Sample records for homes-a randomized control

  1. Cockroach allergen reduction by cockroach control alone in low-income urban homes: a randomized control trial.

    PubMed

    Sever, Michelle L; Arbes, Samuel J; Gore, J Chad; Santangelo, Richard G; Vaughn, Ben; Mitchell, Herman; Schal, Coby; Zeldin, Darryl C

    2007-10-01

    We previously reported significant reductions in cockroach allergen concentrations in urban homes by reducing cockroach infestations. To determine the effectiveness of pest control performed by professional entomologists, compared with commercial companies, in reducing cockroach allergen. This 3-arm randomized controlled trial enrolled 60 cockroach-infested homes in North Carolina. Homes were randomly assigned to a control group or 1 of 2 treatment groups. Treatment 1 had insecticide baits placed by entomologists from North Carolina State University. Treatment 2 received pest control from a randomly assigned commercial company. Vacuumed dust sampling and cockroach trapping were conducted at 0, 6, and 12 months. Dust samples were analyzed by ELISA. In treatment 1 homes, there were significant reductions in geometric mean trap counts compared with control and treatment 2 homes at 12 months. Relative to control, significant 12-month reductions in Bla g 1 were evident in treatment 1 homes at all sampled sites, except bedroom floor. From baseline to month 12, geometric mean Bla g 1 concentrations (U/g) decreased from 64.2 to 5.6 in kitchen, 10.6 to 1.1 in living room, 10.7 to 1.9 on bedroom floor, and 3.6 to 2.3 in bed. Treatment 2 homes showed no significant 12-month allergen reductions versus control. Reductions in Bla g 1 in cockroach-infested homes can be achieved by reducing infestations; however, the magnitude of allergen reduction is dependent on the thoroughness and effectiveness of cockroach eradication efforts. Elimination of cockroaches is an effective method for reducing exposure to cockroach allergen.

  2. Cultivating teacher mindfulness: Effects of a randomized controlled trial on work, home, and sleep outcomes.

    PubMed

    Crain, Tori L; Schonert-Reichl, Kimberly A; Roeser, Robert W

    2017-04-01

    The effects of randomization to a workplace mindfulness training (WMT) or a waitlist control condition on teachers' well-being (moods and satisfaction at work and home), quantity of sleep, quality of sleep, and sleepiness during the day were examined in 2 randomized, waitlist controlled trials (RCTs). The combined sample of the 2 RCTs, conducted in Canada and the United States, included 113 elementary and secondary school teachers (89% female). Measures were collected at baseline, postprogram, and 3-month follow-up; teachers were randomly assigned to condition after baseline assessment. Results showed that teachers randomized to WMT reported less frequent bad moods at work and home, greater satisfaction at work and home, more sleep on weekday nights, better quality sleep, and decreased insomnia symptoms and daytime sleepiness. Training-related group differences in mindfulness and rumination on work at home at postprogram partially mediated the reductions in negative moods at home and increases in sleep quality at follow-up. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  3. Hospital-Level Care at Home for Acutely Ill Adults: a Pilot Randomized Controlled Trial.

    PubMed

    Levine, David M; Ouchi, Kei; Blanchfield, Bonnie; Diamond, Keren; Licurse, Adam; Pu, Charles T; Schnipper, Jeffrey L

    2018-05-01

    Hospitals are standard of care for acute illness, but hospitals can be unsafe, uncomfortable, and expensive. Providing substitutive hospital-level care in a patient's home potentially reduces cost while maintaining or improving quality, safety, and patient experience, although evidence from randomized controlled trials in the US is lacking. Determine if home hospital care reduces cost while maintaining quality, safety, and patient experience. Randomized controlled trial. Adults admitted via the emergency department with any infection or exacerbation of heart failure, chronic obstructive pulmonary disease, or asthma. Home hospital care, including nurse and physician home visits, intravenous medications, continuous monitoring, video communication, and point-of-care testing. Primary outcome was direct cost of the acute care episode. Secondary outcomes included utilization, 30-day cost, physical activity, and patient experience. Nine patients were randomized to home, 11 to usual care. Median direct cost of the acute care episode for home patients was 52% (IQR, 28%; p = 0.05) lower than for control patients. During the care episode, home patients had fewer laboratory orders (median per admission: 6 vs. 19; p < 0.01) and less often received consultations (0% vs. 27%; p = 0.04). Home patients were more physically active (median minutes, 209 vs. 78; p < 0.01), with a trend toward more sleep. No adverse events occurred in home patients, one occurred in control patients. Median direct cost for the acute care plus 30-day post-discharge period for home patients was 67% (IQR, 77%; p < 0.01) lower, with trends toward less use of home-care services (22% vs. 55%; p = 0.08) and fewer readmissions (11% vs. 36%; p = 0.32). Patient experience was similar in both groups. The use of substitutive home-hospitalization compared to in-hospital usual care reduced cost and utilization and improved physical activity. No significant differences in quality, safety

  4. A Facility Specialist Model for Improving Retention of Nursing Home Staff: Results from a Randomized, Controlled Study

    ERIC Educational Resources Information Center

    Pillemer, Karl; Meador, Rhoda; Henderson, Charles, Jr.; Robison, Julie; Hegeman, Carol; Graham, Edwin; Schultz, Leslie

    2008-01-01

    Purpose: This article reports on a randomized, controlled intervention study designed to reduce employee turnover by creating a retention specialist position in nursing homes. Design and Methods: We collected data three times over a 1-year period in 30 nursing homes, sampled in stratified random manner from facilities in New York State and…

  5. Effectiveness of preventive home visits in reducing the risk of falls in old age: a randomized controlled trial

    PubMed Central

    Luck, Tobias; Motzek, Tom; Luppa, Melanie; Matschinger, Herbert; Fleischer, Steffen; Sesselmann, Yves; Roling, Gudrun; Beutner, Katrin; König, Hans-Helmut; Behrens, Johann; Riedel-Heller, Steffi G

    2013-01-01

    Background Falls in older people are a major public health issue, but the underlying causes are complex. We sought to evaluate the effectiveness of preventive home visits as a multifactorial, individualized strategy to reduce falls in community-dwelling older people. Methods Data were derived from a prospective randomized controlled trial with follow-up examination after 18 months. Two hundred and thirty participants (≥80 years of age) with functional impairment were randomized to intervention and control groups. The intervention group received up to three preventive home visits including risk assessment, home counseling intervention, and a booster session. The control group received no preventive home visits. Structured interviews at baseline and follow-up provided information concerning falls in both study groups. Random-effects Poisson regression evaluated the effect of preventive home visits on the number of falls controlling for covariates. Results Random-effects Poisson regression showed a significant increase in the number of falls between baseline and follow-up in the control group (incidence rate ratio 1.96) and a significant decrease in the intervention group (incidence rate ratio 0.63) controlling for age, sex, family status, level of care, and impairment in activities of daily living. Conclusion Our results indicate that a preventive home visiting program can be effective in reducing falls in community-dwelling older people. PMID:23788832

  6. Implementation and Randomized Controlled Trial Evaluation of Universal Postnatal Nurse Home Visiting

    PubMed Central

    Goodman, W. Benjamin; Murphy, Robert A.; O’Donnell, Karen; Sato, Jeannine; Guptill, Susan

    2014-01-01

    Objectives. We evaluated whether a brief, universal, postnatal nurse home-visiting intervention can be implemented with high penetration and fidelity, prevent emergency health care services, and promote positive parenting by infant age 6 months. Methods. Durham Connects is a manualized 4- to 7-session program to assess family needs and connect parents with community resources to improve infant health and well-being. All 4777 resident births in Durham, North Carolina, between July 1, 2009, and December 31, 2010, were randomly assigned to intervention and control conditions. A random, representative subset of 549 families received blinded interviews for impact evaluation. Results. Of all families, 80% initiated participation; adherence was 84%. Hospital records indicated that Durham Connects infants had 59% fewer infant emergency medical care episodes than did control infants. Durham Connects mothers reported fewer infant emergency care episodes and more community connections, more positive parenting behaviors, participation in higher quality out-of-home child care, and lower rates of anxiety than control mothers. Blinded observers reported higher quality home environments for Durham Connects than for control families. Conclusions. A brief universal home-visiting program implemented with high penetration and fidelity can lower costly emergency medical care and improve family outcomes. PMID:24354833

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

    PubMed

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

    2008-06-25

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

  8. Use of telehealth technology for home spirometry after lung transplantation: a randomized controlled trial.

    PubMed

    Sengpiel, Juliane; Fuehner, Thomas; Kugler, Christiane; Avsar, Murat; Bodmann, Isabelle; Boemke, Annelies; Simon, Andre; Welte, Tobias; Gottlieb, Jens

    2010-12-01

    Complications often occur during the early phase after lung transplantation, and rapid diagnosis is vital. Home spirometry is used to detect early changes in graft function. Bluetooth-equipped cell phones are easy to use and facilitate data transfer from home spirometry. To explore use of home spirometry with Bluetooth data transfer in outpatient lung transplant recipients. Single-center prospective randomized controlled trial. Intervention-Fifty-six patients were randomized either to home spirometry with data transfer via Bluetooth-equipped cell phones or to home spirometry alone before discharge after lung transplantation. In the Bluetooth group, results were transferred to a database capable of generating alarm messages. Time from onset of symptoms to physician consultation during the first 6 months after lung transplantation was the primary end point. Adherence to home spirometry was 97.2% in the Bluetooth group and 95.3% in the home spirometry alone group (P = .73). Median time to first consultation (P = .60) and frequency of consultation (P = .06) did not differ significantly in the 2 groups. Mean scores on the Hospital Anxiety and Depression Scale were lower in patients in the Bluetooth group (1.5; range, 0.0-4.0) than in the home spirometry alone group (4.0; range, 2.0-6.0; P = .04). Home spirometry with data transfer is feasible and safe in lung transplant recipients. Compared with home spirometry alone, additional data transfer was equally effective regarding the time interval from symptom onset to consultation. Patients in the Bluetooth group reported less anxiety, which may improve emotional well-being.

  9. Educational program for nursing home physicians and staff to reduce use of non-steroidal anti-inflammatory drugs among nursing home residents: a randomized controlled trial.

    PubMed

    Stein, C M; Griffin, M R; Taylor, J A; Pichert, J W; Brandt, K D; Ray, W A

    2001-05-01

    The risk for serious gastrointestinal complications due to nonsteroidal anti-inflammatory drugs (NSAIDs) is high in the elderly. Acetaminophen-based regimens are safer and may be as effective as NSAIDs for the treatment of osteoarthritis in many patients. To determine the effects of an educational program on NSAID use and clinical outcomes in nursing homes. Randomized controlled study. Ten pairs of Tennessee nursing homes with > or = 8% of residents receiving NSAIDs were randomized to intervention or control. Nursing home residents (intervention n = 76 and control n = 71) aged 65 years and older taking NSAIDs regularly. An educational program for physicians and nursing home staff that included the risks and benefits of NSAIDs in the elderly and an algorithm that substituted acetaminophen, topical agents, and nonpharmacologic measures for the treatment of noninflammatory musculoskeletal pain. Intervention and control subjects were assessed at baseline and 3 months later. Differences in NSAID and acetaminophen use, and pain, function, and disability scores in intervention and control nursing home subjects. The intervention was effective resulting in markedly decreased NSAID use and increased acetaminophen use. Mean number of days of NSAID use in the 7 day periods before the baseline and 3 month assessments decreased from 7.0 to 1.9 days in intervention home subjects compared with a decrease from 7.0 to 6.2 days in control homes (P = 0.0001). Acetaminophen use in the 7 days immediately before the 3 month assessment increased by 3.1 days in intervention home subjects compared with 0.31 days in control homes (P = 0.0001). A similar proportion of subjects in control (32.5%) and intervention (35.4%) groups had worsening of their arthritis pain score (P = 0.81). An educational intervention effectively reduced NSAID use in nursing homes without worsening of arthritis pain.

  10. Attrition in longitudinal randomized controlled trials: home visits make a difference.

    PubMed

    Peterson, Janey C; Pirraglia, Paul A; Wells, Martin T; Charlson, Mary E

    2012-11-23

    Participant attrition in longitudinal studies can introduce systematic bias, favoring participants who return for follow-up, and increase the likelihood that those with complications will be underestimated. Our aim was to examine the effectiveness of home follow-up (Home F/U) to complete the final study evaluation on potentially "lost" participants by: 1) evaluating the impact of including and excluding potentially "lost" participants (e.g., those who required Home F/U to complete the final evaluation) on the rates of study complications; 2) examining the relationship between timing and number of complications on the requirement for subsequent Home F/U; and 3) determining predictors of those who required Home F/U. We used data from a randomized controlled trial (RCT) conducted from 1991-1994 among coronary artery bypass graft surgery patients that investigated the effect of High mean arterial pressure (MAP) (intervention) vs. Low MAP (control) during cardiopulmonary bypass on 5 complications: cardiac morbidity/mortality, neurologic morbidity/mortality, all-cause mortality, neurocognitive dysfunction and functional decline. We enhanced completion of the final 6-month evaluation using Home F/U. Among 248 participants, 61 (25%) required Home F/U and the remaining 187 (75%) received Routine F/U. By employing Home F/U, we detected 11 additional complications at 6 months: 1 major neurologic complication, 6 cases of neurocognitive dysfunction and 4 cases of functional decline. Follow-up of 61 additional Home F/U participants enabled us to reach statistical significance on our main trial outcome. Specifically, the High MAP group had a significantly lower rate of the Combined Trial Outcome compared to the Low MAP group, 16.1% vs. 27.4% (p=0.032). In multivariate analysis, participants who were ≥ 75 years (OR=3.23, 95% CI 1.52-6.88, p=0.002) or on baseline diuretic therapy (OR=2.44, 95% CI 1.14-5.21, p=0.02) were more likely to require Home F/U. In addition, those in the

  11. Effect of postnatal home visits on maternal/infant outcomes in Syria: a randomized controlled trial.

    PubMed

    Bashour, Hyam N; Kharouf, Mayada H; Abdulsalam, Asma A; El Asmar, Khalil; Tabbaa, Mohammed A; Cheikha, Salah A

    2008-01-01

    Early postpartum home visiting is universal in many Western countries. Studies from developing countries on the effects of home visits are rare. In Syria, where the postpartum period is rather ignored, this study aimed to assess whether a community-based intervention of postnatal home visits has an effect on maternal postpartum morbidities; infant morbidity; uptake of postpartum care; use of contraceptive methods; and on selected neonatal health practices. A randomized controlled trial was carried out in Damascus. Three groups of new mothers were randomly allocated to receive either 4 postnatal home visits (A), one visit (B), or no visit (C). A total of 876 women were allocated and followed up. Registered midwives with special training made a one or a series of home visits providing information, educating, and supporting women. A significantly higher proportion of mothers in Groups A and B reported exclusively breastfeeding their infants (28.5% and 30%, respectively) as compared with Group C (20%), who received no visits. There were no reported differences between groups in other outcomes. While postpartum home visits significantly increased exclusive breastfeeding, other outcomes did not change. Further studies framed in a nonbiomedical context are needed. Other innovative approaches to improve postnatal care in Syria are needed.

  12. Effects of Horticulture on Frail and Prefrail Nursing Home Residents: A Randomized Controlled Trial.

    PubMed

    Lai, Claudia K Y; Kwan, Rick Y C; Lo, Shirley K L; Fung, Connie Y Y; Lau, Jordan K H; Tse, Mimi M Y

    2018-05-24

    Frail nursing home residents face multiple health challenges as a result of their frail status. The aim of this study was to examine the effects of HT on the psychosocial well-being of frail and prefrail nursing home residents. Randomized controlled trial. Nursing homes. One hundred eleven participants were randomly allocated into the intervention [horticultural therapy (HT)] and control (social activities) conditions. HT group participants attended a weekly 60-minute session for 8 consecutive weeks. Control group activities were social in nature, without any horticulture components. The outcome measures include happiness, depressive symptoms, self-efficacy, well-being, social network, and social engagement. The time points of measurement were at baseline (T 0 ), immediately postintervention (T 1 ), and 12 weeks postintervention (T 2 ). A modified intention-to-treat approach was adopted. A multivariate general estimating equation was used to analyze the data. Forty-six and 50 participants received at least 1 session of the intervention and control condition protocol, respectively. A significant interaction effect between group and time was observed only on the happiness scale (β = 1.457, P = .036), but not on other outcome variables. In a follow-up cluster analysis of those who received HT, a greater effect on subjective happiness (mean difference = 6.23, P < .001) was observed for participants who were happier at baseline. HT was found to be effective in promoting subjective happiness for frail and prefrail nursing home residents. Its favorable effect suggests that HT should be used to promote the psychosocial well-being of those who are frail. Copyright © 2018 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

  13. A randomized, controlled comparison of home versus institutional rehabilitation of patients with hip fracture.

    PubMed

    Kuisma, Raija

    2002-08-01

    To compare ambulation outcomes between home and institutional rehabilitation of patients with hip fracture. Randomized controlled clinical equivalence trial. The Queen Elizabeth Hospital in Hong Kong. Eighty-one patients with hip fracture. Study group patients (40) were discharged directly home from the acute hospital and visited by a physiotherapist an average of 4.6 times. The control group subjects (41) were discharged to a rehabilitation centre for further treatment lasting on average 36.2 days (SD 14.6) and they received physiotherapy daily. Ambulation ability measured on a categorical scale. The mean age of the subjects was 75 years (SD 8.3 years). Females comprised 60% of all the subjects and majority were retired or home makers. Both groups of patients improved in their ambulation ability during their rehabilitation period but neither group achieved their pre-ambulatory status by the time of completion of the study. The study group achieved significantly higher ambulation scores (p < 0.05) for community and household ambulation compared with the control group by the end of the study, a year after operation. Five visits by a physiotherapist in the patient's home after discharge from an acute hospital after surgical treatment for hip fracture yielded better results in ambulation ability than one month of conventional institution-based rehabilitation.

  14. Mechanism of Developmental Change in the PLAY Project Home Consultation Program: Evidence from a Randomized Control Trial

    ERIC Educational Resources Information Center

    Mahoney, Gerald; Solomon, Richard

    2016-01-01

    This investigation is a secondary analysis of data from a randomized control trial of the PLAY Home Consultation Intervention Program which was conducted with 112 preschool children with Autism Spectrum Disorders and their parents (Solomon et al. in "J Dev Behav Pediatr" 35:475-485, 2014). Subjects were randomly assigned to either a…

  15. 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.

  16. A facility specialist model for improving retention of nursing home staff: results from a randomized, controlled study.

    PubMed

    Pillemer, Karl; Meador, Rhoda; Henderson, Charles; Robison, Julie; Hegeman, Carol; Graham, Edwin; Schultz, Leslie

    2008-07-01

    This article reports on a randomized, controlled intervention study designed to reduce employee turnover by creating a retention specialist position in nursing homes. We collected data three times over a 1-year period in 30 nursing homes, sampled in stratified random manner from facilities in New York State and Connecticut and randomly assigned to treatment and control conditions. Staff outcomes were measured through certified nursing assistant interviews, and turnover rates were measured over the course of the year. In the intervention condition, a staff member was selected to be the facility retention specialist, who would advocate for and implement programs to improve staff retention and commitment throughout the facility. Retention specialists received an intensive 3-day training in retention leadership and in a number of evidence-based retention programs. Ongoing support was provided throughout the project. Treatment facilities experienced significant declines in turnover rates compared to control facilities. As predicted, we found positive effects on certified nursing assistant assessments of the quality of retention efforts and of care provided in the facility; we did not find effects for job satisfaction or stress. The study provides evidence for the effectiveness of the retention specialist model. Findings from a detailed process evaluation suggest modifications of the program that may increase program effects.

  17. Internet-based home training is capable to improve balance in multiple sclerosis: a randomized controlled trial.

    PubMed

    Frevel, D; Mäurer, M

    2015-02-01

    Balance disorders are common in multiple sclerosis. Aim of the study is to investigate the effectiveness of an Internet-based home training program (e-Training) to improve balance in patients with multiple sclerosis. A randomized, controlled study. Academic teaching hospital in cooperation with the therapeutic riding center Gut Üttingshof, Bad Mergentheim. Eighteen multiple sclerosis patients (mean EDSS 3,5) took part in the trial. Outcome of patients using e-Training (N.=9) was compared to the outcome of patients receiving hippotherapy (N.=9), which can be considered as an advanced concept for the improvement of balance and postural control in multiple sclerosis. After simple random allocation patients received hippotherapy or Internet-based home training (balance, postural control and strength training) twice a week for 12 weeks. Assessments were done before and after the intervention and included static and dynamic balance (primary outcome). Isometric muscle strength of the knee and trunk extension/flexion (dynamometer), walking capacity, fatigue and quality of life served as secondary outcome parameters. Both intervention groups showed comparable and highly significant improvement in static and dynamic balance capacity, no difference was seen between the both intervention groups. However looking at fatigue and quality of life only the group receiving hippotherapy improved significantly. Since e-Training shows even comparable effects to hippotherapy to improve balance, we believe that the established Internet-based home training program, specialized on balance and postural control training, is feasible for a balance and strength training in persons with multiple sclerosis. We demonstrated that Internet-based home training is possible in patients with multiple sclerosis.

  18. The Effectiveness of Healthy Start Home Visit Program: Cluster Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Leung, Cynthia; Tsang, Sandra; Heung, Kitty

    2015-01-01

    Purpose: The study reported the effectiveness of a home visit program for disadvantaged Chinese parents with preschool children, using cluster randomized controlled trial design. Method: Participants included 191 parents and their children from 24 preschools, with 84 dyads (12 preschools) in the intervention group and 107 dyads (12 preschools) in…

  19. Training balance with opto-kinetic stimuli in the home: a randomized controlled feasibility study in people with pure cerebellar disease.

    PubMed

    Bunn, Lisa M; Marsden, Jonathan F; Giunti, Paola; Day, Brian L

    2015-02-01

    To investigate the feasibility of a randomized controlled trial of a home-based balance intervention for people with cerebellar ataxia. A randomized controlled trial design. Intervention and assessment took place in the home environment. A total of 12 people with spinocerebellar ataxia type 6 were randomized into a therapy or control group. Both groups received identical assessments at baseline, four and eight weeks. Therapy group participants undertook balance exercises in front of optokinetic stimuli during weeks 4-8, while control group participants received no intervention. Test-retest reliability was analysed from outcome measures collected twice at baseline and four weeks later. Feasibility issues were evaluated using daily diaries and end trial exit interviews. The home-based training intervention with opto-kinetic stimuli was feasible for people with pure ataxia, with one drop-out. Test-retest reliability is strong (intraclass correlation coefficient >0.7) for selected outcome measures evaluating balance at impairment and activity levels. Some measures reveal trends towards improvement for those in the therapy group. Sample size estimations indicate that Bal-SARA scores could detect a clinically significant change of 0.8 points in this functional balance score if 80 people per group were analysed in future trials. Home-based targeted training of functional balance for people with pure cerebellar ataxia is feasible and the outcome measures employed are reliable. © The Author(s) 2014.

  20. Full and home smoking ban adoption after a randomized controlled trial targeting secondhand smoke exposure reduction.

    PubMed

    Nicholson, Jody S; McDermott, Michael J; Huang, Qinlei; Zhang, Hui; Tyc, Vida L

    2015-05-01

    The current study examined home and full (i.e., home plus car) smoking ban adoption as secondary outcomes to a randomized controlled trial targeting reduced secondhand smoke exposure (SHSe) for children under treatment for cancer. Families with at least 1 adult smoker who reported SHSe for their children (n = 119) were randomized to control or intervention conditions and followed for 1 year with 5 assessments. Both groups were advised of the negative health outcomes associated with SHSe; the intervention group provided more in-depth counseling from baseline to 3 months. Parents reported on household and car smoking behavior, demographic, psychosocial, and medical/treatment-related information. Regardless of group assignment, there was an increase in home (odds ration [OR] = 1.16, p = .074) and full (OR = 1.37, p = .001) smoking ban adoption across time. Families in the intervention group were more likely to adopt a full ban by 3 months, but this difference was nonsignificant by 12 months. Married parents (OR = 2.33, p = .006) and those with higher self-efficacy for controlling children's SHSe (OR = 1.11, p = .023) were more likely to have a home smoking ban; parents who reported smoking fewer cigarettes were more likely to adopt a home (OR = 1.62, p < .0001) or full (OR = 7.32, p = .038) ban. Smoking bans are in-line with Healthy People 2020's tobacco objectives and may be more feasible for parents with medically compromised children for immediate SHSe reduction. Furthermore, interventions targeting full smoking bans may be a more effective for comprehensive elimination of SHSe. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco 2014. This work is written by (a) US Government employee(s) and is in the public domain in the US.

  1. Impact of Improving Home Environments on Energy Intake and Physical Activity: A Randomized Controlled Trial

    PubMed Central

    Haardörfer, Regine; Alcantara, Iris C.; Gazmararian, Julie A.; Veluswamy, J. K.; Hodge, Tarccara L.; Addison, Ann R.; Hotz, James A.

    2016-01-01

    Objectives. We assessed the effectiveness of an intervention targeting home food and activity environments to reduce energy intake and increase physical activity among overweight and obese patients from 3 community health centers in rural Georgia. Methods. We conducted a randomized controlled trial (n = 349) from 2011 to 2013, with follow-up at 6 and 12 months. Health coaches delivered the 16-week intervention by using tailored home environment profiles showing areas in need of improvement and positive aspects of the home environment, behavioral contracts for healthy actions, and mailed support materials. Results. Participants were mostly African American women (84.8%), with a mean age of 50.2 years and a mean body mass index (weight in kilograms divided by the square of height in meters) of 38.3. Daily energy intake decreased more for the intervention than control group at 6 (–274 vs –69 kcal) and 12 months (–195 vs –76 kcal). We observed no change for either objective or self-reported physical activity. At 12 months, 82.6% of intervention participants had not gained weight compared with 71.4% of control participants. Conclusions. The intervention was effective in changing home environments and reducing energy intake. PMID:26696290

  2. Effects of a home-based physical rehabilitation program on physical disability after hip fracture: a randomized controlled trial.

    PubMed

    Edgren, Johanna; Salpakoski, Anu; Sihvonen, Sanna E; Portegijs, Erja; Kallinen, Mauri; Arkela, Marja; Jäntti, Pirkko; Vanhatalo, Jukka; Pekkonen, Mika; Rantanen, Taina; Heinonen, Ari; Sipilä, Sarianna

    2015-04-01

    Fewer than half of the patients with hip fracture will regain the prefracture level of physical functioning. This secondary analysis of a randomized controlled trial investigated the effects of a multicomponent home-based rehabilitation program (ProMo) on physical disability after hip fracture. Randomized, controlled, parallel-group trial. Rehabilitation in participants' homes; measurements in university-based laboratory and local hospital. Population-based clinical sample of community-dwelling people older than 60 years (n = 81) operated for hip fracture were randomized into intervention and control groups. The year-long intervention aimed at restoring mobility. It included evaluation and modification of environmental hazards, guidance for safe walking, pain management, home exercise, physical activity counseling, and standard care. Physical disability was assessed by a questionnaire at baseline, and 3, 6, and 12 months thereafter. Sum scores were computed for basic (ADLs) and instrumental activities of daily living (IADLs). A higher score indicated more difficulty. GEE models were constructed to analyze the effect of the intervention. In the intention-to-treat analysis, no intervention effect was observed for sum scores. For the single disability items, borderline significant positive effects were observed for preparing food and handling medication (interaction P = .061 and P = .061, respectively). In the per-protocol analysis, the mean differences between groups were -0.4 points (SE 0.5), -1.7 (0.7), and -1.2 (0.7) at 3, 6, and 12 months for ADLs and -1.0 (1.2), -3.2 (1.5), and -2.5 (1.4) for IADLs, correspondingly. The current analyses suggest that home-based rehabilitation may reduce disability among older people after hip fracture. The present results need to be confirmed in a study with larger sample size. Potentially a more task-oriented rehabilitation approach might gain more benefits. Current Controlled Trials (ISRCTN53680197). Copyright © 2015 AMDA

  3. Effects of a Home-Based Upper Limb Training Program in Patients With Multiple Sclerosis: A Randomized Controlled Trial.

    PubMed

    Ortiz-Rubio, Araceli; Cabrera-Martos, Irene; Rodríguez-Torres, Janet; Fajardo-Contreras, Waldo; Díaz-Pelegrina, Ana; Valenza, Marie Carmen

    2016-12-01

    To evaluate the effects of a home-based upper limb training program on arm function in patients with multiple sclerosis (MS). Additionally, the effects of this program on manual dexterity, handgrip strength, and finger prehension force were analyzed. Randomized, single-blind controlled trial. Home based. Patients with a clinical diagnosis of MS acknowledging impaired manual ability (N=37) were randomized into 2 groups. Patients in the experimental group were included in a supervised home-based upper limb training program for 8 weeks twice a week. Patients in the control group received information in the form of a leaflet with a schedule of upper limb exercise training. The primary outcome measure was arm function (motor functioning assessed using the finger tapping test and a functional measure, the Action Research Arm Test). The secondary outcome measures were manual dexterity assessed with the Purdue Pegboard Test and handgrip strength and finger prehension force evaluated with a handgrip and a pinch dynamometer, respectively. After 8 weeks, a significant between-group improvement (P<.05) was found on the Action Research Arm Test bilaterally and the finger tapping test in the most affected upper limb. The secondary outcomes also improved in the most affected limb in the experimental group. An 8-week home-based intervention program focused on upper limbs twice a week improved arm function and physiologic variables with a primary focus on the more affected extremity in patients with MS compared with the control group. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  4. Design and rationale for Home Blood Pressure Telemonitoring and Case Management to Control Hypertension (HyperLink): a cluster randomized trial.

    PubMed

    Margolis, Karen L; Kerby, Tessa J; Asche, Stephen E; Bergdall, Anna R; Maciosek, Michael V; O'Connor, Patrick J; Sperl-Hillen, JoAnn M

    2012-07-01

    Patients with high blood pressure (BP) visit a physician an average of 4 times or more per year in the U.S., yet BP is controlled in fewer than half. Practical, robust and sustainable models are needed to improve BP in patients with uncontrolled hypertension. The Home Blood Pressure Telemonitoring and Case Management to Control Hypertension study (HyperLink) is a cluster-randomized trial designed to determine whether an intervention that combines home BP telemonitoring with pharmacist case management improves BP control compared to usual care at 6 and 12 months in patients with uncontrolled hypertension. Secondary outcomes are maintenance of BP control at 18 months, patient satisfaction with their health care, and costs of care. HyperLink enrolled 450 hypertensive patients with uncontrolled BP from 16 primary care clinics. Eight clinics were randomized to provide usual care (UC) to their patients (n=222) and 8 were randomized to provide the telemonitoring intervention (TI) (n=228). TI patients received home BP telemonitors that internally store and electronically transmit BP data to a secure database. Pharmacist case managers adjust antihypertensive therapy based on the home BP data under a collaborative practice agreement with the clinics' primary care teams. The length of the intervention is 12 months, with follow-up to 18 months to determine the durability of the intervention. We will test in a real primary care setting whether combining BP telemonitoring and pharmacist case management can achieve and maintain high rates of BP control compared to usual care. Copyright © 2012 Elsevier Inc. All rights reserved.

  5. Supervising for Home Safety Program: A Randomized Controlled Trial (RCT) Testing Community-Based Group Delivery.

    PubMed

    Morrongiello, Barbara A; Hou, Sharon; Bell, Melissa; Walton, Kathryn; Filion, A Jordan; Haines, Jess

    2017-08-01

    The individually delivered Supervising for Home Safety (SHS) program improves caregivers' injury-related beliefs and supervision practices. The current randomized controlled trial used a group delivery in a community setting and assessed program impact, feasibility, and acceptance. Caregivers of 2-5-year-olds were randomized to receive either the SHS or an attention-matched control program. In the SHS group only, there were increases from baseline to postintervention in the following: beliefs about children's vulnerability to injury, caregiver preventability of injuries, and self-efficacy to do so; readiness for change in supervision; and watchful supervision. Face-to-face recruitment by staff at community organizations proved most successful. Caregivers' satisfaction ratings were high, as was caregiver engagement (95% completed at least seven of the nine sessions). The SHS program can be delivered to groups of caregivers in community settings, is positively received by caregivers, and produces desirable changes that can be expected to improve caregivers' home safety practices. © The Author 2016. 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

  6. Home exercise programmes supported by video and automated reminders compared with standard paper-based home exercise programmes in patients with stroke: a randomized controlled trial.

    PubMed

    Emmerson, Kellie B; Harding, Katherine E; Taylor, Nicholas F

    2017-08-01

    To determine whether patients with stroke receiving rehabilitation for upper limb deficits using smart technology (video and reminder functions) demonstrate greater adherence to prescribed home exercise programmes and better functional outcomes when compared with traditional paper-based exercise prescription. Randomized controlled trial comparing upper limb home exercise programmes supported by video and automated reminders on smart technology, with standard paper-based home exercise programmes. A community rehabilitation programme within a large metropolitan health service. Patients with stroke with upper limb deficits, referred for outpatient rehabilitation. Participants were randomly assigned to the control (paper-based home exercise programme) or intervention group (home exercise programme filmed on an electronic tablet, with an automated reminder). Both groups completed their prescribed home exercise programme for four weeks. The primary outcome was adherence using a self-reported log book. Secondary outcomes were change in upper limb function and patient satisfaction. A total of 62 participants were allocated to the intervention ( n = 30) and control groups ( n = 32). There were no differences between the groups for measures of adherence (mean difference 2%, 95% CI -12 to 17) or change in the Wolf Motor Function Test log transformed time (mean difference 0.02 seconds, 95% CI -0.1 to 0.1). There were no between-group differences in how participants found instructions ( p = 0.452), whether they remembered to do their exercises ( p = 0.485), or whether they enjoyed doing their exercises ( p = 0.864). The use of smart technology was not superior to standard paper-based home exercise programmes for patients recovering from stroke. This trial design was registered prospectively with the Australian and New Zealand Clinical Trials Register, ID: ACTRN 12613000786796. http://www.anzctr.org.au/trialSearch.aspx.

  7. Efficacy and acceptability of a home-based, family-inclusive intervention for veterans with TBI: A randomized controlled trial.

    PubMed

    Winter, Laraine; Moriarty, Helene J; Robinson, Keith; Piersol, Catherine V; Vause-Earland, Tracey; Newhart, Brian; Iacovone, Delores Blazer; Hodgson, Nancy; Gitlin, Laura N

    2016-01-01

    Traumatic brain injury (TBI) often undermines community re-integration, impairs functioning and produces other symptoms. This study tested an innovative programme for veterans with TBI, the Veterans' In-home Programme (VIP), delivered in veterans' homes, involving a family member and targeting the environment (social and physical) to promote community re-integration, mitigate difficulty with the most troubling TBI symptoms and facilitate daily functioning. Interviews and intervention sessions were conducted in homes or by telephone. Eighty-one veterans with TBI at a VA polytrauma programme and a key family member. This was a 2-group randomized controlled trial. Control-group participants received usual-care enhanced by two attention-control telephone calls. Follow-up interviews occurred up to 4 months after baseline interview. VIP's efficacy was evaluated using measures of community re-integration, target outcomes reflecting veterans' self-identified problems and self-rated functional competence. At follow-up, VIP participants had significantly higher community re-integration scores and less difficulty managing targeted outcomes, compared to controls. Self-rated functional competence did not differ between groups. In addition, VIP's acceptability was high. A home-based, family-inclusive service for veterans with TBI shows promise for improving meaningful outcomes and warrants further research and clinical application.

  8. A Minimal Intervention to Promote Smoke-Free Homes Among 2-1-1 Callers: A Randomized Controlled Trial

    PubMed Central

    Bundy, Lucja; Haardörfer, Regine; Escoffery, Cam; Berg, Carla; Yembra, Debbie; Kreuter, Matthew; Hovell, Mel; Williams, Rebecca; Mullen, Patricia Dolan; Ribisl, Kurt; Burnham, Donna

    2015-01-01

    Objectives. We tested the efficacy of a minimal intervention to create smoke-free homes in low-income households recruited through the United Way of Greater Atlanta 2-1-1, an information and referral system that connects callers to local social services. Methods. We conducted a randomized controlled trial (n = 498) from June 2012 through June 2013, with follow-up at 3 and 6 months. The intervention consisted of 3 mailings and 1 coaching call. Results. Participants were mostly smokers (79.7%), women (82.7%), African American (83.3%), and not employed (76.5%), with an annual household income of $10 000 or less (55.6%). At 6-months postbaseline, significantly more intervention participants reported a full ban on smoking in the home than did control participants (40.0% vs 25.4%; P = .002). The intervention worked for smokers and nonsmokers, as well as those with or without children. Conclusions. Minimal intervention was effective in promoting smoke-free homes in low income households and offers a potentially scalable model for protecting children and adult nonsmokers from secondhand smoke exposure in their homes. PMID:25602863

  9. The first multicenter, randomized, controlled trial of home telemonitoring for Japanese patients with heart failure: home telemonitoring study for patients with heart failure (HOMES-HF).

    PubMed

    Kotooka, Norihiko; Kitakaze, Masafumi; Nagashima, Kengo; Asaka, Machiko; Kinugasa, Yoshiharu; Nochioka, Kotaro; Mizuno, Atsushi; Nagatomo, Daisuke; Mine, Daigo; Yamada, Yoko; Kuratomi, Akiko; Okada, Norihiro; Fujimatsu, Daisuke; Kuwahata, So; Toyoda, Shigeru; Hirotani, Shin-Ichi; Komori, Takahiro; Eguchi, Kazuo; Kario, Kazuomi; Inomata, Takayuki; Sugi, Kaoru; Yamamoto, Kazuhiro; Tsutsui, Hiroyuki; Masuyama, Tohru; Shimokawa, Hiroaki; Momomura, Shin-Ichi; Seino, Yoshihiko; Sato, Yasunori; Inoue, Teruo; Node, Koichi

    2018-02-15

    Home telemonitoring is becoming more important to home medical care for patients with heart failure. Since there are no data on home telemonitoring for Japanese patients with heart failure, we investigated its effect on cardiovascular outcomes. The HOMES-HF study was the first multicenter, open-label, randomized, controlled trial (RCT) to elucidate the effectiveness of home telemonitoring of physiological data, such as body weight, blood pressure, and pulse rate, for Japanese patients with heart failure (UMIN Clinical Trials Registry 000006839). The primary end-point was a composite of all-cause death or rehospitalization due to worsening heart failure. We analyzed 181 recently hospitalized patients with heart failure who were randomly assigned to a telemonitoring group (n = 90) or a usual care group (n = 91). The mean follow-up period was 15 (range 0-31) months. There was no statistically significant difference in the primary end-point between groups [hazard ratio (HR), 0.95; 95% confidence interval (CI), 0.548-1.648; p = 0.572]. Home telemonitoring for Japanese patients with heart failure was feasible; however, beneficial effects in addition to those of usual care were not demonstrated. Further investigation of more patients with severe heart failure, participation of home medical care providers, and use of a more integrated home telemonitoring system emphasizing communication as well as monitoring of symptoms and physiological data are required.

  10. Screen-Time Weight-loss Intervention Targeting Children at Home (SWITCH): a randomized controlled trial.

    PubMed

    Maddison, Ralph; Marsh, Samantha; Foley, Louise; Epstein, Leonard H; Olds, Timothy; Dewes, Ofa; Heke, Ihirangi; Carter, Karen; Jiang, Yannan; Mhurchu, Cliona Ni

    2014-09-10

    Screen-based activities, such as watching television (TV), playing video games, and using computers, are common sedentary behaviors among young people and have been linked with increased energy intake and overweight. Previous home-based sedentary behaviour interventions have been limited by focusing primarily on the child, small sample sizes, and short follow-up periods. The SWITCH (Screen-Time Weight-loss Intervention Targeting Children at Home) study aimed to determine the effect of a home-based, family-delivered intervention to reduce screen-based sedentary behaviour on body composition, sedentary behaviour, physical activity, and diet over 24 weeks in overweight and obese children. A two-arm, parallel, randomized controlled trial was conducted. Children and their primary caregiver living in Auckland, New Zealand were recruited via schools, community centres, and word of mouth. The intervention, delivered over 20 weeks, consisted of a face-to-face meeting with the parent/caregiver and the child to deliver intervention content, which focused on training and educating them to use a wide range of strategies designed to reduce their child's screen time. Families were given Time Machine TV monitoring devices to assist with allocating screen time, activity packages to promote alternative activities, online support via a website, and monthly newsletters. Control participants were given the intervention material on completion of follow-up. The primary outcome was change in children's BMI z-score from baseline to 24 weeks. Children (n = 251) aged 9-12 years and their primary caregiver were randomized to receive the SWITCH intervention (n = 127) or no intervention (controls; n = 124). There was no significant difference in change of zBMI between the intervention and control groups, although a favorable trend was observed (-0.016; 95% CI: -0.084, 0.051; p = 0.64). There were also no significant differences on secondary outcomes, except for a trend towards

  11. 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

  12. Effectiveness of a lifestyle exercise program for older people receiving a restorative home care service: a pragmatic randomized controlled trial.

    PubMed

    Burton, Elissa; Lewin, Gill; Clemson, Lindy; Boldy, Duncan

    2013-01-01

    Restorative home care services are short-term and aimed at maximizing a person's ability to live independently. They are multidimensional and often include an exercise program to improve strength, mobility, and balance. The aim of this study was to determine whether a lifestyle exercise program would be undertaken more often and result in greater functional gains than the current structured exercise program delivered as part of a restorative home care service for older adults. A pragmatic randomized controlled trial was conducted in an organization with an established restorative home care service. Individuals who were to have an exercise program as part of their service were randomized to receive either a lifestyle and functional exercise program called LiFE (as this was a new program, the intervention) or the structured exercise program currently being used in the service (control). Exercise data collected by the individuals throughout and pre and post intervention testing was used to measure balance, strength, mobility, falls efficacy, vitality, function, and disability. There was no difference between the groups in the amounts of exercise undertaken during the 8-week intervention period. Outcome measurement indicated that the LiFE program was as effective, and on 40% of the measures, more effective, than the structured exercise program. Organizations delivering restorative home care services that include an exercise component should consider whether LiFE rather than the exercise program they are currently using could help their clients achieve better outcomes.

  13. Probiotics to Prevent Respiratory Infections in Nursing Homes: A Pilot Randomized Controlled Trial.

    PubMed

    Wang, Biao; Hylwka, Tammy; Smieja, Marek; Surrette, Michael; Bowdish, Dawn M E; Loeb, Mark

    2018-05-09

    To assess the feasibility of conducting a large clinical trial to evaluate the effectiveness of probiotics to reduce influenza and other respiratory virus infections in residents of long-term and chronic care facilities (LTCFs). Randomized, double-blind, placebo-controlled pilot trial. Fourteen nursing homes in Hamilton and surrounding region, Ontario, Canada. Nursing home residents aged 65 and older (N=209). Those who were taking immunosuppressives (steroids or other immunosuppressives) or had a hematological malignancy, structural heart disease, or gastroesophageal or intestinal injury and others at high risk of an endovascular infection were excluded. Participants were randomized to receive study probiotics-2 capsules of Lactobacillus rhamnosus GG (estimated 10 billion colony forming units of L. rhamnosus GG per capsule) or placebo (calcium carbonate) daily for 6 months. Laboratory-confirmed respiratory viral infections. One hundred ninety-six individuals were included in the analysis: 100 in the probiotics group and 96 in the placebo group. Laboratory-confirmed respiratory viral infections were observed in 14 (15.0%) residents in the probiotic group and 21 (22.9%) in the placebo group (hazard ratio=0.65, 95% confidence interval=0.32-1.31). A larger trial is warranted to determine whether probiotics reduce influenza and other respiratory virus infections in residents of LTCFs. © 2018, Copyright the Authors Journal compilation © 2018, The American Geriatrics Society.

  14. HomeStyles, A Web-Based Childhood Obesity Prevention Program for Families With Preschool Children: Protocol for a Randomized Controlled Trial

    PubMed Central

    2017-01-01

    Background The home environment is where young children spend most of their time, and is critically important to supporting behaviors that promote health and prevent obesity. However, the home environment and lifestyle patterns remain understudied, and few interventions have investigated parent-led makeovers designed to create home environments that are supportive of optimal child health and healthy child weights. Objective The aim of the HomeStyles randomized controlled trial (RCT) is to determine whether the Web-based HomeStyles intervention enables and motivates parents to shape the weight-related aspects of their home environments and lifestyle behavioral practices (diet, exercise, and sleep) to be more supportive of their preschool children’s optimal health and weight. Methods A rigorous RCT utilizing an experimental group and an attention control group, receiving a bona fide contemporaneous treatment equal in nonspecific treatment effects and differing only in subject matter content, will test the effect of HomeStyles on a diverse sample of families with preschool children. This intervention is based on social cognitive theory and uses a social ecological framework, and will assess: intrapersonal characteristics (dietary intake, physical activity level, and sleep) of parents and children; family interpersonal or social characteristics related to diet, physical activity, media use, and parental values and self-efficacy for obesity-preventive practices; and home environment food availability, physical activity space and supports in and near the home, and media availability and controls in the home. Results Enrollment for this study has been completed and statistical data analyses are currently underway. Conclusions This paper describes the HomeStyles intervention with regards to: rationale, the intervention’s logic model, sample eligibility criteria and recruitment, experimental group and attention control intervention content, study design, instruments

  15. HomeStyles, A Web-Based Childhood Obesity Prevention Program for Families With Preschool Children: Protocol for a Randomized Controlled Trial.

    PubMed

    Byrd-Bredbenner, Carol; Martin-Biggers, Jennifer; Koenings, Mallory; Quick, Virginia; Hongu, Nobuko; Worobey, John

    2017-04-25

    The home environment is where young children spend most of their time, and is critically important to supporting behaviors that promote health and prevent obesity. However, the home environment and lifestyle patterns remain understudied, and few interventions have investigated parent-led makeovers designed to create home environments that are supportive of optimal child health and healthy child weights. The aim of the HomeStyles randomized controlled trial (RCT) is to determine whether the Web-based HomeStyles intervention enables and motivates parents to shape the weight-related aspects of their home environments and lifestyle behavioral practices (diet, exercise, and sleep) to be more supportive of their preschool children's optimal health and weight. A rigorous RCT utilizing an experimental group and an attention control group, receiving a bona fide contemporaneous treatment equal in nonspecific treatment effects and differing only in subject matter content, will test the effect of HomeStyles on a diverse sample of families with preschool children. This intervention is based on social cognitive theory and uses a social ecological framework, and will assess: intrapersonal characteristics (dietary intake, physical activity level, and sleep) of parents and children; family interpersonal or social characteristics related to diet, physical activity, media use, and parental values and self-efficacy for obesity-preventive practices; and home environment food availability, physical activity space and supports in and near the home, and media availability and controls in the home. Enrollment for this study has been completed and statistical data analyses are currently underway. This paper describes the HomeStyles intervention with regards to: rationale, the intervention's logic model, sample eligibility criteria and recruitment, experimental group and attention control intervention content, study design, instruments, data management, and planned analyses. ©Carol Byrd

  16. PRagmatic trial Of Video Education in Nursing homes: The design and rationale for a pragmatic cluster randomized trial in the nursing home setting.

    PubMed

    Mor, Vincent; Volandes, Angelo E; Gutman, Roee; Gatsonis, Constantine; Mitchell, Susan L

    2017-04-01

    Background/Aims Nursing homes are complex healthcare systems serving an increasingly sick population. Nursing homes must engage patients in advance care planning, but do so inconsistently. Video decision support tools improved advance care planning in small randomized controlled trials. Pragmatic trials are increasingly employed in health services research, although not commonly in the nursing home setting to which they are well-suited. This report presents the design and rationale for a pragmatic cluster randomized controlled trial that evaluated the "real world" application of an Advance Care Planning Video Program in two large US nursing home healthcare systems. Methods PRagmatic trial Of Video Education in Nursing homes was conducted in 360 nursing homes (N = 119 intervention/N = 241 control) owned by two healthcare systems. Over an 18-month implementation period, intervention facilities were instructed to offer the Advance Care Planning Video Program to all patients. Control facilities employed usual advance care planning practices. Patient characteristics and outcomes were ascertained from Medicare Claims, Minimum Data Set assessments, and facility electronic medical record data. Intervention adherence was measured using a Video Status Report embedded into electronic medical record systems. The primary outcome was the number of hospitalizations/person-day alive among long-stay patients with advanced dementia or cardiopulmonary disease. The rationale for the approaches to facility randomization and recruitment, intervention implementation, population selection, data acquisition, regulatory issues, and statistical analyses are discussed. Results The large number of well-characterized candidate facilities enabled several unique design features including stratification on historical hospitalization rates, randomization prior to recruitment, and 2:1 control to intervention facilities ratio. Strong endorsement from corporate leadership made randomization

  17. Effectiveness of short-term, enhanced, infection control support in improving compliance with infection control guidelines and practice in nursing homes: a cluster randomized trial.

    PubMed

    Gopal Rao, G; Jeanes, A; Russell, H; Wilson, D; Atere-Roberts, E; O'Sullivan, D; Donaldson, N

    2009-10-01

    In this prospective cluster randomized controlled trial we evaluated the impact of short-term provision of enhanced infection control support on infection control practice in nursing homes in South London. Twelve nursing homes were recruited, six each in intervention (300 residents) and control (265 residents) groups. Baseline observations of hand hygiene facilities, environmental cleanliness and safe disposal of clinical waste showed poor compliance in both groups. Post-intervention observations showed improvement in both groups. There was no statistical difference between the two groups in the compliance for hand hygiene facilities (P=0.69); environmental cleanliness (P=0.43) and safe disposal of clinical waste (P=0.96). In both groups, greatest improvement was in compliance with safe disposal of clinical waste and the least improvement was in hand hygiene facilities. Since infection control practice improved in intervention and control groups, we could not demonstrate that provision of short-term, enhanced, infection control support in nursing homes had a significant impact in infection control practice.

  18. Home-based neurologic music therapy for arm hemiparesis following stroke: results from a pilot, feasibility randomized controlled trial.

    PubMed

    Street, Alexander J; Magee, Wendy L; Bateman, Andrew; Parker, Michael; Odell-Miller, Helen; Fachner, Jorg

    2018-01-01

    To assess the feasibility of a randomized controlled trial to evaluate music therapy as a home-based intervention for arm hemiparesis in stroke. A pilot feasibility randomized controlled trial, with cross-over design. Randomization by statistician using computer-generated, random numbers concealed in opaque envelopes. Participants' homes across Cambridgeshire, UK. Eleven people with stroke and arm hemiparesis, 3-60 months post stroke, following discharge from community rehabilitation. Each participant engaged in therapeutic instrumental music performance in 12 individual clinical contacts, twice weekly for six weeks. Feasibility was estimated by recruitment from three community stroke teams over a 12-month period, attrition rates, completion of treatment and successful data collection. Structured interviews were conducted pre and post intervention to establish participant tolerance and preference. Action Research Arm Test and Nine-hole Peg Test data were collected at weeks 1, 6, 9, 15 and 18, pre and post intervention by a blinded assessor. A total of 11 of 14 invited participants were recruited (intervention n = 6, waitlist n = 5). In total, 10 completed treatment and data collection. It cannot be concluded whether a larger trial would be feasible due to unavailable data regarding a number of eligible patients screened. Adherence to treatment, retention and interview responses might suggest that the intervention was motivating for participants. ClinicalTrials.gov identifier NCT 02310438.

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

    PubMed Central

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

    2013-01-01

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

  20. Children diagnosed with type 1 diabetes: a randomized controlled trial comparing hospital versus home-based care.

    PubMed

    Tiberg, Irén; Katarina, Steen Carlsson; Carlsson, Annelie; Hallström, Inger

    2012-10-01

      To compare two different regimens for children diagnosed with type 1 diabetes: hospital-based care or hospital-based home care (HBHC), referring to specialist care in a home-based setting.   The trial took place in Sweden with a randomized controlled design and included 60 children, aged 3-15 years. After 2-3 days with hospital-based care, children were randomized to either continued hospital-based care or to HBHC for 6 days. The primary outcome was the child's metabolic control after 2 years. Secondary outcomes were set to evaluate the family and child situation as well as the healthcare services. This article presents data 6 months after diagnosis.   Results showed equivalence between groups in terms of metabolic control, insulin dose, parents' employment and working hours as well as parents' and significant others' absence from work related to the child's diabetes. Parents in the HBHC were more satisfied with the received health care and showed less subsequent healthcare resource use. The level of risk for the family's psychosocial distress assessed at diagnosis was associated with the subsequent use of resources, but not with metabolic control.   HBHC was found to be an equally safe and effective way of providing care as hospital-based care at the onset of type 1 diabetes for children who are medically stable. © 2012 The Author(s)/Acta Paediatrica © 2012 Foundation Acta Paediatrica.

  1. Apathy in nursing home residents with dementia: results from a cluster-randomized controlled trial.

    PubMed

    Treusch, Y; Majic, T; Page, J; Gutzmann, H; Heinz, A; Rapp, M A

    2015-02-01

    Here we evaluate an interdisciplinary occupational and sport therapy intervention for dementia patients suffering from apathy. A prospective, controlled, rater-blinded, clinical trial with two follow-ups was conducted as part of a larger cluster-randomized trial in 18 nursing homes in Berlin. n=117 dementia patients with apathy, defined as a score of 40 or more on the apathy evaluation scale (AES) or presence of apathy on the Neuropsychiatric Inventory (NPI), were randomly assigned to intervention or control group. The intervention included 10 months of brief activities, provided once a week. The primary outcome measure was the total score on the AES scale measured directly after the intervention period and again after 12 months. We found significant group differences with respect to apathy during the 10 month intervention period (F2,82=7.79, P<0.01), which reflected an increase in apathy in the control group, but not in the intervention group. Within one year after the intervention was ceased, the treatment group worsened and no longer differed significantly from the control group (P=0.55). Our intervention was effective for the therapy of apathy in dementia, when applied, but not one year after cessation of therapy. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  2. More Than A Meal? A Randomized Control Trial Comparing the Effects of Home-Delivered Meals Programs on Participants' Feelings of Loneliness.

    PubMed

    Thomas, Kali S; Akobundu, Ucheoma; Dosa, David

    2016-11-01

    Nutrition service providers are seeking alternative delivery models to control costs and meet the growing need for home-delivered meals. The objective of this study was to evaluate the extent to which the home-delivered meals program, and the type of delivery model, reduces homebound older adults' feelings of loneliness. This project utilizes data from a three-arm, fixed randomized control study conducted with 626 seniors on waiting lists at eight Meals on Wheels programs across the United States. Seniors were randomly assigned to either (i) receive daily meal delivery; (ii) receive once-weekly meal delivery; or (iii) remain on the waiting list. Participants were surveyed at baseline and again at 15 weeks. Analysis of covariance was used to test for differences in loneliness between groups, over time and logistic regression was used to assess differences in self-rated improvement in loneliness. Participants receiving meals had lower adjusted loneliness scores at follow-up compared with the control group. Individuals who received daily-delivered meals were more likely to self-report that home-delivered meals improved their loneliness than the group receiving once-weekly delivered meals. This article includes important implications for organizations that provide home-delivered meals in terms of cost, delivery modality, and potential recipient benefits. Published by Oxford University Press on behalf of the Gerontological Society of America 2015. This work is written by (a) US Government employee(s) and is in the public domain in the US.

  3. The "Don't smoke in our home" randomized controlled trial to protect children from second-hand smoke exposure at home.

    PubMed

    Chellini, Elisabetta; Gorini, Giuseppe; Carreras, Giulia

    2013-01-01

    Increasing smoke-free homes is an important public health goal, but only few interventions have yielded positive results. The aim of the "Don't smoke in our home" trial was to evaluate a counseling intervention focused on promoting totally smoke-free homes and cars (TSFHC) delivered to women with children resident in four Tuscan towns. We used a two-group randomized controlled trial design. Participants were asked about their smoking habits and about restrictions on smoking in their homes and cars. All women received a self-help booklet promoting TSFHC, and 110 women randomized to the intervention also attended brief counseling on second-hand smoke exposure protection and received three gifts to remember the commitment to TSFHC. Follow-up was conducted by phone after four months. We recruited 218 women, 64 of whom had a university degree and 131 of whom were smokers; 62% reported smoking indoors and 58% in cars. Before the intervention, nonsmokers were more likely to report totally smoke-free homes (TSFH, 52%) and cars (TSFC, 53%) than smokers (26% and 17% respectively; P <0.001). Participants of the experimental arm had similar odds as controls of having implemented TSFH after the intervention, and nonsignificantly increased odds of having introduced TSFC (odds ratio [OR] 1.47; 95% confidence interval [CI] 0.69-3.11), particularly among smokers (OR 2.24, 95%CI 0.69-7.26). All participants independently of the study arm recorded significant increases of 12 and 15 percentage points in TSFH and TSFC, respectively. Few smokers quit smoking (7%), stopped smoking indoors (5%), and stopped smoking in cars (7%), with no differences between the intervention and control groups. Adding brief counseling to written materials did not significantly increase TSFHC. However, delivering written materials only may produce modest but noteworthy TSFHC increases at the population level, even though the participants in the study did not represent a population-based sample, given the

  4. The Falls In Care Home study: a feasibility randomized controlled trial of the use of a risk assessment and decision support tool to prevent falls in care homes

    PubMed Central

    Walker, Gemma M; Armstrong, Sarah; Gordon, Adam L; Gladman, John; Robertson, Kate; Ward, Marie; Conroy, Simon; Arnold, Gail; Darby, Janet; Frowd, Nadia; Williams, Wynne; Knowles, Sue; Logan, Pip A

    2015-01-01

    Objective: To explore the feasibility of implementing and evaluating the Guide to Action Care Home fall prevention intervention. Design: Two-centre, cluster feasibility randomized controlled trial and process evaluation. Setting: Purposive sample of six diverse old age/learning disability, long stay care homes in Nottinghamshire, UK. Subjects: Residents aged over 50 years, who had fallen at least once in the past year, not bed-bound, hoist-dependent or terminally ill. Interventions: Intervention homes (n = 3) received Guide to Action Care Home fall prevention intervention training and support. Control homes (n = 3) received usual care. Outcomes: Recruitment, attrition, baseline and six-month outcome completion, contamination and intervention fidelity, compliance, tolerability, acceptance and impact. Results: A total of 81 of 145 (56%) care homes expressed participatory interest. Six of 22 letter respondent homes (27%) participated. The expected resident recruitment target was achieved by 76% (52/68). Ten (19%) residents did not complete follow-up (seven died, three moved). In intervention homes 36/114 (32%) staff attended training. Two of three (75%) care homes received protocol compliant training. Staff valued the training, but advised greater management involvement to improve intervention implementation. Fall risks were assessed, actioned and recorded in care records. Of 115 recorded falls, 533/570 (93%) of details were complete. Six-month resident fall rates were 1.9 and 4.0 per year for intervention and control homes, respectively. Conclusions: The Guide to Action Care Home is implementable under trial conditions. Recruitment and follow-up rates indicate that a definitive trial can be completed. Falls (primary outcome) can be ascertained reliably from care records. PMID:26385358

  5. Promoting healthful family meals to prevent obesity: HOME Plus, a randomized controlled trial.

    PubMed

    Fulkerson, Jayne A; Friend, Sarah; Flattum, Colleen; Horning, Melissa; Draxten, Michelle; Neumark-Sztainer, Dianne; Gurvich, Olga; Story, Mary; Garwick, Ann; Kubik, Martha Y

    2015-12-15

    Family meal frequency has been shown to be strongly associated with better dietary intake; however, associations with weight status have been mixed. Family meals-focused randomized controlled trials with weight outcomes have not been previously conducted. Therefore, this study purpose was to describe weight-related outcomes of the HOME Plus study, the first family meals-focused randomized controlled trial to prevent excess weight gain among youth. Families (n = 160 8-12-year-old children and their parents/guardians) were randomized to intervention (n = 81) or control (n = 79) groups. Data were collected at baseline (2011-2012), post-intervention (12-months post-baseline) and follow-up (21-months post-baseline). The intervention included ten monthly group sessions (nutrition education; hands-on meal and snack planning, preparation, and skill development; screen time reductions) and five motivational, goal-setting phone calls. The main outcome was child body mass index (BMI) z-score. General linear models, adjusted for baseline values and demographics, showed no significant treatment group differences in BMI z-scores at post-intervention or follow-up; however, a promising reduction in excess weight gain was observed. Post-hoc stratification by pubertal onset indicated prepubescent children in the intervention group had significantly lower BMI z-scores than their control group counterparts. The study used a strong theoretical framework, rigorous design, quality measurement and a program with high fidelity to test a family meals-focused obesity prevention intervention. It showed a modest decrease in excess weight gain. The significant intervention effect among prepubescent children suggests the intervention may be more efficacious among relatively young children, although more research with appropriately powered samples are needed to replicate this finding. This study is registered at www.clinicaltrials.gov NCT01538615. Registered 01/17/2012.

  6. Home-based neurologic music therapy for arm hemiparesis following stroke: results from a pilot, feasibility randomized controlled trial

    PubMed Central

    Street, Alexander J; Magee, Wendy L; Bateman, Andrew; Parker, Michael; Odell-Miller, Helen; Fachner, Jorg

    2017-01-01

    Objective: To assess the feasibility of a randomized controlled trial to evaluate music therapy as a home-based intervention for arm hemiparesis in stroke. Design: A pilot feasibility randomized controlled trial, with cross-over design. Randomization by statistician using computer-generated, random numbers concealed in opaque envelopes. Setting: Participants’ homes across Cambridgeshire, UK. Subjects: Eleven people with stroke and arm hemiparesis, 3–60 months post stroke, following discharge from community rehabilitation. Interventions: Each participant engaged in therapeutic instrumental music performance in 12 individual clinical contacts, twice weekly for six weeks. Main measures: Feasibility was estimated by recruitment from three community stroke teams over a 12-month period, attrition rates, completion of treatment and successful data collection. Structured interviews were conducted pre and post intervention to establish participant tolerance and preference. Action Research Arm Test and Nine-hole Peg Test data were collected at weeks 1, 6, 9, 15 and 18, pre and post intervention by a blinded assessor. Results: A total of 11 of 14 invited participants were recruited (intervention n = 6, waitlist n = 5). In total, 10 completed treatment and data collection. Conclusion: It cannot be concluded whether a larger trial would be feasible due to unavailable data regarding a number of eligible patients screened. Adherence to treatment, retention and interview responses might suggest that the intervention was motivating for participants. Trial registration: ClinicalTrials.gov identifier NCT 02310438. PMID:28643570

  7. Home-based family intervention for low-income children with asthma: a randomized controlled pilot study.

    PubMed

    Celano, Marianne P; Holsey, Chanda Nicole; Kobrynski, Lisa J

    2012-04-01

    Low-income African American children have disproportionately higher asthma morbidity and mortality. Education alone may not address barriers to asthma management due to psychosocial stress. This study evaluated the efficacy of a home-based family intervention integrating asthma education and strategies to address stress using a community-based participatory research model. Children age 8 to 13 with poorly controlled asthma and their caregivers were recruited from an urban hospital and an asthma camp. Caregivers with elevated scores on a stress measure were enrolled. Forty-three families were randomized to the 4- to 6-session Home Based Family Intervention (HBFI) or the single session of Enhanced Treatment as Usual (ETAU). All families received an asthma action plan and dust mite covers; children performed spirometry and demonstrated MDI/spacer technique at each home visit. The HBFI addressed family-selected goals targeting asthma management and stressors. Asthma management, morbidity, family functioning, and caregiver stress were assessed at baseline, postintervention, and 6 months after the intervention. ED visits and hospitalizations were ascertained by medical record review for a year after intervention completion. Only one child (5%) in HBFI had an asthma-related hospitalization compared to 7 patients (35%) in ETAU in the year following intervention. Participants in both groups demonstrated improved asthma management and family functioning, and reduced ED visits, symptom days, missed school days, and caregiver stress, but there were no differential treatment effects. The results suggest that a home-based intervention addressing medical and psychosocial needs may prevent hospitalizations for children with poorly controlled asthma and caregivers under stress. (c) 2012 APA, all rights reserved.

  8. A randomized controlled study about the use of eHealth in the home health care of premature infants.

    PubMed

    Gund, Anna; Sjöqvist, Bengt Arne; Wigert, Helena; Hentz, Elisabet; Lindecrantz, Kaj; Bry, Kristina

    2013-02-09

    One area where the use of information and communication technology (ICT), or eHealth, could be developed is the home health care of premature infants. The aim of this randomized controlled study was to investigate whether the use of video conferencing or a web application improves parents' satisfaction in taking care of a premature infant at home and decreases the need of home visits. In addition, nurses' attitudes regarding the use of these tools were examined. Thirty-four families were randomized to one of three groups before their premature infant was discharged from the hospital to home health care: a control group receiving standard home health care (13 families); a web group receiving home health care supplemented with the use of a web application (12 families); a video group with home health care supplemented with video conferencing using Skype (9 families). Families and nursing staff answered questionnaires about the usefulness of ICT. In addition, semi-structured interviews were conducted with 16 families. All the parents in the web group found the web application easy to use. 83% of the families thought it was good to have access to their child's data through the application. All the families in the video group found Skype easy to use and were satisfied with the video calls. 88% of the families thought that video calls were better than ordinary phone calls. 33% of the families in the web group and 75% of those in the video group thought the need for home visits was decreased by the web application or Skype. 50% of the families in the web group and 100% of those in the video group thought the web application or the video calls had helped them feel more confident in caring for their child. Most of the nurses were motivated to use ICT but some were reluctant and avoided using the web application and video conferencing. The families were satisfied with both the web application and video conferencing. The families readily embraced the use of ICT, whereas

  9. A randomized controlled study about the use of eHealth in the home health care of premature infants

    PubMed Central

    2013-01-01

    Background One area where the use of information and communication technology (ICT), or eHealth, could be developed is the home health care of premature infants. The aim of this randomized controlled study was to investigate whether the use of video conferencing or a web application improves parents’ satisfaction in taking care of a premature infant at home and decreases the need of home visits. In addition, nurses’ attitudes regarding the use of these tools were examined. Method Thirty-four families were randomized to one of three groups before their premature infant was discharged from the hospital to home health care: a control group receiving standard home health care (13 families); a web group receiving home health care supplemented with the use of a web application (12 families); a video group with home health care supplemented with video conferencing using Skype (9 families). Families and nursing staff answered questionnaires about the usefulness of ICT. In addition, semi-structured interviews were conducted with 16 families. Results All the parents in the web group found the web application easy to use. 83% of the families thought it was good to have access to their child’s data through the application. All the families in the video group found Skype easy to use and were satisfied with the video calls. 88% of the families thought that video calls were better than ordinary phone calls. 33% of the families in the web group and 75% of those in the video group thought the need for home visits was decreased by the web application or Skype. 50% of the families in the web group and 100% of those in the video group thought the web application or the video calls had helped them feel more confident in caring for their child. Most of the nurses were motivated to use ICT but some were reluctant and avoided using the web application and video conferencing. Conclusion The families were satisfied with both the web application and video conferencing. The families

  10. Universal screening and decolonization for control of MRSA in nursing homes: a cluster randomized controlled study.

    PubMed

    Bellini, Cristina; Petignat, Christiane; Masserey, Eric; Büla, Christophe; Burnand, Bernard; Rousson, Valentin; Blanc, Dominique S; Zanetti, Giorgio

    2015-04-01

    The risk of carrying methicillin-resistant Staphylococcus aureus (MRSA) is higher among nursing home (NH) residents than in the general population. However, control strategies are not clearly defined in this setting. In this study, we compared the impact of standard precautions either alone (control) or combined with screening of residents and decolonization of carriers (intervention) to control MRSA in NHs. Cluster randomized controlled trial. NHs of the state of Vaud, Switzerland. Of 157 total NHs in Vaud, 104 (67%) participated in the study. Standard precautions were enforced in all participating NHs, and residents underwent MRSA screening at baseline and 12 months thereafter. All carriers identified in intervention NHs, either at study entry or among newly admitted residents, underwent topical decolonization combined with environmental disinfection, except in cases of MRSA infection, MRSA bacteriuria, or deep skin ulcers. NHs were randomly allocated to a control group (51 NHs, 2,412 residents) or an intervention group (53 NHs, 2,338 residents). Characteristics of NHs and residents were similar in both groups. The mean screening rates were 86% (range, 27%-100%) in control NHs and 87% (20%-100%) in intervention NHs. Prevalence of MRSA carriage averaged 8.9% in both control NHs (range, 0%-43%) and intervention NHs (range, 0%-38%) at baseline, and this rate significantly declined to 6.6% in control NHs and to 5.8% in intervention NHs after 12 months. However, the decline did not differ between groups (P=.66). Universal screening followed by decolonization of carriers did not significantly reduce the prevalence of the MRSA carriage rate at 1 year compared with standard precautions.

  11. Supporting Heart Failure Patient Transitions From Acute to Community Care With Home Telemonitoring Technology: A Protocol for a Provincial Randomized Controlled Trial (TEC4Home)

    PubMed Central

    2016-01-01

    Background Seniors with chronic diseases such as heart failure have complex care needs. They are vulnerable to their condition deteriorating and, without timely intervention, may require multiple emergency department visits and/or repeated hospitalizations. Upon discharge, the transition from the emergency department to home can be a vulnerable time for recovering patients with disruptions in the continuity of care. Remote monitoring of heart failure patients using home telemonitoring, coupled with clear communication protocols between health care professionals, can be effective in increasing the safety and quality of care for seniors with heart failure discharged from the emergency department. Objective The aim of the Telehealth for Emergency-Community Continuity of Care Connectivity via Home Telemonitoring (TEC4Home) study is to generate evidence through a programmatic evaluation and a clinical trial to determine how home telemonitoring may improve care and increase patient safety during the transition of care and determine how it is best implemented to support patients with heart failure within this context. Methods This 4-year project consists of 3 studies to comprehensively evaluate the outcomes and effectiveness of TEC4Home. Study 1 is a feasibility study with 90 patients recruited from 2 emergency department sites to test implementation and evaluation procedures. Findings from the feasibility study will be used to refine protocols for the larger trial. Study 2 is a cluster randomized controlled trial that will include 30 emergency department sites and 900 patients across British Columbia. The primary outcome of the randomized controlled trial will be emergency department revisits and hospital readmission rates. Secondary outcomes include health care resource utilization/costs, communication between members of the care team, and patient quality of life. Study 3 will run concurrently to study 2 and test the effectiveness of predictive analytic software to

  12. The home stroke rehabilitation and monitoring system trial: a randomized controlled trial.

    PubMed

    Linder, Susan M; Rosenfeldt, Anson B; Reiss, Aimee; Buchanan, Sharon; Sahu, Komal; Bay, Curtis R; Wolf, Steven L; Alberts, Jay L

    2013-01-01

    Because many individuals poststroke lack access to the quality and intensity of rehabilitation to improve upper extremity motor function, a home-based robotic-assisted upper extremity rehabilitation device is being paired with an individualized home exercise program. The primary aim of this project is to determine the effectiveness of robotic-assisted home therapy compared with a home exercise program on upper extremity motor recovery and health-related quality of life for stroke survivors in rural and underserved locations. The secondary aim is to explore whether initial degree of motor function of the upper limb may be a factor in predicting the extent to which patients with stroke may be responsive to a home therapy approach. We hypothesize that the home exercise program intervention, when enhanced with robotic-assisted therapy, will result in significantly better outcomes in motor function and quality of life. A total of 96 participants within six-months of a single, unilateral ischemic, or hemorrhagic stroke will be recruited in this prospective, single-blind, multisite randomized clinical trial. The primary outcome is the change in upper extremity function using the Action Research Arm Test. Secondary outcomes include changes in: upper extremity function (Wolf Motor Function Test), upper extremity impairment (upper extremity portion of the Fugl-Meyer Test), self-reported quality of life (Stroke Impact Scale), and affect (Centers for Epidemiologic Studies Depression Scale). Similar or greater improvements in upper extremity function using the combined robotic home exercise program intervention compared with home exercise program alone will be interpreted as evidence that supports the introduction of in-home technology to augment the recovery of function poststroke. © 2012 The Authors. International Journal of Stroke © 2012 World Stroke Organization.

  13. Predictors of Study Attrition in a Randomized Controlled Trial Evaluating a Perinatal Home-Visiting Program with Mothers with Psychosocial Vulnerabilities

    PubMed Central

    Foulon, Stéphanie; Greacen, Tim; Pasquet, Blandine; Dugravier, Romain; Saïas, Thomas; Guedeney, Nicole; Guedeney, Antoine; Tubach, Florence

    2015-01-01

    Objective Randomised controlled trials evaluating perinatal home-visiting programs are frequently confronted with the problem of high attrition rates. The aim of the present study is to identify predictors of study attrition in a trial evaluating a perinatal home-visiting program in France. Materials and Methods CAPEDP is a French randomized trial comparing a perinatal home-visiting program using psychologists versus usual care (N = 440). The first assessment was at inclusion into the trial at the 27th week of pregnancy and the final assessment when the child reached the age of two. Attrition rates were calculated at 3 and 24 months postpartum. Stepwise logistic regression was used to identify predictors of early (between inclusion and 3 months postpartum) and later (between 3 and 24 months postpartum) attrition among social, psychological and parenting factors. Results Attrition rates were 17% and 63% at 3 and 24 months respectively. At 24 months, there was significantly more attrition in the control arm (70.6%) compared to the intervention arm (55.2%). Five independent predictors of early attrition were identified: having already had an abortion; having greater attachment insecurity as measured with the Vulnerable Attachment Style Questionnaire (VASQ); having lower global severity of psychiatric symptoms as assessed with the Symptom Check-List (SCL-90) at inclusion, being neither currently employed nor studying; and declaring no tobacco consumption during pregnancy. Being randomized into the control arm, having undergone early parental loss before age 11 and having lower global severity of psychiatric symptoms (SCL-90) at 3 months postpartum were the only variables associated with later attrition. Conclusion This study provides key information for identifying mothers who may require specific support to avoid study attrition in trials evaluating a home-visiting program. PMID:26554839

  14. Effect of home-based exercise intervention on fasting insulin and Adipocytokines in colorectal cancer survivors: a randomized controlled trial.

    PubMed

    Lee, Mi Kyung; Kim, Ji-Young; Kim, Dong-Il; Kang, Dong-Woo; Park, Ji-Hye; Ahn, Ki-Yong; In Yang, Hyuk; Lee, Dong Hoon; Roh, Yun Ho; Lee, Ji-Won; Chu, Sang-Hui; Meyerhardt, Jeffrey A; Jones, Lee W; Kim, Nam-Kyu; Jeon, Justin Y

    2017-11-01

    Elevated circulating insulin is associated with increased risk of recurrence and cancer mortality in early-stage colorectal cancer (CRC). We conducted a randomized controlled trial to determine the effect of a 12-week home-based exercise program on fasting insulin, adipocytokines, and physical function in CRC survivors. One hundred and twenty-three stage II-III CRC patients were randomly assigned to either a home-based exercise (n=62) or standard care control group (n=61) for 12weeks. Home-based exercise consisted of aerobic and resistance training, with a goal of obtaining ≥18 metabolic equivalent task (MET)-h/wk. Participants in the exercise group were instructed to participate in >18MET-h/wk. of aerobic and resistance exercise while the participants in the control group were asked to maintain their usual daily activity. The primary outcome was fasting insulin levels. Secondary outcomes were adiponectin, TNF-α levels and 6min walk distance from baseline to post-intervention. After the 12-weeks, moderate-vigorous physical activity participation increased from 9.1±14.7MET-h/wk. to 26.6±21.7MET-h/wk. in the exercise group, with no change in the control group (p<0.01 for group and time interaction). Circulating insulin level decreased by 1μU/ml (6.0±3.9 vs. 5.0±3.5, p=0.009) in the exercise group with no change in the control group (p=0.022 for group and time interaction). A similar trend was observed in TNF-α (p=0.030 for group and time interaction). Six minute walk distance increased by 25.2m in the exercise group with no change in the control group (p=0.061 for group and time interaction). The 12week home-based exercise program increased level of physical activity and decreased circulating insulin levels in CRC survivors. Copyright © 2017 Elsevier Inc. All rights reserved.

  15. A home-based exercise program for children with congenital heart disease following interventional cardiac catheterization: study protocol for a randomized controlled trial.

    PubMed

    Du, Qing; Salem, Yasser; Liu, Hao Howe; Zhou, Xuan; Chen, Sun; Chen, Nan; Yang, Xiaoyan; Liang, Juping; Sun, Kun

    2017-01-23

    Cardiac catheterization has opened an innovative treatment field for cardiac disease; this treatment is becoming the most popular approach for pediatric congenital heart disease (CHD) and has led to a significant growth in the number of children with cardiac catheterization. Unfortunately, based on evidence, it has been demonstrated that the majority of children with CHD are at an increased risk of "non-cardiac" problems. Effective exercise therapy could improve their functional status significantly. As studies identifying the efficacy of exercise therapy are rare in this field, the aims of this study are to (1) identify the efficacy of a home-based exercise program to improve the motor function of children with CHD with cardiac catheterization, (2) reduce parental anxiety and parenting burden, and (3) improve the quality of life for parents whose children are diagnosed with CHD with cardiac catheterization through the program. A total of 300 children who will perform a cardiac catheterization will be randomly assigned to two groups: a home-based intervention group and a control group. The home-based intervention group will carry out a home-based exercise program, and the control group will receive only home-based exercise education. Assessments will be undertaken before catheterization and at 1, 3, and 6 months after catheterization. Motor ability quotients will be assessed as the primary outcomes. The modified Ross score, cardiac function, speed of sound at the tibia, functional independence of the children, anxiety, quality of life, and caregiver burden of their parents or the main caregivers will be the secondary outcome measurements. The proposed prospective randomized controlled trial will evaluate the efficiency of a home-based exercise program for children with CHD with cardiac catheterization. We anticipate that the home-based exercise program may represent a valuable and efficient intervention for children with CHD and their families. http

  16. The carry-over effects of school gardens on fruit and vegetable availability at home: A randomized controlled trial with low-income elementary schools.

    PubMed

    Wells, Nancy M; Meyers, Beth M; Todd, Lauren E; Henderson, Charles R; Barale, Karen; Gaolach, Brad; Ferenz, Gretchen; Aitken, Martha; Tse, Caroline C; Pattison, Karen Ostlie; Hendrix, Laura; Carson, Janet B; Taylor, Cayla; Franz, Nancy K

    2018-07-01

    This group-randomized controlled trial examines the effects of a school garden intervention on availability of fruits and vegetables (FV) in elementary school children's homes. Within each region, low income U.S. schools in Arkansas, Iowa, New York, and Washington State were randomly assigned to intervention group (n = 24) or waitlist control group (n = 22). Children were in grades 2, 4, and 5 at baseline (n = 2768). The garden intervention consisted of both raised-bed garden kits and a series of grade-appropriate lessons. FV availability at home was measured with a modified version of the GEMS FJV Availability Questionnaire. The instrument was administered at baseline (Fall 2011) and throughout the intervention (Spring 2012, Fall 2012, Spring 2013). Analyses were completed using general linear mixed models. The garden intervention led to an overall increase in availability of low-fat vegetables at home. Among younger children (2nd grade at baseline), the garden intervention led to greater home availability of vegetables, especially, low-fat vegetables. Moreover, for the younger group, garden intervention fidelity (GIF) or robustness predicted home availability of fruit, vegetables, and low-fat vegetables. School gardens have potential to affect FV availability in the home environment. Copyright © 2018 Elsevier Inc. All rights reserved.

  17. A group randomized controlled trial integrating obesity prevention and control for postpartum adolescents in a home visiting program.

    PubMed

    Haire-Joshu, Debra L; Schwarz, Cynthia D; Peskoe, Sarah B; Budd, Elizabeth L; Brownson, Ross C; Joshu, Corinne E

    2015-06-26

    Adolescence represents a critical period for the development of overweight that tracks into adulthood. This risk is significantly heightened for adolescents that become pregnant, many of whom experience postpartum weight retention. The aim of this study was to evaluate Balance Adolescent Lifestyle Activities and Nutrition Choices for Energy (BALANCE), a multicomponent obesity prevention intervention targeting postpartum adolescents participating in a national home visiting child development-parent education program. A group randomized, nested cohort design was used with 1325 adolescents, 694 intervention and 490 control, (mean age = 17.8 years, 52 % underrepresented minorities) located across 30 states. Participatory methods were used to integrate lifestyle behavior change strategies within standard parent education practice. Content targeted replacement of high-risk obesogenic patterns (e.g. sweetened drink and high fat snack consumption, sedentary activity) with positive behaviors (e.g. water intake, fruit and vegetables, increased walking). Parent educators delivered BALANCE through home visits, school based classroom-group meetings, and website activities. Control adolescents received standard child development information. Phase I included baseline to posttest (12 months); Phase II included baseline to follow-up (24 months). When compared to the control group, BALANCE adolescents who were ≥12 weeks postpartum were 89 % more likely (p = 0.02) to maintain a normal BMI or improve an overweight/obese BMI by 12 months; this change was not sustained at 24 months. When compared to the control group, BALANCE adolescents significantly improved fruit and vegetable intake (p = .03). In stratified analyses, water intake improved among younger BALANCE teens (p = .001) and overweight/obese BALANCE teens (p = .05) when compared to control counterparts. There were no significant differences between groups in sweetened drink and snack consumption

  18. Supporting Heart Failure Patient Transitions From Acute to Community Care With Home Telemonitoring Technology: A Protocol for a Provincial Randomized Controlled Trial (TEC4Home).

    PubMed

    2016-12-18

    Seniors with chronic diseases such as heart failure have complex care needs. They are vulnerable to their condition deteriorating and, without timely intervention, may require multiple emergency department visits and/or repeated hospitalizations. Upon discharge, the transition from the emergency department to home can be a vulnerable time for recovering patients with disruptions in the continuity of care. Remote monitoring of heart failure patients using home telemonitoring, coupled with clear communication protocols between health care professionals, can be effective in increasing the safety and quality of care for seniors with heart failure discharged from the emergency department. The aim of the Telehealth for Emergency-Community Continuity of Care Connectivity via Home Telemonitoring (TEC4Home) study is to generate evidence through a programmatic evaluation and a clinical trial to determine how home telemonitoring may improve care and increase patient safety during the transition of care and determine how it is best implemented to support patients with heart failure within this context. This 4-year project consists of 3 studies to comprehensively evaluate the outcomes and effectiveness of TEC4Home. Study 1 is a feasibility study with 90 patients recruited from 2 emergency department sites to test implementation and evaluation procedures. Findings from the feasibility study will be used to refine protocols for the larger trial. Study 2 is a cluster randomized controlled trial that will include 30 emergency department sites and 900 patients across British Columbia. The primary outcome of the randomized controlled trial will be emergency department revisits and hospital readmission rates. Secondary outcomes include health care resource utilization/costs, communication between members of the care team, and patient quality of life. Study 3 will run concurrently to study 2 and test the effectiveness of predictive analytic software to detect patient deterioration

  19. Randomized Controlled Trial of a Home-Based Action Observation Intervention to Improve Walking in Parkinson Disease.

    PubMed

    Jaywant, Abhishek; Ellis, Terry D; Roy, Serge; Lin, Cheng-Chieh; Neargarder, Sandy; Cronin-Golomb, Alice

    2016-05-01

    To examine the feasibility and efficacy of a home-based gait observation intervention for improving walking in Parkinson disease (PD). Participants were randomly assigned to an intervention or control condition. A baseline walking assessment, a training period at home, and a posttraining assessment were conducted. The laboratory and participants' home and community environments. Nondemented individuals with PD (N=23) experiencing walking difficulty. In the gait observation (intervention) condition, participants viewed videos of healthy and parkinsonian gait. In the landscape observation (control) condition, participants viewed videos of moving water. These tasks were completed daily for 8 days. Spatiotemporal walking variables were assessed using accelerometers in the laboratory (baseline and posttraining assessments) and continuously at home during the training period. Variables included daily activity, walking speed, stride length, stride frequency, leg swing time, and gait asymmetry. Questionnaires including the 39-item Parkinson Disease Questionnaire (PDQ-39) were administered to determine self-reported change in walking, as well as feasibility. At posttraining assessment, only the gait observation group reported significantly improved mobility (PDQ-39). No improvements were seen in accelerometer-derived walking data. Participants found the at-home training tasks and accelerometer feasible to use. Participants found procedures feasible and reported improved mobility, suggesting that observational training holds promise in the rehabilitation of walking in PD. Observational training alone, however, may not be sufficient to enhance walking in PD. A more challenging and adaptive task, and the use of explicit perceptual learning and practice of actions, may be required to effect change. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  20. Hospital Inpatient versus HOme-based rehabilitation after knee arthroplasty (The HIHO study): study protocol for a randomized controlled trial.

    PubMed

    Buhagiar, Mark A; Naylor, Justine M; Harris, Ian A; Xuan, Wei; Kohler, Friedbert; Wright, Rachael J; Fortunato, Renee

    2013-12-17

    Formal rehabilitation programs are often assumed to be required after total knee arthroplasty to optimize patient recovery. Inpatient rehabilitation is a costly rehabilitation option after total knee arthroplasty and, in Australia, is utilized most frequently for privately insured patients. With the exception of comparisons with domiciliary services, no randomized trial has compared inpatient rehabilitation to any outpatient based program. The Hospital Inpatient versus HOme (HIHO) study primarily aims to determine whether 10 days of post-acute inpatient rehabilitation followed by a hybrid home program provides superior recovery of functional mobility on the 6-minute walk test (6MWT) compared to a hybrid home program alone following total knee arthroplasty. Secondarily, the trial aims to determine whether inpatient rehabilitation yields superior recovery in patient-reported function. This is a two-arm parallel randomized controlled trial (RCT), with a third, non-randomized, observational group. One hundred and forty eligible, consenting participants who have undergone a primary total knee arthroplasty at a high-volume joint replacement center will be randomly allocated when cleared for discharge from acute care to either 10 days of inpatient rehabilitation followed by usual care (a 6-week hybrid home program) or to usual care. Seventy participants in each group (140 in total) will provide 80% power at a significance level of 5% to detect an increase in walking capacity from 400 m to 460 m between the Home and Inpatient groups, respectively, in the 6MWT at 6 months post-surgery, assuming a SD of 120 m and a drop-out rate of <10%.The outcome assessor will assess participants at 10, 26 and 52 weeks post-operatively, and will remain blind to group allocation for the duration of the study, as will the statistician. Participant preference for rehabilitation mode stated prior to randomization will be accounted for in the analysis together with any baseline differences in

  1. Hospital Inpatient versus HOme-based rehabilitation after knee arthroplasty (The HIHO study): study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Formal rehabilitation programs are often assumed to be required after total knee arthroplasty to optimize patient recovery. Inpatient rehabilitation is a costly rehabilitation option after total knee arthroplasty and, in Australia, is utilized most frequently for privately insured patients. With the exception of comparisons with domiciliary services, no randomized trial has compared inpatient rehabilitation to any outpatient based program. The Hospital Inpatient versus HOme (HIHO) study primarily aims to determine whether 10 days of post-acute inpatient rehabilitation followed by a hybrid home program provides superior recovery of functional mobility on the 6-minute walk test (6MWT) compared to a hybrid home program alone following total knee arthroplasty. Secondarily, the trial aims to determine whether inpatient rehabilitation yields superior recovery in patient-reported function. Methods/Design This is a two-arm parallel randomized controlled trial (RCT), with a third, non-randomized, observational group. One hundred and forty eligible, consenting participants who have undergone a primary total knee arthroplasty at a high-volume joint replacement center will be randomly allocated when cleared for discharge from acute care to either 10 days of inpatient rehabilitation followed by usual care (a 6-week hybrid home program) or to usual care. Seventy participants in each group (140 in total) will provide 80% power at a significance level of 5% to detect an increase in walking capacity from 400 m to 460 m between the Home and Inpatient groups, respectively, in the 6MWT at 6 months post-surgery, assuming a SD of 120 m and a drop-out rate of <10%. The outcome assessor will assess participants at 10, 26 and 52 weeks post-operatively, and will remain blind to group allocation for the duration of the study, as will the statistician. Participant preference for rehabilitation mode stated prior to randomization will be accounted for in the analysis together

  2. Home-Based HIV Testing and Counseling for Male Couples (Project Nexus): A Protocol for a Randomized Controlled Trial.

    PubMed

    Stephenson, Rob; Freeland, Ryan; Sullivan, Stephen P; Riley, Erin; Johnson, Brent A; Mitchell, Jason; McFarland, Deborah; Sullivan, Patrick S

    2017-05-30

    HIV prevalence remains high among men who have sex with men (MSM) in the United States, yet the majority of research has focused on MSM as individuals, not as dyads, and has discussed HIV risks primarily in the context of casual sex. Nexus is an online prevention program that combines home-based HIV testing and couples HIV testing and counseling (CHTC). It allows partners in dyadic MSM relationships to receive HIV testing and care in the comfort of their designated residence, via video-based chat. By using video-based technologies (eg, VSee video chat), male couples receive counseling and support from a remote online counselor, while testing for HIV at home. This randomized control trial (RCT) aims to examine the effects of video-based counseling combined with home-based HIV testing on couples' management of HIV risk, formation and adherence to explicit sexual agreements, and sexual risk-taking. The research implements a prospective RCT of 400 online-recruited male couples: 200 self-reported concordant-negative couples and 200 self-reported discordant couples. Couples in the control arm will receive one or two home-based HIV self-testing kits and will be asked to report their results via the study's website. Couples in the experimental arm will receive one or two home-based HIV self-testing kits and will conduct these tests together under the facilitation of a remotely located counselor during a prescheduled VSee-based video CHTC session. Study assessments are taken at baseline, as well as at 3- and 6-month follow-up sessions. Project Nexus was launched in April 2016 and is ongoing. To date, 219 eligible couples have been enrolled and randomized. Combining home-based HIV testing with video-based counseling creates an opportunity to expand CHTC to male couples who (1) live outside metro areas, (2) live in rural areas without access to testing services or LGBTQ resources, or (3) feel that current clinic-based testing is not for them (eg, due to fears of

  3. Effects of a home care mobile app on the outcomes of discharged patients with a stoma: a randomized controlled trial.

    PubMed

    Wang, Qing-Qing; Zhao, Jing; Huo, Xiao-Rong; Wu, Ling; Yang, Li-Fang; Li, Ju-Yun; Wang, Jie

    2018-05-18

    The aim of this study is to explore the effects of a home care mobile app on the outcomes of stoma patients who discharged from hospital. Patients with a newly formed stoma experience many difficulties after surgery. Mobile application (app) has the potential to help patients self-manage their diseases and adjust to the changes in their lives and is a convenient way to ensure the continuity of care. However, there is a lack of studies about the effects of a mobile app on the transitional care for improving discharged stoma-related health outcomes. A randomized controlled trial. 203 patients with a permanent stoma in tertiary hospitals in China were randomly assigned into two groups. Patients in the control group (n=103) received routine discharge care. Patients in the intervention group (n=100) received home care via a mobile app besides routine care. The psychosocial adjustment level, self-efficacy scale and stoma complications incidence were measured in the follow-up period and compared between the two groups. Data was collected at four time points: before intervention (baseline), at 1, 3 and 6 months after discharge. The psychosocial adjustment level and stoma self-efficacy score of the intervention group were significantly higher than those of the control group respectively at 1, 3 and 6-month follow-up (all P<0.05). The incidence of stoma complications in the intervention group were tending to reduce at 1, 3 and 6 months after discharge. The findings indicated that follow-up care at home via a mobile app can effectively improve the psychosocial adjustment level, self-efficacy scale and other related outcomes of stoma patients. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  4. The effectiveness of a life style modification and peer support home blood pressure monitoring in control of hypertension: protocol for a cluster randomized controlled trial.

    PubMed

    Su, Tin Tin; Majid, Hazreen Abdul; Nahar, Azmi Mohamed; Azizan, Nurul Ain; Hairi, Farizah Mohd; Thangiah, Nithiah; Dahlui, Maznah; Bulgiba, Awang; Murray, Liam J

    2014-01-01

    Death rates due to hypertension in low and middle income countries are higher compared to high income countries. The present study is designed to combine life style modification and home blood pressure monitoring for control of hypertension in the context of low and middle income countries. The study is a two armed, parallel group, un-blinded, cluster randomized controlled trial undertaken within lower income areas in Kuala Lumpur. Two housing complexes will be assigned to the intervention group and the other two housing complexes will be allocated in the control group. Based on power analysis, 320 participants will be recruited. The participants in the intervention group (n = 160) will undergo three main components in the intervention which are the peer support for home blood pressure monitoring, face to face health coaching on healthy diet and demonstration and training for indoor home based exercise activities while the control group will receive a pamphlet containing information on hypertension. The primary outcomes are systolic and diastolic blood pressure. Secondary outcome measures include practice of self-blood pressure monitoring, dietary intake, level of physical activity and physical fitness. The present study will evaluate the effect of lifestyle modification and peer support home blood pressure monitoring on blood pressure control, during a 6 month intervention period. Moreover, the study aims to assess whether these effects can be sustainable more than six months after the intervention has ended.

  5. Occupational Therapy Home Program for Children with Intellectual Disabilities: A Randomized, Controlled Trial

    ERIC Educational Resources Information Center

    Wuang, Yee-Pay; Ho, Guang-Sheng; Su, Chwen-Yng

    2013-01-01

    This study aimed to investigate the effectiveness of a proposed occupational therapy home program (OTHP) for children with intellectual disabilities (ID). Children with ID were randomly and equally assigned to OTHP or to no OTHP groups. The primary outcome measures were Canadian Occupational Performance, Bruininks-Oseretsky Test of Motor…

  6. Study protocol: cost-effectiveness of multidisciplinary nutritional support for undernutrition in older adults in nursing home and home-care: cluster randomized controlled trial.

    PubMed

    Beck, Anne Marie; Gøgsig Christensen, Annette; Stenbæk Hansen, Birthe; Damsbo-Svendsen, Signe; Kreinfeldt Skovgaard Møller, Tina; Boll Hansen, Eigil; Keiding, Hans

    2014-08-28

    support.Furthermore, interviews with nursing home and home-care management, nursing staff and nutrition coordinators in both the control and intervention groups, participants in the intervention group and the involved multidisciplinary team will be performed. In this study we will evaluate in a randomized controlled trial whether multidisciplinary nutritional support is cost-effective, in undernourished older adults in home-care and nursing home and contribute to important research. ClinicalTrials.gov 2013 NCT01873456.

