; Pillai Riddell, Rebecca; Lang, Eddy; Chambers, Christine T; Noel, Melanie; MacDonald, Noni E

2015-10-01

A knowledge synthesis was undertaken to inform the development of a revised and expanded clinical practice guideline about managing vaccination pain in children to include the management of pain across the lifespan and the management of fear in individuals with high levels of needle fear. This manuscript describes the methodological details of the knowledge synthesis and presents the list of included clinical questions, critical and important outcomes, search strategy, and search strategy results. The Grading of Assessments, Recommendations, Development and Evaluation (GRADE) and Cochrane methodologies provided the general framework. The project team voted on clinical questions for inclusion and critically important and important outcomes. A broad search strategy was used to identify relevant randomized-controlled trials and quasi-randomized-controlled trials. Quality of research evidence was assessed using the Cochrane risk of bias tool and quality across studies was assessed using GRADE. Multiple measures of the same construct within studies (eg, observer-rated and parent-rated infant distress) were combined before pooling. The standardized mean difference and 95% confidence intervals (CI) or relative risk and 95% CI was used to express the effects of an intervention. Altogether, 55 clinical questions were selected for inclusion in the knowledge synthesis; 49 pertained to pain management during vaccine injections and 6 pertained to fear management in individuals with high levels of needle fear. Pain, fear, and distress were typically prioritized as critically important outcomes across clinical questions. The search strategy identified 136 relevant studies. This manuscript describes the methodological details of a knowledge synthesis about pain management during vaccination and fear management in individuals with high levels of needle fear. Subsequent manuscripts in this series will present the results for the included questions.

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

Use of a case manager to improve osteoporosis treatment after hip fracture: results of a randomized controlled trial.

PubMed

Majumdar, Sumit R; Beaupre, Lauren A; Harley, Charles H; Hanley, David A; Lier, Douglas A; Juby, Angela G; Maksymowych, Walter P; Cinats, John G; Bell, Neil R; Morrish, Donald W

2007-10-22

Patients who survive hip fracture are at high risk of recurrent fractures, but rates of osteoporosis treatment 1 year after sustaining a fracture are less than 10% to 20%. We have developed an osteoporosis case manager intervention. The case manager educated patients, arranged bone mineral density tests, provided prescriptions, and communicated with primary care physicians. The intervention was compared with usual care in a randomized controlled trial. We recruited from all hospitals that participate in the Capital Health system (Alberta, Canada), including patients 50 years or older who had sustained a hip fracture and excluding those who were receiving osteoporosis treatment or who lived in a long-term care facility. Primary outcome was bisphosphonate therapy 6 months after fracture; secondary outcomes included bone mineral density testing, appropriate care (bone mineral density testing and treatment if bone mass was low), and intervention costs. We screened 2219 patients and allocated 220, as follows: 110 to the intervention group and 110 to the control group. Median age was 74 years, 60% were women, and 37% reported having had previous fractures. Six months after hip fracture, 56 patients in the intervention group (51%) were receiving bisphosphonate therapy compared with 24 patients in the control group (22%) (adjusted odds ratio, 4.7; 95% confidence interval, 2.4-8.9; P < .001). Bone mineral density tests were performed in 88 patients in the intervention group (80%) vs 32 patients in the control group (29%) (P < .001). Of the 120 patients who underwent bone mineral density testing, 25 (21%) had normal bone mass. Patients in the intervention group were more likely to receive appropriate care than were patients in the control group (67% vs 26%; P < .001). The average intervention cost was $50.00 per patient. For a modest cost, a case manager was able to substantially increase rates of osteoporosis treatment in a vulnerable elderly population at high risk of future fractures.

Influence of Music Therapy on Coping Skills and Anger Management in Forensic Psychiatric Patients: An Exploratory Study.

PubMed

Hakvoort, Laurien; Bogaerts, Stefan; Thaut, Michael H; Spreen, Marinus

2015-07-01

The effect of music therapy on anger management and coping skills is an innovative subject in the field of forensic psychiatry. This study explores the following research question: Can music therapy treatment contribute to positive changes in coping skills, anger management, and dysfunctional behavior of forensic psychiatric patients? To investigate this question, first a literature review is offered on music therapy and anger management in forensic psychiatry. Then, an explorative study is presented. In the study, a pre- and post-test design was used with a random assignment of patients to either treatment or control condition. Fourteen participants' complete datasets were collected. All participants received "treatment as usual." Nine of the participants received a standardized, music therapy anger management program; the five controls received, unplanned, an aggression management program. Results suggested that anger management skills improved for all participants. The improvement of positive coping skills and diminishing of avoidance as a coping skill were measured to show greater changes in music therapy participants. When controlling for the exact number of treatment hours, the outcomes suggested that music therapy might accelerate the process of behavioral changes. © The Author(s) 2013.

[Using an ovarian drilling by hydrolaparoscopy or recombinant follicle stimulating hormone plus metformin to treat polycystic ovary syndrome: Why a randomized controlled trial fail?].

PubMed

Fernandez, H; Cedrin-Durnerin, I; Gallot, V; Rongieres, C; Watrelot, A; Mayenga-Mankezi, J-M; Arnoux, A

2015-10-01

To evaluate pregnancy rates after randomized controlled trial (RCT) between ovarian drilling by fertiloscopy or ovarian hyperstimulation+insemination+metformine after clomifène citrate (cc) treatment fails. Randomized controlled trial with 126 patients in each arm in 9 university centers. After 6-9 months of stimulation by cc, 2 groups were randomized: group 1, ovarian drilling with bipolar energy versus group 2: 3 months treatment by metformine followed by 3 hyperstimulation by FSH+insemination. The success rate was pregnancy rate above 12 weeks. RCT was stopped after the screening of 40 patients. In spite of the low number of patients, the pregnancy rate is significantly higher in medical group 8/16 versus 3/18 (p=0.04). The causes of fail of RCT were in relationship with difficulties of inclusion, with absence of final agreement by team included. Moreover, RCT between medical and surgical management is often root of difficulties for patients who decline surgical strategy. However, medical treatment appeared better than drilling in this RCT. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

Knee osteoarthritis and role for surgical intervention: lessons learned from randomized clinical trials and population-based cohorts.

PubMed

Buchbinder, Rachelle; Richards, Bethan; Harris, Ian

2014-03-01

Over the last decade, there has been increased recognition of the importance of high-quality randomized controlled trials in determining the role of surgery for knee osteoarthritis. This review highlights key findings from the best available studies, and considers whether or not this knowledge has resulted in better evidence-based care. Use of arthroscopy to treat knee osteoarthritis has not declined despite strong evidence-based recommendations that do not sanction its use. A large randomized controlled trial has demonstrated that arthroscopic partial meniscectomy followed by a standardized physical therapy program results in similar improvements in pain and function at 6 and 12 months in comparison to physical therapy alone in patients with knee osteoarthritis and a symptomatic meniscal tear, confirming the findings of two previous trials. Two recent randomized controlled trials have demonstrated that decision aids help people to reach better-informed decisions about total knee arthroplasty. A majority of studies have indicated that for people with obesity the positive results of total knee arthroplasty may be compromised by postoperative complications, particularly infection. More efforts are needed to overcome significant evidence-practice gaps in the surgical management of knee osteoarthritis, particularly arthroscopy. Decision aids are a promising tool.

An Educational Intervention to Reduce Pain and Improve Pain Management for Malawian People Living With HIV/AIDS and Their Family Carers: A Randomized Controlled Trial.