  7. Economic Evaluation of Frequent Home Nocturnal Hemodialysis Based on a Randomized Controlled Trial

    PubMed Central

    Tonelli, Marcello; Pauly, Robert; Walsh, Michael; Culleton, Bruce; So, Helen; Hemmelgarn, Brenda; Manns, Braden

    2014-01-01

    Provider and patient enthusiasm for frequent home nocturnal hemodialysis (FHNHD) has been renewed; however, the cost-effectiveness of this technique is unknown. We performed a cost-utility analysis of FHNHD compared with conventional hemodialysis (CvHD; 4 hours three times per week) from a health payer perspective over a lifetime horizon using patient information from the Alberta NHD randomized controlled trial. Costs, including training costs, were obtained using microcosting and administrative data (CAN$2012). We determined the incremental cost per quality-adjusted life year (QALY) gained. Robustness was assessed using scenario, sensitivity, and probabilistic sensitivity analyses. Compared with CvHD (61% in-center, 14% satellite, and 25% home dialysis), FHNHD led to incremental cost savings (−$6700) and an additional 0.38 QALYs. In sensitivity analyses, when the annual probability of technique failure with FHNHD increased from 7.6% (reference case) to ≥19%, FHNHD became unattractive (>$75,000/QALY). The cost/QALY gained became $13,000 if average training time for FHNHD increased from 3.7 to 6 weeks. In scenarios with alternate comparator modalities, FHNHD remained dominant compared with in-center CvHD; cost/QALYs gained were $18,500, $198,000, and $423,000 compared with satellite CvHD, home CvHD, and peritoneal dialysis, respectively. In summary, FHNHD is attractive compared with in-center CvHD in this cohort. However, the attractiveness of FHNHD varies by technique failure rate, training time, and dialysis modalities from which patients are drawn, and these variables should be considered when establishing FHNHD programs. PMID:24231665

  8. Home-based exercise program and fall-risk reduction in older adults with multiple sclerosis: phase 1 randomized controlled trial.

    PubMed

    Sosnoff, Jacob J; Finlayson, Marcia; McAuley, Edward; Morrison, Steve; Motl, Robert W

    2014-03-01

    To determine the feasibility, safety, and efficacy of a home-based exercise intervention targeting fall risk in older adults with multiple sclerosis. A randomized controlled pilot trial. A home-based exercise program. Participants were randomly allocated to either a home-based exercise intervention group (n = 13) or a waiting list control group (n = 14). The exercise group completed exercises targeting lower muscle strength and balance three times a week for 12 weeks. The control group continued normal activity. Fall risk (Physiological Profile Assessment scores), balance (Berg Balance Scale), and walking testing prior to and immediately following the 12-week intervention. Each outcome measure was placed in an analysis of covariance with group as the between-subject factor and baseline values as the covariate. Effect sizes were calculated. Twelve participants from the control group and ten from the exercise group completed the study. There were no related adverse events. Fall risk was found to decrease in the exercise group following the intervention (1.1 SD 1.0 vs. 0.6 SD 0.6) while there was an increase in fall risk in the control group (1.9 SD 1.5 vs. 2.2 SD 1.9). Effect sizes for most outcomes were large (η(2) > 0.15). Home-based exercise was found to be feasible, safe, and effective for reducing physiological fall risk in older adults with multiple sclerosis. Our findings support the implementation of a larger trial to reduce fall risk in persons with multiple sclerosis.

  9. Home noninvasive positive pressure ventilation with built-in software in stable hypercapnic COPD: a short-term prospective, multicenter, randomized, controlled trial.

    PubMed

    Zhou, Luqian; Li, Xiaoying; Guan, Lili; Chen, Jianhua; Guo, Bingpeng; Wu, Weiliang; Huo, Yating; Zhou, Ziqing; Liang, Zhenyu; Zhou, Yuqi; Tan, Jie; Chen, Xin; Song, Yuanlin; Chen, Rongchang

    2017-01-01

    The benefits of noninvasive positive pressure ventilation (NPPV) in patients with hypercapnic COPD are controversial. It is presumed that methodology and appropriate use of NIV ventilator might be crucial for the outcomes. With the new built-in software, the performance of NIV can be monitored at home, which can guarantee the compliance and appropriate use. This study investigated effects of home use of NIV in hypercapnia in COPD patients using the NIV ventilator with built-in software for monitoring. The current multicenter prospective, randomized, controlled trial enrolled patients with stable GOLD stages III and IV hypercapnic COPD. Patients were randomly assigned via a computer-generated randomization sequence, with a block size of four patients, to continue optimized treatment (control group) or to receive additional NPPV (intervention group) for 3 months. The primary outcome was arterial carbon dioxide pressure (PaCO 2 ). Data were derived from built-in software and analyzed every 4 weeks. Analysis was carried out with the intention to treat. This study is registered with ClinicalTrials.gov, number NCT02499718. Patients were recruited from 20 respiratory units in China from October 1, 2015, and recruitment was terminated with a record of the vital statistics on May 31, 2016. A total of 115 patients were randomly assigned to the NPPV group (n=57) or the control group (n=58). Patients complied well with NPPV therapy (mean [± standard deviation] day use 5.6±1.4 h). The mean estimation of leaks was 37.99±13.71 L/min. The changes in PaCO 2 (-10.41±0.97 vs -4.32±0.68 mmHg, P =0.03) and 6-min walk distance (6MWD) (38.2% vs 18.2%, P =0.02) were statistically significant in the NPPV group versus the control group. COPD assessment test (CAT) showed a positive trend ( P =0.06) in favor of the NPPV group. Pulmonary function and dyspnea were not different between groups. Ventilators equipped with built-in software provided methodology for monitoring NIV use at home

  10. Study protocol of a cluster randomized controlled trial evaluating the efficacy of a comprehensive pressure ulcer prevention programme for private for-profit nursing homes.

    PubMed

    Kwong, Enid Wai-yung; Lee, Paul Hong; Yeung, Kwan-mo

    2016-01-18

    Because the demand for government-subsidized nursing homes in Hong Kong outstrips the supply, the number of for-profit private nursing homes has been increasing rapidly. However, the standard of care in such homes is always criticized. Pressure ulcers are a major long-term care issue that is closely associated with the quality of care delivered in nursing home settings. The aim of this study is to evaluate the effectiveness of a pressure ulcer prevention programme for residents in private for-profit nursing homes. This is a two-arm cluster randomized controlled trial with an estimated sample size of 1088 residents and 74 care staff from eight for-profit private nursing homes. Eligible nursing homes will be those classified as category A2 homes in the Enhanced Bought Place Scheme (EBPS), having a capacity of around 130-150 beds, and no structured PU prevention protocol and/or programmes in place. Care staff will be health workers, personal care workers, and nurses who are front-line staff providing direct care to residents. Eight nursing homes will be randomly assigned to either an experimental or control group. The experimental group will be provided with an intensive training programme and will be involved in the implementation of a 16-week pressure ulcer prevention protocol, while the control group will deliver the usual pressure ulcer prevention care. The study outcomes are the pressure ulcer prevention knowledge and skills of the care staff and the prevalence and incidence of pressure ulcers. Data on the knowledge and skills of care staff, and prevalence of pressure ulcer will be collected at the base line, and then at the 8(th) week and at completion of the implementation of the protocol. The assessment of the incidence of pressures will start from before the commencement of the intensive training course to the end of the implementation of the protocol. In view of the negative impact of pressure ulcers, it is important to have an effective and evidence

  11. Adolescent Pregnancy Prevention Among Youths Living in Group Care Homes: A Cluster Randomized Controlled Trial

    PubMed Central

    Vesely, Sara K.; Green, Jennifer; Clements-Nolle, Kristen; Lu, Minggen

    2018-01-01

    Objectives. To determine if the Power Through Choices (PTC) intervention can increase the use of birth control and reduce pregnancy among system-involved youths living in group care homes. Methods. We performed a 2-arm cluster randomized controlled trial involving group care homes operated by child welfare or juvenile justice systems in California, Maryland, and Oklahoma with assessments immediately before and after the intervention, and at 6- and 12-month follow-up. We collected data from 2012 to 2014 via self-administered questionnaires. Participants (n = 1036) were young (mean age = 16.1 years), predominantly male (79%), racially/ethnically diverse (37% Hispanic, 20% Black, 21% White, 17% multiracial), and sexually experienced (88%). Results. At 6-month follow-up, participants in the intervention group had significantly lower odds of having recent sexual intercourse without using birth control (adjusted odds ratio [AOR] = 0.72; 95% confidence interval [CI] = 0.52, 0.98). At 12-month follow-up assessment, participants in the intervention group had significantly lower odds of ever being pregnant or getting someone pregnant (AOR = 0.67; 95% CI = 0.46, 0.99). Conclusions. The results suggest that PTC is an effective sexual health education intervention that can be implemented with system-involved youths who represent a sexually experienced multiracial youth population. PMID:29443557

  12. Home-based family intervention increases knowledge, communication and living donation rates: a randomized controlled trial.

    PubMed

    Ismail, S Y; Luchtenburg, A E; Timman, R; Zuidema, W C; Boonstra, C; Weimar, W; Busschbach, J J V; Massey, E K

    2014-08-01

    Our aim was to develop and test an educational program to support well-informed decision making among patients and their social network regarding living donor kidney transplantation (LDKT). One hundred sixty-three patients who were unable to find a living donor were randomized to standard care or standard care plus home-based education. In the education condition, patients and members of their social network participated in home-based educational meetings and discussed renal replacement therapy options. Patients and invitees completed pre-post self-report questionnaires measuring knowledge, risk perception, communication, self-efficacy and subjective norm. LDKT activities were observed for 6 months postintervention. Patients in the experimental group showed significantly more improvements in knowledge (p < 0.001) and communication (p = 0.012) compared with the control group. The invitees showed pre-post increases in knowledge (p < 0.001), attitude toward discussing renal replacement therapies (p = 0.020), attitude toward donating a kidney (p = 0.023) and willingness to donate a kidney (p = 0.039) and a decrease in risk perception (p = 0.003). Finally, there were significantly more inquiries (29/39 vs. 13/41, p < 0.001), evaluations (25/39 vs. 7/41, p < 0.001) and actual LDKTs (17/39 vs. 4/41, p = 0.003) in the experimental group compared with the control group. Home-based family education supports well-informed decision making and promotes access to LDKT. © Copyright 2014 The American Society of Transplantation and the American Society of Transplant Surgeons.

  13. Home blood pressure monitoring with nurse-led telephone support among patients with hypertension and a history of stroke: a community-based randomized controlled trial

    PubMed Central

    Kerry, Sally M.; Markus, Hugh S.; Khong, Teck K.; Cloud, Geoffrey C.; Tulloch, Jenny; Coster, Denise; Ibison, Judith; Oakeshott, Pippa

    2013-01-01

    Background: Adequate control of blood pressure reduces the risk of recurrent stroke. We conducted a randomized controlled study to determine whether home blood pressure monitoring with nurse-led telephone support would reduce blood pressure in patients with hypertension and a history of stroke. Methods: We recruited 381 participants (mean age 72 years) from outpatient and inpatient stroke clinics between Mar. 1, 2007, and Aug. 31, 2009. Nearly half (45%, 170) of the participants had some disability due to stroke. Participants were visited at home for a baseline assessment and randomly allocated to home blood pressure monitoring (n = 187) or usual care (n = 194). Those in the intervention group were given a monitor, brief training and telephone support. Participants who had home blood pressure readings consistently over target (target < 130/80 mm Hg) were advised to consult their family physician. The main outcome measure was a fall in systolic blood pressure after 12 months, measured by an independent researcher unaware of group allocation. Results: Despite more patients in the intervention group than in the control group having changes to antihypertensive treatment during the trial period (60.1% [98/163] v. 47.6% [78/164], p = 0.02), the fall in systolic blood pressure from baseline did not differ significantly between the groups (adjusted mean difference 0.3 mm Hg, 95% confidence interval –3.6 to 4.2 mm Hg). Subgroup analysis showed significant interaction with disability due to stroke (p = 0.03 at 6 months) and baseline blood pressure (p = 0.03 at 12 months). Interpretation: Overall, home monitoring did not improve blood pressure control in patients with hypertension and a history of stroke. It was associated with a fall in systolic pressure in patients who had uncontrolled blood pressure at baseline and those without disability due to stroke. Trial registration: ClinicalTrials.gov registration NCT00514800 PMID:23128283

  14. Exercise rehabilitation on home-dwelling patients with Alzheimer's disease--a randomized, controlled trial. Study protocol.

    PubMed

    Pitkala, Kaisu H; Raivio, Minna M; Laakkonen, Marja-Liisa; Tilvis, Reijo S; Kautiainen, Hannu; Strandberg, Timo E

    2010-10-06

    Besides cognitive decline, Alzheimer's disease (AD) leads to physical disability, need for help and permanent institutional care. The trials investigating effects of exercise rehabilitation on physical functioning of home-dwelling older dementia patients are still scarce. The aim of this study is to investigate the effectiveness of intensive exercise rehabilitation lasting for one year on mobility and physical functioning of home-dwelling patients with AD. During years 2008-2010, patients with AD (n = 210) living with their spousal caregiver in community are recruited using central AD registers in Finland, and they are offered exercise rehabilitation lasting for one year. The patients are randomized into three arms: 1) tailored home-based exercise twice weekly 2) group-based exercise twice weekly in rehabilitation center 3) control group with usual care and information of exercise and nutrition. Main outcome measures will be Guralnik's mobility and balance tests and FIM-test to assess physical functioning. Secondary measures will be cognition, neuropsychiatric symptoms according to the Neuropsychiatric Inventory, caregivers' burden, depression and health-related quality of life (RAND-36). Data concerning admissions to institutional care and the use and costs of health and social services will be collected during a two year follow-up. To our knowledge this is the first large scale trial exploring whether home-dwelling patients with AD will benefit from intense and long-lasting exercise rehabilitation in respect to their mobility and physical functioning. It will also provide data on cost-effectiveness of the intervention. ACTRN12608000037303.

  15. The efficacy of early initiated, supervised, progressive resistance training compared to unsupervised, home-based exercise after unicompartmental knee arthroplasty: a single-blinded randomized controlled trial.

    PubMed

    Jørgensen, Peter B; Bogh, Søren B; Kierkegaard, Signe; Sørensen, Henrik; Odgaard, Anders; Søballe, Kjeld; Mechlenburg, Inger

    2017-01-01

    To examine if supervised progressive resistance training was superior to home-based exercise in rehabilitation after unicompartmental knee arthroplasty. Single blinded, randomized clinical trial. Surgery, progressive resistance training and testing was carried out at Aarhus University Hospital and home-based exercise was carried out in the home of the patient. Fifty five patients were randomized to either progressive resistance training or home-based exercise. Patients were randomized to either progressive resistance training (home based exercise five days/week and progressive resistance training two days/week) or control group (home based exercise seven days/week). Preoperative assessment, 10-week (primary endpoint) and one-year follow-up were performed for leg extension power, spatiotemporal gait parameters and knee injury and osteoarthritis outcome score (KOOS). Forty patients (73%) completed 1-year follow-up. Patients in the progressive resistance training group participated in average 11 of 16 training sessions. Leg extension power increased from baseline to 10-week follow-up in progressive resistance training group (progressive resistance training: 0.28 W/kg, P= 0.01, control group: 0.01 W/kg, P=0.93) with no between-group difference. Walking speed and KOOS scores increased from baseline to 10-week follow-up in both groups with no between-group difference (six minutes walk test P=0.63, KOOS P>0.29). Progressive resistance training two days/week combined with home based exercise five days/week was not superior to home based exercise seven days/week in improving leg extension power of the operated leg.

  16. Randomized Controlled Trial of Problem-Solving Therapy for Minor Depression in Home Care

    ERIC Educational Resources Information Center

    Gellis, Zvi D.; McGinty, Jean; Tierney, Lynda; Jordan, Cindy; Burton, Jean; Misener, Elizabeth

    2008-01-01

    Objective: Data are presented from a pilot research program initiated to develop, refine, and test the outcomes of problem-solving therapy that targets the needs of older adults with minor depression in home care settings. Method: A pilot randomized clinical trial compares the impact of problem-solving therapy for home care to treatment as usual…

  17. Feasibility, safety and preliminary evidence of the effectiveness of a home-based exercise programme for older people with Alzheimer's disease: a pilot randomized controlled trial.

    PubMed

    Suttanon, Plaiwan; Hill, Keith D; Said, Catherine M; Williams, Susan B; Byrne, Karin N; LoGiudice, Dina; Lautenschlager, Nicola T; Dodd, Karen J

    2013-05-01

    To evaluate the feasibility and safety of a home-based exercise programme for people with Alzheimer's disease, and to provide preliminary evidence of programme effectiveness in improving balance and mobility and reducing falls risk. A randomized controlled trial. Community. Forty people with mild to moderate Alzheimer's disease (mean age 81.9, SD 5.72; 62.5% female). Participants were randomized to a six-month home-based individually tailored balance, strengthening and walking exercise programme (physiotherapist) or a six-month home-based education programme (control) (occupational therapist). Both programmes provided six home-visits and five follow-up phone calls. Balance, mobility, falls and falls risk were measured at baseline and programme completion. Intention-to-treat analysis using a generalized linear model with group allocation as a predictor variable was performed to evaluate programme effectiveness. Feasibility and adverse events were systematically recorded at each contact. Fifty-eight per cent of the exercise group finished the programme, completing an average of 83% of prescribed sessions, with no adverse events reported. Functional Reach improved significantly (P = 0.002) in the exercise group (mean (SD), 2.28 (4.36)) compared to the control group (-2.99 (4.87)). Significant improvement was also observed for the Falls Risk for Older People - Community score (P = 0.008) and trends for improvement on several other balance, mobility, falls and falls risk measures for the exercise group compared to the control group. The exercise programme was feasible and safe and may help improve balance and mobility performance and reduce falls risk in people with Alzheimer's disease.

  18. The COMmunity of Practice And Safety Support (COMPASS) Total Worker Health™ study among home care workers: study protocol for a randomized controlled trial.

    PubMed

    Olson, Ryan; Elliot, Diane; Hess, Jennifer; Thompson, Sharon; Luther, Kristy; Wipfli, Brad; Wright, Robert; Buckmaster, Annie Mancini

    2014-10-27

    Home care workers are a high-risk group for injury and illness. Their unique work structure presents challenges to delivering a program to enhance their health and safety. No randomized controlled trials have assessed the impact of a Total Worker Health™ program designed for their needs. The COMPASS (COMmunity of Practice And Safety Support) study is a cluster randomized trial being implemented among Oregon's unionized home care workers. Partnering with the Oregon Home Care Commission allowed recruiting 10 pairs of home care worker groups with 8 participants per group (n = 160) for balanced randomization of groups to intervention and control conditions. Physiologic and survey evaluation of all participants will be at enrollment, 6 months and 12 months. Primary outcomes are to increase health promoting (for example, healthy nutrition and regular physical activity) and health protecting (that is, safety) behaviors. In addition to assessing outcomes adjusted for the hierarchical design, mediation analyses will be used to deconstruct and confirm the program's theoretical underpinnings and intervention processes. Intervention groups will participate in a series of monthly 2-hour meetings designed as ritualized, scripted peer-led sessions to increase knowledge, practice skills and build support for healthy actions. Self-monitoring and individual and team level goals are included to augment change. Because generalizability, reach and achieving dissemination are priorities, following initial wave findings, a second wave of COMPASS groups will be recruited and enrolled with tailoring of the program to align with existing Home Care Commission educational offerings. Outcomes, process and mediation of those tailored groups will be compared with the original wave's findings. The COMPASS trial will assess a novel program to enhance the safety and health of a vulnerable, rapidly expanding group of isolated caregivers, whose critical work allows independent living of frail

  19. A Feasibility Randomized Controlled Crossover Trial of Home-Based Warm Footbath to Improve Sleep in the Chronic Phase of Traumatic Brain Injury.

    PubMed

    Chiu, Hsiao-Yean; Lin, En-Yuan; Chiu, Hsiao-Ting; Chen, Pin-Yuan

    2017-12-01

    Sleep disturbance is a common complaint after traumatic brain injury (TBI). The aim of this study was to examine the effects of a home-based warm footbath intervention on sleep in patients with TBI. This was a randomized controlled crossover study, and 23 adults with TBI were recruited and randomized to receive first a 30-minute, 41°C warm footbath and then a usual care, or vice versa, with each lasting 3 days and separated by a 3-day washout. Sleep efficiency, sleep onset latency (SOL), total sleep time, and wake after sleep onset (WASO) were assessed by actigraphy. We found that home-based warm footbath significantly had a reduced SOL (difference, -5.11 minutes) and a suppressed WASO (difference, -2.57 minutes) compared with those of usual care, but not in sleep efficiency and total sleep time. No adverse effect was reported. This study suggested that home-based warm footbath is practical and effective in relieving post-TBI sleep disturbances, particular in SOL and WASO. Nurses can use home-based warm footbath as an effective intervention for management of sleep disturbances after TBI.

  20. Effect of home visit training program on growth and development of preterm infants: a double blind randomized controlled trial.

    PubMed

    Edraki, Mitra; Moravej, Hossian; Rambod, Masoume

    2015-01-01

    Home visit program can be effective in infants' growth and development. The present study aimed to investigate the effect of home visit program on preterm infants' growth and development within 6 months. It was a double-blind clinical trial study. The study was conducted in Hafez, Hazrat-e-Zeinab, and Namazee Hospitals affiliated to Shiraz University of Medical Sciences, Shiraz, Iran from 2010 to 2011. Preterm infants were divided into intervention (n=30) and control groups (n=30) through blocked randomization. The intervention group received home visit training program for 6 months, while the control group only received the hospital's routine care. Then, the infants' growth indexes, including weight, height, and head circumference, and development criteria were compared on the first day of admission in Neonatal Intensive Care Unit, and then first, second, third, and sixth months. The data were analyzed using Chi-square, independent t-test, and repeated measures ANCOVA. The mean weight of the intervention and control group infants was 7207.3±1129.74 and 6366.7±922.26 gr in the sixth month. Besides, the intervention group infants' mean weight was higher compared to the control group after six months (t=-3.05, P=0.03). Also, a significant difference was found between the two groups regarding development indexes, such as following moving objects with the head, keeping the head stable when changing the position from lying to sitting,  producing "Agha" sound, and taking objects by hand (P<0.05) during six months of age. The results showed that the home visit program was effective in preterm infants' weight gain and some development indexes at the sixth month. Considering the importance of infants' growth and development, healthcare staff is recommended to incorporate home visit training into their programs, so that steps can be taken towards improvement of preterm infants' health. IRCT2014082013690N3 

  1. EHLS at School: school-age follow-up of the Early Home Learning Study cluster randomized controlled trial.

    PubMed

    Westrupp, Elizabeth M; Bennett, Clair; Cullinane, Meabh; Hackworth, Naomi J; Berthelsen, Donna; Reilly, Sheena; Mensah, Fiona K; Gold, Lisa; Bennetts, Shannon K; Levickis, Penny; Nicholson, Jan M

    2018-05-02

    Targeted interventions during early childhood can assist families in providing strong foundations that promote children's health and wellbeing across the life course. There is growing recognition that longer follow-up times are necessary to assess intervention outcomes, as effects may change as children develop. The Early Home Learning Study, or 'EHLS', comprised two cluster randomized controlled superiority trials of a brief parenting intervention, smalltalk, aimed at supporting parents to strengthen the early childhood home learning environment of infants (6-12 months) or toddlers (12-36 months). Results showed sustained improvements in parent-child interactions and the home environment at the 32 week follow-up for the toddler but not the infant trial. The current study will therefore follow up the EHLS toddler cohort to primary school age, with the aim of addressing a gap in literature concerning long-term effects of early childhood interventions focused on improving school readiness and later developmental outcomes. 'EHLS at School' is a school-aged follow-up study of the toddler cluster randomized controlled trial (n = 1226). Data will be collected by parent-, child- and teacher-report questionnaires, recorded observations of parent-child interactions, and direct child assessment when children are aged 7.5 years old. Data linkage will provide additional data on child health and academic functioning at ages 5, 8 and 10 years. Child outcomes will be compared for families allocated to standard/usual care (control) versus those allocated to the smalltalk program (group program only or group program with additional home coaching). Findings from The Early Home Learning Study provided evidence of the benefits of the smalltalk intervention delivered via facilitated playgroups for parents of toddlers. The EHLS at School Study aims to examine the long-term outcomes of this initiative to determine whether improvements in the quality of the parent

  2. A dual-task home-based rehabilitation programme for improving balance control in patients with acquired brain injury: a single-blind, randomized controlled pilot study.

    PubMed

    Peirone, Eliana; Goria, Paolo Filiberto; Anselmino, Arianna

    2014-04-01

    To evaluate the safety, feasibility and effectiveness of a dual-task home-based rehabilitation programme on balance impairments among adult patients with acquired brain injury. Single-blind, randomized controlled pilot study. Single rehabilitation centre. Sixteen participants between 12 and 18 months post-acquired brain injury with balance impairments and a score <10 seconds on the One-Leg Stance Test (eyes open). All participants received 50-minutes individualised traditional physiotherapy sessions three times a week for seven weeks. In addition, the intervention group (N = 8) performed an individualised dual-task home-based programme six days a week for seven weeks. The primary outcome measure was the Balance Evaluation System Test; secondary measures were the Activities-specific Balance Confidence Scale and Goal Attainment Scaling. At the end of the pilot study, the intervention group showed significantly greater improvement in Balance Evaluation System Test scores (17.87, SD 6.05) vs. the control group (5.5, SD 3.53; P = 0.008, r = 0.63). There was no significant difference in improvement in Activities-specific Balance Confidence Scale scores between the intervention group (25.25, SD 25.51) and the control group (7.00, SD 14.73; P = 0.11, r = 0.63). There was no significant improvement in Goal Attainment Scaling scores in the intervention (19.37, SD 9.03) vs. the control group (16.28, SD 6.58; P = 0.093, r = 0.63). This pilot study shows the safety, feasibility and short-term benefit of a dual-task home-based rehabilitation programme to improve balance control in patients with acquired brain injury. A sample size of 26 participants is required for a definitive study.

  3. A home-based program of transcutaneous electrical nerve stimulation and task-related trunk training improves trunk control in patients with stroke: a randomized controlled clinical trial.

    PubMed

    Chan, Bill K S; Ng, Shamay S M; Ng, Gabriel Y F

    2015-01-01

    Impaired trunk motor control is common after stroke. Combining transcutaneous electrical nerve stimulation (TENS) with task-related trunk training (TRTT) has been shown to enhance the recovery of lower limb motor function. This study investigated whether combining TENS with TRTT would enhance trunk control after stroke. Methods. Thirty-seven subjects with stroke were recruited into a randomized controlled clinical trial. Subjects were randomly assigned to any one of the three 6-week home-based training groups: (1) TENS + TRTT, (2) placebo TENS + TRTT, or (3) control without active training. The outcome measures included isometric peak trunk flexion torque and extension torque; forward seated and lateral seated reaching distance to the affected and unaffected side; and Trunk Impairment Scale (TIS) scores. All outcome measures were assessed at baseline, after 3 and 6 weeks of training, and 4 weeks after training ended at follow-up. Both the TENS + TRTT and the placebo-TENS + TRTT groups had significantly greater improvements in isometric peak trunk flexion torque and extension torque, lateral seated reaching distance to affected and unaffected side, and TIS score than the control group after 3 weeks of training. The TENS + TRTT group had significantly greater and earlier improvement in its mean TIS score than the other 2 groups. Home-based TRTT is effective for improving trunk muscle strength, sitting functional reach and trunk motor control after stroke in subjects without somatosensory deficits. The addition of TENS to the trunk augments the effectiveness of the exercise in terms of TIS scores within the first 3 weeks of training. © The Author(s) 2014.

  4. Home exercise improves the quality of sleep and daytime sleepiness of elderlies: a randomized controlled trial.

    PubMed

    Brandão, Glauber Sá; Gomes, Glaucia Sá Brandão Freitas; Brandão, Glaudson Sá; Callou Sampaio, Antônia A; Donner, Claudio F; Oliveira, Luis V F; Camelier, Aquiles Assunção

    2018-01-01

    Aging causes physiological changes which affect the quality of sleep. Supervised physical exercise is an important therapeutic resource to improve the sleep of the elderlies, however there is a low adherence to those type of programs, so it is necessary to implement an exercise program which is feasible and effective. The study aimed to test the hypothesis that a semi-supervised home exercise program, improves sleep quality and daytime sleepiness of elderlies of the community who present poor sleep quality. This was a randomized controlled trial study, conducted from May to September 2017, in Northeastern Brazil, with elderlies of the community aging 60 years old or older, sedentary, with lower scores or equal to 5 at the Pittsburgh Sleep Quality Index (PSQI) and without cognitive decline. From one hundred ninety-one potential participants twenty-eight refused to participate, therefore, one hundred thirty-one (mean age 68 ± 7 years), and 88% female, were randomly assigned to an intervention group - IG (home exercise and sleep hygiene, n  = 65) and a control group - CG (sleep hygiene only, n  = 66). Sleep assessment tools were used: PSQI, Epworth sleepiness scale (ESS) and clinical questionnaire of Berlin. The level of physical activity has been assessed by means of International Physical Activity Questionnaire adapted for the elderly (IPAQ) and Mini-Mental State Examination for cognitive decline. All participants were assessed before and after the 12-week intervention period and, also, the assessors were blind. The IG showed significant improvement in quality of sleep with a mean reduction of 4.9 ± 2.7 points in the overall PSQI ( p  < 0.01) and in all its 7 components of evaluation ( p  < 0.05), and improvement of secondary endpoint, daytime sleepiness, a decline of 2.8 ± 2.2 points in the ESS (p < 0.01). Our results suggest that semi-supervised home exercise is effective in improving the quality of sleep and self

  5. Development of a home-based training program for post-ward geriatric rehabilitation patients with cognitive impairment: study protocol of a randomized-controlled trail.

    PubMed

    Bongartz, Martin; Kiss, Rainer; Ullrich, Phoebe; Eckert, Tobias; Bauer, Jürgen; Hauer, Klaus

    2017-09-12

    Geriatric patients with cognitive impairment (CI) show an increased risk for a negative rehabilitation outcome and reduced functional recovery following inpatient rehabilitation. Despite this obvious demand, evidence-based training programs at the transition from rehabilitation to the home environments are lacking. The aim of this study is to evaluate the efficacy of a feasible and cost-effective home-based training program to improve motor performance and to promote physical activity, specifically-tailored for post-ward geriatric patients with CI. A sample of 101 geriatric patients with mild to moderate stage CI following ward-based rehabilitation will be recruited for a blinded, randomized controlled trial with two arms. The intervention group will conduct a 12 week home-based training, consisting of (1) Exercises to improve strength/power, and postural control; (2) Individual walking trails to enhance physical activity; (3) Implementation of patient-specific motivational strategies to promote behavioral changes. The control group will conduct 12 weeks of unspecific flexibility exercise. Both groups will complete a baseline measurement before starting the program, at the end of the intervention, and after 24 weeks for follow-up. Sensor-based as well as questionnaire-based measures will be applied to comprehensively assess intervention effects. Primary outcomes document motor performance, assessed by the Short Physical Performance Battery, and level of physical activity (PA), as assessed by duration of active episodes (i.e., sum of standing and walking). Secondary outcomes include various medical, psycho-social, various PA and motor outcomes, including sensor-based assessment as well as cost effectiveness. Our study is among the first to provide home-based training in geriatric patients with CI at the transition from a rehabilitation unit to the home environment. The program offers several unique approaches, e.g., a comprehensive and innovative assessment

  6. Home-based walking during pregnancy affects mood and birth outcomes among sedentary women: A randomized controlled trial.

    PubMed

    Taniguchi, Chie; Sato, Chifumi

    2016-10-01

    We examined the effects of home-based walking on sedentary Japanese women's pregnancy outcomes and mood. A randomized controlled trial was conducted, involving 118 women aged 22-36 years. Participants were randomly assigned to walking intervention (n = 60) or control (n = 58) groups. The walking group was instructed to walk briskly for 30 min, three times weekly from 30 weeks' gestation until delivery. Both groups counted their daily steps using pedometers. Pregnancy and delivery outcomes were assessed, participants completed the Profile of Mood States, and we used the intention-to-treat principle. Groups showed no differences regarding pregnancy or delivery outcomes. The walking group exhibited decreased scores on the depression-dejection and confusion subscales of the Profile of Mood States. Five of the 54 women in the intervention group who remained in the study (9.2%) completed 100% of the prescribed walking program; 32 (59.3%) women completed 80% or more. Unsupervised walking improves sedentary pregnant women's mood, indicating that regular walking during pregnancy should be promoted in this group. © 2016 John Wiley & Sons Australia, Ltd.

  7. The TECH@HOME study, a technological intervention to reduce caregiver burden for informal caregivers of people with dementia: study protocol for a randomized controlled trial.

    PubMed

    Malmgren Fänge, Agneta; Schmidt, Steven M; Nilsson, Maria H; Carlsson, Gunilla; Liwander, Anna; Dahlgren Bergström, Caroline; Olivetti, Paolo; Johansson, Per; Chiatti, Carlos

    2017-02-09

    It is estimated that global dementia rates will more than triple by 2050 and result in a staggering economic burden on families and societies. Dementia carries significant physical, psychological and social challenges for individuals and caregivers. Informal caregiving is common and increasing as more people with dementia are being cared for at home instead of in nursing homes. Caregiver burden is associated with lower perceived health, lower social coherence, and increased risk of morbidity and mortality. The aim of this trial is to evaluate the effects of information and communication technology (ICT) on caregiver burden among informal caregivers of people with dementia by reducing the need for supervision. This randomized controlled trial aims to recruit 320 dyads composed of people with dementia living in community settings and their primary informal caregivers. In the intervention group, people with dementia will have a home monitoring kit installed in their home while dyads in the control group will receive usual care. The ICT kit includes home-leaving sensors, smoke and water leak sensors, bed sensors, and automatic lights that monitor the individual's behavior. Alerts (text message and/or phone call) will be sent to the caregiver if anything unusual occurs. All study dyads will receive three home visits by project administrators who have received project-specific training in order to harmonize data collection. Home visits will take place at enrollment and 3 and 12 months following installation of the ICT kit. At every home visit, a standardized questionnaire will be administered to all dyads to assess their health, quality of life and resource utilization. The primary outcome of this trial is the amount of informal care support provided by primary informal caregivers to people with dementia. This is the first randomized controlled trial exploring the implementation of ICT for people with dementia in a large sample in Sweden and one of the first at the

  8. A randomized controlled trial of home visits by neighborhood mentor mothers to improve children's nutrition in South Africa

    PubMed Central

    le Roux, Ingrid M.; le Roux, Karl; Mbeutu, Kwanie; Comulada, W. Scott; Desmond, Katherine A.; Rotheram-Borus, Mary Jane

    2011-01-01

    Malnourished children and babies with birth weights under 2500 g are at high risk for negative outcomes over their lifespans. Philani, a paraprofessional home visiting program, was developed to improve nutritional outcomes for young children in South Africa. One “mentor mother” was recruited from each of 37 neighborhoods in Cape Town, South Africa. Mentor mothers were trained to conduct home visits to weigh children under six years old and to support mothers to problem-solve life challenges, especially around nutrition. Households with underweight children were assigned randomly on a 2:1 ratio to the Philani program (n = 500) or to a standard care condition (n = 179); selection effects occurred and children in the intervention households weighed less at recruitment. Children were evaluated over a one-year period (n = 679 at recruitment and n = 638 with at least one follow-up; 94%). Longitudinal random effects models indicated that, over 12 months, the children in the intervention condition gained significantly more weight than children in the control condition. Mentor mothers who are positive peer deviants may be a viable strategy that is efficacious and can build community, and the use of mentor mothers for other problems in South Africa is discussed. PMID:22299019

  9. Improving psychotropic drug prescription in nursing home patients with dementia: design of a cluster randomized controlled trial

    PubMed Central

    2013-01-01

    Background Neuropsychiatric symptoms are highly prevalent in nursing home patients with dementia. Despite modest effectiveness and considerable side effects, psychotropic drugs are frequently prescribed for these neuropsychiatric symptoms. This raises questions whether psychotropic drugs are appropriately prescribed. The aim of the PROPER (PRescription Optimization of Psychotropic drugs in Elderly nuRsing home patients with dementia) II study is to investigate the efficacy of an intervention for improving the appropriateness of psychotropic drug prescription in nursing home patients with dementia. Methods/design The PROPER II study is a multi-center cluster randomized controlled, pragmatic trial using parallel groups. It has a duration of eighteen months and four six-monthly assessments. Six nursing homes will participate in the intervention and six will continue care as usual. The nursing homes will be located throughout the Netherlands, each participating with two dementia special care units with an average of fifteen patients per unit, resulting in 360 patients. The intervention consists of a structured and repeated multidisciplinary medication review supported by education and continuous evaluation. It is conducted by pharmacists, physicians, and nurses and consists of three components: 1) preparation and education, 2) conduct, and 3) evaluation/guidance. The primary outcome is the proportion of patients with appropriate psychotropic drug use. Secondary outcomes are the overall frequency of psychotropic drug use, neuropsychiatric symptoms, quality of life, activities of daily living, psychotropic drug side effects and adverse events (including cognition, comorbidity, and mortality). Besides, a process analysis on the intervention will be carried out. Discussion This study is expected to improve the appropriateness of psychotropic drug prescription for neuropsychiatric symptoms in nursing home patients with dementia by introducing a structured and repeated

  10. A Randomized, Controlled Trial of Integrated Home-School Behavioral Treatment for ADHD, Predominantly Inattentive Type

    ERIC Educational Resources Information Center

    Pfiffner, Linda J.; Mikami, Amori Yee; Huang-Pollock, Cynthia; Easterlin, Barbara; Zalecki, Christine; McBurnett, Keith

    2007-01-01

    Objective: To evaluate the efficacy of a behavioral psychosocial treatment integrated across home and school (Child Life and Attention Skills Program) with attention-deficit/hyperactivity disorder (ADHD) predominantly inattentive type (ADHD-I). Method: Sixty-nine children ages 7 to 11 years were randomized to the Child Life and Attention Skills…

  11. Effect of Home Visit Training Program on Growth and Development of Preterm Infants: A Double Blind Randomized Controlled Trial

    PubMed Central

    Edraki, Mitra; Moravej, Hossian; Rambod, Masoume

    2015-01-01

    Background: Home visit program can be effective in infants’ growth and development. The present study aimed to investigate the effect of home visit program on preterm infants’ growth and development within 6 months. Methods: It was a double-blind clinical trial study. The study was conducted in Hafez, Hazrat-e-Zeinab, and Namazee Hospitals affiliated to Shiraz University of Medical Sciences, Shiraz, Iran from 2010 to 2011. Preterm infants were divided into intervention (n=30) and control groups (n=30) through blocked randomization. The intervention group received home visit training program for 6 months, while the control group only received the hospital’s routine care. Then, the infants’ growth indexes, including weight, height, and head circumference, and development criteria were compared on the first day of admission in Neonatal Intensive Care Unit, and then first, second, third, and sixth months. The data were analyzed using Chi-square, independent t-test, and repeated measures ANCOVA. Results: The mean weight of the intervention and control group infants was 7207.3±1129.74 and 6366.7±922.26 gr in the sixth month. Besides, the intervention group infants’ mean weight was higher compared to the control group after six months (t=-3.05, P=0.03). Also, a significant difference was found between the two groups regarding development indexes, such as following moving objects with the head, keeping the head stable when changing the position from lying to sitting,  producing “Agha” sound, and taking objects by hand (P<0.05) during six months of age. Conclusion: The results showed that the home visit program was effective in preterm infants’ weight gain and some development indexes at the sixth month. Considering the importance of infants’ growth and development, healthcare staff is recommended to incorporate home visit training into their programs, so that steps can be taken towards improvement of preterm infants’ health. Trial Registration Number

  12. A randomized controlled comparison of flushing protocols in home care patients with peripherally inserted central catheters.

    PubMed

    Lyons, Margaret G; Phalen, Ann G

    2014-01-01

    Research has failed to demonstrate an optimal flushing solution or frequency for central catheters. In a 2002 study of 50 000 home care patients, catheter dysfunction with loss of patency was the most common complication and occurred in 29% of the peripherally inserted central catheters (PICCs) tracked. With the advent of the Affordable Care Act and the promise of expanded home care services, this study offers evidence as to a preferred flushing protocol to prevent catheter patency complications for home infusion patients with PICCs. This prospective, randomized, 1-way, single-blinded posttest with control group study was performed to compare 3 commonly used flushing protocols in home infusion patients with PICCs. The independent variable was the flushing protocol, and dependent variables included the development of patency-related complications and other significant issues such as sluggishness, occlusion, missed medication doses, catheter replacement, additional nursing visits, and the use of alteplase (Cathflo Activase). Each of the study groups had patients who experienced 1 or more patency-related complications. Additional factors that may affect catheter function, including patient age, gender, diagnosis, therapy type, frequency of catheter use, catheter brand/size/number of lumens, concomitant use of anticoagulant medications, and whether PICCs were used for routine lab testing, were analyzed, and no statistical significance was determined. Catheter dwell time (catheter days) was statistically significant (p = .003, confidence interval = 95%; assuming equal variance) and confirmed the assumption that the longer a home care patient's catheter was in place, the more complications occurred. There were no cases of heparin allergy, heparin-induced thrombocytopenia, or line infection. The data provide some evidence to support the elimination of heparin flushing in home care patients with PICCs, although data in the saline-only group that related to additional

  13. Is home-based pelvic floor muscle training effective in treatment of urinary incontinence after birth in primiparous women? A randomized controlled trial.

    PubMed

    Ahlund, Susanne; Nordgren, Birgitta; Wilander, Eva-Lotta; Wiklund, Ingela; Fridén, Cecilia

    2013-08-01

    To assess the effect of pelvic floor muscle training (PFMT) on pelvic floor muscle strength and urinary incontinence (UI) in primiparous women who underwent a home training program between three and 9 months after delivery. Randomized controlled trial. One hundred primiparous women were consecutively recruited from four different antenatal clinics in the urban area of Stockholm, Sweden. Women with UI who had undergone normal term singleton vaginal delivery, 10-16 weeks postpartum were randomly allocated to either intervention or control group. Maximally voluntary contraction (MVC) and endurance were measured with a perionometer. The Oxford grading scale was used to manually estimate the strength of the pelvic floor muscle and self-reported symptoms of UI was registered through the Bristol Female Lower Urinary Tract Symptoms Module (ICIQ FLUTS) questionnaire. Maximally voluntary contraction of the pelvic floor muscle measured with a perionometer. Maximally voluntary contraction increased significantly in both groups between baseline and follow up (p < 0.05). The median MVC in cmHg for the intervention and control group was 16.2 and 12.1 at baseline and 26.0 and 18.2 at follow up, respectively. The median endurance, in seconds, for the intervention and control group was 9.6 and 12.0 at baseline and 26.7 and 23.4 at follow up, respectively. Pelvic floor muscle strength measured with the Oxford Scale increased significantly in both groups between baseline and follow up (p < 0.05). The results indicate that home-based PFMT is effective. However, written training instructions were as efficient as home-based training with follow up visits every sixth week. © 2013 Nordic Federation of Societies of Obstetrics and Gynecology.

  14. A Novel Home-Based Intervention for Child and Adolescent Obesity: The Results of the Whānau Pakari Randomized Controlled Trial.

    PubMed

    Anderson, Yvonne C; Wynter, Lisa E; Grant, Cameron C; Cave, Tami L; Derraik, José G B; Cutfield, Wayne S; Hofman, Paul L

    2017-11-01

    To report 12-month outcomes from a multidisciplinary child obesity intervention program, targeting high-risk groups. In this unblinded randomized controlled trial, participants (recruited January 2012-August 2014) were aged 5 to 16 years, resided in Taranaki, Aotearoa/New Zealand, and had BMI ≥ 98th percentile or BMI > 91st percentile with weight-related comorbidities. Randomization was by minimization (age and ethnicity), with participants assigned to an intense intervention group (home-based assessments at 6-month intervals and a 12-month multidisciplinary program with weekly group sessions) or to a minimal-intensity control group with home-based assessments and advice at each 6-month follow-up. The primary outcome was the change in BMI standard deviation score (SDS) at 12 months from baseline. A mixed model analysis was undertaken, incorporating all 6- and 12-month data. Two hundred and three children were randomly assigned (47% Māori, 43% New Zealand European, 53% female, 28% from the most deprived quintile, mean age 10.7 years, mean BMI SDS 3.12). Both groups displayed a change in BMI SDS at 12 months from baseline (-0.12 control, -0.10 intervention), improvements in cardiovascular fitness (P < 0.0001), and improvements in quality of life (P < 0.001). Achieving ≥ 70% attendance in the intense intervention group resulted in a change in BMI SDS of -0.22. This program achieved a high recruitment of target groups and a high rate of BMI SDS reduction, irrespective of intervention intensity. If retention is optimized, the intensive program doubles its effect. © 2017 The Obesity Society.

  15. Feasibility and effects of preventive home visits for at-risk older people: design of a randomized controlled trial.

    PubMed

    Cutchin, Malcolm P; Coppola, Susan; Talley, Vibeke; Svihula, Judie; Catellier, Diane; Shank, Kendra Heatwole

    2009-12-03

    The search for preventive methods to mitigate functional decline and unwanted relocation by older adults living in the community is important. Preventive home visit (PHV) models use infrequent but regular visits to older adults by trained practitioners with the goal of maintaining function and quality of life. Evidence about PHV efficacy is mixed but generally supportive. Yet interventions have rarely combined a comprehensive (biopsychosocial) occupational therapy intervention protocol with a home visit to older adults. There is a particular need in the USA to create and examine such a protocol. The study is a single-blind randomized controlled pilot trial designed to assess the feasibility, and to obtain preliminary efficacy estimates, of an intervention consisting of preventive home visits to community-dwelling older adults. An occupational therapy-based preventive home visit (PHV) intervention was developed and is being implemented and evaluated using a repeated measures design. We recruited a sample of 110 from a population of older adults (75+) who were screened and found to be at-risk for functional decline. Participants are currently living in the community (not in assisted living or a skilled nursing facility) in one of three central North Carolina counties. After consent, participants were randomly assigned into experimental and comparison groups. The experimental group receives the intervention 4 times over a 12 month follow-up period while the comparison group receives a minimal intervention of mailed printed materials. Pre- and post-intervention measures are being gathered by questionnaires administered face-to-face by a treatment-blinded research associate. Key outcome measures include functional ability, participation, life satisfaction, self-rated health, and depression. Additional information is collected from participants in the experimental group during the intervention to assess the feasibility of the intervention and potential modifiers

  16. Effects of a simple home-based exercise program on fall prevention in older adults: A 12-month primary care setting, randomized controlled trial.

    PubMed

    Boongird, Chitima; Keesukphan, Prasit; Phiphadthakusolkul, Soontraporn; Rattanasiri, Sasivimol; Thakkinstian, Ammarin

    2017-11-01

    To investigate the effects of a simple home-based exercise program on falls, physical functioning, fear of falling and quality of life in a primary care setting. Participants (n = 439), aged ≥65 years with mild-to-moderate balance dysfunction were randomly assigned to an exercise (n = 219) or control (n = 220) group. The program consisted of five combined exercises, which progressed in difficulty, and a walking plan. Controls received fall prevention education. Physical functioning and other outcomes were measured at 3- and 6-month follow-up visits. Falls were monitored with fall diaries and phone interviews at 3, 6, 9, and 12 months respectively. The 12 months of the home-based exercise program showed the incidence of falls was 0.30 falls per person year in the exercise group, compared with 0.40 in the control group. The estimated incidence rate ratio was 0.75 (95% CI 0.55-1.04), which was not statistically significant. The fear of falling (measured by the Thai fall efficacy scale) was significantly lower in the exercise than control group (24.7 vs 27.0, P = 0.003). Also, the trend of program adherence increased in the exercise group. (29.6% to 56.8%). This simple home-based exercise program showed a reduction in fear of falling and a positive trend towards exercise adherence. Further studies should focus on factors associated with exercise adherence, the benefits of increased home visits and should follow participants longer in order to evaluate the effects of the program. Geriatr Gerontol Int 2017; 17: 2157-2163. © 2017 Japan Geriatrics Society.

  17. CONNECT for quality: protocol of a cluster randomized controlled trial to improve fall prevention in nursing homes

    PubMed Central

    2012-01-01

    Background Quality improvement (QI) programs focused on mastery of content by individual staff members are the current standard to improve resident outcomes in nursing homes. However, complexity science suggests that learning is a social process that occurs within the context of relationships and interactions among individuals. Thus, QI programs will not result in optimal changes in staff behavior unless the context for social learning is present. Accordingly, we developed CONNECT, an intervention to foster systematic use of management practices, which we propose will enhance effectiveness of a nursing home Falls QI program by strengthening the staff-to-staff interactions necessary for clinical problem-solving about complex problems such as falls. The study aims are to compare the impact of the CONNECT intervention, plus a falls reduction QI intervention (CONNECT + FALLS), to the falls reduction QI intervention alone (FALLS), on fall-related process measures, fall rates, and staff interaction measures. Methods/design Sixteen nursing homes will be randomized to one of two study arms, CONNECT + FALLS or FALLS alone. Subjects (staff and residents) are clustered within nursing homes because the intervention addresses social processes and thus must be delivered within the social context, rather than to individuals. Nursing homes randomized to CONNECT + FALLS will receive three months of CONNECT first, followed by three months of FALLS. Nursing homes randomized to FALLS alone receive three months of FALLs QI and are offered CONNECT after data collection is completed. Complexity science measures, which reflect staff perceptions of communication, safety climate, and care quality, will be collected from staff at baseline, three months after, and six months after baseline to evaluate immediate and sustained impacts. FALLS measures including quality indicators (process measures) and fall rates will be collected for the six months prior to baseline and the six months after the

  18. Randomized controlled trial of a comprehensive home environment-focused weight loss program for adults

    PubMed Central

    Gorin, Amy A.; Raynor, Hollie A.; Fava, Joseph; Maguire, Kimberly; Robichaud, Erica; Trautvetter, Jennifer; Crane, Melissa; Wing, Rena R.

    2012-01-01

    Objective Behavioral weight loss programs (BWL) provide limited instruction on how to change the environmental context of weight-regulating behaviors, perhaps contributing to regain. Drawing on social ecological models, this trial evaluated a comprehensive weight loss program that targeted both an individual’s behavior and their physical and social home environment. Methods Overweight and obese adults (N=201; 48.9±10.5 years; 78.1% women) were randomized to BWL or to BWL plus home environment changes (BWL+H). Groups met weekly for 6 months and bi-monthly for 12 months. BWL+H participants were given items to facilitate healthy choices in their homes (e.g., exercise equipment, portion plates) and attended treatment with a household partner. Weight loss at 6 and 18 months was the primary outcome. Results BWL+H changed many aspects of the home environment and produced better 6 month weight losses than BWL (p=.017). At 18 months, no weight loss differences were observed (p=.19) and rates of regain were equivalent (p=.30). Treatment response was moderated by gender (6 month p=.01; 18 month p=.006). Women lost more weight in BWL+H than BWL at 6 and 18 months, whereas men in BWL lost more weight than those in BWL+H at 18 months. Partners, regardless of gender, lost more weight in BWL+H than BWL at both time points (ps<.0001). Conclusion The home food and exercise environment is malleable and targeting this microenvironment appears to improve initial weight loss, and in women, 18-month outcomes. Research is needed to understand this gender difference and to develop home-focused strategies with more powerful and sustained weight loss effects. PMID:22309885

  19. Home Computers and Child Outcomes: Short-Term Impacts from a Randomized Experiment in Peru. NBER Working Paper No. 18818

    ERIC Educational Resources Information Center

    Beuermann, Diether W.; Cristia, Julian P.; Cruz-Aguayo, Yyannu; Cueto, Santiago; Malamud, Ofer

    2013-01-01

    This paper presents results from a randomized control trial in which approximately 1,000 OLPC XO laptops were provided for home use to children attending primary schools in Lima, Peru. The intervention increased access and use of home computers, with some substitution away from computer use outside the home. Beneficiaries were more likely to…

  20. Massage therapy for patients with metastatic cancer: a pilot randomized controlled trial.

    PubMed

    Toth, Maria; Marcantonio, Edward R; Davis, Roger B; Walton, Tracy; Kahn, Janet R; Phillips, Russell S

    2013-07-01

    The study objectives were to determine the feasibility and effects of providing therapeutic massage at home for patients with metastatic cancer. This was a randomized controlled trial. Patients were enrolled at Oncology Clinics at a large urban academic medical center; massage therapy was provided in patients' homes. Subjects were patients with metastatic cancer. There were three interventions: massage therapy, no-touch intervention, and usual care. Primary outcomes were pain, anxiety, and alertness; secondary outcomes were quality of life and sleep. In this study, it was possible to provide interventions for all patients at home by professional massage therapists. The mean number of massage therapy sessions per patient was 2.8. A significant improvement was found in the quality of life of the patients who received massage therapy after 1-week follow-up, which was not observed in either the No Touch control or the Usual Care control groups, but the difference was not sustained at 1 month. There were trends toward improvement in pain and sleep of the patients after therapeutic massage but not in patients in the control groups. There were no serious adverse events related to the interventions. The study results showed that it is feasible to provide therapeutic massage at home for patients with advanced cancer, and to randomize patients to a no-touch intervention. Providing therapeutic massage improves the quality of life at the end of life for patients and may be associated with further beneficial effects, such as improvement in pain and sleep quality. Larger randomized controlled trials are needed to substantiate these findings.

  1. Effect of home exercise of quadriceps on knee osteoarthritis compared with nonsteroidal antiinflammatory drugs: a randomized controlled trial.

    PubMed

    Doi, Tokuhide; Akai, Masami; Fujino, Keiji; Iwaya, Tsutomu; Kurosawa, Hisashi; Hayashi, Kunihiko; Marui, Eiji

    2008-04-01

    To examine the effect of home-based exercise on knee osteoarthritis among Japanese in comparison with that of nonsteroidal antiinflammatory drugs (NSAIDs). An open-labeled, randomized, controlled, multiclinic trial compared home-based quadriceps exercise with NSAIDs. Treatments were basically evaluated after 8 wks and compared with the baseline scores. Outcomes were evaluated with a set of psychometric measurements including the Western Ontario and McMaster Universities Arthritis Index (WOMAC), 36-Item Short-Form Health Survey (SF-36), Japanese Knee Osteoarthritis Measure (JKOM), and pain with the visual analog scale. A total of 142 patients entered this trial to provide the baseline data. After 21 cases withdrew, the final number analyzed was 121 cases: 63 for the exercise group and 58 for the NSAIDs group. Between these two groups, there was no significant difference in gender, age, body height and weight, body mass index, or each score at baseline. The subjects in both groups showed improvements in all scores at the end of intervention. The difference in improvement rate of each score between the two groups was not statistically significant, though the mean rank score measured with JKOM in the exercise was slightly better than that of the NSAIDs. Home-based exercise using quadriceps strengthening improves knee osteoarthritis no less than NSAIDs.

  2. Effectiveness of advance care planning with family carers in dementia nursing homes: A paired cluster randomized controlled trial.

    PubMed

    Brazil, Kevin; Carter, Gillian; Cardwell, Chris; Clarke, Mike; Hudson, Peter; Froggatt, Katherine; McLaughlin, Dorry; Passmore, Peter; Kernohan, W George

    2018-03-01

    In dementia care, a large number of treatment decisions are made by family carers on behalf of their family member who lacks decisional capacity; advance care planning can support such carers in the decision-making of care goals. However, given the relative importance of advance care planning in dementia care, the prevalence of advance care planning in dementia care is poor. To evaluate the effectiveness of advance care planning with family carers in dementia care homes. Paired cluster randomized controlled trial. The intervention comprised a trained facilitator, family education, family meetings, documentation of advance care planning decisions and intervention orientation for general practitioners and nursing home staff. A total of 24 nursing homes with a dementia nursing category located in Northern Ireland, United Kingdom. Family carers of nursing home residents classified as having dementia and judged as not having decisional capacity to participate in advance care planning discussions. The primary outcome was family carer uncertainty in decision-making about the care of the resident (Decisional Conflict Scale). There was evidence of a reduction in total Decisional Conflict Scale score in the intervention group compared with the usual care group (-10.5, 95% confidence interval: -16.4 to -4.7; p < 0.001). Advance care planning was effective in reducing family carer uncertainty in decision-making concerning the care of their family member and improving perceptions of quality of care in nursing homes. Given the global significance of dementia, the implications for clinicians and policy makers include them recognizing the importance of family carer education and improving communication between family carers and formal care providers.

  3. Benefits of home-based rocking-chair exercise for physical performance in community-dwelling elderly women: a randomized controlled trial.

    PubMed

    Niemelä, Kristiina; Väänänen, Ilkka; Leinonen, Raija; Laukkanen, Pia

    2011-08-01

    Home-based exercise is a viable alternative for older adults with difficulties in exercise opportunities outside the home. The aim of this study was to investigate the benefits of home-based rocking-chair training, and its effects on the physical performance of elderly women. Community- dwelling women (n=51) aged 73-87 years were randomly assigned to the rocking-chair group (RCG, n=26) or control group (CG, n=25) by drawing lots. Baseline and outcome measurements were hand grip strength, maximal isometric knee extension, maximal walking speed over 10 meters, rising from a chair five times, and the Berg Balance Scale (BBS). The RCG carried out a six-week rocking-chair training program at home, involving ten sessions per week, twice a day for 15 minutes per session, and ten different movements. The CG continued their usual daily lives. After three months, the RCG responded to a mail questionnaire. After the intervention, the RCG improved and the CG declined. The data showed significant interactions of group by time in the BBS score (p=0.001), maximal knee extension strength (p=0.006) and maximal walking speed (p=0.046), which indicates that the change between groups during the follow-up period was significant. Adherence to the training protocol was high (96%). After three months, the exercise program had become a regular home exercise habit for 88.5% of the subjects. Results indicate that home-based elderly women benefit from this easily implemented rocking-chair exercise program. The subjects became motivated to participate in training and continued the exercises. This is a promising alternative exercise method for maintaining physical activity and leads to improvements in physical performance.

  4. Effectiveness of the 'Home-but not Alone' mobile health application educational programme on parental outcomes: a randomized controlled trial, study protocol.

    PubMed

    Shorey, Shefaly; Ng, Yvonne Peng Mei; Danbjørg, Dorthe Boe; Dennis, Cindy-Lee; Morelius, Evalotte

    2017-01-01

    The aim of this study was to describe a study protocol that evaluates the effectiveness of the 'Home-but not Alone' educational programme delivered via a mobile health application in improving parenting outcomes. The development in mobile-based technology gives us the opportunity to develop an accessible educational programme that can be potentially beneficial to new parents. However, there is a scarcity of theory-based educational programmes that have incorporated technology such as a mobile health application in the early postpartum period. A randomized controlled trial with a two-group pre-test and post-test design. The data will be collected from 118 couples. Eligible parents will be randomly allocated to either a control group (receiving routine care) or an intervention group (routine care plus access to the 'Home-but not Alone' mobile health application. Outcome measures comprise of parenting self-efficacy, social support, parenting satisfaction and postnatal depression. Data will be collected at the baseline (on the day of discharge) and at four weeks postpartum. This will be an empirical study that evaluates a theory-based educational programme delivered via an innovative mobile health application on parental outcomes. Results from this study will enhance parenting self-efficacy, social support and parenting satisfaction, which may then reduce parental risks of postnatal depression. © 2016 John Wiley & Sons Ltd.

  5. Twenty weeks of isometric handgrip home training to lower blood pressure in hypertensive older adults: a study protocol for a randomized controlled trial.

    PubMed

    Jørgensen, Martin Grønbech; Ryg, Jesper; Danielsen, Mathias Brix; Madeleine, Pascal; Andersen, Stig

    2018-02-09

    Hypertension markedly increases the risk of cardiovascular diseases and overall mortality. Lifestyle modifications, such as increased levels of physical activity, are recommended as the first line of anti-hypertensive treatment. A recent systematic review showed that isometric handgrip (IHG) training was superior to traditional endurance and strength training in lowering resting systolic blood pressure (SBP). The average length of previous IHG training studies is approximately 7.5 weeks with the longest being 10 weeks. Therefore, presently it is unknown if it is possible to further lower blood pressure levels beyond the 10-week mark. Recently, we developed a novel method for monitoring handgrip intensity using a standard Nintendo Wii Board (Wii). The primary aim of this study is to explore the effects of a 20-week IHG home training facilitated by a Wii in hypertensive older adults (50 + years of age) on lowering SBP compared to usual care. Secondary aims are to explore if/when a leveling-off effect on SBP will occur during the 20-week intervention period in the training group and to explore adherence and potential harms related to the IHG home training. Based on previous evidence, we calculated that 50 hypertensive (SBP between 140 and 179 mmHg), older adults (50 + years of age) are needed to achieve a power of 80% or more. Participants will be randomly assigned to either an intervention >group (IHG home training + hypertension guidelines on lifestyle changes) or to a control group (hypertension guidelines on lifestyle changes). Participants in the intervention group will perform IHG home training (30% of maximum grip strength for a total of 8 min per day per hand) three times a week for 20 weeks. Resting blood pressure and maximal handgrip strength will be obtained by a blinded outcome assessor in both groups at specific time points (baseline, follow-up at 5, 10, 15, and 20 weeks) throughout the study. This assessor-blinded, randomized controlled

  6. A multi-faceted tailored strategy to implement an electronic clinical decision support system for pressure ulcer prevention in nursing homes: a two-armed randomized controlled trial.

    PubMed

    Beeckman, Dimitri; Clays, Els; Van Hecke, Ann; Vanderwee, Katrien; Schoonhoven, Lisette; Verhaeghe, Sofie

    2013-04-01

    Frail older people admitted to nursing homes are at risk of a range of adverse outcomes, including pressure ulcers. Clinical decision support systems are believed to have the potential to improve care and to change the behaviour of healthcare professionals. To determine whether a multi-faceted tailored strategy to implement an electronic clinical decision support system for pressure ulcer prevention improves adherence to recommendations for pressure ulcer prevention in nursing homes. Two-armed randomized controlled trial in a nursing home setting in Belgium. The trial consisted of a 16-week implementation intervention between February and June 2010, including one baseline, four intermediate, and one post-testing measurement. Primary outcome was the adherence to guideline-based care recommendations (in terms of allocating adequate pressure ulcer prevention in residents at risk). Secondary outcomes were the change in resident outcomes (pressure ulcer prevalence) and intermediate outcomes (knowledge and attitudes of healthcare professionals). Random sample of 11 wards (6 experimental; 5 control) in a convenience sample of 4 nursing homes in Belgium. In total, 464 nursing home residents and 118 healthcare professionals participated. The experimental arm was involved in a multi-faceted tailored implementation intervention of a clinical decision support system, including interactive education, reminders, monitoring, feedback and leadership. The control arm received a hard-copy of the pressure ulcer prevention protocol, supported by standardized 30 min group lecture. Patients in the intervention arm were significantly more likely to receive fully adequate pressure ulcer prevention when seated in a chair (F=16.4, P=0.003). No significant improvement was observed on pressure ulcer prevalence and knowledge of the professionals. While baseline attitude scores were comparable between both groups [exp. 74.3% vs. contr. 74.5% (P=0.92)], the mean score after the intervention was

  7. Massage Therapy for Patients with Metastatic Cancer: A Pilot Randomized Controlled Trial

    PubMed Central

    Toth, Maria; Marcantonio, Edward R.; Davis, Roger B.; Walton, Tracy; Kahn, Janet R.

    2013-01-01

    Abstract Objectives The study objectives were to determine the feasibility and effects of providing therapeutic massage at home for patients with metastatic cancer. Design This was a randomized controlled trial. Settings/location Patients were enrolled at Oncology Clinics at a large urban academic medical center; massage therapy was provided in patients' homes. Subjects Subjects were patients with metastatic cancer. Interventions There were three interventions: massage therapy, no-touch intervention, and usual care. Outcome measures Primary outcomes were pain, anxiety, and alertness; secondary outcomes were quality of life and sleep. Results In this study, it was possible to provide interventions for all patients at home by professional massage therapists. The mean number of massage therapy sessions per patient was 2.8. A significant improvement was found in the quality of life of the patients who received massage therapy after 1-week follow-up, which was not observed in either the No Touch control or the Usual Care control groups, but the difference was not sustained at 1 month. There were trends toward improvement in pain and sleep of the patients after therapeutic massage but not in patients in the control groups. There were no serious adverse events related to the interventions. Conclusions The study results showed that it is feasible to provide therapeutic massage at home for patients with advanced cancer, and to randomize patients to a no-touch intervention. Providing therapeutic massage improves the quality of life at the end of life for patients and may be associated with further beneficial effects, such as improvement in pain and sleep quality. Larger randomized controlled trials are needed to substantiate these findings. PMID:23368724

  8. Promoting Early Intervention Referral through a Randomized Controlled Home-Visiting Program

    ERIC Educational Resources Information Center

    Schwarz, Donald F.; O'Sullivan, Ann L.; Guinn, Judith; Mautone, Jennifer A.; Carlson, Elyse C.; Zhao, Huaqing; Zhang, Xuemei; Esposito, Tara L.; Askew, Megan; Radcliffe, Jerilynn

    2012-01-01

    The MOM Program is a randomized, controlled trial of an intervention to promote mothers' care for the health and development of their children, including accessing early intervention (EI) services. Study aims were to determine whether, relative to controls, this intervention increased receipt of and referral to EI services. Mothers (N = 302)…

  9. Improving the outcome of infants born at <30 weeks' gestation - a randomized controlled trial of preventative care at home

    PubMed Central

    2009-01-01

    Background Early developmental interventions to prevent the high rate of neurodevelopmental problems in very preterm children, including cognitive, motor and behavioral impairments, are urgently needed. These interventions should be multi-faceted and include modules for caregivers given their high rates of mental health problems. Methods/Design We have designed a randomized controlled trial to assess the effectiveness of a preventative care program delivered at home over the first 12 months of life for infants born very preterm (<30 weeks of gestational age) and their families, compared with standard medical follow-up. The aim of the program, delivered over nine sessions by a team comprising a physiotherapist and psychologist, is to improve infant development (cognitive, motor and language), behavioral regulation, caregiver-child interactions and caregiver mental health at 24 months' corrected age. The infants will be stratified by severity of brain white matter injury (assessed by magnetic resonance imaging) at term equivalent age, and then randomized. At 12 months' corrected age interim outcome measures will include motor development assessed using the Alberta Infant Motor Scale and the Neurological Sensory Motor Developmental Assessment. Caregivers will also complete a questionnaire at this time to obtain information on behavior, parenting, caregiver mental health, and social support. The primary outcomes are at 24 months' corrected age and include cognitive, motor and language development assessed with the Bayley Scales of Infant and Toddler Development (Bayley-III). Secondary outcomes at 24 months include caregiver-child interaction measured using an observational task, and infant behavior, parenting, caregiver mental health and social support measured via standardized parental questionnaires. Discussion This paper presents the background, study design and protocol for a randomized controlled trial in very preterm infants utilizing a preventative care program

  10. Impact of Text Message Reminders on Caregivers’ Adherence to a Home Fortification Program Against Child Anemia in Rural Western China: A Cluster-Randomized Controlled Trial

    PubMed Central

    Zhou, Huan; Sun, Shuai; Sylvia, Sean; Yue, Ai; Shi, Yaojiang; Zhang, Linxiu; Medina, Alexis; Rozelle, Scott

    2016-01-01

    Objectives. To test whether text message reminders sent to caregivers improve the effectiveness of a home micronutrient fortification program in western China. Methods. We carried out a cluster-randomized controlled trial in 351 villages (clusters) in Shaanxi Province in 2013 and 2014, enrolling children aged 6 to 12 months. We randomly assigned each village to 1 of 3 groups: free delivery group, text messaging group, or control group. We collected information on compliance with treatments and hemoglobin concentrations from all children at baseline and 6-month follow-up. We estimated the intent-to-treat effects on compliance and child anemia using a logistic regression model. Results. There were 1393 eligible children. We found that assignment to the text messaging group led to an increase in full compliance (marginal effect = 0.10; 95% confidence interval [CI] = 0.03, 0.16) compared with the free delivery group and decrease in the rate of anemia at end line relative to the control group (marginal effect = −0.07; 95% CI = −0.12, −0.01), but not relative to the free delivery group (marginal effect = −0.03; 95% CI = −0.09, 0.03). Conclusions. Text messages improved compliance of caregivers to a home fortification program and children’s nutrition. PMID:27077354

  11. Randomized Face-to-Face vs. Home Exercise Interventions in Pregnant Women with Gestational Diabetes.

    PubMed

    Downs, Danielle Symons; Dinallo, Jennifer M; Birch, Leann L; Paul, Ian M; Ulbrecht, Jan S

    2017-05-01

    Evaluate effects of a theoretically-based, semi-intensive (Face-to-Face; F2F) exercise intervention and minimum-contact (Home) exercise intervention to the standard care (Control) on exercise, its motivational determinants, blood glucose levels, and insulin use of pregnant women with gestational diabetes mellitus (GDM). Randomized control trial with two intervention arms and control (standard care). Participants ( N =65) were randomized to a Control (standard prenatal care/GDM dietary counseling), Home (standard care + phone education/support + home exercise), or F2F (standard care + on-site education/support + guided exercise with instructor on 2 days/week) group from ~20 weeks gestation to delivery. Assessments of exercise and motivational determinants were obtained at baseline (20-weeks gestation) and follow-up (32-weeks gestation). Blood glucose levels (fasting/postprandial mg/dL) and insulin use were extrapolated from medical records. At the 32-week follow-up, the F2F group had significantly higher exercise min, pedometer steps/day, and motivational determinants (attitude, subjective norm, perceived control, intention) than controls ( p 's < .05) and significantly higher exercise min and subjective norm than the Home group ( p 's < .05); these effect sizes were medium-large (η 2 = .11-.23). There was a medium effect (η 2 = .13) on postprandial blood glucose at 36-weeks gestation with the F2F group having lower values than controls. Although not significant, the F2F group started insulin later (33 weeks gestation) than the Home (27 weeks) and Control (31 weeks) groups. A theoretically-based, F2F exercise intervention has multiple health benefits and may be the necessary approach for promoting exercise motivation and behavior among GDM women.

  12. The economics of dementia-care mapping in nursing homes: a cluster-randomised controlled trial.

    PubMed

    van de Ven, Geertje; Draskovic, Irena; van Herpen, Elke; Koopmans, Raymond T C M; Donders, Rogier; Zuidema, Sytse U; Adang, Eddy M M; Vernooij-Dassen, Myrra J F J

    2014-01-01

    Dementia-care mapping (DCM) is a cyclic intervention aiming at reducing neuropsychiatric symptoms in people with dementia in nursing homes. Alongside an 18-month cluster-randomized controlled trial in which we studied the effectiveness of DCM on residents and staff outcomes, we investigated differences in costs of care between DCM and usual care in nursing homes. Dementia special care units were randomly assigned to DCM or usual care. Nurses from the intervention care homes received DCM training, a DCM organizational briefing day and conducted the 4-months DCM-intervention twice during the study. A single DCM cycle consists of observation, feedback to the staff, and action plans for the residents. We measured costs related to health care consumption, falls and psychotropic drug use at the resident level and absenteeism at the staff level. Data were extracted from resident files and the nursing home records. Prizes were determined using the Dutch manual of health care cost and the cost prices delivered by a pharmacy and a nursing home. Total costs were evaluated by means of linear mixed-effect models for longitudinal data, with the unit as a random effect to correct for dependencies within units. 34 units from 11 nursing homes, including 318 residents and 376 nursing staff members participated in the cost analyses. Analyses showed no difference in total costs. However certain changes within costs could be noticed. The intervention group showed lower costs associated with outpatient hospital appointments over time (p = 0.05) than the control group. In both groups, the number of falls, costs associated with the elderly-care physician and nurse practitioner increased equally during the study (p<0.02). DCM is a cost-neutral intervention. It effectively reduces outpatient hospital appointments compared to usual care. Other considerations than costs, such as nursing homes' preferences, may determine whether they adopt the DCM method. Dutch Trials Registry NTR2314.

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

    PubMed

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

    2011-02-01

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

  14. Randomized trial of a home monitoring system for early detection of choroidal neovascularization home monitoring of the Eye (HOME) study.

    PubMed

    Chew, Emily Y; Clemons, Traci E; Bressler, Susan B; Elman, Michael J; Danis, Ronald P; Domalpally, Amitha; Heier, Jeffrey S; Kim, Judy E; Garfinkel, Richard

    2014-02-01

    To determine whether home monitoring with the ForeseeHome device (Notal Vision Ltd, Tel Aviv, Israel), using macular visual field testing with hyperacuity techniques and telemonitoring, results in earlier detection of age-related macular degeneration-associated choroidal neovascularization (CNV), reflected in better visual acuity, when compared with standard care. The main predictor of treatment outcome from anti-vascular endothelial growth factor (VEGF) agents is the visual acuity at the time of CNV treatment. Unmasked, controlled, randomized clinical trial. One thousand nine hundred and seventy participants 53 to 90 years of age at high risk of CNV developing were screened. Of these, 1520 participants with a mean age of 72.5 years were enrolled in the Home Monitoring of the Eye study at 44 Age-Related Eye Disease Study 2 clinical centers. In the standard care and device arms arm, investigator-specific instructions were provided for self-monitoring vision at home followed by report of new symptoms to the clinic. In the device arm, the device was provided with recommendations for daily testing. The device monitoring center received test results and reported changes to the clinical centers, which contacted participants for examination. The main outcome measure was the difference in best-corrected visual acuity scores between baseline and detection of CNV. The event was determined by investigators based on clinical examination, color fundus photography, fluorescein angiography, and optical coherence tomography findings. Masked graders at a central reading center evaluated the images using standardized protocols. Seven hundred sixty-three participants were randomized to device monitoring and 757 participants were randomized to standard care and were followed up for a mean of 1.4 years between July 2010 and April 2013. At the prespecified interim analysis, 82 participants progressed to CNV, 51 in the device arm and 31 in the standard care arm. The primary analysis

  15. Children Learning About Second-Hand Smoking: A Feasibility Cluster Randomized Controlled Trial.

    PubMed

    Huque, Rumana; Dogar, Omara; Cameron, Ian; Thomson, Heather; Amos, Amanda; Siddiqi, Kamran

    2015-12-01

    Exposure to second-hand smoke is a threat to children's health. We developed a school-based smoke-free intervention (SFI) to support families in implementing smoke-free homes in Bangladesh, and gathered preliminary evidence of its effectiveness. A feasibility cluster randomized controlled trial of SFI was conducted in 24 schools in Mirpur, an urban area within Dhaka. Using simple stratified randomization, schools were allocated to: Arm A (SFI only), Arm B (SFI plus reminders), and Arm C (the control group). A total of 781 year-5 children (10-12 years old) in the consenting schools, participated in the study. Outcomes including "smoke-free homes" and "social visibility" that is, not smoking in front of children at home were assessed through questionnaire-based children's surveys, administered by researchers, at baseline and at weeks 1, 12, 27, and 52 in all arms. "Smoke-free homes" were significantly higher in Arm A (odds ratio [OR] = 4.8; 95% CI = 2.6-9.0) and in Arm B (OR = 3.9; 95% CI = 2.0-7.5) than in Arm C, when controlled for the baseline levels, at year 1. Similarly, "social visibility" was significantly reduced in Arm A (OR = 5.8; 95% CI = 2.8-11.7) and in Arm B (OR = 7.2; 95% CI = 3.3-15.9) than Arm C, when controlled for the baseline levels, at year 1. We observed an increasing trend (Cochrane Armitage test statistic [Z] = 3.8; p < .0001) in homes becoming smoke-free with increasing intensity of the intervention (control < Arm A < Arm B), and a decreasing trend (Z = -5.13; p < .0001) in social visibility at homes. SFI has the potential to encourage children to negotiate a smoke-free environment in their homes. © The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  16. Randomized controlled resistance training based physical activity trial for central European nursing home residing older adults.

    PubMed

    Barthalos, Istvan; Dorgo, Sandor; Kopkáné Plachy, Judit; Szakály, Zsolt; Ihász, Ferenc; Ráczné Németh, Teodóra; Bognár, József

    2016-10-01

    Nursing home residing older adults often experience fear of sickness or death, functional impairment and pain. It is difficult for these older adults to maintain a physically active lifestyle and to keep a positive outlook on life. This study evaluated the changes in quality of life, attitude to aging, assertiveness, physical fitness and body composition of nursing home residing elderly through a 15-week organized resistance training based physical activity program. Inactive older adults living in a state financed nursing home (N.=45) were randomly divided into two intervention groups and a control group. Both intervention groups were assigned to two physical activity sessions a week, but one of these groups also had weekly discussions on health and quality of life (Mental group). Data on anthropometric measures, fitness performance, as well as quality of life and attitudes to aging survey data were collected. Due to low attendance rate 12 subjects were excluded from the analyses. Statistical analysis included Paired Samples t-tests and Repeated Measures Analysis of Variance. Both intervention groups significantly improved their social participation, and their upper- and lower-body strength scores. Also, subjects in the Mental group showed improvement in agility fitness test and certain survey scales. No positive changes were detected in attitude towards aging and body composition measures in any groups. The post-hoc results suggest that Mental group improved significantly more than the Control group. Regular physical activity with discussions on health and quality of life made a more meaningful difference for the older adults living in nursing home than physical activity alone. Due to the fact that all participants were influenced by the program, it is suggested to further explore this area for better understanding of enhanced quality of life.

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

    PubMed

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

    2012-09-01

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

  18. Randomized Face-to-Face vs. Home Exercise Interventions in Pregnant Women with Gestational Diabetes

    PubMed Central

    DOWNS, Danielle Symons; DINALLO, Jennifer M.; BIRCH, Leann L.; PAUL, Ian M.; ULBRECHT, Jan S.

    2017-01-01

    Objectives Evaluate effects of a theoretically-based, semi-intensive (Face-to-Face; F2F) exercise intervention and minimum-contact (Home) exercise intervention to the standard care (Control) on exercise, its motivational determinants, blood glucose levels, and insulin use of pregnant women with gestational diabetes mellitus (GDM). Design Randomized control trial with two intervention arms and control (standard care). Method Participants (N=65) were randomized to a Control (standard prenatal care/GDM dietary counseling), Home (standard care + phone education/support + home exercise), or F2F (standard care + on-site education/support + guided exercise with instructor on 2 days/week) group from ~20 weeks gestation to delivery. Assessments of exercise and motivational determinants were obtained at baseline (20-weeks gestation) and follow-up (32-weeks gestation). Blood glucose levels (fasting/postprandial mg/dL) and insulin use were extrapolated from medical records. Results At the 32-week follow-up, the F2F group had significantly higher exercise min, pedometer steps/day, and motivational determinants (attitude, subjective norm, perceived control, intention) than controls (p’s < .05) and significantly higher exercise min and subjective norm than the Home group (p’s < .05); these effect sizes were medium-large (η2 = .11–.23). There was a medium effect (η2 = .13) on postprandial blood glucose at 36-weeks gestation with the F2F group having lower values than controls. Although not significant, the F2F group started insulin later (33 weeks gestation) than the Home (27 weeks) and Control (31 weeks) groups. Conclusion A theoretically-based, F2F exercise intervention has multiple health benefits and may be the necessary approach for promoting exercise motivation and behavior among GDM women. PMID:28428728

  19. Screen-time Weight-loss Intervention Targeting Children at Home (SWITCH): A randomized controlled trial study protocol

    PubMed Central

    2011-01-01

    Background Approximately one third of New Zealand children and young people are overweight or obese. A similar proportion (33%) do not meet recommendations for physical activity, and 70% do not meet recommendations for screen time. Increased time being sedentary is positively associated with being overweight. There are few family-based interventions aimed at reducing sedentary behavior in children. The aim of this trial is to determine the effects of a 24 week home-based, family oriented intervention to reduce sedentary screen time on children's body composition, sedentary behavior, physical activity, and diet. Methods/Design The study design is a pragmatic two-arm parallel randomized controlled trial. Two hundred and seventy overweight children aged 9-12 years and primary caregivers are being recruited. Participants are randomized to intervention (family-based screen time intervention) or control (no change). At the end of the study, the control group is offered the intervention content. Data collection is undertaken at baseline and 24 weeks. The primary trial outcome is child body mass index (BMI) and standardized body mass index (zBMI). Secondary outcomes are change from baseline to 24 weeks in child percentage body fat; waist circumference; self-reported average daily time spent in physical and sedentary activities; dietary intake; and enjoyment of physical activity and sedentary behavior. Secondary outcomes for the primary caregiver include change in BMI and self-reported physical activity. Discussion This study provides an excellent example of a theory-based, pragmatic, community-based trial targeting sedentary behavior in overweight children. The study has been specifically designed to allow for estimation of the consistency of effects on body composition for Māori (indigenous), Pacific and non-Māori/non-Pacific ethnic groups. If effective, this intervention is imminently scalable and could be integrated within existing weight management programs. Trial

  20. A Home-Based Walking Program Improves Respiratory Endurance in Patients With Acute Myocardial Infarction: A Randomized Controlled Trial.

    PubMed

    Matos-Garcia, Bruna C; Rocco, Isadora S; Maiorano, Lara D; Peixoto, Thatiana C A; Moreira, Rita Simone L; Carvalho, Antonio C C; Catai, Aparecida Maria; Arena, Ross; Gomes, Walter J; Guizilini, Solange

    2017-06-01

    The purpose of this study was to evaluate respiratory muscle strength and endurance in the inpatient period in patients who recently experienced myocardial infarction (MI) and investigate the effects of a home-based walking program on respiratory strength and endurance in low-risk patients after MI. Patients were randomized into a usual-care group (UCG) entailing regular care (n = 23) and an intervention group (IG) entailing an outpatient home-based walking program (n = 31). Healthy sex- and age-matched participants served as a control group for respiratory endurance variables. Respiratory muscle strength was evaluated through maximal inspiratory pressure (MIP) and endurance during the inpatient period, at 15 days, and at 60 days after MI. Submaximal functional capacity was determined by a 6-minute walk test (6MWT) at hospital discharge and 60 days after MI. Both groups showed impaired inspiratory muscle strength at hospital discharge. When compared with healthy individuals, after MI, patients had worse respiratory muscle endurance pressure (PTH max  = 73.02 ± 8.40 vs 44.47 ± 16.32; P < 0.05) and time (Tlim = 324.1 ± 12.2 vs 58.7 ± 93.3; P < 0.05). Only the IG showed a significant improvement in MIP and PTH max at 15 days and 60 days after MI (P < 0.05). When comparing groups, the IG achieved higher values for MIP, PTH max , and Tlim 15 and 60 days after MI (P < 0.01). The 60-day assessment revealed that the 6MWT distance and level of physical activity was significantly higher in the IG compared with the UCG. Low-risk patients recently experiencing MI demonstrate impaired MIP and respiratory endurance compared with healthy participants. A home-based walking program improved respiratory endurance and functional capacity. Copyright © 2017 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

  1. Exercise program for nursing home residents with Alzheimer's disease: a 1-year randomized, controlled trial.

    PubMed

    Rolland, Yves; Pillard, Fabien; Klapouszczak, Adrian; Reynish, Emma; Thomas, David; Andrieu, Sandrine; Rivière, Daniel; Vellas, Bruno

    2007-02-01

    To investigate the effectiveness of an exercise program in improving ability to perform activities of daily living (ADLs), physical performance, and nutritional status and decreasing behavioral disturbance and depression in patients with Alzheimer's disease (AD). Randomized, controlled trial. Five nursing homes. One hundred thirty-four ambulatory patients with mild to severe AD. Collective exercise program (1 hour, twice weekly of walk, strength, balance, and flexibility training) or routine medical care for 12 months. ADLs were assessed using the Katz Index of ADLs. Physical performance was evaluated using 6-meter walking speed, the get-up-and-go test, and the one-leg-balance test. Behavioral disturbance, depression, and nutritional status were evaluated using the Neuropsychiatric Inventory, the Montgomery and Asberg Depression Rating Scale, and the Mini-Nutritional Assessment. For each outcome measure, the mean change from baseline to 12 months was calculated using intention-to-treat analysis. ADL mean change from baseline score for exercise program patients showed a slower decline than in patients receiving routine medical care (12-month mean treatment differences: ADL=0.39, P=.02). A significant difference between the groups in favor of the exercise program was observed for 6-meter walking speed at 12 months. No effect was observed for behavioral disturbance, depression, or nutritional assessment scores. In the intervention group, adherence to the program sessions in exploratory analysis predicted change in ability to perform ADLs. No adverse effects of exercise occurred. A simple exercise program, 1 hour twice a week, led to significantly slower decline in ADL score in patients with AD living in a nursing home than routine medical care.

  2. Staff Distress Improves by Treating Pain in Nursing Home Patients With Dementia: Results From a Cluster-Randomized Controlled Trial.

    PubMed

    Aasmul, Irene; Husebo, Bettina Sandgathe; Flo, Elisabeth

    2016-12-01

    Most people with dementia develop neuropsychiatric symptoms (NPSs), which are distressing for their carers. Untreated pain may increase the prevalence and severity of NPSs and thereby staff burden. We investigated the association between NPSs and the impact of individual pain treatment on distress in nursing home staff. Nursing home (NH) units were cluster-randomized to an intervention group (33 NH units; n = 175) or control group (27 NH units; n = 177). Patients in the intervention group received individual pain treatment for eight weeks, followed by a four-week washout period; control groups received care as usual. Staff informants (n = 138) used the Neuropsychiatric Inventory-NH version (including caregiver distress) as primary outcome to assess their own distress. Other outcomes were pain (Mobilization-Observation-Behavior-Intensity-Dementia-2 Pain Scale) and cognitive functioning (Mini-Mental State Examination). Using hierarchical regression analysis, all NPS items at baseline were associated with staff distress (P < 0.01) apart from euphoria; agitation had the largest contribution (β = 0.24). Using mixed models, we found significantly lower staff distress in the intervention group compared to the control group. Moreover, we also found significantly reduced distress in the control group, and there were still effects in both groups throughout the washout period. Individual pain treatment reduced staff distress in the intervention group compared to control group especially in regard to agitation-related symptoms and apathy. Furthermore, our results indicated a multifactorial model of staff distress, in which enhanced knowledge and understanding of NPSs and pain in people with advanced dementia may play an important role. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  3. The effect of music therapy on depression and physiological parameters in elderly people living in a Turkish nursing home: a randomized-controlled trial.

    PubMed

    Gök Ugur, Hacer; Yaman Aktaş, Yeşim; Orak, Oya Sevcan; Saglambilen, Okan; Aydin Avci, İlknur

    2017-12-01

    This study was carried out in an effort to determine the effect of music therapy on depression and physiological parameters in elderly people who were living in a nursing home. The study was a randomized controlled trial. The study sample consisted of 64 elderly people who complied with the criteria of inclusion for the study. The data were collected using the 'Elderly Information Form' and 'Geriatric Depression Scale'. The music group listened to music three days in a week during 8 weeks. The depression levels were assessed at baseline (week 0) and follow-up in the eight week. It was found that the difference between post-test depression scores of the two groups was found to be statistically significant (t = -2.86, p <.01). The mean scores of post-test systolic blood pressure in the music group were found to be significantly lower than those of the control group (t = -3.11, p < .05). It was concluded that music therapy decreased the depression level and systolic blood pressure in elderly people. The study results implies that music therapy can be an effective practice for public health and home care nurses attempting to reduce depression and control physiological parameters of elderly people.

  4. Delaying second births among adolescent mothers: a randomized, controlled trial of a home-based mentoring program.

    PubMed

    Black, Maureen M; Bentley, Margaret E; Papas, Mia A; Oberlander, Sarah; Teti, Laureen O; McNary, Scot; Le, Katherine; O'Connell, Melissa

    2006-10-01

    Rates of rapid second births among low-income black adolescent mothers range from 20% to 50%. Most efforts to prevent rapid second births have been unsuccessful. There were 4 objectives: (1) to examine whether a home-based mentoring intervention was effective in preventing second births within 2 years of the adolescent mother's first delivery; (2) to examine whether greater intervention participation increased the likelihood of preventing a second birth; (3) to examine whether second births were better predicted from a risk practice perspective or a family formation perspective, based on information collected at delivery; and (4) to examine how risk practices or family formation over the first 2 years of parenthood were related to a second birth. We conducted a randomized, controlled trial of a home-based intervention curriculum, based on social cognitive theory, and focused on interpersonal negotiation skills, adolescent development, and parenting. The curriculum was delivered biweekly until the infant's first birthday by college-educated, black, single mothers who served as mentors, presenting themselves as "big sisters." The control group received usual care. Follow-up evaluations were conducted in the homes 6, 13, and 24 months after recruitment. Participants were recruited from urban hospitals at delivery and were 181 first time, black adolescent mothers (< 18 years of age); 82% (149 of 181) completed the 24-month evaluation. Intent-to-treat analyses revealed that control mothers were more likely than intervention mothers to have a second infant. The complier average causal effect was used to account for variability in intervention participation. Having > or = 2 intervention visits increased the odds of not having a second infant more than threefold. Only 1 mother who completed > or = 6 visits had a second infant. At delivery of their first infant, mothers who had a second infant were slightly older (16.7 vs 16.2 years) and were more likely to have been

  5. Porvoo sarcopenia and nutrition trial: effects of protein supplementation on functional performance in home-dwelling sarcopenic older people - study protocol for a randomized controlled trial.

    PubMed

    Bjorkman, Mikko P; Suominen, Merja H; Pitkälä, Kaisu H; Finne-Soveri, Harriet U; Tilvis, Reijo S

    2013-11-14

    Age-related muscle loss (that is, sarcopenia) is a common health problem among older people. Physical exercise and dietary protein have been emphasized in prevention and treatment of sarcopenia. Rigorous trials investigating the effects of protein supplementation on physical performance in sarcopenic populations are still scarce. The aim of this study is to investigate the effects of protein supplementation along with simple home-based exercises on physical performance among home-dwelling sarcopenic older people. During 2012 the entire 75 and older population (N = 3,275) living in Porvoo, Finland was contacted via a postal questionnaire. Persons at risk of sarcopenia are screened with hand grip strength and gait speed. Poorly performing persons are further examined by segmental bioimpendance spectroscopy to determine their skeletal muscle index. Sarcopenic patients (target N = 250) will be enrolled in a 12-month randomized controlled trial with three arms: 1) no supplementation, 2) protein supplementation (20 grams twice a day), and 3) isocaloric placebo. All the participants will receive instructions on simple home-based exercises, dietary protein, and vitamin D supplementation (20 μg/d). The recruitment of patients will be completed during 2013. The primary endpoint of the trial is the change in short physical performance battery score and percentage of patients maintaining or improving their physical performance. Secondary endpoints will be, among other things, changes in muscle functions, nutritional status, body composition, cognition, quality of life, use of health care services, falls, and mortality. The assessment times will be 0, 6, 12 and 24 months. To our knowledge, this is the first large scale randomized controlled trial among community dwelling older people with sarcopenia that focuses on the effects of protein supplementation on physical performance. ACTRN12612001253897, date of registration 28 October 2012, first patient was randomized 11 April

  6. Home ovulation tests and stress in women trying to conceive: a randomized controlled trial

    PubMed Central

    Tiplady, S.; Jones, G.; Campbell, M.; Johnson, S.; Ledger, W.

    2013-01-01

    STUDY QUESTION Does the use of a digital home ovulation test have any effect on the level of stress in women seeking to conceive? SUMMARY ANSWER No difference was found in levels of stress between women using digital ovulation tests to time intercourse compared with women who were trying to conceive without any additional aids: in addition, their use did not negatively impact time to conception in users but may provide additional benefits, including an increased understanding of the menstrual cycle, reassurance and confidence in focusing conception attempts to the correct time in the cycle. WHAT IS KNOWN ALREADY It has been suggested that timing of intercourse in such a way that it coincides with ovulation by using ovulation tests can lead to emotional distress; however, no study has been conducted to investigate this hypothesis specifically, until now. STUDY DESIGN, SIZE AND DURATION The study was performed over two complete menstrual cycles as a prospective, randomized, controlled trial including quantitative and qualitative methods. The intervention (test) group were given digital ovulation tests to time intercourse to the most fertile time of the cycle and the control group were provided with the current National Institute for Health and Clinical Excellence guidelines for increasing the chances of conception (intercourse every 2–3 days) and asked not to use any additional methods to time when ovulation occurs. PARTICIPANTS/MATERIALS, SETTING AND METHODS A total of 210 women who were seeking to conceive were recruited from the general UK population. A total of 115 women were randomized to the test group and 95 to the control group through block randomization. The positive and negative affect schedule (PANAS) and the Perceived Stress Scale (PSS) were used to measure subjective stress levels, the Short-Form 12 health survey was used as a measure of general health and well-being and urine samples were measured for biochemical markers of stress including urinary

  7. Acceptability of Home-Assessment Post Medical Abortion and Medical Abortion in a Low-Resource Setting in Rajasthan, India. Secondary Outcome Analysis of a Non-Inferiority Randomized Controlled Trial

    PubMed Central

    Paul, Mandira; Iyengar, Kirti; Essén, Birgitta; Gemzell-Danielsson, Kristina; Iyengar, Sharad D.; Bring, Johan; Soni, Sunita; Klingberg-Allvin, Marie

    2015-01-01

    Background Studies evaluating acceptability of simplified follow-up after medical abortion have focused on high-resource or urban settings where telephones, road connections, and modes of transport are available and where women have formal education. Objective To investigate women’s acceptability of home-assessment of abortion and whether acceptability of medical abortion differs by in-clinic or home-assessment of abortion outcome in a low-resource setting in India. Design Secondary outcome of a randomised, controlled, non-inferiority trial. Setting Outpatient primary health care clinics in rural and urban Rajasthan, India. Population Women were eligible if they sought abortion with a gestation up to 9 weeks, lived within defined study area and agreed to follow-up. Women were ineligible if they had known contraindications to medical abortion, haemoglobin < 85mg/l and were below 18 years. Methods Abortion outcome assessment through routine clinic follow-up by a doctor was compared with home-assessment using a low-sensitivity pregnancy test and a pictorial instruction sheet. A computerized random number generator generated the randomisation sequence (1:1) in blocks of six. Research assistants randomly allocated eligible women who opted for medical abortion (mifepristone and misoprostol), using opaque sealed envelopes. Blinding during outcome assessment was not possible. Main Outcome Measures Women’s acceptability of home-assessment was measured as future preference of follow-up. Overall satisfaction, expectations, and comparison with previous abortion experiences were compared between study groups. Results 731 women were randomized to the clinic follow-up group (n = 353) or home-assessment group (n = 378). 623 (85%) women were successfully followed up, of those 597 (96%) were satisfied and 592 (95%) found the abortion better or as expected, with no difference between study groups. The majority, 355 (57%) women, preferred home-assessment in the event of a future

  8. Specific muscle stabilizing as home exercises for persistent pelvic girdle pain after pregnancy: a randomized, controlled clinical trial.

    PubMed

    Gutke, Annelie; Sjödahl, Jenny; Oberg, Birgitta

    2010-11-01

    To investigate the efficacy of home-based specific stabilizing exercises focusing on the local stabilizing muscles as the only intervention in the treatment of persistent postpartum pelvic girdle pain. A prospective, randomized, single-blinded, clinically controlled study. Eighty-eight women with pelvic girdle pain were recruited 3 months after delivery. The treatment consisted of specific stabilizing exercises targeting the local trunk muscles. The reference group had a single telephone contact with a physiotherapist. Primary outcome was disability measured with Oswestry Disability Index. Secondary outcomes were pain, health-related quality of life (EQ-5D), symptom satisfaction, and muscle function. No significant differences between groups could be found at 3- or 6-month follow-up regarding primary outcome in disability. Within-group comparisons showed some improvement in both groups in terms of disability, pain, symptom satisfaction and muscle function compared with baseline, although the majority still experienced pelvic girdle pain. Treatment with this home-training concept of specific stabilizing exercises targeting the local muscles was no more effective in improving consequences of persistent postpartum pelvic girdle pain than the clinically natural course. Regardless of whether treatment with specific stabilizing exercises was carried out, the majority of women still experienced some back pain almost one year after pregnancy.

  9. Children's postoperative symptoms at home through nurse-led telephone counseling and its effects on parents' anxiety: A randomized controlled trial.

    PubMed

    Özalp Gerçeker, Gülçin; Karayağız Muslu, Gonca; Yardimci, Figen

    2016-10-01

    The objective of this study was to evaluate children's postoperative symptoms at home after outpatient surgery through nurse-led telephone counseling and the effects of the nurse-led telephone counseling on parents' state-trait anxiety scores. In this prospective randomized controlled study, nurse-led telephone counseling was provided every day to parents in the intervention group until they came for the follow-up visit. Parents of children (n = 54) ages 3-17 years who had undergone outpatient surgery for appendicitis, cholecystectomy, or ovarian cysts were eligible to participate in the study. On the first postoperative day and at the follow-up visit, the Spielberger State-Trait-Anxiety Inventory (STAI) was administered to parents who were randomly allocated to the intervention (n = 24) and control groups (n = 30). The parents reported on postoperative symptoms such as pain, activity levels, excretion, sleep, nutrition, and wound infection. While there was no difference in STAI scores for parents between the groups at the first postoperative day, there was a significant decrease in STAI scores in the intervention group versus the control group, with parents in the intervention group reporting lower anxiety scores. Our results suggest that nurse-led telephone counseling is effective at reducing anxiety in parents of children after outpatient surgery. © 2016, Wiley Periodicals, Inc.

  10. Effects of home-based locomotor treadmill training on gross motor function in young children with cerebral palsy: a quasi-randomized controlled trial.

    PubMed

    Mattern-Baxter, Katrin; McNeil, Stefani; Mansoor, Jim K

    2013-11-01

    To examine the effects of an intensive home-based program of treadmill training on motor skills related to walking in preambulatory children with cerebral palsy (CP). Quasi-randomized controlled trial. Homes of the participants. Children with CP (N=12) with Gross Motor Function Classification System levels I and II were assigned to the intervention group (n=6; mean age ± SD, 21.76±6.50mo) and control group (n=6; 21.25±6.07mo). All children were tested preintervention, postintervention, at a 1-month follow-up, and at a 4-month follow-up. All children received their weekly scheduled physical therapy sessions at their homes. In addition, children in the intervention group walked on a portable treadmill in their homes 6 times per week, twice daily for 10- to 20-minute sessions, for 6 weeks. The intervention was carried out by the children's parents with weekly supervision by a physical therapist. Gross Motor Function Measure-66 Dimensions D/E, Peabody Developmental Motor Scales-2 (PDMS-2), Pediatric Evaluation of Disability Inventory (PEDI), timed 10-m walk test (10MWT), and Functional Mobility Scale (FMS). The Friedman test and Mann-Whitney U test were conducted for within-group and between-group differences, respectively. There was a significant between-group treatment effect for the PDMS-2 at posttest (P=.01) and 1-month postintervention follow-up (P=.09), as well as for the PEDI at posttest (P=.01), the 1-month postintervention follow-up (P=.009), and the 4-month postintervention follow-up (P=.04). The FMS was significant at the posttest (P=.04). Home-based treadmill training accelerates the attainment of walking skills and decreases the amount of support used for walking in young children with CP. Copyright © 2013 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  11. Effect of workplace- versus home-based physical exercise on pain in healthcare workers: study protocol for a single blinded cluster randomized controlled trial.

    PubMed

    Jakobsen, Markus D; Sundstrup, Emil; Brandt, Mikkel; Kristensen, Anne Zoëga; Jay, Kenneth; Stelter, Reinhard; Lavendt, Ebbe; Aagaard, Per; Andersen, Lars L

    2014-04-07

    The prevalence and consequences of musculoskeletal pain is considerable among healthcare workers, allegedly due to high physical work demands of healthcare work. Previous investigations have shown promising results of physical exercise for relieving pain among different occupational groups, but the question remains whether such physical exercise should be performed at the workplace or conducted as home-based exercise. Performing physical exercise at the workplace together with colleagues may be more motivating for some employees and thus increase adherence. On the other hand, physical exercise performed during working hours at the workplace may be costly for the employers in terms of time spend. Thus, it seems relevant to compare the efficacy of workplace- versus home-based training on musculoskeletal pain. This study is intended to investigate the effect of workplace-based versus home-based physical exercise on musculoskeletal pain among healthcare workers. This study was designed as a cluster randomized controlled trial performed at 3 hospitals in Copenhagen, Denmark. Clusters are hospital departments and hospital units. Cluster randomization was chosen to increase adherence and avoid contamination between interventions. Two hundred healthcare workers from 18 departments located at three different hospitals is allocated to 10 weeks of 1) workplace based physical exercise performed during working hours (using kettlebells, elastic bands and exercise balls) for 5 × 10 minutes per week and up to 5 group-based coaching sessions, or 2) home based physical exercise performed during leisure time (using elastic bands and body weight exercises) for 5 × 10 minutes per week. Both intervention groups will also receive ergonomic instructions on patient handling and use of lifting aides etc. Inclusion criteria are female healthcare workers working at a hospital. Average pain intensity (VAS scale 0-10) of the back, neck and shoulder (primary outcome) and physical

  12. A randomized, controlled trial of a multifaceted intervention including alcohol-based hand sanitizer and hand-hygiene education to reduce illness transmission in the home.

    PubMed

    Sandora, Thomas J; Taveras, Elsie M; Shih, Mei-Chiung; Resnick, Elissa A; Lee, Grace M; Ross-Degnan, Dennis; Goldmann, Donald A

    2005-09-01

    Good hand hygiene may reduce the spread of infections in families with children who are in out-of-home child care. Alcohol-based hand sanitizers rapidly kill viruses that are commonly associated with respiratory and gastrointestinal (GI) infections. The objective of this study was to determine whether a multifactorial campaign centered on increasing alcohol-based hand sanitizer use and hand-hygiene education reduces illness transmission in the home. A cluster randomized, controlled trial was conducted of homes of 292 families with children who were enrolled in out-of-home child care in 26 child care centers. Eligible families had > or =1 child who was 6 months to 5 years of age and in child care for > or =10 hours/week. Intervention families received a supply of hand sanitizer and biweekly hand-hygiene educational materials for 5 months; control families received only materials promoting good nutrition. Primary caregivers were phoned biweekly and reported respiratory and GI illnesses in family members. Respiratory and GI-illness-transmission rates (measured as secondary illnesses per susceptible person-month) were compared between groups, adjusting for demographic variables, hand-hygiene practices, and previous experience using hand sanitizers. Baseline demographics were similar in the 2 groups. A total of 1802 respiratory illnesses occurred during the study; 443 (25%) were secondary illnesses. A total of 252 GI illnesses occurred during the study; 28 (11%) were secondary illnesses. The secondary GI-illness rate was significantly lower in intervention families compared with control families (incidence rate ratio [IRR]: 0.41; 95% confidence interval [CI]: 0.19-0.90). The overall rate of secondary respiratory illness was not significantly different between groups (IRR: 0.97; 95% CI: 0.72-1.30). However, families with higher sanitizer usage had a marginally lower secondary respiratory illness rate than those with less usage (IRR: 0.81; 95% CI: 0.65-1.09). A

  13. Effects of Standardized Home Training in Patients with Cognitive Impairment following Geriatric Rehabilitation: A Randomized Controlled Pilot Study.

    PubMed

    Hauer, Klaus; Ullrich, Phoebe; Dutzi, Ilona; Beurskens, Rainer; Kern, Sylvia; Bauer, Jürgen; Schwenk, Michael

    2017-01-01

    Post-ward geriatric rehabilitation programs have hardly been developed and validated, which leaves a substantial gap in rehabilitative care in older adults and hinders full exploitation of maintained, but often unrecognized rehabilitation potentials. Geriatric rehabilitation patients with cognitive impairment represent a highly vulnerable population which is often affected by a lack of an ongoing support at the intersection between ward-based and post-ward rehabilitation. To determine the effect of a standardized home-based training program in geriatric patients with cognitive impairment following ward-based rehabilitation. A randomized controlled, single-blinded intervention trial (RCT) with wait list control design was used. Geriatric patients (n = 34; age: 81.9 ± 5.7 years) with cognitive impairment (MMSE: 18.8 ± 4.7), identified by predefined in- and exclusion criteria, were consecutively recruited from a geriatric rehab ward. Patients in the intervention group (IG, n = 17) performed a 6-week strength and functional home training. The control group (CG, n = 17) started an identical training 6 weeks later with an initial usual care period during the intervention for the IG. Functional performance (Short Physical Performance Battery; SPPB), clinically relevant functional deficits (Performance Oriented Assessment; POMA), and physical activity (Assessment of Physical Activity For Older Persons questionnaire; APAFOP) represented primary outcome measurements complemented by additional secondary outcome parameters. The IG significantly increased functional performances in SPPB (total score: p = 0.012; chair rise: p = 0.007, balance: p = 0.066), reduced gait and balance deficits in POMA (total score: p = 0.006; balance: p = 0.034; gait: p = 0.019), and increased physical activity (APAFOP; p = 0.05) compared to the CG. Effect sizes showed medium to large effects for significant parameters (eta2 = 0.14-0.45). Training benefits and adherence were more pronounced

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

    PubMed

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

    2018-03-01

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

  15. Randomized Trial to Reduce Air Particle Levels in Homes of Smokers and Children.

    PubMed

    Hughes, Suzanne C; Bellettiere, John; Nguyen, Benjamin; Liles, Sandy; Klepeis, Neil E; Quintana, Penelope J E; Berardi, Vincent; Obayashi, Saori; Bradley, Savannah; Hofstetter, C Richard; Hovell, Melbourne F

    2018-03-01

    Exposure to fine particulate matter in the home from sources such as smoking, cooking, and cleaning may put residents, especially children, at risk for detrimental health effects. A randomized clinical trial was conducted from 2011 to 2016 to determine whether real-time feedback in the home plus brief coaching of parents or guardians could reduce fine particle levels in homes with smokers and children. A randomized trial with two groups-intervention and control. A total of 298 participants from predominantly low-income households with an adult smoker and a child aged <14 years. Participants were recruited during 2012-2015 from multiple sources in San Diego, mainly Women, Infants and Children Program sites. The multicomponent intervention consisted of continuous lights and brief sound alerts based on fine particle levels in real time and four brief coaching sessions using particle level graphs and motivational interviewing techniques. Motivational interviewing coaching focused on particle reduction to protect children and other occupants from elevated particle levels, especially from tobacco-related sources. In-home air particle levels were measured by laser particle counters continuously in both study groups. The two outcomes were daily mean particle counts and percentage time with high particle concentrations (>15,000 particles/0.01 ft 3 ). Linear mixed models were used to analyze the differential change in the outcomes over time by group, during 2016-2017. Intervention homes had significantly larger reductions than controls in daily geometric mean particle concentrations (18.8% reduction vs 6.5% reduction, p<0.001). Intervention homes' average percentage time with high particle concentrations decreased 45.1% compared with a 4.2% increase among controls (difference between groups p<0.001). Real-time feedback for air particle levels and brief coaching can reduce fine particle levels in homes with smokers and young children. Results set the stage for refining

  16. Effects of Home Access to Active Videogames on Child Self-Esteem, Enjoyment of Physical Activity, and Anxiety Related to Electronic Games: Results from a Randomized Controlled Trial.

    PubMed

    Abbott, Rebecca A; Smith, Anne J; Howie, Erin K; Pollock, Clare; Straker, Leon

    2014-08-01

    Active-input videogames could provide a useful conduit for increasing physical activity by improving a child's self-confidence, physical activity enjoyment, and reducing anxiety. Therefore this study evaluated the impact of (a) the removal of home access to traditional electronic games or (b) their replacement with active-input videogames, on child self-perception, enjoyment of physical activity, and electronic game use anxiety. This was a crossover, randomized controlled trial, conducted over a 6-month period in participants' family homes in metropolitan Perth, Australia, from 2007 to 2010. Children 10-12 years old were recruited through school and community media. Of 210 children who were eligible, 74 met inclusion criteria, and 8 withdrew, leaving 66 children (33 girls) for analysis. A counterbalanced randomized order of three conditions sustained for 8 weeks each: No home access to electronic games, home access to traditional electronic games, and home access to active-input electronic games. Perception of self-esteem (Harter's Self Perception Profile for Children), enjoyment of physical activity (Physical Activity Enjoyment Scale questionnaire), and anxiety toward electronic game use (modified Loyd and Gressard Computer Anxiety Subscale) were assessed. Compared with home access to traditional electronic games, neither removal of all electronic games nor replacement with active-input games resulted in any significant change to child self-esteem, enjoyment of physical activity, or anxiety related to electronic games. Although active-input videogames have been shown to be enjoyable in the short term, their ability to impact on psychological outcomes is yet to be established.

  17. The psychosocial effects of a companion robot: a randomized controlled trial.

    PubMed

    Robinson, Hayley; Macdonald, Bruce; Kerse, Ngaire; Broadbent, Elizabeth

    2013-09-01

    To investigate the psychosocial effects of the companion robot, Paro, in a rest home/hospital setting in comparison to a control group. Randomized controlled trial. Residents were randomized to the robot intervention group or a control group that attended normal activities instead of Paro sessions. Sessions took place twice a week for an hour over 12 weeks. Over the trial period, observations were conducted of residents' social behavior when interacting as a group with the robot. As a comparison, observations were also conducted of all the residents during general activities when the resident dog was or was not present. A residential care facility in Auckland, New Zealand. Forty residents in hospital and rest home care. Residents completed a baseline measure assessing cognitive status, loneliness, depression, and quality of life. At follow-up, residents completed a questionnaire assessing loneliness, depression, and quality of life. During observations, behavior was noted and collated for instances of talking and stroking the dog/robot. In comparison with the control group, residents who interacted with the robot had significant decreases in loneliness over the period of the trial. Both the resident dog and the seal robot made an impact on the social environment in comparison to when neither was present. Residents talked to and touched the robot significantly more than the resident dog. A greater number of residents were involved in discussion about the robot in comparison with the resident dog and conversation about the robot occurred more. Paro is a positive addition to this environment and has benefits for older people in nursing home care. Paro may be able to address some of the unmet needs of older people that a resident animal may not, particularly relating to loneliness. Copyright © 2013 American Medical Directors Association, Inc. Published by Elsevier Inc. All rights reserved.

  18. Formal Physical Therapy After Total Hip Arthroplasty Is Not Required: A Randomized Controlled Trial.

    PubMed

    Austin, Matthew S; Urbani, Brian T; Fleischman, Andrew N; Fernando, Navin D; Purtill, James J; Hozack, William J; Parvizi, Javad; Rothman, Richard H

    2017-04-19

    The value of formal physical therapy after total hip arthroplasty is unknown. With substantial changes that have occurred in surgical and anesthesia techniques, self-directed therapy may be efficacious in restoring function to patients undergoing total hip arthroplasty. We conducted a single-center, randomized trial of 120 patients undergoing primary, unilateral total hip arthroplasty who were eligible for direct home discharge. The experimental group followed a self-directed home exercise program for 10 weeks. The control group received the standard protocol for physical therapy that included in-home visits with a physical therapist for the first 2 weeks followed by formal outpatient physical therapy for 8 weeks. Functional outcomes were measured using validated instruments including the Harris hip score (HHS), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the Short Form-36 Health Survey (SF-36) preoperatively, at 1 month postoperatively, and at 6 to 12 months postoperatively. Of 120 randomized patients, 108 were included in the final analysis. Ten patients (19%) were randomized to unsupervised home exercise and 20 patients (37%) were randomized to formal outpatient therapy crossed over between groups. There was no significant difference in any of the measured functional outcomes between patients receiving formal therapy (n = 54) and those participating in unsupervised home exercise (n = 54) at any time point (HHS, p = 0.82; WOMAC, p = 0.80; and SF-36 physical health, p = 0.90). This randomized trial suggests that unsupervised home exercise is both safe and efficacious for a majority of patients undergoing total hip arthroplasty, and formal physical therapy may not be required. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

  19. Effectiveness of a home-based cognitive behavioral program to manage concerns about falls in community-dwelling, frail older people: results of a randomized controlled trial.

    PubMed

    Dorresteijn, Tanja A C; Zijlstra, G A Rixt; Ambergen, Antonius W; Delbaere, Kim; Vlaeyen, Johan W S; Kempen, Gertrudis I J M

    2016-01-06

    Concerns about falls are common among older people. These concerns, also referred to as fear of falling, can have serious physical and psychosocial consequences, such as functional decline, increased risk of falls, activity restriction, and lower social participation. Although cognitive behavioral group programs to reduce concerns about falls are available, no home-based approaches for older people with health problems, who may not be able to attend such group programs are available yet. The aim of this study was to assess the effectiveness of a home-based cognitive behavioral program on concerns about falls, in frail, older people living in the community. In a randomized controlled trial in the Netherlands, 389 people aged 70 years and older, in fair or poor perceived health, who reported at least some concerns about falls and related activity avoidance were allocated to a control (n = 195) or intervention group (n = 194). The intervention was a home-based, cognitive behavioral program consisting of seven sessions including three home visits and four telephone contacts. The program aims to instill adaptive and realistic views about fall risks via cognitive restructuring and to increase activity and safe behavior using goal setting and action planning and was facilitated by community nurses. Control group participants received usual care. Outcomes at 5 and 12 months follow-up were concerns about falls, activity avoidance due to concerns about falls, disability and falls. At 12 months, the intervention group showed significant lower levels of concerns about falls compared to the control group. Furthermore, significant reductions in activity avoidance, disability and indoor falls were identified in the intervention group compared with the control group. Effect sizes were small to medium. No significant difference in total number of falls was noted between the groups. The home-based, cognitive behavioral program significantly reduces concerns about falls

  20. A multicenter randomized controlled evaluation of automated home monitoring and telephonic disease management in patients recently hospitalized for congestive heart failure: the SPAN-CHF II trial.

    PubMed

    Weintraub, Andrew; Gregory, Douglas; Patel, Ayan R; Levine, Daniel; Venesy, David; Perry, Kathleen; Delano, Christine; Konstam, Marvin A

    2010-04-01

    We performed a prospective, randomized investigation assessing the incremental effect of automated health monitoring (AHM) technology over and above that of a previously described nurse directed heart failure (HF) disease management program. The AHM system measured and transmitted body weight, blood pressure, and heart rate data as well as subjective patient self-assessments via a standard telephone line to a central server. A total of 188 consented and eligible patients were randomized between intervention and control groups in 1:1 ratio. Subjects randomized to the control arm received the Specialized Primary and Networked Care in Heart Failure (SPAN-CHF) heart failure disease management program. Subjects randomized to the intervention arm received the SPAN-CHF disease management program in conjunction with the AHM system. The primary end point was prespecified as the relative event rate of HF hospitalization between intervention and control groups at 90 days. The relative event rate of HF hospitalization for the intervention group compared with controls was 0.50 (95%CI [0.25-0.99], P = .05). Short-term reductions in the heart failure hospitalization rate were associated with the use of automated home monitoring equipment. Long-term benefits in this model remain to be studied. (c) 2010 Elsevier Inc. All rights reserved.

  1. Night glucose control with MD-Logic artificial pancreas in home setting: a single blind, randomized crossover trial-interim analysis.

    PubMed

    Nimri, Revital; Muller, Ido; Atlas, Eran; Miller, Shahar; Kordonouri, Olga; Bratina, Natasa; Tsioli, Christiana; Stefanija, Magdalena A; Danne, Thomas; Battelino, Tadej; Phillip, Moshe

    2014-03-01

    Artificial pancreas (AP) systems have shown an improvement in glucose control and a reduced risk of nocturnal hypoglycemia under controlled conditions but remain to be evaluated under daily-life conditions. To assess the feasibility, safety, and efficacy of the MD-Logic AP in controlling nocturnal glucose levels in the patient's home. Two-arm study, each covering four consecutive nights comparing the MD-Logic AP ('closed-loop' arm) with sensor-augmented pump therapy ('control' arm). Fifteen patients (mean age 19 ± 10.4 yr, A1c 7.5 ± 0.5% or 58 ± 5.9 mmol/mol, diabetes duration 9.9 ± 8.2 yr) were randomly assigned either to 'Group A' (first 'closed-loop', then 'control' arm) or to 'Group B' (vice versa). Investigators were masked to treatment intervention. Primary endpoints were the time spent with glucose levels below 70 mg/dL and the percentage of nights in which the mean overnight glucose levels were within 90-140 mg/dL. Endpoint analyses were based on unmodified sensor glucose readings of the four study nights. Time of glucose levels spent below 70 mg/dL was significantly shorter on the closed-loop nights than on control nights, median and interquartile range 3.8 (0, 11.6) and 48.7 (0.6, 67.9) min, respectively; p = 0.0034. The percentage of individual nights in which mean overnight glucose level was within 90-140 mg/dL was 67 (33, 88), and 50 (25, 75), under closed-loop and control nights, respectively, with no statistical difference. Secondary endpoint analyses demonstrated significant improvements in hypoglycemia parameters. No serious adverse events were reported. This interim analysis demonstrates the feasibility, safety, and efficiency of the MD-Logic AP system in home use, and demonstrates an improvement over sensor-augmented pump therapy. (ClinicalTrials.gov identifier NCT01726829). © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  2. Need-based intervention is an effective strategy for improving the nutritional status of older people living in a nursing home: a randomized controlled trial.

    PubMed

    Lee, Li-Chin; Tsai, Alan C; Wang, Jiun-Yi; Hurng, Baai-Shyun; Hsu, Hui-Chuan; Tsai, Hsin-Jen

    2013-12-01

    Nutrition is a key element in geriatric health. Protein-energy malnutrition is common in institutionalized persons. This study examined the effectiveness of a need-based "routine screening and timely intervention" strategy in improving the nutritional status of persons living in nursing homes. A 24-week randomized, double-blind, controlled trial. A privately managed geriatric nursing home in Taiwan. Ninety-two ≥65-year old persons who were ≤25kg/m(2), >1 month residence, able to self-feed or receive oral feeding, without acute infection and non-bed-ridden. Prospective participants were stratified by gender and then randomly assigned to either the control group (n=45) or the intervention group (n=47). Each subject in the intervention group was given a 50g/day soy-protein-based nutritional supplement if he/she was rated as undernourished according to the Mini Nutritional Assessment (MNA, score ≤24) and BMI ≤24kg/m(2). The supplement contained 9.5g protein, 250kcal energy and all essential micro-nutrients. The supplementation would be suspended once either one of the "at risk" condition was corrected. Nutritional rating with the MNA took place at baseline and every 4 weeks during the trial. Biochemical indicators were measured at baseline, mid-point (week-12) and end-point (week-24). Results were analyzed with the two-sample t-test, and the generalized estimating equations (GEE) controlled for demographic and health-related variables. Of the 92 subjects, 82 completed the trial; 7 withdrew and 3 died during the trial. Results showed that the need-based intervention was an effective and appropriate strategy for improving the nutritional status of persons at risk of undernourishment. The intervention significantly improved body weight, BMI, mid-arm circumference, calf circumference, and serum albumin and cholesterol concentrations at all intervals (all p<0.05). However, the intervention did not significantly improve hematocrit, hemoglobin or lymphocyte count

  3. The Seattle–King County Healthy Homes II Project: A Randomized Controlled Trial of Asthma Self-management Support Comparing Clinic-Based Nurses and In-Home Community Health Workers

    PubMed Central

    Krieger, James; Takaro, Tim K.; Song, Lin; Beaudet, Nancy; Edwards, Kristine

    2009-01-01

    Objective To compare the marginal benefit of in-home asthma self-management support provided by community health workers (CHWs) with standard asthma education from clinic-based nurses. Design Randomized controlled trial. Setting Community and public health clinics and homes. Participants Three hundred nine children aged 3 to 13 years with asthma living in low-income households. Interventions All participants received nurse-provided asthma education and referrals to community resources. Some participants also received CHW-provided home environmental assessments, asthma education, social support, and asthma-control resources. Outcome Measures Asthma symptom–free days, Pediatric Asthma Caretaker Quality of Life Scale score, and use of urgent health services. Results Both groups showed significant increases in caretaker quality of life (nurse-only group: 0.4 points; 95% confidence interval [CI], 0.3–0.6; nurse + CHW group: 0.6 points; 95% CI, 0.4–0.8) and number of symptom-free days (nurse only: 1.3 days; 95% CI, 0.5–2.1; nurse + CHW: 1.9 days; 95% CI, 1.1–2.8), and absolute decreases in the proportion of children who used urgent health services in the prior 3 months (nurse only: 17.6%; 95% CI, 8.1%–27.2%; nurse + CHW: 23.1%; 95% CI, 13.6%–32.6%). Quality of life improved by 0.22 more points in the nurse + CHW group (95% CI, 0.00–0.44; P=.049). The number of symptom-free days increased by 0.94 days per 2 weeks (95% CI, 0.02–1.86; P = .046), or 24.4 days per year, in the nurse + CHW group. While use of urgent health services decreased more in the nurse + CHW group, the difference between groups was not significant. Conclusion The addition of CHW home visits to clinic-based asthma education yielded a clinically important increase in symptom-free days and a modest improvement in caretaker quality of life. PMID:19188646

  4. A randomized controlled trial of a community-based dementia care coordination intervention: effects of MIND at Home on caregiver outcomes.

    PubMed

    Tanner, Jeremy A; Black, Betty S; Johnston, Deirdre; Hess, Edward; Leoutsakos, Jeannie-Marie; Gitlin, Laura N; Rabins, Peter V; Lyketsos, Constantine G; Samus, Quincy M

    2015-04-01

    To assess whether MIND at Home, a community-based, multicomponent, care coordination intervention, reduces unmet caregiving needs and burden in informal caregivers of persons with memory disorders. An 18-month randomized controlled trial of 289 community-living care recipient (CR)-caregiver (informal caregivers, i.e., unpaid individuals who regularly assisted the CR) dyads from 28 postal code areas of Baltimore, Maryland was conducted. All dyads and the CR's primary care physician received the written needs assessment results and intervention recommendations. Intervention dyads then received an 18-month care coordination intervention delivered by nonclinical community workers to address unmet care needs through individualized care planning, referral and linkage to dementia services, provision of caregiver dementia education and skill-building strategies, and care progress monitoring by an interdisciplinary team. Primary outcome was total percent of unmet caregiver needs at 18 months. Secondary outcomes included objective and subjective caregiver burden measures, quality of life (QOL), and depression. Total percent of unmet caregiver needs declined in both groups from baseline to 18 months, with no statistically significant between-group difference. No significant group differences occurred in most caregiver burden measures, depression, or QOL. There was a potentially clinically relevant reduction in self-reported number of hours caregivers spent with the CR for MIND participants compared with control subjects. No statistically significant impacts on caregiver outcomes were found after multiple comparison adjustments. However, MIND at Home appeared to have had a modest and clinically meaningful impact on informal caregiver time spent with CRs. Copyright © 2015 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights reserved.

  5. Mediating Parent Learning to Promote Social Communication for Toddlers with Autism: Effects from a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Schertz, Hannah H.; Odom, Samuel L.; Baggett, Kathleen M.; Sideris, John H.

    2018-01-01

    A randomized controlled trial was conducted to evaluate effects of the Joint Attention Mediated Learning (JAML) intervention. Toddlers with autism spectrum disorders (ASD) aged 16-30 months (n = 144) were randomized to intervention and community control conditions. Parents, who participated in 32 weekly home-based sessions, followed a mediated…

  6. The IVAIRE project--a randomized controlled study of the impact of ventilation on indoor air quality and the respiratory symptoms of asthmatic children in single family homes.

    PubMed

    Lajoie, P; Aubin, D; Gingras, V; Daigneault, P; Ducharme, F; Gauvin, D; Fugler, D; Leclerc, J-M; Won, D; Courteau, M; Gingras, S; Héroux, M-È; Yang, W; Schleibinger, H

    2015-12-01

    A randomized controlled trial was carried out to measure the impact of an intervention on ventilation, indoor air contaminants, and asthma symptoms of children. Eighty-three asthmatic children living in low-ventilated homes were followed over 2 years. Several environmental parameters were measured during the summer, fall, and winter. The children were randomized after Year 1 (43 Intervention; 40 Control). The intervention included the installation of either a Heat Recovery Ventilator (HRV) or Energy Recovery Ventilator (ERV). During the fall and winter seasons, there was a significant increase in the mean ventilation rate in the homes of the intervention group. A statistically significant reduction in mean formaldehyde, airborne mold spores, toluene, styrene, limonene, and α-pinene concentrations was observed in the intervention group. There was no significant group difference in change in the number of days with symptoms per 14 days. However, there was a significant decrease in the proportion of children who experienced any wheezing (≥1 episode) and those with ≥4 episodes in the 12-month period in the intervention group. This study indicates that improved ventilation reduces air contaminants and may prevent wheezing. Due to lack of power, a bigger study is needed. Positive findings from this study include the fact that, upon recruitment, most of the single family homes with asthmatic children were already equipped with a mechanical ventilation system and had relatively good indoor air quality. However, the 8-h indoor guideline for formaldehyde (50 μg/m3) was frequently exceeded and the ventilation rates were low in most of the homes, even those with a ventilation system. Both ERVs and HRVs were equally effective at increasing air exchange rates above 0.30 ACH and at preventing formaldehyde concentrations from exceeding the 50 μg/m3 guideline during the fall and winter seasons. Furthermore, the ERVs were effective at preventing excessively low relative

  7. First outline and baseline data of a randomized, controlled multicenter trial to evaluate the health economic impact of home telemonitoring in chronic heart failure - CardioBBEAT.

    PubMed

    Hofmann, Reiner; Völler, Heinz; Nagels, Klaus; Bindl, Dominik; Vettorazzi, Eik; Dittmar, Ronny; Wohlgemuth, Walter; Neumann, Till; Störk, Stefan; Bruder, Oliver; Wegscheider, Karl; Nagel, Eckhard; Fleck, Eckart

    2015-08-11

    Evidence that home telemonitoring for patients with chronic heart failure (CHF) offers clinical benefit over usual care is controversial as is evidence of a health economic advantage. Between January 2010 and June 2013, patients with a confirmed diagnosis of CHF were enrolled and randomly assigned to 2 study groups comprising usual care with and without an interactive bi-directional remote monitoring system (Motiva®). The primary endpoint in CardioBBEAT is the Incremental Cost-Effectiveness Ratio (ICER) established by the groups' difference in total cost and in the combined clinical endpoint "days alive and not in hospital nor inpatient care per potential days in study" within the follow-up of 12 months. A total of 621 predominantly male patients were enrolled, whereof 302 patients were assigned to the intervention group and 319 to the control group. Ischemic cardiomyopathy was the leading cause of heart failure. Despite randomization, subjects of the control group were more often in NYHA functional class III-IV, and exhibited peripheral edema and renal dysfunction more often. Additionally, the control and intervention groups differed in heart rhythm disorders. No differences existed regarding risk factor profile, comorbidities, echocardiographic parameters, especially left ventricular and diastolic diameter and ejection fraction, as well as functional test results, medication and quality of life. While the observed baseline differences may well be a play of chance, they are of clinical relevance. Therefore, the statistical analysis plan was extended to include adjusted analyses with respect to the baseline imbalances. CardioBBEAT provides prospective outcome data on both, clinical and health economic impact of home telemonitoring in CHF. The study differs by the use of a high evidence level randomized controlled trial (RCT) design along with actual cost data obtained from health insurance companies. Its results are conducive to informed political and economic

  8. Enhancing the parent-child relationship: a Hong Kong community-based randomized controlled trial.

    PubMed

    Fabrizio, Cecilia S; Stewart, Sunita M; Ip, Alison K Y; Lam, Tai Hing

    2014-02-01

    Adolescence is a critical risk period for negative academic and behavioral outcomes, but a strong parent-child relationship can be a powerful protective factor. Our previous pilot of an academic-community agency collaborative randomized controlled trial (RCT) demonstrated initial evidence of benefit for a parenting intervention with preadolescents in Hong Kong. The present RCT assessed the effect of brief training in positive discipline parenting skills on parental satisfaction with the parent-child relationship. A community sample of 461 Hong Kong Chinese parents of children aged 10-13 years were randomized to (a) the Harmony@Home intervention, (b) an attention control, or (c) a third active intervention that shared the control group. Participants were followed for 12 months and multiple methods of assessment were used. Compared with the control group, the Harmony@Home group reported an increase in the primary outcome of satisfaction with the parent-child relationship at 3 months' postintervention. Although results are mixed, this study demonstrates how a culturally adaptive community intervention can improve the parental behaviors that serve as protective factors against negative academic and behavioral outcomes for Chinese adolescents.

  9. Follow-up home visits with registered dietitians have a positive effect on the functional and nutritional status of geriatric medical patients after discharge: a randomized controlled trial.

    PubMed

    Beck, Anne Marie; Kjær, Stine; Hansen, Birthe Stenbæk; Storm, Rikke Lunau; Thal-Jantzen, Kirsten; Bitz, Christian

    2013-06-01

    To assess the additional benefits of individualized nutritional counselling by a registered dietitian in geriatric patients' home after discharge from hospital, in relation to risk of re-admissions, functional status, nutritional status, use of social services and mortality. Twelve-week single-blind randomized controlled study. Geriatric medical patients (65+ years) at nutritional risk. Participants were randomly allocated to receive a visit in their homes, either three individualized nutritional counselling by a registered dietitian complemented with three follow-up visits by general practitioners or three follow-up visits by general practitioners alone. Primary outcome was risk of re-admissions. Secondary outcomes were functional status (hand grip strength, chair stand, mobility, disability and tiredness in daily activities, rehabilitation capacity), nutritional status (weight, BMI, energy and protein intake), need of social services (home care, home nursing, meals-on-wheels) and mortality. One hundred and fifty-two patients were included; 132 (87%) completed the first and 124 (82%) the second data collection after 12 weeks. Ten per cent of the participants had three contacts with their general practitioner, while compliance with the dietetic intervention was almost 100%. Odds ratio for re-admission and mortality after 26 weeks was 1.62 (95% confidence interval (CI) 0.85 to 3.10) and 0.60 (95% CI 0.17 to 2.13). The intervention had a positive effect on functional status (i.e. mobility, P = 0.029), and nutritional status (i.e. weight, P = 0.035; energy intake, P < 0.001; protein intake, P = 0.001) and the use of meals-on wheels was reduced (P = 0.084). Follow-up home visits with registered dietitians have a positive effect on the functional and nutritional status of geriatric medical patients after discharge.

  10. Effect of workplace- versus home-based physical exercise on pain in healthcare workers: study protocol for a single blinded cluster randomized controlled trial

    PubMed Central

    2014-01-01

    Background The prevalence and consequences of musculoskeletal pain is considerable among healthcare workers, allegedly due to high physical work demands of healthcare work. Previous investigations have shown promising results of physical exercise for relieving pain among different occupational groups, but the question remains whether such physical exercise should be performed at the workplace or conducted as home-based exercise. Performing physical exercise at the workplace together with colleagues may be more motivating for some employees and thus increase adherence. On the other hand, physical exercise performed during working hours at the workplace may be costly for the employers in terms of time spend. Thus, it seems relevant to compare the efficacy of workplace- versus home-based training on musculoskeletal pain. This study is intended to investigate the effect of workplace-based versus home-based physical exercise on musculoskeletal pain among healthcare workers. Methods/Design This study was designed as a cluster randomized controlled trial performed at 3 hospitals in Copenhagen, Denmark. Clusters are hospital departments and hospital units. Cluster randomization was chosen to increase adherence and avoid contamination between interventions. Two hundred healthcare workers from 18 departments located at three different hospitals is allocated to 10 weeks of 1) workplace based physical exercise performed during working hours (using kettlebells, elastic bands and exercise balls) for 5 × 10 minutes per week and up to 5 group-based coaching sessions, or 2) home based physical exercise performed during leisure time (using elastic bands and body weight exercises) for 5 × 10 minutes per week. Both intervention groups will also receive ergonomic instructions on patient handling and use of lifting aides etc. Inclusion criteria are female healthcare workers working at a hospital. Average pain intensity (VAS scale 0-10) of the back, neck and shoulder

  11. Effects of an Updated Preventive Home Visit Program Based on a Systematic Structured Assessment of Care Needs for Ambulatory Frail Older Adults in Japan: A Randomized Controlled Trial.

    PubMed

    Kono, Ayumi; Izumi, Kyoko; Yoshiyuki, Noriko; Kanaya, Yukiko; Rubenstein, Laurence Z

    2016-12-01

    The aim of this randomized controlled trial was to determine the effects on functional parameters of an updated preventive home visit program for frail older adults in the Japanese Long-term Care Insurance (LTCI) system. The program included home visits by nurses or care managers every 3 months for 24 months, with a systematic assessment of care needs to prevent functional decline. Eligible participants (N = 360) were randomly assigned to the visit (VG: n = 179) or control group (CG: n = 181). Functional parameters were gathered via mail questionnaires at baseline and at 12- and 24-month follow-ups. Care-need levels in the LTCI were obtained at 12-, 24-, and 36-month follow-ups and the utilization of the LTCI service through 36 months. Participants in VG were significantly more likely to maintain their activities of daily living (ADL) functioning (p = .0113) and less likely to increase care-needs level, compared with CG participants, over 24 months. A generalized linear model showed that the estimate of the effect on increase in care-needs level (ie, functional decline) was -0.53 (p = .042) over 36 months. These results suggest that the updated preventive home visit program could be effective for the prevention of ADL and care-needs deterioration, and these effects could continue up to 1 year after program completion. © The Author 2016. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  12. Effects of home-based play-assisted stimulation on developmental performances of children living in extreme poverty: a randomized single-blind controlled trial.

    PubMed

    Worku, Berhanu Nigussie; Abessa, Teklu Gemechu; Wondafrash, Mekitie; Lemmens, Johan; Valy, Jan; Bruckers, Liesbeth; Kolsteren, Patrick; Granitzer, Marita

    2018-02-05

    Children living with foster families in a resource-limited setting such as Ethiopia are at risk of developmental problems. It is not yet clear whether intensive home-based developmental stimulation assisted by play can reduce these problems. The main objective of this study was to examine the effects of play-assisted intervention integrated into basic services on the developmental performance of children living with foster families in extreme poverty. A randomized single-blind (investigator) controlled trial design was used. The study was conducted in Jimma, South West Ethiopia. Using computer-generated codes, eligible children of 3-59 months in age were randomly allocated to intervention (n = 39) and control (n = 39) groups at a 1:1 ratio. Children in the intervention group received home-based play-assisted stimulation in addition to the basic services provided to children in both groups. The intervention consisted of an hour of play stimulation conducted during a weekly home visit over the course of six months. Personal-social, language, fine and gross motor outcomes were assessed using Denver II-Jimma, and social-emotional outcome was obtained using an adapted Ages and Stages Questionnaire: Social-Emotional (ASQ: SE). Information about sociodemographic characteristics was collected using a structured questionnaire. Anthropometric methods were used to determine nutritional status. The effects of the intervention on the abovementioned outcomes over the study period and group differences in change over time were examined using Generalized Estimating Equations (GEE). Statistically significant intervention effects were found for language (P = 0.0014), personal-social (P = 0.0087) and social-emotional (P <  0.0001) performances. At the midline of the study, language (effect size = 0.34) and social-emotional (effect size = - 0.603) benefits from the play-assisted stimulation had already been observed for the children in the intervention

  13. Effects of a mobility monitoring system on the cost of care in relation to reimbursement at Swiss nursing homes: learnings from a randomized controlled trial.

    PubMed

    Stark, Mario; Tietz, Rigo; Gattinger, Heidrun; Hantikainen, Virpi; Ott, Stefan

    2017-12-01

    Nursing homes in Switzerland are under pressure to efficiently coordinate staff activities to cover their personnel costs under the care financing system. In this study, the use of a mobility monitoring system accompanied with case conferences was investigated in order to improve sleep quality and estimate the cost benefit of this intervention. In an open two-phase randomized controlled trial at three nursing homes, residents with cognitive impairment were randomly assigned to an intervention group and a control group. In the intervention group, a 10-week period of intensive use of the monitoring system and case conferences led by an advanced nurse practitioner (Phase I) was followed by 3 months of reduced use of the monitoring system and case conferences led by an internal registered nurse (Phase II). In the control group, the monitoring system was only used for data acquisition. Nurses reported the activities with a specifically developed tool. Based on the recorded activities, the cost of care was calculated. The correlating reimbursement per patient was calculated from the care levels in the Swiss reimbursement system. Data from 44 residents was included in the analysis with a linear mixed model. Although analysis revealed no statistically significant effects, results indicate that the use of a monitoring system can guide nurses in organizing their tasks to increase effectiveness. Information systems such as the mobility monitor can help to identify single outliers that do not correspond with the overall situation. In the health care system, problematic individual cases can account for a disproportionally high cost levels. It was shown that information systems can have a significant economic impact in the long run. The study is registered at the German Clinical Trials Register under the Nr. DRKS00006829 .

  14. Effect of a Home-Based Exercise Program on Functional Recovery Following Rehabilitation After Hip Fracture A Randomized Clinical Trial

    PubMed Central

    Latham, Nancy K.; Harris, Bette Ann; Bean, Jonathan F.; Heeren, Timothy; Goodyear, Christine; Zawacki, Stacey; Heislein, Diane M.; Mustafa, Jabed; Pardasaney, Poonam; Giorgetti, Marie; Holt, Nicole; Goehring, Lori; Jette, Alan M.

    2015-01-01

    IMPORTANCE For many older people, long-term functional limitations persist after a hip fracture. The efficacy of a home exercise program with minimal supervision after formal hip fracture rehabilitation ends has not been established. OBJECTIVE To determine whether a home exercise program with minimal contact with a physical therapist improved function after formal hip fracture rehabilitation ended. DESIGN, SETTING, AND PARTICIPANTS Randomized clinical trial conducted from September 2008 to October 2012 in the homes of 232 functionally limited older adults who had completed traditional rehabilitation after a hip fracture. INTERVENTIONS The intervention group (n = 120) received functionally oriented exercises (such as standing from a chair, climbing a step) taught by a physical therapist and performed independently by the participants in their homes for 6 months. The attention control group (n = 112) received in-home and telephone-based cardiovascular nutrition education. MAIN OUTCOMES AND MEASURES Physical function assessed at baseline, 6 months (ie, at completion of the intervention), and 9 months by blinded assessors. The primary outcome was change in function at 6 months measured by the Short Physical Performance Battery (SPPB; range 0-12, higher score indicates better function) and the Activity Measure for Post-Acute Care (AM-PAC) mobility and daily activity (range, 23-85 and 9-101, higher score indicates better function). RESULTS Among the 232 randomized patients, 195 were followed up at 6 months and included in the primary analysis. The intervention group (n=100) showed significant improvement relative to the control group (n=95) in functional mobility (mean SPPB scores for intervention group: 6.2 [SD, 2.7] at baseline, 7.2 [SD, 3] at 6 months; control group: 6.0 [SD, 2.8] at baseline, 6.2 [SD, 3] at 6 months; and between-group differences: 0.8 [95% CI, 0.4 to 1.2], P < .001; mean AM-PAC mobility scores for intervention group: 56.2 [SD, 7.3] at baseline, 58

  15. Effect of a home-based exercise program on functional recovery following rehabilitation after hip fracture: a randomized clinical trial.

    PubMed

    Latham, Nancy K; Harris, Bette Ann; Bean, Jonathan F; Heeren, Timothy; Goodyear, Christine; Zawacki, Stacey; Heislein, Diane M; Mustafa, Jabed; Pardasaney, Poonam; Giorgetti, Marie; Holt, Nicole; Goehring, Lori; Jette, Alan M

    2014-02-19

    For many older people, long-term functional limitations persist after a hip fracture. The efficacy of a home exercise program with minimal supervision after formal hip fracture rehabilitation ends has not been established. To determine whether a home exercise program with minimal contact with a physical therapist improved function after formal hip fracture rehabilitation ended. Randomized clinical trial conducted from September 2008 to October 2012 in the homes of 232 functionally limited older adults who had completed traditional rehabilitation after a hip fracture. The intervention group (n = 120) received functionally oriented exercises (such as standing from a chair, climbing a step) taught by a physical therapist and performed independently by the participants in their homes for 6 months. The attention control group (n = 112) received in-home and telephone-based cardiovascular nutrition education. Physical function assessed at baseline, 6 months (ie, at completion of the intervention), and 9 months by blinded assessors. The primary outcome was change in function at 6 months measured by the Short Physical Performance Battery (SPPB; range 0-12, higher score indicates better function) and the Activity Measure for Post-Acute Care (AM-PAC) mobility and daily activity (range, 23-85 and 9-101, higher score indicates better function). Among the 232 randomized patients, 195 were followed up at 6 months and included in the primary analysis. The intervention group (n=100) showed significant improvement relative to the control group (n=95) in functional mobility (mean SPPB scores for intervention group: 6.2 [SD, 2.7] at baseline, 7.2 [SD, 3] at 6 months; control group: 6.0 [SD, 2.8] at baseline, 6.2 [SD, 3] at 6 months; and between-group differences: 0.8 [95% CI, 0.4 to 1.2], P < .001; mean AM-PAC mobility scores for intervention group: 56.2 [SD, 7.3] at baseline, 58.1 [SD, 7.9] at 6 months; control group: 56 [SD, 7.1] at baseline, 56.6 [SD, 8.1] at 6 months

  16. Long-term effects of a 12 weeks high-intensity functional exercise program on physical function and mental health in nursing home residents with dementia: a single blinded randomized controlled trial.

    PubMed

    Telenius, Elisabeth Wiken; Engedal, Knut; Bergland, Astrid

    2015-12-03

    Research indicates that exercise can have a positive effect on both physical and mental health in nursing home patients with dementia, however the lasting effect is rarely studied. In a previously published article we investigated the immediate effect of a 12 weeks functional exercise program on physical function and mental health in nursing home residents with dementia. In this paper we studied the long-term effect of this exercise program. We explored the differences between the exercise and control group from baseline to 6 months follow-up and during the detraining period from month 3 to 6. A single blind, randomized controlled trial was conducted and a total of 170 nursing home residents with dementia were included. The participants were randomly allocated to an intervention (n = 87) or a control group (n = 83). The intervention consisted of intensive strengthening and balance exercises in small groups twice a week for 12 weeks. The control condition was leisure activities. Thirty participants were lost between baseline and six-month follow-up. Linear mixed model analyses for repeated measurements were used to investigate the effect of exercise after detraining period. The exercise group improved their scores on Berg Balance Scale from baseline to 6 months follow-up by 2.7 points in average. The control group deteriorated in the same period and the difference between groups was statistically significant (p = 0.031). The exercise group also scored better on NPI agitation sub-score after 6 months (p = 0.045). The results demonstrate long-time positive effects of a high intensity functional exercise program on balance and indicate a positive effect on agitation, after an intervention period of 12 weeks followed by a detraining period of 12 weeks. Identifier at ClinicalTrials.gov: NCT02262104.

  17. Exercise or Social Intervention for Nursing Home Residents with Dementia: A Pilot Randomized, Controlled Trial.

    PubMed

    de Souto Barreto, Philipe; Cesari, Matteo; Denormandie, Philippe; Armaingaud, Didier; Vellas, Bruno; Rolland, Yves

    2017-09-01

    To compare the effects of exercise with those of a structured nonphysical intervention on ability to perform activities of daily living (ADLs) and physical and cognitive function of persons with dementia (PWDs) living in nursing homes (NH). Cluster-randomized pilot-controlled trial. Seven French NHs. PWDs living in NHs. NHs were randomized to an exercise group (4 NHs, n = 47) or structured social activity group (3 NHs, n = 50) for a 24-week intervention performed twice per week for 60 minutes per session. The main endpoint was ADL performance (Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory for Severe Alzheimer's Disease Scale (ADCS-ADL-sev); range 0-54, higher is better); secondary endpoints were overall cognitive function (Mini-Mental State Examination (MMSE)) and performance-based tests of physical function (Short Physical Performance Battery (SPPB), usual gait speed). Ninety-one participants with at least one postbaseline ADL assessment were included in efficacy analysis. Groups differed at baseline in terms of sex, neuropsychiatric symptoms, and nutritional status. Multilevel analysis adjusted for baseline differences between groups found no significant difference between effects of exercise and social activity (group-by-time interaction), with adjusted mean differences at 6 months of 1.9 points for ADCS-ADL-sev and 0.55 points for MMSE favoring social activity and 0.6 points for SPPB and 0.05 m/s favoring exercise. Adverse events did not differ between groups, except that the social activity group had more falls than the exercise group. A larger, longer trial is required to determine whether exercise has greater health benefits than nonphysical interventions for institutionalized PWDs. © 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics Society.

  18. Impact of a short home-based yoga programme on blood pressure in patients with hypertension: a randomized controlled trial in primary care.

    PubMed

    Wolff, M; Rogers, K; Erdal, B; Chalmers, J P; Sundquist, K; Midlöv, P

    2016-10-01

    The present study was designed to evaluate yoga's impact on blood pressure (BP) and quality of life (QOL) and on stress, depression and anxiety in patients with hypertension in a primary care setting. We conducted a multi-centre randomized controlled trial with follow-up after 12-week intervention completion. Adult primary care patients diagnosed with hypertension were randomly allocated to yoga or usual care. The intervention group performed a short home-based Kundalini yoga programme 15 min twice-daily during the 12-week intervention period. At baseline and follow-up, the participants underwent standardized BP measurements and completed questionnaires on QOL, stress, anxiety and depression. Data obtained from 191 patients (mean age 64.7 years, s.d. 8.4) allocated to yoga intervention (n=96) and control group (n=95), with a total proportion of 52% women, showed a significant reduction in systolic and diastolic BP for both groups (-3.8/-1.7 mm Hg for yoga and -4.5/-3.0 mm Hg for control groups, respectively). However, the BP reduction for the yoga group was not significantly different from control. There were small but significant improvements for the yoga group in some of the QOL and depression measures (P<0.05, Hospital Anxiety and Depression scale, HADS-D) compared with control. The findings of our study, which is the largest study from an OECD country (Organization for Economic Co-operation and Development) to date, do not support the suggestion from previous smaller studies that yoga lowers the BP. Further clinical trials are needed to confirm these findings. However, the yoga patients had other health benefits.

  19. The cost-effectiveness of a new disease management model for frail elderly living in homes for the elderly, design of a cluster randomized controlled clinical trial.

    PubMed

    Boorsma, Marijke; van Hout, Hein P J; Frijters, Dinnus H; Ribbe, Miel W; Nijpels, Giel

    2008-07-07

    The objective of this article is to describe the design of a study to evaluate the clinical and economic effects of a Disease Management model on functional health, quality of care and quality of life of persons living in homes for the elderly. This study concerns a cluster randomized controlled clinical trial among five intervention homes and five usual care homes in the North-West of the Netherlands with a total of over 500 residents. All persons who are not terminally ill, are able to be interviewed and sign informed consent are included. For cognitively impaired persons family proxies will be approached to provide outcome information. The Disease Management Model consists of several elements: (1) Trained staff carries out a multidimensional assessment of the patients functional health and care needs with the interRAI Long Term Care Facilities instrument (LTCF). Computerization of the LTCF produces immediate identification of problem areas and thereby guides individualized care planning. (2) The assessment outcomes are discussed in a Multidisciplinary Meeting (MM) with the nurse, primary care physician, nursing home physician and Psychotherapist and if necessary other members of the care team. The MM presents individualized care plans to manage or treat modifiable disabilities and risk factors. (3) Consultation by an nursing home physician and psychotherapist is offered to the frailest residents at risk for nursing home admission (according to the interRAI LTCF). Outcome measures are Quality of Care indicators (LTCF based), Quality Adjusted Life Years (Euroqol), Functional health (SF12, COOP-WONCA), Disability (GARS), Patients care satisfaction (QUOTE), hospital and nursing home days and mortality, health care utilization and costs. This design is unique because no earlier studies were performed to evaluate the effects and costs of this Disease Management Model for disabled persons in homes for the elderly on functional health and quality of care. TRAIL

  20. Impact of a Home-Based Physical and Nutritional Intervention Program Conducted by Lay-Volunteers on Handgrip Strength in Prefrail and Frail Older Adults: A Randomized Control Trial.

    PubMed

    Haider, Sandra; Dorner, Thomas E; Luger, Eva; Kapan, Ali; Titze, Sylvia; Lackinger, Christian; Schindler, Karin E

    2017-01-01

    A randomized controlled trial was performed to compare the effects of a home-based physical and nutritional intervention program carried out by lay-volunteers to home visits with social support alone. Buddies visited 80 prefrail or frail older persons at home twice a week for 12 weeks. The physical training and nutrition group (PTN, n = 39) performed two sets of six strength exercises, discussed nutritional topics and received social support. The social support group (SoSu, n = 41) received home visits with social support only. In the PTN group, handgrip strength increased significantly by 2.4 kg (95% CI: 1.0-3.8). In the SoSu group we did not see a significant improvement. However, no significant between-group difference was found. Physical performance increased in both groups, although with a higher increase of 1.0 point (95% CI: 0.1-2.0) in the PTN group. In none of the groups muscle mass changed. Further results showed that frail individuals benefit more from the intervention than prefrail individuals (OR: 2.78; 95% CI: 1.01-7.66). Handgrip strength in the intervention group increased by a clinically relevant value and this effect is comparable to that obtained by health-care professionals. Therefore, home visits with a physical training and nutritional program could offer a new perspective in the care of community-dwelling prefrail and frail older persons.

  1. A Hybrid Process Fidelity Assessment in a Home-based Randomized Clinical Trial

    PubMed Central

    WILDE, MARY H.; LIEBEL, DIANNE; FAIRBANKS, EILEEN; WILSON, PAULA; LASH, MARGARET; SHAH, SHIVANI; McDONALD, MARGARET V.; BRASCH, JUDITH; ZHANG, FENG; SCHEID, EILEEN; McMAHON, JAMES M.

    2016-01-01

    A process fidelity assessment was conducted as a nested study within a home-based randomized clinical trial teaching self-management to 101 long-term indwelling urinary catheter users in the treatment group. Our hybrid model combined external assessments (outside observations and tape recordings) with internal evaluation methods (through study nurse forms and notes) for a comprehensive process fidelity assessment. Barriers, patient-related issues, and nurse perspectives were identified demonstrating the complexity in home care intervention research. The complementary and synergistic approaches provided in depth information about the context of the delivery and the impact of the intervention on study outcomes. PMID:25894688

  2. Paraprofessional-delivered home-visiting intervention for American Indian teen mothers and children: 3-year outcomes from a randomized controlled trial.

    PubMed

    Barlow, Allison; Mullany, Britta; Neault, Nicole; Goklish, Novalene; Billy, Trudy; Hastings, Ranelda; Lorenzo, Sherilynn; Kee, Crystal; Lake, Kristin; Redmond, Cleve; Carter, Alice; Walkup, John T

    2015-02-01

    The Affordable Care Act provides funding for home-visiting programs to reduce health care disparities, despite limited evidence that existing programs can overcome implementation and evaluation challenges with at-risk populations. The authors report 36-month outcomes of the paraprofessional-delivered Family Spirit home-visiting intervention for American Indian teen mothers and children. Expectant American Indian teens (N=322, mean age=18.1 years) from four southwestern reservation communities were randomly assigned to the Family Spirit intervention plus optimized standard care or optimized standard care alone. Maternal and child outcomes were evaluated at 28 and 36 weeks gestation and 2, 6, 12, 18, 24, 30, and 36 months postpartum. At baseline the mothers had high rates of substance use (>84%), depressive symptoms (>32%), dropping out of school (>57%), and residential instability (51%). Study retention was ≥83%. From pregnancy to 36 months postpartum, mothers in the intervention group had significantly greater parenting knowledge (effect size=0.42) and parental locus of control (effect size=0.17), fewer depressive symptoms (effect size=0.16) and externalizing problems (effect size=0.14), and lower past month use of marijuana (odds ratio=0.65) and illegal drugs (odds ratio=0.67). Children in the intervention group had fewer externalizing (effect size=0.23), internalizing (effect size=0.23), and dysregulation (effect size=0.27) problems. The paraprofessional home-visiting intervention promoted effective parenting, reduced maternal risks, and improved child developmental outcomes in the U.S. population subgroup with the fewest resources and highest behavioral health disparities. The methods and results can inform federal efforts to disseminate and sustain evidence-based home-visiting interventions in at-risk populations.

  3. Randomized controlled trial of a home-visiting intervention on infant cognitive development in peri-urban South Africa.

    PubMed

    Murray, Lynne; Cooper, Peter; Arteche, Adriane; Stein, Alan; Tomlinson, Mark

    2016-03-01

    To determine whether, in an impoverished South African community, an intervention that benefitted infant attachment also benefitted cognitive development. Pregnant females were randomized to intervention (n=220) and no-treatment control groups (n=229). The intervention was home-based parenting support for attachment, delivered until 6 months postpartum. At 18 months, infants were assessed on attachment and cognitive development (Bayley Scales Mental Development Index [MDI]) (n=127 intervention, n=136 control participants). Infant MDI was examined in relation to intervention, socio-economic risk, antenatal depression, and infant sex and attachment. Overall, there was little effect of the intervention on MDI (p=0.094, d=0.20), but there was an interaction between intervention and risk (p=0.03, ηp2=0.02). MDI scores of infants of lower risk intervention group mothers were, on average, 4.84 points higher than those of other infants (p=0.002, d=0.41). Antenatal depression was not significant once intervention and risk were controlled (p=0.08); there was no association between infant MDI and either sex (p=0.41) or attachment (p=0.56). Parenting interventions for infant cognitive development may benefit from inclusion of specific components to support infant cognition beyond those that support attachment, and may be most effective for infants over 6 months. They may need augmentation with other input where adversity is extreme. © 2015 Mac Keith Press.

  4. A randomized, home-based, childhood obesity intervention delivered by patient navigators.

    PubMed

    Yun, Lourdes; Boles, Richard E; Haemer, Matthew A; Knierim, Shanna; Dickinson, L Miriam; Mancinas, Heather; Hambidge, Simon J; Davidson, Arthur J

    2015-05-23

    Although Colorado is perceived as a healthy state, in 2010, 14.1 % of children aged 2-5 were overweight and 9.1 % were obese. Despite the high prevalence of obesity in this population, evidence to support particular strategies to treat obese preschoolers is lacking. The efficacy of home-based, childhood obesity interventions to reduce a child's body mass index is inconclusive. However, this model uniquely provides an opportunity to observe and intervene with the home food and activity environment and engage the entire family in promoting changes that fit each family's unique dynamics. Eligible participants are children aged 2-5 years who attended a well-child care visit at a Denver Health Community Health Service clinic within 12 months prior to recruitment and on that visit had a body mass index (BMI) >85th percentile-for-age. Participants are randomly recruited at study inception and allocated to the intervention in one of five defined 6-month stepped wedge engagements; the delayed intervention groups serves as control groups until the start of the intervention. The program is delivered by a patient navigator at the family' home and consists of a 16-session curriculum focused on 1) parenting styles, 2) nutrition, and 3) physical activity. At each visit, a portion of curriculum is delivered to guide parents and children in selecting one goal for behavior change in each of three work areas to work on during the following week. The primary study outcome measure is change in BMI z-score from baseline to post-intervention period. This childhood obesity study, innovative for its home-based intervention venue, provides rich data characterizing barriers and facilitators to healthy behavior change within the home. The study population is innovative as it is focused on preschool-aged, Latino children from low-income families; this population has not typically been targeted in obesity management assessments. The home-based intervention is linked to clinical care through

  5. Home-Based Versus Laboratory-Based Robotic Ankle Training for Children With Cerebral Palsy: A Pilot Randomized Comparative Trial.

    PubMed

    Chen, Kai; Wu, Yi-Ning; Ren, Yupeng; Liu, Lin; Gaebler-Spira, Deborah; Tankard, Kelly; Lee, Julia; Song, Weiqun; Wang, Maobin; Zhang, Li-Qun

    2016-08-01

    To examine the outcomes of home-based robot-guided therapy and compare it to laboratory-based robot-guided therapy for the treatment of impaired ankles in children with cerebral palsy. A randomized comparative trial design comparing a home-based training group and a laboratory-based training group. Home versus laboratory within a research hospital. Children (N=41) with cerebral palsy who were at Gross Motor Function Classification System level I, II, or III were randomly assigned to 2 groups. Children in home-based and laboratory-based groups were 8.7±2.8 (n=23) and 10.7±6.0 (n=18) years old, respectively. Six-week combined passive stretching and active movement intervention of impaired ankle in a laboratory or home environment using a portable rehabilitation robot. Active dorsiflexion range of motion (as the primary outcome), mobility (6-minute walk test and timed Up and Go test), balance (Pediatric Balance Scale), Selective Motor Control Assessment of the Lower Extremity, Modified Ashworth Scale (MAS) for spasticity, passive range of motion (PROM), strength, and joint stiffness. Significant improvements were found for the home-based group in all biomechanical outcome measures except for PROM and all clinical outcome measures except the MAS. The laboratory-based group also showed significant improvements in all the biomechanical outcome measures and all clinical outcome measures except the MAS. There were no significant differences in the outcome measures between the 2 groups. These findings suggest that the translation of repetitive, goal-directed, biofeedback training through motivating games from the laboratory to the home environment is feasible. The benefits of home-based robot-guided therapy were similar to those of laboratory-based robot-guided therapy. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  6. The effect of staff training on agitation and use of restraint in nursing home residents with dementia: a single-blind, randomized controlled trial.

    PubMed

    Testad, Ingelin; Ballard, Clive; Brønnick, Kolbjørn; Aarsland, Dag

    2010-01-01

    Agitation is common in dementia and is associated with use of restraints and use of psychotropic drugs. The aim of this study was to determine whether an education and supervision intervention could reduce agitation and the use of restraints and antipsychotic drugs in nursing homes. Four Norwegian nursing homes were randomly allocated to receive either treatment as usual or an intervention consisting of a 2-day educational seminar and monthly group guidance for 6 months. One hundred forty-five residents with dementia (based on medical records and corroborated with a Functional Assessment Staging score >or= 4) completed baseline and 6-month intervention assessments and were included in the analyses. The co-primary outcome measures were the proportion of residents subject to interactional restraint and the severity of agitation using the Cohen-Mansfield Agitation Inventory (CMAI). Patients were assessed at baseline, immediately after completion of the intervention at 6 months, and 12 months after baseline. Comparison of change in the 2 groups was made using repeated-measures analysis of variance (CMAI) and Mann-Whitney test (restraints). The study was conducted from 2003 to 2004. The proportion of residents starting new restraint was lower in the intervention than in the control group at 6-month evaluation (P = .02), but no statistically significant differences were found at 12-month assessment (P = .57). The total CMAI score declined from baseline to 6 and 12 months' follow-up in the intervention homes compared to a small increase in the control homes (F2,176 = 3.46, P = .034). There were no statistically significant differences in use of antipsychotic drugs. A brief 2-day staff education program followed by continued monthly guidance was able both to improve quality of care by reducing the frequency of interactional restraints and to reduce severity of agitation. ©Copyright 2010 Physicians Postgraduate Press, Inc.

  7. A randomized controlled trial comparing two types of pneumatic compression for breast cancer-related lymphedema treatment in the home.

    PubMed

    Fife, Caroline E; Davey, Suzanne; Maus, Erik A; Guilliod, Renie; Mayrovitz, Harvey N

    2012-12-01

    Pneumatic compression devices (PCDs) are used in the home setting as adjunctive treatment for lymphedema after acute treatment in a clinical setting. PCDs range in complexity from simple to technologically advanced. The objective of this prospective, randomized study was to determine whether an advanced PCD (APCD) provides better outcomes as measured by arm edema and tissue water reductions compared to a standard PCD (SPCD) in patients with arm lymphedema after breast cancer treatment. Subjects were randomized to an APCD (Flexitouch system, HCPCS E0652) or SPCD (Bio Compression 2004, HCPCS E0651) used for home treatment 1 h/day for 12 weeks. Pressure settings were 30 mmHg for the SPCD and upper extremity treatment program (UE01) with standard pressure for the APCD. Thirty-six subjects (18 per group) with unilateral upper extremity lymphedema with at least 5% arm edema volume at the time of enrollment, completed treatments over the 12-week period. Arm volumes were determined from arm girth measurements and suitable model calculations, and tissue water was determined based on measurements of the arm tissue dielectric constant (TDC). The APCD-treated group experienced an average of 29% reduction in edema compared to a 16% increase in the SPCD group. Mean changes in TDC values were a 5.8% reduction for the APCD group and a 1.9% increase for the SPCD group. This study suggests that for the home maintenance phase of treatment of arm lymphedema secondary to breast cancer therapy, the adjuvant treatment with an APCD provides better outcomes than with a SPCD.

  8. Rationale and study protocol for the Nursing Home Compare Plus (NHCPlus) randomized controlled trial: A personalized decision aid for patients transitioning from the hospital to a skilled-nursing facility

    PubMed Central

    Sorkin, Dara H.; Amin, Alpesh; Weimer, David L.; Sharit, Joseph; Ladd, Heather

    2016-01-01

    Background Annually more than 3 million people are admitted to one of the 15,965 skilled nursing facilities (SNFs) in the United States with 90% of admissions occurring from a hospital. Although the Centers for Medicare and Medicaid Services (CMS) publishes several web-based report cards, including one for nursing homes (Nursing Home Compare, NHC), they are not widely used. This is due, in part, to the complexity of the information available and the fact that the choice of nursing homes is typically made while in the hospital without access to the web-based NHC. We developed Nursing Home Compare Plus (NHCPlus) to address these limitations and to improve the decision-making process. Methods/Design This paper describes the design and rationale of a two-arm randomized controlled trial designed to test the effectiveness of NHCPlus compared to usual care only, in a sample of patients being discharged from the hospital to an SNF (N=229). Assessments were conducted within 24-hours prior to patient discharge and 30-days post discharge. Primary outcomes to be examined included use of NHC, increased choice of nursing homes with better reported outcomes, and increased distance between patient/family residence and nursing home. Secondary outcomes included satisfaction with the decision to go to a nursing home, confidence in the choice of nursing home, and reduced hospital length of stay. Discussion NHCPlus is an innovative mobile application designed to allow patients to personalize their choice of nursing homes to meet their medical needs and preferences. The application to other quality report cards is discussed. PMID:26772624

  9. The efficacy of a nutrition education intervention to prevent risk of malnutrition for dependent elderly patients receiving Home Care: A randomized controlled trial.

    PubMed

    Fernández-Barrés, Sílvia; García-Barco, Montse; Basora, Josep; Martínez, Teresa; Pedret, Roser; Arija, Victoria

    2017-05-01

    To assess the effect of a nutrition education intervention included in the Home Care Program for caregivers to prevent the increasing risk of malnutrition of dependent patients at risk of malnutrition. Randomized controlled multicenter trial of 6 months of duration and 12 months follow-up. 10 Primary Care Centers, Spain. Patients enrolled in the Home Care Program between January 2010 and March 2012, who were dependent and at risk of malnutrition, older than 65, and had caregivers (n=190). The nurses conducted initial educational intervention sessions for caregivers and then monitored at home every month for 6 months. The nutritional status was assessed using the Mini Nutritional Assessment test (primary outcome), diet, anthropometry, and biochemical parameters (albumin, prealbumin, hemoglobin and cholesterol). Other descriptive and outcome measures were recorded: current medical history, Activities of daily living (Barthel test), cognitive state (Pfeiffer test), and mood status (Yesavage test). All the measures were recorded in a schedule of 0-6-12 months. 173 individuals participated after exclusions (intervention n=101; control n=72). Mean age was 87.8±8.9years, 68.2% were women. Difference were found between the groups for Mini Nutritional Assessment test score change (repeated measures ANOVA, F=10.1; P<0.001), the intervention improved the Mini Nutritional Assessment test score of the participants in the intervention group. The egg consumption (F=4.1; P=0.018), protein intake (F=3.0; P=0.050), polyunsaturated fatty acid intake (F=5.3; P=0.006), folate (F=3.3; P=0.041) and vitamin E (F=6.4; P=0.002) showed significant group×time interactions. A nutrition education intervention for caregivers halted the tendency of nutritional decline, and reduced the risk of malnutrition of older dependent patients. Clinical Trial Registration-URL: www.clinicaltrials.gov. Identifier: NCT01360775. Copyright © 2017 Elsevier Ltd. All rights reserved.

  10. Effect of animal-assisted interventions on depression, agitation and quality of life in nursing home residents suffering from cognitive impairment or dementia: a cluster randomized controlled trial.

    PubMed

    Olsen, Christine; Pedersen, Ingeborg; Bergland, Astrid; Enders-Slegers, Marie-José; Patil, Grete; Ihlebaek, Camilla

    2016-12-01

    The prevalence of neuropsychiatric symptoms in cognitively impaired nursing home residents is known to be very high, with depression and agitation being the most common symptoms. The possible effects of a 12-week intervention with animal-assisted activities (AAA) in nursing homes were studied. The primary outcomes related to depression, agitation and quality of life (QoL). A prospective, cluster randomized multicentre trial with a follow-up measurement 3 months after end of intervention was used. Inclusion criteria were men and women aged 65 years or older, with a diagnosis of dementia or having a cognitive deficit. Ten nursing homes were randomized to either AAA with a dog or a control group with treatment as usual. In total, 58 participants were recruited: 28 in the intervention group and 30 in the control group. The intervention consisted of a 30-min session with AAA twice weekly for 12 weeks in groups of three to six participants, led by a qualified dog handler. Norwegian versions of the Cornell Scale for Depression, the Brief Agitation Rating Scale and the Quality of Life in Late-stage Dementia scale were used. A significant effect on depression and QoL was found for participants with severe dementia at follow-up. For QoL, a significant effect of AAA was also found immediately after the intervention. No effects on agitation were found. Animal-assisted activities may have a positive effect on symptoms of depression and QoL in older people with dementia, especially those in a late stage. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  11. Incentive Spirometry after Lung Resection: A Randomized Controlled Trial.

    PubMed

    Malik, Peter Ra; Fahim, Christine; Vernon, Jordyn; Thomas, Priya; Schieman, Colin; Finley, Christian J; Agzarian, John; Shargall, Yaron; Farrokhyar, Forough; Hanna, Wael C

    2018-04-24

    Incentive spirometry (IS) is thought to reduce the incidence of postoperative pulmonary complications (PPC) after lung resection. We sought to determine whether the addition of IS to routine physiotherapy following lung resection results in a lower rate of PPC, as compared to physiotherapy alone. A single-blind prospective randomized controlled trial was conducted in adults undergoing lung resection. Individuals with previous lung surgery or home oxygen were excluded. Participants randomized to the control arm (PHY) received routine physiotherapy alone (deep breathing, ambulation and shoulder exercises). Those randomized to the intervention arm (PHY/IS) received IS in addition to routine physiotherapy. The trial was powered to detect a 10% difference in the rate of PPC (beta=80%). Student's t-test and chi-square were utilized for continuous and categorical variables respectively, with a significance level of p=0.05. A total of 387 participants (n=195 PHY/IS; n=192 PHY) were randomized between 2014-2017. Baseline characteristics were comparable for both arms. The majority of patients underwent a pulmonary lobectomy (PHY/IS=59.5%, PHY=61.0%, p=0.84), with no difference in the rates of minimally invasive and open procedures. There were no differences in the incidence of PPC at 30 days postoperatively (PHY/IS=12.3%, PHY=13.0%, p=0.88). There were no differences in rates of pneumonia (PHY/IS=4.6%, PHY=7.8%, p=0.21), mechanical ventilation (PHY/IS=2.1%, PHY=1.0%, p=0.41), home-oxygen (PHY/IS=13.8%, PHY=14.6%, p=0.89), hospital length of stay (PHY/IS=4 days, PHY=4 days, p=0.34), or rate of readmission to hospital (PHY/IS=10.3%, PH=9.9%, p=1.00). The addition of IS to routine postoperative physiotherapy does not reduce the incidence of PPC after lung resection. Copyright © 2018. Published by Elsevier Inc.

  12. Providing Home-Based HIV Testing and Counseling for Transgender Youth (Project Moxie): Protocol for a Pilot Randomized Controlled Trial.

    PubMed

    Stephenson, Rob; Metheny, Nicholas; Sharma, Akshay; Sullivan, Stephen; Riley, Erin

    2017-11-28

    Transgender and gender nonconforming people experience some of the highest human immunodeficiency virus (HIV) rates in the United States, and experience many structural and behavioral barriers that may limit their engagement in HIV testing, prevention, and care. Evidence suggests that transgender and gender nonconforming youth (TY) are especially vulnerable to acquiring HIV, yet there is little research on TY and few services are targeted towards HIV testing, prevention, and care for this population. Telehealth presents an opportunity to mitigate some structural barriers that TY experience in accessing HIV testing, allowing TY to engage in HIV testing and counseling in a safe and nonjudgmental space of their choosing. Project Moxie is an HIV prevention intervention that pairs the use of HIV self-testing with remote video-based counseling and support from a trained, gender-affirming counselor. This study aims to offer a more positive HIV testing and counseling experience, with the goal of improving HIV testing frequency. Project Moxie involves a pilot randomized controlled trial (RCT) of 200 TY aged 15-24 years, who are randomized on a 1:1 basis to control or intervention arms. The aim is to examine whether the addition of counseling provided via telehealth, coupled with home-based HIV testing, can create gains in routine HIV testing among TY over a six-month follow-up period. This study implements a prospective pilot RCT of 200 TY recruited online. Participants in the control arm will receive one HIV self-testing kit and will be asked to report their results via the study's website. Participants in the experimental arm will receive one HIV self-testing kit and will test with a remotely-located counselor during a prescheduled video-counseling session. Participants are assessed at baseline, and at three and six months posttesting. Project Moxie was launched in June 2017 and recruitment is ongoing. As of August 21, 2017, the study had enrolled 130 eligible

  13. A Parent-Directed Language Intervention for Children of Low Socioeconomic Status: A Randomized Controlled Pilot Study

    ERIC Educational Resources Information Center

    Suskind, Dana L.; Leffel, Kristin R.; Graf, Eileen; Hernandez, Marc W.; Gunderson, Elizabeth A.; Sapolich, Shannon G.; Suskind, Elizabeth; Leininger, Lindsey; Goldin-Meadow, Susan; Levine, Susan C.

    2016-01-01

    We designed a parent-directed home-visiting intervention targeting socioeconomic status (SES) disparities in children's early language environments. A randomized controlled trial was used to evaluate whether the intervention improved parents' knowledge of child language development and increased the amount and diversity of parent talk.…

  14. A randomized controlled trial of a new behavioral home-based nutrition education program, "Eat Well with CF," in adults with cystic fibrosis.

    PubMed

    Watson, Helen; Bilton, Diana; Truby, Helen

    2008-05-01

    Cystic fibrosis (CF) remains the most common genetically inherited disease in the white population and its prognosis is affected by nutritional status. Adults with the disease are now surviving longer and new strategies are required to ensure that they maintain optimal nutrition. This article reports preliminary data from a randomized controlled trial of a 10-week home-based behavioral nutrition intervention, "Eat Well with CF." Outcome measures of weight change over 6 and 12 months and changes in CF-specific nutrition knowledge score, self-efficacy score, reported dietary fat intake and health-related quality-of-life score were compared between the intervention group (n=34) and a standard care control group (n=34). The hypotheses to be tested were that adults with CF completing "Eat Well with CF" would have an improved nutritional status, improvement in specific nutrition knowledge, and an improvement in self-efficacy regarding their ability to cope with a special diet, compared to those receiving standard care. There were substantial improvements in the intervention group's specific CF nutrition knowledge score, self-efficacy score, and reported fat intake compared to control, but no substantial change in body mass index or health-related quality of life over time. Home-based nutrition education incorporating behavioral strategies can be an effective way to support adults with CF, enabling improvement in self-management skills in relation to diet and pancreatic enzyme replacement therapy. This study revealed gaps in basic nutrition knowledge and skills, inadequate knowledge of diet-disease links and pancreatic enzyme replacement therapy. These need to be identified when subjects progress from pediatric to adult care, and programs such as "Eat Well with CF" are a useful adjunct for registered dietitians trying to manage this diverse but growing population.

  15. The cost-effectiveness of a new disease management model for frail elderly living in homes for the elderly, design of a cluster randomized controlled clinical trial

    PubMed Central

    Boorsma, Marijke; van Hout, Hein PJ; Frijters, Dinnus H; Ribbe, Miel W; Nijpels, Giel

    2008-01-01

    Background The objective of this article is to describe the design of a study to evaluate the clinical and economic effects of a Disease Management model on functional health, quality of care and quality of life of persons living in homes for the elderly. Methods This study concerns a cluster randomized controlled clinical trial among five intervention homes and five usual care homes in the North-West of the Netherlands with a total of over 500 residents. All persons who are not terminally ill, are able to be interviewed and sign informed consent are included. For cognitively impaired persons family proxies will be approached to provide outcome information. The Disease Management Model consists of several elements: (1) Trained staff carries out a multidimensional assessment of the patients functional health and care needs with the interRAI Long Term Care Facilities instrument (LTCF). Computerization of the LTCF produces immediate identification of problem areas and thereby guides individualized care planning. (2) The assessment outcomes are discussed in a Multidisciplinary Meeting (MM) with the nurse, primary care physician, nursing home physician and Psychotherapist and if necessary other members of the care team. The MM presents individualized care plans to manage or treat modifiable disabilities and risk factors. (3) Consultation by an nursing home physician and psychotherapist is offered to the frailest residents at risk for nursing home admission (according to the interRAI LTCF). Outcome measures are Quality of Care indicators (LTCF based), Quality Adjusted Life Years (Euroqol), Functional health (SF12, COOP-WONCA), Disability (GARS), Patients care satisfaction (QUOTE), hospital and nursing home days and mortality, health care utilization and costs. Discussion This design is unique because no earlier studies were performed to evaluate the effects and costs of this Disease Management Model for disabled persons in homes for the elderly on functional health and

  16. Effects of two physiotherapy booster sessions on outcomes with home exercise in people with knee osteoarthritis: a randomized controlled trial.

    PubMed

    Bennell, Kim L; Kyriakides, Mary; Hodges, Paul W; Hinman, Rana S

    2014-11-01

    Enhancing exercise adherence over the longer term is an important goal in self-management of knee osteoarthritis (OA). Following an initial period of more intensive exercise supervision, this study investigated whether 2 additional physiotherapy visits improved outcomes with continued home exercise over a subsequent 24-week period. A total of 78 people with medial knee OA (mean ± SD age 62.1 ± 6.9 years, mean ± SD body mass index 29.4 ± 4.0 kg/m(2) , and radiographic disease severity 19% mild, 49% moderate, and 32% severe) who completed a 12-week physiotherapist-supervised exercise trial were randomly allocated to 2 30-minute physiotherapy booster sessions (delivered by 8 physiotherapists in private clinics) or no booster sessions for the subsequent 24 weeks. All participants were asked to continue home exercises 4 times weekly. Primary outcomes were change in pain, using a 100-mm visual analog scale, and self-reported physical function, measured using the Western Ontario McMaster Universities Osteoarthritis Index. Participants and physiotherapists were unblinded to group allocation, although participants were blinded to the study hypothesis. A total of 74 participants (95%) completed the trial. There was no significant difference between groups for change in pain (mean difference [95% confidence interval (95% CI)] 0.7 mm [-9.4, 8.0]; P = 0.88) or physical function (-0.3 units [95% CI -4.0, 3.5]; P = 0.88). The mean ± SD percentage of home exercise sessions completed was 56% ± 34% in the booster group and 51% ± 37% in the control group (P > 0.05). Two booster sessions with a physiotherapist did not influence pain or physical function outcomes, or measures of home exercise adherence. These findings suggest other more effective strategies are needed to maximize longer-term adherence with the aim to achieve greater improvements in clinical outcomes from exercise in this patient population. Copyright © 2014 by the American College of Rheumatology.

  17. A randomized comparison of home visits and hospital-based group follow-up visits after early postpartum discharge.

    PubMed

    Escobar, G J; Braveman, P A; Ackerson, L; Odouli, R; Coleman-Phox, K; Capra, A M; Wong, C; Lieu, T A

    2001-09-01

    Short postpartum stays are common. Current guidelines provide scant guidance on how routine follow-up of newly discharged mother-infant pairs should be performed. We aimed to compare 2 short-term (within 72 hours of discharge) follow-up strategies for low-risk mother-infant pairs with postpartum length of stay (LOS) of <48 hours: home visits by a nurse and hospital-based follow-up anchored in group visits. We used a randomized clinical trial design with intention-to-treat analysis in an integrated managed care setting that serves a largely middle class population. Mother-infant pairs that met LOS and risk criteria were randomized to the control arm (hospital-based follow-up) or to the intervention arm (home nurse visit). Clinical utilization and costs were studied using computerized databases and chart review. Breastfeeding continuation, maternal depressive symptoms, and maternal satisfaction were assessed by means of telephone interviews at 2 weeks postpartum. During a 17-month period in 1998 to 1999, we enrolled and randomized 1014 mother-infant pairs (506 to the control group and 508 to the intervention group). There were no significant differences between the study groups with respect to maternal age, race, education, household income, parity, previous breastfeeding experience, early initiation of prenatal care, or postpartum LOS. There were no differences with respect to neonatal LOS or Apgar scores. In the control group, 264 mother-infant pairs had an individual visit only, 157 had a group visit only, 64 had both a group and an individual visit, 4 had a home health and a hospital-based follow-up, 13 had no follow-up within 72 hours, and 4 were lost to follow-up. With respect to outcomes within 2 weeks after discharge, there were no significant differences in newborn or maternal hospitalizations or urgent care visits, breastfeeding discontinuation, maternal depressive symptoms, or a combined clinical outcome measure indicating whether a mother-infant pair had

  18. Outcomes of a Randomized Trial of a Cognitive Behavioral Enhancement to Address Maternal Distress in Home Visited Mothers.

    PubMed

    McFarlane, Elizabeth; Burrell, Lori; Duggan, Anne; Tandon, Darius

    2017-03-01

    Objectives To assess the effectiveness of a 6-week, cognitive behavioral therapy (CBT) group-based enhancement to home visiting to address stress and prevent depression as compared with home visiting as usual in low income mothers of young children. Methods We conducted a randomized controlled trial with 95 low-income mothers of young children to assess the effectiveness of a 6-week, cognitive behavioral group-based enhancement to Healthy Families America and Parents as Teachers home visiting (HV/CBT = 49) to address stress and prevent depression as compared with home visiting as usual (HV = 46). Booster sessions for the HV/CBT group were offered at 3 and 6 months. Participants completed measures of coping, stress and depression at three points: baseline prior to randomization, post-intervention, and 6 months post-intervention. Parent child interaction was also measured at 6 months. Results Intent-to-treat analyses found improved coping and reduced stress and depression post-intervention. While impacts on these outcomes were attenuated at 6 months, positive impacts were observed for selected aspects of mothers' interactions with their children. Maternal characteristics at baseline were associated with participation in the intervention and with post-intervention and 6-month outcomes. Mothers with lower levels of stress and those with fewer children were more likely to attend intervention sessions. Mothers with lower levels of stress had more favorable post intervention outcomes. Conclusions CBT group-based enhancement to home visiting improved maternal coping, reduced stress and depression immediately post intervention but not at 6 months, suggesting more work is needed to sustain positive gains in low-income mothers of young children.

  19. Rationale and study protocol for the Nursing Home Compare Plus (NHCPlus) randomized controlled trial: A personalized decision aid for patients transitioning from the hospital to a skilled-nursing facility.

    PubMed

    Sorkin, Dara H; Amin, Alpesh; Weimer, David L; Sharit, Joseph; Ladd, Heather; Mukamel, Dana B

    2016-03-01

    Annually more than 3 million people are admitted to one of the 15,965 skilled nursing facilities (SNFs) in the United States, with 90% of admissions occurring from a hospital. Although the Centers for Medicare and Medicaid Services (CMS) publishes several internet-based report cards, including one for nursing homes (Nursing Home Compare, NHC), they are not widely used. This is due, in part, to the complexity of the information available and the fact that the choice of nursing homes is typically made while in the hospital without access to the web-based NHC. We developed Nursing Home Compare Plus (NHCPlus) to address these limitations and to improve the decision-making process. This paper describes the design and rationale of a two-arm randomized controlled trial designed to test the effectiveness of NHCPlus compared to usual care only, in a sample of patients being discharged from the hospital to an SNF (N=229). Assessments were conducted within 24h prior to patient discharge and 30-days post discharge. Primary outcomes to be examined included the use of NHC, increased choice of nursing homes with better reported outcomes, and increased distance between patient/family residence and nursing home. Secondary outcomes included satisfaction with the decision to go to a nursing home, confidence in the choice of nursing home, and reduced hospital length of stay. NHCPlus is an innovative mobile application designed to allow patients to personalize their choice of nursing homes to meet their medical needs and preferences. The application to other quality report cards is discussed. Copyright © 2016 Elsevier Inc. All rights reserved.

  20. Healthy Habits, Happy Homes: methods and baseline data of a randomized controlled trial to improve household routines for obesity prevention.

    PubMed

    Taveras, Elsie M; McDonald, Julia; O'Brien, Ashley; Haines, Jess; Sherry, Bettylou; Bottino, Clement J; Troncoso, Karen; Schmidt, Marie Evans; Koziol, Renata

    2012-11-01

    To develop a home-based intervention for parents of 2-5 year old children to promote household routines to prevent overweight/obesity. We recruited 121 children from health centers in Boston between 2011 and 2012 and randomized 62 to intervention and 59 to the control condition. The 6-month intervention included 1) motivational coaching at home and by phone with a health educator, 2) mailed educational materials, and 3) weekly text messages. The intervention promoted three household routines: eating meals as a family, obtaining adequate sleep, and limiting screen time. Of the 121 children, mean (SD) age was 4.0 (1.1) years; 52% were Hispanic, 34% Black, and 14% White/Other. Nearly 60% of the sample had annual household incomes ≤ $20,000. Approximately 64% of families reported eating together ≥ 7 times per week, however, many meals were eaten in front of a TV. Over half of the children slept less than the recommended 11h/night and 78% viewed ≥ 2 h/day of screen time. Household routines that increase obesity risk were prevalent among low-income families in this study. If proven to be effective, promotion of household routines related to family meals, sleep, and screen time may prevent young children from becoming overweight/obese. Copyright © 2012 Elsevier Inc. All rights reserved.

  1. Effectiveness of home-based nutritional counselling and support on exclusive breastfeeding in urban poor settings in Nairobi: a cluster randomized controlled trial.

    PubMed

    Kimani-Murage, Elizabeth W; Griffiths, Paula L; Wekesah, Frederick Murunga; Wanjohi, Milka; Muhia, Nelson; Muriuki, Peter; Egondi, Thaddaeus; Kyobutungi, Catherine; Ezeh, Alex C; McGarvey, Stephen T; Musoke, Rachel N; Norris, Shane A; Madise, Nyovani J

    2017-12-19

    Exclusive breastfeeding (EBF) improves infant health and survival. We tested the effectiveness of a home-based intervention using Community Health Workers (CHWs) on EBF for six months in urban poor settings in Kenya. We conducted a cluster-randomized controlled trial in Korogocho and Viwandani slums in Nairobi. We recruited pregnant women and followed them until the infant's first birthday. Fourteen community clusters were randomized to intervention or control arm. The intervention arm received home-based nutritional counselling during scheduled visits by CHWs trained to provide specific maternal infant and young child nutrition (MIYCN) messages and standard care. The control arm was visited by CHWs who were not trained in MIYCN and they provided standard care (which included aspects of ante-natal and post-natal care, family planning, water, sanitation and hygiene, delivery with skilled attendance, immunization and community nutrition). CHWs in both groups distributed similar information materials on MIYCN. Differences in EBF by intervention status were tested using chi square and logistic regression, employing intention-to-treat analysis. A total of 1110 mother-child pairs were involved, about half in each arm. At baseline, demographic and socioeconomic factors were similar between the two arms. The rates of EBF for 6 months increased from 2% pre-intervention to 55.2% (95% CI 50.4-59.9) in the intervention group and 54.6% (95% CI 50.0-59.1) in the control group. The adjusted odds of EBF (after adjusting for baseline characteristics) were slightly higher in the intervention arm compared to the control arm but not significantly different: for 0-2 months (OR 1.27, 95% CI 0.55 to 2.96; p = 0.550); 0-4 months (OR 1.15; 95% CI 0.54 to 2.42; p = 0.696), and 0-6 months (OR 1.11, 95% CI 0.61 to 2.02; p = 0.718). EBF for six months significantly increased in both arms indicating potential effectiveness of using CHWs to provide home-based counselling to

  2. Assessing a change mechanism in a randomized home-visiting trial: Reducing disrupted maternal communication decreases infant disorganization.

    PubMed

    Tereno, Susana; Madigan, Sheri; Lyons-Ruth, Karlen; Plamondon, Andre; Atkinson, Leslie; Guedeney, Nicole; Greacen, Tim; Dugravier, Romain; Saias, Thomas; Guedeney, Antoine

    2017-05-01

    Although randomized interventions trials have been shown to reduce the incidence of disorganized attachment, no studies to date have identified the mechanisms of change responsible for such reductions. Maternal sensitivity has been assessed in various studies and shown to change with intervention, but in the only study to formally assess mediation, changes in maternal sensitivity did not mediate changes in infant security of attachment (Cicchetti, Rogosch, & Toth, 2006). Primary aims of the current randomized controlled intervention trial in a high-risk population were to fill gaps in the literature by assessing whether the intervention (a) reduced disorganization, (b) reduced disrupted maternal communication, and (c) whether reductions in disrupted maternal communication mediated changes in infant disorganization. The results indicated that, compared to controls (n = 52), both infant disorganization and disrupted maternal communication were significantly reduced in the intervention group (n = 65) that received regular home-visiting during pregnancy and the first year of life. Furthermore, reductions in disrupted maternal communication partially accounted for the observed reductions in infant disorganization compared to randomized controls. The results are discussed in relation to the societal cost effectiveness of early attachment-informed interventions for mothers and infants, as well as the importance of formally assessing underlying mechanisms of change in order to improve and appropriately target preventive interventions.

  3. Development of a Clinical Tool to Predict Home Death of a Discharged Cancer Patient in Japan: a Case-Control Study.

    PubMed

    Fukui, Sakiko; Morita, Tatsuya; Yoshiuchi, Kazuhiro

    2017-08-01

    The aim of this study was to investigate the predictive value of a clinical tool to predict whether discharged cancer patients die at home, comparing groups of case who died at home and control who died in hospitals or other facilities. We conducted a nationwide case-control study to identify the determinants of home death for a discharged cancer patient. We randomly selected nurses in charge of 2000 home-visit nursing agencies from all 5813 agencies in Japan by referring to the nationwide databases in January 2013. The nurses were asked to report variables of their patients' place of death, patients' and caregivers' clinical statuses, and their preferences for home death. We used logistic regression analysis and developed a clinical tool to accurately predict it and investigated their predictive values. We identified 466 case and 478 control patients. Five predictive variables of home death were obtained: patients' and caregivers' preferences for home death [OR (95% CI) 2.66 (1.99-3.55)], availability of visiting physicians [2.13 (1.67-2.70)], 24-h contact between physicians and nurses [1.68 (1.30-2.18)], caregivers' experiences of deathwatch at home [1.41 (1.13-1.75)], and patients' insights as to their own prognosis [1.23 (1.02-1.50)]. We calculated the scores predicting home death for each variable (range 6-28). When using a cutoff point of 16, home death was predicted with a sensitivity of 0.72 and a specificity of 0.81 with the Harrell's c-statistic of 0.84. This simple clinical tool for healthcare professionals can help predict whether a discharged patient is likely to die at home.

  4. A home-based exercise program to improve function, fatigue, and sleep quality in patients with Stage IV lung and colorectal cancer: a randomized controlled trial.

    PubMed

    Cheville, Andrea L; Kollasch, Jenny; Vandenberg, Justin; Shen, Tiffany; Grothey, Axel; Gamble, Gail; Basford, Jeffrey R

    2013-05-01

    Exercise benefits patients with cancer, but studies of home-based approaches, particularly among those with Stage IV disease, remain small and exploratory. To conduct an adequately powered trial of a home-based exercise intervention that can be facilely integrated into established delivery and reimbursement structures. Sixty-six adults with Stage IV lung or colorectal cancer were randomized, in an eight-week trial, to usual care or incremental walking and home-based strength training. The exercising participants were instructed during a single physiotherapy visit and subsequently exercised four days or more per week; training and step-count goals were advanced during bimonthly telephone calls. The primary outcome measure was mobility assessed with the Ambulatory Post Acute Care Basic Mobility Short Form. Secondary outcomes included ratings of pain and sleep quality as well as the ability to perform daily activities (Ambulatory Post Acute Care Daily Activities Short Form), quality of life (Functional Assessment of Cancer Therapy-General), and fatigue (Functional Assessment of Cancer Therapy-Fatigue). Three participants dropped out and seven died (five in the intervention and two in the control group, P=0.28). At Week 8, the intervention group reported improved mobility (P=0.01), fatigue (P=0.02), and sleep quality (P=0.05) compared with the usual care group, but did not differ on the other measures. A home-based exercise program seems capable of improving the mobility, fatigue, and sleep quality of patients with Stage IV lung and colorectal cancer. Copyright © 2013. Published by Elsevier Inc.

  5. Association Between In-Office And At-Home Tooth Bleaching: A Single Blind Randomized Clinical Trial.

    PubMed

    Rodrigues, João Lima; Rocha, Patrícia Souza; Pardim, Silvia Letícia de Souza; Machado, Ana Cláudia Vieira; Faria-E-Silva, André Luis; Seraidarian, Paulo Isaías

    2018-01-01

    This controlled randomized clinical trial evaluated the effect of associating at-home and in-office bleaching procedures on tooth sensitivity (TS) and bleaching effectiveness. Forty patients subjected to on session of in-office bleaching with 38% peroxide hydrogen. Subsequently, the patients were randomly allocated to receive a second session of in-office bleaching or to use a tray containing 10% carbamide peroxide delivered during 7 consecutive days. The worst TS score reported during or after each bleaching procedure was recorded using a verbal rating scale and TS risk (score different from 0) was calculated. Color changes were measured 7 days after each in-office session (for patients receiving in-office procedures only) or after the end of at-home bleaching (for the combined protocol), and 6 months after the last procedure for both bleaching protocols. Color was assessed by a spectrophotometer and by color match with the Vita Classical and Bleach guide scales. Statistical analyses were carried out to assess possible differences between the protocols regarding the outcomes and to analyze the effect of time of assessment on color changes. The bleaching protocol did not affect the risk for and the maximum level of TS reported, irrespective of the time of assessment. In the color evaluation, the bleaching protocol also did not affect the ultimate tooth color. In conclusion, after one in-office bleaching session, there was no difference in bleaching effectiveness and TS between performing a second in-office session and associating it with 1-week at-home bleaching.