PubMed

Nkhoma, Kennedy; Seymour, Jane; Arthur, Antony

2015-07-01

Advances being made in improving access to HIV drugs in resource-poor countries mean HIV patients are living longer, and, therefore, experiencing pain over a longer period of time. There is a need to provide effective interventions for alleviating and managing pain. To assess whether a pain educational intervention compared with usual care reduces pain severity and improves pain management in patients with HIV/AIDS and their family carers. This was a randomized, parallel group, superiority trial conducted at HIV and palliative care clinics of two public hospitals in Malawi. A total of 182 adults with HIV/AIDS (Stage III or IV) and their family carers participated; carer participants were those individuals most involved in the patient's unpaid care. The educational intervention comprised a 30 minute face-to-face meeting, a leaflet, and a follow-up telephone call at two weeks. The content of the educational intervention covered definition, causes, and characteristics of pain in HIV/AIDS; beliefs and myths about pain and pain medication; assessment of pain; and pharmacological and nonpharmacological management. The primary outcome was average pain severity measured by the Brief Pain Inventory-Pain Severity subscale. Assessments were recorded at baseline before randomization and at eight weeks after randomization. Of the 182 patient/carer dyads randomly allocated, 157 patient/carer dyads completed the trial. Patients in the intervention group experienced a greater decrease in pain severity (mean difference = 21.09 points, 95% confidence interval = 16.56-25.63; P < 0.001). A short pain education intervention is effective in reducing pain and improving pain management for Malawian people living with HIV/AIDS and their family carers. Copyright © 2015 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

A Randomized Controlled Trial of the Effects of Online Pain Management Education on Primary Care Providers.

PubMed

Trudeau, Kimberlee J; Hildebrand, Cristina; Garg, Priyanka; Chiauzzi, Emil; Zacharoff, Kevin L

2017-04-01

To improve pain management practices, we developed an online interactive continuing education (CE) program for primary care providers (PCPs). This program follows the flow of clinical decision-making through simulated cases at critical pain treatment points along the pain treatment continuum. A randomized controlled trial was conducted to test the efficacy of this program. Participants were randomized to either the experimental condition or the control condition (online, text-based CE program). A total of 238 primary care providers were recruited through hospitals, professional newsletters, and pain conferences. Participants in both conditions reported significantly improved scores on knowledge (KNOW-PAIN 50), attitudes (CAOS), and pain practice behaviors (PPBS) scales over the four-month study. The experimental condition showed significantly greater change over time on the tamper-resistant formulations (TRFs) of opioids and dosing CAOS subscale compared with the control condition. Post hoc comparisons suggested that participants in the experimental condition were less likely to endorse use of opioid TRFs over time compared with the control condition. Exploratory analyses for potential moderators indicated a significant three-way interaction with time, condition, and discipline (i.e., physician vs other) for the impediments and concerns attitudes subscale and the early refill behaviors subscale. Post hoc comparisons indicated that physicians in the experimental condition exhibited the greatest change in attitudes and the nonphysicians exhibited the greatest change in reported behaviors in response to requests for early refills. Findings suggest online CE programs may positively impact PCPs' knowledge, attitudes, and pain practice behaviors but provide minimal evidence for the value of including interactivity. © 2016 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

Role of reflexology and antiepileptic drugs in managing intractable epilepsy--a randomized controlled trial.

PubMed

Dalal, Krishna; Devarajan, Elanchezhiyan; Pandey, Ravindra Mohan; Subbiah, Vivekanandan; Tripathi, Manjari

2013-01-01

This report is based on the results of a randomized parallel controlled trial conducted to determine the efficacy of reflexology therapy in managing intractable epilepsy. Subjects who failed epilepsy surgery or were not candidates for epilepsy surgery or were non-responders of antiepileptic drugs (AEDs) took part in this study. The trial was completed by 77 subjects randomly assigned to 2 arms: control (AEDs) and reflexology (AEDs + reflexology therapy). The hypothesis was that hand reflexology therapy could produce results similar to those of vagus nerve stimulation, and foot reflexology therapy could maintain homeostasis in the functional status of individual body parts. Reflexology therapy was applied by family members. The follow-up period was 1.5 years. Quality of life in epilepsy patients was assessed with the QOLIE-31 instrument. In the reflexology group, the median baseline seizure frequency decreased from 9.5 (range 2-120) to 2 (range 0-110) with statistical significance (p < 0.001). In the control arm, the decrease was less than 25% with a baseline value of 16 (range 2-150). The pretherapy QOLIE-31 scores in the control group and the reflexology group were 41.05 ± 7 and 43.6 ± 8, respectively. Posttherapy data were 49.07 ± 6 and 65.4 ± 9, respectively (p < 0.002). The reflexology method allowed detection of knee pain in 85% of the reflexology group patients (p < 0.001), and 85.3% of patients derived 81% relief from it (p < 0.001). 4 reflexology group patients reported nausea/vomiting (n = 1), change in voice (n = 2), and hoarseness (n = 1). Reflexology therapy together with AEDs may help reducing seizure frequency and improving quality of life in individuals with epilepsy. Copyright © 2013 S. Karger AG, Basel.

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.

Cognitive behavioral therapy for insomnia in stable heart failure: Protocol for a randomized controlled trial.

PubMed

Redeker, Nancy S; Knies, Andrea K; Hollenbeak, Christopher; Klar Yaggi, H; Cline, John; Andrews, Laura; Jacoby, Daniel; Sullivan, Anna; O'Connell, Meghan; Iennaco, Joanne; Finoia, Lisa; Jeon, Sangchoon

2017-04-01

Chronic insomnia is associated with disabling symptoms and decrements in functional performance. It may contribute to the development of heart failure (HF) and incident mortality. In our previous work, cognitive-behavioral therapy for insomnia (CBT-I), compared to HF self-management education, provided as an attention control condition, was feasible, acceptable, and had large effects on insomnia and fatigue among HF patients. The purpose of this randomized controlled trial (RCT) is to evaluate the sustained effects of group CBT-I compared with HF self-management education (attention control) on insomnia severity, sleep characteristics, daytime symptoms, symptom clusters, functional performance, and health care utilization among patients with stable HF. We will estimate the cost-effectiveness of CBT-I and explore the effects of CBT-I on event-free survival (EFS). Two hundred participants will be randomized in clusters to a single center parallel group (CBT-I vs. attention control) RCT. Wrist actigraphy and self-report will elicit insomnia, sleep characteristics, symptoms, and functional performance. We will use the psychomotor vigilance test to evaluate sleep loss effects and the Six Minute Walk Test to evaluate effects on daytime function. Medical record review and interviews will elicit health care utilization and EFS. Statistical methods will include general linear mixed models and latent transition analysis. Stochastic cost-effectiveness analysis with a competing risk approach will be employed to conduct the cost-effectiveness analysis. The results will be generalizable to HF patients with chronic comorbid insomnia and pave the way for future research focused on the dissemination and translation of CBT-I into HF settings. Copyright © 2017 Elsevier Inc. All rights reserved.

Short-term impact of a stress management and health promotion program on perceived stress, parental stress, health locus of control, and cortisol levels in parents of children and adolescents with diabetes type 1: a pilot randomized controlled trial.

PubMed

Tsiouli, Eleni; Pavlopoulos, Vassilis; Alexopoulos, Evangelos C; Chrousos, George; Darviri, Christina

2014-01-01

Parents of children and adolescents with diabetes type 1 (DT1) usually experience high stress levels, as they have to cope with multiple demands in their everyday life. Different complex interventions have been implemented, which sometimes have led to opposite results. The purpose of this study was to assess stress levels in parents of children and adolescents with DT1 and to evaluate the effectiveness of a stress management program (progressive muscle relaxation combined with diaphragmatic breathing) in reducing perceived and parenting stress, increasing internal locus of control, promoting healthy lifestyle, and normalizing cortisol levels. Randomized controlled trial. A total of 44 parents were randomly assigned to the intervention group (performing relaxation for eight weeks, n = 19) and control group (n = 25). Pre-post measurements included cortisol levels, lifestyle characteristics, perceived stress, perception of health, and parenting stress. A statistically significant decrease in perceived stress (from 27.21 to 19.00, P = .001), as well as in parenting stress (from 85.79 to 73.68, P = .003), was observed in the intervention group. A statistically significant difference was found in perceived stress between the two groups after the intervention (Dmean = 6.64, P = .010). No significant difference was revealed between or within the groups in cortisol levels. Significant improvement was reported by the subjects of the intervention group in various lifestyle parameters. Relaxation techniques seem to have a positive impact on stress and on various lifestyle factors in parents of children and adolescents with DT1. Future research on long-term benefits of an intervention program comprising of various relaxation schemes is warranted. Copyright © 2014 Elsevier Inc. All rights reserved.