  6. An elastic band exercise program for older adults using wheelchairs in Taiwan nursing homes: a cluster randomized trial.

    PubMed

    Chen, Kuei-Min; Li, Chun-Huw; Chang, Ya-Hui; Huang, Hsin-Ting; Cheng, Yin-Yin

    2015-01-01

    The number of older adults using wheelchairs in nursing homes is over 50% of that population, and many of them use wheelchairs due to muscle weakness in the lower extremities. Muscles of older adults are trainable, and progressive resistance exercises using elastic bands can increase muscle strength in older adults. To test the effectiveness of six-month Wheelchair-bound Senior Elastic Band exercises on the functional fitness of older adults in nursing homes. Cluster randomized trial. Ten nursing homes, southern Taiwan. 127 participants were recruited, and 114 of them completed the study. Inclusion criteria were: (1) aged 65 and over, (2) using wheelchairs for mobility, (3) living in the facility for at least three months, (4) cognitively intact, and (5) heavily or moderate dependency in their activities of daily living. The mean age of the participants was 79.15 (7.03) years, and 98.20% of them had chronic illnesses. Participants were randomly assigned to the experimental (five nursing homes, n=59) or the control (five nursing homes, n=55) group based on the nursing homes where they stayed. A 40-min Wheelchair-bound Senior Elastic Band exercise program was implemented three times per week for six months for the experimental group participants. The functional fitness (activities of daily living, lung capacity, body flexibilities, muscle power and endurance) of the participants was examined at baseline, after three months, and at the end of the six months study. The mixed-design, two-way analysis of variance was used to detect the interaction effects, and one-way repeated measures analysis of variance and analysis of covariance were performed to analyze the within-group and between-group differences. At the end of the six-month study, the Wheelchair-bound Senior Elastic Band group had better performances in all of the functional fitness indicators than the control group (all p<0.05). The Wheelchair-bound Senior Elastic Band exercises significantly improved the

  7. Motions and functional performance after supervised physical therapy program versus home-based program after arthroscopic anterior shoulder stabilization: a randomized clinical trial.

    PubMed

    Ismail, M M; El Shorbagy, K M

    2014-01-01

    To compare the effects of a standardized supervised physical therapy versus a controlled home-based programs on the rate of shoulder motion and functional recovery after arthroscopic anterior shoulder stabilization. Twenty-seven patients (18-35years) underwent arthroscopic anterior shoulder stabilization. Patients were randomized into two groups. A supervised group (n=14) received a rehabilitation program, 3 sessions/week for 24 weeks and a controlled home treated group (n=13) who followed a home-based program for same period. Range of motion (ROM) of the shoulder was assessed 4 times after each phase of rehabilitation and function was assessed after the 3rd and 4th phase of rehabilitation. Both groups achieved a significant progressive increase in all shoulder motions throughout the study period. Patients in the supervised group achieved 92.6% and 94.2% of the contralateral side in abduction and forward elevation respectively. The controlled home-based group achieved 87.1% and 94.7% of abduction and forward elevation respectively. For external rotation, the percentage ROM achieved was 81.1% for the supervised group and 76.4% for the controlled home-based group. For function assessment, the two groups showed a significant improvement. However, the two groups were not significantly different from each other in all measured variables. A controlled home-based physical therapy program is as effective as a supervised program in increasing shoulder range of motion and function after arthroscopic anterior shoulder stabilization. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  8. Mechanism of Developmental Change in the PLAY Project Home Consultation Program: Evidence from a Randomized Control Trial.

    PubMed

    Mahoney, Gerald; Solomon, Richard

    2016-05-01

    This investigation is a secondary analysis of data from a randomized control trial of the PLAY Home Consultation Intervention Program which was conducted with 112 preschool children with Autism Spectrum Disorders and their parents (Solomon et al. in J Dev Behav Pediatr 35:475-485, 2014). Subjects were randomly assigned to either a community standard (CS) treatment group or to the PLAY Project plus CS Treatment (PLAY). PLAY subjects received monthly parent-child intervention sessions for 1 year during which parents learned how to use the rationale and interactive strategies of the Developmental, Individual-differences, Relationship-based (DIR) intervention model (Greenspan and Weider in The child with special needs: encouraging intellectual and emotional growth. DeCapo Press, Cambridge, MA, 1998) to engage in more responsive, affective and less directive interactions with their children. This investigation examined whether PLAY intervention effects on parents' style of interacting with their children as well as on children's social engagement mediated the effects of PLAY on children's autism severity as measured by ADOS calibrated severity scores. Regression procedures were used to test for mediation. There were two main findings. First the effects of PLAY on children's social engagement were mediated by the increases in parental responsiveness and affect that were promoted by PLAY. Second, the effects of PLAY on the severity children's Social Affect disorders were mediated by changes in parental responsiveness and affect; however, the effects of Responsive/Affect were mediated by the impact these variables had on children's social engagement. Results are discussed in terms of contemporary models of developmental change including the developmental change model that is the foundation for DIR.

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

    PubMed

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

    2012-09-01

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

  10. Use of in-home stationary cycling equipment among parents in a family-based randomized trial intervention.

    PubMed

    Rhodes, Ryan E; Beauchamp, Mark R; Blanchard, Chris M; Bredin, Shannon S D; Warburton, Darren E R; Maddison, Ralph

    2018-04-03

    The purpose of this study was to examine the use of home exercise equipment in the form of exergame cycling compared to a stationary recumbent bicycle ergometer in front of TV in the home over 3 months among parents of an intervention with their inactive children. The primary outcome was bike use (total weekly duration). Predictors of bike use in the form of theory of planned behavior and self-determination theory were also examined. Randomized controlled trial. Sixty eight parents of children aged 10-14 were randomized to either the exergame condition (n=36) or the standard bike condition (n=32). Weekly bike use was recorded in a log-book. The exergame bike and a standard bike in front of a TV had similar use across three months (p=.13, η p 2 =.02), which declined over time (p<.01, η p 2 =.14). Parents who were active at baseline and had the intention to use the bikes were more likely to use the bikes (p<.05). Furthermore, those who reported higher perceived control, intrinsic motivation, and affective attitude were more likely to use the bikes (p<.05). The findings suggested that irrespective of modality, use of exercise equipment declined considerably for parents over three-months. Parents may also benefit from family physical activity interventions, but it depends on their physical activity status, how much they would enjoy using the equipment, and their overall perceived control over being physically active. clinicaltrials.gov #NCT01373762. Registered 1 June 2011. Copyright © 2018 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

  11. Using Robots at Home to Support Patients With Chronic Obstructive Pulmonary Disease: Pilot Randomized Controlled Trial

    PubMed Central

    Garrett, Jeff; Jepsen, Nicola; Li Ogilvie, Vickie; Ahn, Ho Seok; Robinson, Hayley; Peri, Kathryn; Kerse, Ngaire; Rouse, Paul; Pillai, Avinesh; MacDonald, Bruce

    2018-01-01

    Background Socially assistive robots are being developed for patients to help manage chronic health conditions such as chronic obstructive pulmonary disease (COPD). Adherence to medication and availability of rehabilitation are suboptimal in this patient group, which increases the risk of hospitalization. Objective This pilot study aimed to investigate the effectiveness of a robot delivering telehealth care to increase adherence to medication and home rehabilitation, improve quality of life, and reduce hospital readmission compared with a standard care control group. Methods At discharge from hospital for a COPD admission, 60 patients were randomized to receive a robot at home for 4 months or to a control group. Number of hospitalization days for respiratory admissions over the 4-month study period was the primary outcome. Medication adherence, frequency of rehabilitation exercise, and quality of life were also assessed. Implementation interviews as well as benefit-cost analysis were conducted. Results Intention-to-treat and per protocol analyses showed no significant differences in the number of respiratory-related hospitalizations between groups. The intervention group was more adherent to their long-acting inhalers (mean number of prescribed puffs taken per day=48.5%) than the control group (mean 29.5%, P=.03, d=0.68) assessed via electronic recording. Self-reported adherence was also higher in the intervention group after controlling for covariates (P=.04). The intervention group increased their rehabilitation exercise frequency compared with the control group (mean difference −4.53, 95% CI −7.16 to −1.92). There were no significant differences in quality of life. Of the 25 patients who had the robot, 19 had favorable attitudes. Conclusions This pilot study suggests that a homecare robot can improve adherence to medication and increase exercise. Further research is needed with a larger sample size to further investigate effects on hospitalizations after

  12. The effectiveness of a clinical and home-based physical activity program and simple lymphatic drainage in the prevention of breast cancer-related lymphedema: A prospective randomized controlled study.

    PubMed

    Dönmez, Ayşe Arıkan; Kapucu, Sevgisun

    2017-12-01

    To investigate the effectiveness of a clinical and home-based, nurse-led physical activity program (PAP) and simple lymphatic drainage (SLD) in the prevention of breast cancer-related lymphedema. A total of 52 breast cancer patients were randomized to either a PAP and SLD program (n = 25) or a control group (n = 27). Patients in both groups were also provided training for lymphedema. The PAP and SLD were administered through home visits by the investigators, twice a week for six weeks, in the intervention group. The control group did not undergo intervention. The circumference of the upper extremity, symptom severity, and physical function were measured in both groups. The upper extremity circumference increased by about two times from the baseline, in the control group, especially in the sixth week (p < 0.05). Lymphedema-related symptom severity scores were found to decrease significantly in the intervention group, compared to those at the baseline (p < 0.05). It was recommended that PAP and SLD, with a follow-up program, be used for patients who planned to undergo breast cancer surgery, starting from before surgery and continuing until after, to prevent breast cancer-related lymphedema. Copyright © 2017 Elsevier Ltd. All rights reserved.

  13. Home-based virtual reality balance training and conventional balance training in Parkinson's disease: A randomized controlled trial.

    PubMed

    Yang, Wen-Chieh; Wang, Hsing-Kuo; Wu, Ruey-Meei; Lo, Chien-Shun; Lin, Kwan-Hwa

    2016-09-01

    Virtual reality has the advantage to provide rich sensory feedbacks for training balance function. This study tested if the home-based virtual reality balance training is more effective than the conventional home balance training in improving balance, walking, and quality of life in patients with Parkinson's disease (PD). Twenty-three patients with idiopathic PD were recruited and underwent twelve 50-minute training sessions during the 6-week training period. The experimental group (n = 11) was trained with a custom-made virtual reality balance training system, and the control group (n = 12) was trained by a licensed physical therapist. Outcomes were measured at Week 0 (pretest), Week 6 (posttest), and Week 8 (follow-up). The primary outcome was the Berg Balance Scale. The secondary outcomes included the Dynamic Gait Index, timed Up-and-Go test, Parkinson's Disease Questionnaire, and the motor score of the Unified Parkinson's Disease Rating Scale. The experimental and control groups were comparable at pretest. After training, both groups performed better in the Berg Balance Scale, Dynamic Gait Index, timed Up-and-Go test, and Parkinson's Disease Questionnaire at posttest and follow-up than at pretest. However, no significant differences were found between these two groups at posttest and follow-up. This study did not find any difference between the effects of the home-based virtual reality balance training and conventional home balance training. The two training options were equally effective in improving balance, walking, and quality of life among community-dwelling patients with PD. Copyright © 2015. Published by Elsevier B.V.

  14. Comparison between the effect of lumbopelvic belt and home based pelvic stabilizing exercise on pregnant women with pelvic girdle pain; a randomized controlled trial.

    PubMed

    Kordi, Ramin; Abolhasani, Maryam; Rostami, Mohsen; Hantoushzadeh, Sedigheh; Mansournia, Mohammad Ali; Vasheghani-Farahani, Farzaneh

    2013-01-01

    Pelvic girdle pain is a common complaint of pregnant women. There are limited data on comparison between the effectiveness of stabilizing exercises and lumbopelvic belt on the treatment of these patients. The objective of this study was to compare the effect of lumbopelvic belt plus information, home based pelvic girdle stabilizing exercises plus information and information alone on pain intensity, functional status and quality of life of pregnant women with pelvic girdle pain. In this randomized clinical trial pregnant women with pelvic girdle pain (n=105) were randomly allocated to three groups; Control group (n=35) that received general information, exercise group (n=31) that in addition to general information were asked to perform specific pelvic stabilizing exercises at home and belt group (n=31) that received non-rigid lumbopelvic belt and the information. The primary outcome variables were pain intensity and functional status of the participants which were measured using visual analogue scale and Oswestry Disability Index (ODI) respectively. Quality of life of participants was measured using WHOQOL-BREF questionnaire. All measurements were performed at baseline, 3 and 6 weeks after the study conduction. The pain intensity of patients in belt group in comparison to other groups was decreased significantly at both 3 and 6 weeks follow-ups. The mean score of ODI of patients in belt group was also improved more than exercise and control groups significantly. On base of our results, it can be found that in short term lumbopelvic belt and information in treatment of pregnant women with pelvic girdle pain is superior to exercise plus information or information alone.

  15. The Effectiveness and Cost-Effectiveness of Web-Based and Home-Based Postnatal Psychoeducational Interventions for First-Time Mothers: Randomized Controlled Trial Protocol

    PubMed Central

    Chong, Yap-Seng; Jiao, Nana; Luo, Nan

    2018-01-01

    Background In addition to recuperating from the physical and emotional demands of childbirth, first-time mothers are met with demands of adapting to their social roles while picking up new skills to take care of their newborn. Mothers may not feel adequately prepared for parenthood if they are situated in an unsupported environment. Postnatal psychoeducational interventions have been shown to be useful and can offer a cost-effective solution for improving maternal outcomes. Objective The objective of this study was to examine the effectiveness and cost-effectiveness of Web-based and home-based postnatal psychoeducational programs for first-time mothers on maternal outcomes. Methods A randomized controlled three-group pre- and posttests experimental design is proposed. This study plans to recruit 204 first-time mothers on their day of discharge from a public tertiary hospital in Singapore. Eligible first-time mothers will be randomly allocated to either a Web-based psychoeducation group, a home-based psychoeducation group, or a control group receiving standard care. The outcomes include maternal parental self-efficacy, social support, psychological well-being (anxiety and postnatal depression), and cost evaluation. Data will be collected at baseline, 1 month, 3 months, and 6 months post-delivery. Results The recruitment (n=204) commenced in October 2016 and was completed in February 2017, with 68 mothers in each group. The 6-month follow-up data collection was completed in August 2017. Conclusions This study may identify an effective and cost-effective Web-based postnatal psychoeducational program to improve first-time mothers’ health outcomes. The provision of a widely-accessed Web-based postnatal psychoeducational program will eventually lead to more positive postnatal experiences for first-time mothers and positively influence their future birth plans. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): 45202278; http

  16. Randomized Trial of Interventions to Improve Childhood Asthma in Homes with Wood-burning Stoves.

    PubMed

    Noonan, Curtis W; Semmens, Erin O; Smith, Paul; Harrar, Solomon W; Montrose, Luke; Weiler, Emily; McNamara, Marcy; Ward, Tony J

    2017-09-13

    Household air pollution due to biomass combustion for residential heating adversely affects vulnerable populations. Randomized controlled trials to improve indoor air quality in homes of children with asthma are limited, and no such studies have been conducted in homes using wood for heating. Our aims were to test the hypothesis that household-level interventions, specifically improved-technology wood-burning appliances or air-filtration devices, would improve health measures, in particular Pediatric Asthma Quality of Life Questionnaire (PAQLQ) scores, relative to placebo, among children living with asthma in homes with wood-burning stoves. A three-arm placebo-controlled randomized trial was conducted in homes with wood-burning stoves among children with asthma. Multiple preintervention and postintervention data included PAQLQ (primary outcome), peak expiratory flow (PEF) monitoring, diurnal peak flow variability (dPFV, an indicator of airway hyperreactivity) and indoor particulate matter (PM) PM2.5. Relative to placebo, neither the air filter nor the woodstove intervention showed improvement in quality-of-life measures. Among the secondary outcomes, dPFV showed a 4.1 percentage point decrease in variability [95% confidence interval (CI)=-7.8 to -0.4] for air-filtration use in comparison with placebo. The air-filter intervention showed a 67% (95% CI: 50% to 77%) reduction in indoor PM2.5, but no change was observed with the improved-technology woodstove intervention. Among children with asthma and chronic exposure to woodsmoke, an air-filter intervention that improved indoor air quality did not affect quality-of-life measures. Intent-to-treat analysis did show an improvement in the secondary measure of dPFV. ClincialTrials.gov NCT00807183. https://doi.org/10.1289/EHP849.

  17. Effect of physical training on urinary incontinence: a randomized parallel group trial in nursing homes.

    PubMed

    Vinsnes, Anne G; Helbostad, Jorunn L; Nyrønning, Signe; Harkless, Gene E; Granbo, Randi; Seim, Arnfinn

    2012-01-01

    Residents in nursing homes (NHs) are often frail older persons who have impaired physical activity. Urinary incontinence (UI) is a common complaint for residents in NHs. Reduced functional ability and residence in NHs are documented to be risk factors for UI. To investigate if an individualized training program designed to improve activity of daily living (ADL) and physical capacity among residents in nursing homes has any impact on UI. This randomized controlled trial was a substudy of a Nordic multicenter study. Participants had to be >65 years, have stayed in the NH for more than 3 months and in need of assistance in at least one ADL. A total of 98 residents were randomly allocated to either a training group (n = 48) or a control group (n = 50) after baseline registrations. The training program lasted for 3 months and included accommodated physical activity and ADL training. Personal treatment goals were elicited for each subject. The control group received their usual care. The main outcome measure was UI as measured by a 24-hour pad-weighing test. There was no statistically significant difference between the groups on this measure at baseline (P = 0.15). Changes were calculated from baseline to 3 months after the end of the intervention. Altogether, 68 participants were included in the analysis, 35 in the intervention group and 33 in the control group. The average age was 84.3 years. The 3 months' postintervention adjusted mean difference between groups according to amount of leakage was 191 g (P = 0.03). This result was statistically significant after adjusting for baseline level, age, sex, and functional status. The leakage increased in residents not receiving the experimental intervention, while UI in the training group showed improvement. The intervention group had significant better results compared with the control group after an individualized training program designed to improve ADL and physical capacity. Further studies are needed to evaluate the

  18. A prospective randomized controlled trial comparing occupational therapy with home-based exercises in conservative treatment of rotator cuff tears.

    PubMed

    Krischak, Gert; Gebhard, Florian; Reichel, Heiko; Friemert, Benedikt; Schneider, Florian; Fisser, Christoph; Kaluscha, Rainer; Kraus, Michael

    2013-09-01

    This pilot study evaluates the outcome after occupational therapy, compared to home-based exercises in the conservative treatment of patients with full thickness rotator cuff tears. Forty-three adult subjects (range, 18-75 years), who had a full thickness rupture of the rotator cuff which was verified by magnetic imaging tomography, with clinical signs of a chronic rotator cuff impingement, and who were available for follow-up, were randomized to occupational therapy or to independent home-based exercises using a booklet. After drop-out, 38 patients were available for full examination at follow-up. Before therapy and after 2 months of conservative treatment, pain intensity, the Constant-Murley score, isokinetic strength testing in abduction and external rotation, functional limitation, clinical shoulder tests and health-related quality of life (EQ-5D) were evaluated. Two-thirds of the patients improved in clinical shoulder tests, regardless of the therapy group. There were no significant differences between the groups with reference to pain, range of motion, maximum peak force (abduction, external rotation), the Constant-Murley score, and the EQ-5D index. The only significant difference observed was the improvement in the self-assessed health- related quality of life (EQ-5D VAS) favoring home-based exercises. Home-based exercise, on the basis of an illustrated booklet with exercises twice a day, supplies comparable results to formal occupational therapy in the conservative treatment of rotator cuff tears. The results of this pilot study suggest some potential advantages related to psychological benefits using home-based treatment. Copyright © 2013 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Mosby, Inc. All rights reserved.

  19. Improving early relationships: a randomized, controlled trial of an age-paced parenting newsletter.

    PubMed

    Waterston, Tony; Welsh, Brenda; Keane, Brigid; Cook, Margaret; Hammal, Donna; Parker, Louise; McConachie, Helen

    2009-01-01

    Parenting is recognized as a key mediator in both health and educational outcomes. Much is known on the value of support and group work in benefiting parenting, but little is known on the effect of written information. A randomized, controlled trial was conducted to evaluate the effect of a parenting newsletter, sent monthly to the parents' home from birth to 1 year, on maternal well-being and parenting style. We tested the hypothesis that mothers receiving the newsletter would show less stress and better parenting characteristics than controls. Parents of first infants born in a North East England District General Hospital between February and October 2003 who consented to take part in the study were randomly allocated to either the intervention or control arm. Those in the intervention arm were sent 12 monthly issues of an age-paced parenting newsletter containing information on emotional development, parent-child interaction, and play. Both the intervention and control group received normal parenting support. Mothers in both groups completed the Well-being Index, Parenting Daily Hassles Scale, and the Adult-Adolescent Parenting Inventory at birth and at 1 year. One hundred eighty-five mothers were recruited, with 94 randomly assigned to the intervention group, and 91 controls. Allowing for differences at recruitment, there were significant differences between the groups at 1 year: the intervention mothers had lower frequency and intensity of perceived hassles and fewer inappropriate expectations of the infant on the Adult-Adolescent Parenting Inventory than the control mothers. A monthly parenting newsletter sent directly to the home in the first year of life seems to help parents to understand their infant better and feel less hassled. This intervention is low cost and can be applied to all parents, so it is nonstigmatizing.

  20. Meals Enhancing Nutrition after Discharge (MEND): Findings from a Pilot Randomized Controlled Trial

    PubMed Central

    Campbell, Anthony D.; Godfryd, Alice; Flood, Kellie; Kitchin, Elizabeth; Kilgore, Meredith L.; Allocca, Sally; Locher, Julie L.

    2016-01-01

    Background After older adults experience episodes of poor health or are hospitalized, they may not return to pre-morbid eating behaviors. Furthermore, poor nutrition increases hospital readmission risk, but evidence-based interventions addressing these risks are limited. Objective The pilot study’s objective was to evaluate the feasibility of conducting a randomized controlled trial assessing a post-discharge home-delivered meals program’s impact on older adults’ nutritional intake and hospital readmissions and to assess patient acceptability and satisfaction with the program. The aims of the study were to 1) to evaluate successful recruitment, randomization, and retention of at least 80% of the 24 participants sought; 2) to compare the outcomes of hospital readmission and total daily caloric intake between participants in the intervention and control groups; and 3) to assess patient acceptability and satisfaction with the program. Design This study used a two-arm randomized controlled trial design, and baseline data were collected at enrollment; three 24-hour food recalls were collected during the intervention period; and health services utilization and intervention satisfaction was evaluated 45 days post-discharge. Participants/setting Twenty-four patients from the University of Alabama at Birmingham (UAB) Hospital’s Acute Care for Elders Unit were enrolled from May 2014 to June 2015. They were 65 or older, at risk of malnutrition, cognitively intact, able to communicate, discharged to a place where the patient or family was responsible for preparing meals, and diagnosed with congestive heart failure, chronic obstructive pulmonary disease, acute myocardial infarction, or pneumonia. Final analysis included 21 participants. Intervention The intervention group received 10 days of home-delivered meals and nutrition education; the control group received usual care and nutrition education. Main outcome measures The main outcome was intervention feasibility

  1. Combining a Multi-Agent System and Communication Middleware for Smart Home Control: A Universal Control Platform Architecture

    PubMed Central

    Zheng, Song; Zhang, Qi; Zheng, Rong; Huang, Bi-Qin; Song, Yi-Lin; Chen, Xin-Chu

    2017-01-01

    In recent years, the smart home field has gained wide attention for its broad application prospects. However, families using smart home systems must usually adopt various heterogeneous smart devices, including sensors and devices, which makes it more difficult to manage and control their home system. How to design a unified control platform to deal with the collaborative control problem of heterogeneous smart devices is one of the greatest challenges in the current smart home field. The main contribution of this paper is to propose a universal smart home control platform architecture (IAPhome) based on a multi-agent system and communication middleware, which shows significant adaptability and advantages in many aspects, including heterogeneous devices connectivity, collaborative control, human-computer interaction and user self-management. The communication middleware is an important foundation to design and implement this architecture which makes it possible to integrate heterogeneous smart devices in a flexible way. A concrete method of applying the multi-agent software technique to solve the integrated control problem of the smart home system is also presented. The proposed platform architecture has been tested in a real smart home environment, and the results indicate that the effectiveness of our approach for solving the collaborative control problem of different smart devices. PMID:28926957

  2. Combining a Multi-Agent System and Communication Middleware for Smart Home Control: A Universal Control Platform Architecture.

    PubMed

    Zheng, Song; Zhang, Qi; Zheng, Rong; Huang, Bi-Qin; Song, Yi-Lin; Chen, Xin-Chu

    2017-09-16

    In recent years, the smart home field has gained wide attention for its broad application prospects. However, families using smart home systems must usually adopt various heterogeneous smart devices, including sensors and devices, which makes it more difficult to manage and control their home system. How to design a unified control platform to deal with the collaborative control problem of heterogeneous smart devices is one of the greatest challenges in the current smart home field. The main contribution of this paper is to propose a universal smart home control platform architecture (IAPhome) based on a multi-agent system and communication middleware, which shows significant adaptability and advantages in many aspects, including heterogeneous devices connectivity, collaborative control, human-computer interaction and user self-management. The communication middleware is an important foundation to design and implement this architecture which makes it possible to integrate heterogeneous smart devices in a flexible way. A concrete method of applying the multi-agent software technique to solve the integrated control problem of the smart home system is also presented. The proposed platform architecture has been tested in a real smart home environment, and the results indicate that the effectiveness of our approach for solving the collaborative control problem of different smart devices.

  3. A randomized controlled trial of qigong for fibromyalgia

    PubMed Central

    2012-01-01

    Introduction Fibromyalgia is difficult to treat and requires the use of multiple approaches. This study is a randomized controlled trial of qigong compared with a wait-list control group in fibromyalgia. Methods One hundred participants were randomly assigned to immediate or delayed practice groups, with the delayed group receiving training at the end of the control period. Qigong training (level 1 Chaoyi Fanhuan Qigong, CFQ), given over three half-days, was followed by weekly review/practice sessions for eight weeks; participants were also asked to practice at home for 45 to 60 minutes per day for this interval. Outcomes were pain, impact, sleep, physical function and mental function, and these were recorded at baseline, eight weeks, four months and six months. Immediate and delayed practice groups were analyzed individually compared to the control group, and as a combination group. Results In both the immediate and delayed treatment groups, CFQ demonstrated significant improvements in pain, impact, sleep, physical function and mental function when compared to the wait-list/usual care control group at eight weeks, with benefits extending beyond this time. Analysis of combined data indicated significant changes for all measures at all times for six months, with only one exception. Post-hoc analysis based on self-reported practice times indicated greater benefit with the per protocol group compared to minimal practice. Conclusions This study demonstrates that CFQ, a particular form of qigong, provides long-term benefits in several core domains in fibromyalgia. CFQ may be a useful adjuvant self-care treatment for fibromyalgia. Trial registration clinicaltrials.gov NCT00938834. PMID:22863206

  4. To evaluate if increased supervision and support of South African Government health workers' home visits improves maternal and child outcomes: study protocol for a randomized control trial.

    PubMed

    Rotheram-Borus, Mary Jane; Le Roux, Karl; Le Roux, Ingrid M; Christodoulou, Joan; Laurenzi, Christina; Mbewu, Nokwanele; Tomlinson, Mark

    2017-08-07

    Concurrent epidemics of HIV, depression, alcohol abuse, and partner violence threaten maternal and child health (MCH) in South Africa. Although home visiting has been repeatedly demonstrated efficacious in research evaluations, efficacy disappears when programs are scaled broadly. In this cluster randomized controlled trial (RCT), we examine whether the benefits of ongoing accountability and supervision within an existing government funded and implemented community health workers (CHW) home visiting program ensure the effectiveness of home visiting. In the deeply rural, Eastern Cape of South Africa, CHW will be hired by the government and will be initially trained by the Philani Programme to conduct home visits with all pregnant mothers and their children until the children are 2 years old. Eight clinics will be randomized to receive either (1) the Accountable Care Condition in which additional monitoring and accountability systems that Philani routinely uses are implemented (4 clinics, 16 CHW, 450 households); or (2) a Standard Care Condition of initial Philani training, but with supervision and monitoring being delivered by local government structures and systems (4 clinics, 21 CHW, 450 households). In the Accountable Care Condition areas, the CHW's mobile phone reports, which are time-location stamped, will be monitored and data-informed supervision will be provided, as well as monitoring growth, medical adherence, mental health, and alcohol use outcomes. Interviewers will independently assess outcomes at pregnancy at 3, 6, 15, and 24 months post-birth. The primary outcome will be a composite score of documenting maternal HIV/TB testing, linkage to care, treatment adherence and retention, as well as child physical growth, cognitive functioning, and child behavior and developmental milestones. The proposed cluster RCT will evaluate whether routinely implementing supervision and accountability procedures and monitoring CHWs' over time will improve MCH outcomes

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

    PubMed

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

    2018-01-12

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

  6. Effect of Home Care Nursing on Patients Discharged From Hospital With Self-Reported Signs of Constipation: A Randomized Trial.

    PubMed

    Konradsen, Hanne; Rasmussen, Marie Louise Thiese; Noiesen, Eline; Trosborg, Ingelise

    Constipation is a common health problem in relation to hospitalization. This randomized controlled trial aimed to investigate whether advice from a home care nurse after discharge had an effect on self-reported signs of constipation. A total of 59 patients were included in the study on the basis of their self-reported signs of constipation evaluated using the Constipation Assessment Scale. Advice from the home care nurses was given on the intake of fiber and liquid and mobilization related to scorings on the Constipation Risk Assessment Scale, the administration of laxatives, and referral to a physician when needed. Results showed a tendency toward the visits being effective, but a more complex intervention might be needed.

  7. Development and face validation of a Virtual Reality Epley Maneuver System (VREMS) for home Epley treatment of benign paroxysmal positional vertigo: A randomized, controlled trial.

    PubMed

    Tabanfar, Reza; Chan, Harley H L; Lin, Vincent; Le, Trung; Irish, Jonathan C

    To develop and validate a smartphone based Virtual Reality Epley Maneuver System (VREMS) for home use. A smartphone application was designed to produce stereoscopic views of a Virtual Reality (VR) environment, which when viewed after placing a smartphone in a virtual reality headset, allowed the user to be guided step-by-step through the Epley maneuver in a VR environment. Twenty healthy participants were recruited and randomized to undergo either assisted Epleys or self-administered Epleys following reading instructions from an Instructional Handout (IH). All participants were filmed and two expert Otologists reviewed the videos, assigning each participant a score (out of 10) for performance on each step. Participants rated their perceived workload by completing a validated task-load questionnaire (NASA Task Load Index) and averages for both groups were calculated. Twenty participants were evaluated with average age 26.4±7.12years old in the VREMS group and 26.1±7.72 in the IH group. The VR assisted group achieved an average score of 7.78±0.99 compared to 6.65±1.72 in the IH group. This result was statistically significant with p=0.0001 and side dominance did not appear to play a factor. Analyzing each step of the Epley maneuver demonstrated that assisted Epleys were done more accurately with statically significant results in steps 2-4. Results of the NASA-TLX scores were variable with no significant findings. We have developed and demonstrated face validity for VREMS through our randomized controlled trial. The VREMS platform is promising technology, which may improve the accuracy and effectiveness of home Epley treatments. N/A. Copyright © 2017 Elsevier Inc. All rights reserved.

  8. Dual Intervention to Increase Chlamydia Retesting: A Randomized Controlled Trial in Three Populations.

    PubMed

    Smith, Kirsty S; Hocking, Jane S; Chen, Marcus Y; Fairley, Christopher K; McNulty, Anna M; Read, Phillip; Bradshaw, Catriona S; Tabrizi, Sepehr N; Wand, Handan; Saville, Marion; Rawlinson, William; Garland, Suzanne M; Donovan, Basil; Kaldor, John M; Guy, Rebecca J

    2015-07-01

    Chlamydia retesting 3 months after treatment is recommended to detect reinfections, but retesting rates are typically low. The purpose of this study is to determine if the addition of a postal home collection kit to a short message service (SMS) reminder at 3 months increases the percentage of patients retested for chlamydia at 1-4 months, compared to SMS alone. In this unblinded randomized controlled trial, participants were randomized 1:1 to intervention (home arm) or control (clinic arm) status. Participants included 200 each of women, heterosexual men, and men who have sex with men diagnosed and treated for chlamydia at sexual health services. Three months after chlamydia diagnosis, home arm participants received an SMS reminder and postal home collection kit (women, vaginal swab; heterosexual men, Copan UriSwab; men who have sex with men, UriSwab and rectal swab). The main outcome measures were the percentage of participants retested at 1-4 months after chlamydia diagnosis and the percentage in each arm with repeat positive tests, by risk group and overall, analyzed by intention to treat. Data were collected from 2011 to 2013 and analyzed in 2014. The percentage retested within 1-4 months of chlamydia diagnosis was significantly higher in home versus clinic arm participants among women (64% [66/103] vs 39% [38/97], p<0.001); heterosexual men (56% [57/101] vs 34% [34/99], p=0.002); men who have sex with men (62% [61/98] vs 44% [45/102], p=0.010); and overall (61% [184/302] vs 39% [117/298], p<0.001). The percentage in the home versus clinic arm with repeat positive tests was significantly higher among men who have sex with men (16% [16/98] vs 5% [5/102], p=0.021) and overall (10% [31/302] vs 4% [12/298], p=0.006). The addition of a postal home collection kit to routine SMS reminders resulted in substantial improvements in chlamydia retesting rates in all three risk groups and detection of more repeat positive tests, compared with SMS alone. Extending the

  9. Nine-year follow-up of a home-visitation program: a randomized trial.

    PubMed

    Fergusson, David M; Boden, Joseph M; Horwood, L John

    2013-02-01

    To evaluate the extent to which a home-visitation program (Early Start) had benefits for child abuse, child behavior, and parental- and family-level benefits to the 9-year follow-up. A randomized controlled trial in which 220 families receiving Early Start were contrasted with a control series of 223 families not receiving the program. Families were enrolled in the program for up to 5 years. Outcomes were assessed at 6 months, annually from 1 year to 6 years, and at 9 years after trial entry. Comparisons between the Early Start and control series showed that families in the Early Start program showed significant (P < .05) benefits in reduced risk of hospital attendance for unintentional injury, lower risk of parent-reported harsh punishment, lower levels of physical punishment, higher parenting competence scores, and more positive child behavioral adjustment scores. Effect sizes (Cohen's "d") ranged from 0.13 to 0.29 (median = 0.25). There were no significant differences (all P values > .05) between the Early Start and control series on a range of measures of parental behavior and family outcomes, including maternal depression, parental substance use, intimate partner violence, adverse economic outcomes, and life stress. The Early Start program was associated with small to moderate benefits in a range of areas relating to child abuse, physical punishment, child behavior, and parenting competence. There was little evidence to suggest that the Early Start program had benefits that extended to the level of parents or family overall.

  10. Randomized Trial of Interventions to Improve Childhood Asthma in Homes with Wood-burning Stoves

    PubMed Central

    Semmens, Erin O.; Smith, Paul; Harrar, Solomon W.; Montrose, Luke; Weiler, Emily; McNamara, Marcy; Ward, Tony J.

    2017-01-01

    Background: Household air pollution due to biomass combustion for residential heating adversely affects vulnerable populations. Randomized controlled trials to improve indoor air quality in homes of children with asthma are limited, and no such studies have been conducted in homes using wood for heating. Objectives: Our aims were to test the hypothesis that household-level interventions, specifically improved-technology wood-burning appliances or air-filtration devices, would improve health measures, in particular Pediatric Asthma Quality of Life Questionnaire (PAQLQ) scores, relative to placebo, among children living with asthma in homes with wood-burning stoves. Methods: A three-arm placebo-controlled randomized trial was conducted in homes with wood-burning stoves among children with asthma. Multiple preintervention and postintervention data included PAQLQ (primary outcome), peak expiratory flow (PEF) monitoring, diurnal peak flow variability (dPFV, an indicator of airway hyperreactivity) and indoor particulate matter (PM) PM2.5. Results: Relative to placebo, neither the air filter nor the woodstove intervention showed improvement in quality-of-life measures. Among the secondary outcomes, dPFV showed a 4.1 percentage point decrease in variability [95% confidence interval (CI)=−7.8 to −0.4] for air-filtration use in comparison with placebo. The air-filter intervention showed a 67% (95% CI: 50% to 77%) reduction in indoor PM2.5, but no change was observed with the improved-technology woodstove intervention. Conclusions: Among children with asthma and chronic exposure to woodsmoke, an air-filter intervention that improved indoor air quality did not affect quality-of-life measures. Intent-to-treat analysis did show an improvement in the secondary measure of dPFV. Trial registration: ClincialTrials.gov NCT00807183. https://doi.org/10.1289/EHP849 PMID:28935614

  11. Effectiveness of educational nursing home visits on quality of life, functional status and care dependency in older adults with mobility impairments: a randomized controlled trial.

    PubMed

    Buss, Arne; Wolf-Ostermann, Karin; Dassen, Theo; Lahmann, Nils; Strupeit, Steve

    2016-04-01

    Facilitating and maintaining functional status (FS) and quality of life (QoL) and avoiding care dependency (CD) are and will increasingly become major tasks of nursing. Educational nursing home visits may have positive effects on FS and QoL in older adults. The aim of this study was to determine the effectiveness of educational home visits on FS, QoL and CD in older adults with mobility impairments. We performed a randomized controlled trial. The study was conducted in the living environments of 123 participants with functional impairments living in Hamburg, Germany. The intervention group received an additional nursing education intervention on mobility and QoL; the control group received care as usual. Data were collected from August 2011 to December 2012 at baseline, 6 months and 12 months of follow-up. The main outcomes were FS (Barthel Index), QoL (WHOQOL-BREF) and CD (Care Dependency Scale). Data were analyzed using descriptive statistics and generalized linear models. In total, 113 participants (57 in the intervention and 56 in the control group) were included in the study. The intervention had no statistical significant effect on FS, QoL and CD. The intervention did not show the benefits that we assumed. Further studies on the effects of educational nursing interventions should be performed using different concepts and rigorous research methods. © 2015 John Wiley & Sons, Ltd.

  12. Design and pilot results of a single blind randomized controlled trial of systematic demand-led home visits by nurses to frail elderly persons in primary care [ISRCTN05358495].

    PubMed

    van Hout, Hein P J; Nijpels, Giel; van Marwijk, Harm W J; Jansen, Aaltje P D; Van't Veer, Petronella J; Tybout, Willemijn; Stalman, Wim A B

    2005-09-08

    The objective of this article is to describe the design of an evaluation of the cost-effectiveness of systematic home visits by nurses to frail elderly primary care patients. Pilot objectives were: 1. To determine the feasibility of postal multidimensional frailty screening instruments; 2. to identify the need for home visits to elderly. Main study: The main study concerns a randomized controlled in primary care practices (PCP) with 18 months follow-up and blinded PCPs. Frail persons aged 75 years or older and living at home but neither terminally ill nor demented from 33 PCPs were eligible. Trained community nurses (1) visit patients at home and assess the care needs with the Resident Assessment Instrument-Home Care, a multidimensional computerized geriatric assessment instrument, enabling direct identification of problem areas; (2) determine the care priorities together with the patient; (3) design and execute interventions according to protocols; (4) and visit patients at least five times during a year in order to execute and monitor the care-plan. Controls receive usual care. Outcome measures are Quality of life, and Quality Adjusted Life Years; time to nursing home admission; mortality; hospital admissions; health care utilization. Pilot 1: Three brief postal multidimensional screening measures to identify frail health among elderly persons were tested on percentage complete item response (selected after a literature search): 1) Vulnerable Elders Screen, 2) Strawbridge's frailty screen, and 3) COOP-WONCA charts. Pilot 2: Three nurses visited elderly frail patients as identified by PCPs in a health center of 5400 patients and used an assessment protocol to identify psychosocial and medical problems. The needs and experiences of all participants were gathered by semi-structured interviews. The design holds several unique elements such as early identification of frail persons combined with case-management by nurses. From two pilots we learned that of three

  13. Fall risk and incidence reduction in high risk individuals with multiple sclerosis: a pilot randomized control trial.

    PubMed

    Sosnoff, Jacob J; Moon, Yaejin; Wajda, Douglas A; Finlayson, Marcia L; McAuley, Edward; Peterson, Elizabeth W; Morrison, Steve; Motl, Robert W

    2015-10-01

    To determine the feasibility of three fall prevention programs delivered over 12 weeks among individuals with multiple sclerosis: (A) a home-based exercise program targeting physiological risk factors; (B) an educational program targeting behavioral risk factors; and (C) a combined exercise-and-education program targeting both factors. Randomized controlled trial. Home-based training with assessments at research laboratory. A total of 103 individuals inquired about the investigation. After screening, 37 individuals with multiple sclerosis who had fallen in the last year and ranged in age from 45-75 years volunteered for the investigation. A total of 34 participants completed postassessment following the 12-week intervention. Participants were randomly assigned into one of four conditions: (1) wait-list control (n = 9); (2) home-based exercise (n = 11); (3) education (n = 9); or (4) a combined exercise and education (n = 8) group. Before and after the 12-week interventions, participants underwent a fall risk assessment as determined by the physiological profile assessment and provided information on their fall prevention behaviors as indexed by the Falls Prevention Strategy Survey. Participants completed falls diaries during the three-months postintervention. A total of 34 participants completed postintervention testing. Procedures and processes were found to be feasible. Overall, fall risk scores were lower in the exercise groups (1.15 SD 1.31) compared with the non-exercise groups (2.04 SD 1.04) following the intervention (p < 0.01). There was no group difference in fall prevention behaviors (p > 0.05). Further examination of home-based exercise/education programs for reducing falls in individuals with multiple sclerosis is warranted. A total of 108 participants would be needed in a larger randomized controlled trial.ClinicalTrials.org #NCT01956227. © The Author(s) 2014.

  14. Effectiveness of an Educational Physiotherapy and Therapeutic Exercise Program in Adult Patients With Hemophilia: A Randomized Controlled Trial.

    PubMed

    Cuesta-Barriuso, Rubén; Torres-Ortuño, Ana; Nieto-Munuera, Joaquín; López-Pina, José Antonio

    2017-05-01

    To assess the efficacy of an educational physiotherapy home exercise intervention for physical improvement, pain perception, quality of life, and illness behavior in patients with hemophilic arthropathy. Single-blind randomized controlled trial. Home. Patients with hemophilia (N=20) were randomly allocated to an educational intervention group or to a control group. The educational intervention was performed every 2 weeks over a 15-week period, and home exercises were carried out once a day, 6 days a week, over the same period. Joint status was evaluated using the Gilbert scale; pain was assessed using the visual analog scale; illness behavior was evaluated using the Illness Behavior Questionnaire; and the perception of the quality of life was evaluated using the A36 Hemophilia-QoL questionnaire. We observed significant differences in the intervention group and the control group for both quality of life and illness behavior. There was no significant improvement in joint status; however, an improvement was noted in terms of perception of pain in the ankle. A physiotherapy program based on educational sessions and home exercises can improve the perception of pain in patients with hemophilic arthropathy of the ankle. It improves some variables in the perception of the quality of life and illness behavior. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  15. A prospective pilot study of home monitoring in adults with cystic fibrosis (HOME-CF): protocol for a randomised controlled trial.

    PubMed

    Choyce, Jocelyn; Shaw, Karen L; Sitch, Alice J; Mistry, Hema; Whitehouse, Joanna L; Nash, Edward F

    2017-01-23

    Home monitoring has the potential to detect early pulmonary exacerbations in people with cystic fibrosis (CF), with consequent improvements in health outcomes and healthcare associated costs. This study aims to assess the effects of home monitoring on hospital admissions, quality of life, antibiotic requirements, exacerbation frequency, lung function, nutritional outcomes, anxiety, depression, costs and health outcomes, as well as the qualitative effects on the patient experience. This randomised controlled mixed-methods trial aims to recruit 100 adults with CF cared for in one large regional CF centre. Participants are randomly allocated 1:1 to the intervention group (twice-weekly home monitoring of symptoms measured by the Cystic Fibrosis Respiratory Symptom Diary - Chronic Respiratory Infection Symptom Score (CFRSD-CRISS) and Forced Expiratory Volume in one second (FEV 1 )) or a control group (routine clinical care) for the 12-month study period. Measurements are recorded at study visits at baseline, 3, 6, 9 and 12 months. Spirometry, body weight, co-morbidities, medications, hospital inpatient days, courses of antibiotics (oral and intravenous), pulmonary exacerbations (defined by the modified Fuchs criteria) are recorded at each study visit. Health status, capability and health economics are measured at each study visit by the Hospital Anxiety and Depression Scale (HADS), the ICEpop CAPability measure for Adults (ICECAP-A), EuroQol 5 dimensions (EQ-5D-5L) questionnaire and an adapted resource use questionnaire. The patient experience is assessed by semi-structured qualitative interviews at baseline and 12 months. Results from this study will help to determine the effect of home monitoring on inpatient bed days and quality of life in adults with CF, as well as other relevant health and health economic outcomes. This study protocol is registered with Clinicaltrials.gov ( NCT02994706 ), date registered 16 th July 2014.

  16. Using Robots at Home to Support Patients With Chronic Obstructive Pulmonary Disease: Pilot Randomized Controlled Trial.

    PubMed

    Broadbent, Elizabeth; Garrett, Jeff; Jepsen, Nicola; Li Ogilvie, Vickie; Ahn, Ho Seok; Robinson, Hayley; Peri, Kathryn; Kerse, Ngaire; Rouse, Paul; Pillai, Avinesh; MacDonald, Bruce

    2018-02-13

    Socially assistive robots are being developed for patients to help manage chronic health conditions such as chronic obstructive pulmonary disease (COPD). Adherence to medication and availability of rehabilitation are suboptimal in this patient group, which increases the risk of hospitalization. This pilot study aimed to investigate the effectiveness of a robot delivering telehealth care to increase adherence to medication and home rehabilitation, improve quality of life, and reduce hospital readmission compared with a standard care control group. At discharge from hospital for a COPD admission, 60 patients were randomized to receive a robot at home for 4 months or to a control group. Number of hospitalization days for respiratory admissions over the 4-month study period was the primary outcome. Medication adherence, frequency of rehabilitation exercise, and quality of life were also assessed. Implementation interviews as well as benefit-cost analysis were conducted. Intention-to-treat and per protocol analyses showed no significant differences in the number of respiratory-related hospitalizations between groups. The intervention group was more adherent to their long-acting inhalers (mean number of prescribed puffs taken per day=48.5%) than the control group (mean 29.5%, P=.03, d=0.68) assessed via electronic recording. Self-reported adherence was also higher in the intervention group after controlling for covariates (P=.04). The intervention group increased their rehabilitation exercise frequency compared with the control group (mean difference -4.53, 95% CI -7.16 to -1.92). There were no significant differences in quality of life. Of the 25 patients who had the robot, 19 had favorable attitudes. This pilot study suggests that a homecare robot can improve adherence to medication and increase exercise. Further research is needed with a larger sample size to further investigate effects on hospitalizations after improvements are made to the robots. The robots could be

  17. Domestic Violence Enhanced Perinatal Home Visits: The DOVE Randomized Clinical Trial.

    PubMed

    Sharps, Phyllis W; Bullock, Linda F; Campbell, Jacquelyn C; Alhusen, Jeanne L; Ghazarian, Sharon R; Bhandari, Shreya S; Schminkey, Donna L

    2016-11-01

    Perinatal intimate partner violence (IPV) is common and has significant negative health outcomes for mothers and infants. This study evaluated the effectiveness of an IPV intervention in reducing violence among abused women in perinatal home visiting programs. This assessor-blinded multisite randomized control trial of 239 women experiencing perinatal IPV was conducted from 2006 to 2012 in U.S. urban and rural settings. The Domestic Violence Enhanced Home Visitation Program (DOVE) intervention group (n = 124) received a structured abuse assessment and six home visitor-delivered empowerment sessions integrated into home visits. All participants were screened for IPV and referred appropriately. IPV was measured by the Conflicts Tactics Scale2 at baseline through 24 months postpartum. There was a significant decrease in IPV over time (F = 114.23; p < 0.001) from baseline to 1, 3, 6, 12, 18, and 24 months postpartum (all p < 0.001). Additional models examining change in IPV from baseline indicated a significant treatment effect (F = 6.45; p < 0.01). Women in the DOVE treatment group reported a larger mean decrease in IPV scores from baseline compared to women in the usual care group (mean decline 40.82 vs. 35.87). All models accounted for age and maternal depression as covariates. The DOVE intervention was effective in decreasing IPV and is brief, thereby facilitating its incorporation within well-woman and well-child care visits, as well as home visiting programs, while satisfying recommendations set forth in the Affordable Care Act for IPV screening and brief counseling.

  18. A randomized clinical trial of theory-based activities for the behavioral symptoms of dementia in nursing home residents.

    PubMed

    Kolanowski, Ann; Litaker, Mark; Buettner, Lin; Moeller, Joyel; Costa, Paul T

    2011-06-01

    To test the main and interactive effects of activities derived from the Need-Driven Dementia-Compromised Behavior model for responding to behavioral symptoms in nursing home residents. Randomized double-blind clinical trial. Nine community-based nursing homes. One hundred twenty-eight cognitively impaired residents randomly assigned to activities adjusted to functional level (FL) (n=32), personality style of interest (PSI) (n=33), functional level and personality style of interest (FL+PSI) (n=31), or active control (AC) (n=32). Three weeks of activities provided twice daily. Agitation, passivity, engagement, affect, and mood assessed from video recordings and real-time observations during baseline, intervention, random times outside of intervention, and 1 week after intervention. All treatments improved outcomes during intervention except mood, which worsened under AC. During intervention the PSI group demonstrated greater engagement, alertness, and attention than the other groups; the FL+PSI group demonstrated greater pleasure. During random times, engagement returned to baseline levels except in the FL group in which it decreased. There was also less agitation and passivity in groups with a component adjusted to PSI. One week after the intervention, mood, anxiety, and passivity improved over baseline; significantly less pleasure was displayed after withdrawal of treatment. The hypothesis that activities adjusted to FL+PSI would improve behavioral outcomes to a greater extent than partially adjusted or nonadjusted activities was partially supported. PSI is a critical component of individualized activity prescription. © 2011, Copyright the Authors. Journal compilation © 2011, The American Geriatrics Society.

  19. The marketing plan and outcome indicators for recruiting and retaining parents in the HomeStyles randomized controlled trial.

    PubMed

    Byrd-Bredbenner, Carol; Delaney, Colleen; Martin-Biggers, Jennifer; Koenings, Mallory; Quick, Virginia

    2017-11-15

    Despite the critical importance of successful recruitment and retention to study integrity, reporting of recruitment and retention strategies along with factors associated with successful recruitment and retention of participants in health-related interventions remain rare, especially for health and obesity prevention programs. Thus, the purpose of this article is to retrospectively examine the recruitment and retention marketing plan used in the online HomeStyles randomized controlled trial (RCT) and discuss outcomes associated with completion of the intervention. The HomeStyles RCT is an online intervention developed to motivate parents of young children to gain the skills and self-confidence needed to shape home environments and lifestyles to be protective against childhood obesity. Using the seven Ps of services marketing (i.e., people, place, product, physical evidence, price, promotion, and process), a comprehensive and systematic plan for recruitment and retention was implemented and outcomes assessed. A total of 489 parents with a young child aged 2 to < 6 years were eligible to participate, a final capture rate of 33%. Only 23% of Hispanic participants chose to use the Spanish-language version of HomeStyles intervention materials, below the demand anticipated. However, Hispanic enrollment overall was substantially higher than the U.S. population proportion (i.e., 17%). The number of participants prematurely leaving the study was similar in both treatment groups, indicating attrition was not differential. Completers reported high satisfaction of HomeStyles, using a 1-5 scale (strongly disagree to strongly agree) on guide attractiveness, interestingness, and usefulness. Despite all the retention efforts, the average monthly recruitment accrual rate of ~ 33 eligible enrolled participants at baseline (i.e., 489 participants/15-month recruitment period), declined to ~ 18, 11, 9, and 8 remaining recruited participants/month at midpoint, post, follow

  20. Interventions to address deficits of pharmacological pain management in nursing home residents--A cluster-randomized trial.

    PubMed

    Könner, F; Budnick, A; Kuhnert, R; Wulff, I; Kalinowski, S; Martus, P; Dräger, D; Kreutz, R

    2015-10-01

    To evaluate the effect of interventions for general practitioners and nursing home staff to improve pain severity and appropriateness of pain medication in nursing home residents (NHR). This cluster-randomized controlled trial was conducted in six nursing homes in the intervention and control group, respectively. Pain management was analysed before (T0) and after (T1, T2) an educational intervention in 239 NHR, aged ≥65 years, without moderate or severe cognitive impairment. Primary and secondary outcomes were average pain severity and appropriateness of pain medication as determined with the Numeric Rating Scale and Pain Medication Appropriateness Scale (PMASD ), respectively. At T0, 72.2% and 73.7% of NHR (mean age 83 years) reported pain (average pain severity 2.4) in the intervention and control group, respectively. The PMASD at T0 was 53.9 in the intervention group and 60.8 in the control group (p = 0.12), while 20.6% compared to 6.9% (p = 0.009) received no pain medication in the two groups. At T2, non-significant improvements in the average pain severity (1.59) and PMASD (61.07) were observed in the intervention group. Moreover, the mean individual PMASD increased by 8.09 (p = 0.03) and the proportion of NHR without pain medication decreased by 50% (p = 0.03) in the intervention group. No appreciable changes were found in the control group at T2. NHR exhibited a high prevalence of pain with overall low severity, while a high proportion of individuals received inappropriate pain medications. Both findings were not significantly improved by the intervention, although some aspects of drug treatment were meaningful improved. © 2015 European Pain Federation - EFIC®

  1. Combined transcranial direct current stimulation and home-based occupational therapy for upper limb motor impairment following intracerebral hemorrhage: a double-blind randomized controlled trial.

    PubMed

    Mortensen, Jesper; Figlewski, Krystian; Andersen, Henning

    2016-01-01

    To investigate the combined effect of transcranial direct current stimulation (tDCS) and home-based occupational therapy on activities of daily living (ADL) and grip strength, in patients with upper limb motor impairment following intracerebral hemorrhage (ICH). A double-blind randomized controlled trial with one-week follow-up. Patients received five consecutive days of occupational therapy at home, combined with either anodal (n = 8) or sham (n = 7) tDCS. The primary outcome was ADL performance, which was assessed with the Jebsen-Taylor test (JTT). Both groups improved JTT over time (p < 0.01). The anodal group improved grip strength compared with the sham group from baseline to post-assessment (p = 0.025). However, this difference was attenuated at one-week follow-up. There was a non-significant tendency for greater improvement in JTT in the anodal group compared with the sham group, from baseline to post-assessment (p = 0.158). Five consecutive days of tDCS combined with occupational therapy provided greater improvements in grip strength compared with occupational therapy alone. tDCS is a promising add-on intervention regarding training of upper limb motor impairment. It is well tolerated by patients and can easily be applied for home-based training. Larger studies with long-term follow-up are needed to further explore possible effects of tDCS in patients with ICH. Five consecutive days of tDCS combined with occupational therapy provided greater improvements in grip strength compared with occupational therapy alone. tDCS is well tolerated by patients and can easily be applied for home-based rehabilitation.

  2. Systematic screening with information and home sampling for genital Chlamydia trachomatis infections in young men and women in Norway: a randomized controlled trial.

    PubMed

    Kløvstad, Hilde; Natås, Olav; Tverdal, Aage; Aavitsland, Preben

    2013-01-23

    As most genital Chlamydia trachomatis infections are asymptomatic, many patients do not seek health care for testing. Infections remain undiagnosed and untreated. We studied whether screening with information and home sampling resulted in more young people getting tested, diagnosed and treated for chlamydia in the three months following the intervention compared to the current strategy of testing in the health care system. We conducted a population based randomized controlled trial among all persons aged 18-25 years in one Norwegian county (41 519 persons). 10 000 persons (intervention) received an invitation by mail with chlamydia information and a mail-back urine sampling kit. 31 519 persons received no intervention and continued with usual care (control). All samples from both groups were analysed in the same laboratory. Information on treatment was obtained from the Norwegian Prescription Database (NorPD). We estimated risk ratios and risk differences of being tested, diagnosed and treated in the intervention group compared to the control group. In the intervention group 16.5% got tested and in the control group 3.4%, risk ratio 4.9 (95% CI 4.5-5.2). The intervention led to 2.6 (95% CI 2.0-3.4) times as many individuals being diagnosed and 2.5 (95% CI 1.9-3.4) times as many individuals receiving treatment for chlamydia compared to no intervention in the three months following the intervention. In Norway, systematic screening with information and home sampling results in more young people being tested, diagnosed and treated for chlamydia in the three months following the intervention than the current strategy of testing in the health care system. However, the study has not established that the intervention will reduce the chlamydia prevalence or the risk of complications from chlamydia.

  3. Feasibility of BCI Control in a Realistic Smart Home Environment.

    PubMed

    Kosmyna, Nataliya; Tarpin-Bernard, Franck; Bonnefond, Nicolas; Rivet, Bertrand

    2016-01-01

    Smart homes have been an active area of research, however despite considerable investment, they are not yet a reality for end-users. Moreover, there are still accessibility challenges for the elderly or the disabled, two of the main potential targets for home automation. In this exploratory study we design a control mechanism for smart homes based on Brain Computer Interfaces (BCI) and apply it in the "Domus" smart home platform in order to evaluate the potential interest of users about BCIs at home. We enable users to control lighting, a TV set, a coffee machine and the shutters of the smart home. We evaluate the performance (accuracy, interaction time), usability and feasibility (USE questionnaire) on 12 healthy subjects and 2 disabled subjects. We find that healthy subjects achieve 77% task accuracy. However, disabled subjects achieved a better accuracy (81% compared to 77%).

  4. Effect of the 6-week home-based exercise program on physical activity level and physical fitness in colorectal cancer survivors: A randomized controlled pilot study.

    PubMed

    Lee, Mi Kyung; Kim, Nam Kyu; Jeon, Justin Y

    2018-01-01

    Despite improvement in prognosis of colorectal cancer, colorectal cancer survivors often suffer from adverse effects of cancer treatment, including reduced health-related fitness level. Therefore, this study aimed to examine the feasibility and efficacy of the 6-week home-based exercise program on the level of physical activity and physical fitness in stage II to III colorectal cancer survivors. Seventy-two stage II to III colorectal cancer survivors were randomly assigned to either a home-based exercise (n = 38) or usual care (n = 34) group for 6 weeks. The goal of the home-based exercise program was to increase the level of exercise to 18 metabolic equivalent task hours per week. The primary and the secondary outcomes of this study were physical activity level and physical fitness, respectively. A total of 57 participants (79.2%) completed the trial. Intention-to-treat analysis indicated that moderate physical activity level increased significantly by 269.4 ± 260.6 minutes per week in the exercise group (mean between-group difference, 254.6 minutes; 95% confidence interval, 172.7-434.7; p < 0.001). Physical fitness measured by using the step test (-3.9 vs. 2.6, p = 0.012) and push-up test (3.0 vs. -1.2, p = 0.012) also improved significantly in the exercise group compared to the control group. The 6-week home-based mixed aerobic and resistance exercise program was feasible and effective for increasing physical activity level and physical fitness in stage II to III colorectal cancer survivors.

  5. PLCs used in smart home control

    NASA Astrophysics Data System (ADS)

    Barz, C.; Deaconu, S. I.; Latinovic, T.; Berdie, A.; Pop-Vadean, A.; Horgos, M.

    2016-02-01

    This paper presents the realization of a smart home automation using Siemens PLCs. The smart home interface is realized using the HMI Weintek eMT3070a touchscreen, which shows the window for controlling and monitoring the lighting, room temperature, irrigation systems, swimming pool, etc. By using PLCs, the smart home can be controlled via Ethernet and it can be programmed to the needs of tenants.

  6. Use of Low Level of Continuous Heat as an Adjunct to Physical Therapy Improves Knee Pain Recovery and the Compliance for Home Exercise in Patients With Chronic Knee Pain: A Randomized Controlled Trial.

    PubMed

    Petrofsky, Jerrold S; Laymon, Michael S; Alshammari, Faris S; Lee, Haneul

    2016-11-01

    Petrofsky, JS, Laymon, MS, Alshammari, FS, and Lee, H. Use of low level of continuous heat as an adjunct to physical therapy improves knee pain recovery and the compliance for home exercise in patients with chronic knee pain: a randomized controlled trial. J Strength Cond Res 30(11): 3107-3115, 2016-This study examined if the use of low level continuous heat (LLCH) wraps at home between physical therapy sessions at a clinic resulted in better therapy outcomes in patients with chronic knee pain. Fifty individuals with chronic nonspecific knee pain was randomly allocated to 2 groups: the LLCH group and the placebo group. All subjects underwent 1 hour of conventional physical therapy twice per week for 2 weeks at the outpatient clinic and they were asked to accomplish 1 hour of therapeutic exercise at home each day between sessions. The LLCH group applied LLCH knee wraps for 6 hours at home before home exercise while placebo group took a placebo ibuprofen. (This was done since placebo heat is impossible to use since subjects would notice that the wraps were cold) Before, during, and after intervention, pain intensity, active range of motion of the knee (AROM), knee strength, and home exercise compliance were measured. The LLCH group showed pain attenuation after 2 weeks of therapy sessions (p ≤ 0.05). AROM and strength of the knee significantly improved over time compared to the placebo group. Home exercise compliance was significantly higher in the LLCH group than placebo group (p ≤ 0.05). These results indicated that the use of LLCH as an adjunct to conventional physical therapy for chronic knee pain significantly improved pain attenuation and recovery of strength and movement in patients with chronic knee pain.

  7. Home-based hand rehabilitation after chronic stroke: Randomized, controlled single-blind trial comparing the MusicGlove with a conventional exercise program.

    PubMed

    Zondervan, Daniel K; Friedman, Nizan; Chang, Enoch; Zhao, Xing; Augsburger, Renee; Reinkensmeyer, David J; Cramer, Steven C

    2016-01-01

    Individuals with chronic stroke have limited options for hand rehabilitation at home. Here, we sought to determine the feasibility and efficacy of home-based MusicGlove therapy. Seventeen participants with moderate hand impairment in the chronic phase of stroke were randomized to 3 wk of home-based exercise with either the MusicGlove or conventional tabletop exercises. The primary outcome measure was the change in the Box and Blocks test score from baseline to 1 mo posttreatment. Both groups significantly improved their Box and Blocks test score, but no significant difference was found between groups. The MusicGlove group did exhibit significantly greater improvements than the conventional exercise group in motor activity log quality of movement and amount of use scores 1 mo posttherapy (p = 0.007 and p = 0.04, respectively). Participants significantly increased their use of MusicGlove over time, completing 466 gripping movements per day on average at study end. MusicGlove therapy was not superior to conventional tabletop exercises for the primary end point but was nevertheless feasible and led to a significantly greater increase in self-reported functional use and quality of movement of the impaired hand than conventional home exercises. ClinicalTrials.gov; "Influence of Timing on Motor Learning"; NCT01769326; https://clinicaltrials.gov/ct2/show/NCT01769326.

  8. 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

  9. Locus of control and home mortgage loan behaviour.

    PubMed

    Wang, Mingji; Chen, Hong; Wang, Lei

    2008-04-01

    The present study investigated the impact of locus of control on home mortgage loan behaviours. The results showed that participants with stronger external control were more likely to purchase a lower priced home, have a lower ratio of mortgage loan amount to the total home value, and have a shorter term of mortgage loan. Moreover, among participants who have owned a home, those not using mortgage loans showed more external control than those using mortgage loans; among participants who have not owned a home but want to buy a home, those not planning to use mortgage loans showed more external control than those planning to use mortgage loans.

  10. The implementation of intelligent home controller

    NASA Astrophysics Data System (ADS)

    Li, Biqing; Li, Zhao

    2018-04-01

    This paper mainly talks about the working way of smart home terminal controller and the design of hardware and software. Controlling the lights and by simulating the lamp and the test of the curtain, destroy the light of lamp ON-OFF and the curtain's UP-DOWN by simulating the lamp and the test of the cuetain. Through the sensor collects the ambient information and sends to the network, such as light, temperature and humidity. Besides, it can realise the control of intelligent home control by PCS. Terminal controller of intelligent home which is based on ZiBee technology has into the intelligent home system, it provides people with convenient, safe and intelligent household experience.

  11. Depression treatment for impoverished mothers by point-of-care providers: A randomized controlled trial.

    PubMed

    Segre, Lisa S; Brock, Rebecca L; O'Hara, Michael W

    2015-04-01

    Depression in low-income, ethnic-minority women of childbearing age is prevalent and compromises infant and child development. Yet numerous barriers prevent treatment delivery. Listening Visits (LV), an empirically supported intervention developed for delivery by British home-visiting nurses, could address this unmet mental health need. This randomized controlled trial (RCT) evaluated the effectiveness of LV delivered at a woman's usual point-of-care, including home visits or an ob-gyn office. Listening Visits were delivered to depressed pregnant women or mothers of young children by their point-of-care provider (e.g., home visitor or physician's assistant), all of whom had low levels of prior counseling experience. Three quarters of the study's participants were low-income. Of those who reported ethnicity, all identified themselves as minorities. Participants from 4 study sites (N = 66) were randomized in a 2:1 ratio, to LV or a wait-list control group (WLC). Assessments, conducted at baseline and 8 weeks, evaluated depression, quality of life, and treatment satisfaction. Depressive severity, depressive symptoms, and quality of life significantly improved among LV recipients as compared with women receiving standard social/health services. Women valued LV as evidenced by their high attendance rates and treatment satisfaction ratings. In a stepped model of depression care, LV can provide an accessible, acceptable, and effective first-line treatment option for at-risk women who otherwise are unlikely to receive treatment. (PsycINFO Database Record (c) 2015 APA, all rights reserved).

  12. Kangaroo mother care for low birth weight infants: a randomized controlled trial.

    PubMed

    Suman, Rao P N; Udani, Rekha; Nanavati, Ruchi

    2008-01-01

    To compare the effect of Kangaroo mother care (KMC) and conventional methods of care (CMC) on growth in LBW babies (> 2000 g). Randomized controlled trial. Level III NICU of a teaching institution in western India. 206 neonates with birth weight < 2000 g. The subjects were randomized into two groups: the intervention group (KMC-103) received Kangaroo mother care. The control group (CMC: 103) received conventional care. Growth, as measured by average daily weight gain and by other anthropometrical parameters at 40 weeks postmenstrual age in preterm babies and at 2500 g in term SGA infants was assessed. The KMC babies had better average weight gain per day (KMC: 23.99 g vs CMC: 15.58 g, P< 0.0001). The weekly increments in head circumference (KMC: 0.75 cm vs CMC: 0.49 cm, P = 0.02) and length (KMC: 0.99 cm vs CMC: 0.7 cm, P = 0.008) were higher in the KMC group. A significantly higher number of babies in the CMC group suffered from hypothermia, hypoglycemia, and sepsis. There was no effect on time to discharge. More KMC babies were exclusively breastfed at the end of the study (98% vs 76%). KMC was acceptable to most mothers and families at home. Kangaroo mother care improves growth and reduces morbidities in low birth weight infants. It is simple, acceptable to mothers and can be continued at home.

  13. Feasibility of BCI Control in a Realistic Smart Home Environment

    PubMed Central

    Kosmyna, Nataliya; Tarpin-Bernard, Franck; Bonnefond, Nicolas; Rivet, Bertrand

    2016-01-01

    Smart homes have been an active area of research, however despite considerable investment, they are not yet a reality for end-users. Moreover, there are still accessibility challenges for the elderly or the disabled, two of the main potential targets for home automation. In this exploratory study we design a control mechanism for smart homes based on Brain Computer Interfaces (BCI) and apply it in the “Domus”1 smart home platform in order to evaluate the potential interest of users about BCIs at home. We enable users to control lighting, a TV set, a coffee machine and the shutters of the smart home. We evaluate the performance (accuracy, interaction time), usability and feasibility (USE questionnaire) on 12 healthy subjects and 2 disabled subjects. We find that healthy subjects achieve 77% task accuracy. However, disabled subjects achieved a better accuracy (81% compared to 77%). PMID:27616986

  14. Nurse-led disease management for hypertension control in a diverse urban community: a randomized trial.

    PubMed

    Hebert, Paul L; Sisk, Jane E; Tuzzio, Leah; Casabianca, Jodi M; Pogue, Velvie A; Wang, Jason J; Chen, Yingchun; Cowles, Christine; McLaughlin, Mary Ann

    2012-06-01

    Treated but uncontrolled hypertension is highly prevalent in African American and Hispanic communities. To test the effectiveness on blood pressure of home blood pressure monitors alone or in combination with follow-up by a nurse manager. Randomized controlled effectiveness trial. Four hundred and sixteen African American or Hispanic patients with a history of uncontrolled hypertension. Patients with blood pressure ≥150/95, or ≥140/85 for patients with diabetes or renal disease, at enrollment were recruited from one community clinic and four hospital outpatient clinics in East and Central Harlem, New York City. Patients were randomized to receive usual care or a home blood pressure monitor plus one in-person counseling session and 9 months of telephone follow-up with a registered nurse. During the trial, the home monitor alone arm was added. Change in systolic and diastolic blood pressure at 9 and 18 months. Changes from baseline to 9 months in systolic blood pressure relative to usual care was -7.0 mm Hg (Confidence Interval [CI], -13.4 to -0.6) in the nurse management plus home blood pressure monitor arm, and +1.1 mm Hg (95% CI, -5.5 to 7.8) in the home blood pressure monitor only arm. No statistically significant differences in systolic blood pressure were observed among treatment arms at 18 months. No statistically significant improvements in diastolic blood pressure were found across treatment arms at 9 or 18 months. Changes in prescribing practices did not explain the decrease in blood pressure in the nurse management arm. A nurse management intervention combining an in-person visit, periodic phone calls, and home blood pressure monitoring over 9 months was associated with a statistically significant reduction in systolic, but not diastolic, blood pressure compared to usual care in a high risk population. Home blood pressure monitoring alone was no more effective than usual care.

  15. Short-term effects of a home-based smoking prevention program on antismoking socialization and smoking-related cognitions: a cluster randomized controlled trial.

    PubMed

    Hiemstra, Marieke; Ringlever, Linda; Otten, Roy; van Schayck, Onno C P; Engels, Rutger C M E

    2013-01-01

    This study aims to evaluate the short-term effects of a home-based smoking prevention program called 'Smoke-free Kids' on antismoking socialization and smoking-related cognitions and the moderating role of parental smoking. A cluster randomized controlled trial was carried out using one intervention condition compared with a control condition. A total of 1,398 never-smoking children (mean age 10.11 years, SD 0.78) participated. Intention-to-treat and completers-only analyses were performed. Participants in the intervention condition (n=728) received 5 activity modules by mail at 4-week intervals. Modules included communication sheets for their mothers. Participants in the control condition (n=750) received a fact-based intervention only. The main outcomes were the frequency and quality of communication, nonsmoking agreement, house rules, availability of cigarettes, perceived maternal influence, anticipated maternal reactions, attitude, self-efficacy and social norms. Significant effects of the program were found for frequency of communication (B=0.11, p<0.001), nonsmoking agreement (B=0.07, p<0.01), perceived maternal influences (B=0.09, p<0.05), self-efficacy (B=-0.09, p<0.05) and social norms of friends (B=-0.08, p=0.05) and best friends (B=-0.11, p<0.05). Parental smoking had no moderating effect. The Smoke-free Kids program shows promising short-term effects on antismoking socialization and cognitions. Long-term follow-up on the effects of smoking behavior are needed. Copyright © 2012 S. Karger AG, Basel.

  16. Domestic Violence Enhanced Perinatal Home Visits: The DOVE Randomized Clinical Trial

    PubMed Central

    Bullock, Linda F.; Campbell, Jacquelyn C.; Alhusen, Jeanne L.; Ghazarian, Sharon R.; Bhandari, Shreya S.; Schminkey, Donna L.

    2016-01-01

    Abstract Background: Perinatal intimate partner violence (IPV) is common and has significant negative health outcomes for mothers and infants. This study evaluated the effectiveness of an IPV intervention in reducing violence among abused women in perinatal home visiting programs. Materials and Methods: This assessor-blinded multisite randomized control trial of 239 women experiencing perinatal IPV was conducted from 2006 to 2012 in U.S. urban and rural settings. The Domestic Violence Enhanced Home Visitation Program (DOVE) intervention group (n = 124) received a structured abuse assessment and six home visitor-delivered empowerment sessions integrated into home visits. All participants were screened for IPV and referred appropriately. IPV was measured by the Conflicts Tactics Scale2 at baseline through 24 months postpartum. Results: There was a significant decrease in IPV over time (F = 114.23; p < 0.001) from baseline to 1, 3, 6, 12, 18, and 24 months postpartum (all p < 0.001). Additional models examining change in IPV from baseline indicated a significant treatment effect (F = 6.45; p < 0.01). Women in the DOVE treatment group reported a larger mean decrease in IPV scores from baseline compared to women in the usual care group (mean decline 40.82 vs. 35.87). All models accounted for age and maternal depression as covariates. Conclusions: The DOVE intervention was effective in decreasing IPV and is brief, thereby facilitating its incorporation within well-woman and well-child care visits, as well as home visiting programs, while satisfying recommendations set forth in the Affordable Care Act for IPV screening and brief counseling. PMID:27206047

  17. Randomized controlled trial of the effect of a home visiting intervention on infant cognitive development in peri-urban South Africa

    PubMed Central

    Murray, Lynne; Cooper, Peter; Arteche, Adriane; Stein, Alan; Tomlinson, Mark

    2016-01-01

    Summary Aim To determine whether, in an impoverished South African community, an intervention that benefitted infant attachment also benefitted cognitive development. Method Pregnant women were randomized to intervention (220) and no treatment control groups (229). The intervention was home-based parenting support for attachment, delivered until six months postpartum. At 18 months, infants were assessed on attachment6, and cognitive development (Bayley MDI) (127 intervention, 136 control). Infant MDI was examined in relation to intervention, socio-economic risk, antenatal depression, and infant sex and attachment. Results Overall, there was little effect of the intervention on MDI (p=.094, d=0.20), but there was an interaction between intervention and risk (p=.03, ŋp2=.02): MDI scores of infants of lower risk intervention group mothers were, on average, 4·84 points higher than those of other infants (p=.002, d=.41). Antenatal depression was not significant once intervention and risk were controlled (p= .08); there was no association between infant MDI and either sex (p =.41) or attachment (p=.56). Conclusion Parenting interventions for infant cognitive development may benefit from inclusion of specific components to support infant cognition, beyond those that support attachment, and may be most effective for infants over six months. They may need augmentation with other input where adversity is extreme. PMID:26303135

  18. Pure random search for ambient sensor distribution optimisation in a smart home environment.

    PubMed

    Poland, Michael P; Nugent, Chris D; Wang, Hui; Chen, Liming

    2011-01-01

    Smart homes are living spaces facilitated with technology to allow individuals to remain in their own homes for longer, rather than be institutionalised. Sensors are the fundamental physical layer with any smart home, as the data they generate is used to inform decision support systems, facilitating appropriate actuator actions. Positioning of sensors is therefore a fundamental characteristic of a smart home. Contemporary smart home sensor distribution is aligned to either a) a total coverage approach; b) a human assessment approach. These methods for sensor arrangement are not data driven strategies, are unempirical and frequently irrational. This Study hypothesised that sensor deployment directed by an optimisation method that utilises inhabitants' spatial frequency data as the search space, would produce more optimal sensor distributions vs. the current method of sensor deployment by engineers. Seven human engineers were tasked to create sensor distributions based on perceived utility for 9 deployment scenarios. A Pure Random Search (PRS) algorithm was then tasked to create matched sensor distributions. The PRS method produced superior distributions in 98.4% of test cases (n=64) against human engineer instructed deployments when the engineers had no access to the spatial frequency data, and in 92.0% of test cases (n=64) when engineers had full access to these data. These results thus confirmed the hypothesis.

  19. Effect of Cranberry Capsules on Bacteriuria Plus Pyuria among Older Women in Nursing Homes: A Randomized Clinical Trial

    PubMed Central

    Juthani-Mehta, Manisha; Van Ness, Peter H.; Bianco, Luann; Rink, Andrea; Rubeck, Sabina; Ginter, Sandra; Argraves, Stephanie; Charpentier, Peter; Acampora, Denise; Trentalange, Mark; Quagliarello, Vincent; Peduzzi, Peter

    2017-01-01

    Importance Bacteriuria plus pyuria is highly prevalent among older women living in nursing homes. Cranberry capsules are an understudied, non-antimicrobial, prevention strategy used in this population. Objective To test the effect of two oral cranberry capsules once per day on presence of bacteriuria plus pyuria among women residing in nursing homes Design, Setting, and Participants This study was a double-blind, randomized, placebo-controlled efficacy trial with stratification by nursing home and surveillance of one year. 21 nursing homes with at least 90 beds and within 50 miles of New Haven, CT participated. 185 English-speaking, female, nursing home residents, age 65 or older, with or without bacteriuria and pyuria at baseline, were randomized. The study was conducted from 8/24/12-10/26/15. Intervention Two oral cranberry capsules, each capsule containing 36mg of the active ingredient proanthocyanidin (i.e., 72mg total, equivalent to 20 ounces of cranberry juice), versus placebo administered once per day in 92 treatment and 93 control group participants. Main Outcomes and Measures The primary outcome was the presence of bacteriuria (i.e., at least 105 cfu/mL of one or two microorganisms on urine culture) plus pyuria (i.e., any number of white blood cells on urinalysis) assessed every two months for a total of six assessments over the one year of surveillance; any positive finding was considered to meet the primary outcome. Secondary outcomes were symptomatic urinary tract infection (UTI), all-cause death, all-cause hospitalization, all multi-drug antibiotic resistant organisms, antibiotics administered for suspected UTI, and total antimicrobial administration. Results Among 185 women who were randomized (mean age 86.4 years [± 8.2], 90.3% white, 31.4% with bacteriuria plus pyuria at baseline), 147 completed the study. Overall adherence to capsule administration was 80.1%. Unadjusted results showed the presence of bacteriuria plus pyuria in 25.5% (95% CI 18

  20. Evaluation of the Efficiency of the Nursing Care Plan Applied Using NANDA, NOC, and NIC Linkages to Elderly Women with Incontinence Living in a Nursing Home: A Randomized Controlled Study.

    PubMed

    Gencbas, Dercan; Bebis, Hatice; Cicek, Hatice

    2017-05-30

    Evaluate the efficiency of the nursing care plan, applied with the use of NANDA-I, NOC, and NIC (NNN) linkages, for elderly women with incontinence who live in nursing homes. A randomized controlled experimental design was applied. NNN linkages were prepared and applied for 12 weeks in an experimental group. NOC scales were evaluated again for two groups. A 0.5 NOC point change targeted in all elderly in the experimental group were provided between pretest-posttest scores. The experimental group had higher life quality and lower incontinence severity/symptoms than the control group. It is important that NNN linkages effective for solving the problems are used in different groups and with larger samples to create further evidence linking NNN. © 2017 NANDA International, Inc.

  1. The Promotion of Well-Being in Aging Individuals Living in Nursing Homes: A Controlled Pilot Intervention with Narrative Strategies.

    PubMed

    Cesetti, Giulia; Vescovelli, Francesca; Ruini, Chiara

    2017-01-01

    The study aimed: (1) to compare levels of well-being and distress in older adults living in nursing homes with those living in community; and (2) to test the feasibility of a positive narrative intervention for improving well-being versus a control art-and-craft intervention in a nursing home setting. Sixty older adults participated in the study (M = 77.37; SD = 5.00), Male = 20 (33.3%). In Study 1, 30 adults living in nursing homes were compared with 30 community-dwellers using the following measures: Satisfaction with Life Scale, Psychological Well-being Scale, Social Well-being Scale, Geriatric Depression Scale, and sleep quality. In Study 2, the same 30 adults living in nursing homes were allocated to a positive narrative intervention group (N = 20) or to a control group (N = 10) and assessed at post-intervention. In Study 1, older adults in nursing homes presented more depression and impairments in well-being, compared to community-dwellers. In Study 2, at post-treatment, individuals assigned to the narrative intervention reported significantly increased well-being and sleep quality. Although preliminary, results showed that older adults living in nursing homes are more vulnerable than community-dwellers. These patients experienced improvement when given a short group positive narrative intervention applicable in nursing homes. A brief group intervention based on fairy tales yielded improvements in well-being and sleep quality in nursing home residents, who enjoyed and appreciated its content. These promising results need to be confirmed by future randomized controlled trials.

  2. Moxibustion for breech version: a randomized controlled trial.

    PubMed

    Guittier, Marie-Julia; Pichon, Michelle; Dong, Hongguang; Irion, Olivier; Boulvain, Michel

    2009-11-01

    To estimate the efficacy of moxibustion between 34 and 38 weeks of gestation to facilitate the cephalic version of fetuses in breech presentation and the acceptability of this method by women. We conducted a randomized controlled trial in a Swiss university hospital maternity unit. We proposed to stimulate the acupoint BL 67 by moxibustion daily for 2 weeks for 212 consenting women between 34 and 36 weeks of gestation with a single fetus in breech presentation. We did the intervention three times weekly in the hospital and a teaching session and information leaflet on the technique for additional daily therapy at home. The control group received expectant management care. The availability of external cephalic version was maintained for both groups. The main outcome measure was the comparison of the proportion of women with cephalic presentation at delivery. Baseline characteristics were similar between groups, except more nulliparous women were randomized to moxibustion. The percentage of versions was similar between groups: 18% in the moxibustion group compared with 16% in the control group (relative risk 1.12, 95% confidence interval 0.62 to 2.03). Adjustment for the imbalance in parity did not change these results. The frequency of cesarean delivery was similar (64% compared with 58% in the moxibustion group and the control group, respectively). Acceptability of the intervention and women's perceptions of moxibustion were favorable. We observed no beneficial effect of moxibustion to facilitate the cephalic version of fetuses in breech presentation. Despite this lack of proven effectiveness, women had positive opinions on the intervention. ClinicalTrials.gov, www.clinicaltrials.gov,NCT00890474. I.

  3. Physical Changes In The Home Environment To Reduce Television Viewing And Sugar Sweetened Beverage Consumption Among 5-12 Year Old Children: A Randomized Pilot Study

    PubMed Central

    French, SA; Sherwood, NE; JaKa, MM; Haapala, JL; Ebbeling, CB; Ludwig, DS

    2016-01-01

    This study evaluated the feasibility of a home-based intervention to reduce sugar sweetened beverage intake and television viewing among children. Lower-income parents of overweight children ages 5-12 yrs (n=40) were randomized to a home environment intervention to reduce television viewing with locking devices and displace availability of sugar sweetened beverages with home delivery of non-caloric beverages (n=25), or to a no-intervention control group (n=15) for six months. Data were collected at baseline and six months. After six months, television viewing hours per day was significantly lower in the intervention group compared with the control group (1.7 [se=.02] vs. 2.6 [se = .25] hrs/day, respectively, p < .01). Sugar sweetened beverage intake was marginally significantly lower among intervention group compared to control group children (0.21 [se=.09] vs. 0.45 [se=.10], respectively, p < .09). BMI z-score was not significantly lower among intervention compared to control children. Among a lower-income sample of children, a home-based intervention reduced television viewing, but not sugar-sweetened beverage intake or BMI z-score. PMID:26317968

  4. Healthy Homes/Healthy Kids: A Randomized Trial of a Pediatric Primary Care Based Obesity Prevention Intervention for At-Risk 5-10 Year Olds

    PubMed Central

    Sherwood, Nancy E.; Levy, Rona L.; Langer, Shelby L.; Senso, Meghan M.; Crain, A. Lauren; Hayes, Marcia G.; Anderson, Julie D.; Seburg, Elisabeth M.; Jeffery, Robert W.

    2014-01-01

    Pediatric primary care is an important setting in which to address obesity prevention, yet relatively few interventions have been evaluated and even fewer have been shown to be effective. The development and evaluation of cost-effective approaches to obesity prevention that leverage opportunities of direct access to families in the pediatric primary care setting, overcome barriers to implementation in busy practice settings, and facilitate sustained involvement of parents is an important public health priority. The goal of the Healthy Homes/Healthy Kids (HHHK 5-10) randomized controlled trial is to evaluate the efficacy of a relatively low-cost primary care-based obesity prevention intervention aimed at 5 to 10 year old children who are at risk for obesity. Four hundred twenty one parent/child dyads were recruited and randomized to either the obesity prevention arm or a contact control condition that focuses on safety and injury prevention. The HHHK 5-10 obesity prevention intervention combines brief counseling with a pediatric primary care provider during routine well-child visits and follow-up telephone coaching that supports parents in making home environmental changes to support healthful eating, activity patterns, and body weight. The contact control condition combines the same provider counseling with telephone coaching focused on safety and injury prevention messages. This manuscript describes the study design and baseline characteristics of participants enrolled in the HHHK 5-10 trial. PMID:23816490

  5. Short-Term Impact of a Teen Pregnancy-Prevention Intervention Implemented in Group Homes.

    PubMed

    Oman, Roy F; Vesely, Sara K; Green, Jennifer; Fluhr, Janene; Williams, Jean

    2016-11-01

    Youth living in group home settings are at significantly greater risk for sexual risk behaviors; however, there are no sexual health programs designed specifically for these youth. The study's purpose was to assess the effectiveness of a teen pregnancy-prevention program for youth living in group home foster care settings and other out-of-home placements. The study design was a cluster randomized controlled trial involving youth (N = 1,037) recruited from 44 residential group homes located in California, Maryland, and Oklahoma. Within each state, youth (mean age = 16.2 years; 82% male; 37% Hispanic, 20% African-American, 20% white, and 17% multiracial) in half the group homes were randomly assigned to the intervention group (n = 40 clusters) and the other half were randomly assigned to a control group that offered "usual care" (n = 40 clusters). The intervention (i.e., Power Through Choices [PTC]) was a 10-session, age-appropriate, and medically accurate sexual health education program. Compared to the control group, youth in the PTC intervention showed significantly greater improvements (p < .05) from preintervention to postintervention in all three knowledge areas, one of two attitude areas, all three self-efficacy areas, and two of three behavioral intention areas. This is the first published randomized controlled trial of a teen pregnancy-prevention program designed for youth living in foster care settings and other out-of-home placements. The numerous significant improvements in short-term outcomes are encouraging and provide preliminary evidence that the PTC program is an effective pregnancy-prevention program. Copyright © 2016 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

  6. Does hospital at home for palliative care facilitate death at home? Randomised controlled trial

    PubMed Central

    Grande, Gunn E; Todd, Chris J; Barclay, Stephen I G; Farquhar, Morag C

    1999-01-01

    Objective To evaluate the impact on place of death of a hospital at home service for palliative care. Design Pragmatic randomised controlled trial. Setting Former Cambridge health district. Participants 229 patients referred to the hospital at home service; 43 randomised to control group (standard care), 186 randomised to hospital at home. Intervention Hospital at home versus standard care. Main outcome measures Place of death. Results Twenty five (58%) control patients died at home compared with 124 (67%) patients allocated to hospital at home. This difference was not significant; intention to treat analysis did not show that hospital at home increased the number of deaths at home. Seventy three patients randomised to hospital at home were not admitted to the service. Patients admitted to hospital at home were significantly more likely to die at home (88/113; 78%) than control patients. It is not possible to determine whether this was due to hospital at home itself or other characteristics of the patients admitted to the service. The study attained less statistical power than initially planned. Conclusion In a locality with good provision of standard community care we could not show that hospital at home allowed more patients to die at home, although neither does the study refute this. Problems relating to recruitment, attrition, and the vulnerability of the patient group make randomised controlled trials in palliative care difficult. While these difficulties have to be recognised they are not insurmountable with the appropriate resourcing and setting. Key messagesTerminally ill patients allocated to hospital at home were no more likely to die at home than patients receiving standard careAlthough the subsample of patients actually admitted to hospital at home did show a significant increase in likelihood of dying at home, whether this was due to the service itself or the characteristics of patients admitted to hospital at home could not be determinedThe need to

  7. Effect of high-intensity home-based respiratory muscle training on strength of respiratory muscles following a stroke: a protocol for a randomized controlled trial.

    PubMed

    Menezes, Kênia Kiefer Parreiras De; Nascimento, Lucas Rodrigues; Polese, Janaine Cunha; Ada, Louise; Teixeira-Salmela, Luci Fuscaldi

    Respiratory muscle training has shown to increase strength of the respiratory muscles following a stroke. However, low duration and/or intensity of training may be responsible for the small effect size seen and/or absence of carry-over effects to an activity, e.g., walking. Therefore, an investigation of the effects of long-duration, high-intensity respiratory muscle training is warranted. This proposed protocol for a randomized clinical trial will examine the efficacy of high-intensity respiratory muscle training to increase strength and improve activity following a stroke. This study will be a two-arm, prospectively registered, randomized controlled trial, with blinded assessors. Thirty-eight individuals who have suffered a stroke will participate. The experimental group will undertake a 40-min of respiratory muscle training program, seven days/week, for eight weeks in their homes. Training loads will be increased weekly. The control group will undertake a sham respiratory muscle training program with equivalent duration and scheduling of training. The primary outcome will be the strength of the inspiratory muscles, measured as maximal inspiratory pressure. Secondary outcomes will include expiratory muscle strength, inspiratory muscle endurance, dyspnea, respiratory complications, and walking capacity. Outcomes will be collected by a researcher blinded to group allocation at baseline (Week 0), after intervention (Week 8), and one month beyond intervention (Week 12). High-intensity respiratory muscle training may have the potential to optimize the strength of the respiratory muscles following a stroke. If benefits are carried over to activity, the findings may have broader implications, since walking capacity has been shown to predict physical activity and community participation on this population. Copyright © 2017 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier Editora Ltda. All rights reserved.

  8. Randomized trial of a statewide home visiting program: impact in preventing child abuse and neglect.

    PubMed

    Duggan, Anne; McFarlane, Elizabeth; Fuddy, Loretta; Burrell, Lori; Higman, Susan M; Windham, Amy; Sia, Calvin

    2004-06-01

    To assess the impact of home visiting in preventing child abuse and neglect in the first 3 years of life in families identified as at-risk of child abuse through population-based screening at the child's birth. This experimental study focused on Hawaii Healthy Start Program (HSP) sites operated by three community-based agencies. From 11/94 to 12/95, 643 families were enrolled and randomly assigned to intervention and control groups. Child abuse and neglect were measured by observed and self-reported parenting behaviors, all hospitalizations for trauma and for conditions where hospitalization might have been avoided with adequate preventive care, maternal relinquishment of her role as primary caregiver, and substantiated CPS reports. Data were collected through annual maternal interviews (88% follow-up each year of all families with baseline interviews); observation of the home environment; and review of CPS, HSP, and pediatric medical records. HSP records rarely noted home visitor concern about possible abuse. The HSP and control groups were similar on most measures of maltreatment. HSP group mothers were less likely to use common corporal/verbal punishment (AOR=.59, p=.01) but this was attributable to one agency's reduction in threatening to spank the child. HSP group mothers reported less neglectful behavior (AOR=.72, .02), related to a trend toward decreased maternal preoccupation with problems and to improved access to medical care for intervention families at one agency. The program did not prevent child abuse or promote use of nonviolent discipline; it had a modest impact in preventing neglect. Possible targets for improved effectiveness include the program's implementation system and model.

  9. A Randomized Controlled Trial of Home-Based Exercise for Cancer-Related Fatigue in Women during and after Chemotherapy with or without Radiation Therapy

    PubMed Central

    Dodd, Marylin J.; Cho, Maria H.; Miaskowski, Christine; Painter, Patricia L.; Paul, Steven M.; Cooper, Bruce A.; Duda, John; Krasnoff, Joanne; Bank, Kayee A.

    2010-01-01

    Background Few studies have evaluated an individualized home-based exercise prescription during and after cancer treatment. Objective The purpose was to evaluate the effectiveness of a home-based exercise training intervention, the PRO-SELF FATIGUE CONTROL PROGRAM on the management of cancer related fatigue. Interventions/Methods Participants (N=119) were randomized into one of three groups: Group 1 (EE) received the exercise prescription throughout the study; Group 2 (CE) received their exercise prescription after completing cancer treatment; Group 3 (CC) received usual care. Patients completed the Piper Fatigue Scale, General Sleep Disturbance Scale, Center for Epidemiological Studies-Depression scale, and Worst Pain Intensity Scale. Results All groups reported mild fatigue levels, sleep disturbance and mild pain, but not depression. Using multilevel regression analysis significant linear and quadratic trends were found for change in fatigue and pain (i.e., scores increased, then decreased over time). No group differences were found in the changing scores over time. A significant quadratic effect for the trajectory of sleep disturbance was found, but no group differences were detected over time. No significant time or group effects were found for depression. Conclusions Our home-based exercise intervention had no effect on fatigue or related symptoms associated with cancer treatment. The optimal timing of exercise remains to be determined. Implications for practice Clinicians need to be aware that some physical activity is better than none, and there is no harm in exercise as tolerated during cancer treatment. Further analysis is needed to examine the adherence to exercise. More frequent assessments of fatigue, sleep disturbance, depression, and pain may capture the effect of exercise. PMID:20467301

  10. Creating a meaningful infection control program: one home healthcare agency's lessons.

    PubMed

    Poff, Renee McCoy; Browning, Sarah Via

    2014-03-01

    Creating a meaningful infection control program in the home care setting proved to be challenging for agency leaders of one hospital-based home healthcare agency. Challenges arose when agency leaders provided infection control (IC) data to the hospital's IC Committee. The IC Section Chief asked for national benchmark comparisons to align home healthcare reporting to that of the hospital level. At that point, it was evident that the home healthcare IC program lacked definition and structure. The purpose of this article is to share how one agency built a meaningful IC program.

  11. Prevention of falls in nursing homes: subgroup analyses of a randomized fall prevention trial.

    PubMed

    Rapp, Kilian; Lamb, Sarah E; Büchele, Gisela; Lall, Ranjit; Lindemann, Ulrich; Becker, Clemens

    2008-06-01

    To evaluate the effectiveness of a multifactorial fall prevention program in prespecified subgroups of nursing home residents. Secondary analysis of a cluster-randomized, controlled trial. Six nursing homes in Germany. Seven hundred twenty-five long-stay residents; median age 86; 80% female. Staff and resident education on fall prevention, advice on environmental adaptations, recommendation to wear hip protectors, and progressive balance and resistance training. Time to first fall and the number of falls. Falls were assessed during the 12-month intervention period. Univariate regression analyses were performed, including a confirmatory test of interaction. The intervention was more effective in people with cognitive impairment (hazard ratio (HR)=0.49, 95% confidence interval (CI)=0.35-0.69) than in those who were cognitively intact (HR=0.91, 95% CI=0.68-1.22), in people with a prior history of falls (HR=0.47, 95% CI=0.33-0.67) than in those with no prior fall history (HR=0.77, 95% CI=0.58-1.01), in people with urinary incontinence (HR=0.59, 95% CI=0.45-0.77) than in those with no urinary incontinence (HR=0.98, 95% CI=0.68-1.42), and in people with no mood problems (incidence rate ratio (IRR)=0.41, 95% CI=0.27-0.61) than in those with mood problems (IRR=0.74, 95% CI=0.51-1.09). The effectiveness of a multifactorial fall prevention program differed between subgroups of nursing home residents. Cognitive impairment, a history of falls, urinary incontinence, and depressed mood were important in determining response.