Exercise in Patients on Dialysis: A Multicenter, Randomized Clinical Trial

PubMed Central

Manfredini, Fabio; Mallamaci, Francesca; D’Arrigo, Graziella; Baggetta, Rossella; Bolignano, Davide; Torino, Claudia; Lamberti, Nicola; Bertoli, Silvio; Ciurlino, Daniele; Rocca-Rey, Lisa; Barillà, Antonio; Battaglia, Yuri; Rapanà, Renato Mario; Zuccalà, Alessandro; Bonanno, Graziella; Fatuzzo, Pasquale; Rapisarda, Francesco; Rastelli, Stefania; Fabrizi, Fabrizio; Messa, Piergiorgio; De Paola, Luciano; Lombardi, Luigi; Cupisti, Adamasco; Fuiano, Giorgio; Lucisano, Gaetano; Summaria, Chiara; Felisatti, Michele; Pozzato, Enrico; Malagoni, Anna Maria; Castellino, Pietro; Aucella, Filippo; Abd ElHafeez, Samar; Provenzano, Pasquale Fabio; Tripepi, Giovanni; Catizone, Luigi

2017-01-01

Previous studies have suggested the benefits of physical exercise for patients on dialysis. We conducted the Exercise Introduction to Enhance Performance in Dialysis trial, a 6-month randomized, multicenter trial to test whether a simple, personalized walking exercise program at home, managed by dialysis staff, improves functional status in adult patients on dialysis. The main study outcomes included change in physical performance at 6 months, assessed by the 6-minute walking test and the five times sit-to-stand test, and in quality of life, assessed by the Kidney Disease Quality of Life Short Form (KDQOL-SF) questionnaire. We randomized 296 patients to normal physical activity (control; n=145) or walking exercise (n=151); 227 patients (exercise n=104; control n=123) repeated the 6-month evaluations. The distance covered during the 6-minute walking test improved in the exercise group (mean distance±SD: baseline, 328±96 m; 6 months, 367±113 m) but not in the control group (baseline, 321±107 m; 6 months, 324±116 m; P<0.001 between groups). Similarly, the five times sit-to-stand test time improved in the exercise group (mean time±SD: baseline, 20.5±6.0 seconds; 6 months, 18.2±5.7 seconds) but not in the control group (baseline, 20.9±5.8 seconds; 6 months, 20.2±6.4 seconds; P=0.001 between groups). The cognitive function score (P=0.04) and quality of social interaction score (P=0.01) in the kidney disease component of the KDQOL-SF improved significantly in the exercise arm compared with the control arm. Hence, a simple, personalized, home-based, low-intensity exercise program managed by dialysis staff may improve physical performance and quality of life in patients on dialysis. PMID:27909047

Renal denervation for the management of resistant hypertension

PubMed Central

Patel, Hitesh C; Hayward, Carl; Vassiliou, Vassilis; Patel, Ketna; Howard, James P; Di Mario, Carlo

2015-01-01

Renal sympathetic denervation (RSD) as a therapy for patients with resistant hypertension has attracted great interest. The majority of studies in this field have demonstrated impressive reductions in blood pressure (BP). However, these trials were not randomized or sham-controlled and hence, the findings may have been overinflated due to trial biases. SYMPLICITY HTN-3 was the first randomized controlled trial to use a blinded sham-control and ambulatory BP monitoring. A surprise to many was that this study was neutral. Possible reasons for this neutrality include the fact that RSD may not be effective at lowering BP in man, RSD was not performed adequately due to limited operator experience, patients’ adherence with their anti-hypertensive drugs may have changed during the trial period, and perhaps the intervention only works in certain subgroups that are yet to be identified. Future studies seeking to demonstrate efficacy of RSD should be designed as randomized blinded sham-controlled trials. The efficacy of RSD is in doubt, but many feel that its safety has been established through the thousands of patients in whom the procedure has been performed. Over 90% of these data, however, are for the Symplicity™ system and rarely extend beyond 12 months of follow-up. Long-term safety cannot be assumed with RSD and nor should it be assumed that if one catheter system is safe then all are. We hope that in the near future, with the benefit of well-designed clinical trials, the role of renal denervation in the management of hypertension will be established. PMID:26672761

Effect of Vibration on Pain Response to Heel Lance: A Pilot Randomized Control Trial.

PubMed

McGinnis, Kate; Murray, Eileen; Cherven, Brooke; McCracken, Courtney; Travers, Curtis

2016-12-01

Applied mechanical vibration in pediatric and adult populations has been shown to be an effective analgesic for acute and chronic pain, including needle pain. Studies among the neonatal population are lacking. According to the Gate Control Theory, it is expected that applied mechanical vibration will have a summative effect with standard nonpharmacologic pain control strategies, reducing behavioral and physiologic pain responses to heel lancing. To determine the safety and efficacy of mechanical vibration for relief of heel lance pain among neonates. In this parallel design randomized controlled trial, eligible enrolled term or term-corrected neonates (n = 56) in a level IV neonatal intensive care unit were randomized to receive either sucrose and swaddling or sucrose, swaddling, and vibration for heel lance analgesia. Vibration was applied using a handheld battery-powered vibrator (Norco MiniVibrator, Hz = 92) to the lateral aspect of the lower leg along the sural dermatome throughout the heel lance procedure. Neonatal Pain, Agitation, and Sedation Scale (N-PASS) scores, heart rate, and oxygen saturations were collected at defined intervals surrounding heel lancing. Infants in the vibration group (n = 30) had significantly lower N-PASS scores and more stable heart rates during heel stick (P = .006, P = .037) and 2 minutes after heel lance (P = .002, P = .016) than those in the nonvibration group. There were no adverse behavioral or physiologic responses to applied vibration in the sample. Applied mechanical vibration is a safe and effective method for managing heel lance pain. This pilot study suggests that mechanical vibration warrants further exploration as a nonpharmacologic pain management tool among the neonatal population.

Mindfulness instruction for HIV-infected youth: a randomized controlled trial.

PubMed

Webb, Lindsey; Perry-Parrish, Carisa; Ellen, Jonathan; Sibinga, Erica

2018-06-01

HIV-infected youth experience many stressors, including stress related to their illness, which can negatively impact their mental and physical health. Therefore, there is a significant need to identify potentially effective interventions to improve stress management, coping, and self-regulation. The object of the study was to assess the effect of a mindfulness-based stress reduction (MBSR) program compared to an active control group on psychological symptoms and HIV disease management in youth utilizing a randomized controlled trial. Seventy-two HIV-infected adolescents, ages 14-22 (mean age 18.71 years), were enrolled from two urban clinics and randomized to MBSR or an active control. Data were collected on mindfulness, stress, self-regulation, psychological symptoms, medication adherence, and cognitive flexibility at baseline, post-program, and 3-month follow-up. CD4+ T lymphocyte and HIV viral load (HIV VL) counts were also pulled from medical records. HIV-infected youth in the MBSR group reported higher levels of mindfulness (P = .03), problem-solving coping (P = .03), and life satisfaction (P = .047), and lower aggression (P = .002) than those in the control group at the 3-month follow-up. At post-program, MBSR participants had higher cognitive accuracy when faced with negative emotion stimuli (P = .02). Also, those in the MBSR study arm were more likely to have or maintain reductions in HIV VL at 3-month follow-up than those in the control group (P = .04). In our sample, MBSR instruction proved beneficial for important psychological and HIV-disease outcomes, even when compared with an active control condition. Lower HIV VL levels suggest improved HIV disease control, possibly due to higher levels of HIV medication adherence, which is of great significance in both HIV treatment and prevention. Additional research is needed to explore further the role of MBSR for improving the psychological and physical health of HIV-positive youth.

Effects of Dual-Task Management and Resistance Training on Gait Performance in Older Individuals: A Randomized Controlled Trial.

PubMed

Wollesen, Bettina; Mattes, Klaus; Schulz, Sören; Bischoff, Laura L; Seydell, L; Bell, Jeffrey W; von Duvillard, Serge P

2017-01-01

Background: Dual-task (DT) training is a well-accepted modality for fall prevention in older adults. DT training should include task-managing strategies such as task switching or task prioritization to improve gait performance under DT conditions. Methods: We conducted a randomized controlled trial to evaluate a balance and task managing training (BDT group) in gait performance compared to a single task (ST) strength and resistance training and a control group, which received no training. A total of 78 older individuals (72.0 ± 4.9 years) participated in this study. The DT group performed task managing training incorporating balance and coordination tasks while the ST group performed resistance training only. Training consisted of 12 weekly sessions, 60 min each, for 12 weeks. We assessed the effects of ST and BDT training on walking performance under ST and DT conditions in independent living elderly adults. ST and DT walking (visual verbal Stroop task) were measured utilizing a treadmill at self-selected walking speed (mean for all groups: 4.4 ± 1 km h -1 ). Specific gait variables, cognitive performance, and fear of falling were compared between all groups. > Results: Training improved gait performance for step length ( p < 0.001) and gait-line (ST: p < 0.01; DT p < 0.05) in both training groups. The BDT training group showed greater improvements in step length ( p < 0.001) and gait-line ( p < 0.01) during DT walking but did not have changes in cognitive performance. Both interventions reduced fear of falling ( p < 0.05). Conclusion: Implementation of task management strategies into balance and strength training in our population revealed a promising modality to prevent falls in older individuals. Trial registration: German register of clinical trials DRKS00012382.

A randomized controlled trial of an HIV/AIDS Symptom Management Manual for depressive symptoms.

PubMed

Eller, Lucille S; Kirksey, Kenn M; Nicholas, Patrice K; Corless, Inge B; Holzemer, William L; Wantland, Dean J; Willard, Suzanne S; Robinson, Linda; Hamilton, Mary Jane; Sefcik, Elizabeth F; Moezzi, Shahnaz; Mendez, Marta Rivero; Rosa, Maria; Human, Sarie

2013-01-01

Abstract Depressive symptoms are highly prevalent, underdiagnosed, and undertreated in people living with HIV/AIDS (PLWH), and are associated with poorer health outcomes. This randomized controlled trial examined the effects of the HIV/AIDS Symptom Management Manual self-care symptom management strategies compared with a nutrition manual on depressive symptoms in an international sample of PLWH. The sample consisted of a sub-group (N=222) of participants in a larger study symptom management study who reported depressive symptoms. Depressive symptoms of the intervention (n=124) and control (n=98) groups were compared over three months: baseline, one-month, and two-months. Use and effectiveness of specific strategies were examined. Depressive symptom frequency at baseline varied significantly by country (χ (2) 12.9; p=0.04). Within the intervention group there were significant differences across time in depressive symptom frequency [F(2, 207) = 3.27, p=0.05], intensity [F(2, 91) = 4.6, p=0.01], and impact [F(2, 252) = 2.92, p= 0.05), and these were significantly lower at one month but not at two months, suggesting that self-care strategies are effective in reducing depressive symptoms, however effects may be short term. Most used and most effective self-care strategies were distraction techniques and prayer. This study suggests that people living with HIV can be taught and will employ self-care strategies for management of depressive symptoms and that these strategies are effective in reducing these symptoms. Self-care strategies are noninvasive, have no side-effects, and can be readily taught as an adjunct to other forms of treatment. Studies are needed to identify the most effective self-care strategies and quantify optimum dose and frequency of use as a basis for evidence-based practice.

The effects of music intervention in the management of chronic pain: a single-blind, randomized, controlled trial.

PubMed

Guétin, Stéphane; Giniès, Patrick; Siou, Didier Kong A; Picot, Marie-Christine; Pommié, Christelle; Guldner, Elisabeth; Gosp, Anne-Marie; Ostyn, Katelyne; Coudeyre, Emmanuel; Touchon, Jacques

2012-05-01

A music intervention method in the management of pain was recently developed while taking account of recommendations in the scientific literature. The objective of this study was to assess the usefulness of this music intervention to the management of patients with chronic pain. A controlled, single-blind, randomized trial was used. Eighty-seven patients presenting with lumbar pain, fibromyalgia, inflammatory disease, or neurological disease were included in the study. During their hospitalization, the intervention arm (n=44) received at least 2 daily sessions of music listening between D0 and D10, associated with their standard treatment, and then pursued the music intervention at home until D60 using a multimedia player in which the music listening software program had been installed. The control arm received standard treatment only (n=43). The end points measured at D0, D10, D60, and D90 were: pain (VAS), anxiety-depression (HAD) and the consumption of medication. At D60 in the music intervention arm, this technique enabled a more significant reduction (P<0.001) in pain (6.3 ± 1.7 at D0 vs. 3 ± 1.7 at D60) when compared with the arm without music intervention (6.2 ± 1.5 at D0 vs. 4.6 ± 1.7 at D60). In addition, music intervention contributed to significantly reducing both anxiety/depression and the consumption of anxiolytic agents. These results confirm the value of music intervention to the management of chronic pain and anxiety/depression. This music intervention method appears to be useful in managing chronic pain as it enables a significant reduction in the consumption of medication.

Increasing capacity to deliver diabetes self-management education: results of the DESMOND lay educator non-randomized controlled equivalence trial.

PubMed

Carey, M E; Mandalia, P K; Daly, H; Gray, L J; Hale, R; Martin Stacey, L; Taub, N; Skinner, T C; Stone, M; Heller, S; Khunti, K; Davies, M J

2014-11-01

To develop and test a format of delivery of diabetes self-management education by paired professional and lay educators. We conducted an equivalence trial with non-randomized participant allocation to a Diabetes Education and Self Management for Ongoing and Newly Diagnosed Type 2 diabetes (DESMOND) course, delivered in the standard format by two trained healthcare professional educators (to the control group) or by one trained lay educator and one professional educator (to the intervention group). A total of 260 people with Type 2 diabetes diagnosed within the previous 12 months were referred for self-management education as part of routine care and attended either a control or intervention format DESMOND course. The primary outcome measure was change in illness coherence score (derived from the Diabetes Illness Perception Questionnaire-Revised) between baseline and 4 months after attending education sessions. Secondary outcome measures included change in HbA1c level. The trial was conducted in four primary care organizations across England and Scotland. The 95% CI for the between-group difference in positive change in coherence scores was within the pre-set limits of equivalence (difference = 0.22, 95% CI 1.07 to 1.52). Equivalent changes related to secondary outcome measures were also observed, including equivalent reductions in HbA1c levels. Diabetes education delivered jointly by a trained lay person and a healthcare professional educator with the same educator role can provide equivalent patient benefits. This could provide a method that increases capacity, maintains quality and is cost-effective, while increasing access to self-management education. © 2014 The Authors. Diabetic Medicine © 2014 Diabetes UK.

A Randomized Controlled Trial of an HIV/AIDS Symptom Management Manual for Depressive Symptoms

PubMed Central

Eller, Lucille Sanzero; Kirksey, Kenn M.; Nicholas, Patrice K.; Corless, Inge B.; Holzemer, William L.; Wantland, Dean J.; Willard, Suzanne S.; Robinson, Linda; Hamilton, Mary Jane; Sefcik, Elizabeth F.; Moezzi, Shahnaz; Mendez, Marta Rivero; Rosa, Maria; Human, Sarie

2012-01-01

Depressive symptoms are highly prevalent, underdiagnosed and undertreated in people living with HIV/AIDS (PLWH), and are associated with poorer health outcomes. This randomized controlled trial examined the effects of the HIV/AIDS Symptom Management Manual self-care symptom management strategies compared to a nutrition manual on depressive symptoms in an international sample of PLWH. The sample consisted of a sub-group (N=222) of participants in a larger study symptom management study who reported depressive symptoms. Depressive symptoms of the intervention (n=124) and control (n=98) groups were compared over three months: baseline, one-month and two-months. Use and effectiveness of specific strategies were examined. Depressive symptom frequency at baseline varied significantly by country (χ2 12.9; p=0.04). Within the intervention group there were significant differences across time in depressive symptom frequency [F(2, 207) = 3.27, p=0.05], intensity [F(2, 91) = 4.6, p=0.01] and impact [F(2, 252) = 2.92, p= 0.05), and these were significantly lower at one-month but not at two-months, suggesting that self-care strategies are effective in reducing depressive symptoms, however effects may be short-term. Most used and most effective self-care strategies were distraction techniques and prayer. This study suggests the people living with HIV can be taught and will employ self-care strategies for management of depressive symptoms, and that they are effective in reducing these symptoms. Self-care strategies are non-invasive, have no side-effects and can be readily taught as an adjunct to other forms of treatment. Studies are needed to identify the most effective self-care strategies and quantify optimum dose and frequency of use as a basis for evidence-based practice. PMID:22880943

A randomized controlled trial to examine the effectiveness of case management model for community dwelling older persons with mild dementia in Hong Kong.