  12. Efficacy of smoking prevention program 'Smoke-free Kids': study protocol of a randomized controlled trial

    PubMed Central

    2009-01-01

    Background A strong increase in smoking is noted especially among adolescents. In the Netherlands, about 5% of all 10-year olds, 25% of all 13-year olds and 62% of all 17-year olds report ever smoking. In the U.S., an intervention program called 'Smoke-free Kids' was developed to prevent children from smoking. The present study aims to assess the effects of this home-based smoking prevention program in the Netherlands. Methods/Design A randomized controlled trial is conducted among 9 to 11-year old children of primary schools. Participants are randomly assigned to the intervention and control conditions. The intervention program consists of five printed activity modules designed to improve parenting skills specific to smoking prevention and parent-child communication regarding smoking. These modules will include additional sheets with communication tips. The modules for the control condition will include solely information on smoking and tobacco use. Initiation of cigarette smoking (first instance of puffing on a lighted cigarette), susceptibility to cigarette smoking, smoking-related cognitions, and anti-smoking socialization will be the outcome measures. To collect the data, telephone interviews with mothers as well as with their child will be conducted at baseline. Only the children will be examined at post-intervention follow-ups (6, 12, 24, and 36 months after the baseline). Discussion This study protocol describes the design of a randomized controlled trial that will evaluate the effectiveness of a home-based smoking prevention program. We expect that a significantly lower number of children will start smoking in the intervention condition compared to control condition as a direct result of this intervention. If the program is effective, it is applicable in daily live, which will facilitate implementation of the prevention protocol. Trial registration Netherlands Trial Register NTR1465 PMID:20025727

  13. Effects of a Home-Based and Volunteer-Administered Physical Training, Nutritional, and Social Support Program on Malnutrition and Frailty in Older Persons: A Randomized Controlled Trial.

    PubMed

    Luger, Eva; Dorner, Thomas Ernst; Haider, Sandra; Kapan, Ali; Lackinger, Christian; Schindler, Karin

    2016-07-01

    The aim of this study was to examine the effects of a home-based and volunteer-administered physical training and nutritional intervention program compared with social support intervention on nutritional and frailty status in prefrail and frail community-dwelling older persons. This was a randomized controlled trial in which community-dwelling persons (mean age = 83 years) were recruited and randomly assigned to the physical training and nutritional intervention group (PTN, n = 39) and the social support group (SoSu, n = 41). The study was conducted by trained lay nonprofessionals. The community-dwelling older persons in both groups were visited twice a week by trained nonprofessional volunteers (buddies) in Vienna, Austria. Eighty prefrail and frail adults aged 65 years or older. In the PTN group, both the buddies and older persons performed 6 strength exercises within a circuit training session and discussed nutrition-related aspects. The active control group (SoSu) had the opportunity to perform cognitive training in addition to the social contact. Outcome measures as nutritional (Mini Nutritional Assessment long form [MNA-LF]) and frailty status (Frailty Instrument for Primary Care of the Survey of Health, Ageing and Retirement in Europe [SHARE-FI]) were obtained at baseline and after 12 weeks. Significant improvements in the MNA-LF score (1.54 points, 95% confidence interval [CI] 0.51-2.56; P = .004) and the SHARE-FI score (-0.71 discrete factor score values, 95% CI -1.07, -0.35; P < .001) were observed in the PTN group after 12 weeks. In both groups, the prevalence of impaired nutritional status and frailty decreased significantly over time. The prevalence of impaired nutritional status decreased by 25% in the PTN group and by 23% in the SoSu group. Moreover, the prevalence of frailty decreased by 17% in the PTN group and by 16% in the SoSu group. The presence of impaired nutritional status at baseline was independently associated with greater

  14. 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.

  15. 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

  16. Region based Brain Computer Interface for a home control application.

    PubMed

    Akman Aydin, Eda; Bay, Omer Faruk; Guler, Inan

    2015-08-01

    Environment control is one of the important challenges for disabled people who suffer from neuromuscular diseases. Brain Computer Interface (BCI) provides a communication channel between the human brain and the environment without requiring any muscular activation. The most important expectation for a home control application is high accuracy and reliable control. Region-based paradigm is a stimulus paradigm based on oddball principle and requires selection of a target at two levels. This paper presents an application of region based paradigm for a smart home control application for people with neuromuscular diseases. In this study, a region based stimulus interface containing 49 commands was designed. Five non-disabled subjects were attended to the experiments. Offline analysis results of the experiments yielded 95% accuracy for five flashes. This result showed that region based paradigm can be used to select commands of a smart home control application with high accuracy in the low number of repetitions successfully. Furthermore, a statistically significant difference was not observed between the level accuracies.

  17. Early home-based group education to support informed decision-making among patients with end-stage renal disease: a multi-centre randomized controlled trial.

    PubMed

    Massey, Emma K; Gregoor, Peter J H Smak; Nette, Robert W; van den Dorpel, Marinus A; van Kooij, Anthony; Zietse, Robert; Zuidema, Willij C; Timman, Reinier; Busschbach, Jan J; Weimar, Willem

    2016-05-01

    The aim was to test the effectiveness of early home-based group education on knowledge and communication about renal replacement therapy (RRT). We conducted a randomized controlled trial using a cross-over design among 80 end-stage renal disease (ESRD) patients. Between T0 and T1 (weeks 1-4) Group 1 received the intervention and Group 2 received standard care. Between T1 and T2 (weeks 5-8) Group 1 received standard care and Group 2 received the intervention. The intervention was a group education session on RRT options held in the patient's home given by social workers. Patients invited members from their social network to attend. Self-report questionnaires were used at T0, T1 and T2 to measure patients' knowledge and communication, and concepts from the Theory of Planned Behaviour such as attitude. Comparable questionnaires were completed pre-post intervention by 229 attendees. Primary RRT was registered up to 2 years post-intervention. Multilevel linear modelling was used to analyse patient data and paired t-tests for attendee data. Statistically significant increases in the primary targets knowledge and communication were found among patients and attendees after receiving the intervention. The intervention also had a significant effect in increasing positive attitude toward living donation and haemodialysis. Of the 80 participants, 49 underwent RRT during follow-up. Of these, 34 underwent a living donor kidney transplant, of which 22 were pre-emptive. Early home-based group education supports informed decision-making regarding primary RRT for ESRD patients and their social networks and may remove barriers to pre-emptive transplantation. © The Author 2015. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.

  18. A randomized clinical trial of care for women with preterm labour: home management versus hospital management.

    PubMed

    Goulet, C; Gévry, H; Lemay, M; Gauthier, R J; Lepage, L; Fraser, W; Polomeno, V

    2001-04-03

    Preterm labour occurs in about 10% of all pregnancies and is the most important cause of premature birth. Women with preterm labour are admitted to hospital to have the contractions stopped. Thereafter, many women remain in hospital until delivery. We conducted a randomized clinical trial to compare hospital care with home care of women who had been admitted to hospital for preterm labour. After they had received treatment for an acute episode of premature labour, women at 2 regional perinatal centres associated with teaching hospitals were randomly assigned to home care or hospital care. Eligible women (n = 250) were aged 18 years or older, lived within 50 km of the hospital, had a gestational age between 20 and 35 weeks, had no prior preterm delivery and were experiencing their first episode of preterm labour and first admission to hospital for preterm labour. Analysis was by intention to treat. There were no significant differences between the 2 groups in mean gestational age at delivery (home: 37.52 weeks, hospital: 37.50 weeks) or in mean birth weight (home: 2974 g, hospital: 3020 g). There were no significant differences between the 2 groups with respect to the proportions of babies born before term or the mean duration of neonatal hospital stay, neonatal intensive care unit stay and intermediate care nursery stay. The mean duration of the first stay in hospital for the women in the home group (3.8 days) was significantly shorter than the mean duration for women in the hospital group (6.1 days). In addition, the mean duration of all maternal stays in hospital was significantly shorter for the women in the home group (3.7 days) than in the hospital group (5.0 days). Home care management is an efficient and acceptable alternative to hospital care for women experiencing preterm labour.

  19. Promoting Health and Home Safety for Children of Parents with Intellectual Disability: A Randomized Controlled Trial.

    ERIC Educational Resources Information Center

    Llewellyn, Gwynnyth; McConnell, David; Honey, Anne; Mayes, Rachel; Russo, Domenica

    2003-01-01

    This study evaluated a home-based intervention for parents with intellectual disability to promote child health and home safety in the preschool years. The intervention improved parents' ability to recognize home dangers and to handle emergencies, increased their knowledge about illness and medicines, and increased the number of safety precautions…

  20. Explore Transplant at Home: a randomized control trial of an educational intervention to increase transplant knowledge for Black and White socioeconomically disadvantaged dialysis patients.

    PubMed

    Waterman, Amy D; McSorley, Anna-Michelle M; Peipert, John D; Goalby, Christina J; Peace, Leanne J; Lutz, Patricia A; Thein, Jessica L

    2015-08-28

    Compared to others, dialysis patients who are socioeconomically disadvantaged or Black are less likely to receive education about deceased donor kidney transplant (DDKT) and living donor kidney transplant (LDKT) before they reach transplant centers, often due to limited availability of transplant education within dialysis centers. Since these patients are often less knowledgeable or ready to pursue transplant, educational content must be simplified, made culturally sensitive, and presented gradually across multiple sessions to increase learning and honor where they are in their decision-making about transplant. The Explore Transplant at Home (ETH) program was developed to help patients learn more about DDKT and LDKT at home, with and without telephone conversations with an educator. In this randomized controlled trial (RCT), 540 low-income Black and White dialysis patients with household incomes at or below 250 % of the federal poverty line, some of whom receive financial assistance from the Missouri Kidney Program, will be randomly assigned to one of three education conditions: (1) standard-of-care transplant education provided by the dialysis center, (2) patient-guided ETH (ETH-PG), and (3) health educator-guided ETH (ETH-EG). Patients in the standard-of-care condition will only receive education provided in their dialysis centers. Those in the two ETH conditions will receive four video and print modules delivered over an 8 month period by mail, with the option of receiving supplementary text messages weekly. In addition, patients in the ETH-EG condition will participate in multiple telephonic educational sessions with a health educator. Changes in transplant knowledge, decisional balance, self-efficacy, and informed decision making will be captured with surveys administered before and after the ETH education. At the conclusion of this RCT, we will have determined whether an education program administered to socioeconomically disadvantaged dialysis patients

  1. Intensive home treatment for patients in acute psychiatric crisis situations: a multicentre randomized controlled trial.

    PubMed

    Cornelis, Jurgen; Barakat, Ansam; Dekker, Jack; Schut, Tessy; Berk, Sandra; Nusselder, Hans; Ruhl, Nikander; Zoeteman, Jeroen; Van, Rien; Beekman, Aartjan; Blankers, Matthijs

    2018-02-27

    Hospitalization is a common method to intensify care for patients experiencing a psychiatric crisis. A short-term, specialised, out-patient crisis intervention by a Crisis Resolution Team (CRT) in the Netherlands, called Intensive Home Treatment (IHT), is a viable intervention which may help reduce hospital admission days. However, research on the (cost-)effectiveness of alternatives to hospitalisation such as IHT are scarce. In the study presented in this protocol, IHT will be compared to care-as-usual (CAU) in a randomized controlled trial (RCT). CAU comprises low-intensity outpatient care and hospitalisation if necessary. In this RCT it is hypothesized that IHT will reduce inpatient days by 33% compared to CAU while safety and clinical outcomes will be non-inferior. Secondary hypotheses are that treatment satisfaction of patients and their relatives are expected to be higher in the IHT condition compared to CAU. A 2-centre, 2-arm Zelen double consent RCT will be employed. Participants will be recruited in the Amsterdam area, the Netherlands. Clinical assessments will be carried out at baseline and at 6, 26 and 52 weeks post treatment allocation. The primary outcome measure is the number of admission days. Secondary outcomes include psychological well-being, safety and patients' and their relatives' treatment satisfaction. Alongside this RCT an economic evaluation will be carried out to assess the cost-effectiveness and cost-utility of IHT compared to CAU. RCTs on the effectiveness of crisis treatment in psychiatry are scarce and including patients in studies performed in acute psychiatric crisis care is a challenge due to the ethical and practical hurdles. The Zelen design may offer a feasible opportunity to carry out such an RCT. If our study finds that IHT is a safe and cost-effective alternative for CAU it may help support a further decrease of in-patient bed days and may foster the widespread implementation of IHT by mental health care organisations

  2. A randomized trial of a home system to reduce nocturnal hypoglycemia in type 1 diabetes.

    PubMed

    Maahs, David M; Calhoun, Peter; Buckingham, Bruce A; Chase, H Peter; Hramiak, Irene; Lum, John; Cameron, Fraser; Bequette, B Wayne; Aye, Tandy; Paul, Terri; Slover, Robert; Wadwa, R Paul; Wilson, Darrell M; Kollman, Craig; Beck, Roy W

    2014-07-01

    Overnight hypoglycemia occurs frequently in individuals with type 1 diabetes and can result in loss of consciousness, seizure, or even death. We conducted an in-home randomized trial to determine whether nocturnal hypoglycemia could be safely reduced by temporarily suspending pump insulin delivery when hypoglycemia was predicted by an algorithm based on continuous glucose monitoring (CGM) glucose levels. Following an initial run-in phase, a 42-night trial was conducted in 45 individuals aged 15-45 years with type 1 diabetes in which each night was assigned randomly to either having the predictive low-glucose suspend system active (intervention night) or inactive (control night). The primary outcome was the proportion of nights in which ≥1 CGM glucose values ≤60 mg/dL occurred. Overnight hypoglycemia with at least one CGM value ≤60 mg/dL occurred on 196 of 942 (21%) intervention nights versus 322 of 970 (33%) control nights (odds ratio 0.52 [95% CI 0.43-0.64]; P < 0.001). Median hypoglycemia area under the curve was reduced by 81%, and hypoglycemia lasting >2 h was reduced by 74%. Overnight sensor glucose was >180 mg/dL during 57% of control nights and 59% of intervention nights (P = 0.17), while morning blood glucose was >180 mg/dL following 21% and 27% of nights, respectively (P < 0.001), and >250 mg/dL following 6% and 6%, respectively. Morning ketosis was present <1% of the time in each arm. Use of a nocturnal low-glucose suspend system can substantially reduce overnight hypoglycemia without an increase in morning ketosis. © 2014 by the American Diabetes Association.

  3. Home blood pressure monitoring, secure electronic messaging and medication intensification for improving hypertension control: a mediation analysis.

    PubMed

    Ralston, J D; Cook, A J; Anderson, M L; Catz, S L; Fishman, P A; Carlson, J; Johnson, R; Green, B B

    2014-01-01

    We evaluated the role of home monitoring, communication with pharmacists, medication intensification, medication adherence and lifestyle factors in contributing to the effectiveness of an intervention to improve blood pressure control in patients with uncontrolled essential hypertension. We performed a mediation analysis of a published randomized trial based on the Chronic Care Model delivered over a secure patient website from June 2005 to December 2007. Study arms analyzed included usual care with a home blood pressure monitor and usual care with home blood pressure monitor and web-based pharmacist care. Mediator measures included secure messaging and telephone encounters; home blood pressure monitoring; medications intensification and adherence and lifestyle factors. Overall fidelity to the Chronic Care Model was assessed with the Patient Assessment of Chronic Care (PACIC) instrument. The primary outcome was percent of participants with blood pressure (BP) <140/90 mm Hg. At 12 months follow-up, patients in the web-based pharmacist care group were more likely to have BP <140/90 mm Hg (55%) compared to patients in the group with home blood pressure monitors only (37%) (p = 0.001). Home blood pressure monitoring accounted for 30.3% of the intervention effect, secure electronic messaging accounted for 96%, and medication intensification for 29.3%. Medication adherence and self-report of fruit and vegetable intake and weight change were not different between the two study groups. The PACIC score accounted for 22.0 % of the main intervention effect. The effect of web-based pharmacist care on improved blood pressure control was explained in part through a combination of home blood pressure monitoring, secure messaging, and antihypertensive medication intensification.

  4. Virtual reality exercise on a home-based phase III cardiac rehabilitation program, effect on executive function, quality of life and depression, anxiety and stress: a randomized controlled trial.

    PubMed

    Vieira, Ágata; Melo, Cristina; Machado, Jorge; Gabriel, Joaquim

    2018-02-01

    To analyse the effect of a six-month home-based phase III cardiac rehabilitation (CR) specific exercise program, performed in a virtual reality (Kinect) or conventional (booklet) environment, on executive function, quality of life and depression, anxiety and stress of subjects with coronary artery disease. A randomized controlled trial was conducted with subjects, who had completed phase II, randomly assigned to intervention group 1 (IG1), whose program encompassed the use of Kinect (n = 11); or intervention group 2 (IG2), a paper booklet (n = 11); or a control group (CG), only subjected to the usual care (n = 11). The three groups received education on cardiovascular risk factors. The assessed parameters, at baseline (M0), 3 (M1) and 6 months (M2), were executive function, control and integration in the implementation of an adequate behaviour in relation to a certain objective, specifically the ability to switch information (Trail Making Test), working memory (Verbal Digit Span test), and selective attention and conflict resolution ability (Stroop test), quality of life (MacNew questionnaire) and depression, anxiety and stress (Depression, Anxiety and Stress Scale 21). Descriptive and inferential statistical measures were used, significance level was set at .05. The IG1 revealed significant improvements, in the selective attention and conflict resolution ability, in comparison with the CG in the variable difference M0 - M2 (p = .021) and in comparison with the IG2 in the variable difference M1 - M2 and M0 - M2 (p = .001 and p = .002, respectively). No significant differences were found in the quality of life, and depression, anxiety and stress. The virtual reality format had improved selective attention and conflict resolution ability, revealing the potential of CR, specifically with virtual reality exercise, on executive function. Implications for Rehabilitation In cardiac rehabilitation, especially in phase III, it is

  5. A randomized clinical trial in preterm infants on the effects of a home-based early intervention with the 'CareToy System'

    PubMed Central

    Sgandurra, Giuseppina; Lorentzen, Jakob; Inguaggiato, Emanuela; Bartalena, Laura; Beani, Elena; Cecchi, Francesca; Dario, Paolo; Giampietri, Matteo; Greisen, Gorm; Herskind, Anna; Nielsen, Jens Bo; Rossi, Giuseppe; Cioni, Giovanni

    2017-01-01

    CareToy system is an innovative tele-rehabilitative tool, useful in providing intensive, individualized, home-based, family-centred Early Intervention (EI) in infants. Our aim was to evaluate, through a Randomized Clinical Trial (RCT) study, the effects of CareToy intervention on early motor and visual development in preterm infants. 41 preterm infants (range age: 3.0–5.9 months of corrected age) were enrolled and randomized into two groups, CareToy and Standard Care. 19 infants randomized in CareToy group performed a 4-week CareToy program, while 22 allocated to control group completed 4 weeks of Standard Care. Infant Motor Profile (IMP) was primary outcome measure, Alberta Infant Motor Scale (AIMS) and Teller Acuity Cards were secondary ones. Assessments were carried out at baseline (T0) and at the end of CareToy training or Standard Care period (T1). T1 was the primary endpoint. After RCT phase, 17 infants from control group carried out a 4-week CareToy program, while 18 infants from the CareToy group continued with Standard Care. At the end of this phase, infants were re-assessed at T2. In RCT phase, delta IMP total score and variation and performance sub-domains were significantly higher (P<0.050) in CareToy group if compared to Standard Care group. Similar results were found for Teller Acuity Cards, while no differences between groups were found for AIMS. No differences were found in any outcome measure results (T2-T0), between infants who started CareToy training before or after one month of standard care. This RCT study confirms the results of a previous pilot study, indicating that CareToy system can provide effective home-based EI. Trial Registration: This trial has been registered at www.clinicaltrials.gov (Identifier NCT01990183). PMID:28328946

  6. Improving children's health and development in British Columbia through nurse home visiting: a randomized controlled trial protocol.

    PubMed

    Catherine, Nicole L A; Gonzalez, Andrea; Boyle, Michael; Sheehan, Debbie; Jack, Susan M; Hougham, Kaitlyn A; McCandless, Lawrence; MacMillan, Harriet L; Waddell, Charlotte

    2016-08-04

    Nurse-Family Partnership is a nurse home visitation program that aims to improve the lives of young mothers and their children. The program focuses on women who are parenting for the first time and experiencing socioeconomic disadvantage. Nurse visits start as early in pregnancy as possible and continue until the child reaches age two years. The program has proven effective in the United States - improving children's mental health and development and maternal wellbeing, and showing long-term cost-effectiveness. But it is not known whether the same benefits will be obtained in Canada, where public services differ. The British Columbia Healthy Connections Project therefore involves a randomized controlled trial evaluating Nurse-Family Partnership's effectiveness compared with existing (usual) services in improving children's mental health and early development and mother's life circumstances. The trial's main aims are to: reduce childhood injuries by age two years (primary outcome indicator); reduce prenatal nicotine and alcohol use; improve child cognitive and language development and behaviour at age two years; and reduce subsequent pregnancies by 24 months postpartum. Potential explanatory factors such as maternal mental health (including self-efficacy) are also being assessed, as is the program's impact on exposure to intimate-partner violence. To inform future economic evaluation, data are also being collected on health and social service access and use. Eligible and consenting participants (N = 1040) are being recruited prior to 28 weeks gestation then individually randomized to receive existing services (comparison group) or Nurse-Family Partnership plus existing services (intervention group). Nurse-Family Partnership is being delivered following fidelity guidelines. Data are being collected during in person and telephone interviews at: baseline; 34-36 weeks gestation; and two, 10, 18 and 24 months postpartum. Additional data will be obtained via

  7. Effects of home visits by paraprofessionals and by nurses: age 4 follow-up results of a randomized trial.

    PubMed

    Olds, David L; Robinson, JoAnn; Pettitt, Lisa; Luckey, Dennis W; Holmberg, John; Ng, Rosanna K; Isacks, Kathy; Sheff, Karen; Henderson, Charles R

    2004-12-01

    To examine the effects of prenatal and infancy home visiting by paraprofessionals and by nurses from child age 2 through age 4 years. We conducted, in public and private care settings in Denver, Colorado, a randomized, controlled trial with 3 arms, ie, control, paraprofessional visits, and nurse visits. Home visits were provided from pregnancy through child age 2 years. We invited 1178 consecutive, low-income, pregnant women with no previous live births to participate, and we randomized 735; 85% were unmarried, 47% Mexican American, 35% white non-Mexican American, 15% black, and 3% American Indian/Asian. Outcomes consisted of maternal reports of subsequent pregnancies, participation in education and work, use of welfare, marriage, cohabitation, experience of domestic violence, mental health, substance use, and sense of mastery; observations of mother-child interaction and the home environment; tests of children's language and executive functioning; and mothers' reports of children's externalizing behavior problems. Two years after the program ended, women who were visited by paraprofessionals, compared with control subjects, were less likely to be married (32.2% vs 44.0%) and to live with the biological father of the child (32.7% vs 43.1%) but worked more (15.13 months vs 13.38 months) and reported a greater sense of mastery and better mental health (standardized scores [mean = 100, SD = 10] of 101.25 vs 99.31 and 101.21 vs 99.16, respectively). Paraprofessional-visited women had fewer subsequent miscarriages (6.6% vs 12.3%) and low birth weight newborns (2.8% vs 7.7%). Mothers and children who were visited by paraprofessionals, compared with control subjects, displayed greater sensitivity and responsiveness toward one another (standardized score [mean = 100, SD = 10] of 100.92 vs 98.66) and, in cases in which the mothers had low levels of psychologic resources at registration, had home environments that were more supportive of children's early learning (score of

  8. A randomized trial using telehealth technology to link caregivers with dementia care experts for in-home caregiving support: FamTechCare protocol.

    PubMed

    Williams, Kristine; Blyler, Diane; Vidoni, Eric D; Shaw, Clarissa; Wurth, JoEllen; Seabold, Denise; Perkhounkova, Yelena; Van Sciver, Angela

    2018-06-01

    The number of persons with dementia (PWD) in the United States is expected to reach 16 million by 2050. Due to the behavioral and psychological symptoms of dementia, caregivers face challenging in-home care situations that lead to a range of negative health outcomes such as anxiety and depression for the caregivers and nursing home placement for PWD. Supporting Family Caregivers with Technology for Dementia Home Care (FamTechCare) is a multisite randomized controlled trial evaluating the effects of a telehealth intervention on caregiver well-being and PWD behavioral symptoms. The FamTechCare intervention provides individualized dementia-care strategies to in-home caregivers based on video recordings that the caregiver creates of challenging care situations. A team of dementia care experts review videos submitted by caregivers and provide interventions to improve care weekly for the experimental group. Caregivers in the control group receive feedback for improving care based on a weekly phone call with the interventionist and receive feedback on their videos at the end of the 3-month study. Using linear mixed modeling, we will compare experimental and control group outcomes (PWD behavioral symptoms and caregiver burden) after 1 and 3 months. An exploratory descriptive design will identify a typology of interventions for telehealth support for in-home dementia caregivers. Finally, the cost for FamTechCare will be determined and examined in relation to hypothesized effects on PWD behavioral symptoms, placement rates, and caregiver burden. This research will provide the foundation for future research for telehealth interventions with this population, especially for families in rural or remote locations. © 2018 Wiley Periodicals, Inc.

  9. Stochastic control of smart home energy management with plug-in electric vehicle battery energy storage and photovoltaic array

    NASA Astrophysics Data System (ADS)

    Wu, Xiaohua; Hu, Xiaosong; Moura, Scott; Yin, Xiaofeng; Pickert, Volker

    2016-11-01

    Energy management strategies are instrumental in the performance and economy of smart homes integrating renewable energy and energy storage. This article focuses on stochastic energy management of a smart home with PEV (plug-in electric vehicle) energy storage and photovoltaic (PV) array. It is motivated by the challenges associated with sustainable energy supplies and the local energy storage opportunity provided by vehicle electrification. This paper seeks to minimize a consumer's energy charges under a time-of-use tariff, while satisfying home power demand and PEV charging requirements, and accommodating the variability of solar power. First, the random-variable models are developed, including Markov Chain model of PEV mobility, as well as predictive models of home power demand and PV power supply. Second, a stochastic optimal control problem is mathematically formulated for managing the power flow among energy sources in the smart home. Finally, based on time-varying electricity price, we systematically examine the performance of the proposed control strategy. As a result, the electric cost is 493.6% less for a Tesla Model S with optimal stochastic dynamic programming (SDP) control relative to the no optimal control case, and it is by 175.89% for a Nissan Leaf.

  10. Unsupervised exercise and mobility loss in peripheral artery disease: a randomized controlled trial.

    PubMed

    McDermott, Mary M; Guralnik, Jack M; Criqui, Michael H; Ferrucci, Luigi; Liu, Kiang; Spring, Bonnie; Tian, Lu; Domanchuk, Kathryn; Kibbe, Melina; Zhao, Lihui; Lloyd Jones, Donald; Liao, Yihua; Gao, Ying; Rejeski, W Jack

    2015-05-20

    Few medical therapies improve lower extremity functioning in people with lower extremity peripheral artery disease (PAD). Among people with PAD, we studied whether a group-mediated cognitive behavioral intervention promoting home-based unsupervised exercise prevented mobility loss and improved functional performance compared to control. One hundred ninety-four PAD participants were randomized. During months 1 to 6, the intervention group met weekly with other PAD participants and a facilitator. Group support and self-regulatory skills were used to help participants adhere to walking exercise. Ninety-percent of exercise was conducted at or near home. The control group attended weekly lectures. During months 6 to 12, each group received telephone contact only. Primary outcomes have been reported. Here we compare changes in exploratory outcomes of mobility loss (the inability to climb a flight of stairs or walk one-quarter mile without assistance), walking velocity, and the Short Physical Performance Battery. Compared to controls, fewer participants randomized to the intervention experienced mobility loss at 6-month follow-up: 6.3% versus 26.5%, P=0.002, odds ratio=0.19 (95% CI=0.06 to 0.58) and at 12-month follow-up: 5.2% versus 18.5%, P=0.029, odds ratio=0.24 (95% CI=0.06 to 0.97). The intervention improved fast-paced 4-m walking velocity at 6-month follow-up (P=0.005) and the Short Physical Performance Battery at 12-month follow-up (P=0.027), compared to controls. In exploratory analyses, a group-mediated cognitive behavioral intervention promoting unsupervised walking exercise prevented mobility loss and improved functioning at 6- and 12-month follow-up in PAD patients. URL: http://clinicaltrials.gov. Unique identifier: NCT00693940. © 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

  11. Unsupervised Exercise and Mobility Loss in Peripheral Artery Disease: A Randomized Controlled Trial

    PubMed Central

    McDermott, Mary M; Guralnik, Jack M; Criqui, Michael H; Ferrucci, Luigi; Liu, Kiang; Spring, Bonnie; Tian, Lu; Domanchuk, Kathryn; Kibbe, Melina; Zhao, Lihui; Lloyd Jones, Donald; Liao, Yihua; Gao, Ying; Rejeski, W Jack

    2015-01-01

    Background Few medical therapies improve lower extremity functioning in people with lower extremity peripheral artery disease (PAD). Among people with PAD, we studied whether a group-mediated cognitive behavioral intervention promoting home-based unsupervised exercise prevented mobility loss and improved functional performance compared to control. Methods and Results One hundred ninety-four PAD participants were randomized. During months 1 to 6, the intervention group met weekly with other PAD participants and a facilitator. Group support and self-regulatory skills were used to help participants adhere to walking exercise. Ninety-percent of exercise was conducted at or near home. The control group attended weekly lectures. During months 6 to 12, each group received telephone contact only. Primary outcomes have been reported. Here we compare changes in exploratory outcomes of mobility loss (the inability to climb a flight of stairs or walk one-quarter mile without assistance), walking velocity, and the Short Physical Performance Battery. Compared to controls, fewer participants randomized to the intervention experienced mobility loss at 6-month follow-up: 6.3% versus 26.5%, P=0.002, odds ratio=0.19 (95% CI=0.06 to 0.58) and at 12-month follow-up: 5.2% versus 18.5%, P=0.029, odds ratio=0.24 (95% CI=0.06 to 0.97). The intervention improved fast-paced 4-m walking velocity at 6-month follow-up (P=0.005) and the Short Physical Performance Battery at 12-month follow-up (P=0.027), compared to controls. Conclusions In exploratory analyses, a group-mediated cognitive behavioral intervention promoting unsupervised walking exercise prevented mobility loss and improved functioning at 6- and 12-month follow-up in PAD patients. Clinical Trial Registration URL: http://clinicaltrials.gov. Unique identifier: NCT00693940. PMID:25994445

  12. Evaluation of the Efficacy and Color Stability of Two Different At-Home Bleaching Systems on Teeth of Different Shades: A Randomized Controlled Clinical Trial.

    PubMed

    Aka, Betül; Celik, Esra Uzer

    2017-09-01

    This randomized controlled clinical trial compared the bleaching efficacy of two different at-home bleaching systems on teeth of different shades and their color stability after a 6-month follow-up. Ninety-two patients (777 teeth) were randomly divided into three groups: (a) negative control, (b) patients treated with a custom-made tray containing 10% carbamide peroxide (10% CP/PF) (Opalescence PF), and (c) patients treated with a pre-loaded tray containing 6% hydrogen peroxide (6% HP/Go) (Opalescence Go). Teeth in all groups were divided into three sub-groups according to the VITA Classic Shade Guide: light (A1-C1), medium dark (C2-B3), and dark (A3.5-C4). Bleaching systems were performed in accordance with manufacturers' instructions for 14 days. The color values were measured at the baseline, 10 days and 14 days of bleaching, 2 weeks, and 6 months after bleaching. Three-way ANOVA and Mann-Whitney U tests were used for statistical analysis (α = 0.05). Irrespective of original shade, both bleaching groups showed significantly higher ΔE* values than the control groups, and the ΔE* values were significantly higher in the 10% CP/PF groups than those in the 6% HP/Go groups (p < 0.05). In both bleaching systems, the dark teeth showed higher ΔE* values than the light teeth (p < 0.05). The ΔE* values decreased significantly only in the 10% CP/PF groups after 6 months (p < 0.05). Both bleaching agents produced a bleaching effect, but 10% CP/PF was more effective. A pre-loaded tray system may be used for dental bleaching, but it is still less effective than conventional a 10% carbamide peroxide system, irrespective of the initial shade. (J Esthet Restor Dent 29:325-338, 2017). © 2017 Wiley Periodicals, Inc.

  13. Effects of training with a passive hand orthosis and games at home in chronic stroke: a pilot randomised controlled trial.

    PubMed

    Nijenhuis, Sharon M; Prange-Lasonder, Gerdienke B; Stienen, Arno Ha; Rietman, Johan S; Buurke, Jaap H

    2017-02-01

    To compare user acceptance and arm and hand function changes after technology-supported training at home with conventional exercises in chronic stroke. Secondly, to investigate the relation between training duration and clinical changes. A randomised controlled trial. Training at home, evaluation at research institute. Twenty chronic stroke patients with severely to mildly impaired arm and hand function. Participants were randomly assigned to six weeks (30 minutes per day, six days a week) of self-administered home-based arm and hand training using either a passive dynamic wrist and hand orthosis combined with computerised gaming exercises (experimental group) or prescribed conventional exercises from an exercise book (control group). Main outcome measures are the training duration for user acceptance and the Action Research Arm Test for arm and hand function. Secondary outcomes are the Intrinsic Motivation Inventory, Fugl-Meyer assessment, Motor Activity Log, Stroke Impact Scale and grip strength. The control group reported a higher training duration (189 versus 118 minutes per week, P = 0.025). Perceived motivation was positive and equal between groups ( P = 0.935). No differences in clinical outcomes over training between groups were found (P ⩾ 0.165). Changes in Box and Block Test correlated positively with training duration ( P = 0.001). Both interventions were accepted. An additional benefit of technology-supported arm and hand training over conventional arm and hand exercises at home was not demonstrated. Training duration in itself is a major contributor to arm and hand function improvements.

  14. Effect of Cranberry Capsules on Bacteriuria Plus Pyuria Among Older Women in Nursing Homes: A Randomized Clinical Trial.

    PubMed

    Juthani-Mehta, Manisha; Van Ness, Peter H; Bianco, Luann; Rink, Andrea; Rubeck, Sabina; Ginter, Sandra; Argraves, Stephanie; Charpentier, Peter; Acampora, Denise; Trentalange, Mark; Quagliarello, Vincent; Peduzzi, Peter

    2016-11-08

    Bacteriuria plus pyuria is highly prevalent among older women living in nursing homes. Cranberry capsules are an understudied, nonantimicrobial prevention strategy used in this population. To test the effect of 2 oral cranberry capsules once a day on presence of bacteriuria plus pyuria among women residing in nursing homes. Double-blind, randomized, placebo-controlled efficacy trial with stratification by nursing home and involving 185 English-speaking women aged 65 years or older, with or without bacteriuria plus pyuria at baseline, residing in 21 nursing homes located within 50 miles (80 km) of New Haven, Connecticut (August 24, 2012-October 26, 2015). Two oral cranberry capsules, each capsule containing 36 mg of the active ingredient proanthocyanidin (ie, 72 mg total, equivalent to 20 ounces of cranberry juice) vs placebo administered once a day in 92 treatment and 93 control group participants. Presence of bacteriuria (ie, at least 105 colony-forming units [CFUs] per milliliter of 1 or 2 microorganisms in urine culture) plus pyuria (ie, any number of white blood cells on urinalysis) assessed every 2 months over the 1-year study surveillance; any positive finding was considered to meet the primary outcome. Secondary outcomes were symptomatic urinary tract infection (UTI), all-cause death, all-cause hospitalization, all multidrug antibiotic-resistant organisms, antibiotics administered for suspected UTI, and total antimicrobial administration. Of the 185 randomized study participants (mean age, 86.4 years [SD, 8.2], 90.3% white, 31.4% with bacteriuria plus pyuria at baseline), 147 completed the study. Overall adherence was 80.1%. Unadjusted results showed the presence of bacteriuria plus pyuria in 25.5% (95% CI, 18.6%-33.9%) of the treatment group and in 29.5% (95% CI, 22.2%-37.9%) of the control group. The adjusted generalized estimating equations model that accounted for missing data and covariates showed no significant difference in the presence of bacteriuria

  15. Effectiveness of home-based cupping massage compared to progressive muscle relaxation in patients with chronic neck pain--a randomized controlled trial.

    PubMed

    Lauche, Romy; Materdey, Svitlana; Cramer, Holger; Haller, Heidemarie; Stange, Rainer; Dobos, Gustav; Rampp, Thomas

    2013-01-01

    Chronic neck pain is a major public health problem with very few evidence-based complementary treatment options. This study aimed to test the efficacy of 12 weeks of a partner-delivered home-based cupping massage, compared to the same period of progressive muscle relaxation in patients with chronic non-specific neck pain. Patients were randomly assigned to self-directed cupping massage or progressive muscle relaxation. They were trained and asked to undertake the assigned treatment twice weekly for 12 weeks. Primary outcome measure was the current neck pain intensity (0-100 mm visual analog scale; VAS) after 12 weeks. Secondary outcome measures included pain on motion, affective pain perception, functional disability, psychological distress, wellbeing, health-related quality of life, pressure pain thresholds and adverse events. Sixty one patients (54.1±12.7 years; 73.8%female) were randomized to cupping massage (n = 30) or progressive muscle relaxation (n = 31). After treatment, both groups showed significantly less pain compared to baseline however without significant group differences. Significant effects in favor of cupping massage were only found for wellbeing and pressure pain thresholds. In conclusion, cupping massage is no more effective than progressive muscle relaxation in reducing chronic non-specific neck pain. Both therapies can be easily used at home and can reduce pain to a minimal clinically relevant extent. Cupping massage may however be better than PMR in improving well-being and decreasing pressure pain sensitivity but more studies with larger samples and longer follow-up periods are needed to confirm these results. ClinicalTrials.gov NCT01500330.

  16. A randomized controlled trial of household-based flocculant-disinfectant drinking water treatment for diarrhea prevention in rural Guatemala.

    PubMed

    Reller, Megan E; Mendoza, Carlos E; Lopez, M Beatriz; Alvarez, Maricruz; Hoekstra, Robert M; Olson, Christy A; Baier, Kathleen G; Keswick, Bruce H; Luby, Stephen P

    2003-10-01

    We conducted a study to determine if use of a new flocculant-disinfectant home water treatment reduced diarrhea. We randomly assigned 492 rural Guatemalan households to five different water treatment groups: flocculant-disinfectant, flocculant-disinfectant plus a customized vessel, bleach, bleach plus a vessel, and control. During one year of observation, residents of control households had 4.31 episodes of diarrhea per 100 person-weeks, whereas the incidence of diarrhea was 24% lower among residents of households receiving flocculant-disinfectant, 29% lower among those receiving flocculant-disinfectant plus vessel, 25% lower among those receiving bleach, and 12% lower among households receiving bleach plus vessel. In unannounced evaluations of home drinking water, free chlorine was detected in samples from 27% of flocculant-disinfectant households, 35% of flocculant-disinfectant plus vessel households, 35% of bleach households, and 43% of bleach plus vessel households. In a setting where diarrhea was a leading cause of death, intermittent use of home water treatment with flocculant-disinfectant decreased the incidence of diarrhea.

  17. Improving household air, drinking water and hygiene in rural Peru: a community-randomized-controlled trial of an integrated environmental home-based intervention package to improve child health.

    PubMed

    Hartinger, S M; Lanata, C F; Hattendorf, J; Verastegui, H; Gil, A I; Wolf, J; Mäusezahl, D

    2016-12-01

    Diarrhoea and acute lower respiratory infections are leading causes of childhood morbidity and mortality, which can be prevented by simple low-cost interventions. Integrated strategies can provide additional benefits by addressing multiple health burdens simultaneously. We conducted a community-randomized-controlled trial in 51 rural communities in Peru to evaluate whether an environmental home-based intervention package, consisting of improved solid-fuel stoves, kitchen sinks, solar disinfection of drinking water and hygiene promotion, reduces lower respiratory infections, diarrhoeal disease and improves growth in children younger than 36 months. The attention control group received an early child stimulation programme. We recorded 24 647 child-days of observation from 250 households in the intervention and 253 in the attention control group during 12-month follow-up. Mean diarrhoea incidence was 2.8 episodes per child-year in the intervention compared with 3.1 episodes in the control arm. This corresponds to a relative rate of 0.78 [95% confidence interval (CI): 0.58-1.05] for diarrhoea incidence and an odds ratio of 0.71 (95% CI: 0.47-1.06) for diarrhoea prevalence. No effects on acute lower respiratory infections or children's growth rates were observed. Combined home-based environmental interventions slightly reduced childhood diarrhoea, but the confidence interval included unity. Effects on growth and respiratory outcomes were not observed, despite high user compliance of the interventions. The absent effect on respiratory health might be due to insufficient household air quality improvements of the improved stoves and additional time needed to achieve attitudinal and behaviour change when providing composite interventions. © The Author 2016. Published by Oxford University Press on behalf of the International Epidemiological Association

  18. Dextrose prolotherapy for knee osteoarthritis: a randomized controlled trial.

    PubMed

    Rabago, David; Patterson, Jeffrey J; Mundt, Marlon; Kijowski, Richard; Grettie, Jessica; Segal, Neil A; Zgierska, Aleksandra

    2013-01-01

    Knee osteoarthritis is a common, debilitating chronic disease. Prolotherapy is an injection therapy for chronic musculoskeletal pain. We conducted a 3-arm, blinded (injector, assessor, injection group participants), randomized controlled trial to assess the efficacy of prolotherapy for knee osteoarthritis. Ninety adults with at least 3 months of painful knee osteoarthritis were randomized to blinded injection (dextrose prolotherapy or saline) or at-home exercise. Extra- and intra-articular injections were done at 1, 5, and 9 weeks with as-needed additional treatments at weeks 13 and 17. Exercise participants received an exercise manual and in-person instruction. Outcome measures included a composite score on the Western Ontario McMaster University Osteoarthritis Index (WOMAC; 100 points); knee pain scale (KPS; individual knee), post-procedure opioid medication use, and participant satisfaction. Intention-to-treat analysis using analysis of variance was used. No baseline differences existed between groups. All groups reported improved composite WOMAC scores compared with baseline status (P <.01) at 52 weeks. Adjusted for sex, age, and body mass index, WOMAC scores for patients receiving dextrose prolotherapy improved more (P <.05) at 52 weeks than did scores for patients receiving saline and exercise (score change: 15.3 ± 3.5 vs 7.6 ± 3.4, and 8.2 ± 3.3 points, respectively) and exceeded the WOMAC-based minimal clinically important difference. Individual knee pain scores also improved more in the prolotherapy group (P = .05). Use of prescribed postprocedure opioid medication resulted in rapid diminution of injection-related pain. Satisfaction with prolotherapy was high. There were no adverse events. Prolotherapy resulted in clinically meaningful sustained improvement of pain, function, and stiffness scores for knee osteoarthritis compared with blinded saline injections and at-home exercises.

  19. The effectiveness of the use of a digital activity coaching system in addition to a two-week home-based exercise program in patients after total knee arthroplasty: study protocol for a randomized controlled trial.

    PubMed

    Harmelink, Karen E M; Zeegers, A V C M; Tönis, Thijs M; Hullegie, Wim; Nijhuis-van der Sanden, Maria W G; Staal, J Bart

    2017-07-05

    There is consistent evidence that supervised programs are not superior to home-based programs after total knee arthroplasty (TKA), especially in patients without complications. Home-based exercise programs are effective, but we hypothesize that their effectiveness can be improved by increasing the adherence to physical therapy advice to reach an adequate exercise level during the program and thereafter. Our hypothesis is that an activity coaching system (accelerometer-based activity sensor), alongside a home-based exercise program, will increase adherence to exercises and the activity level, thereby improving physical functioning and recovery. The objective of this study is to determine the effectiveness of an activity coaching system in addition to a home-based exercise program after a TKA compared to only the home-based exercise program with physical functioning as outcome. This study is a single-blind randomized controlled trial. Both the intervention (n = 55) and the control group (n = 55) receive a two-week home-based exercise program, and the intervention group receives an additional activity coaching system. This is a hand-held electronic device together with an app on a smartphone providing information and advice on exercise behavior during the day. The primary outcome is physical functioning, measured with the Timed Up and Go test (TUG) after two weeks, six weeks and three months. Secondary outcomes are 1) adherence to the activity level (activity diary); 2) physical functioning, measured with the 2-Minute Walk Test (2MWT) and the Knee Osteoarthritis Outcome Score; 3) quality of life (SF-36); 4) healthcare use up to one year postoperatively and 5) cost-effectiveness. Data are collected preoperatively, three days, two and six weeks, three months and one year postoperatively. The strengths of the study are the use of both performance-based tests and self-reported questionnaires and the personalized tailored program after TKA given by specialized physical

  20. Home-based interventions improve trained, but not novel, dual-task balance performance in older adults: A randomized controlled trial.

    PubMed

    Wongcharoen, Suleeporn; Sungkarat, Somporn; Munkhetvit, Peeraya; Lugade, Vipul; Silsupadol, Patima

    2017-02-01

    The purpose of this study was to compare the efficacy of four different home-based interventions on dual-task balance performance and to determine the generalizability of the four trainings to untrained tasks. Sixty older adults, aged 65 and older, were randomly assigned to one of four home-based interventions: single-task motor training, single-task cognitive training, dual-task motor-cognitive training, and dual-task cognitive-cognitive training. Participants received 60-min individualized training sessions, 3 times a week for 4 weeks. Prior to and following the training program, participants were asked to walk under two single-task conditions (i.e. narrow walking and obstacle crossing) and two dual-task conditions (i.e. a trained narrow walking while performing verbal fluency task and an untrained obstacle crossing while counting backward by 3s task). A nine-camera motion capture system was used to collect the trajectories of 32 reflective markers placed on bony landmarks of participants. Three-dimensional kinematics of the whole body center of mass and base of support were computed. Results from the extrapolated center of mass displacement indicated that motor-cognitive training was more effective than the single-task motor training to improve dual-task balance performance (p=0.04, ES=0.11). Interestingly, balance performance under both single-task and dual-task conditions can also be improved through a non-motor, single-task cognitive training program (p=0.01, ES=0.13, and p=0.01, ES=0.11, respectively). However, improved dual-task processing skills during training were not transferred to the novel dual task (p=0.15, ES=0.09). This is the first study demonstrating that home-based dual-task training can be effectively implemented to improve balance performance during gait in older adults. Copyright © 2016 Elsevier B.V. All rights reserved.

  1. Costs of Home Versus Inpatient Treatment for Fever and Neutropenia: Analysis of a Multicenter Randomized Trial

    PubMed Central

    Hendricks, Ann M.; Loggers, Elizabeth Trice; Talcott, James A.

    2011-01-01

    Purpose For patients with cancer who have febrile neutropenia, relative costs of home versus hospital treatment, including unreimbursed costs borne by patients and families, are poorly characterized. We estimated costs from a randomized trial of patients with low-risk febrile neutropenia for whom outpatient care was feasible, comparing inpatient treatment with discharge to home care after inpatient observation. Methods We collected direct medical and self-reported indirect costs for 57 inpatient and 35 outpatient treatment episodes of patients enrolled in a randomized trial from 1996 through 2000. Charges from hospital bills were converted to costs using Medicare cost-to-charge ratios. Patients kept daily logs of out-of-pocket payments and time spent by informal caregivers providing care. Dollar amounts were standardized to June 2008. Results Mean total charges for the hospital arm were 49% higher than for the home treatment arm ($16,341 v $10,977; P < .01). Mean estimated total costs for the hospital arm were 30% higher ($10,143 v $7,830; P < .01). Inspection of sparse available data suggests that payments made were similar by treatment arm. Inpatients and their caregivers spent more out of pocket than their outpatient counterparts (mean, $201 v $74; P < .01). Informal caregivers for both treatment arms reported similar time caring and lost from work. Conclusion Home intravenous antibiotic treatment was less costly than continued inpatient care for carefully selected patients with cancer having febrile neutropenia without significantly increased indirect costs or caregiver burden. PMID:21931037

  2. Case management: a randomized controlled study comparing a neighborhood team and a centralized individual model.

    PubMed

    Eggert, G M; Zimmer, J G; Hall, W J; Friedman, B

    1991-10-01

    This randomized controlled study compared two types of case management for skilled nursing level patients living at home: the centralized individual model and the neighborhood team model. The team model differed from the individual model in that team case managers performed client assessments, care planning, some direct services, and reassessments; they also had much smaller caseloads and were assigned a specific catchment area. While patients in both groups incurred very high estimated health services costs, the average annual cost during 1983-85 for team cases was 13.6 percent less than that of individual model cases. While the team cases were 18.3 percent less expensive among "old" patients (patients who entered the study from the existing ACCESS caseload), they were only 2.7 percent less costly among "new" cases. The lower costs were due to reductions in hospital days and home care. Team cases averaged 26 percent fewer hospital days per year and 17 percent fewer home health aide hours. Nursing home use was 48 percent higher for the team group than for the individual model group. Mortality was almost exactly the same for both groups during the first year (about 30 percent), but was lower for team patients during the second year (11 percent as compared to 16 percent). Probable mechanisms for the observed results are discussed.

  3. Inspiratory muscle training in bronchiectasis patients: a prospective randomized controlled study.

    PubMed

    Liaw, Mei-Yun; Wang, Yi-Hsi; Tsai, Yu-Chin; Huang, Kuo-Tung; Chang, Pei-Wen; Chen, Yung-Che; Lin, Meng-Chih

    2011-06-01

    To investigate the efficacy and feasibility of home-based inspiratory muscle training in patients with bronchiectasis. A prospective, single-blind, randomized, controlled study. Outpatient clinic of a tertiary care medical centre. Twenty-six patients with bronchiectasis were randomly divided into inspiratory muscle training and control groups. In the inspiratory muscle training group (n = 13), the training programme started with an intensity of 30% maximal inspiratory pressure (MIP), which was increased by 2 cmH(2)O each week, for 30 minutes daily, 5 days a week for eight weeks. The control group (n = 13) did not receive inspiratory muscle training. Main outcome measures included spirometry, resting oxyhaemoglobin saturation by pulse oximetry (SpO(2)), lowest SpO(2) and Borg Scale during 6-minute walking tests, 6-minute walking distance (6MWD), 6-minute walking work (6M(work)), MIP, maximal expiratory pressure (MEP) and St George's Respiratory Questionnaire. There were significant differences in change from baseline in 6MWD (411.9 (133.5) vs. 473.2 (117.2) m, P = 0.021), 6M(work) (21 051.0 (8286.7) vs. 23 915.5 (8343.0) kg-m, P = 0.022), MIP (60.8 (21.8) vs. 84.6 (29.0) cmH(2)O, P = 0.004), and MEP (72.3 (31.1) vs. 104.2 (35.7) cmH(2)O, P = 0.004) in the inspiratory muscle training group. Significant improvements in both MIP (23.8 (25.3) vs. 2.3 (16.4) cmH(2)O, adjusted P-value = 0.005) and MEP (31.9 (30.8) vs. 11.5 (20.8) cmH(2)O, adjusted P-value = 0.038) levels after adjusting for age by linear regression analysis were observed between groups. An eight-week home-based inspiratory muscle training is feasible and effective in improving both inspiratory and expiratory muscle strength, but has no effect on respiratory function and quality of life in patients with bronchiectasis.

  4. Smart homes and home health monitoring technologies for older adults: A systematic review.

    PubMed

    Liu, Lili; Stroulia, Eleni; Nikolaidis, Ioanis; Miguel-Cruz, Antonio; Rios Rincon, Adriana

    2016-07-01

    Around the world, populations are aging and there is a growing concern about ways that older adults can maintain their health and well-being while living in their homes. The aim of this paper was to conduct a systematic literature review to determine: (1) the levels of technology readiness among older adults and, (2) evidence for smart homes and home-based health-monitoring technologies that support aging in place for older adults who have complex needs. We identified and analyzed 48 of 1863 relevant papers. Our analyses found that: (1) technology-readiness level for smart homes and home health monitoring technologies is low; (2) the highest level of evidence is 1b (i.e., one randomized controlled trial with a PEDro score ≥6); smart homes and home health monitoring technologies are used to monitor activities of daily living, cognitive decline and mental health, and heart conditions in older adults with complex needs; (3) there is no evidence that smart homes and home health monitoring technologies help address disability prediction and health-related quality of life, or fall prevention; and (4) there is conflicting evidence that smart homes and home health monitoring technologies help address chronic obstructive pulmonary disease. The level of technology readiness for smart homes and home health monitoring technologies is still low. The highest level of evidence found was in a study that supported home health technologies for use in monitoring activities of daily living, cognitive decline, mental health, and heart conditions in older adults with complex needs. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  5. A randomized trial of effects of health risk appraisal combined with group sessions or home visits on preventive behaviors in older adults.

    PubMed

    Dapp, Ulrike; Anders, Jennifer A M; von Renteln-Kruse, Wolfgang; Minder, Christoph E; Meier-Baumgartner, Hans Peter; Swift, Cameron G; Gillmann, Gerhard; Egger, Matthias; Beck, John C; Stuck, Andreas E

    2011-05-01

    To explore effects of a health risk appraisal for older people (HRA-O) program with reinforcement, we conducted a randomized controlled trial in 21 general practices in Hamburg, Germany. Overall, 2,580 older patients of 14 general practitioners trained in reinforcing recommendations related to HRA-O-identified risk factors were randomized into intervention (n = 878) and control (n = 1,702) groups. Patients (n = 746) of seven additional matched general practitioners who did not receive this training served as a comparison group. Patients allocated to the intervention group, and their general practitioners, received computer-tailored written recommendations, and patients were offered the choice between interdisciplinary group sessions (geriatrician, physiotherapist, social worker, and nutritionist) and home visits (nurse). Among the intervention group, 580 (66%) persons made use of personal reinforcement (group sessions: 503 [87%], home visits: 77 [13%]). At 1-year follow-up, persons in the intervention group had higher use of preventive services (eg, influenza vaccinations, adjusted odds ratio 1.7; 95% confidence interval 1.4-2.1) and more favorable health behavior (eg, high fruit/fiber intake, odds ratio 2.0; 95% confidence interval 1.6-2.6), as compared with controls. Comparisons between intervention and comparison group data revealed similar effects, suggesting that physician training alone had no effect. Subgroup analyses indicated favorable effects for HRA-O with personal reinforcement, but not for HRA-O without reinforcement. HRA-O combined with physician training and personal reinforcement had favorable effects on preventive care use and health behavior.

  6. LA Sprouts: A 12-Week Gardening, Nutrition, and Cooking Randomized Control Trial Improves Determinants of Dietary Behaviors.

    PubMed

    Davis, Jaimie N; Martinez, Lauren C; Spruijt-Metz, Donna; Gatto, Nicole M

    2016-01-01

    To evaluate the effect of an exploratory 12-week nutrition, cooking, and gardening trial (LA Sprouts) on preference for fruit and vegetables (FV); willingness to try FV; identification of FV; self-efficacy to garden, eat, and cook FV; motivation to garden, eat, and cook FV; attitudes toward FV; nutrition and gardening knowledge; and home gardening habits. Randomized controlled trial. Four elementary schools. Three hundred four predominately Hispanic/Latino third- through fifth-grade students were randomized to either the LA Sprouts group (n = 167 students) or control group (n = 137 students). Twelve-week after-school nutrition, cooking, and gardening intervention. Determinants of dietary behavior as measured by questionnaire at baseline and postintervention. Analyses of covariance. After the 12-week program, compared with controls, LA Sprouts participants improved scores for identification of vegetables (+11% vs +5%; P = .001) and nutrition and gardening knowledge (+14.5% vs -5.0%; P = .003), and were more likely to garden at home (+7.5% vs -4.4%; P = .003). The LA Sprouts program positively affected a number of determinants of dietary behaviors that suggest possible mechanisms by which gardening and nutrition education act to improve dietary intake and health outcomes. Copyright © 2016 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

  7. A Randomized Controlled Trial of a Telephone Intervention for Alcohol Misuse with Injured Emergency Department Patients

    PubMed Central

    Mello, Michael J.; Baird, Janette; Lee, Christina; Strezsak, Valerie; French, Michael T.; Longabaugh, Richard

    2015-01-01

    Objective This was a randomized controlled trial to test efficacy of a telephone intervention (TBMI) for injured ED patients with alcohol misuse to decrease alcohol use, impaired driving, alcohol-related injuries and alcohol-related negative consequences. Methods ED patients screening positive for alcohol misuse were randomized to a three-session telephone brief motivational intervention on alcohol (TBMI) delivered by a counselor trained in motivational interviewing over 6 weeks or a control intervention of a scripted home fire and burn safety education delivered in three calls. Patients were followed for 12 months and assessed for changes in alcohol use, impaired driving, alcohol-related injuries and alcohol-related negative consequences. Results 730 ED patients were randomized; 78% received their assigned intervention by telephone and of those, 72% completed 12 months assessments. There were no differential benefits of TBMI intervention versus assessment and a control intervention in all three variables of alcohol use (frequency of binge alcohol use over the prior 30 days, maximum number of drinks at one time in past 30 days, typical alcohol use in past 30 days), alcohol impaired driving, alcohol related injuries and alcohol-related negative consequences. Conclusions Despite the potential advantage of delivering a TBMI in not disrupting ED clinical care, our study found no efficacy for it over an assessment and control intervention. Potential etiologies for our finding include that injury itself or alcohol assessments, or the control intervention had active ingredients for alcohol change. PMID:26585044

  8. A home-based rehabilitation intervention for people living with HIV and disability in a resource-poor community, KwaZulu-Natal: study protocol for a randomised controlled trial.

    PubMed

    Cobbing, Saul; Hanass-Hancock, Jill; Myezwa, Hellen

    2015-11-02

    In the era of highly active antiretroviral therapy HIV is now viewed as a chronic disease. Although people living with HIV are living longer lives, they are prone to a number of disabilities. Home-based rehabilitation has been shown to be an effective means of improving quality of life and function for people with a wide range of chronic diseases. There is a dearth of evidence, however, related to home-based rehabilitation interventions for people living with HIV, particularly in sub-Saharan Africa - the region with the highest global prevalence of HIV. A randomised controlled trial design will be employed. Adults living with HIV who have been on antiretroviral therapy for at least six months and with defined limited mobility will be randomly allocated to either an intervention group or the control group. Pre and post-intervention testing will be conducted at a public hospital in KwaZulu-Natal, South Africa in order to assess the participants' quality of life, perceived level of disability, functional ability and endurance. Individuals randomly allocated to the intervention group will participate in a four-month home-based rehabilitation programme, conducted once a week in their homes. This programme will be implemented by community workers who will be trained and supervised by a qualified physiotherapist. The participants in the control group will continue with the standard clinic management offered to them. On completion of the intervention, all participants will be re-assessed using the same outcome measures. Analysis of results will be carried out on intention-to-treat basis in order to identify any changes between intervention and control groups. The researchers aim to employ a novel task shifting approach to implement a needs-based home-based rehabilitation programme for people living with HIV in order to improve their quality of life and functional ability. It is hoped that this study will provide rehabilitation professionals and researchers with evidence

  9. Prolonged impact of home versus clinic-based management of chronic heart failure: extended follow-up of a pragmatic, multicentre randomized trial cohort.

    PubMed

    Stewart, Simon; Carrington, Melinda J; Horowitz, John D; Marwick, Thomas H; Newton, Phillip J; Davidson, Patricia M; Macdonald, Peter; Thompson, David R; Chan, Yih-Kai; Krum, Henry; Reid, Christopher; Scuffham, Paul A

    2014-07-01

    We compared the longer-term impact of the two most commonly applied forms of post-discharge management designed to minimize recurrent hospitalization and prolong survival in typically older patients with chronic heart failure (CHF). We followed a multi-center randomized controlled trial cohort of Australian patients hospitalized with CHF and initially allocated to home-based or specialized CHF clinic-based intervention for 1368 ± 216 days. Blinded endpoints included event-free survival from all-cause emergency hospitalization or death, all-cause mortality and rate of all-cause hospitalization and stay. 280 patients (73% male, aged 71 ± 14 years and 73% left ventricular systolic dysfunction) were initially randomized to home-based (n=143) or clinic-based (n=137) intervention. During extended follow-up (complete for 274 patients), 1139 all-cause hospitalizations (7477 days of hospital stay) and 121 (43.2%) deaths occurred. There was no difference in the primary endpoint; 20 (14.0%) home-based versus 13 (7.4%) clinic-based patients remained event-free (adjusted HR 0.89, 95% CI 0.70 to 1.15; p=0.378). Significantly fewer home-based (51/143, 35.7%) than clinic-based intervention (71/137, 51.8%) patients died (adjusted HR 0.62, 95% CI 0.42 to 0.90: p=0.012). Home-based versus clinic-based intervention patients accumulated 592 and 547 all-cause hospitalizations (p=0.087) associated with 3067 (median 4.0, IQR 2.0 to 6.8) versus 4410 (6.0, IQR 3.0 to 12.0) days of hospital stay (p<0.01 for rate and duration of hospital stay). Relative to clinic-based intervention, home-based intervention was not associated with prolonged event-free survival. Home-based intervention was, however, associated with significantly fewer all-cause deaths and significantly fewer days of hospital stay in the longer-term. Australian New Zealand Clinical Trials Registry number 12607000069459 (http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=81803). Copyright © 2013 Elsevier Ireland

  10. Promoting First Relationships® : Randomized Trial of a 10-Week Home Visiting Program With Families Referred to Child Protective Services.

    PubMed

    Oxford, Monica L; Spieker, Susan J; Lohr, Mary Jane; Fleming, Charles B

    2016-09-19

    We conducted a community-based randomized control trial with intent-to-treat analysis on Promoting First Relationships® (PFR), a 10-week home visiting program. The study included 247 families with 10- to 24-month-old children who had a recent, open child protective services investigation of child maltreatment. Families were randomly assigned to receive either the 10-week home visiting PFR service or a telephone-based, three-call resource and referral (R&R) service. Across postintervention time points, parents in the PFR condition scored higher than families in the R&R condition in parent understanding of toddlers' social emotional needs (d = .35) and observed parental sensitivity (d = .20). Children in the PFR condition scored lower than children in the comparison condition on an observational measure of atypical affective communication (d = .19) and were less likely than children in the comparison group to be placed into foster care through 1-year postintervention (6% vs. 13%, p = .042). No significant differences were found on measures of parenting stress or child social-emotional competence, behavior problems, or secure base behavior. Overall, the results show support for the promise of PFR as an intervention for enhancing parent sensitivity and preventing child removals for families in the child welfare system. © The Author(s) 2016.

  11. Nurse-Moderated Internet-Based Support for New Mothers: Non-Inferiority, Randomized Controlled Trial

    PubMed Central

    Reece, Christy E; Bowering, Kerrie; Jeffs, Debra; Sawyer, Alyssa C P; Mittinty, Murthy; Lynch, John W

    2017-01-01

    Background Internet-based interventions moderated by community nurses have the potential to improve support offered to new mothers, many of whom now make extensive use of the Internet to obtain information about infant care. However, evidence from population-based randomized controlled trials is lacking. Objective The aim of this study was to test the non-inferiority of outcomes for mothers and infants who received a clinic-based postnatal health check plus nurse-moderated, Internet-based group support when infants were aged 1-7 months as compared with outcomes for those who received standard care consisting of postnatal home-based support provided by a community nurse. Methods The design of the study was a pragmatic, preference, non-inferiority randomized control trial. Participants were recruited from mothers contacted for their postnatal health check, which is offered to all mothers in South Australia. Mothers were assigned either (1) on the basis of their preference to clinic+Internet or home-based support groups (n=328), or (2) randomly assigned to clinic+Internet or home-based groups if they declared no strong preference (n=491). The overall response rate was 44.8% (819/1827). The primary outcome was parenting self-competence, as measured by the Parenting Stress Index (PSI) Competence subscale, and the Karitane Parenting Confidence Scale scores. Secondary outcome measures included PSI Isolation, Interpersonal Support Evaluation List–Short Form, Maternal Support Scale, Ages and Stages Questionnaire–Social-Emotional and MacArthur Communicative Development Inventory (MCDI) scores. Assessments were completed offline via self-assessment questionnaires at enrolment (mean child age=4.1 weeks, SD 1.3) and again when infants were aged 9, 15, and 21 months. Results Generalized estimating equations adjusting for post-randomization baseline imbalances showed that differences in outcomes between mothers in the clinic+Internet and home-based support groups did not

  12. Nurse-Moderated Internet-Based Support for New Mothers: Non-Inferiority, Randomized Controlled Trial.

    PubMed

    Sawyer, Michael G; Reece, Christy E; Bowering, Kerrie; Jeffs, Debra; Sawyer, Alyssa C P; Mittinty, Murthy; Lynch, John W

    2017-07-24

    Internet-based interventions moderated by community nurses have the potential to improve support offered to new mothers, many of whom now make extensive use of the Internet to obtain information about infant care. However, evidence from population-based randomized controlled trials is lacking. The aim of this study was to test the non-inferiority of outcomes for mothers and infants who received a clinic-based postnatal health check plus nurse-moderated, Internet-based group support when infants were aged 1-7 months as compared with outcomes for those who received standard care consisting of postnatal home-based support provided by a community nurse. The design of the study was a pragmatic, preference, non-inferiority randomized control trial. Participants were recruited from mothers contacted for their postnatal health check, which is offered to all mothers in South Australia. Mothers were assigned either (1) on the basis of their preference to clinic+Internet or home-based support groups (n=328), or (2) randomly assigned to clinic+Internet or home-based groups if they declared no strong preference (n=491). The overall response rate was 44.8% (819/1827). The primary outcome was parenting self-competence, as measured by the Parenting Stress Index (PSI) Competence subscale, and the Karitane Parenting Confidence Scale scores. Secondary outcome measures included PSI Isolation, Interpersonal Support Evaluation List-Short Form, Maternal Support Scale, Ages and Stages Questionnaire-Social-Emotional and MacArthur Communicative Development Inventory (MCDI) scores. Assessments were completed offline via self-assessment questionnaires at enrolment (mean child age=4.1 weeks, SD 1.3) and again when infants were aged 9, 15, and 21 months. Generalized estimating equations adjusting for post-randomization baseline imbalances showed that differences in outcomes between mothers in the clinic+Internet and home-based support groups did not exceed the pre-specified margin of

  13. A Randomized Controlled Trial Evaluating Efficacy of Promoting a Home-Based HIV Self-Testing with Online Counseling on Increasing HIV Testing Among Men Who Have Sex with Men.

    PubMed

    Wang, Zixin; Lau, Joseph T F; Ip, Mary; Ho, Shara P Y; Mo, Phoenix K H; Latkin, Carl; Ma, Yee Ling; Kim, Yoona

    2018-01-01

    We developed an innovative home-based HIV self-testing (HIVST) service that included mailing of a free HIVST kit, and providing online real-time instructions and pre-test/post-test counseling (HIVST-OIC). The present parallel-group and non-blinded randomized controlled trial was conducted to evaluate the efficacy of promoting HIVST-OIC in increasing HIV testing rate among 430 men who have sex with men (MSM), with access to online live-chat applications in Hong Kong. At month 6, as compared to the control group, the intervention group reported significantly higher prevalence of HIV testing of any type (89.8 vs. 50.7%; relative risk (RR): 1.77; p < 0.001). Among those who have taken up any HIV testing in the last six months, significant between-group difference was found in multiple male sex partnerships (34.2 vs. 47.7%, RR: 0.72; p = 0.021). HIVST-OIC has a strong potential in increasing prevalence of HIV testing and reducing sexual risk behaviors. Implementation research is warranted.

  14. Integrating Depression Care Management into Medicare Home Health Reduces Risk of 30- and 60-Day Hospitalization: The Depression Care for Patients at Home Cluster-Randomized Trial.

    PubMed

    Bruce, Martha L; Lohman, Matthew C; Greenberg, Rebecca L; Bao, Yuhua; Raue, Patrick J

    2016-11-01

    To determine whether a depression care management intervention in Medicare home health recipients decreases risk of hospitalization. Cluster-randomized trial. Nurse teams were randomized to intervention (12 teams) or enhanced usual care (EUC; 9 teams). Six home health agencies from distinct geographic regions. Home health recipients were interviewed at home and over the telephone. Individuals aged 65 and older who screened positive for depression on nurse assessments (N = 755) and a subset who consented to interviews (n = 306). The Depression CARE for PATients at Home (CAREPATH) guides nurses in managing depression during routine home visits. Clinical functions include weekly symptom assessment, medication management, care coordination, patient education, and goal setting. Researchers conducted telephone conferences with team supervisors every 2 weeks. Hospitalization while receiving home health services was assessed using data from the home health record. Hospitalization within 30 days of starting home health, regardless of how long recipients received home health services, was assessed using data from the home care record and research assessments. The relative hazard of being admitted to the hospital directly from home health was 35% lower within 30 days of starting home health care (hazard ratio (HR) = 0.65, P = .01) and 28% lower within 60 days (HR = 0.72, P = .03) for CAREPATH participants than for participants receiving EUC. In participants referred to home health directly from the hospital, the relative hazard of being rehospitalized was approximately 55% lower (HR = 0.45, P = .001) for CAREPATH participants. Integrating CAREPATH depression care management into routine nursing practice reduces hospitalization and rehospitalization risk in older adults receiving Medicare home health nursing services. © 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.

  15. Gut-directed hypnotherapy in children with irritable bowel syndrome or functional abdominal pain (syndrome): a randomized controlled trial on self exercises at home using CD versus individual therapy by qualified therapists.

    PubMed

    Rutten, Juliette M T M; Vlieger, Arine M; Frankenhuis, Carla; George, Elvira K; Groeneweg, Michael; Norbruis, Obbe F; Tjon a Ten, Walther; Van Wering, Herbert; Dijkgraaf, Marcel G W; Merkus, Maruschka P; Benninga, Marc A

    2014-06-04

    Irritable bowel syndrome (IBS) and functional abdominal pain (syndrome) (FAP(S)) are common pediatric disorders, characterized by chronic or recurrent abdominal pain. Treatment is challenging, especially in children with persisting symptoms. Gut-directed hypnotherapy (HT) performed by a therapist has been shown to be effective in these children, but is still unavailable to many children due to costs, a lack of qualified child-hypnotherapists and because it requires a significant investment of time by child and parent(s). Home-based hypnotherapy by means of exercises on CD has been shown effective as well, and has potential benefits, such as lower costs and less time investment. The aim of this randomized controlled trial (RCT) is to compare cost-effectiveness of individual HT performed by a qualified therapist with HT by means of CD recorded self-exercises at home in children with IBS or FAP(S). 260 children, aged 8-18 years with IBS or FAP(S) according to Rome III criteria are included in this currently conducted RCT with a follow-up period of one year. Children are randomized to either 6 sessions of individual HT given by a qualified therapist over a 3-month period or HT through self-exercises at home with CD for 3 months.The primary outcome is the proportion of patients in which treatment is successful at the end of treatment and after one year follow-up. Treatment success is defined as at least 50% reduction in both abdominal pain frequency and intensity scores. Secondary outcomes include adequate relief, cost-effectiveness and effects of both therapies on depression and anxiety scores, somatization scores, QoL, pain beliefs and coping strategies. If the effectiveness of home-based HT with CD is comparable to, or only slightly lower, than HT by a therapist, this treatment may become an attractive form of therapy in children with IBS or FAP(S), because of its low costs and direct availability. Dutch Trial Register number NTR2725 (date of registration: 1 February

  16. Gut-directed hypnotherapy in children with irritable bowel syndrome or functional abdominal pain (syndrome): a randomized controlled trial on self exercises at home using CD versus individual therapy by qualified therapists

    PubMed Central

    2014-01-01

    Background Irritable bowel syndrome (IBS) and functional abdominal pain (syndrome) (FAP(S)) are common pediatric disorders, characterized by chronic or recurrent abdominal pain. Treatment is challenging, especially in children with persisting symptoms. Gut-directed hypnotherapy (HT) performed by a therapist has been shown to be effective in these children, but is still unavailable to many children due to costs, a lack of qualified child-hypnotherapists and because it requires a significant investment of time by child and parent(s). Home-based hypnotherapy by means of exercises on CD has been shown effective as well, and has potential benefits, such as lower costs and less time investment. The aim of this randomized controlled trial (RCT) is to compare cost-effectiveness of individual HT performed by a qualified therapist with HT by means of CD recorded self-exercises at home in children with IBS or FAP(S). Methods/Design 260 children, aged 8-18 years with IBS or FAP(S) according to Rome III criteria are included in this currently conducted RCT with a follow-up period of one year. Children are randomized to either 6 sessions of individual HT given by a qualified therapist over a 3-month period or HT through self-exercises at home with CD for 3 months. The primary outcome is the proportion of patients in which treatment is successful at the end of treatment and after one year follow-up. Treatment success is defined as at least 50% reduction in both abdominal pain frequency and intensity scores. Secondary outcomes include adequate relief, cost-effectiveness and effects of both therapies on depression and anxiety scores, somatization scores, QoL, pain beliefs and coping strategies. Discussion If the effectiveness of home-based HT with CD is comparable to, or only slightly lower, than HT by a therapist, this treatment may become an attractive form of therapy in children with IBS or FAP(S), because of its low costs and direct availability. Trial registration Dutch Trial

  17. Psychosocial benefits of workplace physical exercise: cluster randomized controlled trial.

    PubMed

    Jakobsen, Markus D; Sundstrup, Emil; Brandt, Mikkel; Andersen, Lars L

    2017-10-10

    While benefits of workplace physical exercise on physical health is well known, little is known about the psychosocial effects of such initiatives. This study evaluates the effect of workplace versus home-based physical exercise on psychosocial factors among healthcare workers. A total of 200 female healthcare workers (Age: 42.0, BMI: 24.1) from 18 departments at three hospitals were cluster-randomized to 10 weeks of: 1) home-based physical exercise (HOME) performed alone during leisure time for 10 min 5 days per week or 2) workplace physical exercise (WORK) performed in groups during working hours for 10 min 5 days per week and up to 5 group-based coaching sessions on motivation for regular physical exercise. Vitality and mental health (SF-36, scale 0-100), psychosocial work environment (COPSOQ, scale 0-100), work- and leisure disability (DASH, 0-100), control- (Bournemouth, scale 0-10) and concern about pain (Pain Catastrophizing Scale, scale 0-10) were assessed at baseline and at 10-week follow-up. Vitality as well as control and concern about pain improved more following WORK than HOME (all p < 0.05) in spite of increased work pace (p < 0.05). Work- and leisure disability, emotional demands, influence at work, sense of community, social support and mental health remained unchanged. Between-group differences at follow-up (WORK vs. HOME) were 7 [95% confidence interval (95% CI) 3 to 10] for vitality, -0.8 [95% CI -1.3 to -0.3] for control of pain and -0.9 [95% CI -1.4 to -0.5] for concern about pain, respectively. Performing physical exercise together with colleagues during working hours was more effective than home-based exercise in improving vitality and concern and control of pain among healthcare workers. These benefits occurred in spite of increased work pace. NCT01921764 at ClinicalTrials.gov . Registered 10 August 2013.

  18. Effectiveness of Home-Based Cupping Massage Compared to Progressive Muscle Relaxation in Patients with Chronic Neck Pain—A Randomized Controlled Trial

    PubMed Central

    Lauche, Romy; Materdey, Svitlana; Cramer, Holger; Haller, Heidemarie; Stange, Rainer; Dobos, Gustav; Rampp, Thomas

    2013-01-01

    Chronic neck pain is a major public health problem with very few evidence-based complementary treatment options. This study aimed to test the efficacy of 12 weeks of a partner-delivered home-based cupping massage, compared to the same period of progressive muscle relaxation in patients with chronic non-specific neck pain. Patients were randomly assigned to self-directed cupping massage or progressive muscle relaxation. They were trained and asked to undertake the assigned treatment twice weekly for 12 weeks. Primary outcome measure was the current neck pain intensity (0–100 mm visual analog scale; VAS) after 12 weeks. Secondary outcome measures included pain on motion, affective pain perception, functional disability, psychological distress, wellbeing, health-related quality of life, pressure pain thresholds and adverse events. Sixty one patients (54.1±12.7 years; 73.8%female) were randomized to cupping massage (n = 30) or progressive muscle relaxation (n = 31). After treatment, both groups showed significantly less pain compared to baseline however without significant group differences. Significant effects in favor of cupping massage were only found for wellbeing and pressure pain thresholds. In conclusion, cupping massage is no more effective than progressive muscle relaxation in reducing chronic non-specific neck pain. Both therapies can be easily used at home and can reduce pain to a minimal clinically relevant extent. Cupping massage may however be better than PMR in improving well-being and decreasing pressure pain sensitivity but more studies with larger samples and longer follow-up periods are needed to confirm these results. Trial Registration ClinicalTrials.gov NCT01500330 PMID:23762355

  19. An intervention to preschool children for reducing screen time: a randomized controlled trial.

    PubMed

    Yilmaz, G; Demirli Caylan, N; Karacan, C D

    2015-05-01

    Screen time, defined as time spent watching television, DVDs, or videos or playing computer or video games, has been related to serious health consequences in children, such as impaired language acquisition, violent behaviour, tobacco smoking and obesity. Our aim was to determine if a simple intervention aimed at preschool-aged children, applied at the health maintenance visits, in the primary care setting, would be effective in reducing screen time. We used a two group randomized controlled trial design. Two- to 6-year-old children and their parents were randomly assigned to receive an intervention to reduce their screen time, BMI and parental report of aggressive behaviour. At the end of the intervention we made home visits at 2, 6 and 9 months and the parents completed questionnaire. Parents in the intervention group reported less screen time and less aggressive behaviour than those in the control group but there were no differences in BMI z scores. This study shows that a preschool-based intervention can lead to reductions in young children's television/video viewing. © 2014 John Wiley & Sons Ltd.

  20. Study protocol of the CHOiCE trial: a three-armed, randomized, controlled trial of home-based HPV self-sampling for non-participants in an organized cervical cancer screening program.

    PubMed

    Tranberg, Mette; Bech, Bodil Hammer; Blaakær, Jan; Jensen, Jørgen Skov; Svanholm, Hans; Andersen, Berit

    2016-11-03

    The effectiveness of cervical cancer screening programs is challenged by suboptimal participation and coverage. Offering cervico-vaginal self-sampling for human papillomavirus testing (HPV self-sampling) to non-participants can increase screening participation. However, the effect varies substantially among studies, especially depending on the approach used to offer HPV self-sampling. The present trial evaluates the effect on participation in an organized screening program of a HPV self-sampling kit mailed directly to the home of the woman or mailed to the woman's home on demand only, compared with the standard second reminder for regular screening. The CHOiCE trial is a parallel, randomized, controlled, open-label trial. It will include 9327 women aged 30-64 years who are living in the Central Denmark Region and who have not participated in cervical cancer screening after an invitation and one reminder. The women will be equally randomized into three arms: 1) Directly mailed a second reminder including a HPV self-sampling kit; 2) Mailed a second reminder offering a HPV self-sampling kit, to be ordered by e-mail, text message, phone, or through a webpage; and 3) Mailed a second reminder for a practitioner-collected sample (control group). The primary outcome will be the proportion of women in the intervention groups who participate by returning their HPV self-sampling kit or have a practitioner-collected sample compared with the proportion of women who have a practitioner-collected sample in the control group at 90 and 180 days after mail out of the second reminders. Per-protocol and intention-to-treat analyses will be performed. The secondary outcome will be the proportion of women with a positive HPV self-collected sample who attend follow-up testing at 30, 60, or 90 days after mail out of the results. The CHOiCE trial will provide strong and important evidence allowing us to determine if and how HPV self-sampling can be used to increase participation in

  1. Yoga vs. physical therapy vs. education for chronic low back pain in predominantly minority populations: study protocol for a randomized controlled trial.

    PubMed

    Saper, Robert B; Sherman, Karen J; Delitto, Anthony; Herman, Patricia M; Stevans, Joel; Paris, Ruth; Keosaian, Julia E; Cerrada, Christian J; Lemaster, Chelsey M; Faulkner, Carol; Breuer, Maya; Weinberg, Janice

    2014-02-26

    Chronic low back pain causes substantial morbidity and cost to society while disproportionately impacting low-income and minority adults. Several randomized controlled trials show yoga is an effective treatment. However, the comparative effectiveness of yoga and physical therapy, a common mainstream treatment for chronic low back pain, is unknown. This is a randomized controlled trial for 320 predominantly low-income minority adults with chronic low back pain, comparing yoga, physical therapy, and education. Inclusion criteria are adults 18-64 years old with non-specific low back pain lasting ≥ 12 weeks and a self-reported average pain intensity of ≥ 4 on a 0-10 scale. Recruitment takes place at Boston Medical Center, an urban academic safety-net hospital and seven federally qualified community health centers located in diverse neighborhoods. The 52-week study has an initial 12-week Treatment Phase where participants are randomized in a 2:2:1 ratio into i) a standardized weekly hatha yoga class supplemented by home practice; ii) a standardized evidence-based exercise therapy protocol adapted from the Treatment Based Classification method, individually delivered by a physical therapist and supplemented by home practice; and iii) education delivered through a self-care book. Co-primary outcome measures are 12-week pain intensity measured on an 11-point numerical rating scale and back-specific function measured using the modified Roland Morris Disability Questionnaire. In the subsequent 40-week Maintenance Phase, yoga participants are re-randomized in a 1:1 ratio to either structured maintenance yoga classes or home practice only. Physical therapy participants are similarly re-randomized to either five booster sessions or home practice only. Education participants continue to follow recommendations of educational materials. We will also assess cost effectiveness from the perspectives of the individual, insurers, and society using claims databases, electronic

  2. Individual and contextual determinants of resident-on-resident abuse in nursing homes: a random sample telephone survey of adults with an older family member in a nursing home.

    PubMed

    Schiamberg, Lawrence B; von Heydrich, Levente; Chee, Grace; Post, Lori A

    2015-01-01

    Few empirical investigations of elder abuse in nursing homes address the frequency and determinants of resident-on-resident abuse (RRA). A random sample of 452 adults with an older adult relative, ≥65 years of age, in a nursing home completed a telephone survey regarding elder abuse experienced by that elder family member. Using a Linear Structural Relations (LISREL) modeling design, the study examined the association of nursing home resident demographic characteristics (e.g., age, gender), health and behavioral characteristics (e.g., diagnosis of Alzheimer's Disease, Activities of Daily Living (ADLs), Instrumental Activities of Daily Living (IADLs), types of staff abuse (e.g., physical, emotional), and factors beyond the immediate nursing home setting (e.g., emotional closeness of resident with family members) with RRA. Mplus statistical software was used for structural equation modeling. Main findings indicated that resident-on-resident mistreatment of elderly nursing home residents is associated with the age of the nursing home resident, all forms of staff abuse, all ADLs and IADLs, and emotional closeness of the older adult to the family. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  3. Effects of the Finnish Alzheimer disease exercise trial (FINALEX): a randomized controlled trial.

    PubMed

    Pitkälä, Kaisu H; Pöysti, Minna M; Laakkonen, Marja-Liisa; Tilvis, Reijo S; Savikko, Niina; Kautiainen, Hannu; Strandberg, Timo E

    2013-05-27

    Few rigorous clinical trials have investigated the effectiveness of exercise on the physical functioning of patients with Alzheimer disease (AD). To investigate the effects of intense and long-term exercise on the physical functioning and mobility of home-dwelling patients with AD and to explore its effects on the use and costs of health and social services. A randomized controlled trial. A total of 210 home-dwelling patients with AD living with their spousal caregiver. The 3 trial arms included (1) group-based exercise (GE; 4-hour sessions with approximately 1-hour training) and (2) tailored home-based exercise (HE; 1-hour training), both twice a week for 1 year, and (3) a control group (CG) receiving the usual community care. The Functional Independence Measure (FIM), the Short Physical Performance Battery, and information on the use and costs of social and health care services. All groups deteriorated in functioning during the year after randomization, but deterioration was significantly faster in the CG than in the HE or GE group at 6 (P = .003) and 12 (P = .015) months. The FIM changes at 12 months were -7.1 (95% CI, -3.7 to -10.5), -10.3 (95% CI, -6.7 to -13.9), and -14.4 (95% CI, -10.9 to -18.0) in the HE group, GE group, and CG, respectively. The HE and GE groups had significantly fewer falls than the CG during the follow-up year. The total costs of health and social services for the HE patient-caregiver dyads (in US dollars per dyad per year) were $25,112 (95% CI, $17,642 to $32,581) (P = .13 for comparison with the CG), $22,066 in the GE group ($15,931 to $28,199; P = .03 vs CG), and $34,121 ($24,559 to $43,681) in the CG. An intensive and long-term exercise program had beneficial effects on the physical functioning of patients with AD without increasing the total costs of health and social services or causing any significant adverse effects. anzctr.org.au Identifier: ACTRN12608000037303.

  4. Nonpharmacologic Pain Management Interventions in German Nursing Homes: A Cluster Randomized Trial.

    PubMed

    Kalinowski, Sonja; Budnick, Andrea; Kuhnert, Ronny; Könner, Franziska; Kissel-Kröll, Angela; Kreutz, Reinhold; Dräger, Dagmar

    2015-08-01

    The reported prevalence of pain among nursing home residents (NHRs) is high. Insufficient use of analgesics, the conventional pain management strategy, is often reported. Whether and to what extent nonpharmacologic therapies (NPTs) are used to manage the pain of NHRs in Germany is largely unknown. The aim of this cluster-randomized trial was to assess the NPTs provided and to enhance the application and prescription of NPTs in NHRs on an individual level. There were six nursing homes in the intervention group and six in the control group. There were 239 NHRs, aged ≥65 years, with an average Mini-Mental State Examination score of at least 18 at baseline. Pain management interventions (cluster level) included an online course for physicians and 1-day seminar for nurses. Data on NPT applied by nurses and therapeutic NPT prescribed by physicians were obtained from residents' nursing documentation. Face-to-face interviews with NHRs assessed the NPT received. At baseline, 82.6% of NHR (mean age 83 years) were affected by pain, but less than 1 in 10 received NPT. The intervention did not result in a significant increase in the NPT applied by nurses, but did significantly increase the therapeutic NPT prescribed by physicians. Residents were active in using NPT to self-manage their pain. Given the prevalence of pain in NHRs, there is a clear need to improve pain management in this population. Extended use of NPT offers a promising approach. We recommend that nurses provide residents with education on pain-management techniques to support them in taking a proactive role in managing their pain. Copyright © 2015 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

  5. Rationale and design of the HOME trial: A pragmatic randomized controlled trial of home-based human papillomavirus (HPV) self-sampling for increasing cervical cancer screening uptake and effectiveness in a U.S. healthcare system.

    PubMed

    Winer, Rachel L; Tiro, Jasmin A; Miglioretti, Diana L; Thayer, Chris; Beatty, Tara; Lin, John; Gao, Hongyuan; Kimbel, Kilian; Buist, Diana S M

    2018-01-01

    Women who delay or do not attend Papanicolaou (Pap) screening are at increased risk for cervical cancer. Trials in countries with organized screening programs have demonstrated that mailing high-risk (hr) human papillomavirus (HPV) self-sampling kits to under-screened women increases participation, but U.S. data are lacking. HOME is a pragmatic randomized controlled trial set within a U.S. integrated healthcare delivery system to compare two programmatic approaches for increasing cervical cancer screening uptake and effectiveness in under-screened women (≥3.4years since last Pap) aged 30-64years: 1) usual care (annual patient reminders and ad hoc outreach by clinics) and 2) usual care plus mailed hrHPV self-screening kits. Over 2.5years, eligible women were identified through electronic medical record (EMR) data and randomized 1:1 to the intervention or control arm. Women in the intervention arm were mailed kits with pre-paid envelopes to return samples to the central clinical laboratory for hrHPV testing. Results were documented in the EMR to notify women's primary care providers of appropriate follow-up. Primary outcomes are detection and treatment of cervical neoplasia. Secondary outcomes are cervical cancer screening uptake, abnormal screening results, and women's experiences and attitudes towards hrHPV self-sampling and follow-up of hrHPV-positive results (measured through surveys and interviews). The trial was designed to evaluate whether a programmatic strategy incorporating hrHPV self-sampling is effective in promoting adherence to the complete screening process (including follow-up of abnormal screening results and treatment). The objective of this report is to describe the rationale and design of this pragmatic trial. Copyright © 2017 Elsevier Inc. All rights reserved.

  6. Clinical Effectiveness of Integrating Depression Care Management into Medicare Home Health: The Depression CAREPATH Cluster-Randomized Trial

    PubMed Central

    Bruce, Martha L.; Raue, Patrick J.; Reilly, Catherine F.; Greenberg, Rebecca L.; Meyers, Barnett S.; Banerjee, Samprit; Pickett, Yolonda R.; Sheeran, Thomas F.; Ghesquiere, Angela; Zukowski, Diane; Rosas, Vianca H.; McLaughlin, Jeanne; Pledger, Lori; Doyle, Joan; Joachim, Pamela; Leon, Andrew C.

    2015-01-01

    Importance Depression is highly prevalent, inadequately treated, and contributes to hospitalization and other poor outcomes in older home healthcare patients. Feasible and effective interventions are needed to reduce this burden of depression. Objective To determine whether among older Medicare home health recipients who screen positive for depression, patients of nurses randomized to intervention have greater improvement in depressive symptoms over one year compared to patients receiving enhanced usual care. Design The cluster-randomized effectiveness trial randomized nurse-teams to Intervention (12 teams) or enhanced usual care (9 teams). Patients were recruited 2009–2012, assessed, and followed at 3, 6, and 12-months by research staff blind to intervention status. Setting Conducted at six home healthcare agencies nationwide. Patients interviewed at home and by telephone. Participants Medicare home health patients age ≥65 who screened positive for depression on routine nurse assessments. Of 502 eligible patients, 306 enrolled. Intervention Depression CAREPATH (CARE for PATients at Home) requires nurses to manage depression during routine home visits by weekly symptom assessment, medication management, care coordination, education, goal setting. Training totaled 7 hours (4 on-site, 3 web). Researchers telephoned supervisors every other week. Main Outcome and Measure Depression severity, assessed by 24-item Hamilton Depression Rating Scale (HDRS). Results 306 participants were predominately female (69.6%), diverse (18.0% Black, 16.0% Hispanic), average age 76.5 (SD=8.0) years. In full sample, the intervention had no effect (treatment × time interaction: P=0.13). Adjusted HDRS scores (CAREPATH vs control) did not differ at three (10.5 vs 11.4; P=0.26) or six months (9.3 vs 10.5; P=0.12), barely reaching significance at twelve months (8.7 vs 10.6; P=0.05). In subsample with mild depression (HDRS<10), the intervention had no effect (P=.90) and HDRS did not differ

  7. Improved Functional Performance in Individuals With Dementia After a Moderate-Intensity Home-Based Exercise Program: A Randomized Controlled Trial.

    PubMed

    Dawson, Nicole; Judge, Katherine S; Gerhart, Hayden

    2017-03-01

    Individuals with dementia (IWDs) experience difficulties across cognitive and functional domains. Nonpharmacological interventions aimed at reducing disability are greatly needed. Exercise is a low-cost and easily implemented approach, but investigation has yielded mixed evidence to date. The purpose of the current study was to evaluate a novel and innovative moderate-intensity functional exercise intervention for IWDs, which was developed using principles from exercise science along with a Strength-Based Approach, consisting of 24 home-based sessions. A randomized, controlled intervention trial with a 2-group pretest and posttest design was used with a sample of 23 community-dwelling IWDs (intervention group: n = 13; comparison group: n = 10). Average age of participants was 73.9 years (standard deviation, 9.1) with mild to moderate cognitive impairment (Mini-Mental State Examination, Mean = 20.8; standard deviation, 5.0). A 99.0% attendance rate indicated high adherence to the moderate-intensity exercise program. Efficacy was examined using multiple linear regression. Group assignment significantly predicted performance in key outcome measures, with IWDs from the intervention group improving in lower extremity strength (B = 5.92, t = 3.26, P = .004), balance (B = 4.04, t = 4.13, P = .001), and fast gait speed (B = .32, t = 2.61, P = .02). These findings indicated IWDs are able to participate in and benefit from a moderate-intensity functional exercise program, consisting of strength and balance activities. The current intervention used a Strength-Based Approach to facilitate implementation of exercise activities that could be completed by the sample. Therefore, integration of these techniques into mainstream clinical practice and research should be feasible with this patient population. Future research directions and implications of these findings also are discussed.

  8. Specialized home treatment versus hospital-based outpatient treatment for first-episode psychosis: a randomized clinical trial.

    PubMed

    Dewa, Carolyn S; Zipursky, Robert B; Chau, Nancy; Furimsky, Ivana; Collins, April; Agid, Ofer; Goering, Paula

    2009-11-01

    This pilot study compared the effectiveness of specialized care that was home based versus hospital based for individuals experiencing their first psychotic episode. A randomized controlled trial design was used. A total of 29 subjects were interviewed at baseline, 3 and 9 months. Repeated measures analysis of variance was employed to test for statistically significant changes over time within and between groups with regard to community psychosocial functioning and symptom severity. Our findings indicate that subjects in both the home-based and hospital-based programmes significantly improved with regard to symptoms and community functioning over time. However, the rates of change over time were not significantly different between the two programmes. There was a statistically significant difference between programmes with regard to the proportion of subjects with less than two visits (i.e. either did not attend their first assessment or attended follow-up visits after their assessment). This was a modest pilot study and the sample was too small to allow definitive conclusions to be drawn. However, the results raise questions about differences in initial treatment engagement. They suggest the need for additional research focusing on interventions that promote initial treatment seeking. © 2009 The Authors. Journal compilation © 2009 Blackwell Publishing Asia Pty Ltd.

  9. Integrated care at home reduces unnecessary hospitalizations of community-dwelling frail older adults: a prospective controlled trial.