PubMed

Lam, Linda C W; Lee, Jenny S W; Chung, Jenny C C; Lau, Anna; Woo, Jean; Kwok, Timothy C Y

2010-04-01

To evaluate a case management (CM) model for people with mild dementia, whereby resources within the family and in the community were mobilized and optimally used. Community dwelling psychiatric and geriatrics outpatients with mild dementia were randomized to receive CM by a trained occupational therapist for 4 months (CM group, N = 59) or usual care only (control group, N = 43). Primary outcome indicators included the Zarit Burden Scale (ZBI), General Health Questionnaire (GHQ), and Personal Well-Being Index for Adult (PWI-A) of the family caregivers. Secondary outcome indicators included the Mini-Mental State Examination (MMSE), Neuropsychiatric Inventory (NPI), Cornell Scale for Depression in Dementia (CSDD), and Personal Well-Being Index for Intellectually Disabled (PWI-ID) of the demented subjects as measured at fourth and twelfth months. CSDDis reduced in the CM group at fourth month, but not at twelfth month. The changes in outcome variables of persons with dementia did not differ between the groups (Mann-Whitney U-test, p > 0.05). At follow-up, CM group used more day care and domestic helpers than control group (chi (2), p > 0.05). Case management for Chinese persons with mild dementia outpatients did not show significant effects in reducing caregiver burden, but encouraged family caregivers to seek external support.

Sleep quality and fatigue after a stress management intervention for women with early-stage breast cancer in southern Florida.

PubMed

Vargas, Sara; Antoni, Michael H; Carver, Charles S; Lechner, Suzanne C; Wohlgemuth, William; Llabre, Maria; Blomberg, Bonnie B; Glück, Stefan; DerHagopian, Robert P

2014-12-01

Sleep disruption and fatigue are ubiquitous among cancer patients and are sources of stress that may compromise treatment outcomes. Previously, we showed that a cognitive behavioral stress management (CBSM) intervention reduced anxiety and other stress-related processes in women undergoing primary treatment for breast cancer. This study examined secondary outcomes from a CBSM intervention trial for women with early-stage breast cancer to test if CBSM would improve sleep quality and fatigue among these patients at a single site in southern Florida. CBSM-related effects have already been demonstrated for indicators of psychosocial adaptation (e.g., general and cancer-related anxiety). Patients were randomized to CBSM (n= 120) or a 1-day psychoeducation control group (n= 120). The Pittsburgh Sleep Quality Index (PSQI) and Fatigue Symptom Inventory were completed prior to randomization and 6 and 12 months after the baseline assignment. In latent growth analyses, women in CBSM reported greater improvements in PSQI sleep quality scores than controls, although there were no significant differences between conditions on PSQI total scores. Women in CBSM also reported greater reductions in fatigue-related daytime interference than controls, though there were no significant differences in changes in fatigue intensity. Changes in sleep quality were associated with changes in fatigue. Future work may consider integrating sleep and fatigue content into stress management interventions for women with early-stage breast cancer.

Behavioral Weight Loss for the Management of Menopausal Hot Flashes: A Pilot Study

PubMed Central

Thurston, Rebecca C.; Ewing, Linda J.; Low, Carissa A.; Christie, Aimee J.; Levine, Michele D.

2014-01-01

Objective Although adiposity has been considered protective against hot flashes, newer data suggest positive relations between flashes and adiposity. No studies have been specifically designed to test whether weight loss reduces hot flashes. This pilot study aimed to evaluate the feasibility, acceptability, and initial efficacy of behavioral weight loss to reduce hot flashes. Methods Forty overweight/obese women with hot flashes (≥4/day) were randomized to a behavioral weight loss intervention or to wait list control. Hot flashes were assessed pre- and post-intervention via physiologic monitor, diary, and questionnaire. Comparisons of changes in hot flashes and anthropometrics between conditions were tested via Wilcoxon tests. Results Study retention (83%) and intervention satisfaction (93.8%) were high. Most women (74.1%) reported that hot flash reduction was a main motivator to lose weight. Women randomized to the weight loss intervention lost more weight (-8.86 kg) than did women randomized to control (+0.23 kg, p<.0001). Women randomized to weight loss also showed greater reductions in questionnaire-reported hot flashes (2-week hot flashes: −63.0) than did women in the control (−28.0, p=.03), a difference not demonstrated in other hot flash measures. Reductions in weight and hot flashes were significantly correlated (e.g., r=.47, p=.006). Conclusions This pilot study showed a behavioral weight loss program to be feasible, acceptable, and effective in producing weight loss among overweight/obese women with hot flashes. Findings indicate the importance of a larger study designed to test behavioral weight loss for hot flash reduction. Hot flash management could motivate women to engage in this health-promoting behavior. PMID:24977456

Effects of a Multicomponent Life-Style Intervention on Weight, Glycemic Control, Depressive Symptoms, and Renal Function in Low-Income, Minority Patients With Type 2 Diabetes: Results of the Community Approach to Lifestyle Modification for Diabetes Randomized Controlled Trial.

PubMed

Moncrieft, Ashley E; Llabre, Maria M; McCalla, Judith Rey; Gutt, Miriam; Mendez, Armando J; Gellman, Marc D; Goldberg, Ronald B; Schneiderman, Neil

2016-09-01

Few interventions have combined life-style and psychosocial approaches in the context of Type 2 diabetes management. The purpose of this study was to determine the effect of a multicomponent behavioral intervention on weight, glycemic control, renal function, and depressive symptoms in a sample of overweight/obese adults with Type 2 diabetes and marked depressive symptoms. A sample of 111 adults with Type 2 diabetes were randomly assigned to a 1-year intervention (n = 57) or usual care (n = 54) in a parallel groups design. Primary outcomes included weight, glycosylated hemoglobin, and Beck Depression Inventory II score. Estimated glomerular filtration rate served as a secondary outcome. All measures were assessed at baseline and 6 and 12 months after randomization by assessors blind to randomization. Latent growth modeling was used to examine intervention effects on each outcome. The intervention resulted in decreased weight (mean [M] = 0.322 kg, standard error [SE] = 0.124 kg, p = .010) and glycosylated hemoglobin (M = 0.066%, SE = 0.028%, p = .017), and Beck Depression Inventory II scores (M = 1.009, SE = 0.226, p < .001), and improved estimated glomerular filtration rate (M = 0.742 ml·min·1.73 m, SE = 0.318 ml·min·1.73 m, p = .020) each month during the first 6 months relative to usual care. Multicomponent behavioral interventions targeting weight loss and depressive symptoms as well as diet and physical activity are efficacious in the management of Type 2 diabetes. This study is registered at Clinicaltrials.gov ID: NCT01739205.

Effectiveness of treatment based on PiCCO parameters in critically ill patients with septic shock and/or acute respiratory distress syndrome: a randomized controlled trial.

PubMed

Zhang, Zhongheng; Ni, Hongying; Qian, Zhixian

2015-03-01

To compare treatment based on either PiCCO-derived physiological values or central venous pressure (CVP) monitoring, we performed a prospective randomized controlled trial with group sequential analysis. Consecutive critically ill patients with septic shock and/or ARDS were included. The planned total sample size was 715. The primary outcome was 28-day mortality after randomization. Participants underwent stratified randomization according to the classification of ARDS and/or septic shock. Caregivers were not blinded to the intervention, but participants and outcome assessors were blinded to group assignment. The study was stopped early because of futility after enrollment of 350 patients including 168 in the PiCCO group and 182 in the control group. There was no loss to follow-up and data from all enrolled participants were analyzed. The result showed that treatment based on PiCCO-derived physiological values was not able to reduce the 28-day mortality risk (odds ratio 1.00, 95 % CI 0.66-1.52; p = 0.993). There was no difference between the two groups in secondary outcomes such as 14-day mortality (40.5 vs. 41.2 %; p = 0.889), ICU length of stay (median 9 vs. 7.5 days; p = 0.598), days free of vasopressors (median 14.5 vs. 19 days; p = 0.676), and days free of mechanical ventilation (median 3 vs. 6 days; p = 0.168). No severe adverse event was reported in both groups. On the basis of our study, PICCO-based fluid management does not improve outcome when compared to CVP-based fluid management.