    PubMed

    Di Pollina, Laura; Guessous, Idris; Petoud, Véronique; Combescure, Christophe; Buchs, Bertrand; Schaller, Philippe; Kossovsky, Michel; Gaspoz, Jean-Michel

    2017-02-14

    Care of frail and dependent older adults with multiple chronic conditions is a major challenge for health care systems. The study objective was to test the efficacy of providing integrated care at home to reduce unnecessary hospitalizations, emergency room visits, institutionalization, and mortality in community dwelling frail and dependent older adults. A prospective controlled trial was conducted, in real-life clinical practice settings, in a suburban region in Geneva, Switzerland, served by two home visiting nursing service centers. Three hundred and one community-dwelling frail and dependent people over 60 years old were allocated to previously randomized nursing teams into Control (N = 179) and Intervention (N = 122) groups: Controls received usual care by their primary care physician and home visiting nursing services, the Intervention group received an additional home evaluation by a community geriatrics unit with access to a call service and coordinated follow-up. Recruitment began in July 2009, goals were obtained in July 2012, and outcomes assessed until December 2012. Length of follow-up ranged from 5 to 41 months (mean 16.3). Primary outcome measure was the number of hospitalizations. Secondary outcomes were reasons for hospitalizations, the number and reason of emergency room visits, institutionalization, death, and place of death. The number of hospitalizations did not differ between groups however, the intervention led to lower cumulative incidence for the first hospitalization after the first year of follow-up (69.8%, CI 59.9 to 79.6 versus 87 · 6%, CI 78 · 2 to 97 · 0; p = .01). Secondary outcomes showed that the intervention compared to the control group had less frequent unnecessary hospitalizations (4.1% versus 11.7%, p = .03), lower cumulative incidence for the first emergency room visit, 8.3%, CI 2.6 to 13.9 versus 23.2%, CI 13.1 to 33.3; p = .01), and death occurred more frequently at home (44.4 versus 14

  10. The impact of community health worker-led home delivery of antiretroviral therapy on virological suppression: a non-inferiority cluster-randomized health systems trial in Dar es Salaam, Tanzania.

    PubMed

    Geldsetzer, Pascal; Francis, Joel M; Ulenga, Nzovu; Sando, David; Lema, Irene A; Mboggo, Eric; Vaikath, Maria; Koda, Happiness; Lwezaula, Sharon; Hu, Janice; Noor, Ramadhani A; Olofin, Ibironke; Larson, Elysia; Fawzi, Wafaie; Bärnighausen, Till

    2017-02-22

    Home delivery of antiretroviral therapy (ART) by community health workers (CHWs) may improve ART retention by reducing the time burden and out-of-pocket expenditures to regularly attend an ART clinic. In addition, ART home delivery may shorten waiting times and improve quality of care for those in facility-based care by decongesting ART clinics. This trial aims to determine whether ART home delivery for patients who are clinically stable on ART combined with facility-based care for those who are not stable on ART is non-inferior to the standard of care (facility-based care for all ART patients) in achieving and maintaining virological suppression. This is a non-inferiority cluster-randomized trial set in Dar es Salaam, Tanzania. A cluster is one of 48 healthcare facilities with its surrounding catchment area. 24 clusters were randomized to ART home delivery and 24 to the standard of care. The intervention consists of home visits by CHWs to provide counseling and deliver ART to patients who are stable on ART, while the control is the standard of care (facility-based ART and CHW home visits without ART home delivery). In addition, half of the healthcare facilities in each study arm were randomized to standard counseling during home visits (covering family planning, prevention of HIV transmission, and ART adherence), and half to standard plus nutrition counseling (covering food production and dietary advice). The non-inferiority design applies to the endpoints of the ART home delivery trial; the primary endpoint is the proportion of ART patients at a healthcare facility who are virally suppressed at the end of the study period. The margin of non-inferiority for this primary endpoint was set at nine percentage points. As the number of ART patients in sub-Saharan Africa is expected to rise, this trial provides causal evidence on the effectiveness of a home-based care model that could decongest ART clinics and reduce patients' healthcare expenditures. More broadly, this

  11. Maximizing post-stroke upper limb rehabilitation using a novel telerehabilitation interactive virtual reality system in the patient's home: study protocol of a randomized clinical trial.

    PubMed

    Kairy, Dahlia; Veras, Mirella; Archambault, Philippe; Hernandez, Alejandro; Higgins, Johanne; Levin, Mindy F; Poissant, Lise; Raz, Amir; Kaizer, Franceen

    2016-03-01

    Telerehabilitation (TR), or the provision of rehabilitation services from a distance using telecommunication tools such as the Internet, can contribute to ensure that patients receive the best care at the right time. This study aims to assess the effect of an interactive virtual reality (VR) system that allows ongoing rehabilitation of the upper extremity (UE) following a stroke, while the person is in their own home, with offline monitoring and feedback from a therapist at a distance. A single-blind (evaluator is blind to group assignment) two-arm randomized controlled trial is proposed, with participants who have had a stroke and are no longer receiving rehabilitation services randomly allocated to: (1) 4-week written home exercise program, i.e. usual care discharge home program or (2) a 4-week home-based TR exercise program using VR in addition to usual care i.e. treatment group. Motor recovery of the UE will be assessed using the Fugl-Meyer Assessment-UE and the Box and Block tests. To determine the efficacy of the system in terms of functional recovery, the Motor Activity Log, a self-reported measure of UE use will be used. Impact on quality of life will be determined using the Stroke Impact Scale-16. Lastly, a preliminary cost-effectiveness analysis will be conducted using costs and outcomes for all groups. Findings will contribute to evidence regarding the use of TR and VR to provide stroke rehabilitation services from a distance. This approach can enhance continuity of care once patients are discharged from rehabilitation, in order to maximize their recovery beyond the current available services. Copyright © 2015 Elsevier Inc. All rights reserved.

  12. Animal-assisted therapy and agitation and depression in nursing home residents with dementia: a matched case-control trial.

    PubMed

    Majić, Tomislav; Gutzmann, Hans; Heinz, Andreas; Lang, Undine E; Rapp, Michael A

    2013-11-01

    To investigate the efficacy of animal-assisted therapy (AAT) on symptoms of agitation/aggression and depression in nursing home residents with dementia in a randomized controlled trial. Previous studies have indicated that AAT has beneficial effects on neuropsychiatric symptoms in various psychiatric disorders but few studies have investigated the efficacy of AAT in patients suffering from dementia. Of 65 nursing home residents with dementia (mean [standard deviation] age: 81.8 [9.2] years; mean Mini-Mental State Examination score: 7.1 [0.7]), 27 matched pairs (N = 54) were randomly assigned to either treatment as usual or treatment as usual combined with AAT, administered over 10 weekly sessions. Blinded raters assessed cognitive impairment with the Mini-Mental State Examination, presence of agitation/aggression with the Cohen-Mansfield Agitation Inventory, and depression with the Dementia Mood Assessment Scale at baseline and during a period of 4 weeks after AAT intervention. In the control group, symptoms of agitation/aggression and depression significantly increased over 10 weeks; in the intervention group, patients receiving combined treatment displayed constant frequency and severity of symptoms of agitation/aggression (F1,48 = 6.43; p <0.05) and depression (F1,48 = 26.54; p <0.001). Symptom amelioration did not occur in either group. AAT is a promising option for the treatment of agitation/aggression and depression in patients with dementia. Our results suggest that AAT may delay progression of neuropsychiatric symptoms in demented nursing home residents. Further research is needed to determine its long-time effects. Copyright © 2013 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights reserved.

  13. A randomized controlled trial of the effects of multi-sensory stimulation (MSS) for people with dementia.

    PubMed

    Baker, R; Bell, S; Baker, E; Gibson, S; Holloway, J; Pearce, R; Dowling, Z; Thomas, P; Assey, J; Wareing, L A

    2001-03-01

    To investigate short-term effects of Multi-Sensory Stimulation (MSS) on behaviour, mood and cognition of older adults with dementia, the generalization of effects to day hospital and home environments and the endurance of any effects over time. A randomized controlled trial comparing MSS with a credible control of one-to-one activities. Fifty patients with diagnoses of moderate to severe dementia were randomized to either MSS or Activity groups. Patients participated in eight 30-minute sessions over a 4-week period. Ratings of behaviour and mood were taken before, during and after sessions to investigate immediate effects. Pre, mid, post-trial, and follow-up assessments were taken to investigate any generalization of effects on cognition, behaviour at the day hospital and behaviour and mood at home and endurance of effects once sessions had ceased. Immediately after MSS and Activity sessions patients talked more spontaneously, related better to others, did more from their own initiative, were less bored/inactive, and were more happy, active or alert. Both groups were more attentive to their environment than before, with a significantly greater improvement from the MSS group. At the day hospital, patients in the Activity group improved on their 'speech skills' (amount of speech; initiation of speech), whereas the MSS group remained unchanged during the trial. The MSS group showed a significant improvement in mood and behaviour at home compared to the Activity group whose behaviour deteriorated. No longer-term benefits were shown; indeed, behaviour declined sharply during the month follow-up period. Both MSS and Activity sessions appear to be effective and appropriate therapies for people with dementia.

  14. Promoting psychosocial well-being following stroke: study protocol for a randomized, controlled trial.

    PubMed

    Kirkevold, Marit; Kildal Bragstad, Line; Bronken, Berit A; Kvigne, Kari; Martinsen, Randi; Gabrielsen Hjelle, Ellen; Kitzmüller, Gabriele; Mangset, Margrete; Angel, Sanne; Aadal, Lena; Eriksen, Siren; Wyller, Torgeir B; Sveen, Unni

    2018-04-03

    Stroke is a major public health threat globally. Psychosocial well-being may be affected following stroke. Depressive symptoms, anxiety, general psychological distress and social isolation are prevalent. Approximately one third report depressive symptoms and 20% report anxiety during the first months or years after the stroke. Psychosocial difficulties may impact significantly on long-term functioning and quality of life, reduce the effects of rehabilitation services and lead to higher mortality rates. The aim of the study is to evaluate the effect of a previously developed and feasibility tested dialogue-based psychosocial intervention aimed at promoting psychosocial well-being and coping following stroke among stroke survivors with and without aphasia. The study will be conducted as a multicenter, randomized, single blind controlled trial with one intervention and one control arm. It will include a total of 330 stroke survivors randomly allocated into either an intervention group (dialogue-based intervention to promote psychosocial well-being) or a control group (usual care). Participants in the intervention group will receive eight individual sessions of supported dialogues in their homes during the first six months following an acute stroke. The primary outcome measure will be psychosocial well-being measured by the General Health Questionnaire (GHQ). Secondary outcome measures will be quality of life (SAQoL), sense of coherence (SOC), and depression (Yale). Process evaluation will be conducted in a longitudinal mixed methods study by individual qualitative interviews with 15-20 participants in the intervention and control groups, focus group interviews with the intervention personnel and data collectors, and a comprehensive analysis of implementation fidelity. The intervention described in this study protocol is based on thorough development and feasibility work, guided by the UK medical research council framework for developing and testing complex

  15. Evaluating a Website to Teach Children Safety with Dogs: A Randomized Controlled Trial

    PubMed Central

    Schwebel, David C.; Li, Peng; McClure, Leslie A.; Severson, Joan

    2016-01-01

    Dog bites represent a significant threat to child health. Theory-driven interventions scalable for broad dissemination are sparse. A website was developed to teach children dog safety via increased knowledge, improved cognitive skills in relevant domains, and increased perception of vulnerability to bites. A randomized controlled trial was conducted with 69 children aged 4–5 randomly assigned to use the dog safety website or a control transportation safety website for ~3 weeks. Assessment of dog safety knowledge and behavior plus skill in three relevant cognitive constructs (impulse control, noticing details, and perspective-taking) was conducted both at baseline and following website use. The dog safety website incorporated interactive games, instructional videos including testimonials, a motivational rewards system, and messaging to parents concerning child lessons. Our results showed that about two-thirds of the intervention sample was not adherent to website use at home, so both intent-to-treat and per-protocol analyses were conducted. Intent-to-treat analyses yielded mostly null results. Per-protocol analyses suggested children compliant to the intervention protocol scored higher on knowledge and recognition of safe behavior with dogs following the intervention compared to the control group. Adherent children also had improved scores post-intervention on the cognitive skill of noticing details compared to the control group. We concluded that young children’s immature cognition can lead to dog bites. Interactive eHealth training on websites shows potential to teach children relevant cognitive and safety skills to reduce risk. Compliance to website use is a challenge, and some relevant cognitive skills (e.g., noticing details) may be more amenable to computer-based training than others (e.g., impulse control). PMID:27918466

  16. Evaluating a Website to Teach Children Safety with Dogs: A Randomized Controlled Trial.

    PubMed

    Schwebel, David C; Li, Peng; McClure, Leslie A; Severson, Joan

    2016-12-02

    Dog bites represent a significant threat to child health. Theory-driven interventions scalable for broad dissemination are sparse. A website was developed to teach children dog safety via increased knowledge, improved cognitive skills in relevant domains, and increased perception of vulnerability to bites. A randomized controlled trial was conducted with 69 children aged 4-5 randomly assigned to use the dog safety website or a control transportation safety website for ~3 weeks. Assessment of dog safety knowledge and behavior plus skill in three relevant cognitive constructs (impulse control, noticing details, and perspective-taking) was conducted both at baseline and following website use. The dog safety website incorporated interactive games, instructional videos including testimonials, a motivational rewards system, and messaging to parents concerning child lessons. Our results showed that about two-thirds of the intervention sample was not adherent to website use at home, so both intent-to-treat and per-protocol analyses were conducted. Intent-to-treat analyses yielded mostly null results. Per-protocol analyses suggested children compliant to the intervention protocol scored higher on knowledge and recognition of safe behavior with dogs following the intervention compared to the control group. Adherent children also had improved scores post-intervention on the cognitive skill of noticing details compared to the control group. We concluded that young children's immature cognition can lead to dog bites. Interactive eHealth training on websites shows potential to teach children relevant cognitive and safety skills to reduce risk. Compliance to website use is a challenge, and some relevant cognitive skills (e.g., noticing details) may be more amenable to computer-based training than others (e.g., impulse control).

  17. Task-Oriented Training with Computer Games for People with Rheumatoid Arthritis or Hand Osteoarthritis: A Feasibility Randomized Controlled Trial.

    PubMed

    Srikesavan, Cynthia Swarnalatha; Shay, Barbara; Szturm, Tony

    2016-09-13

    To examine the feasibility of a clinical trial on a novel, home-based task-oriented training with conventional hand exercises in people with rheumatoid arthritis or hand osteoarthritis. To explore the experiences of participants who completed their respective home exercise programmes. Thirty volunteer participants aged between 30 and 60 years and diagnosed with rheumatoid arthritis or hand osteoarthritis were proposed for a single-center, assessor-blinded, randomized controlled trial ( ClinicalTrials.gov : NCT01635582). Participants received task-oriented training with interactive computer games and objects of daily life or finger mobility and strengthening exercises. Both programmes were home based and were done four sessions per week with 20 minutes each session for 6 weeks. Major feasibility outcomes were number of volunteers screened, randomized, and retained; completion of blinded assessments, exercise training, and home exercise sessions; equipment and data management; and clinical outcomes of hand function. Reaching the recruitment target in 18 months and achieving exercise compliance >80% were set as success criteria. Concurrent with the trial, focus group interviews explored experiences of those participants who completed their respective programmes. After trial initiation, revisions in inclusion criteria were required to promote recruitment. A total of 17 participants were randomized and 15 were retained. Completion of assessments, exercise training, and home exercise sessions; equipment and data collection and management demonstrated excellent feasibility. Both groups improved in hand function outcomes and exercise compliance was above 85%. Participants perceived both programmes as appropriate and acceptable. Participants who completed task-oriented training also agreed that playing different computer games was enjoyable, engaging, and motivating. Findings demonstrate initial evidence on recruitment, feasibility of trial procedures, and acceptability of

  18. Effect of a pragmatic, cluster-randomized controlled trial on patient experience with care: The Transforming Outcomes for Patients through Medical home Evaluation and reDesign (TOPMED) study

    PubMed Central

    Dorr, David A.; Anastas, Tracy; Ramsey, Katrina; Wagner, Jesse; Sachdeva, Bhavaya; Michaels, LeAnn; Fagnan, Lyle

    2016-01-01

    Background Health reform programs like the Patient-Centered Medical Home (PCMH) are intended to improve the Triple Aim. Previous studies on PCMHs have shown mixed effects, but High Value Elements (HVEs) are expected to improve the Triple Aim. Objective To understand whether focusing on high value elements (HVEs) would improve patient experience with care. Methods Eight clinics were cluster-randomized in a year-long trial. Both arms received practice facilitation, IT-based reporting, and financial incentives. Intervention practices were encouraged to choose HVEs for QI goals. To assess patient experience, 1,597 Consumer Assessment of Healthcare Providers and Systems (CAHPS) surveys were sent pre- and post-trial to a stratified random sample of patients. Difference in difference multivariate analysis was used to compare patient responses from intervention and control practices, adjusting for confounders. Results The response rate was 43% (n=686). Non-respondent analysis showed no difference between arms, although differences were seen by risk status and age. The overall difference in difference was 2.8%, favoring the intervention. The intervention performed better in 9 of 11 composites. The intervention performed significantly better in Follow-up on test results (p=.091) and Patients’ rating of the provider (p=.091), while the control performed better in Access to care (p=.093). Both arms also had decreases, including 4 of 11 composites for the intervention, and 8 of 11 for the control. Discussion Practices that targeted HVEs showed significantly more improvement in patient experience of care. However, contemporaneous trends may have affected results, leading to declines in patient experience in both arms. PMID:27116107

  19. Can typical US home visits affect infant attachment? Preliminary findings from a randomized trial of Healthy Families Durham.

    PubMed

    Berlin, Lisa J; Martoccio, Tiffany L; Appleyard Carmody, Karen; Goodman, W Benjamin; O'Donnell, Karen; Williams, Janis; Murphy, Robert A; Dodge, Kenneth A

    2017-12-01

    US government-funded early home visiting services are expanding significantly. The most widely implemented home visiting models target at-risk new mothers and their infants. Such home visiting programs typically aim to support infant-parent relationships; yet, such programs' effects on infant attachment quality per se are as yet untested. Given these programs' aims, and the crucial role of early attachments in human development, it is important to understand attachment processes in home visited families. The current, preliminary study examined 94 high-risk mother-infant dyads participating in a randomized evaluation of the Healthy Families Durham (HFD) home visiting program. We tested (a) infant attachment security and disorganization as predictors of toddler behavior problems and (b) program effects on attachment security and disorganization. We found that (a) infant attachment disorganization (but not security) predicted toddler behavior problems and (b) participation in HFD did not significantly affect infant attachment security or disorganization. Findings are discussed in terms of the potential for attachment-specific interventions to enhance the typical array of home visiting services.

  20. Effects on Symptoms of Agitation and Depression in Persons With Dementia Participating in Robot-Assisted Activity: A Cluster-Randomized Controlled Trial.

    PubMed

    Jøranson, Nina; Pedersen, Ingeborg; Rokstad, Anne Marie Mork; Ihlebæk, Camilla

    2015-10-01

    To examine effects on symptoms of agitation and depression in nursing home residents with moderate to severe dementia participating in a robot-assisted group activity with the robot seal Paro. A cluster-randomized controlled trial. Ten nursing home units were randomized to either robot-assisted intervention or a control group with treatment as usual during 3 intervention periods from 2013 to 2014. Ten adapted units in nursing homes in 3 counties in eastern Norway. Sixty residents (67% women, age range 62-95 years) in adapted nursing home units with a dementia diagnosis or cognitive impairment (Mini-Mental State Examination score lower than 25/30). Group sessions with Paro took place in a separate room at nursing homes for 30 minutes twice a week over the course of 12 weeks. Local nurses were trained to conduct the intervention. Participants were scored on baseline measures (T0) assessing cognitive status, regular medication, agitation (BARS), and depression (CSDD). The data collection was repeated at end of intervention (T1) and at follow-up (3 months after end of intervention) (T2). Mixed models were used to test treatment and time effects. Statistically significant differences in changes were found on agitation and depression between groups from T0 to T2. Although the symptoms of the intervention group declined, the control group's symptoms developed in the opposite direction. Agitation showed an effect estimate of -5.51, CI 0.06-10.97, P = .048, and depression -3.88, CI 0.43-7.33, P = .028. There were no significant differences in changes on either agitation or depression between groups from T0 to T1. This study found a long-term effect on depression and agitation by using Paro in activity groups for elderly with dementia in nursing homes. Paro might be a suitable nonpharmacological treatment for neuropsychiatric symptoms and should be considered as a useful tool in clinical practice. Copyright © 2015 AMDA – The Society for Post-Acute and Long-Term Care

  1. Intelligent Home Control System Based on ARM10

    NASA Astrophysics Data System (ADS)

    Chen, G. X.; Jiang, J.; Zhong, L. H.

    2017-10-01

    Intelligent home is becoming the hot spot of social attention in the 21st century. When it is in China, it is a really new industry. However, there is no doubt that Intelligent home will become a new economic growth point of social development; it will change the life-style of human being. To develop the intelligent home, we should keep up with the development trend of technology. This is the reason why I talk about the intelligent home control system here. In this paper, intelligent home control system is designed for alarm and remote control on gas- leaking, fire disaster, earthquake prediction, etc., by examining environmental changes around house. When the Intelligent home control system has detected an accident occurs, the processor will communicate with the GSM module, informing the house keeper the occurrence of accident. User can receive and send the message to the system to cut the power by mobile phone. The system can get access to DCCthrough ARM10 JTAG interface, using DCC to send and receive messages. At the same time, the debugger on the host is mainly used to receive the user’s command and send it to the debug component in the target system. The data that returned from the target system is received and displayed to the user in a certain format.

  2. A home-based intervention to reduce depressive symptoms and improve quality of life in older African Americans: a randomized trial.

    PubMed

    Gitlin, Laura N; Harris, Lynn Fields; McCoy, Megan C; Chernett, Nancy L; Pizzi, Laura T; Jutkowitz, Eric; Hess, Edward; Hauck, Walter W

    2013-08-20

    Effective care models for treating older African Americans with depressive symptoms are needed. To determine whether a home-based intervention alleviates depressive symptoms and improves quality of life in older African Americans. Parallel, randomized trial stratified by recruitment site. Interviewers assessing outcomes were blinded to treatment assignment. (ClinicalTrials.gov: NCT00511680). A senior center and participants' homes from 2008 to 2010. African Americans aged 55 years or older with depressive symptoms. A multicomponent, home-based intervention delivered by social workers or a wait-list control group that received the intervention at 4 months. Self-reported depression severity at 4 months (primary outcome) and depression knowledge, quality of life, behavioral activation, anxiety, function, and remission at 4 and 8 months. Of 208 participants (106 and 102 in the intervention and wait-list groups, respectively), 182 (89 and 93, respectively) completed 4 months and 160 (79 and 81, respectively) completed 8 months. At 4 months, participants in the intervention group showed reduced depression severity (difference in mean change in Patient Health Questionnaire-9 score from baseline, -2.9 [95% CI, -4.6 to -1.2]; difference in mean change in Center for Epidemiologic Studies Depression Scale score from baseline, -3.7 [CI, -5.4 to -2.1]); improved depression knowledge, quality of life, behavioral activation, and anxiety (P < 0.001); and improved function (P = 0.014) compared with wait-list participants. More intervention than wait-list participants entered remission at 4 months (43.8% vs. 26.9%). After treatment, control participants showed benefits similar in magnitude to those of participants in the initial intervention group. Those in the initial intervention group maintained benefits at 8 months. The study had a small sample, short duration, and differential withdrawal rate. A home-based intervention delivered by social workers could reduce depressive

  3. 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.

  4. Cost-effectiveness of home telemonitoring in chronic kidney disease patients at different stages by a pragmatic randomized controlled trial (eNephro): rationale and study design.

    PubMed

    Thilly, Nathalie; Chanliau, Jacques; Frimat, Luc; Combe, Christian; Merville, Pierre; Chauveau, Philippe; Bataille, Pierre; Azar, Raymond; Laplaud, David; Noël, Christian; Kessler, Michèle

    2017-04-05

    Home telemonitoring has developed considerably over recent years in chronic diseases in order to improve communication between healthcare professionals and patients and to promote early detection of deteriorating health status. In the nephrology setting, home telemonitoring has been evaluated in home dialysis patients but data are scarce concerning chronic kidney disease (CKD) patients before and after renal replacement therapy. The eNephro study is designed to assess the cost effectiveness, clinical/biological impact, and patient perception of a home telemonitoring for CKD patients. Our purpose is to present the rationale, design and organisational aspects of this study. eNephro is a pragmatic randomised controlled trial, comparing home telemonitoring versus usual care in three populations of CKD patients: stage 3B/4 (n = 320); stage 5D CKD on dialysis (n = 260); stage 5 T CKD treated with transplantation (n= 260). Five hospitals and three not-for-profit providers managing self-care dialysis situated in three administrative regions in France are participating. The trial began in December 2015, with a scheduled 12-month inclusion period and 12 months follow-up. Outcomes include clinical and biological data (e.g. blood pressure, haemoglobin) collected from patient records, perceived health status (e.g. health related quality of life) collected from self-administered questionnaires, and health expenditure data retrieved from the French health insurance database (SNIIRAM) using a probabilistic matching procedure. The hypothesis is that home telemonitoring enables better control of clinical and biological parameters as well as improved perceived health status. This better control should limit emergency consultations and hospitalisations leading to decreased healthcare expenditure, compensating for the financial investment due to the telemedicine system. This study has been registered at ClinicalTrials.gov under NCT02082093 (date of registration: February 14

  5. Effects of Exercise on Cognition: The Finnish Alzheimer Disease Exercise Trial: A Randomized, Controlled Trial.

    PubMed

    Öhman, Hannareeta; Savikko, Niina; Strandberg, Timo E; Kautiainen, Hannu; Raivio, Minna M; Laakkonen, Marja-Liisa; Tilvis, Reijo; Pitkälä, Kaisu H

    2016-04-01

    To examine whether a regular, long-term exercise program performed by individuals with Alzheimer's disease (AD) at home or as group-based exercise at an adult daycare center has beneficial effects on cognition; to examine secondary outcomes of a trial that has been published earlier. Randomized, controlled trial. Community. Community-dwelling dyads (N = 210) of individuals with AD and their spousal caregivers randomized into three groups. Two types of intervention comprising customized home-based exercise (HE) and group-based exercise (GE), each twice a week for 1 year, were compared with a control group (CG) receiving usual community care. Cognitive function was measured using the Clock Drawing Test (CDT), Verbal Fluency (VF), Clinical Dementia Rating (CDR), and Mini-Mental State Examination (MMSE) at baseline and 3, 6, and 12 months of follow-up. Executive function, measured using CDT, improved in the HE group, and changes in the score were significantly better than those of the CG at 12 months (adjusted for age, sex, and CDR, P = .03). All groups deteriorated in VF and MMSE score during the intervention, and no significant differences between the groups were detected at 12-month follow-up when analyses were adjusted for age, sex, and CDR. Regular, long-term, customized HE improved the executive function of community-dwelling older people with memory disorders, but the effects were mild and were not observed in other domains of cognition. © 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.

  6. Postpartum depression peer support: maternal perceptions from a randomized controlled trial.

    PubMed

    Dennis, Cindy-Lee

    2010-05-01

    Peer support in the early postpartum period is effective in the prevention of postpartum depression among women identified as high-risk. To describe maternal perceptions of peer support received while participating in a trial. Cross-sectional survey of women participating in a randomized controlled trial to evaluate the effect of peer support in the prevention of postpartum depression. Seven health regions across Ontario Canada. 701 women were recruited between November 2004 and September 2006. Women eligible for the study were all mothers with an Edinburgh Postnatal Depression Scale score >9 who were within 2 weeks postpartum, at least 18 years of age, able to speak English, had a live birth, and had been discharged home from the hospital. Exclusion criteria included an infant not discharged home with the mother and current use of antidepressant or antipsychotic medication. Two hundred and twenty-one mothers completed the mailed questionnaire. Women were randomly allocated to receive usual postpartum care (control group) or usual postpartum care plus telephone-based peer support (intervention group). Maternal perceptions of peer support were evaluated at 12 weeks postpartum using the validated Peer Support Evaluation Inventory. Interactions provided by the peer volunteer included the provision of emotional (92.7%), informational (72.4%), and appraisal (72.0%) support. Mothers reported high levels of positive relationship qualities such as trust (83.6%) and perceived acceptance (79.1%). Most (80.5%) mothers indicated they were very satisfied with their peer support experience. Maternal satisfaction was associated with the number and duration of peer volunteer contacts. The majority of mothers perceived their peer volunteer experience positively lending further support to telephone-based peer support as a preventative strategy for postpartum depression. The following program modifications were suggested: (a) adapt training to enhance the provision of appraisal

  7. The Seattle-King County Healthy Homes Project: A Randomized, Controlled Trial of a Community Health Worker Intervention to Decrease Exposure to Indoor Asthma Triggers

    PubMed Central

    Krieger, James W.; Takaro, Tim K.; Song, Lin; Weaver, Marcia

    2005-01-01

    Objectives. We assessed the effectiveness of a community health worker intervention focused on reducing exposure to indoor asthma triggers. Methods. We conducted a randomized controlled trial with 1-year follow-up among 274 low-income households containing a child aged 4–12 years who had asthma. Community health workers provided in-home environmental assessments, education, support for behavior change, and resources. Participants were assigned to either a high-intensity group receiving 7 visits and a full set of resources or a low-intensity group receiving a single visit and limited resources. Results. The high-intensity group improved significantly more than the low-intensity group in its pediatric asthma caregiver quality-of-life score (P=.005) and asthma-related urgent health services use (P=.026). Asthma symptom days declined more in the high-intensity group, although the across-group difference did not reach statistical significance (P= .138). Participant actions to reduce triggers generally increased in the high-intensity group. The projected 4-year net savings per participant among the high-intensity group relative to the low-intensity group were $189–$721. Conclusions. Community health workers reduced asthma symptom days and urgent health services use while improving caregiver quality-of-life score. Improvement was greater with a higher-intensity intervention. PMID:15798126

  8. Effectiveness of breastfeeding peer counseling in a low-income, predominantly Latina population: a randomized controlled trial.

    PubMed

    Chapman, Donna J; Damio, Grace; Young, Sara; Pérez-Escamilla, Rafael

    2004-09-01

    Breastfeeding peer counseling has improved breastfeeding rates in developing countries; however, its impact in this country has not been adequately evaluated. To evaluate the effectiveness of an existing, breastfeeding peer counseling program within the United States. Randomized, prospective, controlled trial in which participants were recruited prenatally and randomly assigned to receive either routine breastfeeding education or routine breastfeeding education plus peer counseling. An urban hospital serving a large population of low-income Latinas. Pregnant women (< or =26 weeks' gestation) were recruited from the hospital's prenatal clinic. Inclusion criteria specified that participants be low income, be considering breastfeeding, have delivered a healthy, full-term singleton, and have access to a telephone. Intervention Breastfeeding peer counseling services included 1 prenatal home visit, daily perinatal visits, 3 postpartum home visits, and telephone contact as needed. Breastfeeding rates at birth and 1, 3, and 6 months postpartum. The proportion not initiating breastfeeding was significantly lower in the intervention group than among controls (8/90 [9%] vs 17/75 [23%]; relative risk, 0.39; 95% confidence interval, 0.18-0.86). The probability of stopping breastfeeding also tended to be lower in the intervention group at both 1 month (36% vs 49%; relative risk, 0.72; 95% confidence interval, 0.50-1.05) and 3 months (56% vs 71%; relative risk, 0.78; 95% confidence interval, 0.61-1.00). These findings demonstrate that, in the United States, peer counselors can significantly improve breastfeeding initiation rates and have an impact on breastfeeding rates at 1 and 3 months post partum.

  9. Investigation effect of oral chamomilla on sleep quality in elderly people in Isfahan: A randomized control trial.

    PubMed

    Abdullahzadeh, Mehrdad; Matourypour, Pegah; Naji, Sayed Ali

    2017-01-01

    Elderly people often suffer from sleep disorders. Chamomile due to the many health benefits such as sedation may be effective in improving sleep quality in elderly people. This study aimed to determine the effect of Matricaria chamomilla extract on sleep quality in elderly people admitted to nursing homes of Isfahan in 2014. The present study is a quasi-experimental clinical trial. The study population was 77 cases of elderly hospitalized in nursing homes. Participants were selected through random continuous sampling and divided into intervention and control groups. The intervention group received 400 mg oral capsules of chamomile twice daily, after lunch and after dinner for 4 weeks. The control group did not receive the intervention. Sleep quality in older adults before and after intervention were compared using the Pittsburgh Sleep Quality Index questionnaire. Data were analyzed using descriptive statistics and paired t - and independent t -tests, one-way analysis of variance and liner regression analysis, using SPSS software version 17. Before intervention, the mean score of sleep quality both experimental and control groups showed no significant difference ( P > 0.05). After intervention, the mean score of sleep quality was a significant difference between experimental and control groups ( P < 0.001). Oral administration of chamomile extract has sedative properties in sleep quality of hospitalized elderly patients in nursing homes. Therefore, it can be used in similar cases and nursing care.

  10. Comparison of Sleep Latency and Number of SOREMPs in the Home and Hospital With a Modified Multiple Sleep Latency Test: A Randomized Crossover Study.

    PubMed

    Beiske, Kornelia K; Sand, Trond; Rugland, Eyvind; Stavem, Knut

    2017-05-01

    Comparison of mean sleep latencies and number of sleep-onset rapid eye movement periods (SOREMPs) between modified multiple sleep latency test (MSLT) performed in the unattended home and in-hospital laboratory setting. A randomized crossover single-blinded design. Thirty-four subjects referred to MSLT for suspected hypersomnia or narcolepsy were included. Participants were randomized to perform modified MSLT in the unattended home or in the hospital first. Scores in the two settings were compared using Wilcoxon signed-rank test or exact McNemar test. Agreement between home and hospital categorized mean sleep latency and number of SOREMPs was assessed using simple kappa (κ) and proportion agreement. Agreement between home and hospital mean sleep latency was assessed using a Bland-Altman plot and an intraclass correlation coefficient. There was no difference between home and hospital assessment of mean sleep latency (P = 0.86). Two or more SOREMPs were found more frequently on modified MSLTs performed at home compared with those at the hospital (7 and 2, respectively; P = 0.025). Agreement was moderate for categorized sleep latency (κ = 0.53) and fair for categorized SOREMPs (κ = 0.39) in the 2 settings. Analysis of mean sleep latency using intraclass correlation coefficient showed a very good agreement between the two settings. Group mean sleep latency for home modified MSLTs seems to be reliable compared with that for the attended sleep-laboratory setting. Higher rate of SOREMP in the unattended home suggests that napping in a familiar environment facilitates the transition into REM sleep. Further studies are needed to assess the normal limit, sensitivity, and specificity for SOREMP at home before the clinical utility of home-based napping can be determined.

  11. Long-term follow-up effects of the HomeStyles randomized controlled trial in families with preschool children on social cognitive theory constructs associated with physical activity cognitions and behaviors.

    PubMed

    Quick, Virginia; Martin-Biggers, Jennifer; Povis, Gayle Alleman; Worobey, John; Hongu, Nobuko; Byrd-Bredbenner, Carol

    2018-05-01

    This study examined long-term follow-up effects of participation in the HomeStyles RCT, using Social Cognitive Theory constructs, on physical activity cognitions, home environment, and lifestyle behavioral practices of families with preschool children (ages 2 to 5 years). Parents were systematically randomized to experimental or attention control group at baseline. Those completing all surveys that comprised of valid, reliable measures were the analytic sample (n = 61 experimental, n = 63 control; mean age 32.8 ± 5.9SD years). Repeated measures ANCOVA, controlling for prognostic variables (e.g., parent sex) revealed that variables assessing modeling of physical activity for children increased significantly (P ≤ .01) in both groups with no significant time by group effects. Paired t-tests indicated the experimental group's self-efficacy for keeping children's weight healthy and performing health promoting behaviors increased significantly over time whereas the control group did not but with no significant time by group effects. Self-regulation paired t-test findings indicated that total screentime the experimental group allowed children decreased significantly over time with no significant time by group effect. The value parents placed on physical activity for children increased over time in both groups with a significant time effect. The experimental group over time had significantly greater increases in the availability of physical activity space and supports inside the home than the control group. Improvements noted have the potential to help protect children and parents from excess weight gain, yet findings indicate considerable opportunity for continued improvement as well as elucidation of factors affecting concomitant changes in both study groups. Copyright © 2018 Elsevier Inc. All rights reserved.

  12. Effects of Exercise on Cognitive Function in Older People with Dementia: A Randomized Controlled Trial.

    PubMed

    Toots, Annika; Littbrand, Håkan; Boström, Gustaf; Hörnsten, Carl; Holmberg, Henrik; Lundin-Olsson, Lillemor; Lindelöf, Nina; Nordström, Peter; Gustafson, Yngve; Rosendahl, Erik

    2017-01-01

    Although physical exercise has been suggested to influence cognitive function, previous exercise studies show inconsistent results in people with dementia. To investigate effects of exercise on cognitive function in people with dementia. The Umeå Dementia and Exercise (UMDEX) study, a cluster-randomized controlled trial, was set in 16 nursing homes in Umeå, Sweden. One hundred-and-forty-one women and 45 men with dementia; mean age of 85 y and mean Mini-Mental State Examination (MMSE) score of 15, were randomized to a High-Intensity Functional Exercise program or a seated attention control activity. Blinded assessors measured global cognitive function using the MMSE and the Alzheimer's disease Assessment Scale - Cognitive subscale (ADAS-Cog), and executive function using Verbal fluency (VF) at baseline and 4 months (directly after intervention completion), and MMSE and VF at 7 months. Linear mixed models showed no between-group effects in mean difference from baseline (95% confidence intervals, CI) at 4 months in MMSE (-0.27; 95% CI -1.4 to 0.87, p = 0.644), ADAS-Cog (-1.04, 95% CI -4 to 1.92, p = 0.491), or VF (-0.53, 95% CI -1.42 to 0.35, p = 0.241) or at 7 months in MMSE (-1.15, 95% CI -2.32 to 0.03, p = 0.056) or VF (-0.18, 95% CI -1.09 to 0.74, p = 0.707). A 4-month, high-intensity functional exercise program had no superior effects on global cognition or executive function in people with dementia living in nursing homes when compared with an attention control activity.

  13. Effects of a physician-led home care team on terminal care.

    PubMed

    Zimmer, J G; Groth-Juncker, A; McCusker, J

    1984-04-01

    Inconsistent results in studies of cost-effectiveness of home health care have led to the need for identification of target populations for whom cost-savings can be anticipated if expanded home care programs are introduced. This analysis of results of a randomized controlled study of efficacy of a physician/geriatric nurse practitioner/social worker home care team identifies such a potential target population. The team provides round-the-clock on-call medical services in the home when needed, in addition to usual nursing and other home care services, to home-bound chronically or terminally ill elderly patients. Overall health services utilization and estimated costs were not substantially different for the patients who did not die while in the study; however, for those who did die, team patients had considerably lower rates of hospitalization and overall cost than controls, and more frequently died at home. Of 21 team and 12 control patients who died but had at least two weeks of utilization experience in the study, team patients had about half the number of hospital days compared with controls during the terminal two weeks, and although they had more home care services, had only 69 per cent of the estimated total health care costs of the controls. Satisfaction with care received was significantly greater among the total group of team patients, and especially among their family caretakers, than among controls. This model is effective in providing appropriate medical care for seriously ill and terminal patients, and in enabling them to die at home if they so wish, while at the same time reducing costs of care during the terminal period.

  14. Randomized controlled trial of patient navigation for newly diagnosed cancer patients: effects on quality of life.

    PubMed

    Hendren, Samantha; Griggs, Jennifer J; Epstein, Ronald; Humiston, Sharon; Jean-Pierre, Pascal; Winters, Paul; Sanders, Mechelle; Loader, Starlene; Fiscella, Kevin

    2012-10-01

    Patient navigation is a promising intervention to ameliorate cancer health disparities. This study objective was to measure patient navigation effects on cancer-specific quality of life (QOL) among patients with newly diagnosed cancer. A randomized controlled trial of patient navigation was conducted in Rochester, NY. Patients with breast cancer and colorectal cancer were randomly assigned to receive a patient navigation intervention or usual care. QOL was measured at baseline and four subsequent time points, using the validated Functional Assessment of Cancer Therapy (FACT-B, FACT-C) instruments. Among 319 randomized patients (165 patient navigation, 154 control), median age was 57 years and 32.5% were from minority race/ethnicity groups. Patient navigation and control groups were comparable on baseline factors, except home ownership versus renting (more home ownership among controls, P = 0.05) and race (more whites among controls, P = 0.05). Total and subscale FACT scores did not differ between groups when analyzed as a change from baseline to 3 months, or at various time points. The emotional well-being subscale change from baseline approached significance (better change among patient navigation group, P = 0.05). Time trends of QOL measures did not differ significantly between groups. Adjustment for baseline patient factors did not reveal a benefit of patient navigation on QOL. In this randomized trial of patient navigation, there was no statistically significant effect on disease-specific QOL. These results suggest that patient navigation may not affect QOL during cancer treatment, that social/medical support are adequate in this study's setting, or that the trial failed to target patients likely to experience QOL benefit from patient navigation. 2012 AACR

  15. REDUCTION IN ASTHMA MORBIDITY IN CHILDREN AS A RESULT OF HOME REMEDIATION AIMED AT MOISTURE SOURCES

    EPA Science Inventory

    Objective: Home dampness, presence of mold and allergens have been associated with asthma morbidity. We examined changes in asthma morbidity in children as a result of home remediation aimed at moisture sources.

    Design: Prospective, randomized controlled trial.

    Part...

  16. Computer modeling with randomized-controlled trial data informs the development of person-centered aged care homes.

    PubMed

    Chenoweth, Lynn; Vickland, Victor; Stein-Parbury, Jane; Jeon, Yun-Hee; Kenny, Patricia; Brodaty, Henry

    2015-10-01

    To answer questions on the essential components (services, operations and resources) of a person-centered aged care home (iHome) using computer simulation. iHome was developed with AnyLogic software using extant study data obtained from 60 Australian aged care homes, 900+ clients and 700+ aged care staff. Bayesian analysis of simulated trial data will determine the influence of different iHome characteristics on care service quality and client outcomes. Interim results: A person-centered aged care home (socio-cultural context) and care/lifestyle services (interactional environment) can produce positive outcomes for aged care clients (subjective experiences) in the simulated environment. Further testing will define essential characteristics of a person-centered care home.

  17. Yoga vs. physical therapy vs. education for chronic low back pain in predominantly minority populations: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Chronic low back pain causes substantial morbidity and cost to society while disproportionately impacting low-income and minority adults. Several randomized controlled trials show yoga is an effective treatment. However, the comparative effectiveness of yoga and physical therapy, a common mainstream treatment for chronic low back pain, is unknown. Methods/Design This is a randomized controlled trial for 320 predominantly low-income minority adults with chronic low back pain, comparing yoga, physical therapy, and education. Inclusion criteria are adults 18–64 years old with non-specific low back pain lasting ≥12 weeks and a self-reported average pain intensity of ≥4 on a 0–10 scale. Recruitment takes place at Boston Medical Center, an urban academic safety-net hospital and seven federally qualified community health centers located in diverse neighborhoods. The 52-week study has an initial 12-week Treatment Phase where participants are randomized in a 2:2:1 ratio into i) a standardized weekly hatha yoga class supplemented by home practice; ii) a standardized evidence-based exercise therapy protocol adapted from the Treatment Based Classification method, individually delivered by a physical therapist and supplemented by home practice; and iii) education delivered through a self-care book. Co-primary outcome measures are 12-week pain intensity measured on an 11-point numerical rating scale and back-specific function measured using the modified Roland Morris Disability Questionnaire. In the subsequent 40-week Maintenance Phase, yoga participants are re-randomized in a 1:1 ratio to either structured maintenance yoga classes or home practice only. Physical therapy participants are similarly re-randomized to either five booster sessions or home practice only. Education participants continue to follow recommendations of educational materials. We will also assess cost effectiveness from the perspectives of the individual, insurers, and society using

  18. Does self-efficacy mediate functional change in older adults participating in an exercise program after hip fracture? A randomized controlled trial.

    PubMed

    Chang, Feng-Hang; Latham, Nancy K; Ni, Pengsheng; Jette, Alan M

    2015-06-01

    To examine whether self-efficacy mediated the effect of the Home-based Post-Hip Fracture Rehabilitation program on activity limitations in older adults after hip fracture and whether the mediating effect was different between sex and age groups. Randomized controlled trial. Community. Participants with hip fracture (N=232; mean age ± SD, 79±9.4y) were randomly assigned to intervention (n=120, 51.7%) and attention control (n=112, 48.3%) groups. The 6-month intervention, the Home-based Post-Hip Fracture Rehabilitation, is a functionally oriented, home-based exercise program. Data were collected at baseline, postintervention (6mo), and follow-up (9mo). Activity Measure for Post-Acute Care. The mediating effect of the Home-based Post-Hip Fracture Rehabilitation program on Basic Mobility function through self-efficacy for exercise was significant at 9 months (βindirect=.21). Similarly, the mediating effect of the intervention on Daily Activity function through self-efficacy for exercise was significant at 9 months (βindirect=.49). In subgroup analyses, the mediating effect was significant at 9 months in the younger group (age, ≤79y) in comparison to the older group and was significant in women in comparison to men. Self-efficacy may play a partial mediating role in the effect on some longer-term functional outcomes in the Home-based Post-Hip Fracture Rehabilitation intervention. The results suggest that program components that target self-efficacy should be incorporated in future hip fracture rehabilitation interventions. Age and sex of the targeted participants may also need to be considered when developing interventions. Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  19. A pilot randomized, controlled trial of the effectiveness of a psychoeducational intervention on family caregivers of patients with advanced cancer.

    PubMed

    Leow, Mabel; Chan, Sally; Chan, Moon

    2015-03-01

    To evaluate the effectiveness of a psychoeducational intervention, the Caring for the Caregiver Programme (CCP).
 A pilot randomized, controlled trial, two-group pretest, and repeated post-tests.
 Four home hospice organizations and an outpatient clinic in Singapore.
 80 caregivers were randomized into experimental and standard care groups.
 Outcomes were measured at baseline, week 4, and week 8 after the intervention. The standard care group received routine home hospice care, and the intervention group received the CCP in addition to routine care.
 Quality of life (QOL), social support, stress and depression, self-efficacy in self-care, closeness with the patient, rewards, and knowledge.
 Compared to the standard care group, the intervention group reported significantly higher QOL, social support satisfaction and number of supported people, closeness with the patient, self-efficacy in self-care, rewards of caregiving, and knowledge, and lower stress and depression. 
 The CCP had positive effects on family caregivers of patients with advanced cancer. 
 A psychoeducational intervention potentially could help caregivers cope with the demands of caregiving. 


  20. Home-based balance training using the Wii balance board: a randomized, crossover pilot study in multiple sclerosis.

    PubMed

    Prosperini, Luca; Fortuna, Deborah; Giannì, Costanza; Leonardi, Laura; Marchetti, Maria Rita; Pozzilli, Carlo

    2013-01-01

    To evaluate the effectiveness of a home-based rehabilitation of balance using the Nintendo Wii Balance Board System (WBBS) in patients affected by multiple sclerosis (MS). In this 24-week, randomized, 2-period crossover pilot study, 36 patients having an objective balance disorder were randomly assigned in a 1:1 ratio to 2 counterbalanced arms. Group A started a 12-week period of home-based WBBS training followed by a 12-week period without any intervention; group B received the treatment in reverse order. As endpoints, we considered the mean difference (compared with baseline) in force platform measures (i.e., the displacement of body center of pressure in 30 seconds), 4-step square test (FSST), 25-foot timed walking test (25-FWT), and 29-item MS Impact Scale (MSIS-29), as evaluated after 12 weeks and at the end of the 24-week study period. The 2 groups did not differ in baseline characteristics. Repeated-measures analyses of variance showed significant time × treatment effects, indicating that WBBS was effective in ameliorating force platform measures (F = 4.608, P = .016), FSST (F = 3.745, P = .034), 25-FWT (F = 3.339, P = .048), and MSIS-29 (F = 4.282, P = .023). Five adverse events attributable to the WBSS training (knee or low back pain) were recorded, but only 1 patient had to retire from the study. A home-based WBBS training might potentially provide an effective, engaging, balance rehabilitation solution for people with MS. However, the risk of WBBS training-related injuries should be carefully balanced with benefits. Further studies, including cost-effectiveness analyses, are warranted to establish whether WBBS may be useful in the home setting.

  1. Randomized controlled trial of home-based 4-week tDCS in chronic minimally conscious state.

    PubMed

    Martens, Géraldine; Lejeune, Nicolas; O'Brien, Anthony Terrence; Fregni, Felipe; Martial, Charlotte; Wannez, Sarah; Laureys, Steven; Thibaut, Aurore

    2018-05-02

    Patients with chronic disorders of consciousness face a significant lack of treatment options. We aimed at investigating the feasibility and the behavioral effects of home-based transcranial direct current stimulation (tDCS), applied by relatives or caregivers, in chronic patients in minimally conscious state (MCS). Each participant received, in a randomized order, 20 sessions of active and 20 sessions of sham tDCS applied over the prefrontal cortex for 4 weeks; separated by 8 weeks of washout. Level of consciousness was assessed using the Coma Recovery Scale-Revised before the first stimulation (baseline), at the end of the 20 tDCS sessions (direct effects) and 8 weeks after the end of each stimulation period (long-term effects). Reported adverse events and data relative to the adherence (i.e., amount of sessions effectively received) were collected as well. Twenty-seven patients completed the study and 22 patients received at least 80% of the stimulation sessions. All patients tolerated tDCS well, no severe adverse events were noticed after real stimulation and the overall adherence (i.e., total duration of stimulation) was good. A moderate effect size (0.47 and 0.53, for modified intention to treat and per protocol analysis, respectively) was observed at the end of the 4 weeks of tDCS in favor of the active treatment. We demonstrated that home-based tDCS can be used adequately outside a research facility or hospital by patients' relatives or caregivers. In addition, 4 weeks of tDCS moderately improved the recovery of signs of consciousness in chronic MCS patients. Copyright © 2018 Elsevier Inc. All rights reserved.

  2. Effectiveness of multifaceted hand hygiene interventions in long-term care facilities in Hong Kong: a cluster-randomized controlled trial.

    PubMed

    Ho, Mei-lin; Seto, Wing-hong; Wong, Lai-chin; Wong, Tin-yau

    2012-08-01

    To determine the effectiveness of World Health Organization (WHO) multimodal strategy in promoting hand hygiene (HH) among healthcare workers (HCWs) in long-term care facilities (LTCFs). Cluster-randomized controlled trial. Eighteen homes for the elderly in Hong Kong were randomly allocated to 2 intervention arms and a control arm. Direct observation of HH practice was conducted by trained nurses. Either handrubbing with alcohol-based handrub (ABHR) or handwashing with liquid soap and water was counted as a compliant action. Disease notification data during 2007-2010 were used to calculate incidence rate ratio (IRR). Managers and HCWs of the participating homes. The WHO multimodal strategy was employed. All intervention homes were supplied with ABHR (WHO formulation I), ABHR racks, pull reels, HH posters and reminders, a health talk, video clips, training materials, and performance feedback. The only difference was that intervention arms 1 and 2 were provided with slightly powdered and powderless gloves, respectively. A total of 11,669 HH opportunities were observed. HH compliance increased from 27.0% to 60.6% and from 22.2% to 48.6% in intervention arms 1 and 2, respectively. Both intervention arms showed increased HH compliance after intervention compared to controls, at 21.6% compliance (both [Formula: see text]). Provision of slightly powdered versus powderless gloves did not have any significant impact on ABHR usage. Respiratory outbreaks (IRR, 0.12; 95% confidence interval [CI], 0.01-0.93; [Formula: see text]) and methicillin-resistant Staphylococcus aureus infections requiring hospital admission (IRR, 0.61; 95% CI, 0.38-0.97; [Formula: see text]) were reduced after intervention. A promotion program applying the WHO multimodal strategy was effective in improving HH among HCWs in LTCFs.

  3. Effects of home-based diet and exercise on functional outcomes among older, overweight long-term cancer survivors: RENEW: a randomized controlled trial.

    PubMed

    Morey, Miriam C; Snyder, Denise C; Sloane, Richard; Cohen, Harvey Jay; Peterson, Bercedis; Hartman, Terryl J; Miller, Paige; Mitchell, Diane C; Demark-Wahnefried, Wendy

    2009-05-13

    Five-year survival rates for early stage colorectal, breast, and prostate cancer currently exceed 90% and are increasing. Cancer survivors are at greater risk for second malignancies, other comorbidities, and accelerated functional decline. Lifestyle interventions may provide benefit, but it is unknown whether long-term cancer survivors can modify their lifestyle behaviors sufficiently to improve functional status. To determine whether a telephone counseling and mailed print material-based diet and exercise intervention is effective in reorienting functional decline in older, overweight cancer survivors. Randomized controlled trial of 641 overweight (body mass index > or = 25 and < 40), long-term (> or = 5 years) survivors (aged 65-91 years) of colorectal, breast, and prostate cancer, who were randomly assigned to an intervention group (n = 319) or delayed intervention (control) group (n = 322) in Canada, the United Kingdom, and 21 US states. Individuals were recruited for the Reach out to Enhance Wellness (RENEW) trial from July 1, 2005, through May 17, 2007. A 12-month, home-based tailored program of telephone counseling and mailed materials promoting exercise, improved diet quality, and modest weight loss. The control group was wait-listed for 12 months. Change in self-reported physical function on the Short-Form 36 physical function subscale (score range, 0-100; a high score indicates better functioning) from baseline to 12 months was the primary end point. Secondary outcomes included changes in function on the basic and advanced lower extremity function subscales of the Late Life Function and Disability Index (score range, 0-100), physical activity, body mass index, and overall health-related quality of life. The mean baseline Short-Form 36 physical function score was 75.7. At the 12-month follow-up, the mean function scores declined less rapidly in the intervention group (-2.15; 95% confidence interval [CI], -0.36 to -3.93) compared with the control group (-4

  4. The effects of respiratory muscle training on peak cough flow in patients with Parkinson's disease: a randomized controlled study.

    PubMed

    Reyes, Alvaro; Castillo, Adrián; Castillo, Javiera; Cornejo, Isabel

    2018-05-01

    To compare the effects of an inspiratory versus and expiratory muscle-training program on voluntary and reflex peak cough flow in patients with Parkinson disease. A randomized controlled study. Home-based training program. In all, 40 participants with diagnosis of Parkinson's disease were initially recruited in the study and randomly allocated to three study groups. Of them, 31 participants completed the study protocol (control group, n = 10; inspiratory training group, n = 11; and expiratory training group, n = 10) Intervention: The inspiratory and expiratory group performed a home-based inspiratory and expiratory muscle-training program, respectively (five sets of five repetitions). Both groups trained six times a week for two months using a progressively increased resistance. The control group performed expiratory muscle training using the same protocol and a fixed resistance. Spirometric indices, maximum inspiratory pressure, maximum expiratory pressure, and peak cough flow during voluntary and reflex cough were assessed before and at two months after training. The magnitude of increase in maximum expiratory pressure ( d = 1.40) and voluntary peak cough flow ( d = 0.89) was greater for the expiratory muscle-training group in comparison to the control group. Reflex peak cough flow had a moderate effect ( d = 0.27) in the expiratory group in comparison to the control group. Slow vital capacity ( d = 0.13) and forced vital capacity ( d = 0.02) had trivial effects in the expiratory versus the control group. Two months of expiratory muscle-training program was more beneficial than inspiratory muscle-training program for improving maximum expiratory pressure and voluntary peak cough flow in patients with Parkinson's disease.

  5. Pilot Randomized Controlled Trial of the GO Game Intervention on Cognitive Function.

    PubMed

    Iizuka, Ai; Suzuki, Hiroyuki; Ogawa, Susumu; Kobayashi-Cuya, Kimi Estela; Kobayashi, Momoko; Takebayashi, Toru; Fujiwara, Yoshinori

    2018-05-01

    This study investigated the effects of an intervention using the game "GO" on cognitive function in nursing home residents and evaluated the acquisition of GO according to each stage of dementia. Participants were randomly assigned to either the GO intervention group or a control group, and the intervention was performed once weekly for 15 weeks. Cognitive tests were conducted before and after intervention, and 17 participants were included in the final analysis. Analysis of covariance demonstrated that in the intervention group, the digit span total score significantly improved and the digit span backward score was maintained, whereas these scores decreased in the control group. All participants, including those who had moderate dementia, acquired the rules of the game, and participants with mild cognitive impairment and mild dementia could play the game successfully. This study indicates that GO might improve the cognitive function of residents living in nursing homes.

  6. Improving Nursing Home Care through Feedback On PerfoRMance Data (INFORM): Protocol for a cluster-randomized trial.

    PubMed

    Hoben, Matthias; Norton, Peter G; Ginsburg, Liane R; Anderson, Ruth A; Cummings, Greta G; Lanham, Holly J; Squires, Janet E; Taylor, Deanne; Wagg, Adrian S; Estabrooks, Carole A

    2017-01-10

    Audit and feedback is effective in improving the quality of care. However, methods and results of international studies are heterogeneous, and studies have been criticized for a lack of systematic use of theory. In TREC (Translating Research in Elder Care), a longitudinal health services research program, we collect comprehensive data from care providers and residents in Canadian nursing homes to improve quality of care and life of residents, and quality of worklife of caregivers. The study aims are to a) systematically feed back TREC research data to nursing home care units, and b) compare the effectiveness of three different theory-based feedback strategies in improving performance within care units. INFORM (Improving Nursing Home Care through Feedback On PerfoRMance Data) is a 3.5-year pragmatic, three-arm, parallel, cluster-randomized trial. We will randomize 67 Western Canadian nursing homes with 203 care units to the three study arms, a standard feedback strategy and two assisted and goal-directed feedback strategies. Interventions will target care unit managerial teams. They are based on theory and evidence related to audit and feedback, goal setting, complex adaptive systems, and empirical work on feeding back research results. The primary outcome is the increased number of formal interactions (e.g., resident rounds or family conferences) involving care aides - non-registered caregivers providing up to 80% of direct care. Secondary outcomes are a) other modifiable features of care unit context (improved feedback, social capital, slack time) b) care aides' quality of worklife (improved psychological empowerment, job satisfaction), c) more use of best practices, and d) resident outcomes based on the Resident Assessment Instrument - Minimum Data Set 2.0. Outcomes will be assessed at baseline, immediately after the 12-month intervention period, and 18 months post intervention. INFORM is the first study to systematically assess the effectiveness of different

  7. 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

  8. The effects of family involvement and practitioner home visits on the control of hypertension.

    PubMed Central

    Earp, J A; Ory, M G; Strogatz, D S

    1982-01-01

    The effectiveness of two social support strategies designed to lower hypertensive patients' blood pressure were compared to each other and to a control group (N = 63) receiving routine care in a randomized clinical trial extending over a period of two years. Group 1 (N = 99) received visits and had family members actively participate in their care through home blood pressure monitoring; Group 2 (N = 56) received home visits from nurses and pharmacists. All groups were predominantly Black. After the first year of the trial, the proportion of patients with uncontrolled diastolic blood pressure (greater than or equal to 95mm Hg) had declined significantly for all three groups; no group showed a statistically significant advantage. However, during the last six months of the second year (after visiting had ended), both Groups 1 and 2 demonstrated clear superiority in DBP control over Group 3, achieving borderline statistical significance (p = .07) when multivariable analysis was performed to control for potential confounders. Supplementing routine care with periodic home visits produced an additional 21 per cent of patients with well-controlled DBP, while involving family members plus visits produced a 17 per cent improvement in the percentage of patients with DBP less than 95mm Hg. However, neither support strategy was clearly more effective than the other over time. The efficacy of the interventions is discussed with respect to cost and feasibility of implementation. PMID:7114339

  9. Injuries in Sedentary Individuals Enrolled in a 12-Month, Randomized, Controlled, Exercise Trial

    PubMed Central

    Campbell, Kristin L.; Foster-Schubert, Karen; Xiao, Liren; Cadmus Bertram, Lisa A.; Duggan, Catherine; Irwin, Melinda; McTiernan, Anne

    2014-01-01

    Background The risk of musculoskeletal injury with the introduction of moderate-to-vigorous exercise in sedentary adults is not well established. The purpose of this report is to examine the effect of a 12-month exercise intervention on musculoskeletal injury and bodily pain in predominately overweight, sedentary, men (n=102) and women (n=100), aged 40–75 years. Methods Participants were randomized to a moderate-to-vigorous aerobic exercise intervention (EX) (6 d/wk, 60 min/d, 60–85% max. heart rate) or usual lifestyle control (CON). Participants completed a self-report of musculoskeletal injury and body pain at baseline and 12-months. Results The number of individuals reporting an injury (CON; 27% vs. EX; 28%, p= .95) did not differ by group. The most commonly injured site was lower leg/ankle/foot. The most common causes of injury were sports/physical activity, home maintenance or “other”. In the control group, bodily pain increased over the 12 months compared to the exercise group (CON −7.9, EX −1.4, p=.05). Baseline demographics and volume of exercise were not associated with injury risk. Conclusions Previously sedentary men and women randomized to a 12-month aerobic exercise intervention with a goal of 360 min/wk reported the same number of injuries as those in the control group and less bodily pain. PMID:22368219

  10. Snails home

    NASA Astrophysics Data System (ADS)

    Dunstan, D. J.; Hodgson, D. J.

    2014-06-01

    Many gardeners and horticulturalists seek non-chemical methods to control populations of snails. It has frequently been reported that snails that are marked and removed from a garden are later found in the garden again. This phenomenon is often cited as evidence for a homing instinct. We report a systematic study of the snail population in a small suburban garden, in which large numbers of snails were marked and removed over a period of about 6 months. While many returned, inferring a homing instinct from this evidence requires statistical modelling. Monte Carlo techniques demonstrate that movements of snails are better explained by drift under the influence of a homing instinct than by random diffusion. Maximum likelihood techniques infer the existence of two groups of snails in the garden: members of a larger population that show little affinity to the garden itself, and core members of a local garden population that regularly return to their home if removed. The data are strongly suggestive of a homing instinct, but also reveal that snail-throwing can work as a pest management strategy.

  11. COSMOS--improving the quality of life in nursing home patients: protocol for an effectiveness-implementation cluster randomized clinical hybrid trial.

    PubMed

    Husebo, Bettina S; Flo, Elisabeth; Aarsland, Dag; Selbaek, Geir; Testad, Ingelin; Gulla, Christine; Aasmul, Irene; Ballard, Clive

    2015-09-15

    Nursing home patients have complex mental and physical health problems, disabilities and social needs, combined with widespread prescription of psychotropic drugs. Preservation of their quality of life is an important goal. This can only be achieved within nursing homes that offer competent clinical conditions of treatment and care. COmmunication, Systematic assessment and treatment of pain, Medication review, Occupational therapy, Safety (COSMOS) is an effectiveness-implementation hybrid trial that combines and implements organization of activities evidence-based interventions to improve staff competence and thereby the patients' quality of life, mental health and safety. The aim of this paper is to describe the development, content and implementation process of the COSMOS trial. COSMOS includes a 2-month pilot study with 128 participants distributed among nine Norwegian nursing homes, and a 4-month multicenter, cluster randomized effectiveness-implementation clinical hybrid trial with follow-up at month 9, including 571 patients from 67 nursing home units (one unit defined as one cluster). Clusters are randomized to COSMOS intervention or current best practice (control group). The intervention group will receive a 2-day education program including written guidelines, repeated theoretical and practical training (credited education of caregivers, physicians and nursing home managers), case discussions and role play. The 1-day midway evaluation, information and interviews of nursing staff and a telephone hotline all support the implementation process. Outcome measures include quality of life in late-stage dementia, neuropsychiatric symptoms, activities of daily living, pain, depression, sleep, medication, cost-utility analysis, hospital admission and mortality. Despite complex medical and psychosocial challenges, nursing home patients are often treated by staff possessing low level skills, lacking education and in facilities with a high staff turnover

  12. Offering self-administered oral HIV testing to truck drivers in Kenya to increase testing: a randomized controlled trial.

    PubMed

    Kelvin, Elizabeth A; George, Gavin; Mwai, Eva; Nyaga, Eston; Mantell, Joanne E; Romo, Matthew L; Odhiambo, Jacob O; Starbuck, Lila; Govender, Kaymarlin

    2018-01-01

    We conducted a randomized controlled trial among 305 truck drivers from two North Star Alliance roadside wellness clinics in Kenya to see if offering HIV testing choices would increase HIV testing uptake. Participants were randomized to be offered (1) a provider-administered rapid blood (finger-prick) HIV test (i.e., standard of care [SOC]) or (2) a Choice between SOC or a self-administered oral rapid HIV test with provider supervision in the clinic. Participants in the Choice arm who refused HIV testing in the clinic were offered a test kit for home use with phone-based posttest counseling. We compared HIV test uptake using the Mantel Haenszel odds ratio (OR) adjusting for clinic. Those in the Choice arm had higher odds of HIV test uptake than those in the SOC arm (OR = 1.5), but the difference was not statistically significant (p = 0.189). When adding the option to take an HIV test kit for home use, the Choice arm had significantly greater odds of testing uptake (OR = 2.8, p = 0.002). Of those in the Choice arm who tested, 26.9% selected the SOC test, 64.6% chose supervised self-testing in the clinic, and 8.5% took a test kit for home use. Participants varied in the HIV test they selected when given choices. Importantly, when participants who refused HIV testing in the clinic were offered a test kit for home use, an additional 8.5% tested. Offering truck drivers a variety of HIV testing choices may increase HIV testing uptake in this key population.

  13. Impact of counselling on exclusive breast-feeding practices in a poor urban setting in Kenya: a randomized controlled trial.

    PubMed

    Ochola, Sophie A; Labadarios, Demetre; Nduati, Ruth W

    2013-10-01

    To determine the impact of facility-based semi-intensive and home-based intensive counselling in improving exclusive breast-feeding (EBF) in a low-resource urban setting in Kenya. A cluster randomized controlled trial in which nine villages were assigned on a 1:1:1 ratio, by computer, to two intervention groups and a control group. The home-based intensive counselling group (HBICG) received seven counselling sessions at home by trained peers, one prenatally and six postnatally. The facility-based semi-intensive counselling group (FBSICG) received only one counselling session prenatally. The control group (CG) received no counselling from the research team. Information on infant feeding practices was collected monthly for 6 months after delivery. The data-gathering team was blinded to the intervention allocation. The outcome was EBF prevalence at 6 months. Kibera slum, Nairobi. A total of 360 HIV-negative women, 34-36 weeks pregnant, were selected from an antenatal clinic in Kibera; 120 per study group. Of the 360 women enrolled, 265 completed the study and were included in the analysis (CG n 89; FBSICG n 87; HBICG n 89). Analysis was by intention to treat. The prevalence of EBF at 6 months was 23.6% in HBICG, 9.2% in FBSICG and 5.6% in CG. HBICG mothers had four times increased likelihood to practise EBF compared with those in the CG (adjusted relative risk = 4.01; 95% CI 2.30, 7.01; P=0.001). There was no significant difference between EBF rates in FBSICG and CG. EBF can be promoted in low socio-economic conditions using home-based intensive counselling. One session of facility-based counselling is not sufficient to sustain EBF.

  14. Randomized Controlled Pilot Trial of Mindfulness Training for Stress Reduction during Pregnancy

    PubMed Central

    Guardino, Christine M.; Dunkel Schetter, Christine; Bower, Julienne E.; Lu, Michael C.; Smalley, Susan L.

    2014-01-01

    This randomized controlled pilot trial tested a 6-week mindfulness-based intervention in a sample of pregnant women experiencing high levels of perceived stress and pregnancy anxiety. Forty-seven women enrolled between 10 and 25 weeks gestation were randomly assigned to either a series of weekly Mindful Awareness Practices (MAPS) classes (n = 24) with home practice or to a reading control condition (n = 23). Hierarchical linear models of between-group differences in change over time demonstrated that participants in the mindfulness intervention experienced larger decreases from pre-to post-intervention in pregnancy-specific anxiety and pregnancy-related anxiety than participants in the reading control condition. However, these effects were not sustained through follow-up at six weeks post-intervention. Participants in both groups experienced increased mindfulness, as well as decreased perceived stress and state anxiety over the course of the intervention and follow-up periods. This study is one of the first randomized controlled pilot trials of a mindfulness meditation intervention during pregnancy and provides some evidence that mindfulness training during pregnancy may effectively reduce pregnancy-related anxiety and worry. We discuss some of the dilemmas in pursuing this translational strategy and offer suggestions for researchers interested in conducting mind-body interventions during pregnancy. PMID:24180264

  15. A randomized trial of hospital vs home self administration of vaginal misoprostol for medical abortion.

    PubMed

    Shrestha, A; Sedhai, L B

    2014-01-01

    A combination of mifepristone followed after 24 hrs by misoprostol has proved a safe and effective abortifacient for termination of early pregnancy. Home use of misoprostol for medical abortion is still controversial in many countries including ours where women's literacy rate is low. Particularly in developing countries, this method markedly decreased the hospital visit which would be beneficial to patients and hospital staff. To see whether the home self administration of vaginal misoprostol was equally effective as administered by trained staff in terms of successful termination of early pregnancy. Secondary outcomes were bleeding and pain duration during medical abortion, side effects, reason for termination of pregnancy and women's acceptability of the procedure. One hundred and eighty eight women requesting medical abortion with pregnancy less than 63 days gestation were randomized into two groups either self administration of vaginal misoprostol (800 mcg) at home or hospital administration 24 hours after oral 200 mg mifepristone. Ultrasound was performed after 14 days to confirm complete abortion. The overall success rate was similar in two groups: 89.13% on home group Vs 86.9% in hospital group. Eleven out of 18 women (61.1%) having incomplete abortion had successful termination after 2nd dose misoprostol( 400 mcg). None of the women had continued pregnancy. Multigravida had slightly higher risk of failure (R.R: 1.04). Home self administration of vaginal misoprostol was safe and effective for early termination of medical abortion and was acceptable. Use of extra dose of misoprostol has advantage of higher completion rate of abortion.

  16. Counseling African Americans to Control Hypertension: cluster-randomized clinical trial main effects.

    PubMed

    Ogedegbe, Gbenga; Tobin, Jonathan N; Fernandez, Senaida; Cassells, Andrea; Diaz-Gloster, Marleny; Khalida, Chamanara; Pickering, Thomas; Schwartz, Joseph E

    2014-05-20

    Data are limited on the implementation of evidence-based multilevel interventions targeted at blood pressure (BP) control in hypertensive blacks who receive care in low-resource primary care practices. Counseling African Americans to Control Hypertension is a cluster-randomized clinical trial in which 30 community health centers were randomly assigned to the intervention condition (IC) or usual care (UC). Patients at the IC sites received patient education, home BP monitoring, and monthly lifestyle counseling, whereas physicians attended monthly hypertension case rounds and received feedback on their patients' home BP readings and chart audits. Patients and physicians at the UC sites received printed patient education material and hypertension treatment guidelines, respectively. The primary outcome was BP control, and secondary outcomes were mean changes in systolic and diastolic BPs at 12 months, assessed with an automated BP device. A total of 1059 patients (mean age, 56 years; 28% men, 59% obese, and 36% with diabetes mellitus) were enrolled. The BP control rate was similar in both groups (IC=49.3% versus UC=44.5%; odds ratio, 1.21 [95% confidence interval, 0.90-1.63]; P=0.21). In prespecified subgroup analyses, the intervention was associated with greater BP control in patients without diabetes mellitus (IC=54.0% versus UC=44.7%; odds ratio, 1.45 [confidence interval, 1.02-2.06]); and small-sized community health centers (IC=51.1% versus UC=39.6%; odds ratio, 1.45 [confidence interval, 1.04-2.45]). A practice-based, multicomponent intervention was no better than UC in improving BP control among hypertensive blacks. Future research on the implementation of behavioral modification strategies for hypertension control in low-resource settings should focus on the development of more efficient and tailored interventions in this high-risk population. http://www.clinicaltrials.gov. Unique identifier: NCT00233220. © 2014 American Heart Association, Inc.

  17. Use of Home Telemonitoring to Support Multidisciplinary Care of Heart Failure Patients in Finland: Randomized Controlled Trial

    PubMed Central

    Leppänen, Juha; Kaijanranta, Hannu; Kulju, Minna; Heliö, Tiina; van Gils, Mark; Lähteenmäki, Jaakko

    2014-01-01

    Background Heart failure (HF) patients suffer from frequent and repeated hospitalizations, causing a substantial economic burden on society. Hospitalizations can be reduced considerably by better compliance with self-care. Home telemonitoring has the potential to boost patients’ compliance with self-care, although the results are still contradictory. Objective A randomized controlled trial was conducted in order to study whether the multidisciplinary care of heart failure patients promoted with telemonitoring leads to decreased HF-related hospitalization. Methods HF patients were eligible whose left ventricular ejection fraction was lower than 35%, NYHA functional class ≥2, and who needed regular follow-up. Patients in the telemonitoring group (n=47) measured their body weight, blood pressure, and pulse and answered symptom-related questions on a weekly basis, reporting their values to the heart failure nurse using a mobile phone app. The heart failure nurse followed the status of patients weekly and if necessary contacted the patient. The primary outcome was the number of HF-related hospital days. Control patients (n=47) received multidisciplinary treatment according to standard practices. Patients’ clinical status, use of health care resources, adherence, and user experience from the patients’ and the health care professionals’ perspective were studied. Results Adherence, calculated as a proportion of weekly submitted self-measurements, was close to 90%. No difference was found in the number of HF-related hospital days (incidence rate ratio [IRR]=0.812, P=.351), which was the primary outcome. The intervention group used more health care resources: they paid an increased number of visits to the nurse (IRR=1.73, P<.001), spent more time at the nurse reception (mean difference of 48.7 minutes, P<.001), and there was a greater number of telephone contacts between the nurse and intervention patients (IRR=3.82, P<.001 for nurse-induced contacts and IRR=1

  18. Home delivery of an injury prevention kit for children in four French cities: a controlled randomized trial

    PubMed Central

    Sznajder, M; Leduc, S; Janvrin, M; Bonnin, M; Aegerter, P; Baudier, F; Chevallier, B; Macarthur, C

    2003-01-01

    Objectives: Home delivery of counselling and safety devices to prevent child injuries could help parents to adopt safe behaviour. The aim of this study was to test a safety kit designed and used in Quebec (Canada). Design and subjects: One hundred families from four towns in the Paris suburbs were visited at home by nurses or doctors when their child reached 6–9 months. Selection criteria were: primipara, medical problem, psychological, and/or socioeconomic difficulties. Interventions: During the first visit, 50 families (group 1) received counselling and a kit including preventive devices and pamphlets about indoor injuries and ways to avoid them. The other 50 families (group 2) received counselling but not the kit. A second home visit was made 6–8 weeks later. Main outcome measures: The number of safety improvements was calculated 6–8 weeks after a first home visit. Perceived usefulness of the kit was collected from families and from interviewers. Results: Between the first and the second visits, safety improvement was significantly higher in the group with the kit. This was mainly related to the risk of fall (p<0.02), fire and burns (p<0.001), poisoning (p<0.01), and suffocation (p<0.001). For improvement related to devices provided in the kit, the difference between the groups was significant: 64.4% improvement in group 1 versus 41.2% in group 2 (p<0.01). The relative risk (RR) of safety improvement between groups was 1.56 (95% confidence interval (CI) 1.35 to 1.80). Even for improvements not related to the kit the difference remained significant: 31.2% in group 1 versus 20.2% in group 2 (p<0.05); RR = 1.54 (95% CI 1.22 to 1.93). Conclusion: Routine home visits by social services offer a good opportunity to tackle child injury prevention. Free delivery of prevention kits and counselling allow families to modify their behaviour and homes so as to reduce risks. PMID:12966017

  19. A Homing Missile Control System to Reduce the Effects of Radome Diffraction

    NASA Technical Reports Server (NTRS)

    Smith, Gerald L.

    1960-01-01

    The problem of radome diffraction in radar-controlled homing missiles at high speeds and high altitudes is considered from the point of view of developing a control system configuration which will alleviate the deleterious effects of the diffraction. It is shown that radome diffraction is in essence a kinematic feedback of body angular velocities which causes the radar to sense large apparent line-of-sight angular velocities. The normal control system cannot distinguish between the erroneous and actual line-of-sight rates, and entirely wrong maneuvers are produced which result in large miss distances. The problem is resolved by adding to the control system a special-purpose computer which utilizes measured body angular velocity to extract from the radar output true line-of-sight information for use in steering the missile. The computer operates on the principle of sampling and storing the radar output at instants when the body angular velocity is low and using this stored information for maneuvering commands. In addition, when the angular velocity is not low the computer determines a radome diffraction compensation which is subtracted from the radar output to reduce the error in the sampled information. Analog simulation results for the proposed control system operating in a coplanar (vertical plane) attack indicate a potential decrease in miss distance to an order of magnitude below that for a conventional system. Effects of glint noise, random target maneuvers, initial heading errors, and missile maneuverability are considered in the investigation.

  20. Involving fathers in teaching youth about farm tractor seatbelt safety--a randomized control study.

    PubMed

    Jinnah, Hamida Amirali; Stoneman, Zolinda; Rains, Glen

    2014-03-01

    Farm youth continue to experience high rates of injury and deaths as a result of agricultural activities. Farm machinery, especially tractors, is the most common cause of casualties to youth. A Roll-Over Protection Structure (ROPS) along with a fastened seatbelt can prevent almost all injuries and fatalities from tractor overturns. Despite this knowledge, the use of seatbelts by farmers on ROPS tractors remains low. This study treats farm safety as a family issue and builds on the central role of parents as teachers and role models of farm safety for youth. This research study used a longitudinal, repeated-measures, randomized-control design in which youth 10-19 years of age were randomly assigned to either of two intervention groups (parent-led group and staff-led group) or the control group. Fathers in the parent-led group were less likely to operate ROPS tractors without a seatbelt compared with other groups. They were more likely to have communicated with youth about the importance of wearing seatbelts on ROPS tractors. Consequently, youth in the parent-led group were less likely to operate a ROPS tractor without a seatbelt than the control group at post-test. This randomized control trial supports the effectiveness of a home-based, father-led farm safety intervention as a promising strategy for reducing youth as well as father-unsafe behaviors (related to tractor seatbelts) on the farm. This intervention appealed to fathers' strong motivation to practice tractor safety for the sake of their youth. Involving fathers helped change both father as well as youth unsafe tractor-seatbelt behaviors. Copyright © 2014 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

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

    PubMed

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

    2016-12-05

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

  2. A Randomized Controlled Trial of a Home-Visiting Intervention Aimed at Preventing Relationship Problems in Depressed Mothers and Their Infants

    ERIC Educational Resources Information Center

    van Doesum, Karin T. M.; Riksen-Walraven, J. Marianne; Hosman, Clemens M. H.; Hoefnagels, Cees

    2008-01-01

    This study examined the effect of a mother-baby intervention on the quality of mother-child interaction, infant-mother attachment security, and infant socioemotional functioning in a group of depressed mothers with infants aged 1-12 months. A randomized controlled trial compared an experimental group (n = 35) receiving the intervention (8-10 home…

  3. A home-based program using patterned sensory enhancement improves resistance exercise effects for children with cerebral palsy: a randomized controlled trial.

    PubMed

    Wang, Tze-Hsuan; Peng, Yi-Chun; Chen, Yu-Ling; Lu, Tung-Wu; Liao, Hua-Fang; Tang, Pei-Fang; Shieh, Jeng-Yi

    2013-10-01

    Neurologic music therapy has demonstrated improved walking performance in persons with neurologic disease; however, little evidence supports the use of music with functional resistance exercise to improve motor capacity and daily functions for children with cerebral palsy. To investigate the effect of additional patterned sensory enhancement (PSE) music combined with exercise for children with spastic diplegia. An assessor-blind, randomized controlled trial with 6- and 12-week follow-ups was carried out. Thirty-six children with spastic diplegia, aged 5 to 13 years, were assigned to a PSE group (n = 18) or a no-music group (n = 18). Both groups received 6-week, home-based, loaded sit-to-stand exercise, but only the PSE group exercised with prerecorded PSE music. The primary outcome was Gross Motor Function Measure (GMFM). Secondary outcomes included Pediatric Evaluation of Disability Inventory (PEDI) mobility and self-care domains, 1-repetition maximum of sit-to-stand, and walking speeds. Three children did not complete the program. Intention-to-treat analysis showed both groups improved in GMFM D, E, and Goal dimensions; Functional Skills Scales of PEDI mobility domain; and 1-repetition maximum of sit-to-stand at posttest and follow-ups (P ≤ .005). The PSE group improved significantly greater than the no-music group in the GMFM D and Goal dimensions (P < .005) after training, and the improvement persisted for at least 6 or 12 weeks (P ≤ .013). No significant improvements in the rest PEDI scales and walking speeds were found. Adding neurologic music therapy to functional resistance exercise could induce greater improvements in gross motor capacity for children with cerebral palsy.

  4. Linking clinic and home: a randomized, controlled clinical effectiveness trial of real-time, wireless blood pressure monitoring for older patients with kidney disease and hypertension.

    PubMed

    Rifkin, Dena E; Abdelmalek, Joseph A; Miracle, Cynthia M; Low, Chai; Barsotti, Ryan; Rios, Phil; Stepnowsky, Carl; Agha, Zia

    2013-02-01

    Older adults with chronic kidney disease have a high rate of uncontrolled hypertension. Home monitoring of blood pressure (BP) is an integral part of management, but requires that patients bring records to clinic visits. Telemonitoring interventions, however, have not targeted older, less technologically-skilled populations. Veterans with stage 3 or greater chronic kidney disease and uncontrolled hypertension were randomized to a novel telemonitoring device pairing a Bluetooth-enabled BP cuff with an Internet-enabled hub, which wirelessly transmitted readings (n=28), or usual care (n=15). Home recordings were reviewed weekly and telemonitoring participants were contacted if BP was above goal. The prespecified primary endpoints were improved data exchange and device acceptability. Secondary endpoint was BP change. Forty-three participants (average age 68 years, 75% white) completed the 6-month study. Average start-of-study BP was 147/78 mmHg. Those in the intervention arm had a median of 29 (IQR 22, 53) transmitted BP readings per month, with 78% continuing to use the device regularly, whereas only 20% of those in the usual care group brought readings to in-person visits. The median number of telephone contacts triggered by the wireless monitoring was 2 (IQR 1, 4) per patient. Both groups had a significant improvement in systolic BP (P<0.05, for both changes); systolic BP fell a median of 13 mmHg in monitored participants compared with 8.5 mmHg in usual care participants (P for comparison 0.31). This low-cost wireless monitoring strategy led to greater sharing of data between patients and clinic and produced a trend toward improvements in BP control over usual care at 6 months.

  5. A randomized controlled trial of positioning treatments in infants with positional head shape deformities.

    PubMed

    Hutchison, B Lynne; Stewart, Alistair W; De Chalain, Tristan B; Mitchell, Edwin A

    2010-10-01

    Randomized controlled trials of treatment for deformational plagiocephaly and brachycephaly have been lacking in the literature. Infants (n = 126) presenting to a plagiocephaly clinic were randomized to either positioning strategies or to positioning plus the use of a Safe T Sleep™ positioning wrap. Head shape was measured using a digital photographic technique, and neck function was assessed. They were followed up at home 3, 6 and 12 months later. There was no difference in head shape outcomes for the two treatment groups after 12 months of follow-up, with 42% of infants having head shapes in the normal range by that time. Eighty per cent of children showed good improvement. Those that had poor improvement were more likely to have both plagiocephaly and brachycephaly and to have presented later to clinic. Most infants improved over the 12-month study period, although the use of a sleep positioning wrap did not increase the rate of improvement. © 2010 The Author(s)/Journal Compilation © 2010 Foundation Acta Paediatrica.

  6. Impact of specialist home-based palliative care services in a tertiary oncology set up: a prospective non-randomized observational study.

    PubMed

    Dhiliwal, Sunil R; Muckaden, Maryann

    2015-01-01

    Home-based specialist palliative care services are developed to meet the needs of the patients in advanced stage of cancer at home with physical symptoms and distress. Specialist home care services are intended to improve symptom control and quality of life, enable patients to stay at home, and avoid unnecessary hospital admission. Total 690 new cases registered under home-based palliative care service in the year 2012 were prospectively studied to assess the impact of specialist home-based services using Edmonton symptom assessment scale (ESAS) and other parameters. Out of the 690 registered cases, 506 patients received home-based palliative care. 50.98% patients were cared for at home, 28.85% patients needed hospice referral and 20.15% patients needed brief period of hospitalization. All patients receiving specialist home care had good relief of physical symptoms (P < 0.005). 83.2% patients received out of hours care (OOH) through liaising with local general practitioners; 42.68% received home based bereavement care and 91.66% had good bereavement outcomes. Specialist home-based palliative care improved symptom control, health-related communication and psychosocial support. It promoted increased number of home-based death, appropriate and early hospice referral, and averted needless hospitalization. It improved bereavement outcomes, and caregiver satisfaction.

  7. Helping Seniors Plan for Posthospital Discharge Needs Before a Hospitalization Occurs: Results from the Randomized Control Trial of PlanYourLifespan.org.

    PubMed

    Lindquist, Lee A; Ramirez-Zohfeld, Vanessa; Sunkara, Priya D; Forcucci, Chris; Campbell, Dianne S; Mitzen, Phyllis; Ciolino, Jody D; Kricke, Gayle; Seltzer, Anne; Ramirez, Ana V; Cameron, Kenzie A

    2017-11-01

    Investigate the effect of PlanYourLifespan.org (PYL) on knowledge of posthospital discharge options. Multisite randomized controlled trial. Nonhospitalized adults, aged =65 years, living in urban, suburban, and rural areas of Texas, Illinois, and Indiana. PYL is a national, publicly available tool that provides education on posthospital therapy choices and local home-based resources. Participants completed an in-person baseline survey, followed by exposure to intervention or attention control (AC) websites, then 1-month and 3-month telephone surveys. The primary knowledge outcome was measured with 6 items (possible 0-6 points) pertaining to hospital discharge needs. Among 385 participants randomized, mean age was 71.9 years (standard deviation 5.6) and 79.5% of participants were female. At 1 month, the intervention group had a 0.6 point change (standard deviation = 1.6) versus the AC group who had a -0.1 point change in knowledge score. Linear mixed modeling results suggest sex, health literacy level, level of education, income, and history of high blood pressure/kidney disease were significant predictors of knowledge over time. Controlling for these variables, treatment effect remained significant (P < 0.0001). Seniors who used PYL demonstrated an increased understanding of posthospitalization and home services compared to the control group. © 2017 Society of Hospital Medicine

  8. A randomized controlled trial of hypnosis compared with biofeedback for adults with chronic low back pain.

    PubMed

    Tan, G; Rintala, D H; Jensen, M P; Fukui, T; Smith, D; Williams, W

    2015-02-01

    Chronic low back pain (CLBP) is common and results in significant costs to individuals, families and society. Although some research supports the efficacy of hypnosis for CLBP, we know little about the minimum dose needed to produce meaningful benefits, the roles of home practice and hypnotizability on outcome, or the maintenance of treatment benefits beyond 3 months. One hundred veterans with CLBP participated in a randomized, four-group design study. The groups were (1) an eight-session self-hypnosis training intervention without audio recordings for home practice; (2) an eight-session self-hypnosis training intervention with recordings; (3) a two-session self-hypnosis training intervention with recordings and brief weekly reminder telephone calls; and (4) an eight-session active (biofeedback) control intervention. Participants in all four groups reported significant pre- to post-treatment improvements in pain intensity, pain interference and sleep quality. The hypnosis groups combined reported significantly more pain intensity reduction than the control group. There was no significant difference among the three hypnosis conditions. Over half of the participants who received hypnosis reported clinically meaningful (≥ 30%) reductions in pain intensity, and they maintained these benefits for at least 6 months after treatment. Neither hypnotizability nor amount of home practice was associated significantly with treatment outcome. The findings indicate that two sessions of self-hypnosis training with audio recordings for home practice may be as effective as eight sessions of hypnosis treatment. If replicated in other patient samples, the findings have important implications for the application of hypnosis treatment for chronic pain management. © 2014 European Pain Federation - EFIC®

  9. Home-Based Intervention Program to Reduce Food Insecurity in Elderly Populations Using a TV App: Study Protocol of the Randomized Controlled Trial Saúde.Come Senior.

    PubMed

    Rodrigues, Ana Maria; Gregório, Maria João; Gein, Pierre; Eusébio, Mónica; Santos, Maria José; de Sousa, Rute Dinis; Coelho, Pedro S; Mendes, Jorge M; Graça, Pedro; Oliveira, Pedro; Branco, Jaime C; Canhão, Helena

    2017-03-13

    considering that 50% of the target individuals are food insecure (based on INFOFAMÍLIA Survey) (567) and about 50% of those will adhere to the study (282). The randomized controlled trial with the 12-week home-based intervention with a comprehensive program on healthy eating and physical activity delivery is planned to start recruiting participants at the end of 2017. This study will assess the efficacy of this innovative tool (Saúde.Come Senior) for disseminating relevant health information, modifying behaviors, and decreasing food insecurity in an easy, low-cost, and massive way. ©Ana Maria Rodrigues, Maria João Gregório, Pierre Gein, Mónica Eusébio, Maria José Santos, Rute Dinis de Sousa, Pedro S Coelho, Jorge M Mendes, Pedro Graça, Pedro Oliveira, Jaime C Branco, Helena Canhão. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 13.03.2017.

  10. Home telehealth for diabetes management: a systematic review and meta-analysis.

    PubMed

    Polisena, J; Tran, K; Cimon, K; Hutton, B; McGill, S; Palmer, K

    2009-10-01

    It is estimated that more than 180 million people worldwide have diabetes. Health-care providers can remotely deliver health services to this patient population using information and communication technology, also known as home telehealth. Home telehealth may be classified into two subtypes: home telemonitoring (HTM) and telephone support (TS). The research objective was to systematically review the literature and perform meta-analyses to assess the potential benefits of home telehealth compared with usual care (UC) for patients with diabetes. An electronic literature search was conducted to identify studies on home telehealth and patients with diabetes that were published between 1998 and 2008 using Medline, Medline In-Process & Other Non-Indexed Citations, BIOSIS Previews and EMBASE. Twenty-six studies (n = 5069 patients) on home telehealth for diabetes were selected. Twenty-one studies evaluated HTM and 5 randomized controlled trials assessed TS. HTM had a positive effect on glycaemic control [as measured by lower glycated haemoglobin level] compared with UC (weighted mean difference =-0.21; 95% confidence interval -0.35 to -0.08), but the results were mixed for TS. Study results indicated that home telehealth helps to reduce the number of patients hospitalized, hospitalizations and bed days of care. Home telehealth was similar or favourable to UC across studies for quality-of-life and patient satisfaction outcomes. In general, home telehealth had a positive impact on the use of numerous health services and glycaemic control. More studies of higher methodological quality are required to give more precise insights into the potential clinical effectiveness of home telehealth interventions.

  11. Randomized trial of the ForeseeHome monitoring device for early detection of neovascular age-related macular degeneration. The HOme Monitoring of the Eye (HOME) study design - HOME Study report number 1.

    PubMed

    Chew, Emily Y; Clemons, Traci E; Bressler, Susan B; Elman, Michael J; Danis, Ronald P; Domalpally, Amitha; Heier, Jeffrey S; Kim, Judy E; Garfinkel, Richard A

    2014-03-01

    To evaluate the effects of a home-monitoring device with tele-monitoring compared with standard care in detection of progression to choroidal neovascularization (CNV) associated with age-related macular degeneration (AMD), the leading cause of blindness in the US. Participants, aged 55 to 90 years, at high risk of developing CNV associated with AMD were recruited to the HOme Monitoring of Eye (HOME) Study, an unmasked, multi-center, randomized trial of the ForeseeHome (FH) device plus standard care vs. standard care alone. The FH device utilizes preferential hyperacuity perimetry and tele-monitoring to detect changes in vision function associated with development of CNV, potentially prior to symptom and visual acuity loss. After establishing baseline measurements, subsequent changes on follow-up are detected by the device, causing the monitoring center to alert the clinical center to recall participants for an exam. Standard care consists of instructions for self-monitoring visual changes with subsequent self-report to the clinical center. The primary objective of this study is to determine whether home monitoring plus standard care in comparison with standard care alone, results in earlier detection of incident CNV with better present visual acuity. The primary outcome is the decline in visual acuity at CNV diagnosis from baseline. Detection of CNV prior to substantial vision loss is critical as vision outcome following anti-angiogenic therapy is dependent on the visual acuity at initiation of treatment. HOME Study is the first large scale study to test the use of home tele-monitoring system in the management of AMD patients. Published by Elsevier Inc.

  12. Preventing Urinary Incontinence With Supervised Prenatal Pelvic Floor Exercises: A Randomized Controlled Trial.

    PubMed

    Fritel, Xavier; de Tayrac, Renaud; Bader, Georges; Savary, Denis; Gueye, Ameth; Deffieux, Xavier; Fernandez, Hervé; Richet, Claude; Guilhot, Joëlle; Fauconnier, Arnaud

    2015-08-01

    To compare, in an unselected population of nulliparous pregnant women, the postnatal effect of prenatal supervised pelvic floor muscle training with written instructions on postpartum urinary incontinence (UI). In a randomized controlled trial in two parallel groups, 282 women were recruited from five university teaching hospitals in France and randomized during the second trimester of pregnancy. The physiotherapy group received prenatal individually supervised exercises. Both groups received written instructions about how to perform exercises at home. Women were blindly assessed at baseline, end of pregnancy, and 2 and 12 months postpartum. The primary outcome measured was UI severity, assessed with an International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form score (range 0-21; 1-5 is slight UI) at 12 months postpartum; other outcomes were UI prevalence and pelvic floor troubles assessed using self-administered questionnaires. To give a 1-point difference in UI severity score, we needed 91 women in each group (standard deviation 2.4, α=0.05, β=0.20, and bilateral analysis). Between February 2008 and June 2010, 140 women were randomized in the physiotherapy group and 142 in the control group. No difference was observed between the two groups in UI severity, prevalence, or pelvic floor troubles at baseline, end of pregnancy, and at 2 and 12 months postpartum. At 12 months postpartum, the primary outcome was available for 190 women (67.4%); mean UI severity was 1.9 in the physiotherapy group compared with 2.1 in the control group (P=.38). Prenatal supervised pelvic floor training was not superior to written instructions in reducing postnatal UI. ClinicalTrials.gov; www.clinicaltrials.gov, NCT00551551. I.

  13. Intelligent Home Control System Based on Single Chip Microcomputer

    NASA Astrophysics Data System (ADS)

    Yang, Libo

    2017-12-01

    Intelligent home as a way to achieve the realization of the family information has become an important part of the development of social information, Internet of Things because of its huge application prospects, will be smart home industry in the development process of a more realistic breakthrough in the smart home industry development has great significance. This article is based on easy to implement, easy to operate, close to the use of the design concept, the use of STC89C52 microcontroller as the control core for the control terminal, and including infrared remote control, buttons, Web interface, including multiple control sources to control household appliances. The second chapter of this paper describes the design of the hardware and software part of the specific implementation, the fifth chapter is based on the design of a good function to build a specific example of the environment.

  14. 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

  15. 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.

  16. Home safety measures and the risk of unintentional injury among young children: a multicentre case–control study

    PubMed Central

    LeBlanc, John C.; Pless, I. Barry; King, W. James; Bawden, Harry; Bernard-Bonnin, Anne-Claude; Klassen, Terry; Tenenbein, Milton

    2006-01-01

    Background Young children may sustain injuries when exposed to certain hazards in the home. To better understand the relation between several childproofing strategies and the risk of injuries to children in the home, we undertook a multicentre case–control study in which we compared hazards in the homes of children with and without injuries. Methods We conducted this case-control study using records from 5 pediatric hospital emergency departments for the 2-year period 1995–1996. The 351 case subjects were children aged 7 years and less who presented with injuries from falls, burns or scalds, ingestions or choking. The matched control subjects were children who presented during the same period with acute non-injury-related conditions. A home visitor, blinded to case-control status, assessed 19 injury hazards at the children's homes. Results Hazards found in the homes included baby walkers (21% of homes with infants), no functioning smoke alarm (17% of homes) and no fire extinguisher (51% of homes). Cases did not differ from controls in the mean proportion of home hazards. After controlling for siblings, maternal education and employment, we found that cases differed from controls for 5 hazards: the presence of a baby walker (odds ratio [OR] 9.0, 95% confidence interval [CI] 1.1–71.0), the presence of choking hazards within a child's reach (OR 2.0, 95% CI 1.0–3.7), no child-resistant lids in bathroom (OR 1.6, 95% CI 1.0–2.5), no smoke alarm (OR 3.2, 95% CI 1.4–7.7) and no functioning smoke alarm (OR 1.7, 95% CI 1.0–2.8). Interpretation Homes of children with injuries differed from those of children without injuries in the proportions of specific hazards for falls, choking, poisoning and burns, with a striking difference noted for the presence of a baby walker. In addition to counselling parents about specific hazards, clinicians should consider that the presence of some hazards may indicate an increased risk for home injuries beyond those directly

  17. Impact of implementation of a novel antimicrobial stewardship tool on antibiotic use in nursing homes: a prospective cluster randomized control pilot study.

    PubMed

    Fleet, Elizabeth; Gopal Rao, G; Patel, Bharat; Cookson, Barry; Charlett, Andre; Bowman, Clive; Davey, Peter

    2014-08-01

    To evaluate the impact of 'Resident Antimicrobial Management Plan' (RAMP), a novel antimicrobial stewardship tool on systemic antibiotic use for treatment of infection in nursing homes (NHs). A pilot cluster randomized control study was conducted in 30 NHs in London. Pre-intervention, we collected point prevalence data on antimicrobial use on three occasions and total antimicrobial consumption for a 12 week period. Post-intervention data were collected in the same manner and included assessment of compliance with RAMP in the intervention group (IG). The number of residents included was 1628 pre-intervention [825 IG/803 control group (CG)] and 1610 post-intervention (838 IG/772 CG). The corresponding pre- and post-intervention point prevalence of systemic antibiotic prescribing for treatment of infection was 6.46% and 6.52% in the IG [estimated prevalence ratio: 1.01 (95% CI: 0.81-1.25), P = 0.94] compared with 5.27% and 5.83%, respectively, in the CG [estimated prevalence ratio: 1.11 (95% CI: 0.87-1.41), P = 0.4]. Total antibiotic consumption was 69.78 defined daily doses/1000 residents/day (DRD) pre-intervention and 66.53 DRD post-intervention in the IG compared with 49.68 and 51.92 DRD, respectively, in the CG. There was a significant decrease of 4.9% (3.25 DRD) in the IG (95% CI: 1.0%-8.6%) (P = 0.02) compared with a significant increase of 5.1% (2.24 DRD) in the CG (95% CI: 0.2%-10.2%) (P = 0.04). Main indications for antibiotics were lower respiratory tract infections (34.1%), urinary tract infections (28.5%) and skin/soft tissue infections (25.1%). This pilot study demonstrated that use of RAMP was associated with a statistically significant decrease in total antibiotic consumption and has the potential to be an important antimicrobial stewardship tool for NHs. © The Author 2014. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  18. A novel BCI-controlled pneumatic glove system for home-based neurorehabilitation.

    PubMed

    Coffey, Aodhán L; Leamy, Darren J; Ward, Tomás E

    2014-01-01

    Commercially available devices for Brain-Computer Interface (BCI)-controlled robotic stroke rehabilitation are prohibitively expensive for many researchers who are interested in the topic and physicians who would utilize such a device. Additionally, they are cumbersome and require a technician to operate, increasing the inaccessibility of such devices for home-based robotic stroke rehabilitation therapy. Presented here is the design, implementation and test of an inexpensive, portable and adaptable BCI-controlled hand therapy device. The system utilizes a soft, flexible, pneumatic glove which can be used to deflect the subject's wrist and fingers. Operation is provided by a custom-designed pneumatic circuit. Air flow is controlled by an embedded system, which receives serial port instruction from a PC running real-time BCI software. System tests demonstrate that glove control can be successfully driven by a real-time BCI. A system such as the one described here may be used to explore closed loop neurofeedback rehabilitation in stroke relatively inexpensively and potentially in home environments.

  19. Home Use of Day-and-Night Hybrid Closed-Loop Insulin Delivery in Suboptimally Controlled Adolescents With Type 1 Diabetes: A 3-Week, Free-Living, Randomized Crossover Trial.

    PubMed

    Tauschmann, Martin; Allen, Janet M; Wilinska, Malgorzata E; Thabit, Hood; Acerini, Carlo L; Dunger, David B; Hovorka, Roman

    2016-11-01

    This study evaluated the feasibility, safety, and efficacy of day-and-night hybrid closed-loop insulin delivery in adolescents with type 1 diabetes under free-living conditions. In an open-label randomized crossover study, 12 suboptimally controlled adolescents on insulin pump therapy (mean ± SD age 14.6 ± 3.1 years; HbA 1c 69 ± 8 mmol/mol [8.5 ± 0.7%]; duration of diabetes 7.8 ± 3.5 years) underwent two 21-day periods in which hybrid closed-loop insulin delivery was compared with sensor-augmented insulin pump therapy in random order. During the closed-loop intervention, a model predictive algorithm automatically directed insulin delivery between meals and overnight. Participants used a bolus calculator to administer prandial boluses. The proportion of time that sensor glucose was in the target range (3.9-10 mmol/L; primary end point) was increased during the closed-loop intervention compared with sensor-augmented insulin pump therapy by 18.8 ± 9.8 percentage points (mean ± SD; P < 0.001), the mean sensor glucose level was reduced by 1.8 ± 1.3 mmol/L (P = 0.001), and the time spent above target was reduced by 19.3 ± 11.3 percentage points (P < 0.001). The time spent with sensor glucose levels below 3.9 mmol/L was low and comparable between interventions (median difference 0.4 [interquartile range -2.2 to 1.3] percentage points; P = 0.33). Improved glucose control during closed-loop was associated with increased variability of basal insulin delivery (P < 0.001) and an increase in the total daily insulin dose (53.5 [39.5-72.1] vs. 51.5 [37.6-64.3] units/day; P = 0.006). Participants expressed positive attitudes and experience with the closed-loop system. Free-living home use of day-and-night closed-loop in suboptimally controlled adolescents with type 1 diabetes is safe, feasible, and improves glucose control without increasing the risk of hypoglycemia. Larger and longer studies are warranted. © 2016 by the American Diabetes Association.

  20. Effects of a physiotherapy and occupational therapy intervention on mobility and activity in care home residents: a cluster randomised controlled trial.

    PubMed

    Sackley, Catherine M; van den Berg, Maayken E; Lett, Karen; Patel, Smitaa; Hollands, Kristen; Wright, Christine C; Hoppitt, Thomas J

    2009-09-01

    To compare the clinical effectiveness of a programme of physiotherapy and occupational therapy with standard care in care home residents who have mobility limitations and are dependent in performing activities of daily living. Cluster randomised controlled trial, with random allocation at the level of care home. Care homes within the NHS South Birmingham primary care trust and the NHS Birmingham East and North primary care trust that had more than five beds and provided for people in the care categories "physical disability" and "older people." Care home residents with mobility limitations, limitations in activities of daily living (as screened by the Barthel index), and not receiving end of life care were eligible to take part in the study. A targeted three month occupational therapy and physiotherapy programme. Scores on the Barthel index and the Rivermead mobility index. 24 of 77 nursing and residential homes that catered for residents with mobility limitations and dependency for activities of daily living were selected for study: 12 were randomly allocated to the intervention arm (128 residents, mean age 86 years) and 12 to the control arm (121 residents, mean age 84 years). Participants were evaluated by independent assessors blind to study arm allocation before randomisation (0 months), three months after randomisation (at the end of the treatment period for patients who received the intervention), and again at six months after randomisation. After adjusting for home effect and baseline characteristics, no significant differences were found in mean Barthel index scores at six months post-randomisation between treatment arms (mean effect 0.08, 95% confidence interval -1.14 to 1.30; P=0.90), across assessments (-0.01, -0.63 to 0.60; P=0.96), or in the interaction between assessment and intervention (0.42, -0.48 to 1.32; P=0.36). Similarly, no significant differences were found in the mean Rivermead mobility index scores between treatment arms (0.62, -0.51 to 1

  1. Behavioral neurocardiac training in hypertension: a randomized, controlled trial.

    PubMed

    Nolan, Robert P; Floras, John S; Harvey, Paula J; Kamath, Markad V; Picton, Peter E; Chessex, Caroline; Hiscock, Natalie; Powell, Jonathan; Catt, Michael; Hendrickx, Hilde; Talbot, Duncan; Chen, Maggie H

    2010-04-01

    It is not established whether behavioral interventions add benefit to pharmacological therapy for hypertension. We hypothesized that behavioral neurocardiac training (BNT) with heart rate variability biofeedback would reduce blood pressure further by modifying vagal heart rate modulation during reactivity and recovery from standardized cognitive tasks ("mental stress"). This randomized, controlled trial enrolled 65 patients with uncomplicated hypertension to BNT or active control (autogenic relaxation), with six 1-hour sessions over 2 months with home practice. Outcomes were analyzed with linear mixed models that adjusted for antihypertensive drugs. BNT reduced daytime and 24-hour systolic blood pressures (-2.4+/-0.9 mm Hg, P=0.009, and -2.1+/-0.9 mm Hg, P=0.03, respectively) and pulse pressures (-1.7+/-0.6 mm Hg, P=0.004, and -1.4+/-0.6 mm Hg, P=0.02, respectively). No effect was observed for controls (P>0.10 for all indices). BNT also increased RR-high-frequency power (0.15 to 0.40 Hz; P=0.01) and RR interval (P<0.001) during cognitive tasks. Among controls, high-frequency power was unchanged (P=0.29), and RR interval decreased (P=0.03). Neither intervention altered spontaneous baroreflex sensitivity (P>0.10). In contrast to relaxation therapy, BNT with heart rate variability biofeedback modestly lowers ambulatory blood pressure during wakefulness, and it augments tonic vagal heart rate modulation. It is unknown whether efficacy of this treatment can be improved with biofeedback of baroreflex gain. BNT, alone or as an adjunct to drug therapy, may represent a promising new intervention for hypertension.

  2. A long-term self-managed handwriting intervention for people with Parkinson's disease: results from the control group of a phase II randomized controlled trial.

    PubMed

    Collett, Johnny; Franssen, Marloes; Winward, Charlotte; Izadi, Hooshang; Meaney, Andy; Mahmoud, Wala; Bogdanovic, Marko; Tims, Martin; Wade, Derick; Dawes, Helen

    2017-12-01

    To report on the control group of a trial primarily designed to investigate exercise for improving mobility in people with Parkinson's disease (pwP). The control group undertook a handwriting intervention to control for attention and time spent practising a specific activity. Secondary analysis of a two-arm parallel phase II randomized controlled trial with blind assessment. Community. PwP able to walk ⩾100 m and with no contraindication to exercise were recruited from the Thames Valley, UK, and randomized (1:1) to exercise or handwriting, via a concealed computer-generated list. Handwriting was undertaken at home and exercise in community facilities; both were delivered through workbooks with monthly support visits and involved practice for 1 hour, twice weekly, over a period of six months. Handwriting was assessed, at baseline, 3, 6 and 12 months, using a pangram giving writing speed, amplitude (area) and progressive reduction in amplitude (ratio). The Movement Disorder Society (MDS)-Unified Parkinson's Disease Rating Scale (UPDRS) item 2.7 measured self-reported handwriting deficits. In all, 105 pwP were recruited (analysed: n  = 51 handwriting, n  = 54 exercise). A total of 40 pwP adhered to the handwriting programme, most completing ⩾1 session/week. Moderate effects were found for amplitude (total area: d = 0.32; 95% confidence interval (CI): -0.11 to 0.7; P = 0.13) in favour of handwriting over a period of12 months; effects for writing speed and ratio parameters were small ≤0.11. Self-reported handwriting difficulties also favoured handwriting (UPDRS 2.7: odds ratio (OR) = 0.55; 95% CI: 0.34 to 0.91; P = 0.02). No adverse effects were reported. PwP generally adhere to self-directed home handwriting which may provide benefit with minimal risk. Encouraging effects were found in writing amplitude and, moreover, perceived ability.

  3. Postpartum pelvic floor muscle training and urinary incontinence: a randomized controlled trial.

    PubMed

    Hilde, Gunvor; Stær-Jensen, Jette; Siafarikas, Franziska; Ellström Engh, Marie; Bø, Kari

    2013-12-01

    To evaluate whether postpartum pelvic floor muscle training decrease prevalence of any urinary incontinence (UI) in primiparous women with and without UI at inclusion (mixed population) and further to perform stratified analyses on women with and without major levator ani muscle defects. A two-armed assessor-blinded randomized controlled trial including primiparous women 6 weeks after vaginal delivery was conducted. Participants were stratified on major levator ani muscle defects, verified by transperineal ultrasonography, and thereafter randomly allocated to training or control. All participants were taught to contract the pelvic floor muscles. The control participants received no further intervention, whereas training participants attended a weekly supervised pelvic floor muscle training class and performed daily home exercise for 16 weeks. Primary outcome was self-reported UI analyzed by relative risk. We included 175 women, 55 with major levator ani muscle defects and 120 without. Prevalence of UI at baseline was 39.1% in the training group (n=87) and 50% among those in the control group (n=88). Fifteen women (8.6%) were lost to follow-up. At 6 months after delivery (postintervention), 34.5% and 38.6% reported UI in the training and control groups, respectively. Relative risk analysis of UI gave a nonsignificant effect size of 0.89 (95% confidence interval [CI] 0.60-1.32). Results were similar for the stratum with and without major levator ani muscle defects, 0.89 (95% CI 0.51-1.56) and 0.90 (95% CI 0.53-1.52), respectively. Postpartum pelvic floor training did not decrease UI prevalence 6 months after delivery in primiparous women. Stratified analysis on women with and without major levator ani muscle defects showed similar nonsignificant results. ClinicalTrials.gov, www.clinicaltrials.gov, NCT01069484. : I.

  4. Changing a dangerous rural cultural tradition: a randomized control study of youth as extra riders on tractors.

    PubMed

    Stoneman, Zolinda; Jinnah, Hamida Amirali; Rains, Glen C

    2014-01-01

    This study used a randomized control design to evaluate the effectiveness of AgTeen, an in-home, family-based farm safety intervention, in decreasing extra riding on tractors by youth. Having children as extra riders on tractors has deep roots in farm culture, but it can result in serious injury or death. The study randomized 151 families into 3 groups: parent-led intervention (fathers taught their families about farm safety), staff-led intervention (staff members who were peer farmers taught families), and a no-treatment control. Mothers, fathers, and all children aged 10-19 participated in the lessons. At study entry, 93% of youth reported that they had been an extra rider on a tractor in the past year. Although they were aware of the injury risk, fathers frequently gave tractor rides to their children. After the intervention, fathers in both AgTeen groups were less likely than control fathers to give youth tractor rides. Intervention youth were less likely than control youth to be extra riders. The intervention positively affected the extra-riding attitudes and injury risk perceptions of mothers and fathers. The parent-led and staff-led groups did not significantly differ across study outcomes. Findings confirm the effectiveness of a family-based intervention in decreasing extra riding on tractors by youth. © 2014 National Rural Health Association.

  5. 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.

  6. Feasibility and effects of home-based smartphone-delivered automated feedback training for gait in people with Parkinson's disease: A pilot randomized controlled trial.

    PubMed

    Ginis, Pieter; Nieuwboer, Alice; Dorfman, Moran; Ferrari, Alberto; Gazit, Eran; Canning, Colleen G; Rocchi, Laura; Chiari, Lorenzo; Hausdorff, Jeffrey M; Mirelman, Anat

    2016-01-01

    Inertial measurement units combined with a smartphone application (CuPiD-system) were developed to provide people with Parkinson's disease (PD) real-time feedback on gait performance. This study investigated the CuPiD-system's feasibility and effectiveness compared with conventional gait training when applied in the home environment. Forty persons with PD undertook gait training for 30 min, three times per week for six weeks. Participants were randomly assigned to i) CuPiD, in which a smartphone application offered positive and corrective feedback on gait, or ii) an active control, in which personalized gait advice was provided. Gait, balance, endurance and quality of life were assessed before and after training and at four weeks follow-up using standardized tests. Both groups improved significantly on the primary outcomes (single and dual task gait speed) at post-test and follow-up. The CuPiD group improved significantly more on balance (MiniBESTest) at post-test (from 24.8 to 26.1, SD ∼ 5) and maintained quality of life (SF-36 physical health) at follow-up whereas the control group deteriorated (from 50.4 to 48.3, SD ∼ 16). No other statistically significant differences were found between the two groups. The CuPiD system was well-tolerated and participants found the tool user-friendly. CuPiD was feasible, well-accepted and seemed to be an effective approach to promote gait training, as participants improved equally to controls. This benefit may be ascribed to the real-time feedback, stimulating corrective actions and promoting self-efficacy to achieve optimal performance. Further optimization of the system and adequately-powered studies are warranted to corroborate these findings and determine cost-effectiveness.

  7. An Evaluation of Plaque and Gingivitis Reduction Following Home Use of Sonicare FlexCare Platinum with Premium Plaque Control Brush Head and a Manual Toothbrush.

    PubMed

    Jenkins, Wendy; Souza, Sonia; Ward, Marilyn; Defenbaugh, Jodi; Milleman, Kimberly R; Milleman, Jeffery L

    2017-03-01

    To assess the effect of the Philips Sonicare FlexCare Platinum with Premium plaque control brush head on gingival inflammation, bleeding, and supragingival plaque reduction following a six-week period of home use compared to a manual toothbrush. This was a randomized, single-blind, parallel-design clinical trial. Subjects included in the study were routine manual toothbrush users who were generally healthy non-smokers, aged 18-65 years, with mild to moderate gingivitis. Subjects with advanced periodontal disease, excessive gingival recession, and heavy deposits of calculus or rampant decay were excluded from the study. Eligible participants were dispensed either Philips Sonicare FlexCare Platinum with Premium plaque control brush head (PC), or an ADA Reference manual toothbrush (MTB) for twice-daily home oral hygiene procedures for six weeks. Efficacy measures included the Lobene and Soparker Modification of Quigley and Hein Plaque Index (MPI), the Modified Gingival Index (MGI), and Gingival Bleeding Index (GBI). Safety was evaluated by oral examination and subject report. Efficacy and safety were assessed at Baseline, and at two and six weeks following product home use. Of 154 subjects randomized, 143 subjects completed the study. For the primary endpoint, MGI at Week 2, statistically significantly larger reductions in MGI were observed for PC versus MTB, p < 0.0001. The adjusted mean reduction and standard error estimates (SE) for MGI, expressed as percent reduction versus Baseline to Week 2, were 41.73% (2.00%) for PC and 7.38% (2.02%) for MTB. Statistically significant differences were also observed for MPI and GBI at Week 2, and for all metrics at Week 6. Philips Sonicare FlexCare Platinum with Premium plaque control brush head statistically significantly reduces gingival inflammation, gingival bleeding, and plaque following two and six weeks of home use, compared to manual tooth brushing alone.

  8. Intervention for infants with brain injury: Results of a randomized controlled study

    PubMed Central

    Badr, Lina Kurdahi; Garg, Meena; Kamath, Meghna

    2009-01-01

    A randomized clinical trail (RCT) employed a 12-month individualized cognitive/sensorimotor stimulation program to look at the efficacy of the intervention on 62 infants with suspected brain injury. The control group infants received the State-funded follow-up program provided by the Los Angeles (LA) Regional Centers while the intervention group received intensive stimulation using the Curriculum and Monitoring System (CAMS) taught by public health nurses (PHNs). The developmental assessments and outcome measures were performed at 6, 12 and 18 months corrected age and included the Bayley motor and mental development, the Home, mother–infant interaction (Nursing Child Assessment Feeding Scale (NCAFS) and Nursing Child Assessment Teaching Scale (NCATS)), parental stress and social support. At 18 months, 43 infants remained in the study. The results indicate that the intervention had minimal positive effects on the Bayley mental and motor development scores of infants in the intervention group. Likewise, the intervention did not contribute to less stress or better mother–infant interaction at 12 or 18 months although there were significant differences in the NCAFS scores favoring the intervention group at 6 months. There was a significant trend, however, for the control group to have a significant decrease over time on the Bayley mental scores. Although the sample was not large and attrition was at 31%, this study provides further support to the minimal effects of stimulation and home intervention for infants with brain injury and who may have more significant factors contributing to their developmental outcome. PMID:17138264

  9. 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.

  10. 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

  11. Systematic pain assessment in nursing homes: a cluster-randomized trial using mixed-methods approach.

    PubMed

    Mamhidir, Anna-Greta; Sjölund, Britt-Marie; Fläckman, Birgitta; Wimo, Anders; Sköldunger, Anders; Engström, Maria

    2017-02-28

    Chronic pain affects nursing home residents' daily life. Pain assessment is central to adequate pain management. The overall aim was to investigate effects of a pain management intervention on nursing homes residents and to describe staffs' experiences of the intervention. A cluster-randomized trial and a mixed-methods approach. Randomized nursing home assignment to intervention or comparison group. The intervention group after theoretical and practical training sessions, performed systematic pain assessments using predominately observational scales with external and internal facilitators supporting the implementation. No measures were taken in the comparison group; pain management continued as before, but after the study corresponding training was provided. Resident data were collected baseline and at two follow-ups using validated scales and record reviews. Nurse group interviews were carried out twice. Primary outcome measures were wellbeing and proxy-measured pain. Secondary outcome measures were ADL-dependency and pain documentation. Using both non-parametric statistics on residential level and generalized estimating equation (GEE) models to take clustering effects into account, the results revealed non-significant interaction effects for the primary outcome measures, while for ADL-dependency using Katz-ADL there was a significant interaction effect. Comparison group (n = 66 residents) Katz-ADL values showed increased dependency over time, while the intervention group demonstrated no significant change over time (n = 98). In the intervention group, 13/44 residents showed decreased pain scores over the period, 14/44 had no pain score changes ≥ 30% in either direction measured with Doloplus-2. Furthermore, 17/44 residents showed increased pain scores ≥ 30% over time, indicating pain/risk for pain; 8 identified at the first assessment and 9 were new, i.e. developed pain over time. No significant changes in the use of drugs was found in any of

  12. Enduring effects of prenatal and infancy home visiting by nurses on children: follow-up of a randomized trial among children at age 12 years.

    PubMed

    Kitzman, Harriet J; Olds, David L; Cole, Robert E; Hanks, Carole A; Anson, Elizabeth A; Arcoleo, Kimberly J; Luckey, Dennis W; Knudtson, Michael D; Henderson, Charles R; Holmberg, John R

    2010-05-01

    To test the effect of prenatal and infancy home visits by nurses on 12-year-old, firstborn children's use of substances, behavioral adjustment, and academic achievement. Randomized controlled trial. Public system of obstetric and pediatric care in Memphis, Tennessee. We studied 12-year-old, firstborn children (n = 613) of primarily African American, economically disadvantaged women (743 randomized during pregnancy). Program of prenatal and infancy home visits by nurses. Use of cigarettes, alcohol, and marijuana; internalizing, externalizing, and total behavioral problems; and academic achievement. By the time the firstborn child was 12 years of age, those visited by nurses, compared with those in the control group, reported fewer days of having used cigarettes, alcohol, and marijuana during the 30-day period before the 12-year interview (0.03 vs 0.18, P = .02) and were less likely to report having internalizing disorders that met the borderline or clinical threshold (22.1% vs 30.9%, P = .04). Nurse-visited children born to mothers with low psychological resources, compared with their control group counterparts, scored higher on the Peabody Individual Achievement Tests in reading and math (88.78 vs 85.70, P = .009) and, during their first 6 years of education, scored higher on group-administered standardized tests of math and reading achievement (40.52 vs 34.85, P = .02). No statistically significant program effects were found on children's externalizing or total behavioral problems. Through age 12, the program reduced children's use of substances and internalizing mental health problems and improved the academic achievement of children born to mothers with low psychological resources.

  13. Findings From a Prospective Randomized Controlled Trial of an Individualized Music Listening Program for Persons With Dementia.

    PubMed

    Kwak, Jung; Anderson, Keith; O'Connell Valuch, Katharine

    2018-06-01

    Music & Memory (M&M) is a passive music intervention that uses personalized music playlists delivered on digital music players. This program has been increasingly adopted in nursing homes across the United States to facilitate communication, engagement, and socialization among persons with dementia (PWDs); however, few studies have evaluated the program's effect on PWDs' outcomes. In the present study, a randomized controlled crossover design was used to examine the impact of the M&M program on 59 PWDs in 10 nursing homes over a 14-week period. Residents' evaluated outcomes included agitation, behavioral symptoms, and use of psychotropic medications. Although trends supported the positive effects of M&M, no statistically significant differences were found in any of the outcomes measured over time. Methodological limitations withstanding, these findings call into question the effectiveness of the M&M program and the ability of facility staff to implement this intervention with fidelity.

  14. Family Access to a Dentist Study (FADS): A Multi-Center Randomized Controlled Trial

    PubMed Central

    Nelson, Suchitra; Riedy, Christine; Albert, Jeffrey M; Lee, Wonik; Slusar, Mary Beth; Curtan, Shelley; Ferretti, Gerald; Cunha-Cruz, Joana; Milgrom, Peter

    2015-01-01

    Introduction Many low-income parent/caregivers do not understand the importance of cavity-free primary (baby) teeth and the chronic nature of dental caries (tooth decay). As a consequence, dental preventive and treatment utilization is low even when children are screened in schools and referred for care. This study aims to test a referral letter and Dental Information Guide (DIG) designed using the Common-Sense Model of Self-Regulation (CSM) framework to improve caregivers’ illness perception of dental caries and increase utilization of care by children with restorative dental needs. Methods A multi-site randomized controlled trial with caregivers of Kindergarten to 4th grade children in urban Ohio and rural Washington State will compare five arms: (1) CSM referral letter alone; (2) CSM referral letter + DIG; (3) reduced CSM referral letter alone; (4) reduced CSM referral letter + DIG; (5) standard (control) referral. At baseline, children will be screened at school to determine restorative dental needs. If in need of treatment, caregivers will be randomized to study arms and an intervention packet will be sent home. The primary outcome will be dental care based on a change in oral health status by clinical examination 7 months post-screening (ICDAS sealant codes 1 and 2; restoration codes 3–8; extraction). Enrollment commenced summer 2015 with results in summer 2016. Conclusion This study uses the CSM framework to develop and test behavioral interventions to increase dental utilization among low-income caregivers. If effective this simple intervention has broad applicability in clinical and community-based settings. PMID:26500170

  15. Family Access to a Dentist Study (FADS): A multi-center randomized controlled trial.

    PubMed

    Nelson, Suchitra; Riedy, Christine; Albert, Jeffrey M; Lee, Wonik; Slusar, Mary Beth; Curtan, Shelley; Ferretti, Gerald; Cunha-Cruz, Joana; Milgrom, Peter

    2015-11-01

    Many low-income parent/caregivers do not understand the importance of cavity-free primary (baby) teeth and the chronic nature of dental caries (tooth decay). As a consequence, dental preventive and treatment utilization is low even when children are screened in schools and referred for care. This study aims to test a referral letter and Dental Information Guide (DIG) designed using the Common-Sense Model of Self-Regulation (CSM) framework to improve caregivers' illness perception of dental caries and increase utilization of care by children with restorative dental needs. A multi-site randomized controlled trial with caregivers of Kindergarten to 4th grade children in urban Ohio and rural Washington State will compare five arms: (1) CSM referral letter alone; (2) CSM referral letter+DIG; (3) reduced CSM referral letter alone; (4) reduced CSM referral letter+DIG; and (5) standard (control) referral. At baseline, children will be screened at school to determine restorative dental needs. If in need of treatment, caregivers will be randomized to study arms and an intervention packet will be sent home. The primary outcome will be dental care based on a change in oral health status by clinical examination 7 months post-screening (ICDAS sealant codes 1 and 2; restoration codes 3-8; extraction). Enrollment commenced summer 2015 with results in summer 2016. This study uses the CSM framework to develop and test behavioral interventions to increase dental utilization among low-income caregivers. If effective this simple intervention has broad applicability in clinical and community-based settings. Copyright © 2015 Elsevier Inc. All rights reserved.

  16. Point-of-Use Interventions to Decrease Contamination of Drinking Water: A Randomized, Controlled Pilot Study on Efficacy, Effectiveness, and Acceptability of Closed Containers, Moringa oleifera, and In-home Chlorination in Rural South India

    PubMed Central

    Firth, Jacqueline; Balraj, Vinohar; Muliyil, Jayaprakash; Roy, Sheela; Rani, Lilly Michael; Chandresekhar, R.; Kang, Gagandeep

    2010-01-01

    To assess water contamination and the relative effectiveness of three options for point-of-use water treatment in South India, we conducted a 6-month randomized, controlled intervention trial using chlorine, Moringa oleifera seeds, a closed valved container, and controls. One hundred twenty-six families participated. Approximately 70% of public drinking water sources had thermotolerant coliform counts > 100/100 mL. Neither M. oleifera seeds nor containers reduced coliform counts in water samples from participants' homes. Chlorine reduced thermotolerant coliform counts to potable levels, but was less acceptable to participants. Laboratory testing of M. oleifera seeds in water from the village confirmed the lack of reduction in coliform counts, in contrast to the improvement seen with Escherichia coli seeded distilled water. This discrepancy merits further study, as M. oleifera was effective in reducing coliform counts in other studies and compliance with Moringa use in this study was high. PMID:20439952

  17. Point-of-use interventions to decrease contamination of drinking water: a randomized, controlled pilot study on efficacy, effectiveness, and acceptability of closed containers, Moringa oleifera, and in-home chlorination in rural South India.

    PubMed

    Firth, Jacqueline; Balraj, Vinohar; Muliyil, Jayaprakash; Roy, Sheela; Rani, Lilly Michael; Chandresekhar, R; Kang, Gagandeep

    2010-05-01

    To assess water contamination and the relative effectiveness of three options for point-of-use water treatment in South India, we conducted a 6-month randomized, controlled intervention trial using chlorine, Moringa oleifera seeds, a closed valved container, and controls. One hundred twenty-six families participated. Approximately 70% of public drinking water sources had thermotolerant coliform counts > 100/100 mL. Neither M. oleifera seeds nor containers reduced coliform counts in water samples from participants' homes. Chlorine reduced thermotolerant coliform counts to potable levels, but was less acceptable to participants. Laboratory testing of M. oleifera seeds in water from the village confirmed the lack of reduction in coliform counts, in contrast to the improvement seen with Escherichia coli seeded distilled water. This discrepancy merits further study, as M. oleifera was effective in reducing coliform counts in other studies and compliance with Moringa use in this study was high.

  18. Parent training for preschool ADHD: A randomized controlled trial of specialized and generic programs

    PubMed Central

    Abikoff, Howard B.; Thompson, Margaret; Laver-Bradbury, Cathy; Long, Nicholas; Forehand, Rex L.; Brotman, Laurie Miller; Klein, Rachel G.; Reiss, Philip; Huo, Lan; Sonuga-Barke, Edmund

    2014-01-01

    Background The ‘New Forest Parenting Package’ (NFPP), an 8-week home-based intervention for parents of preschoolers with ADHD, fosters constructive parenting to target ADHD-related dysfunctions in attention and impulse control.Although NFPP has improved parent and laboratory measures of ADHD in community samples of children with ADHD-like problems, its efficacy in a clinical sample, and relative to an active treatment comparator, is unknown. The aims are to evaluate the short and long-term efficacy and generalization effects of NFPP compared to an established clinic-based parenting intervention for treating noncompliant behavior (‘Helping the Noncompliant Child’ [HNC]) in young children with ADHD. Methods A randomized controlled trial with three parallel arms was the design for this study. 164 3-4-year-olds, 73.8% male, meeting DSM-IV ADHD diagnostic criteria were randomized to NFPP (N = 67), HNC (N = 63), or wait-list control (WL, N = 34). All participants were assessed at post-treatment. NFPP and HNC participants were assessed at follow-up in the next school year. Primary outcomes were ADHD ratings by teachers blind to and uninvolved in treatment, and by parents. Secondary ADHD outcomes included clinician assessments, and laboratory measures of on-task behavior and delay of gratification. Other outcomes included parent and teacher ratings of oppositional behavior, and parenting measures. (Trial name: Home-Based Parent Training in ADHD Preschoolers; Registry: ClinicalTrials.gov Identifier: NCT01320098; URL: http://www/clinicaltrials.gov/ct2/show/NCT01320098). Results In both treatment groups, children's ADHD and ODD behaviors, as well as aspects of parenting, were rated improved by parents at the end of treatment compared to controls. Most of these gains in the children's behavior and in some parenting practices were sustained at follow-up. However, these parent-reported improvements were not corroborated by teacher ratings or objective observations. NFPP

  19. A systematic review of randomized controlled trials of interventions designed to decrease child abuse in high-risk families

    PubMed Central

    Levey, Elizabeth J.; Gelaye, Bizu; Bain, Paul; Rondon, Marta B.; Borba, Christina P.C.; Henderson, David C.; Williams, Michelle A.

    2017-01-01

    Child abuse is a global problem, and parents with histories of childhood abuse are at increased risk of abusing their offspring. The objective of this systematic review is to provide a clear overview of the existing literature of randomized controlled trials evaluating the effectiveness of interventions to prevent child abuse. PubMed, PsychINFO, Web of Science, Sociological Abstracts, and CINAHL were systematically searched and expanded by hand search. This review includes all randomized controlled trials (RCTs) of interventions designed to prevent abuse among mothers identified as high-risk. Of the eight studies identified, only three found statistically significant reductions in abuse by any measure, and only two found reductions in incidents reported to child protective services. While much has been written about child abuse in high-risk families, few RCTs have been performed. Only home visitation has a significant evidence base for reducing child abuse, and the findings vary considerably. Also, data from low- and middle-income countries are limited. PMID:28110205

  20. Home-based telerehabilitation via real-time videoconferencing improves endurance exercise capacity in patients with COPD: The randomized controlled TeleR Study.

    PubMed

    Tsai, Ling Ling Y; McNamara, Renae J; Moddel, Chloe; Alison, Jennifer A; McKenzie, David K; McKeough, Zoe J

    2017-05-01

    Telerehabilitation has the potential to increase access to pulmonary rehabilitation (PR) for patients with COPD who have difficulty accessing centre-based PR due to poor mobility, lack of transport and cost of travel. We aimed to determine the effect of supervised, home-based, real-time videoconferencing telerehabilitation on exercise capacity, self-efficacy, health-related quality of life (HRQoL) and physical activity in patients with COPD compared with usual care without exercise training. Patients with COPD were randomized to either a supervised home-based telerehabilitation group (TG) that received exercise training three times a week for 8 weeks or a control group (CG) that received usual care without exercise training. Outcomes were measured at baseline and following the intervention. Thirty-six out of 37 participants (mean ± SD age = 74 ± 8 years, forced expiratory volume in 1 s (FEV 1 ) = 64 ± 21% predicted) completed the study. Compared with the CG, the TG showed a statistically significant increase in endurance shuttle walk test time (mean difference = 340 s (95% CI: 153-526, P < 0.001)), an increase in self-efficacy (mean difference = 8 points (95% CI: 2-14, P < 0.007)), a trend towards a statistically significant increase in the Chronic Respiratory Disease Questionnaire total score (mean difference = 8 points (95% CI: -1 to 16, P = 0.07)) and no difference in physical activity (mean difference = 475 steps per day (95% CI: -200 to 1151, P = 0.16)). This study showed that telerehabilitation improved endurance exercise capacity and self-efficacy in patients with COPD when compared with usual care. © 2016 Asian Pacific Society of Respirology.

  1. Enhancing the early home learning environment through a brief group parenting intervention: study protocol for a cluster randomised controlled trial.

    PubMed

    Nicholson, Jan M; Cann, Warren; Matthews, Jan; Berthelsen, Donna; Ukoumunne, Obioha C; Trajanovska, Misel; Bennetts, Shannon K; Hillgrove, Tessa; Hamilton, Victoria; Westrupp, Elizabeth; Hackworth, Naomi J

    2016-06-02

    The quality of the home learning environment has a significant influence on children's language and communication skills during the early years with children from disadvantaged families disproportionately affected. This paper describes the protocol and participant baseline characteristics of a community-based effectiveness study. It evaluates the effects of 'smalltalk', a brief group parenting intervention (with or without home coaching) on the quality of the early childhood home learning environment. The study comprises two cluster randomised controlled superiority trials (one for infants and one for toddlers) designed and conducted in parallel. In 20 local government areas (LGAs) in Victoria, Australia, six locations (clusters) were randomised to one of three conditions: standard care (control); smalltalk group-only program; or smalltalk plus (group program plus home coaching). Programs were delivered to parents experiencing socioeconomic disadvantage through two existing age-based services, the maternal and child health service (infant program, ages 6-12 months), and facilitated playgroups (toddler program, ages 12-36 months). Outcomes were assessed by parent report and direct observation at baseline (0 weeks), post-intervention (12 weeks) and follow-up (32 weeks). Primary outcomes were parent verbal responsivity and home activities with child at 32 weeks. Secondary outcomes included parenting confidence, parent wellbeing and children's communication, socio-emotional and general development skills. Analyses will use intention-to-treat random effects ("multilevel") models to account for clustering. Across the 20 LGAs, 986 parents of infants and 1200 parents of toddlers enrolled and completed baseline measures. Eighty four percent of families demonstrated one or more of the targeted risk factors for poor child development (low income; receives government benefits; single, socially isolated or young parent; culturally or linguistically diverse background). This

  2. Effects of Group, Individual, and Home Exercise in Persons With Parkinson Disease: A Randomized Clinical Trial.

    PubMed

    King, Laurie A; Wilhelm, Jennifer; Chen, Yiyi; Blehm, Ron; Nutt, John; Chen, Zunqiu; Serdar, Andrea; Horak, Fay B

    2015-10-01

    Comparative studies of exercise interventions for people with Parkinson disease (PD) rarely considered how one should deliver the intervention. The objective of this study was to compare the success of exercise when administered by (1) home exercise program, (2) individualized physical therapy, or (3) a group class. We examined if common comorbidities associated with PD impacted success of each intervention. Fifty-eight people (age = 63.9 ± 8 years) with PD participated. People were randomized into (1) home exercise program, (2) individual physical therapy, or (3) group class intervention. All arms were standardized and based on the Agility Boot Camp exercise program for PD, 3 times per week for 4 weeks. The primary outcome measure was the 7-item Physical Performance Test. Other measures of balance, gait, mobility, quality of life, balance confidence, depressions, apathy, self-efficacy and UPDRS-Motor, and activity of daily living scores were included. Only the individual group significantly improved in the Physical Performance Test. The individual exercise showed the most improvements in functional and balance measures, whereas the group class showed the most improvements in gait. The home exercise program improved the least across all outcomes. Several factors effected success, particularly for the home group. An unsupervised, home exercise program is the least effective way to deliver exercise to people with PD, and individual and group exercises have differing benefits. Furthermore, people with PD who also have other comorbidities did better in a program directly supervised by a physical therapist.Video Abstract available for additional insights from the authors (see Video, Supplemental Digital Content 1, http://links.lww.com/JNPT/A112).

  3. Perinatal depression prevention through home visitation: a cluster randomized trial of mothers and babies 1-on-1.

    PubMed

    Tandon, S Darius; Ward, Erin A; Hamil, Jaime L; Jimenez, Cindy; Carter, Mya

    2018-05-15

    Postpartum depression is highly prevalent in low-income women and has significant health effects on mother and child. This pilot study tested the effectiveness of the newly adapted Mothers and Babies (MB) 1-on-1 intervention. A cluster randomized trial was conducted with 8 programs using trained home visitors to deliver MB 1-on-1 and 6 delivering usual home visiting. One hundred twenty pregnant women not experiencing major depression were enrolled. Outcomes were assessed at baseline and 3- and 6-months postpartum. The rate of change in depressive and anxiety symptoms between groups was significant at 6 months, but not 3 months. No statistically significant differences between groups were found on secondary outcomes except perceptions of social support at 6 months. There was variability in use of MB skills, with fewer women using cognitive restructuring techniques. Although larger studies should be conducted, MB 1-on-1 appears promising in using home visitors to deliver a cognitive behavioral intervention to women at risk for postpartum depression.

  4. A pilot randomized controlled trial of deprescribing.

    PubMed

    Beer, Christopher; Loh, Poh-Kooi; Peng, Yan Gee; Potter, Kathleen; Millar, Alasdair

    2011-04-01

    Polypharmacy and adverse drug reactions are frequent and important among older people. Few clinical trials have evaluated systematic withdrawal of medications among older people. This small, open, study was conducted to determine the feasibility of a randomized controlled deprescribing trial. Ten volunteers living in the community (recruited by media advertising) and 25 volunteers living in residential aged-care facilities (RCFs) were randomized to intervention or control groups. The intervention was gradual withdrawal of one target medication. The primary outcome was the number of intervention participants in whom medication withdrawal could be achieved. Other outcomes measures were quality of life, medication adherence, sleep quality, and cognitive impairment. Participants were aged 80 ± 11 years and were taking 9 ± 2 medications. Fifteen participants commenced medication withdrawal and all ceased or reduced the dose of their target medication. Two subjects withdrew; one was referred for clinical review, and one participant declined further dose reductions. A randomized controlled trial of deprescribing was acceptable to participants. Recruitment in RCFs is feasible. Definitive trials of deprescribing are required.

  5. Increasing Medicaid child health screenings: the effectiveness of mailed pamphlets, phone calls, and home visits.

    PubMed Central

    Selby-Harrington, M; Sorenson, J R; Quade, D; Stearns, S C; Tesh, A S; Donat, P L

    1995-01-01

    OBJECTIVES. A randomized controlled trial was conducted to test the effectiveness and cost effectiveness of three outreach interventions to promote well-child screening for children on Medicaid. METHODS. In rural North Carolina, a random sample of 2053 families with children due or overdue for screening was stratified according to the presence of a home phone. Families were randomly assigned to receive a mailed pamphlet and letter, a phone call, or a home visit outreach intervention, or the usual (control) method of informing at Medicaid intake. RESULTS. All interventions produced more screenings than the control method, but increases were significant only for families with phones. Among families with phones, a home visit was the most effective intervention but a phone call was the most cost-effective. However, absolute rates of effectiveness were low, and incremental costs per effect were high. CONCLUSIONS. Pamphlets, phone calls, and home visits by nurses were minimally effective for increasing well-child screenings. Alternate outreach methods are needed, especially for families without phones. PMID:7573627

  6. Results of a randomized controlled trial to increase cervical cancer screening among rural Latinas.

    PubMed

    Thompson, Beti; Carosso, Elizabeth A; Jhingan, Esther; Wang, Lei; Holte, Sarah E; Byrd, Theresa L; Benavides, Maria C; Lopez, Cathy; Martinez-Gutierrez, Javiera; Ibarra, Genoveva; Gonzalez, Virginia J; Gonzalez, Nora E; Duggan, Catherine R

    2017-02-15

    Latinas have the highest rates of cervical cancer in the United States and the second highest rate of cervical cancer mortality. One factor in the disparity is the relatively low rate of screening for cervical cancer in this population. Eligible women who were out of adherence with cervical cancer screening (>3 years since their last Papanicolaou [Pap] test) were identified via medical record review by a federally qualified local health center. The effects of a low-intensity intervention (video delivered to participants' homes; n = 150) and a high-intensity intervention (video plus a home-based educational session; n = 146) on cervical cancer screening uptake in comparison with a control arm (usual care; n = 147) were investigated. A cost-effectiveness analysis of the interventions was conducted: all intervention costs were calculated, and the incremental cost-effectiveness ratio was computed. Finally, women with positive Pap tests were provided navigation by a community health educator to ensure that they received follow-up care. A total of 443 Latinas participated. Seven months after randomization, significantly more women in the high-intensity arm received a Pap test (53.4%) in comparison with the low-intensity arm (38.7%; P < .001) and the usual-care arm (34.0%; P < .01). The incremental cost-effectiveness ratio for high-intensity women versus the control group amounted to $4.24. Twelve women had positive Pap tests, which encompassed diagnoses ranging from atypical squamous cells of unknown significance to invasive cancer; these women received navigation for follow-up care. A culturally appropriate, in-home, promotora-led educational intervention was successful in increasing cervical cancer screening among Latinas. Cancer 2017;123:666-674. © 2016 American Cancer Society. © 2016 American Cancer Society.

  7. Straight Talk About Birth Control: A Contraceptive Education Protocol for Home Care.

    PubMed

    Schoenberg, Leslie

    Home healthcare providers play a critical role in the prevention of unintended pregnancies by providing evidence-based contraception education during home visits. This article describes an innovative and comprehensive contraception protocol that was developed for Nurse-Family Partnership to improve contraception education for home healthcare patients. The protocol focused on increasing uptake of long-acting reversible contraception (LARC) for high-risk prenatal and postpartum home healthcare patients. The protocol was designed to reduce early subsequent pregnancies and thereby improve outcomes for mothers and their infants. An evidence-based translation project was designed and piloted in three California counties. The protocol consisted of a contraception education module for nurses and a patient education toolkit. The toolkit included an interactive patient education workbook emphasizing LARC methods for nurses to complete with their patients along with other teaching tools. The project was evaluated using pre- and posttest surveys that measured changes in nurses' knowledge, attitudes, and practice before, after, and 2 months after implementation. Outcomes revealed the following statistically significant results: (a) nurses' knowledge doubled at the first posttest and persisted at 2 months, (b) nurses' attitudes improved on two of the three measures, and (c) there was a 17.7% increase in the frequency of LARC birth control education 2 months after implementation. An evidence-based contraception protocol can promote acceptance of LARC methods and improve home healthcare clinician comfort with and frequency of birth control education.

  8. Remote home management for chronic kidney disease: A systematic review.

    PubMed

    He, Ting; Liu, Xing; Li, Ying; Wu, Qiaoyu; Liu, Meilin; Yuan, Hong

    2017-01-01

    Background Remote home management is a new healthcare model that uses information technology to enhance patients' self-management of disease in a home setting. This study is designed to identify the effects of remote home management on patients with chronic kidney disease (CKD). Methods A comprehensive search of PubMed, MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials was performed in January 2015. The reference listings of the included articles in this review were also manually examined. Randomized controlled trials (RCTs) designed to evaluate the effects of remote home management on patients with CKD were included. Results Eight trials were identified. The results of this study suggest that the quality of life (QOL) enabled by remote home management was higher than typical care in certain dimensions. However, the effects of remote home management on blood pressure (BP) remain inconclusive. The studies that assessed health service utilization demonstrated a significant decrease in hospital readmission, emergency room visits, and number of days in the hospital. Another favorable result of this study is that regardless of their gender, age or nationality, patients tend to comply with remote home management programs and the use of related technologies. Conclusions The available data indicate that remote home management may be a novel and effective disease management strategy for improving CKD patients' QOL and influencing their attitudes and behaviors. And, relatively little is known about BP and cost-effectiveness, so future research should focus on these two aspects for the entire population of patients with CKD.

  9. A Single-Blind randomized controlled trial to evaluate the effect of extended counseling on uptake of pre-antiretroviral care in eastern uganda

    PubMed Central

    2011-01-01

    Background Many newly screened people living with HIV (PLHIV) in Sub-Saharan Africa do not understand the importance of regular pre-antiretroviral (ARV) care because most of them have been counseled by staff who lack basic counseling skills. This results in low uptake of pre-ARV care and late treatment initiation in resource-poor settings. The effect of providing post-test counseling by staff equipped with basic counseling skills, combined with home visits by community support agents on uptake of pre-ARV care for newly diagnosed PLHIV was evaluated through a randomized intervention trial in Uganda. Methods An intervention trial was performed consisting of post-test counseling by trained counselors, combined with monthly home visits by community support agents for continued counseling to newly screened PLHIV in Iganga district, Uganda between July 2009 and June 2010, Participants (N = 400) from three public recruitment centres were randomized to receive either the intervention, or the standard care (the existing post-test counseling by ARV clinic staff who lack basic training in counseling skills), the control arm. The outcome measure was the proportion of newly screened and counseled PLHIV in either arm who had been to their nearest health center for clinical check-up in the subsequent three months +2 months. Treatment was randomly assigned using computer-generated random numbers. The statistical significance of differences between the two study arms was assessed using chi-square and t-tests for categorical and quantitative data respectively. Risk ratios and 95% confidence intervals were used to assess the effect of the intervention. Results Participants in the intervention arm were 80% more likely to accept (take up) pre-ARV care compared to those in the control arm (RR 1.8, 95% CI 1.4-2.1). No adverse events were reported. Conclusions Provision of post-test counseling by staff trained in basic counseling skills, combined with home visits by community support

  10. A roundtable discussion: home healthcare-not a hospital in the home.

    PubMed

    Logan, Mary K; Parker, Chuck; Gardner-Bonneau, Daryle; Treu, Denny; Keller, James; Winstel, Lisa; Weick-Brady, Mary; Kramer, Nancy; Cyrus, Reginald; Thiel, Scott; Lewis, Vicki R; Rogers, Wendy

    2013-01-01

    Home healthcare is vital for a large percentage of the population. According to data from the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control (CDC), 7 million people in the United States receive home healthcare annually. The use of medical devices in the home and other nonclinical environments is increasing dramatically. By the year 2050, an estimated 27 million people will need continuing care in the home or in the community and not in a controlled clinical environment. 1 The FDA recently announced its Home Use Devices Initiative and issued the document, "Draft Guidance for Industry and FDA Staff-Design Considerations for Devices Intended for Home Use" on Dec. 12, 2012. 2 The Center for Devices and Radiological Health (CDRH) regulates medical devices, but that regulatory authority alone is not enough to ensure safe and effective use of devices in the home. To address these and other issues, AAMI and FDA will co-host a summit on healthcare technology in nonclinical settings Oct. 9-10, 2013.

  11. Randomized Video-Feedback Intervention in Home-Based Childcare: Improvement of Children's Wellbeing Dependent on Time Spent with Trusted Caregiver.

    PubMed

    Groeneveld, Marleen G; Vermeer, Harriet J; van IJzendoorn, Marinus H; Linting, Mariëlle

    The childcare environment offers a wide array of developmental opportunities for children. Providing children with a feeling of security to explore this environment is one of the most fundamental goals of childcare. In the current study the effectiveness of Video-feedback Intervention to promote Positive Parenting-Child Care (VIPP-CC) was tested on children's wellbeing in home-based childcare in a randomized controlled trial. Forty-seven children and their caregivers were randomly assigned to the intervention group or control group. Children's wellbeing, caregiver sensitivity, and global childcare quality were observed during a pretest and a posttest. We did not find an overall intervention effect on child wellbeing, but a significant interaction effect with months spent with a trusted caregiver was present. Children who were less familiar with the caregiver showed an increase in wellbeing scores in both the intervention and control group, but for the group of children who were more familiar with the caregiver, wellbeing increased only in the intervention group. Although there was no overall effect of the VIPP-CC on children's wellbeing, the VIPP-CC seems effective in children who have been cared for by the same trusted caregiver for a longer period of time.

  12. Effect of Nursing Home Staff Training on Quality of Patient Survival.

    ERIC Educational Resources Information Center

    Linn, Margaret W.; And Others

    1989-01-01

    Assessed effects of nursing home staff training in care for the dying on quality of life of 306 terminally ill patients in 5 pairs of matched nursing homes assigned randomly to trained and not trained staff groups. Patients in trained homes had less depression and greater satisfaction with care than patients in control homes at 1 and 3 months.…

  13. Performance and safety of an integrated bihormonal artificial pancreas for fully automated glucose control at home.

    PubMed

    Blauw, H; van Bon, A C; Koops, R; DeVries, J H

    2016-07-01

    To assess the performance and safety of an integrated bihormonal artificial pancreas system consisting of one wearable device and two wireless glucose sensor transmitters during short-term daily use at home. Adult patients with type 1 diabetes using an insulin pump were invited to enrol in this randomized crossover study. Treatment with the artificial pancreas started with a day and night in the clinical research centre, followed by 3 days at home. The control period consisted of 4 days of insulin pump therapy at home with blinded continuous glucose monitoring for data collection. Days 2-4 were predefined as the analysis period, with median glucose as the primary outcome. A total of 10 patients completed the study. The median [interquartile range (IQR)] glucose level was similar for the two treatments [7.3 (7.0-7.6) mmol/l for the artificial pancreas vs. 7.7 (7.0-9.0) mmol/l for the control; p = 0.123]. The median (IQR) percentage of time spent in euglycaemia (3.9-10 mmol/l) was longer during use of the artificial pancreas [84.7 (82.2-87.8)% for the artificial pancreas vs. 68.5 (57.9-83.6)% for the control; p = 0.007]. Time in hypoglycaemia was 1.3 (0.2-3.2)% for the artificial pancreas and 2.4 (0.4-10.3)% for the control treatment (p = 0.139). Separate analysis of daytime and night-time showed that the improvements were mainly achieved during the night. The results of this pilot study suggest that our integrated artificial pancreas provides better glucose control than insulin pump therapy in patients with type 1 diabetes at home and that the treatment is safe. © 2016 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

  14. Preconception maternal nutrition: a multi-site randomized controlled trial

    PubMed Central

    2014-01-01

    Background Research directed to optimizing maternal nutrition commencing prior to conception remains very limited, despite suggestive evidence of its importance in addition to ensuring an optimal nutrition environment in the periconceptional period and throughout the first trimester of pregnancy. Methods/Study design This is an individually randomized controlled trial of the impact on birth length (primary outcome) of the time at which a maternal nutrition intervention is commenced: Arm 1: ≥ 3 mo preconception vs. Arm 2: 12-14 wk gestation vs. Arm 3: none. 192 (derived from 480) randomized mothers and living offspring in each arm in each of four research sites (Guatemala, India, Pakistan, Democratic Republic of the Congo). The intervention is a daily 20 g lipid-based (118 kcal) multi-micronutient (MMN) supplement. Women randomized to receive this intervention with body mass index (BMI) <20 or whose gestational weight gain is low will receive an additional 300 kcal/d as a balanced energy-protein supplement. Researchers will visit homes biweekly to deliver intervention and monitor compliance, pregnancy status and morbidity; ensure prenatal and delivery care; and promote breast feeding. The primary outcome is birth length. Secondary outcomes include: fetal length at 12 and 34 wk; incidence of low birth weight (LBW); neonatal/infant anthropometry 0-6 mo of age; infectious disease morbidity; maternal, fetal, newborn, and infant epigenetics; maternal and infant nutritional status; maternal and infant microbiome; gut inflammatory biomarkers and bioactive and nutritive compounds in breast milk. The primary analysis will compare birth Length-for-Age Z-score (LAZ) among trial arms (independently for each site, estimated effect size: 0.35). Additional statistical analyses will examine the secondary outcomes and a pooled analysis of data from all sites. Discussion Positive results of this trial will support a paradigm shift in attention to nutrition of all females of

  15. Pilot Randomized Controlled Trial of a Home Vegetable Gardening Intervention among Older Cancer Survivors Shows Feasibility, Satisfaction, and Promise in Improving Vegetable and Fruit Consumption, Reassurance of Worth, and the Trajectory of Central Adiposity.

    PubMed

    Demark-Wahnefried, Wendy; Cases, Mallory G; Cantor, Alan B; Frugé, Andrew D; Smith, Kerry P; Locher, Julie; Cohen, Harvey J; Tsuruta, Yuko; Daniel, Michael; Kala, Rishabh; De Los Santos, Jennifer F

    2018-04-01

    Holistic approaches are sought to improve lifestyle behaviors and health of cancer survivors long term. Our aim was to explore whether a home-based vegetable gardening intervention is feasible and whether it improves diet and other health-related outcomes among older cancer survivors. We conducted a feasibility trial in which cancer survivors were randomized to receive a year-long gardening intervention immediately or to a wait-list control arm. Home visits at baseline and 1 year assessed physical performance, anthropometric indices, behavioral and psychosocial outcomes, and biomarkers. Participants included 46 older (aged 60+ years) survivors of locoregionally staged cancers across Alabama from 2014 to 2016. Forty-two completed 1-year follow-up. Cooperative extension master gardeners delivered guidance to establish three seasonal vegetable gardens at survivors' homes. Plants, seeds, and gardening supplies were provided. Primary outcomes were feasibility targets of 80% accrual and retention, and an absence of serious adverse events; other outcomes were secondary and explored potential benefits. Baseline to follow-up changes were assessed within and between arms using paired t, McNemar's, and χ 2 tests. This trial proved to be safe and demonstrated 91.3% retention; 70% of intervention participants rated their experience as "excellent," and 85% would "do it again." Data suggest significantly increased reassurance of worth (+0.49 vs -0.45) and attenuated increases in waist circumference (+2.30 cm vs +7.96 cm) in the gardening vs control arms (P=0.02). Vegetable and fruit consumption increased by approximately 1 serving/day within the gardening arm from baseline to follow-up (mean [standard error]=1.34 [1.2] to 2.25 [1.9] servings/day; P=0.02)] compared to controls (1.22 [1.1] to 1.12 [0.7]; P=0.77; between-arm P=0.06). The home vegetable gardening intervention among older cancer survivors was feasible and suggested improvements in vegetable and fruit consumption

  16. Home based telemedicine intervention for patients with uncontrolled hypertension: - a real life - non-randomized study

    PubMed Central

    2014-01-01

    Background Control of blood pressure is frequently inadequate in spite of availability of several classes of well tolerated and effective antihypertensive drugs. Several factors, including the use of suboptimal doses of drugs, inadequate or ineffective treatments and poor drug compliance may be the reason for this phenomenon. The aim of the current non- randomized study was to evaluate the effectiveness of a Home-Based Telemedicine service in patients with uncontrolled hypertension. Methods 74 patients were enrolled in a Home Based Telemedicine group and 94 patients in the Usual Care group. At baseline and at the end of the study, patients in both groups were seen in a cardiology office. Patients in Home Based Telemedicine group additionally were followed by a physician-nurse, through scheduled and unscheduled telephone appointments. These patients also received a blood pressure measuring device that could transmit the readings to a central data monitor via secure data connection. Results During the study period (80 ± 25 days), a total of 17401 blood pressure measurements were taken in the Home Based Telemedicine group corresponding to 236 ± 136 readings per patient and a mean daily measurement of 3 ± 1.7. The scheduled telephone contacts (initiated by the nurse) equaled to 5.2 ± 4.3/patient (370 in total) and the unscheduled telephone contacts (initiated by the patients) were 0.4 ± 0.9/patient (30 in total). The mean systolic blood pressure values decreased from 153 ± 19 mmHg to 130 ± 15 mmHg (p < 0.0001) at the end of the study and diastolic blood pressure values decreased from 89 ± 10 mmHg to 76 ± 11 mmHg (p < 0.0001). In the Usual Care group, the mean systolic blood pressure values decreased from 156 ± 16 mmHg to 149 ± 17 mmHg (p < 0.05) at the end of the study and diastolic blood pressure values decreased from 90 ± 8 mmHg to 86 ± 9 mmHg (p < 0.05). The changes in drug

  17. Effects of a Home-Based DVD-Delivered Physical Activity Program on Self-Esteem in Older Adults: Results from A Randomized Controlled Trial

    PubMed Central

    Awick, Elizabeth A; Ehlers, Diane; Fanning, Jason; Phillips, Siobhan M; Wójcicki, Thomas; Mackenzie, Michael J; Motl, Robert; McAuley, Edward

    2016-01-01

    Objective Although center-based supervised physical activity interventions have proven to be successful in attenuating health declines in older adults, such methods can be costly and have limited reach. In the present study, we examined the effects of a DVD-delivered exercise intervention on self-esteem and its subdomains and the extent to which these effects were maintained. In addition, we examined whether psychological, demographic, and biological factors acted as determinants of self-esteem. Methods Low active, older adults (N=307 ; Mean age =71.0 [SD=5.1] years) were randomly assigned to a six-month, home-based exercise program consisting of a DVD-delivered exercise intervention focused on increasing flexibility, toning, and balance (FlexToBa) or an attentional control DVD condition focused on healthy aging. Physical self-worth, three subdomains of self-esteem, global self-esteem, and self-efficacy were assessed at baseline, six months, and 12 months. Results There was a differential effect of time for the two groups for physical self-worth [F interaction (2, 530.10) = 4.17, p = 0.016] and perception of physical condition [F(2, 630.77) = 8.31, p = 0.004]. Self-efficacy, sex, body mass index (BMI), and age were significant predictors of changes in physical self-worth and perception of physical condition. Conclusion Our findings suggest a DVD-delivered exercise intervention is efficacious for improving and maintaining subdomain and domain levels of self-esteem in older adults. Additionally, self-efficacy was the strongest predictor of changes in physical self-worth and perceptions of physical condition. This innovative method of delivering an exercise training program via DVD is practical, effective, and has the potential for broad reach and dissemination. Trial Registration clinicaltrials.gov identifier NCT01030419 PMID:27359182

  18. Effects of a Home-Based DVD-Delivered Physical Activity Program on Self-Esteem in Older Adults: Results From a Randomized Controlled Trial.

    PubMed

    Awick, Elizabeth Ann; Ehlers, Diane; Fanning, Jason; Phillips, Siobhan M; Wójcicki, Thomas; Mackenzie, Michael J; Motl, Robert; McAuley, Edward

    2017-01-01

    Although center-based supervised physical activity interventions have proved to be successful in attenuating health declines in older adults, such methods can be costly and have limited reach. In the present study, we examined the effects of a DVD-delivered exercise intervention on self-esteem and its subdomains and the extent to which these effects were maintained. In addition, we examined whether psychological, demographic, and biological factors acted as determinants of self-esteem. Low-active, older adults (n = 307; mean [standard deviation] age =71.0 [5.1] years) were randomly assigned to a 6-month, home-based exercise program consisting of a DVD-delivered exercise intervention focused on increasing flexibility, toning, and balance (FlexToBa) or an attentional control DVD condition focused on healthy aging. Physical self-worth and three subdomains of self-esteem, global self-esteem, and self-efficacy were assessed at baseline, 6 months, and 12 months. There was a differential effect of time for the two groups for physical self-worth (F interaction(2,530.10) = 4.17, p = .016) and perception of physical condition (F interaction(1,630.77) = 8.31, p = .004). Self-efficacy, sex, body mass index, and age were significant predictors of changes in physical self-worth and perception of physical condition. Our findings suggest that a DVD-delivered exercise intervention is efficacious for improving and maintaining subdomain and domain levels of self-esteem in older adults. In addition, self-efficacy was the strongest predictor of changes in physical self-worth and perceptions of physical condition. This innovative method of delivering an exercise training program via DVD is practical and effective and has the potential for broad reach and dissemination. Clinicaltrials.govidentifier:NCT01030419.

  19. Increasing Water Intake of Children and Parents in the Family Setting: A Randomized, Controlled Intervention Using Installation Theory.

    PubMed

    Lahlou, Saadi; Boesen-Mariani, Sabine; Franks, Bradley; Guelinckx, Isabelle

    2015-01-01

    On average, children and adults in developed countries consume too little water, which can lead to negative health consequences. In a one-year longitudinal field experiment in Poland, we compared the impact of three home-based interventions on helping children and their parents/caregivers to develop sustainable increased plain water consumption habits. Fluid consumption of 334 children and their caregivers were recorded over one year using an online specific fluid dietary record. They were initially randomly allocated to one of the three following conditions: Control, Information (child and carer received information on the health benefits of water), or Placement (in addition to information, free small bottles of still water for a limited time period were delivered at home). After three months, half of the non-controls were randomly assigned to Community (child and caregiver engaged in an online community forum providing support on water consumption). All conditions significantly increased the water consumption of children (by 21.9-56.7%) and of adults (by 22-89%). Placement + Community generated the largest effects. Community enhanced the impact of Placement for children and parents, as well as the impact of Information for parents but not children. The results suggest that the family setting offers considerable scope for successful installation of interventions encouraging children and caregivers to develop healthier consumption habits, in mutually reinforcing ways. Combining information, affordances, and social influence gives the best, and most sustainable, results. © 2015 S. Karger AG, Basel.

  20. Home-based pulmonary rehabilitation in patients with chronic obstructive pulmonary disease: a randomized clinical trial

    PubMed Central

    Dias, Fernanda Dultra; Sampaio, Luciana Maria Malosá; da Silva, Graziela Alves; Gomes, Évelim LF Dantas; do Nascimento, Eloisa Sanches Pereira; Alves, Vera Lucia Santos; Stirbulov, Roberto; Costa, Dirceu

    2013-01-01

    Introduction Pulmonary rehabilitation (PR) is a multidisciplinary program of care for patients with chronic obstructive pulmonary disease (COPD) with the goal of improving the functional capacity and quality of life, as well as maintaining the clinical stability of COPD sufferers. However, not all patients are available for such a program despite discomfort with their condition. The aim of this study was to evaluate the effects of a home-based PR (HBPR) program on functional ability, quality of life, and respiratory muscle strength and endurance. Patients and methods Patients with COPD according to the Global Initiative of Chronic Obstructive Lung Disease were randomized (double-blind) into two groups. One group performed a protocol at home with aerobic and muscle strength exercises and was called the intervention group; the other group received only instructions to perform breathing and stretching exercises, characterizing it as the control group (CG). We assessed the following variables at baseline and 2 months: exercise tolerance (incremental shuttle walk test and upper limb test), respiratory muscle (strength and endurance test), and health-related quality of life (Airways Questionnaire 20). Results There were no significant changes after the intervention in either of the two groups in exercise tolerance and quality of life. However, the intervention group had improved respiratory endurance compared with the CG, while the CG presented a decrease in the load sustained by the respiratory muscles after the HBPR. Conclusion A program of HBPR with biweekly supervision (although not enough to provide significant improvements in physical capacity or quality of life) played an important role in maintaining the stability of the clinical features of patients with COPD; the patients had no worsening of symptoms during the intervention period according to the daily log. PMID:24235824

  1. Economic evaluation of neonatal care packages in a cluster-randomized controlled trial in Sylhet, Bangladesh.

    PubMed

    LeFevre, Amnesty E; Shillcutt, Samuel D; Waters, Hugh R; Haider, Sabbir; El Arifeen, Shams; Mannan, Ishtiaq; Seraji, Habibur R; Shah, Rasheduzzaman; Darmstadt, Gary L; Wall, Steve N; Williams, Emma K; Black, Robert E; Santosham, Mathuram; Baqui, Abdullah H

    2013-10-01

    To evaluate and compare the cost-effectiveness of two strategies for neonatal care in Sylhet division, Bangladesh. In a cluster-randomized controlled trial, two strategies for neonatal care--known as home care and community care--were compared with existing services. For each study arm, economic costs were estimated from a societal perspective, inclusive of programme costs, provider costs and household out-of-pocket payments on care-seeking. Neonatal mortality in each study arm was determined through household surveys. The incremental cost-effectiveness of each strategy--compared with that of the pre-existing levels of maternal and neonatal care--was then estimated. The levels of uncertainty in our estimates were quantified through probabilistic sensitivity analysis. The incremental programme costs of implementing the home-care package were 2939 (95% confidence interval, CI: 1833-7616) United States dollars (US$) per neonatal death averted and US$ 103.49 (95% CI: 64.72-265.93) per disability-adjusted life year (DALY) averted. The corresponding total societal costs were US$ 2971 (95% CI: 1844-7628) and US$ 104.62 (95% CI: 65.15-266.60), respectively. The home-care package was cost-effective--with 95% certainty--if healthy life years were valued above US$ 214 per DALY averted. In contrast, implementation of the community-care strategy led to no reduction in neonatal mortality and did not appear to be cost-effective. The home-care package represents a highly cost-effective intervention strategy that should be considered for replication and scale-up in Bangladesh and similar settings elsewhere.

  2. Hypertension management using mobile technology and home blood pressure monitoring: results of a randomized trial in two low/middle-income countries.

    PubMed

    Piette, John D; Datwani, Hema; Gaudioso, Sofia; Foster, Stephanie M; Westphal, Joslyn; Perry, William; Rodríguez-Saldaña, Joel; Mendoza-Avelares, Milton O; Marinec, Nicolle

    2012-10-01

    Hypertension and other noncommunicable diseases represent a growing threat to low/middle-income countries (LMICs). Mobile health technologies may improve noncommunicable disease outcomes, but LMICs lack resources to provide these services. We evaluated the efficacy of a cloud computing model using automated self-management calls plus home blood pressure (BP) monitoring as a strategy for improving systolic BPs (SBPs) and other outcomes of hypertensive patients in two LMICs. This was a randomized trial with a 6-week follow-up. Participants with high SBPs (≥140 mm Hg if nondiabetic and ≥130 mm Hg if diabetic) were enrolled from clinics in Honduras and Mexico. Intervention patients received weekly automated monitoring and behavior change telephone calls sent from a server in the United States, plus a home BP monitor. At baseline, control patients received BP results, hypertension information, and usual healthcare. The primary outcome, SBP, was examined for all patients in addition to a preplanned subgroup with low literacy or high hypertension information needs. Secondary outcomes included perceived health status and medication-related problems. Of the 200 patients recruited, 181 (90%) completed follow-up, and 117 of 181 had low literacy or high hypertension information needs. The median annual income was $2,900 USD, and average educational attainment was 6.5 years. At follow-up intervention patients' SBPs decreased 4.2 mm Hg relative to controls (95% confidence interval -9.1, 0.7; p=0.09). In the subgroup with high information needs, intervention patients' average SBPs decreased 8.8 mm Hg (-14.2, -3.4, p=0.002). Compared with controls, intervention patients at follow-up reported fewer depressive symptoms (p=0.004), fewer medication problems (p<0.0001), better general health (p<0.0001), and greater satisfaction with care (p≤0.004). Automated telephone care management plus home BP monitors can improve outcomes for hypertensive patients in LMICs. A cloud

  3. Exercise for depression in care home residents: a randomised controlled trial with cost-effectiveness analysis (OPERA).

    PubMed

    Underwood, M; Lamb, S E; Eldridge, S; Sheehan, B; Slowther, A; Spencer, A; Thorogood, M; Atherton, N; Bremner, S A; Devine, A; Diaz-Ordaz, K; Ellard, D R; Potter, R; Spanjers, K; Taylor, S J C

    2013-05-01

    Many older people living in care homes (long term residential care or nursing homes) are depressed. Exercise is a promising non-drug intervention for preventing and treating depression in this population. To evaluate the impact of a 'whole-home' intervention, consisting of training for residential and nursing home staff backed up with a twice-weekly, physiotherapist-led exercise class on depressive symptoms in care home residents. A cluster randomised controlled trial with a cost-effectiveness analysis to compare (1) the prevalence of depression in intervention homes with that in control homes in all residents contributing data 12 months after homes were randomised (cross-sectional analysis); (2) the number of depressive symptoms at 6 months between intervention and control homes in residents who were depressed at pre-randomisation baseline assessment (depressed cohort comparison); and (3) the number of depressive symptoms at 12 months between intervention and control homes in all residents who were present at pre-randomisation baseline assessment (cohort comparison). Seventy-eight care homes in Coventry and Warwickshire and north-east London. Care home residents aged ≥ 65 years. Control intervention: Depression awareness training programme for care home staff. Active intervention: A 'whole-home' exercise intervention, consisting of training for care home staff backed up with a twice-weekly, physiotherapist-led exercise group. Geriatric Depression Scale-15, proxy European Quality of Life-5 Dimensions (EQ-5D), cost-effectiveness from an National Health Service perspective, peripheral fractures and death. We recruited a total of 1054 participants. Cross-sectional analysis: We obtained 595 Geriatric Depression Scale-15 scores and 724 proxy EQ-5D scores. For the cohort analyses we obtained 765 baseline Geriatric Depression Scale-15 scores and 776 proxy EQ-5D scores. Of the 781 who we assessed prior to randomisation, 765 provided a Geriatric Depression Scale-15 score

  4. Elastic Band Exercises Improved Activities of Daily Living and Functional Fitness of Wheelchair-bound Older Adults with Cognitive Impairment: A Cluster Randomized Controlled Trial.

    PubMed

    Chen, Meng-Chun; Chen, Kuei-Min; Chang, Chu-Lin; Chang, Ya-Hui; Cheng, Yin-Yin; Huang, Hsin-Ting

    2016-11-01

    The purpose of this study was to test the effects of a 6-month Wheelchair-bound Senior Elastic Band (WSEB) exercise program on the activities of daily living (ADL) and functional fitness of wheelchair-bound older adults with cognitive impairment. Cluster randomized controlled trial was used. A convenience sample of 138 wheelchair-bound older adults with cognitive impairment were recruited from 8 nursing homes in southern Taiwan and were randomly assigned based on the nursing homes they lived to the experimental (4 nursing homes; n = 73) or the control group (4 nursing homes; n = 65). The experimental group performed WSEB exercises 3 times per week and 40 minutes per session for 6 months. The ADL and functional fitness (cardiopulmonary function, body flexibility, range of joint motion, and muscle strength and endurance) were examined at baseline, 3 months, and the end of 6-month study. The ADL and functional fitness indicators of participants in the experimental group showed significant improvements compared to the control group (all P < 0.05). The WSEB exercises have positive benefits for the ADL and functional fitness of wheelchair-bound older adults with cognitive impairment. It is suggested that WSEB exercises be included as a routine activity in nursing homes. Complete the self-assessment activity and evaluation online at http://www.physiatry.org/JournalCMECME OBJECTIVES:: Upon completion of this article the reader should be able to: (1) Understand the risk factors for functional decline in older adults with dementia; (2) Articulate the benefits of structured activities and exercises in the older adult with dementia; and (3) Incorporate elastic band exercises into the treatment plan of wheelchair bound older adults with dementia. AdvancedACCREDITATION:: The Association of Academic Physiatrists is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The Association of Academic

  5. Home screening for sexually transmitted diseases in high‐risk young women: randomised controlled trial

    PubMed Central

    Cook, Robert L; Østergaard, Lars; Hillier, Sharon L; Murray, Pamela J; Chang, Chung‐Chou H; Comer, Diane M; Ness, Roberta B

    2007-01-01

    Objective Home screening tests could eliminate several barriers to testing sexually transmitted diseases (STDs). Aim To determine whether offering repeated home screening tests would increase the rate of testing for chlamydia and gonorrhoea in a high‐risk sample of young women. Methods In this randomised controlled trial, 403 young women (mean age 18.9 years, 70% black) with a recent STD or with STD‐related risk factors were enrolled. Participants were recruited from clinics and high‐prevalence neighbourhoods and then randomly assigned to receive either a home testing kit or an invitation to attend a medical clinic for testing at 6, 12 and 18 months after enrollment. Over 80% of women were followed for 2 years. The trial is registered with ClinicalTrials.gov, number NCT 00177437. Results Of 197 women in the intervention group, 140 (71%) returned at least one home test and 25 of 249 (10%) home tests were positive. Women who received home screening tests completed significantly more STD tests overall (1.94 vs 1.41 tests per woman‐year, p<0.001) and more STD tests in the absence of symptoms (1.18 vs 0.75 tests per woman‐year, p<0.001). More women in the intervention group completed at least one test when asymptomatic (162 (82.2%) vs 117 (61.3%), p<0.001). The intervention was most effective among women recruited outside medical clinics. There was no significant difference in the overall rate of STDs detected. Conclusions Home screening significantly increased the utilisation of chlamydia and gonorrhoea testing in this sample of high‐risk young women, and thus represents a feasible strategy to facilitate STD testing in young women. PMID:17301105

  6. Comparative effectiveness, safety and acceptability of medical abortion at home and in a clinic: a systematic review

    PubMed Central

    Park, Min Hae; Shakur, Haleema; Free, Caroline

    2011-01-01

    Abstract Objective To compare medical abortion practised at home and in clinics in terms of effectiveness, safety and acceptability. Methods A systematic search for randomized controlled trials and prospective cohort studies comparing home-based and clinic-based medical abortion was conducted. The Cochrane Central Register of Controlled Trials, EMBASE, MEDLINE and Popline were searched. Failure to abort completely, side-effects and acceptability were the main outcomes of interest. Odds ratios and their 95% confidence intervals (CIs) were calculated. Estimates were pooled using a random-effects model. Findings Nine studies met the inclusion criteria (n = 4522 participants). All were prospective cohort studies that used mifepristone and misoprostol to induce abortion. Complete abortion was achieved by 86–97% of the women who underwent home-based abortion (n = 3478) and by 80–99% of those who underwent clinic-based abortion (n = 1044). Pooled analyses from all studies revealed no difference in complete abortion rates between groups (odds ratio = 0.8; 95% CI: 0.5–1.5). Serious complications from abortion were rare. Pain and vomiting lasted 0.3 days longer among women who took misoprostol at home rather than in clinic. Women who chose home-based medical abortion were more likely to be satisfied, to choose the method again and to recommend it to a friend than women who opted for medical abortion in a clinic. Conclusion Home-based abortion is safe under the conditions in place in the included studies. Prospective cohort studies have shown no differences in effectiveness or acceptability between home-based and clinic-based medical abortion across countries. PMID:21556304

  7. Nurse clinic versus home delivery of evidence-based community leg ulcer care: A randomized health services trial

    PubMed Central

    Harrison, Margaret B; Graham, Ian D; Lorimer, Karen; VandenKerkhof, Elizabeth; Buchanan, Maureen; Wells, Phil S; Brandys, Tim; Pierscianowski, Tadeusz

    2008-01-01

    Background International studies report that nurse clinics improve healing rates for the leg ulcer population. However, these studies did not necessarily deliver similar standards of care based on evidence in the treatment venues (home and clinic). A rigorous evaluation of home versus clinic care is required to determine healing rates with equivalent care and establish the acceptability of clinic-delivered care. Methods Health Services RCT was conducted where mobile individuals were allocated to either home or nurse clinic for leg ulcer management. In both arms, care was delivered by specially trained nurses, following an evidence protocol. Primary outcome: 3-month healing rates. Secondary outcomes: durability of healing (recurrence), time free of ulcers, HRQL, satisfaction, resource use. Data were collected at base-line, every 3 months until healing occurred, with 1 year follow-up. Analysis was by intention to treat. Results 126 participants, 65 randomized to receive care in their homes, 61 to nurse-run clinics. No differences found between groups at baseline on socio-demographic, HRQL or clinical characteristics. mean age 69 years, 68% females, 84% English-speaking, half with previous episode of ulceration, 60% ulcers at inclusion < 5 cm2 for < 6 months. No differences in 3-month healing rates: clinic 58.3% compared to home care at 56.7% (p = 0.5) or in secondary outcomes. Conclusion Our findings indicate that organization of care not the setting where care is delivered influences healing rates. Key factors are a system that supports delivery of evidence-based recommendations with care being provided by a trained nursing team resulting in equivalent healing rates, HRQL whether care is delivered in the home or in a community nurse-led clinic. Trial registration ClinicalTrials.gov Protocol Registration System: NCT00656383 PMID:19036149

  8. Change in quality of life in older people with dementia participating in Paro-activity: a cluster-randomized controlled trial.

    PubMed

    Jøranson, Nina; Pedersen, Ingeborg; Rokstad, Anne Marie Mork; Ihlebaek, Camilla

    2016-12-01

    The aim of this study was to investigate effects of robot-assisted group activity with Paro on quality of life in older people with dementia. Nursing home residents with severe dementia often experience social withdrawal and lower quality of life, which are suggested to be enhanced by non-pharmacological interventions. A cluster-randomized controlled trial. Ten nursing home units were randomized to robot-assisted intervention or control group (treatment as usual). Data were collected between March 2013-September 2014. 27 participants participated in group activity for 30 minutes twice a week over 12 weeks, 26 participated in the control group. Change in quality of life was assessed by local nurses through the Quality of Life in Late-Stage Dementia scale at baseline, after end of intervention and at 3 months follow-up. The scale and regular psychotropic medication were analysed stratified by dementia severity. Analysis using mixed model, one-way anova and linear regression were performed. An effect was found among participants with severe dementia from baseline to follow-up showing stable quality of life in the intervention group compared with a decrease in the control group. The intervention explained most of the variance in change in the total scale and in the subscales describing Tension and Well-being for the group with severe dementia. The intervention group used significantly less psychotropic medication compared with the control group after end of intervention. Pleasant and engaging activities facilitated by nursing staff, such as group activity with Paro, could improve quality of life in people with severe dementia. The trial is in adherence with the CONSORT statement and is registered at www.clinicaltrials.gov (study ID number: NCT02008630). © 2016 John Wiley & Sons Ltd.

  9. Effects of Dementia-Care Mapping on Residents and Staff of Care Homes: A Pragmatic Cluster-Randomised Controlled Trial

    PubMed Central

    van de Ven, Geertje; Draskovic, Irena; Adang, Eddy M. M.; Donders, Rogier; Zuidema, Sytse U.; Koopmans, Raymond T. C. M.; Vernooij-Dassen, Myrra J. F. J.

    2013-01-01

    Background The effectiveness of dementia-care mapping (DCM) for institutionalised people with dementia has been demonstrated in an explanatory cluster-randomised controlled trial (cRCT) with two DCM researchers carrying out the DCM intervention. In order to be able to inform daily practice, we studied DCM effectiveness in a pragmatic cRCT involving a wide range of care homes with trained nursing staff carrying out the intervention. Methods Dementia special care units were randomly assigned to DCM or usual care. Nurses from the intervention care homes received DCM training and conducted the 4-months DCM-intervention twice during the study. The primary outcome was agitation, measured with the Cohen-Mansfield agitation inventory (CMAI). The secondary outcomes included residents’ neuropsychiatric symptoms (NPSs) and quality of life, and staff stress and job satisfaction. The nursing staff made all measurements at baseline and two follow-ups at 4-month intervals. We used linear mixed-effect models to test treatment and time effects. Results 34 units from 11 care homes, including 434 residents and 382 nursing staff members, were randomly assigned. Ten nurses from the intervention units completed the basic and advanced DCM training. Intention-to-treat analysis showed no statistically significant effect on the CMAI (mean difference between groups 2·4, 95% CI −2·7 to 7·6; p = 0·34). More NPSs were reported in the intervention group than in usual care (p = 0·02). Intervention staff reported fewer negative and more positive emotional reactions during work (p = 0·02). There were no other significant effects. Conclusions Our pragmatic findings did not confirm the effect on the primary outcome of agitation in the explanatory study. Perhaps the variability of the extent of implementation of DCM may explain the lack of effect. Trial Registration Dutch Trials Registry NTR2314. PMID:23844003

  10. Effects of dementia-care mapping on residents and staff of care homes: a pragmatic cluster-randomised controlled trial.

    PubMed

    van de Ven, Geertje; Draskovic, Irena; Adang, Eddy M M; Donders, Rogier; Zuidema, Sytse U; Koopmans, Raymond T C M; Vernooij-Dassen, Myrra J F J

    2013-01-01

    The effectiveness of dementia-care mapping (DCM) for institutionalised people with dementia has been demonstrated in an explanatory cluster-randomised controlled trial (cRCT) with two DCM researchers carrying out the DCM intervention. In order to be able to inform daily practice, we studied DCM effectiveness in a pragmatic cRCT involving a wide range of care homes with trained nursing staff carrying out the intervention. Dementia special care units were randomly assigned to DCM or usual care. Nurses from the intervention care homes received DCM training and conducted the 4-months DCM-intervention twice during the study. The primary outcome was agitation, measured with the Cohen-Mansfield agitation inventory (CMAI). The secondary outcomes included residents' neuropsychiatric symptoms (NPSs) and quality of life, and staff stress and job satisfaction. The nursing staff made all measurements at baseline and two follow-ups at 4-month intervals. We used linear mixed-effect models to test treatment and time effects. 34 units from 11 care homes, including 434 residents and 382 nursing staff members, were randomly assigned. Ten nurses from the intervention units completed the basic and advanced DCM training. Intention-to-treat analysis showed no statistically significant effect on the CMAI (mean difference between groups 2·4, 95% CI -2·7 to 7·6; p = 0·34). More NPSs were reported in the intervention group than in usual care (p = 0·02). Intervention staff reported fewer negative and more positive emotional reactions during work (p = 0·02). There were no other significant effects. Our pragmatic findings did not confirm the effect on the primary outcome of agitation in the explanatory study. Perhaps the variability of the extent of implementation of DCM may explain the lack of effect. Dutch Trials Registry NTR2314.

  11. Evaluating the Flipped Classroom: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Wozny, Nathan; Balser, Cary; Ives, Drew

    2018-01-01

    Despite recent interest in flipped classrooms, rigorous research evaluating their effectiveness is sparse. In this study, the authors implement a randomized controlled trial to evaluate the effect of a flipped classroom technique relative to a traditional lecture in an introductory undergraduate econometrics course. Random assignment enables the…

  12. Treatment of sleep apnea in chronic heart failure patients with auto-servo ventilation improves sleep fragmentation: a randomized controlled trial.

    PubMed

    Hetzenecker, Andrea; Escourrou, Pierre; Kuna, Samuel T; Series, Frederic; Lewis, Keir; Birner, Christoph; Pfeifer, Michael; Arzt, Michael

    2016-01-01

    Impaired sleep efficiency is independently associated with worse prognosis in patients with chronic heart failure (CHF). Therefore, a test was conducted on whether auto-servo ventilation (ASV, biphasic positive airway pressure [BiPAP]-ASV, Philips Respironics) reduces sleep fragmentation and improves sleep efficiency in CHF patients with central sleep apnea (CSA) or obstructive sleep apnea (OSA). In this multicenter, randomized, parallel group trial, a study was conducted on 63 CHF patients (age 64 ± 10 years; left ventricular ejection fraction 29 ± 7%) with CSA or OSA (apnea-hypopnea Index, AHI 47 ± 18/h; 46% CSA) referred to sleep laboratories of the four participating centers. Participants were randomized to either ASV (n = 32) or optimal medical treatment alone (control, n = 31). Polysomnography (PSG) and actigraphy at home (home) with centralized blinded scoring were obtained at baseline and 12 weeks. ASV significantly reduced sleep fragmentation (total arousal indexPSG: -16.4 ± 20.6 vs. -0.6 ± 13.2/h, p = 0.001; sleep fragmentation indexhome: -7.6 ± 15.6 versus 4.3 ± 13.9/h, p = 0.003, respectively) and significantly increased sleep efficiency assessed by actigraphy (SEhome) compared to controls (2.3 ± 10.1 vs. -2.1 ± 6.9%, p = 0.002). Effects of ASV on sleep fragmentation and efficiency were similar in patients suffering from OSA and CSA. At home, ASV treatment modestly improves sleep fragmentation as well as sleep efficiency in CHF patients having either CSA or OSA. Copyright © 2015 Elsevier B.V. All rights reserved.

  13. Effectiveness of aerobic gymnastic exercise on stress, fatigue, and sleep quality during postpartum: A pilot randomized controlled trial.

    PubMed

    Yang, Chiu-Ling; Chen, Chung-Hey

    2018-01-01

    Gymnastics is a preferable safe exercise for postnatal women performing regularly. The aim of this pilot randomized controlled trial was to determine whether the aerobic gymnastic exercise improves stress, fatigue, sleep quality and depression in postpartum women. Single-blinded, randomized controlled trial held from December 2014 until September 2015. Postnatal clinic of a medical center in southern Taiwan. 140 eligible postnatal women were systematically assigned, with a random start to experimental (n=70) or a control (n=70) group. Engage in aerobic gymnastic exercise at least three times (15min per section) a week for three months using compact disc in the home. Perceived Stress Scale, Postpartum Fatigue Scale, Postpartum Sleep Quality Scale, and Edinburgh Postnatal Depression Scale. In a two-way ANOVA with repeated measures, the aerobic gymnastic exercise group showed significant decrease in fatigue after practicing exercise 4 weeks and the positive effects extended to the 12-week posttests. Paired t-tests revealed that aerobic gymnastic exercise participants had improved significantly in perceived stress and fatigue after 4 weeks gymnastic exercise; these positive effects extended to the 12-week posttests. In addition, the changes in physical symptoms-related sleep inefficiency after 12 weeks gymnastic exercise were significantly decreased in the experimental group compared with the control group. The findings can be used to encourage postnatal women to perform moderate-intensity gymnastic exercise in their daily life to reduce their stress, fatigue and improve sleep quality. Copyright © 2017 Elsevier Ltd. All rights reserved.

  14. Correction to: The effectiveness of a life style modification and peer support home blood pressure monitoring in control of hypertension: protocol for a cluster randomized controlled trial.

    PubMed

    Su, Tin Tin; Majid, Hazreen Abdul; Nahar, Azmi Mohamed; Azizan, Nurul Ain; Hairi, Farizah Mohd; Thangiah, Nithiah; Dahlui, Maznah; Bulgiba, Awang; Murray, Liam J

    2017-11-06

    After publication of the article [1], it has been brought to our attention that the methodology outlined in the original article was not able to be fully carried out. The article planned a two armed randomized control trial. However, due to a lower response than expected and one housing complex dropping out from the study, the method was changed to pre- and post-intervention with no control group. All other methods were conducted as outlined in the original article.

  15. Maternal dietary counseling reduces consumption of energy-dense foods among infants: a randomized controlled trial.

    PubMed

    Vitolo, Marcia Regina; Bortolini, Gisele Ane; Campagnolo, Paula Dal Bo; Hoffman, Daniel J

    2012-01-01

    To evaluate the impact of a dietary counseling in reducing the intake of energy-dense foods by infants. A randomized controlled trial. São Leopoldo, Brazil. Mothers and infants of a low-income-group population were randomized into intervention (n = 163) and received dietary counseling during 10 home visits, or control (n = 234) groups. Child consumption of sugar-dense (SD) and lipid-dense (LD) foods at 12 to 16 months. The effect of the intervention was expressed by relative risks and 95% confidence intervals. Poisson regression analysis was used to determine the association between exclusive breastfeeding and the energy-dense foods intake. A smaller proportion of infants from the intervention group consumed candy, soft drinks, honey, cookies, chocolate, and salty snacks. In the intervention group, there was a reduction of 40% and 50% in the proportion of infants who consumed LD and SD foods, respectively. Being breastfed up to 6 months reduced the risk for consumption of LD and SD foods by 58% and 67%, respectively. Dietary counseling to mothers may be effective in reducing the consumption of energy-dense foods among infants, and it is helpful in improving early dietary habits. Copyright © 2012 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

  16. Exercise and bone mineral density in premenopausal women: a meta-analysis of randomized controlled trials.

    PubMed

    Kelley, George A; Kelley, Kristi S; Kohrt, Wendy M

    2013-01-01

    Objective. Examine the effects of exercise on femoral neck (FN) and lumbar spine (LS) bone mineral density (BMD) in premenopausal women. Methods. Meta-analysis of randomized controlled exercise trials ≥24 weeks in premenopausal women. Standardized effect sizes (g) were calculated for each result and pooled using random-effects models, Z score alpha values, 95% confidence intervals (CIs), and number needed to treat (NNT). Heterogeneity was examined using Q and I(2). Moderator and predictor analyses using mixed-effects ANOVA and simple metaregression were conducted. Statistical significance was set at P ≤ 0.05. Results. Statistically significant improvements were found for both FN (7g's, 466 participants, g = 0.342, 95%  CI = 0.132, 0.553, P = 0.001, Q = 10.8, P = 0.22, I(2) = 25.7%, NNT = 5) and LS (6g's, 402 participants, g = 0.201, 95%  CI = 0.009, 0.394, P = 0.04, Q = 3.3, P = 0.65, I(2) = 0%, NNT = 9) BMD. A trend for greater benefits in FN BMD was observed for studies published in countries other than the United States and for those who participated in home versus facility-based exercise. Statistically significant, or a trend for statistically significant, associations were observed for 7 different moderators and predictors, 6 for FN BMD and 1 for LS BMD. Conclusions. Exercise benefits FN and LS BMD in premenopausal women. The observed moderators and predictors deserve further investigation in well-designed randomized controlled trials.

  17. The effects of therapeutic exercises on pain, muscle strength, functional capacity, balance and hemodynamic parameters in knee osteoarthritis patients: a randomized controlled study of supervised versus home exercises.

    PubMed

    Kuru Çolak, Tuğba; Kavlak, Bahar; Aydoğdu, Onur; Şahin, Emir; Acar, Gönül; Demirbüken, İlkşan; Sarı, Zübeyir; Çolak, İlker; Bulut, Güven; Polat, M Gülden

    2017-03-01

    The aim of the study was to compare the effects of low-intensity exercise programs for lower extremities, either supervised or at home, on pain, muscle strength, balance and the hemodynamic parameters of knee osteoarthritis (OA) patients. This randomized study included 78 patients with knee OA in 2 groups of supervised and home-based exercise program. Exercises were applied to the first group in the clinic as a group exercise program and were demonstrated to the second group to be performed at home. Before and after the 6-week exercise program, assessment was made of pain, quadriceps and hamstring muscle strengths, 6-min walk test (6MWT), and non-invasive hemodynamic parameters. Results of the 78 patients, 56 completed the study. Pain, muscle strength, and 6MWT scores showed significant improvements in both groups. There were also significant differences in the amount of change in pain and muscle strength (pain: p = 0.041, Rqdc: 0.009, Lqdc: 0.013, Rhms: 0.04) which indicated greater improvements in the supervised group. The balance scores of supervised group showed a significant improvement (p = 0.009). No significant change was determined in hemodynamic parameters of either group. Conclusion according to the results of this study showed that low-intensity lower extremity exercises conducted in a clinic under the supervision of a physiotherapist were more effective than home-based exercises in reducing post-activity pain levels and improving quadriceps and right hamstring muscle strength. Both the supervised and home exercise programs were seen to be effective in reducing rest pain and increasing 6 MW distance in knee osteoarthritis patients.

  18. Randomized Multilevel Intervention to Improve Outcomes of Residents in Nursing Homes in Need of Improvement

    PubMed Central

    Rantz, Marilyn J.; Nahm, Helen E.; Zwygart-Stauffacher, Mary; Hicks, Lanis; Mehr, David; Flesner, Marcia; Petroski, Gregory F.; Madsen, Richard W.; Scott-Cawiezell, Jill

    2012-01-01

    Purpose A comprehensive multilevel intervention was tested to build organizational capacity to create and sustain improvement in quality of care and subsequently improve resident outcomes in nursing homes in need of improvement. Intervention facilities (n=29) received a two-year multilevel intervention with monthly on-site consultation from expert nurses with graduate education in gerontological nursing. Attention control facilities (n=29) that also needed to improve resident outcomes received monthly information about aging and physical assessment of elders. Design and Methods Randomized clinical trial of nursing homes in need of improving resident outcomes of bladder and bowel incontinence, weight loss, pressure ulcers, and decline in activities of daily living (ADL). It was hypothesized that following the intervention, experimental facilities would have better resident outcomes, higher quality of care, higher staff retention, more organizational attributes of improved working conditions than control facilities, similar staffing and staff mix, and lower total and direct care costs. Results The intervention did improve quality of care (p=0.02); there were improvements in pressure ulcers (p=0.05), weight loss (p=0.05). Staff retention, organizational working conditions, staffing, and staff mix and most costs were not affected by the intervention. Leadership turnover was surprisingly excessive in both intervention and control groups. Implications Some facilities that are in need of improving quality of care and resident outcomes are able to build the organizational capacity to improve while not increasing staffing or costs of care. Improvement requires continuous supportive consultation and leadership willing to involve staff and work together to build the systematic improvements in care delivery needed. PMID:21816681

  19. Activity Begins in Childhood (ABC) - inspiring healthy active behaviour in preschoolers: study protocol for a cluster randomized controlled trial.