Reduction in 2-year recurrent risk score and improved behavioral outcomes after participation in the "Beating Heart Problems" self-management program: results of a randomized controlled trial.

PubMed

Murphy, Barbara M; Worcester, Marian U C; Higgins, Rosemary O; Elliott, Peter C; Le Grande, Michael R; Mitchell, Fiona; Navaratnam, Hema; Turner, Alyna; Grigg, Leeanne; Tatoulis, James; Goble, Alan J

2013-01-01

While behavior change can improve risk factor profiles and prognosis after an acute cardiac event, patients need assistance to achieve sustained lifestyle changes. We developed the "Beating Heart Problems" cognitive-behavioral therapy and motivational interviewing program to support patients to develop behavioral and cognitive self-management skills. We report the results of a randomized controlled trial of the program. Patients (n = 275) consecutively admitted to 2 Melbourne hospitals after acute myocardial infarction (32%), coronary artery bypass graft surgery (40%), or percutaneous coronary intervention (28%) were randomized to treatment (T; n = 139) or control (C; n = 136). T group patients were invited to participate in the 8-week group-based program. Patients underwent risk factor screening 6 weeks after hospital discharge (before randomization) and again 4 and 12 months later. At both the followups, T and C groups were compared on 2-year risk of a recurrent cardiac event and key behavioral outcomes, using both intention-to-treat and "completers only" analyses. Patients ranged in age from 32 to 75 years (mean = 59.0 years; SD - 9.1 years). Most patients (86%) were men. Compared with the C group patients, T group patients tended toward greater reduction in 2-year risk, at both the 4- and 12-month followups. Significant benefits in dietary fat intake and functional capacity were also evident. The "Beating Heart Problems" program showed modest but important benefit over usual care at 4 and, to a lesser extent, 12 months. Modifications to the program such as the inclusion of booster sessions and translation to online delivery are likely to improve outcomes.

Behavioral weight loss for the management of menopausal hot flashes: a pilot study.

PubMed

Thurston, Rebecca C; Ewing, Linda J; Low, Carissa A; Christie, Aimee J; Levine, Michele D

2015-01-01

Although adiposity has been considered to be protective against hot flashes, newer data suggest positive relationships between hot flashes and adiposity. No studies have been specifically designed to test whether weight loss reduces hot flashes. This pilot study aimed to evaluate the feasibility, acceptability, and initial efficacy of behavioral weight loss in reducing hot flashes. Forty overweight or obese women with hot flashes (≥ 4 hot flashes/d) were randomized to either behavioral weight loss intervention or wait-list control. Hot flashes were assessed before and after intervention via physiologic monitoring, diary, and questionnaire. Comparisons of changes in hot flashes and anthropometrics between conditions were performed via Wilcoxon tests. Study retention (83%) and intervention satisfaction (93.8%) were high. Most women (74.1%) reported that hot flash reduction was a major motivator for losing weight. Women randomized to the weight loss intervention lost more weight (-8.86 kg) than did women randomized to control (+0.23 kg; P < 0.0001). Women randomized to weight loss also showed greater reductions in questionnaire-reported hot flashes (2-wk hot flashes, -63.0) than did women in the control group (-28.0; P = 0.03)-a difference not demonstrated in other hot flash measures. Reductions in weight and hot flashes were significantly correlated (eg, r = 0.47, P = 0.006). This pilot study shows a behavioral weight loss program that is feasible, acceptable, and effective in producing weight loss among overweight or obese women with hot flashes. Findings indicate the importance of a larger study designed to test behavioral weight loss for hot flash reduction. Hot flash management could motivate women to engage in this health-promoting behavior.

Multimodal manual therapy vs. pharmacological care for management of tension type headache: A meta-analysis of randomized trials.

PubMed

Mesa-Jiménez, Juan A; Lozano-López, Cristina; Angulo-Díaz-Parreño, Santiago; Rodríguez-Fernández, Ángel L; De-la-Hoz-Aizpurua, Jose L; Fernández-de-Las-Peñas, Cesar

2015-12-01

Manual therapies are generally requested by patients with tension type headache. To compare the efficacy of multimodal manual therapy vs. pharmacological care for the management of tension type headache pain by conducting a meta-analysis of randomized controlled trials. PubMed, MEDLINE, EMBASE, AMED, CINAHL, EBSCO, Cochrane Database of Systematic Reviews, Cochrane Collaboration Trials Register, PEDro and SCOPUS were searched from their inception until June 2014. All randomized controlled trials comparing any manual therapy vs. medication care for treating tension type headache adults were included. Data were extracted and methodological quality assessed independently by two reviewers. We pooled headache frequency as the main outcome and also intensity and duration. The weighted mean difference between manual therapy and pharmacological care was used to determine effect sizes. Five randomized controlled trials met our inclusion criteria and were included in the meta-analysis. Pooled analyses found that manual therapies were more effective than pharmacological care in reducing frequency (weighted mean difference -0.8036, 95% confidence interval -1.66 to -0.44; three trials), intensity (weighted mean difference -0.5974, 95% confidence interval -0.8875 to -0.3073; five trials) and duration (weighted mean difference -0.5558, 95% confidence interval -0.9124 to -0.1992; three trials) of the headache immediately after treatment. No differences were found at longer follow-up for headache intensity (weighted mean difference -0.3498, 95% confidence interval -1.106 to 0.407; three trials). Manual therapies were associated with moderate effectiveness at short term, but similar effectiveness at longer follow-up for reducing headache frequency, intensity and duration in tension type headache than pharmacological medical drug care. However, due to the heterogeneity of the interventions, these results should be considered with caution at this stage. © International Headache Society 2015.

A goal management intervention for polyarthritis patients: rationale and design of a randomized controlled trial

PubMed Central

2013-01-01

Background A health promotion intervention was developed for inflammatory arthritis patients, based on goal management. Elevated levels of depression and anxiety symptoms, which indicate maladjustment, are found in such patients. Other indicators of adaptation to chronic disease are positive affect, purpose in life and social participation. The new intervention focuses on to improving adaptation by increasing psychological and social well-being and decreasing symptoms of affective disorders. Content includes how patients can cope with activities and life goals that are threatened or have become impossible to attain due to arthritis. The four goal management strategies used are: goal maintenance, goal adjustment, goal disengagement and reengagement. Ability to use various goal management strategies, coping versatility and self-efficacy are hypothesized to mediate the intervention’s effect on primary and secondary outcomes. The primary outcome is depressive symptoms. Secondary outcomes are anxiety symptoms, positive affect, purpose in life, social participation, pain, fatigue and physical functioning. A cost-effectiveness analysis and stakeholders’ analysis are planned. Methods/design The protocol-based psycho-educational program consists of six group-based meetings and homework assignments, led by a trained nurse. Participants are introduced to goal management strategies and learn to use these strategies to cope with threatened personal goals. Four general hospitals participate in a randomized controlled trial with one intervention group and a waiting list control condition. Discussion The purpose of this study is to evaluate the effectiveness of a goal management intervention. The study has a holistic focus as both the absence of psychological distress and presence of well-being are assessed. In the intervention, applicable goal management competencies are learned that assist people in their choice of behaviors to sustain and enhance their quality of life. Trial registration Nederlands Trial Register = NTR3606, registration date 11-09-2012. PMID:23941633

Effect of an educational Inpatient Diabetes Management Program on medical resident knowledge and measures of glycemic control: a randomized controlled trial.

PubMed

Desimone, Marisa E; Blank, Gary E; Virji, Mohamed; Donihi, Amy; DiNardo, Monica; Simak, Deborah M; Buranosky, Raquel; Korytkowski, Mary T

2012-01-01

To investigate the effectiveness of an Inpatient Diabetes Management Program (IDMP) on physician knowledge and inpatient glycemic control. Residents assigned to General Internal Medicine inpatient services were randomized to receive the IDMP (IDMP group) or usual education only (non-IDMP group). Both groups received an overview of inpatient diabetes management in conjunction with reminders of existing order sets on the hospital Web site. The IDMP group received print copies of the program and access to an electronic version for a personal digital assistant (PDA). A Diabetes Knowledge Test (DKT) was administered at baseline and at the end of the 1-month rotation. The frequency of hyperglycemia among patients under surveillance by each group was compared by using capillary blood glucose values and a dispersion index of glycemic variability. IDMP users completed a questionnaire related to the program. Twenty-two residents participated (11 in the IDMP group and 11 in the non-IDMP group). Overall Diabetes Knowledge Test scores improved in both groups (IDMP: 69% ± 1.7% versus 83% ± 2.1%, P = .003; non-IDMP: 76% ± 1.2% versus 84% ± 1.4%, P = .02). The percentage of correct responses for management of corticosteroid-associated hyperglycemia (P = .004) and preoperative glycemic management (P = .006) improved in only the IDMP group. The frequency of hyperglycemia (blood glucose level >180 mg/dL) and the dispersion index (5.3 ± 7.6 versus 3.7 ± 5.6; P = .2) were similar between the 2 groups. An IDMP was effective at improving physician knowledge for managing hyperglycemia in hospitalized patients treated with corticosteroids or in preparation for surgical procedures. Educational programs directed at improving overall health care provider knowledge for inpatient glycemic management may be beneficial; however, improvements in knowledge do not necessarily result in improved glycemic outcomes.

Effects of Structured Group Counseling on Anger Management Skills of Nursing Students.

PubMed

Üzar-Özçetin, Yeter Sinem; Hiçdurmaz, Duygu

2017-03-01

Anger management is an important skill for nurses to prevent conflicts in the health care environment. Efforts, beginning with nursing education, are required to improve this skill and evaluate the effects. This study aimed to evaluate the effects of a structured counseling program on improving the anger management skills of nursing students. The study had an experimental design with pre- and posttests. Twenty-six undergraduate nursing students who were randomly assigned to the groups participated. The authors conducted eight counseling sessions with the experiment group and no intervention with the control group. Data were collected using the State-Trait Anger Expression Inventory. The counseling group had higher anger control and repression scores and lower trait anger scores after the counseling, compared with the control group. This counseling improved the students' anger management skills. Therefore, such programs should be integrated into the services provided for nursing students. [J Nurs Educ. 2017;56(3):174-181.]. Copyright 2017, SLACK Incorporated.

Evaluation of a nurse practitioner disease management model for chronic heart failure: a multi-site implementation study.

PubMed

Lowery, Julie; Hopp, Faith; Subramanian, Usha; Wiitala, Wyndy; Welsh, Deborah E; Larkin, Angela; Stemmer, Karen; Zak, Cassandra; Vaitkevicius, Peter

2012-01-01

While disease management appears to be effective in selected, small groups of CHF patients from randomized controlled trials, its effectiveness in a broader CHF patient population is not known. This prospective, quasi-experimental study compared patient outcomes under a nurse practitioner-led disease management model (intervention group) with outcomes under usual care (control group) in both primary and tertiary medical centers. The study included 969 veterans (458 intervention, 511 control) treated for CHF at six VA medical centers. Intervention patients had significantly fewer (p<0.05) CHF and all-cause admissions at one-year follow-up, and lower mortality at both one- and two-year follow-up. These data provide support for the potential effectiveness of the intervention, and suggest that the evidence from RCTs of disease management models for CHF can be translated into clinical practice, even without the benefits of a selected patient population and dedicated resources often found in RCTs. © 2011 Wiley Periodicals, Inc.

A Novel Mobile App and Population Management System to Manage Rheumatoid Arthritis Flares: Protocol for a Randomized Controlled Trial.

PubMed

Wang, Penny; Luo, Dee; Lu, Fengxin; Elias, Josephine S; Landman, Adam B; Michaud, Kaleb D; Lee, Yvonne C

2018-04-11

Rheumatoid arthritis flares have a profound effect on patients, causing pain and disability. However, flares often occur between regularly scheduled health care provider visits and are, therefore, difficult to monitor and manage. We sought to develop a mobile phone app combined with a population management system to help track RA flares between visits. The objective of this study is to implement the mobile app plus the population management system to monitor rheumatoid arthritis disease activity between scheduled health care provider visits over a period of 6 months. This is a randomized controlled trial that lasts for 6 months for each participant. We aim to recruit 190 patients, randomized 50:50 to the intervention group versus the control group. The intervention group will be assigned the mobile app and be prompted to answer daily questionnaires sent to their mobile devices. Both groups will be assigned a population manager, who will communicate with the participants via telephone at 6 weeks and 18 weeks. The population manager will also communicate with the participants in the intervention group if their responses indicate a sustained increase in rheumatoid arthritis disease activity. To assess patient satisfaction, the primary outcomes will be scores on the Treatment Satisfaction Questionnaire for Medication as well as the Perceived Efficacy in Patient-Physician Interactions questionnaire at 6 months. To determine the effect of the mobile app on rheumatoid arthritis disease activity, the primary outcome will be the Clinical Disease Activity Index at 6 months. The trial started in November 2016, and an estimated 2.5 years will be necessary to complete the study. Study results are expected to be published by the end of 2019. The completion of this study will provide important data regarding the following: (1) the assessment of validated outcome measures to assess rheumatoid arthritis disease activity with a mobile app between routinely scheduled health care provider visits, (2) patient engagement in monitoring their condition, and (3) communication between patients and health care providers through the population management system. ClinicalTrials.gov NCT02822521, http://clinicaltrials.gov/ct2/show/NCT02822521 (Archived by WebCite at http://www.webcitation.org/6xed3kGPd). ©Penny Wang, Dee Luo, Fengxin Lu, Josephine S Elias, Adam B Landman, Kaleb D Michaud, Yvonne C Lee. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 11.04.2018.

Occurrence of host-associated fecal markers on child hands, household soil, and drinking water in rural Bangladeshi households

EPA Science Inventory

Improper feces disposal can lead to environmental contamination and enteric disease transmission. Using the platform of a randomized controlled trial, we evaluated whether provision of improved sanitation hardware (toilets and child feces management tools) and associated behavior...

Continuous femoral versus epidural block for attainment of 120° knee flexion after total knee arthroplasty: a randomized controlled trial.

PubMed

Sakai, Norihiro; Inoue, Takaya; Kunugiza, Yasuo; Tomita, Tetsuya; Mashimo, Takashi

2013-05-01

We conducted the prospective randomized controlled trial to test that continuous femoral nerve block (CFNB) improves attainment of 120° knee flexion compared to continuous epidural analgesia (CEA). Sixty-six patients scheduled for unilateral total knee arthroplasty were randomized into two groups; infusion of ropivacaine 0.15% into CEA or CFNB to third postoperative days. We studied the time required to attain 120° knee flexion, variations in thigh and calf circumferences around the treated knee, pain scores, rehabilitation milestones, the need for adjuvant analgesics, and side effects. CFNB patients attained earlier knee flexion to 120°, lower variations in thigh and calf circumferences, less pain during rehabilitation, and less need for adjuvant analgesics. CFNB is a better pain management strategy that accelerates knee flexion rehabilitation. Copyright © 2013 Elsevier Inc. All rights reserved.

Habitat manipulation influences northern bobwhite resource selection on a reclaimed surface mine

USGS Publications Warehouse

Brooke, Jarred M.; Peters, David C.; Unger, Ashley M.; Tanner, Evan P.; Harper, Craig A.; Keyser, Patrick D.; Clark, Joseph D.; Morgan, John J.

2015-01-01

More than 600,000 ha of mine land have been reclaimed in the eastern United States, providing large contiguous tracts of early successional vegetation that can be managed for northern bobwhite (Colinus virginianus). However, habitat quality on reclaimed mine land can be limited by extensive coverage of non-native invasive species, which are commonly planted during reclamation. We used discrete-choice analysis to investigate bobwhite resource selection throughout the year on Peabody Wildlife Management Area, a 3,330-ha reclaimed surface mine in western Kentucky. We used a treatment-control design to study resource selection at 2 spatial scales to identify important aspects of mine land vegetation and whether resource selection differed between areas with habitat management (i.e., burning, disking, herbicide; treatment) and unmanaged units (control). Our objectives were to estimate bobwhite resource selection on reclaimed mine land and to estimate the influence of habitat management practices on resource selection. We used locations from 283 individuals during the breeding season (1 Apr–30 Sep) and 136 coveys during the non-breeding season (1 Oct–Mar 31) from August 2009 to March 2014. Individuals were located closer to shrub cover than would be expected at random throughout the year. During the breeding season, individuals on treatment units used areas with smaller contagion index values (i.e., greater interspersion) compared with individuals on control units. During the non-breeding season, birds selected areas with greater shrub-open edge density compared with random. At the microhabitat scale, individuals selected areas with increased visual obstruction >1 m aboveground. During the breeding season, birds were closer to disked areas (linear and non-linear) than would be expected at random. Individuals selected non-linear disked areas during winter but did not select linear disked areas (firebreaks) because they were planted to winter wheat each fall and lacked cover during the non-breeding season. Individuals also selected areas treated with herbicide to control sericea lespedeza (Lespedeza cuneata) throughout the year. During the breeding season, bobwhites avoided areas burned during the previous dormant season. Habitat quality of reclaimed mine lands may be limited by a lack of shrub cover and extensive coverage of non-native herbaceous vegetation. Managers aiming to increase bobwhite abundance should focus on increasing interspersion of shrub cover, with no area >100 m from shrub cover. We suggest disking and herbicide application to control invasive species and improve the structure and composition of vegetation for bobwhites.

ICARUSS, the Integrated Care for the Reduction of Secondary Stroke trial: rationale and design of a randomized controlled trial of a multimodal intervention to prevent recurrent stroke in patients with a recent cerebrovascular event, ACTRN = 12611000264987.

PubMed

Joubert, J; Davis, S M; Hankey, G J; Levi, C; Olver, J; Gonzales, G; Donnan, G A

2015-07-01

The majority of strokes, both ischaemic and haemorrhagic, are attributable to a relatively small number of risk factors which are readily manageable in primary care setting. Implementation of best-practice recommendations for risk factor management is calculated to reduce stroke recurrence by around 80%. However, risk factor management in stroke survivors has generally been poor at primary care level. A model of care that supports long-term effective risk factor management is needed. To determine whether the model of Integrated Care for the Reduction of Recurrent Stroke (ICARUSS) will, through promotion of implementation of best-practice recommendations for risk factor management reduce the combined incidence of stroke, myocardial infarction and vascular death in patients with recent stroke or transient ischaemic attack (TIA) of the brain or eye. A prospective, Australian, multicentre, randomized controlled trial. Academic stroke units in Melbourne, Perth and the John Hunter Hospital, New South Wales. 1000 stroke survivors recruited as from March 2007 with a recent (<3 months) stroke (ischaemic or haemorrhagic) or a TIA (brain or eye). Randomization and data collection are performed by means of a central computer generated telephone system (IVRS). Exposure to the ICARUSS model of integrated care or usual care. The composite of stroke, MI or death from any vascular cause, whichever occurs first. Risk factor management in the community, depression, quality of life, disability and dementia. With 1000 patients followed up for a median of one-year, with a recurrence rate of 7-10% per year in patients exposed to usual care, the study will have at least 80% power to detect a significant reduction in primary end-points The ICARUSS study aims to recruit and follow up patients between 2007 and 2013 and demonstrate the effectiveness of exposure to the ICARUSS model in stroke survivors to reduce recurrent stroke or vascular events and promote the implementation of best practice risk factor management at primary care level. © 2015 World Stroke Organization.

Interventions to manage dual practice among health workers.

PubMed

Kiwanuka, Suzanne N; Rutebemberwa, Elizeus; Nalwadda, Christine; Okui, Olico; Ssengooba, Freddie; Kinengyere, Alison A; Pariyo, George W

2011-07-06

Dual practice, whereby health workers hold two or more jobs, is a common phenomenon globally. In resource constrained low- and middle-income countries dual practice poses an ongoing threat to the efficiency, quality and equity of health services, especially in the public sector. Identifying effective interventions to manage dual practice is important. To assess the effects of regulations implemented to manage dual practice. Databases searched included: The Cochrane Central Register of Controlled Trials (CENTRAL) 2011, Issue 4, part of The Cochrane Library. www.thecochranelibrary.com, including the Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register (searched 26 May 2011); MEDLINE In-Process & Other Non-Indexed Citations May 24, 2011 (searched 26 May 2011); MEDLINE, Ovid (1948 to May week 2 2011) (searched 26 May 2011); EMBASE, Ovid (1980 to 2011 week 20) (searched 26 May 2011); Science Citation Index and Social Sciences Citation Index, ISI Web of Science (1975 to present) (searched 04 December 2009); LILACS (searched January 2010); and AIM (December 2009) (searched 18 December 2009). Randomized controlled trials, non-randomized controlled trials, controlled before-and-after studies and interrupted-time-series studies. Dual practice was defined as holding more than one job. Studies for inclusion were those focusing on interventions to manage dual practice among health professionals employed in the public health sector. Two review authors independently applied the criteria for inclusion and exclusion of studies when scanning the identified titles and abstracts. The same two review authors independently screened full reports of selected citations. At each stage, results were compared and discrepancies settled through discussion. No studies were found which were eligible for inclusion in this review. There is a need to rigorously evaluate the effects of interventions implemented to manage dual practice among health workers. However, there is still much that is unknown about dual practice itself. The designing of studies to evaluate the effects of interventions to manage dual practice could benefit from prior studies to assess the various manifestations of dual practice, their prevalence and their likely impacts on health services delivery. These findings would then inform the design of studies to evaluate interventions to manage dual practice.

An mHealth App for Supporting Quitters to Manage Cigarette Cravings With Short Bouts of Physical Activity: A Randomized Pilot Feasibility and Acceptability Study

PubMed Central

Lintunen, Taru; Heikkinen, Risto; Vanhala, Mauno; Kettunen, Tarja

2017-01-01

Background While gains in reducing smoking rates in Finland have been made, prevalence rates are still substantial. Relapse rates among smokers engaged in quit-smoking programs are high. Physical activity has been proposed as one means to help smokers manage cravings. Software and apps on mobile phone and handheld devices offer an opportunity to communicate messages on how to use physical activity to manage cravings as part of quit-smoking programs. Objective We aimed to test the feasibility, acceptability, usability, and preliminary efficacy of an mHealth mobile phone app, Physical activity over Smoking (PhoS), to assist smokers in quitting smoking in a randomized controlled trial. The app was designed to prompt smokers to engage in physical activities to manage their smoking cravings. Methods Regular smokers (n=44) attended a group-based behavioral counselling program aimed at promoting physical activity as an additional aid to quit. After quit day, participants were randomly allocated to an intervention (n=25) or to a comparison (n=19) group. Participants in the intervention group were provided with the PhoS app and training on how to use it to assist with relapse prevention. Participants in the comparison condition were provided with generalized relapse prevention training. Results Some participants reported that the PhoS app was useful in assisting them to successfully manage their cigarette cravings, although compliance across the sample was modest and participants reported low levels of usability. Participants receiving the PhoS app did not report greater abstinence than those who did not receive the app. However, participants receiving the app were more likely to report greater abstinence if they did not use pharmacological support, while those who did not receive the app reported greater abstinence when using pharmacological support. Participants receiving the app reported greater levels of physical activity than those who did not. Results revealed that the app resulted in better retention. Conclusions The PhoS app showed some potential to reduce abstinence among participants not using pharmacological therapy and to increase physical activity. However, problems with usability and lack of effects on abstinence raise questions over the app’s long-term effectiveness. Future research should prioritize further development of the app to maximize usability and test effects of the intervention independent of quit-smoking programs. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): 55259451; http://www.controlled-trials.com/ISRCTN55259451 (Archived by WebCite at http://www.webcitation.org/6cKF2mzEI) PMID:28550004