    PubMed

    Adamo, Kristi B; Barrowman, Nick; Naylor, Patti Jean; Yaya, Sanni; Harvey, Alysha; Grattan, Kimberly P; Goldfield, Gary S

    2014-07-29

    Today's children are more overweight than previous generations and physical inactivity is a contributing factor. Modelling and promoting positive behaviour in the early years is imperative for the development of lifelong health habits. The social and physical environments where children spend their time have a powerful influence on behaviour. Since the majority of preschool children spend time in care outside of the home, this provides an ideal setting to examine the ability of an intervention to enhance movement skills and modify physical activity behaviour. This study aims to evaluate the efficacy of the Activity Begins in Childhood (ABC) intervention delivered in licensed daycare settings alone or in combination with a parent-driven home physical activity-promotion component to increase preschoolers' overall physical activity levels and, specifically, the time spent in moderate to vigorous physical activity. This study is a single site, three-arm, cluster-randomized controlled trial design with a daycare centre as the unit of measurement (clusters). All daycare centres in the National Capital region that serve children between the ages of 3 and 5, expressing an interest in receiving the ABC intervention will be invited to participate. Those who agree will be randomly assigned to one of three groups: i) ABC program delivered at a daycare centre only, ii) ABC program delivered at daycare with a home/parental education component, or iii) regular daycare curriculum. This study will recruit 18 daycare centres, 6 in each of the three groups. The intervention will last approximately 6 months, with baseline assessment prior to ABC implementation and follow-up assessments at 3 and 6 months. Physical activity is an acknowledged component of a healthy lifestyle and childhood experiences as it has an important impact on lifelong behaviour and health. Opportunities for physical activity and motor development in early childhood may, over the lifespan, influence the

  20. Interventions to Improve Suboptimal Prescribing in Nursing Homes: A Narrative Review

    PubMed Central

    Marcum, Zachary A.; Handler, Steven M.; Wright, Rollin; Hanlon, Joseph T.

    2010-01-01

    Background Appropriate medication prescribing for nursing home residents remains a challenge. Objective The purpose of this study was to conduct a narrative review of the published literature describing randomized controlled trials that used interventions to improve suboptimal prescribing in nursing homes. Methods The PubMed, International Pharmaceutical Abstracts, and EMBASE databases were searched for articles published in the English language between January 1975 and December 2009, using the terms drug utilization, pharmaceutical services, aged, long-term care, nursing homes, prescribing, geriatrics, and randomized controlled trial. A manual search of the reference lists of identified articles and the authors’ files, book chapters, and recent review articles was also conducted. Abstracts and posters from meetings were not included in the search. Studies were included if they: (1) had a randomized controlled design; (2) had a process measure outcome for quality of prescribing or a distal outcome measure for medication-related adverse patient events; and (3) involved nursing home residents. Results Eighteen studies met the inclusion criteria for this review. Seven of those studies described educational approaches using various interventions (eg, outreach visits) and measured suboptimal prescribing in different manners (eg, adherence to guidelines). Two studies described computerized decision-support systems to measure the intervention’s impact on adverse drug events (ADEs) and appropriate drug orders. Five studies described clinical pharmacist activities, most commonly involving a medication review, and used various measures of suboptimal prescribing, including a measure of medication appropriateness and the total number of medications prescribed. Two studies each described multidisciplinary and multifaceted approaches that included heterogeneous interventions and measures of prescribing. Most (15/18; 83.3%) of these studies reported statistically significant

  1. Impact of Attention Training on Academic Achievement, Executive Functioning, and Behavior: A Randomized Controlled Trial.

    PubMed

    Kirk, Hannah; Gray, Kylie; Ellis, Kirsten; Taffe, John; Cornish, Kim

    2017-03-01

    Children with intellectual and developmental disabilities (IDD) experience significant difficulties in attention, learning, executive functions, and behavioral regulation. Emerging evidence suggests that computerized cognitive training may remediate these impairments. In a double blind controlled trial, 76 children with IDD (4-11 years) were randomized to either an attention training (n = 38) or control program (n = 38). Both programs were completed at home over a 5-week period. Outcome measures assessed literacy, numeracy, executive functioning, and behavioral/emotional problems, and were conducted at baseline, post-training, and 3-month follow-up. No training effects were observed at post-training; however, children in the training group showed greater improvements in numeracy skills at the 3-month follow-up. These results suggest that attention training may be beneficial for children with IDD; however, the modest nature of the intervention effects indicate that caution should be taken when interpreting clinical significance.

  2. Does pelvic floor muscle training abolish symptoms of urinary incontinence? A randomized controlled trial.

    PubMed

    Celiker Tosun, O; Kaya Mutlu, E; Ergenoglu, A M; Yeniel, A O; Tosun, G; Malkoc, M; Askar, N; Itil, I M

    2015-06-01

    To determine whether symptoms of urinary incontinence is reduced by pelvic floor muscle training, to determine whether urinary incontinence can be totally eliminated by strengthening the pelvic floor muscle to grade 5 on the Oxford scale. Prospective randomized controlled clinical trial. Outpatient urogynecology department. One hundred thirty cases with stress and mixed urinary incontinence. All participants were randomly allocated to the pelvic floor muscle training group or control group. A 12-week home based exercise program, prescribed individually, was performed by the pelvic floor muscle training group. Urinary incontinence symptoms (Incontinence Impact Questionnaire-7, Urogenital Distress Inventory-6, bladder diary, stop test and pad test) were assessed, and the pelvic floor muscle strength was measured for (PERFECT testing, perineometric and ultrasound) all participants before and after 12 weeks of treatment. The pelvic floor muscle training group had significant improvement in their symptoms of urinary incontinence (P=0.001) and an increase in pelvic floor muscle strength (P=0.001, by the dependent t test) compared with the control group. All the symptoms of urinary incontinence were significantly decreased in the patients that had reached pelvic floor muscle strength of grade 5 and continued the pelvic floor muscle training (P<0.05). The study demonstrated that pelvic floor muscle training is effective in reducing the symptoms of stress and mixed urinary incontinence and in increasing pelvic floor muscle strength. © The Author(s) 2014.

  3. Improving Decision Making for Feeding Options in Advanced Dementia: A Randomized, Controlled Trial

    PubMed Central

    Hanson, Laura C.; Carey, Timothy S.; Caprio, Anthony J.; Lee, Tae Joon; Ersek, Mary; Garrett, Joanne; Jackman, Anne; Gilliam, Robin; Wessell, Kathryn; Mitchell, Susan L.

    2011-01-01

    Background Feeding problems are common in dementia, and decision-makers have limited understanding of treatment options. Objectives To test whether a decision aid improves quality of decision-making about feeding options in advanced dementia. Design Cluster randomized controlled trial. Setting 24 nursing homes in North Carolina Participants Residents with advanced dementia and feeding problems and their surrogates. Intervention Intervention surrogates received an audio or print decision aid on feeding options in advanced dementia. Controls received usual care. Measurements Primary outcome was the Decisional Conflict Scale (range 1–5) measured at 3 months; other main outcomes were surrogate knowledge, frequency of communication with providers, and feeding treatment use. Results 256 residents and surrogate decision-makers were recruited. Residents’ average age was 85; 67% were Caucasian and 79% were women. Surrogates’ average age was 59; 67% were Caucasian, and 70% were residents’ children. The intervention improved knowledge scores (16.8 vs 15.1, p<0.001). After 3 months, intervention surrogates had lower Decisional Conflict Scale scores than controls (1.65 vs. 1.90, p<0.001) and more often discussed feeding options with a health care provider (46% vs. 33%, p=0.04). Residents in the intervention group were more likely to receive a dysphagia diet (89% vs.76%, p=0.04), and showed a trend toward increased staff eating assistance (20% vs.10%, p=0.08). Tube feeding was rare in both groups even after 9 months (1 intervention vs. 3 control, p=0.34). Limitations Cluster randomization was necessary to avoid contamination, but limits blinding and may introduce bias by site effect. Conclusion A decision aid about feeding options in advanced dementia reduced decisional conflict for surrogates and increased their knowledge and communication about feeding options with providers. PMID:22091750

  4. Yoga versus education for Veterans with chronic low back pain: study protocol for a randomized controlled trial.

    PubMed

    Saper, Robert B; Lemaster, Chelsey M; Elwy, A Rani; Paris, Ruth; Herman, Patricia M; Plumb, Dorothy N; Sherman, Karen J; Groessl, Erik J; Lynch, Susan; Wang, Shihwe; Weinberg, Janice

    2016-04-29

    Chronic low back pain is the most frequent pain condition in Veterans and causes substantial suffering, decreased functional capacity, and lower quality of life. Symptoms of post-traumatic stress, depression, and mild traumatic brain injury are highly prevalent in Veterans with back pain. Yoga for low back pain has been demonstrated to be effective for civilians in randomized controlled trials. However, it is unknown if results from previously published trials generalize to military populations. This study is a parallel randomized controlled trial comparing yoga to education for 120 Veterans with chronic low back pain. Participants are Veterans ≥18 years old with low back pain present on at least half the days in the past six months and a self-reported average pain intensity in the previous week of ≥4 on a 0-10 scale. The 24-week study has an initial 12-week intervention period, where participants are randomized equally into (1) a standardized weekly group yoga class with home practice or (2) education delivered with a self-care book. Primary outcome measures are change at 12 weeks in low back pain intensity measured by the Defense and Veterans Pain Rating Scale (0-10) and back-related function using the 23-point Roland Morris Disability Questionnaire. In the subsequent 12-week follow-up period, yoga participants are encouraged to continue home yoga practice and education participants continue following recommendations from the book. Qualitative interviews with Veterans in the yoga group and their partners explore the impact of chronic low back pain and yoga on family relationships. We also assess cost-effectiveness from three perspectives: the Veteran, the Veterans Health Administration, and society using electronic medical records, self-reported cost data, and study records. This study will help determine if yoga can become an effective treatment for Veterans with chronic low back pain and psychological comorbidities. ClinicalTrials.gov: NCT02224183.

  5. Associations Among Parental Education, Home Environment Quality, Effortful Control, and Preacademic Knowledge

    PubMed Central

    Merz, Emily C.; Landry, Susan H.; Williams, Jeffrey M.; Barnes, Marcia A.; Eisenberg, Nancy; Spinrad, Tracy L.; Valiente, Carlos; Assel, Michael; Taylor, Heather B.; Lonigan, Christopher J.; Phillips, Beth M.; Clancy-Menchetti, Jeanine

    2014-01-01

    This study used a longitudinal design to examine whether effortful control mediated the associations of parental education and home environment quality with preacademic knowledge in toddlers and young preschoolers. The sample consisted of 226 children (2 to 4 years of age at T1) from socioeconomically disadvantaged backgrounds. Parents provided data on parent education and home environment quality. Children completed effortful control, early literacy, and early math assessments. T2 effortful control partially mediated the associations of T1 parental education and T1 home environment quality with T3 emergent literacy after accounting for child age, gender, race/ethnicity, T1 effortful control, and T2 early literacy. T2 effortful control partially mediated the association between T1 parental education and T3 emergent math after accounting for child age, gender, race/ethnicity, T1 effortful control, and T2 early math. Prior to entry into preschool, parental education and home environment quality may shape effortful control which in turn influences preacademic knowledge. PMID:25110382

  6. Right versus left atrial pacing in patients with sick sinus syndrome and paroxysmal atrial fibrillation (Riverleft study): study protocol for randomized controlled trial.

    PubMed

    Ramdjan, Tanwier T T K; van der Does, Lisette J M E; Knops, Paul; Res, Jan C J; de Groot, Natasja M S

    2014-11-17

    The incidence of sick sinus syndrome will increase due to population ageing. Consequently, this will result in an increase in the number of pacemaker implantations. The atrial lead is usually implanted in the right atrial appendage, but this position may be ineffective for prevention of atrial fibrillation. It has been suggested that pacing distally in the coronary sinus might be more successful in preventing atrial fibrillation episodes. The aim of this trial is to study the efficacy of distal coronary sinus versus right atrial appendage pacing in preventing atrial fibrillation episodes in patients with sick sinus syndrome. This study is designed as a multicenter, randomized controlled trial. Patients with sick sinus syndrome and at least one atrial fibrillation episode of 30 seconds or more in the six months before recruitment will be eligible for participation in this study.All participants will be randomized between pacing distally in the coronary sinus and right atrial appendage. Randomization is stratified for all participating centers. Conventional dual-chamber pacemakers with advanced home monitoring functionality will be implanted. The ventricular lead will be implanted in the right ventricular apex. The first three months of the 36-month follow-up period are considered as run-in time. During the pre-randomization visit and follow-up, an interview, electrocardiogram and pacemaker assessment will be performed, prescribed antiarrhythmic medication will be reviewed and patients will be asked to complete an SF-36 questionnaire. An echocardiographic examination will be conducted in the pre-randomization phase and at the end of each follow-up year. Home monitoring will be used to send daily reports in case of atrial fibrillation episodes. This randomized controlled trial is the first in which home monitoring will be used to compare atrial fibrillation recurrences between pacing in the distal coronary sinus or right atrial appendage. Home monitoring gives the

  7. Reduction in Asthma Morbidity in Children as a Result of Home Remediation Aimed at Moisture Sources

    PubMed Central

    Kercsmar, Carolyn M.; Dearborn, Dorr G.; Schluchter, Mark; Xue, Lintong; Kirchner, H. Lester; Sobolewski, John; Greenberg, Stuart J.; Vesper, Stephen J.; Allan, Terry

    2006-01-01

    Objective Home dampness and the presence of mold and allergens have been associated with asthma morbidity. We examined changes in asthma morbidity in children as a result of home remediation aimed at moisture sources. Design In this prospective, randomized controlled trial, symptomatic, asthmatic children (n = 62), 2–17 years of age, living in a home with indoor mold, received an asthma intervention including an action plan, education, and individualized problem solving. The remediation group also received household repairs, including reduction of water infiltration, removal of water-damaged building materials, and heating/ventilation/air-conditioning alterations. The control group received only home cleaning information. We measured children’s total and allergen-specific serum immuno-globulin E, peripheral blood eosinophil counts, and urinary cotinine. Environmental dust samples were analyzed for dust mite, cockroach, rodent urinary protein, endotoxin, and fungi. The follow-up period was 1 year. Results Children in both groups showed improvement in asthma symptomatic days during the preremediation portion of the study. The remediation group had a significant decrease in symptom days (p = 0.003, as randomized; p = 0.004, intent to treat) after remodeling, whereas these parameters in the control group did not significantly change. In the postremediation period, the remediation group had a lower rate of exacerbations compared with control asthmatics (as treated: 1 of 29 vs. 11 of 33, respectively, p = 0. 003; intent to treat: 28.1% and 10.0%, respectively, p = 0.11). Conclusion Construction remediation aimed at the root cause of moisture sources and combined with a medical/behavioral intervention significantly reduces symptom days and health care use for asthmatic children who live in homes with a documented mold problem. PMID:17035145

  8. Designing, testing, and implementing a sustainable nurse home visiting program: right@home.

    PubMed

    Goldfeld, Sharon; Price, Anna; Kemp, Lynn

    2018-05-01

    Nurse home visiting (NHV) offers a potential platform to both address the factors that limit access to services for families experiencing adversity and provide effective interventions. Currently, the ability to examine program implementation is hampered by a lack of detailed description of actual, rather than expected, program development and delivery in published studies. Home visiting implementation remains a black box in relation to quality and sustainability. However, previous literature would suggest that efforts to both report and improve program implementation are vital for NHV to have population impact and policy sustainability. In this paper, we provide a case study of the design, testing, and implementation of the right@home program, an Australian NHV program and randomized controlled trial. We address existing gaps related to implementation of NHV programs by describing the processes used to develop the program to be trialed, summarizing its effectiveness, and detailing the quality processes and implementation evaluation. The weight of our evidence suggests that NHV can be a powerful and sustainable platform for addressing inequitable outcomes, particularly when the program focuses on parent engagement and partnership, delivers evidence-based strategies shown to improve outcomes, includes fidelity monitoring, and is adapted to and embedded within existing service delivery systems. © 2018 The Authors. Annals of the New York Academy of Sciences published by Wiley Periodicals, Inc. on behalf of The New York Academy of Sciences.

  9. Effect of Promoting High-Quality Staff Interactions on Fall Prevention in Nursing Homes: A Cluster-Randomized Trial.

    PubMed

    Colón-Emeric, Cathleen S; Corazzini, Kirsten; McConnell, Eleanor S; Pan, Wei; Toles, Mark; Hall, Rasheeda; Cary, Michael P; Batchelor-Murphy, Melissa; Yap, Tracey; Anderson, Amber L; Burd, Andrew; Amarasekara, Sathya; Anderson, Ruth A

    2017-11-01

    New approaches are needed to enhance implementation of complex interventions for geriatric syndromes such as falls. To test whether a complexity science-based staff training intervention (CONNECT) promoting high-quality staff interactions improves the impact of an evidence-based falls quality improvement program (FALLS). Cluster-randomized trial in 24 nursing homes receiving either CONNECT followed by FALLS (intervention), or FALLS alone (control). Nursing home staff in all positions were asked to complete surveys at baseline, 3, 6, and 9 months. Medical records of residents with at least 1 fall in the 6-month pre- and postintervention windows (n = 1794) were abstracted for fall risk reduction measures, falls, and injurious falls. CONNECT taught staff to improve their connections with coworkers, increase information flow, and use cognitive diversity in problem solving. Intervention components included 2 classroom sessions, relationship mapping, and self-monitoring. FALLS provided instruction in the Agency for Healthcare Research and Quality's Falls Management Program. Primary outcomes were (1) mean number of fall risk reduction activities documented within 30 days of falls and (2) median fall rates among residents with at least 1 fall during the study period. In addition, validated scales measured staff communication quality, frequency, timeliness, and safety climate. Surveys were completed by 1545 staff members, representing 734 (37%) and 811 (44%) of eligible staff in intervention and control facilities, respectively; 511 (33%) respondents were hands-on care workers. Neither the CONNECT nor the FALLS-only facilities improved the mean count of fall risk reduction activities following FALLS (3.3 [1.6] vs 3.2 [1.5] of 10); furthermore, adjusted median recurrent fall rates did not differ between the groups (4.06 [interquartile range {IQR}, 2.03-8.11] vs 4.06 [IQR, 2.04-8.11] falls/resident/y). A modest improvement in staff communication measures was observed

  10. Economic evaluation of neonatal care packages in a cluster-randomized controlled trial in Sylhet, Bangladesh

    PubMed Central

    Shillcutt, Samuel D; Waters, Hugh R; Haider, Sabbir; El Arifeen, Shams; Mannan, Ishtiaq; Seraji, Habibur R; Shah, Rasheduzzaman; Darmstadt, Gary L; Wall, Steve N; Williams, Emma K; Black, Robert E; Santosham, Mathuram; Baqui, Abdullah H

    2013-01-01

    Abstract Objective To evaluate and compare the cost-effectiveness of two strategies for neonatal care in Sylhet division, Bangladesh. Methods In a cluster-randomized controlled trial, two strategies for neonatal care – known as home care and community care – were compared with existing services. For each study arm, economic costs were estimated from a societal perspective, inclusive of programme costs, provider costs and household out-of-pocket payments on care-seeking. Neonatal mortality in each study arm was determined through household surveys. The incremental cost-effectiveness of each strategy – compared with that of the pre-existing levels of maternal and neonatal care – was then estimated. The levels of uncertainty in our estimates were quantified through probabilistic sensitivity analysis. Findings The incremental programme costs of implementing the home-care package were 2939 (95% confidence interval, CI: 1833–7616) United States dollars (US$) per neonatal death averted and US$ 103.49 (95% CI: 64.72–265.93) per disability-adjusted life year (DALY) averted. The corresponding total societal costs were US$ 2971 (95% CI: 1844–7628) and US$ 104.62 (95% CI: 65.15–266.60), respectively. The home-care package was cost-effective – with 95% certainty – if healthy life years were valued above US$ 214 per DALY averted. In contrast, implementation of the community-care strategy led to no reduction in neonatal mortality and did not appear to be cost-effective. Conclusion The home-care package represents a highly cost-effective intervention strategy that should be considered for replication and scale-up in Bangladesh and similar settings elsewhere. PMID:24115797

  11. [Infection control and hand hygiene in nursing homes in Oslo].

    PubMed

    Sie, Ingrid; Thorstad, Margrete; Andersen, Bjørg Marit

    2008-06-26

    Nosocomial infections and transmission can be substantially reduced by good infection control. The laws and regulations for infection control in heath care institutions emphasize establishment of infection control programs and improved hand hygiene. Our study reviews some factors that are important for practicing adequate hand hygiene (knowledge about infection control and hand-washing facilities). Health care workers (HCW) in nursing homes in Oslo participated in this study in 2006-2007. A questionnaire was made and SPSS was used to analyse the data . 70.7% of 324 HCW (in 42 nursing homes) answered the questionnaires. Nearly all of the respondents (95.6%) knew about the written procedures for hygiene and infection control; 88.5% knew that an infection control program was in place and about 50% had received information through internal education. Three of four had read the National guidelines for hand hygiene, 77.5% thought that hand disinfection was more effective than hand washing, and 97% reported hand hygiene after contact with a patient having an infection. Dispensers for hand disinfection were situated at central work places. At the same time, 17.9% informed that they worked in more than one place at the same time. This study confirms that most nursing homes in Oslo have an infection control program and training that improves the knowledge and awareness of hand hygiene among HCWs. However, the fact that nursing homes in Oslo have the resources, knowledge and education, is not the same as compliance.

  12. 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

  13. 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.

  14. A systematic review of randomized controlled trials of interventions designed to decrease child abuse in high-risk families.

    PubMed

    Levey, Elizabeth J; Gelaye, Bizu; Bain, Paul; Rondon, Marta B; Borba, Christina P C; Henderson, David C; Williams, Michelle A

    2017-03-01

    Child abuse is a global problem, and parents with histories of childhood abuse are at increased risk of abusing their offspring. The objective of this systematic review is to provide a clear overview of the existing literature of randomized controlled trials evaluating the effectiveness of interventions to prevent child abuse. PubMed, PsychINFO, Web of Science, Sociological Abstracts, and CINAHL were systematically searched and expanded by hand search. This review includes all randomized controlled trials (RCTs) of interventions designed to prevent abuse among mothers identified as high-risk. Of the eight studies identified, only three found statistically significant reductions in abuse by any measure, and only two found reductions in incidents reported to child protective services. While much has been written about child abuse in high-risk families, few RCTs have been performed. Only home visitation has a significant evidence base for reducing child abuse, and the findings vary considerably. Also, data from low- and middle-income countries are limited. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  15. Randomized Controlled Trial of Primary Care Pediatric Parenting Programs

    PubMed Central

    Mendelsohn, Alan L.; Dreyer, Benard P.; Brockmeyer, Carolyn A.; Berkule-Silberman, Samantha B.; Huberman, Harris S.; Tomopoulos, Suzy

    2011-01-01

    Objectives To determine whether pediatric primary care–based programs to enhance parenting and early child development reduce media exposure and whether enhanced parenting mediates the effects. Design Randomized controlled trial. Setting Urban public hospital pediatric primary care clinic. Participants A total of 410 mother-newborn dyads enrolled after childbirth. Interventions Patients were randomly assigned to 1 of 2 interventions, the Video Interaction Project (VIP) and Building Blocks (BB) interventions, or to a control group. The VIP intervention comprised 1-on-1 sessions with a child development specialist who facilitated interactions in play and shared reading through review of videotapes made of the parent and child on primary care visit days; learning materials and parenting pamphlets were also provided. The BB intervention mailed parenting materials, including age-specific newsletters suggesting activities to facilitate interactions, learning materials, and parent-completed developmental questionnaires (Ages and Stages questionnaires). Outcome Measures Electronic media exposure in the home using a 24-hour recall diary. Results The mean (SD) exposure at 6 months was 146.5 (125.0) min/d. Exposure to VIP was associated with reduced total duration of media exposure compared with the BB and control groups (mean [SD] min/d for VIP, 131.6 [118.7]; BB, 151.2 [116.7]; control, 155.4 [138.7]; P=.009). Enhanced parent-child interactions were found to partially mediate relations between VIP and media exposure for families with a ninth grade or higher literacy level (Sobel statistic=2.49; P=.01). Conclusion Pediatric primary care may represent an important venue for addressing the public health problem of media exposure in young children at a population level. Trial Registration clinicaltrials.gov Identifier: NCT00212576 PMID:21199979

  16. Economic evaluation of occupational therapy in Parkinson's disease: A randomized controlled trial.

    PubMed

    Sturkenboom, Ingrid H W M; Hendriks, Jan C M; Graff, Maud J L; Adang, Eddy M M; Munneke, Marten; Nijhuis-van der Sanden, Maria W G; Bloem, Bastiaan R

    2015-07-01

    A large randomized clinical trial (the Occupational Therapy in Parkinson's Disease [OTiP] study) recently demonstrated that home-based occupational therapy improves perceived performance in daily activities of people with Parkinson's disease (PD). The aim of the current study was to evaluate the cost-effectiveness of this intervention. We performed an economic evaluation over a 6-month period for both arms of the OTiP study. Participants were 191 community-dwelling PD patients and 180 primary caregivers. The intervention group (n = 124 patients) received 10 weeks of home-based occupational therapy; the control group (n = 67 patients) received usual care (no occupational therapy). Costs were assessed from a societal perspective including healthcare use, absence from work, informal care, and intervention costs. Health utilities were evaluated using EuroQol-5d. We estimated cost differences and cost utility using linear mixed models and presented the net monetary benefit at different values for willingness to pay per quality-adjusted life-year gained. In our primary analysis, we excluded informal care hours because of substantial missing data for this item. The estimated mean total costs for the intervention group compared with controls were €125 lower for patients, €29 lower for caregivers, and €122 higher for patient-caregiver pairs (differences not significant). At a value of €40,000 per quality-adjusted life-year gained (reported threshold for PD), the net monetary benefit of the intervention per patient was €305 (P = 0.74), per caregiver €866 (P = 0.01) and per patient-caregiver pair €845 (P = 0.24). In conclusion, occupational therapy did not significantly impact on total costs compared with usual care. Positive cost-effectiveness of the intervention was only significant for caregivers. © 2015 International Parkinson and Movement Disorder Society.

  17. A cluster-randomized, placebo-controlled, maternal vitamin a or beta-carotene supplementation trial in bangladesh: design and methods

    PubMed Central

    2011-01-01

    Background We present the design, methods and population characteristics of a large community trial that assessed the efficacy of a weekly supplement containing vitamin A or beta-carotene, at recommended dietary levels, in reducing maternal mortality from early gestation through 12 weeks postpartum. We identify challenges faced and report solutions in implementing an intervention trial under low-resource, rural conditions, including the importance of population choice in promoting generalizability, maintaining rigorous data quality control to reduce inter- and intra- worker variation, and optimizing efficiencies in information and resources flow from and to the field. Methods This trial was a double-masked, cluster-randomized, dual intervention, placebo-controlled trial in a contiguous rural area of ~435 sq km with a population of ~650,000 in Gaibandha and Rangpur Districts of Northwestern Bangladesh. Approximately 120,000 married women of reproductive age underwent 5-weekly home surveillance, of whom ~60,000 were detected as pregnant, enrolled into the trial and gave birth to ~44,000 live-born infants. Upon enrollment, at ~ 9 weeks' gestation, pregnant women received a weekly oral supplement containing vitamin A (7000 ug retinol equivalents (RE)), beta-carotene (42 mg, or ~7000 ug RE) or a placebo through 12 weeks postpartum, according to prior randomized allocation of their cluster of residence. Systems described include enlistment and 5-weekly home surveillance for pregnancy based on menstrual history and urine testing, weekly supervised supplementation, periodic risk factor interviews, maternal and infant vital outcome monitoring, birth defect surveillance and clinical/biochemical substudies. Results The primary outcome was pregnancy-related mortality assessed for 3 months following parturition. Secondary outcomes included fetal loss due to miscarriage or stillbirth, infant mortality under three months of age, maternal obstetric and infectious morbidity, infant

  18. A cluster-randomized, placebo-controlled, maternal vitamin A or beta-carotene supplementation trial in Bangladesh: design and methods.

    PubMed

    Labrique, Alain B; Christian, Parul; Klemm, Rolf D W; Rashid, Mahbubur; Shamim, Abu Ahmed; Massie, Allan; Schulze, Kerry; Hackman, Andre; West, Keith P

    2011-04-21

    We present the design, methods and population characteristics of a large community trial that assessed the efficacy of a weekly supplement containing vitamin A or beta-carotene, at recommended dietary levels, in reducing maternal mortality from early gestation through 12 weeks postpartum. We identify challenges faced and report solutions in implementing an intervention trial under low-resource, rural conditions, including the importance of population choice in promoting generalizability, maintaining rigorous data quality control to reduce inter- and intra- worker variation, and optimizing efficiencies in information and resources flow from and to the field. This trial was a double-masked, cluster-randomized, dual intervention, placebo-controlled trial in a contiguous rural area of ~435 sq km with a population of ~650,000 in Gaibandha and Rangpur Districts of Northwestern Bangladesh. Approximately 120,000 married women of reproductive age underwent 5-weekly home surveillance, of whom ~60,000 were detected as pregnant, enrolled into the trial and gave birth to ~44,000 live-born infants. Upon enrollment, at ~ 9 weeks' gestation, pregnant women received a weekly oral supplement containing vitamin A (7000 ug retinol equivalents (RE)), beta-carotene (42 mg, or ~7000 ug RE) or a placebo through 12 weeks postpartum, according to prior randomized allocation of their cluster of residence. Systems described include enlistment and 5-weekly home surveillance for pregnancy based on menstrual history and urine testing, weekly supervised supplementation, periodic risk factor interviews, maternal and infant vital outcome monitoring, birth defect surveillance and clinical/biochemical substudies. The primary outcome was pregnancy-related mortality assessed for 3 months following parturition. Secondary outcomes included fetal loss due to miscarriage or stillbirth, infant mortality under three months of age, maternal obstetric and infectious morbidity, infant infectious morbidity

  19. A randomized controlled trial of an intervention program to Brazilian mothers who use corporal punishment.

    PubMed

    Santini, Paolla Magioni; Williams, Lucia C A

    2017-09-01

    This study evaluated a positive parenting program to Brazilian mothers who used corporal punishment with their children. The intervention was conducted in four agencies serving vulnerable children, and at a home replica laboratory at the University. Mothers who admitted using corporal punishment were randomly assigned between experimental (n=20) and control group (n=20). The program consisted of 12 individual sessions using one unit from Projeto Parceria (Partnership Project), with specific guidelines and materials on positive parenting, followed by observational sessions of mother-child interaction with live coaching and a video feedback session in the lab. The study used an equivalent group experimental design with pre/post-test and follow-up, in randomized controlled trials. Measures involved: Initial Interview; Strengths and Difficulties Questionnaire (SDQ) - parent and child versions; Beck Depression Inventory (BDI); observational sessions with a protocol; and a Program Evaluation by participants. Analysis of mixed models for repeated measures revealed significant positive effects on the BDI and SDQ total scores, as well as less Conduct problems and Hyperactivity in SDQ measures from the experimental group mothers, comparing pre with post-test. Observational data also indicated significant improvement in positive interaction from the experimental group mothers at post-test, in comparison with controls. No significant results were found, however, in children's observational measures. Limitations of the study involved using a restricted sample, among others. Implications for future research are suggested. Copyright © 2017 Elsevier Ltd. All rights reserved.

  20. The impact of occupational therapy in Parkinson's disease: a randomized controlled feasibility study.

    PubMed

    Sturkenboom, Ingrid H; Graff, Maud J; Borm, George F; Veenhuizen, Yvonne; Bloem, Bastiaan R; Munneke, Marten; Nijhuis-van der Sanden, Maria W

    2013-02-01

    To evaluate the feasibility of a randomized controlled trial including process and potential impact of occupational therapy in Parkinson's disease. Process and outcome were quantitatively and qualitatively evaluated in an exploratory multicentre, two-armed randomized controlled trial at three months. Forty-three community-dwelling patients with Parkinson's disease and difficulties in daily activities, their primary caregivers and seven occupational therapists. Ten weeks of home-based occupational therapy according to the Dutch guidelines of occupational therapy in Parkinson's disease versus no occupational therapy in the control group. Process evaluation measured accrual, drop-out, intervention delivery and protocol adherence. Primary outcome measures of patients assessed daily functioning: Canadian Occupational Performance Measure (COPM) and Assessment of Motor and Process Skills. Primary outcome for caregivers was caregiver burden: Zarit Burden Inventory. Participants' perspectives of the intervention were explored using questionnaires and in-depth interviews. Inclusion was 23% (43/189), drop-out 7% (3/43) and unblinding of assessors 33% (13/40). Full intervention protocol adherence was 74% (20/27), but only 60% (71/119) of baseline Canadian Occupational Performance Measure priorities were addressed in the intervention. The outcome measures revealed negligible to small effects in favour of the intervention group. Almost all patients and caregivers of the intervention group were satisfied with the results. They perceived: 'more grip on the situation' and used 'practical advices that make life easier'. Therapists were satisfied, but wished for a longer intervention period. The positive perceived impact of occupational therapy warrants a large-scale trial. Adaptations in instructions and training are needed to use the Canadian Occupational Performance Measure as primary outcome measure.

  1. 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

  2. [Results of a physical therapy program in nursing home residents: A randomized clinical trial].

    PubMed

    Casilda-López, Jesús; Torres-Sánchez, Irene; Garzón-Moreno, Victor Manuel; Cabrera-Martos, Irene; Valenza, Marie Carmen

    2015-01-01

    The maintenance of the physical functionality is a key factor in the care of the elderly. Inactive people have a higher risk of death due to diseases associated with inactivity. In addition, the maintenance of optimal levels of physical and mental activity has been suggested as a protective factor against the development and progression of chronic illnesses and disability. The objective of this study is to assess the effectiveness of an 8-week exercise program with elastic bands, on exercise capacity, walking and balance in nursing home residents. A nursing home sample was divided into two groups, intervention group (n=26) and control group (n=25). The intervention group was included in an 8-week physical activity program using elastic bands, twice a week, while the control group was took part in a walking programme. Outcome measurements were descriptive variables (anthropometric characteristics, quality of life, fatigue, fear of movement) and fundamental variables (exercise capacity, walking and balance). A significant improvement in balance and walking speed was observed after the programme. Additionally, exercise capacity improved significantly (P≤.001), and the patients showed an improvement in perceived dyspnea after the physical activity programme in the intervention group. The exercise program was safe and effective in improving dyspnea, exercise capacity, walking, and balance in elderly. Copyright © 2014 SEGG. Published by Elsevier Espana. All rights reserved.

  3. Walking Aids Moderate Exercise Effects on Gait Speed in People With Dementia: A Randomized Controlled Trial.

    PubMed

    Toots, Annika; Littbrand, Håkan; Holmberg, Henrik; Nordström, Peter; Lundin-Olsson, Lillemor; Gustafson, Yngve; Rosendahl, Erik

    2017-03-01

    To investigate the effects of exercise on gait speed, when tested using walking aids and without, and whether effects differed according to amount of support in the test. A cluster-randomized controlled trial. The Umeå Dementia and Exercise (UMDEX) study was set in 16 nursing homes in Umeå, Sweden. One hundred forty-one women and 45 men (mean age 85 years) with dementia, of whom 145 (78%) habitually used walking aids. Participants were randomized to the high-intensity functional exercise program or a seated attention control activity. Blinded assessors measured 4-m usual gait speed with walking aids if any gait speed (GS), and without walking aids and with minimum amount of support, at baseline, 4 months (on intervention completion), and 7 months. Linear mixed models showed no between-group effect in either gait speed test at 4 or 7 months. In interaction analyses exercise effects differed significantly between participants who walked unsupported compared with when walking aids or minimum support was used. Positive between-group exercise effects on gait speed (m/s) were found in subgroups that walked unsupported at 4 and 7 months (GS: 0.07, P = .009 and 0.13, P < .001; and GS test without walking aids: 0.05, P = .011 and 0.07, P = .029, respectively). In people with dementia living in nursing homes exercise had positive effects on gait when tested unsupported compared with when walking aids or minimum support was used. The study suggests that the use of walking aids in gait speed tests may conceal exercise effects. Copyright © 2016 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

  4. Effectiveness of horticultural therapy: a systematic review of randomized controlled trials.

    PubMed

    Kamioka, Hiroharu; Tsutani, Kiichiro; Yamada, Minoru; Park, Hyuntae; Okuizumi, Hiroyasu; Honda, Takuya; Okada, Shinpei; Park, Sang-Jun; Kitayuguchi, Jun; Abe, Takafumi; Handa, Shuichi; Mutoh, Yoshiteru

    2014-10-01

    To summarize the evidence from randomized controlled trials (RCTs) on the effects of horticultural therapy (HT). Studies were eligible if they were RCTs. Studies included one treatment group in which HT was applied. We searched the following databases from 1990 up to August 20, 2013: MEDLINE via PubMed, CINAHL, Web of Science, Ichushi-Web, GHL, WPRIM, and PsyclNFO. We also searched all Cochrane Database and Campbell Systematic Reviews up to September 20, 2013. Four studies met all inclusion criteria. The language of all eligible publications was English and Korean. Target diseases and/or symptoms were dementia, severe mental illness such as schizophrenia, bipolar disorder, and major depression, frail elderly in nursing home, and hemiplegic patients after stroke. These studies showed significant effectiveness in one or more outcomes for mental health and behavior. However, our review especially detected omissions of the following descriptions: method used to generate randomization, concealment, blinding, and intention-to-treat analysis. In addition, the results of this study suggested that the RCTs conducted have been of relatively low quality. Although there was insufficient evidence in the studies of HT due to poor methodological and reporting quality and heterogeneity, HT may be an effective treatment for mental and behavioral disorders such as dementia, schizophrenia, depression, and terminal-care for cancer. Copyright © 2014 Elsevier Ltd. All rights reserved.

  5. Caring for the Elderly at Work and Home: Can a Randomized Organizational Intervention Improve Psychological Health?

    PubMed

    Kossek, Ellen Ernst; Thompson, Rebecca J; Lawson, Katie M; Bodner, Todd; Perrigino, Matthew B; Hammer, Leslie B; Buxton, Orfeu M; Almeida, David M; Moen, Phyllis; Hurtado, David A; Wipfli, Brad; Berkman, Lisa F; Bray, Jeremy W

    2017-12-07

    Although job stress models suggest that changing the work social environment to increase job resources improves psychological health, many intervention studies have weak designs and overlook influences of family caregiving demands. We tested the effects of an organizational intervention designed to increase supervisor social support for work and nonwork roles, and job control in a results-oriented work environment on the stress and psychological distress of health care employees who care for the elderly, while simultaneously considering their own family caregiving responsibilities. Using a group-randomized organizational field trial with an intent-to-treat design, 420 caregivers in 15 intervention extended-care nursing facilities were compared with 511 caregivers in 15 control facilities at 4 measurement times: preintervention and 6, 12, and 18 months. There were no main intervention effects showing improvements in stress and psychological distress when comparing intervention with control sites. Moderation analyses indicate that the intervention was more effective in reducing stress and psychological distress for caregivers who were also caring for other family members off the job (those with elders and those "sandwiched" with both child and elder caregiving responsibilities) compared with employees without caregiving demands. These findings extend previous studies by showing that the effect of organizational interventions designed to increase job resources to improve psychological health varies according to differences in nonwork caregiving demands. This research suggests that caregivers, especially those with "double-duty" elder caregiving at home and work and "triple-duty" responsibilities, including child care, may benefit from interventions designed to increase work-nonwork social support and job control. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  6. The "at-home LLLT" in temporo-mandibular disorders pain control: a pilot study.

    PubMed

    Fornaini, C; Pelosi, A; Queirolo, V; Vescovi, P; Merigo, E

    2015-03-31

    The Temporo-Mandibular Disorders (TMD) are a set of dysfunctional patterns concerning the temporo-mandibular joints (TMJ) and the masticatory muscles; its main symptom is pain, probably caused by inflammatory changes in the synovial membrane, alterations in the bone marrow of the mandibular condyle and impingement and compression. The aim of this preliminary study was to investigate the effectiveness in the TMD pain reduction of a new laser device recently proposed by the commerce that, due to its reduced dimensions and to be a class I laser according the ANSI classification, may be used at home by the patient himself. Twenty-four patients with TMD were randomly selected: the inclusion criteria for the sample was the diagnosis of mono- or bi-lateral TMD, with acute pain restricted to the joint area, associated with the absence of any muscle tenderness during palpation. The patients were randomly assigned to two groups: Group 1 (12 patients): patients receiving real LLLT (experimental group). Group 2 (12 patients): patients receiving inactive laser (placebo group). The treatment was performed once a day for two weeks with an 808 nm diode laser by the patient himself with irradiation of the cutaneous zone corresponding to the TMJ for 15 minutes each side. Each patient was instructed to express its pain in a visual analogue scale (VAS) making a perpendicular line between the two extremes representing the felt pain level. Statistical analysis was realized with GraphPad Instat Software, where P<0.05 was considered significant and P<0.01 very significant. The patient's pain evaluation was expressed in the two study groups before the treatment, 1 week and two weeks after the treatment. The differences between the two groups result extremely significant with p<0.0001 for the comparison of VAS value after 1 and 2 weeks. This study, even if it may be considered such a pilot study, investigated a new way to control the pain in the temporo-mandibular diseases by an at home

  7. Effects of a social accountability approach, CARE's Community Score Card, on reproductive health-related outcomes in Malawi: A cluster-randomized controlled evaluation.

    PubMed

    Gullo, Sara; Galavotti, Christine; Sebert Kuhlmann, Anne; Msiska, Thumbiko; Hastings, Phil; Marti, C Nathan

    2017-01-01

    Social accountability approaches, which emphasize mutual responsibility and accountability by community members, health care workers, and local health officials for improving health outcomes in the community, are increasingly being employed in low-resource settings. We evaluated the effects of a social accountability approach, CARE's Community Score Card (CSC), on reproductive health outcomes in Ntcheu district, Malawi using a cluster-randomized control design. We matched 10 pairs of communities, randomly assigning one from each pair to intervention and control arms. We conducted two independent cross-sectional surveys of women who had given birth in the last 12 months, at baseline and at two years post-baseline. Using difference-in-difference (DiD) and local average treatment effect (LATE) estimates, we evaluated the effects on outcomes including modern contraceptive use, antenatal and postnatal care service utilization, and service satisfaction. We also evaluated changes in indicators developed by community members and service providers in the intervention areas. DiD analyses showed significantly greater improvements in the proportion of women receiving a home visit during pregnancy (B = 0.20, P < .01), receiving a postnatal visit (B = 0.06, P = .01), and overall service satisfaction (B = 0.16, P < .001) in intervention compared to control areas. LATE analyses estimated significant effects of the CSC intervention on home visits by health workers (114% higher in intervention compared to control) (B = 1.14, P < .001) and current use of modern contraceptives (57% higher) (B = 0.57, P < .01). All 13 community- and provider-developed indicators improved, with 6 of them showing significant improvements. By facilitating the relationship between community members, health service providers, and local government officials, the CSC contributed to important improvements in reproductive health-related outcomes. Further, the CSC builds mutual accountability, and ensures that

  8. Deep breathing exercises performed 2 months following cardiac surgery: a randomized controlled trial.

    PubMed

    Westerdahl, Elisabeth; Urell, Charlotte; Jonsson, Marcus; Bryngelsson, Ing-Liss; Hedenström, Hans; Emtner, Margareta

    2014-01-01

    Postoperative breathing exercises are recommended to cardiac surgery patients. Instructions concerning how long patients should continue exercises after discharge vary, and the significance of treatment needs to be determined. Our aim was to assess the effects of home-based deep breathing exercises performed with a positive expiratory pressure device for 2 months following cardiac surgery. The study design was a prospective, single-blinded, parallel-group, randomized trial. Patients performing breathing exercises 2 months after cardiac surgery (n = 159) were compared with a control group (n = 154) performing no breathing exercises after discharge. The intervention consisted of 30 slow deep breaths performed with a positive expiratory pressure device (10-15 cm H2O), 5 times a day, during the first 2 months after surgery. The outcomes were lung function measurements, oxygen saturation, thoracic excursion mobility, subjective perception of breathing and pain, patient-perceived quality of recovery (40-Item Quality of Recovery score), health-related quality of life (36-Item Short Form Health Survey), and self-reported respiratory tract infection/pneumonia and antibiotic treatment. Two months postoperatively, the patients had significantly reduced lung function, with a mean decrease in forced expiratory volume in 1 second to 93 ± 12% (P< .001) of preoperative values. Oxygenation had returned to preoperative values, and 5 of 8 aspects in the 36-Item Short Form Health Survey were improved compared with preoperative values (P< .01). There were no significant differences between the groups in any of the measured outcomes. No significant differences in lung function, subjective perceptions, or quality of life were found between patients performing home-based deep breathing exercises and control patients 2 months after cardiac surgery.

  9. Family, Community and Clinic Collaboration to Treat Overweight and Obese Children: Stanford GOALS -- a Randomized Controlled Trial of a Three-Year, Multi-Component, Multi-Level, Multi-Setting Intervention

    PubMed Central

    Robinson, Thomas N.; Matheson, Donna; Desai, Manisha; Wilson, Darrell M.; Weintraub, Dana L.; Haskell, William L.; McClain, Arianna; McClure, Samuel; Banda, Jorge; Sanders, Lee M.; Haydel, K. Farish; Killen, Joel D.

    2013-01-01

    Objective To test the effects of a three-year, community-based, multi-component, multi-level, multi-setting (MMM) approach for treating overweight and obese children. Design Two-arm, parallel group, randomized controlled trial with measures at baseline, 12, 24, and 36 months after randomization. Participants Seven through eleven year old, overweight and obese children (BMI ≥ 85th percentile) and their parents/caregivers recruited from community locations in low-income, primarily Latino neighborhoods in Northern California. Interventions Families are randomized to the MMM intervention versus a community health education active-placebo comparison intervention. Interventions last for three years for each participant. The MMM intervention includes a community-based after school team sports program designed specifically for overweight and obese children, a home-based family intervention to reduce screen time, alter the home food/eating environment, and promote self-regulatory skills for eating and activity behavior change, and a primary care behavioral counseling intervention linked to the community and home interventions. The active-placebo comparison intervention includes semi-annual health education home visits, monthly health education newsletters for children and for parents/guardians, and a series of community-based health education events for families. Main Outcome Measure Body mass index trajectory over the three-year study. Secondary outcome measures include waist circumference, triceps skinfold thickness, accelerometer-measured physical activity, 24-hour dietary recalls, screen time and other sedentary behaviors, blood pressure, fasting lipids, glucose, insulin, hemoglobin A1c, C-reactive protein, alanine aminotransferase, and psychosocial measures. Conclusions The Stanford GOALS trial is testing the efficacy of a novel community-based multi-component, multi-level, multi-setting treatment for childhood overweight and obesity in low-income, Latino families

  10. Family, community and clinic collaboration to treat overweight and obese children: Stanford GOALS-A randomized controlled trial of a three-year, multi-component, multi-level, multi-setting intervention.

    PubMed

    Robinson, Thomas N; Matheson, Donna; Desai, Manisha; Wilson, Darrell M; Weintraub, Dana L; Haskell, William L; McClain, Arianna; McClure, Samuel; Banda, Jorge A; Sanders, Lee M; Haydel, K Farish; Killen, Joel D

    2013-11-01

    To test the effects of a three-year, community-based, multi-component, multi-level, multi-setting (MMM) approach for treating overweight and obese children. Two-arm, parallel group, randomized controlled trial with measures at baseline, 12, 24, and 36 months after randomization. Seven through eleven year old, overweight and obese children (BMI ≥ 85th percentile) and their parents/caregivers recruited from community locations in low-income, primarily Latino neighborhoods in Northern California. Families are randomized to the MMM intervention versus a community health education active-placebo comparison intervention. Interventions last for three years for each participant. The MMM intervention includes a community-based after school team sports program designed specifically for overweight and obese children, a home-based family intervention to reduce screen time, alter the home food/eating environment, and promote self-regulatory skills for eating and activity behavior change, and a primary care behavioral counseling intervention linked to the community and home interventions. The active-placebo comparison intervention includes semi-annual health education home visits, monthly health education newsletters for children and for parents/guardians, and a series of community-based health education events for families. Body mass index trajectory over the three-year study. Secondary outcome measures include waist circumference, triceps skinfold thickness, accelerometer-measured physical activity, 24-hour dietary recalls, screen time and other sedentary behaviors, blood pressure, fasting lipids, glucose, insulin, hemoglobin A1c, C-reactive protein, alanine aminotransferase, and psychosocial measures. The Stanford GOALS trial is testing the efficacy of a novel community-based multi-component, multi-level, multi-setting treatment for childhood overweight and obesity in low-income, Latino families. © 2013 Elsevier Inc. All rights reserved.

  11. Recent advances in environmental controls outside the home setting.

    PubMed

    Hauptman, Marissa; Phipatanakul, Wanda

    2016-04-01

    It has been well studied that aeroallergen, mold, and airborne pollutant exposure in the inner-city home environment is associated with significant childhood asthma morbidity. Although the home environment has been extensively studied, the school environment is less well understood. In this article, we discuss the relationship between environmental exposures within the school and daycare environment and pediatric asthma morbidity and novel environmental interventions designed to help mitigate pediatric asthma morbidity. Studies assessing environmental exposures outside the home environment and interventions to mitigate these exposures have the potential to reduce pediatric asthma morbidity. Further study in this area should focus on the complex cost benefit analyses of environmental interventions outside the home setting, while controlling for the home environment.

  12. An IBeacon-Based Location System for Smart Home Control.

    PubMed

    Liu, Qinghe; Yang, Xinshuang; Deng, Lizhen

    2018-06-11

    Indoor location and intelligent control system can bring convenience to people’s daily life. In this paper, an indoor control system is designed to achieve equipment remote control by using low-energy Bluetooth (BLE) beacon and Internet of Things (IoT) technology. The proposed system consists of five parts: web server, home gateway, smart terminal, smartphone app and BLE beacons. In the web server, fingerprint matching based on RSSI stochastic characteristic and posture recognition model based on geomagnetic sensing are used to establish a more efficient equipment control system, combined with Pedestrian Dead Reckoning (PDR) technology to improve the accuracy of location. A personalized menu of remote “one-click” control is finally offered to users in a smartphone app. This smart home control system has been implemented by hardware, and precision and stability tests have been conducted, which proved the practicability and good user experience of this solution.

  13. Integrating Depression Care Management into Medicare Home Health Reduces Risk of 30 and 60 Day Hospitalization: The Depression CAREPATH Cluster-Randomized Trial

    PubMed Central

    Bruce, Martha L.; Lohman, Matthew C.; Greenberg, Rebecca L.; Bao, Yuhua; Raue, Patrick J.

    2016-01-01

    OBJECTIVES To determine whether a depression care management intervention among Medicare home health recipients decreases risks of hospitalization. DESIGN Cluster-randomized trial. Nurse teams were randomized to Intervention (12 teams) or Enhanced Usual Care (EUC; 9 teams). SETTING Six home health agencies from distinct geographic regions. Patients were interviewed at home and by telephone. PARTICIPANTS Patients age>65 who screened positive for depression on nurse assessments (N=755), and a subset who consented to interviews (N=306). INTERVENTION The Depression CAREPATH (CARE for PATients at Home) guides nurses in managing depression during routine home visits. Clinical functions include weekly symptom assessment, medication management, care coordination, patient education, and goal setting. Researchers conducted biweekly telephone conferences with team supervisors. MEASUREMENTS The study examined acute-care hospitalization and days to hospitalization. H1 used data from the home health record to examine hospitalization over 30-day and 60-day periods while a home health patient. H2 used data from both home care record and research assessments to examine 30-day hospitalization from any setting. RESULTS The adjusted hazard ratio (HR) of being admitted to hospital directly from home health within 30 days of start of home health care was 0.65 (p=.013) for CAREPATH compared to EUC patients, and 0.72 (p=.027) within 60 days. In patients referred to home health directly from hospital, the relative hazard of being rehospitalized was approximately 55% lower (HR = 0.45, p=.001) among CAREPATH patients. CONCLUSION Integrating CAREPATH depression care management into routine nursing practice reduces hospitalization and rehospitalization risk among older adults receiving Medicare home health nursing services. PMID:27739067

  14. ADULTS: A RANDOMIZED CONTROLLED CLINICAL TRIAL

    PubMed Central

    Shah, Krupa N.; Majeed, Zahraa; Yoruk, Yilmaz B.; Yang, Hongmei; Hilton, Tiffany N.; McMahon, James M.; Hall, William J.; Walck, Donna; Luque, Amneris E.; Ryan, Richard M.

    2016-01-01

    Objective HIV-infected older adults (HOA) are at risk of functional decline. Interventions promoting physical activity that can attenuate functional decline and are easily translated into the HOA community are of high priority. We conducted a randomized, controlled clinical trial to evaluate whether a physical activity counseling intervention based on self-determination theory (SDT) improves physical function, autonomous motivation, depression and the quality of life (QOL) in HOA. Methods A total of 67 community-dwelling HOA with mild-to-moderate functional limitations were randomized to one of two groups: a physical activity counseling group or the usual care control group. We used SDT to guide the development of the experimental intervention. Outcome measures that were collected at baseline and final study visits included a battery of physical function tests, levels of physical activity, autonomous motivation, depression, and QOL. Results The study participants were similar in their demographic and clinical characteristics in both the treatment and control groups. Overall physical performance, gait speed, measures of endurance and strength, and levels of physical activity improved in the treatment group compared to the control group (p<0.05). Measures of autonomous regulation such as identified regulation, and measures of depression and QOL improved significantly in the treatment group compared to the control group (p<0.05). Across the groups, improvement in intrinsic regulation and QOL correlated with an improvement in physical function (p<0.05). Conclusion Our findings suggest that a physical activity counseling program grounded in SDT can improve physical function, autonomous motivation, depression, and QOL in HOA with functional limitations. PMID:26867045

  15. Effects of home-based exercise on pre-dialysis chronic kidney disease patients: a randomized pilot and feasibility trial.

    PubMed

    Hiraki, Koji; Shibagaki, Yugo; Izawa, Kazuhiro P; Hotta, Chiharu; Wakamiya, Akiko; Sakurada, Tsutomu; Yasuda, Takashi; Kimura, Kenjiro

    2017-06-17

    Only a few research is available on the effects of home-based exercise training on pre-dialysis chronic kidney disease (CKD) patients. Therefore, we aimed to elucidate the effect of home-based exercise therapy on kidney function and arm and leg muscle strength in pre-dialysis CKD patients. Thirty-six male stage 3-4 pre-dialysis CKD patients (age, 68.7 ± 6.8 years; estimated glomerular filtration rate (eGFR), 39.0 ± 11.6 ml/min/1.73 m 2 ) who were being treated as outpatients were included. The subjects were randomly assigned to an exercise intervention group (Ex group: 18) and a control group (C group: 18). The Ex group wore accelerometer pedometers and were instructed to perform home-based aerobic and resistance exercises, such as brisk walking for 30 min per day, for 12 months. The C group subjects wore accelerometer pedometers but received no exercise therapy guidance; the number of steps covered during normal daily activities was recorded for the C group. The outcome measures were changes in kidney function and handgrip and knee extension muscle strength. Values at the baseline (T1) and 12 months later (T2) were compared. There were no significant differences in baseline characteristics between the two groups; however, the C group was more physically active than the Ex group. Eight subjects dropped out, and 28 subjects (14 in each group) were included in the final analysis. Physical activity increased significantly only in the Ex group. Grip strength (F = 7.0, p = 0.01) and knee extension muscle strength (F = 14.3, p < 0.01) were found to improve only in the Ex group. Further, the changes in eGFR were not significantly different between the two groups (F = 0.01, p = 0.93). Home-based exercise therapy for pre-dialysis CKD patients was feasible and improved arm and leg muscle strength without affecting kidney function. UMIN Clinical Trials Registry ( UMIN000005091 ). Registered 2/15/2011.

  16. Clinical Effect Size of an Educational Intervention in the Home and Compliance With Mobile Phone-Based Reminders for People Who Suffer From Stroke: Protocol of a Randomized Controlled Trial

    PubMed Central

    Merchán-Baeza, Jose Antonio

    2015-01-01

    Background Stroke is the third-leading cause of death and the leading cause of long-term neurological disability in the world. Cognitive, communication, and physical weakness combined with environmental changes frequently cause changes in the roles, routines, and daily occupations of stroke sufferers. Educational intervention combines didactic and interactive intervention, which combines the best choices for teaching new behaviors since it involves the active participation of the patient in learning. Nowadays, there are many types of interventions or means to increase adherence to treatment. Objective The aim of this study is to enable patients who have suffered stroke and been discharged to their homes to improve the performance of the activities of daily living (ADL) in their home environment, based on advice given by the therapist. A secondary aim is that these patients continue the treatment through a reminder app installed on their mobile phones. Methods This study is a clinical randomized controlled trial. The total sample will consist of 80 adults who have suffered a stroke with moderate severity and who have been discharged to their homes in the 3 months prior to recruitment to the study. The following tests and scales will be used to measure the outcome variables: Barthel Index, the Functional Independence Measure, the Mini-Mental State Examination, the Canadian Neurological Scale, the Stroke Impact Scale-16, the Trunk Control Test, the Modified Rankin Scale, the Multidimensional Scale of Perceived Social Support, the Quality of Life Scale for Stroke, the Functional Reach Test, the Romberg Test, the Time Up and Go test, the Timed-Stands Test, a portable dynamometer, and a sociodemographic questionnaire. Descriptive analyses will include mean, standard deviation, and 95% confidence intervals of the values for each variable. The Kolmogov-Smirnov (KS) test and a 2x2 mixed-model analysis of variance (ANOVA) will be used. Intergroup effect sizes will be

  17. Clinical effect size of an educational intervention in the home and compliance with mobile phone-based reminders for people who suffer from stroke: protocol of a randomized controlled trial.

    PubMed

    Merchán-Baeza, Jose Antonio; Gonzalez-Sanchez, Manuel; Cuesta-Vargas, Antonio

    2015-03-10

    Stroke is the third-leading cause of death and the leading cause of long-term neurological disability in the world. Cognitive, communication, and physical weakness combined with environmental changes frequently cause changes in the roles, routines, and daily occupations of stroke sufferers. Educational intervention combines didactic and interactive intervention, which combines the best choices for teaching new behaviors since it involves the active participation of the patient in learning. Nowadays, there are many types of interventions or means to increase adherence to treatment. The aim of this study is to enable patients who have suffered stroke and been discharged to their homes to improve the performance of the activities of daily living (ADL) in their home environment, based on advice given by the therapist. A secondary aim is that these patients continue the treatment through a reminder app installed on their mobile phones. This study is a clinical randomized controlled trial. The total sample will consist of 80 adults who have suffered a stroke with moderate severity and who have been discharged to their homes in the 3 months prior to recruitment to the study. The following tests and scales will be used to measure the outcome variables: Barthel Index, the Functional Independence Measure, the Mini-Mental State Examination, the Canadian Neurological Scale, the Stroke Impact Scale-16, the Trunk Control Test, the Modified Rankin Scale, the Multidimensional Scale of Perceived Social Support, the Quality of Life Scale for Stroke, the Functional Reach Test, the Romberg Test, the Time Up and Go test, the Timed-Stands Test, a portable dynamometer, and a sociodemographic questionnaire. Descriptive analyses will include mean, standard deviation, and 95% confidence intervals of the values for each variable. The Kolmogov-Smirnov (KS) test and a 2x2 mixed-model analysis of variance (ANOVA) will be used. Intergroup effect sizes will be calculated (Cohen's d). Currently

  18. Perceived control among migrant live-in and local live-out home care workers in Israel.

    PubMed

    Shinan-Altman, Shiri; Ayalon, Liat

    2017-11-20

    To examine perceived control among live-in and live-out home care workers and to identify factors that contribute to perceived control among both types of caregiving. 338 migrant live-in home care workers and 185 local live-out home care workers were asked to report their perceived control. Burnout, satisfaction with the relationship with the care recipient and the care recipient's family, and satisfaction with social relationship were also gathered. Both types of caregivers reported high levels of perceived control, although live-in home care workers expressed more perceived control. Higher age, higher levels of satisfaction with the relationship with the care recipient and the care recipient's family and lower levels of burnout, predicted perceived control. Satisfaction with social relationship was a stronger predictor of one's perceived control among live-in home care workers. Promoting social relationships outside the home care context by allowing migrant live-in home care workers to take part in social gatherings is recommended as this can strengthen their sense of perceived control.

  19. The Effects of Four-Week Multivitamin Supplementation on Mood in Healthy Older Women: A Randomized Controlled Trial

    PubMed Central

    Rowsell, Renee; Cox, Katherine H. M.; Reddan, Jeffery; Meyer, Denny; Scholey, Andrew; Pipingas, Andrew

    2016-01-01

    Objective. Nutritional deficiencies have been associated with cognitive decline and mood disturbances. Vitamin intake can influence mood and randomized controlled trials have demonstrated that multivitamin supplements are capable of reducing mild symptoms of mood dysfunction. However, few studies have focussed on healthy older women. Methods. This study investigated the effects of four weeks' multivitamin supplementation on mood in 76 healthy women aged 50–75 years. Mood was assessed before and after intervention in the laboratory using measures of current mood and retrospective experiences of mood over the past week or longer. Mobile phones were used to assess changes in real-time mood ratings, twice weekly in the home. Results. There were no multivitamin-related benefits identified for measures of current mood or reflections of recent mood when measured in the laboratory. In-home assessments, where mood was rated several hours after dose, revealed multivitamin supplementation improved ratings of stress, with a trend to reduce mental fatigue. Conclusions. Over four weeks, subtle changes to stress produced by multivitamin supplementation in healthy older women may not be detected when only pre- and posttreatment mood is captured. In-home mobile phone-based assessments may be more sensitive to the effects of nutritional interventions compared to traditional in-laboratory assessments. PMID:27974902

  20. Can Early Intervention Improve Maternal Well-Being? Evidence from a Randomized Controlled Trial

    PubMed Central

    Doyle, Orla; Delaney, Liam; O’Farrelly, Christine; Fitzpatrick, Nick; Daly, Michael

    2017-01-01

    Objective This study estimates the effect of a targeted early childhood intervention program on global and experienced measures of maternal well-being utilizing a randomized controlled trial design. The primary aim of the intervention is to improve children’s school readiness skills by working directly with parents to improve their knowledge of child development and parenting behavior. One potential externality of the program is well-being benefits for parents given its direct focus on improving parental coping, self-efficacy, and problem solving skills, as well as generating an indirect effect on parental well-being by targeting child developmental problems. Methods Participants from a socio-economically disadvantaged community are randomly assigned during pregnancy to an intensive 5-year home visiting parenting program or a control group. We estimate and compare treatment effects on multiple measures of global and experienced well-being using permutation testing to account for small sample size and a stepdown procedure to account for multiple testing. Results The intervention has no impact on global well-being as measured by life satisfaction and parenting stress or experienced negative affect using episodic reports derived from the Day Reconstruction Method (DRM). Treatment effects are observed on measures of experienced positive affect derived from the DRM and a measure of mood yesterday. Conclusion The limited treatment effects suggest that early intervention programs may produce some improvements in experienced positive well-being, but no effects on negative aspects of well-being. Different findings across measures may result as experienced measures of well-being avoid the cognitive biases that impinge upon global assessments. PMID:28095505

  1. Exercise and Bone Mineral Density in Premenopausal Women: A Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Kelley, George A.; Kelley, Kristi S.; Kohrt, Wendy M.

    2013-01-01

    Objective. Examine the effects of exercise on femoral neck (FN) and lumbar spine (LS) bone mineral density (BMD) in premenopausal women. Methods. Meta-analysis of randomized controlled exercise trials ≥24 weeks in premenopausal women. Standardized effect sizes (g) were calculated for each result and pooled using random-effects models, Z score alpha values, 95% confidence intervals (CIs), and number needed to treat (NNT). Heterogeneity was examined using Q and I 2. Moderator and predictor analyses using mixed-effects ANOVA and simple metaregression were conducted. Statistical significance was set at P ≤ 0.05. Results. Statistically significant improvements were found for both FN (7g's, 466 participants, g = 0.342, 95%  CI = 0.132, 0.553, P = 0.001, Q = 10.8, P = 0.22, I 2 = 25.7%, NNT = 5) and LS (6g's, 402 participants, g = 0.201, 95%  CI = 0.009, 0.394, P = 0.04, Q = 3.3, P = 0.65, I 2 = 0%, NNT = 9) BMD. A trend for greater benefits in FN BMD was observed for studies published in countries other than the United States and for those who participated in home versus facility-based exercise. Statistically significant, or a trend for statistically significant, associations were observed for 7 different moderators and predictors, 6 for FN BMD and 1 for LS BMD. Conclusions. Exercise benefits FN and LS BMD in premenopausal women. The observed moderators and predictors deserve further investigation in well-designed randomized controlled trials. PMID:23401684

  2. Assessing the impact of a restorative home care service in New Zealand: a cluster randomised controlled trial.

    PubMed

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

    2012-07-01

    Due to the ageing population, there is an increased demand for home care services. Restorative care is one approach to improving home care services, although there is little evidence to support its use in the community setting. The objective of this trial was to evaluate the impact of a restorative home care service for community-dwelling older people. The study was a cluster randomised controlled trial undertaken at a home care agency in New Zealand. The study period was from December 2005 to May 2007. Older people were interviewed face-to-face at baseline, four and 7 months. A total of 186 older people who received assistance from a home care agency participated in the study, 93 received restorative home care and 93 older people received usual home care. The primary outcome measure was change in health-related quality of life (measured by the Short Form 36 [SF36] Health Survey). Secondary outcomes were the physical, mental, and social well-being of older people (Nottingham Extended Activities of Daily Living, Timed Up and Go, Mastery scale, Duke Social Support Index). Findings revealed that compared with usual care, the intervention demonstrated a statistically significant benefit in health-related quality of life (SF36) at 7 months for older people (mean difference 3.8, 95% CI -0.0 to 7.7, P = 0.05). There were no changes in other scale measurements for older people in either group over time. There was a statistically significant difference in the number of older people in the intervention group identified for reduced hours or discharge (29%) compared with the control group (0%) (P < 0.001). In conclusion, a restorative home care service may be of benefit to older people, and improves home care service efficacy. © 2011 Blackwell Publishing Ltd.

  3. Randomized controlled pilot trial of naloxone‐on‐release to prevent post‐prison opioid overdose deaths

    PubMed Central

    Parmar, Mahesh K. B.; Strang, John; Choo, Louise; Meade, Angela M.

    2016-01-01

    Abstract Background and Aims Naloxone is an opioid antagonist used for emergency resuscitation following opioid overdose. Prisoners with a history of heroin injection have a high risk of drug‐related death soon after release from prison. The NALoxone InVEstigation (N‐ALIVE) pilot trial (ISRCTN34044390) tested feasibility measures for randomized provision of naloxone‐on‐release (NOR) to eligible prisoners in England. Design. Parallel‐group randomized controlled pilot trial. Setting English prisons. Participants A total of 1685 adult heroin injectors, incarcerated for at least 7 days pre‐randomization, release due within 3 months and more than 6 months since previous N‐ALIVE release. Intervention Using 1 : 1 minimization, prisoners were randomized to receive on release a pack containing either a single ‘rescue’ injection of naloxone or a control pack with no syringe. Measurements Key feasibility outcomes were tested against prior expectations: on participation (14 English prisons; 2800 prisoners), consent (75% for randomization), returned prisoner self‐questionnaires (RPSQs: 207), NOR‐carriage (75% in first 4 weeks) and overdose presence (80%). Findings Prisons (16) and prisoners (1685) were willing to participate [consent rate, 95% confidence interval (CI) = 70–74%]; 218 RPSQs were received; NOR‐carriage (95% CI = 63–79%) and overdose presence (95% CI = 75–84%) were as expected. We randomized 842 to NOR and 843 to control during 30 months but stopped early, because only one‐third of NOR administrations were to the ex‐prisoner. Nine deaths within 12 weeks of release were registered for 1557 randomized participants released before 9 December 2014. Conclusions Large randomized trials are feasible with prison populations. Provision of take‐home emergency naloxone prior to prison release may be a life‐saving interim measure to prevent heroin overdose deaths among ex‐prisoners and the wider population. PMID:27776382

  4. A controlled, randomized, comparative study of a radiant heat bandage on the healing of stage 3-4 pressure ulcers: a pilot study.

    PubMed

    Thomas, David R; Diebold, Marilyn R; Eggemeyer, Linda M

    2005-01-01

    Pressure ulcers, like other chronic wounds, fail to proceed through an orderly and timely process to produce anatomical or functional integrity. Treatment of pressure ulcers is directed to improving host factors and providing an optimum wound environment. In addition to providing a moist wound environment, it has been theorized that preventing hypothermia in a wound and maintaining a normothermic state might improve wound healing. Forty-one subjects with a stage 3 or stage 4 truncal pressure ulcer >1.0 cm(2) were recruited from outpatient clinics, long-term care nursing homes, and a rehabilitation center. The experimental group was randomized to a radiant-heat dressing device and the control group was randomized to a hydrocolloid dressing, with or without a calcium alginate filler. Subjects were followed until healed or for 12 weeks. Eight subjects (57%) in the experimental group had complete healing of their pressure ulcer compared with 7 subjects (44%) with complete healing in the control group (P = .46). Although a 13% difference in healing rate between the two arms of the study was found, this difference was not statistically significant. At almost all points along the healing curve, the proportion not healed was higher in the control arm.

  5. Rationale and design for the Asia BP@Home study on home blood pressure control status in 12 Asian countries and regions.

    PubMed

    Kario, Kazuomi; Tomitani, Naoko; Buranakitjaroen, Peera; Chen, Chen-Huan; Chia, Yook-Chin; Divinagracia, Romeo; Park, Sungha; Shin, Jinho; Siddique, Saulat; Sison, Jorge; Soenarta, Arieska Ann; Sogunuru, Guru Prasad; Tay, Jam Chin; Turana, Yuda; Wang, Ji-Guang; Wong, Lawrence; Zhang, Yuqing; Wanthong, Sirisawat; Hoshide, Satoshi; Kanegae, Hiroshi

    2018-01-01

    Home blood pressure (BP) monitoring is endorsed in multiple guidelines as a valuable adjunct to office BP measurements for the diagnosis and management of hypertension. In many countries throughout Asia, physicians are yet to appreciate the significant contribution of BP variability to cardiovascular events. Furthermore, data from Japanese cohort studies have shown that there is a strong association between morning BP surge and cardiovascular events, suggesting that Asians in general may benefit from more effective control of morning BP. We designed the Asia BP@Home study to investigate the distribution of hypertension subtypes, including white-coat hypertension, masked morning hypertension, and well-controlled and uncontrolled hypertension. The study will also investigate the determinants of home BP control status evaluated by the same validated home BP monitoring device and the same standardized method of home BP measurement among 1600 or more medicated patients with hypertension from 12 countries/regions across Asia. ©2017 Wiley Periodicals, Inc.

  6. Effects of nurse home-visiting on maternal life course and child development: age 6 follow-up results of a randomized trial.

    PubMed

    Olds, David L; Kitzman, Harriet; Cole, Robert; Robinson, JoAnn; Sidora, Kimberly; Luckey, Dennis W; Henderson, Charles R; Hanks, Carole; Bondy, Jessica; Holmberg, John

    2004-12-01

    To test, with an urban, primarily black sample, the effects of prenatal and infancy home visits by nurses on mothers' fertility and economic self-sufficiency and the academic and behavioral adjustment of their children as the children finished kindergarten, near their sixth birthday. We conducted a randomized, controlled trial of a program of prenatal and infancy home-visiting in a public system of obstetric and pediatric care in Memphis, Tennessee. A total of 743 primarily black women at <29 weeks of gestation, with no previous live births and with > or =2 sociodemographic risk characteristics (unmarried, <12 years of education, or unemployed), were randomly assigned to receive nurse home visits or comparison services. Outcomes consisted of women's number and timing of subsequent pregnancies, months of employment, use of welfare, food stamps, and Medicaid, educational achievement, behavioral problems attributable to the use of substances, rates of marriage and cohabitation, and duration of relationships with partners and their children's behavior problems, responses to story stems, intellectual functioning, receptive language, and academic achievement. In contrast to counterparts assigned to the comparison group, women visited by nurses had fewer subsequent pregnancies and births (1.16 vs 1.38 pregnancies and 1.08 vs 1.28 births, respectively), longer intervals between births of the first and second children (34.28 vs 30.23 months), longer relationships with current partners (54.36 vs 45.00 months), and, since the previous follow-up evaluation at 4.5 years, fewer months of using welfare (7.21 vs 8.96 months) and food stamps (9.67 vs 11.50 months). Nurse-visited children were more likely to have been enrolled in formal out-of-home care between 2 and 4.5 years of age (82.0% vs 74.9%). Children visited by nurses demonstrated higher intellectual functioning and receptive vocabulary scores (scores of 92.34 vs 90.24 and 84.32 vs 82.13, respectively) and fewer behavior

  7. Effects of Tai Chi on Cognition and Fall Risk in Older Adults with Mild Cognitive Impairment: A Randomized Controlled Trial.

    PubMed

    Sungkarat, Somporn; Boripuntakul, Sirinun; Chattipakorn, Nipon; Watcharasaksilp, Kanokwan; Lord, Stephen R

    2017-04-01

    To examine whether combined center- and home-based Tai Chi training can improve cognitive ability and reduce physiological fall risk in older adults with amnestic mild cognitive impairment (a-MCI). Randomized controlled trial. Chiang Mai, Thailand. Adults aged 60 and older who met Petersen's criteria for multiple-domain a-MCI (N = 66). Three weeks center-based and 12 weeks home-based Tai Chi (50 minutes per session, 3 times per week). Cognitive tests, including Logical Memory (LM) delayed recall, Block Design, Digit Span forward and backward, and Trail-Making Test Part B-A (TMT B-A), and fall risk index using the Physiological Profile Assessment (PPA). At the end of the trial, performance on LM, Block Design, and TMT B-A were significantly better for the Tai Chi group than the control group after adjusting for baseline test performance. The Tai Chi group also had significantly better composite PPA score and PPA parameter scores: knee extension strength, reaction time, postural sway, and lower limb proprioception. Combined center- and home-based Tai Chi training three times per week for 15 weeks significantly improved cognitive function and moderately reduced physiological fall risk in older adults with multiple-domain a-MCI. Tai Chi may be particularly beneficial to older adults with this condition. © 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.

  8. Effectiveness of an interactive telerehabilitation system with home-based exercise training in patients after total hip or knee replacement: study protocol for a multicenter, superiority, no-blinded randomized controlled trial.

    PubMed

    Eichler, Sarah; Rabe, Sophie; Salzwedel, Annett; Müller, Steffen; Stoll, Josefine; Tilgner, Nina; John, Michael; Wegscheider, Karl; Mayer, Frank; Völler, Heinz

    2017-09-21

    Total hip or knee replacement is one of the most frequently performed surgical procedures. Physical rehabilitation following total hip or knee replacement is an essential part of the therapy to improve functional outcomes and quality of life. After discharge from inpatient rehabilitation, a subsequent postoperative exercise therapy is needed to maintain functional mobility. Telerehabilitation may be a potential innovative treatment approach. We aim to investigate the superiority of an interactive telerehabilitation intervention for patients after total hip or knee replacement, in comparison to usual care, regarding physical performance, functional mobility, quality of life and pain. This is an open, randomized controlled, multicenter superiority study with two prospective arms. One hundred and ten eligible and consenting participants with total knee or hip replacement will be recruited at admission to subsequent inpatient rehabilitation. After comprehensive, 3-week, inpatient rehabilitation, the intervention group performs a 3-month, interactive, home-based exercise training with a telerehabilitation system. For this purpose, the physiotherapist creates an individual training plan out of 38 different strength and balance exercises which were implemented in the system. Data about the quality and frequency of training are transmitted to the physiotherapist for further adjustment. Communication between patient and physiotherapist is possible with the system. The control group receives voluntary, usual aftercare programs. Baseline assessments are investigated after discharge from rehabilitation; final assessments 3 months later. The primary outcome is the difference in improvement between intervention and control group in 6-minute walk distance after 3 months. Secondary outcomes include differences in the Timed Up and Go Test, the Five-Times-Sit-to-Stand Test, the Stair Ascend Test, the Short-Form 36, the Western Ontario and McMaster Universities Osteoarthritis Index

  9. Hypertension Management Using Mobile Technology and Home Blood Pressure Monitoring: Results of a Randomized Trial in Two Low/Middle-Income Countries

    PubMed Central

    Datwani, Hema; Gaudioso, Sofia; Foster, Stephanie M.; Westphal, Joslyn; Perry, William; Rodríguez-Saldaña, Joel; Mendoza-Avelares, Milton O.; Marinec, Nicolle

    2012-01-01

    Abstract Objective: Hypertension and other noncommunicable diseases represent a growing threat to low/middle-income countries (LMICs). Mobile health technologies may improve noncommunicable disease outcomes, but LMICs lack resources to provide these services. We evaluated the efficacy of a cloud computing model using automated self-management calls plus home blood pressure (BP) monitoring as a strategy for improving systolic BPs (SBPs) and other outcomes of hypertensive patients in two LMICs. Subjects and Methods: This was a randomized trial with a 6-week follow-up. Participants with high SBPs (≥140 mm Hg if nondiabetic and ≥130 mm Hg if diabetic) were enrolled from clinics in Honduras and Mexico. Intervention patients received weekly automated monitoring and behavior change telephone calls sent from a server in the United States, plus a home BP monitor. At baseline, control patients received BP results, hypertension information, and usual healthcare. The primary outcome, SBP, was examined for all patients in addition to a preplanned subgroup with low literacy or high hypertension information needs. Secondary outcomes included perceived health status and medication-related problems. Results: Of the 200 patients recruited, 181 (90%) completed follow-up, and 117 of 181 had low literacy or high hypertension information needs. The median annual income was $2,900 USD, and average educational attainment was 6.5 years. At follow-up intervention patients' SBPs decreased 4.2 mm Hg relative to controls (95% confidence interval −9.1, 0.7; p=0.09). In the subgroup with high information needs, intervention patients' average SBPs decreased 8.8 mm Hg (−14.2, −3.4, p=0.002). Compared with controls, intervention patients at follow-up reported fewer depressive symptoms (p=0.004), fewer medication problems (p<0.0001), better general health (p<0.0001), and greater satisfaction with care (p≤0.004). Conclusions: Automated telephone care management plus home BP

  10. AAL Platform with a "De Facto" Standard Communication Interface (TICO): Training in Home Control in Special Education.

    PubMed

    Guillomía San Bartolomé, Miguel A; Falcó Boudet, Jorge L; Artigas Maestre, José Ignacio; Sánchez Agustín, Ana

    2017-10-12

    Framed within a long-term cooperation between university and special education teachers, training in alternative communication skills and home control was realized using the "TICO" interface, a communication panel editor extensively used in special education schools. From a technological view we follow AAL technology trends by integrating a successful interface in a heterogeneous services AAL platform, focusing on a functional view. Educationally, a very flexible interface in line with communication training allows dynamic adjustment of complexity, enhanced by an accessible mindset and virtual elements significance already in use, offers specific interaction feedback, adapts to the evolving needs and capacities and improves the personal autonomy and self-confidence of children at school and home. TICO-home-control was installed during the last school year in the library of a special education school to study adaptations and training strategies to enhance the autonomy opportunities of its pupils. The methodology involved a case study and structured and semi-structured observations. Five children, considered unable to use commercial home control systems were trained obtaining good results in enabling them to use an open home control system. Moreover this AAL platform has proved efficient in training children in previous cognitive steps like virtual representation and cause-effect interaction.

  11. A randomized controlled trial of the effects of transcendental meditation on quality of life in older breast cancer patients.

    PubMed

    Nidich, Sanford I; Fields, Jeremy Z; Rainforth, Maxwell V; Pomerantz, Rhoda; Cella, David; Kristeller, Jean; Salerno, John W; Schneider, Robert H

    2009-09-01

    This single-blind, randomized controlled trial evaluated the impact of the Transcendental Meditation program plus standard care as compared with standard care alone on the quality of life (QOL) of older women (>or=55 years) with stage II to IV breast cancer. One hundred and thirty women (mean age = 63.8) were randomly assigned to either experimental (n = 64) or control (n = 66) groups. Functional Assessment of Cancer Therapy-Breast (FACT-B), Functional Assessment of Chronic Illness Therapy- Spiritual Well-Being (FACIT-SP), and Short-Form (SF)-36 mental health and vitality scales were administered every 6 months over an average 18-month intervention period. Significant improvements were found in the Transcendental Meditation group compared with controls in overall QOL, measured by the FACT-B total score (P = .037), emotional well-being (P = .046), and social well-being (P = .003) subscales, and SF-36 mental health ( P = .017). It is recommended that this stress reduction program, with its ease of implementation and home practice, be adopted in public health programs.

  12. A comparison of two stretching programs for hamstring muscles: A randomized controlled assessor-blinded study.

    PubMed

    Demoulin, Christophe; Wolfs, Sébastien; Chevalier, Madeline; Granado, Caroline; Grosdent, Stéphanie; Depas, Yannick; Roussel, Nathalie; Hage, Renaud; Vanderthommen, Marc

    2016-01-01

    Most parameters regarding hamstring flexibility training programs have been investigated; however, the joint (i.e. hip or knee) on which the stretching should preferentially be focused needs to be further explored. This randomized controlled assessor-blinded study aimed to investigate the influence of this parameter. We randomly assigned 111 asymptomatic participants with tight hamstring muscles in three groups: a control group and two groups following a different home-based 8-week (five 10-minute sessions per week) hamstring stretching program (i.e. stretching performed by flexing the hip while keeping the knee extended [SH] or by first flexing the hip with a flexed knee and then extending the knee [SK]). Range of motion (ROM) of hip flexion and knee extension were measured before and after the stretching program by means of the straight leg raising test and the passive knee extension angle test, respectively. Eighty-nine participants completed the study. A significant increase in ROM was observed at post-test. Analyses showed significant group-by-time interactions for changes regarding all outcomes. Whereas the increase in hip flexion and knee extension ROM was higher in the stretching groups than in the CG (especially for the SH group p < 0.05), no differences between the two stretching groups were observed (p > 0.05). In conclusion, the fact that both stretching programs resulted in similar results suggests no influence of the joint at which the stretching is focused upon, as assessed by the straight leg raising and knee extension angle tests.

  13. A Brief Manualized Treatment for Problematic Caffeine Use: A Randomized Control Trial

    PubMed Central

    Evatt, Daniel P.; Juliano, Laura M.; Griffiths, Roland R.

    2015-01-01

    Objective The goal of the present investigation was to develop and test a brief therapist-guided manualized treatment for problematic caffeine use including cognitive-behavioral strategies and 5-weeks of progressively decreased consumption. Methods Individuals seeking treatment for problematic caffeine use (mean daily caffeine consumption of 666.0 mg at baseline) were randomized using a waitlist-control design to receive immediate (N = 33) treatment or delayed (N = 34) treatment (∼6 weeks later). A one-hour long treatment session designed to help individuals quit or reduce caffeine consumption was provided by a trained counselor along with a take-home booklet. After the treatment session, participants completed daily diaries of caffeine consumption for 5 weeks. They returned for follow-up assessments at 6, 12, and 26 weeks and had a telephone interview at 52-weeks post-treatment. Results Treatment resulted in a significant reduction in self reported caffeine use and salivary caffeine levels. No significant post-treatment increases in caffeine use were observed for up to one year follow-up. Comparisons to the waitlist control condition revealed that reductions in caffeine consumption were due to treatment and not the passing of time, with a treatment effect size of R2 = .35 for the model. Conclusions A brief one-session manualized intervention with follow-up was efficacious at reducing caffeine consumption. Future research should replicate and extend these findings, as well as consider factors affecting dissemination of treatment for problematic caffeine use to those in need. PMID:26501499

  14. Feasibility and cost-effectiveness of a multidisciplinary home-telehealth intervention programme to reduce falls among elderly discharged from hospital: study protocol for a randomized controlled trial.

    PubMed

    Giordano, Alessandro; Bonometti, Gian Pietro; Vanoglio, Fabio; Paneroni, Mara; Bernocchi, Palmira; Comini, Laura; Giordano, Amerigo

    2016-12-07

    Fall incidents are the third cause of chronic disablement in elderly according to the World Health Organization (WHO). Recent meta-analyses shows that a multifactorial falls risk assessment and management programmes are effective in all older population studied. However, the application of these programmes may not be the same in all National health care setting and, consequently, needs to be evaluated by cost-effectiveness studies before to plan this intervention in regular care. In Italy structured collaboration between hospital staff and primary care is generally lacking and the role of Information and Communication Technologies (ICT) in a fall prevention programme at home has never been explored. This will be a two-group randomised controlled trial aiming to evaluate the effects of a home-based intervention programme delivered by a multidisciplinary health team. The home tele-management programme, previously adopted in our Institute for chronic patients, will be proposed to elderly people affected by chronic diseases at high risk of falling at hospital discharge. The programme will involve the hospital staff and will be managed thanks to the collaboration between hospital and primary care setting. Patients will be followed for 6 months after hospital discharge. A nurse-tutor telephone support and tele-exercise will characterize the intervention programme. People in the control group will receive usual care. The main outcome measure of the study will be the percentage of patients sustaining a fall during the 6-months follow-up period. An economic evaluation will be performed from a societal perspective and will involve calculating cost-effectiveness and cost utility ratios. To date, no adequately powered studies have investigated the effect of the Information and Communication Technologies (ICT) in a home fall prevention program. We aim the program will be feasible in terms of intensity and characteristics, but particularly in terms of patient and provider

  15. Acupuncture for migraine prophylaxis: a randomized controlled trial

    PubMed Central

    Li, Ying; Zheng, Hui; Witt, Claudia M.; Roll, Stephanie; Yu, Shu-guang; Yan, Jie; Sun, Guo-jie; Zhao, Ling; Huang, Wen-jing; Chang, Xiao-rong; Zhang, Hong-xing; Wang, De-jun; Lan, Lei; Zou, Ran; Liang, Fan-rong

    2012-01-01

    Background: Acupuncture is commonly used to treat migraine. We assessed the efficacy of acupuncture at migraine-specific acupuncture points compared with other acupuncture points and sham acupuncture. Methods: We performed a multicentre, single-blind randomized controlled trial. In total, 480 patients with migraine were randomly assigned to one of four groups (Shaoyang-specific acupuncture, Shaoyang-nonspecific acupuncture, Yangming-specific acupuncture or sham acupuncture [control]). All groups received 20 treatments, which included electrical stimulation, over a period of four weeks. The primary outcome was the number of days with a migraine experienced during weeks 5–8 after randomization. Our secondary outcomes included the frequency of migraine attack, migraine intensity and migraine-specific quality of life. Results: Compared with patients in the control group, patients in the acupuncture groups reported fewer days with a migraine during weeks 5–8, however the differences between treatments were not significant (p > 0.05). There was a significant reduction in the number of days with a migraine during weeks 13–16 in all acupuncture groups compared with control (Shaoyang-specific acupuncture v. control: difference –1.06 [95% confidence interval (CI) –1.77 to –0.5], p = 0.003; Shaoyang-nonspecific acupuncture v. control: difference –1.22 [95% CI –1.92 to –0.52], p < 0.001; Yangming-specific acupuncture v. control: difference –0.91 [95% CI –1.61 to –0.21], p = 0.011). We found that there was a significant, but not clinically relevant, benefit for almost all secondary outcomes in the three acupuncture groups compared with the control group. We found no relevant differences between the three acupuncture groups. Interpretation: Acupuncture tested appeared to have a clinically minor effect on migraine prophylaxis compared with sham acupuncture. Trial Registration: Clinicaltrials.gov NCT00599586 PMID:22231691

  16. Feasibility of the Enhancing Participation In the Community by improving Wheelchair Skills (EPIC Wheels) program: study protocol for a randomized controlled trial.

    PubMed

    Giesbrecht, Edward M; Miller, William C; Eng, Janice J; Mitchell, Ian M; Woodgate, Roberta L; Goldsmith, Charles H

    2013-10-24

    Many older adults rely on a manual wheelchair for mobility but typically receive little, if any, training on how to use their wheelchair effectively and independently. Standardized skill training is an effective intervention, but limited access to clinician trainers is a substantive barrier. Enhancing Participation in the Community by Improving Wheelchair Skills (EPIC Wheels) is a 1-month monitored home training program for improving mobility skills in older novice manual wheelchair users, integrating principles from andragogy and social cognitive theory. The purpose of this study is to determine whether feasibility indicators and primary clinical outcome measures of the EPIC Wheels program are sufficiently robust to justify conducting a subsequent multi-site randomized controlled trial. A 2 × 2 factorial randomized controlled trial at two sites will compare improvement in wheelchair mobility skills between an EPIC Wheels treatment group and a computer-game control group, with additional wheelchair use introduced as a second factor. A total of 40 community-dwelling manual wheelchair users at least 55 years old and living in two Canadian metropolitan cities (n = 20 × 2) will be recruited. Feasibility indicators related to study process, resources, management, and treatment issues will be collected during data collection and at the end of the study period, and evaluated against proposed criteria. Clinical outcome measures will be collected at baseline (pre-randomization) and post-intervention. The primary clinical outcome measure is wheelchair skill capacity, as determined by the Wheelchair Skills Test, version 4.1. Secondary clinical outcome measures include wheelchair skill safety, satisfaction with performance, wheelchair confidence, life-space mobility, divided-attention, and health-related quality of life. The EPIC Wheels training program offers several innovative features. The convenient, portable, economical, and adaptable tablet-based, home program model

  17. Feasibility of the Enhancing Participation In the Community by improving Wheelchair Skills (EPIC Wheels) program: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Many older adults rely on a manual wheelchair for mobility but typically receive little, if any, training on how to use their wheelchair effectively and independently. Standardized skill training is an effective intervention, but limited access to clinician trainers is a substantive barrier. Enhancing Participation in the Community by Improving Wheelchair Skills (EPIC Wheels) is a 1-month monitored home training program for improving mobility skills in older novice manual wheelchair users, integrating principles from andragogy and social cognitive theory. The purpose of this study is to determine whether feasibility indicators and primary clinical outcome measures of the EPIC Wheels program are sufficiently robust to justify conducting a subsequent multi-site randomized controlled trial. Methods A 2 × 2 factorial randomized controlled trial at two sites will compare improvement in wheelchair mobility skills between an EPIC Wheels treatment group and a computer-game control group, with additional wheelchair use introduced as a second factor. A total of 40 community-dwelling manual wheelchair users at least 55 years old and living in two Canadian metropolitan cities (n = 20 × 2) will be recruited. Feasibility indicators related to study process, resources, management, and treatment issues will be collected during data collection and at the end of the study period, and evaluated against proposed criteria. Clinical outcome measures will be collected at baseline (pre-randomization) and post-intervention. The primary clinical outcome measure is wheelchair skill capacity, as determined by the Wheelchair Skills Test, version 4.1. Secondary clinical outcome measures include wheelchair skill safety, satisfaction with performance, wheelchair confidence, life-space mobility, divided-attention, and health-related quality of life. Discussion The EPIC Wheels training program offers several innovative features. The convenient, portable, economical, and adaptable

  18. Access Control for Home Data Sharing: Attitudes, Needs and Practices

    DTIC Science & Technology

    2009-10-01

    cameras, mobile phones and portable music players make creating and interacting with this content easy. Home users are increasingly interested in...messages, photos, home videos, journal files and home musical recordings. Many participants considered unauthorized access by strangers, acquaintances...configuration does not allow users to share different subsets of music with different people. Facebook supplies rich, customizable access controls for

  19. Pulmonary Rehabilitation With Balance Training for Fall Reduction in Chronic Obstructive Pulmonary Disease: Protocol for a Randomized Controlled Trial

    PubMed Central

    Beauchamp, Marla K; Ellerton, Cindy; Lee, Annemarie; Alison, Jennifer; Camp, Pat G; Dechman, Gail; Haines, Kimberley; Harrison, Samantha L; Holland, Anne E; Marques, Alda; Moineddin, Rahim; Skinner, Elizabeth H; Spencer, Lissa; Stickland, Michael K; Xie, Feng; Goldstein, Roger S

    2017-01-01

    Background Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide. A growing body of evidence shows that individuals with COPD have important deficits in balance control that may be associated with an increased risk of falls. Pulmonary rehabilitation (PR) is a key therapeutic intervention for individuals with COPD; however, current international guidelines do not include balance training and fall prevention strategies. Objective The primary aim of this trial is to determine the effects of PR with balance training compared to PR with no balance training on the 12-month rate of falls in individuals with COPD. Secondary aims are to determine the effects of the intervention on balance, balance confidence, and functional lower body strength, and to estimate the cost-effectiveness of the program. Methods A total of 400 individuals from nine PR centers across Canada, Europe, and Australia will be recruited to participate in a randomized controlled trial. Individuals with COPD who have a self-reported decline in balance, a fall in the last 2 years, or recent near fall will be randomly assigned to an intervention or control group. The intervention group will undergo tailored balance training in addition to PR and will receive a personalized home-based balance program. The control group will receive usual PR and a home program that does not include balance training. All participants will receive monthly phone calls to provide support and collect health care utilization and loss of productivity data. Both groups will receive home visits at 3, 6, and 9 months to ensure proper technique and progression of home exercise programs. The primary outcome will be incidence of falls at 12-month follow-up. Falls will be measured using a standardized definition and recorded using monthly self-report fall diary calendars. Participants will be asked to record falls and time spent performing their home exercise program on the fall diary

  20. LA Sprouts: A 12-week gardening, nutrition, and cooking randomized control trial improves determinants of dietary behaviors

    PubMed Central

    Davis, Jaimie N; Martinez, Lauren C.; Spruijt-Metz, Donna; Gatto, Nicole M.

    2015-01-01

    Objective To evaluate the effect of an exploratory 12-week nutrition, cooking and gardening RCT (“LA Sprouts”) on preference for fruit and vegetables (FV); willingness to try FV; identification of FV; self-efficacy to garden/eat/cook FV; motivation to garden/eat/cook FV; attitudes towards FV; nutrition and gardening knowledge; and home gardening habits. Design and Participants Four elementary schools with 304 predominately Hispanic/Latino 3rd–5th grade students were randomized to either the LA Sprouts (n=167 students) or Control group (n=137 students). LA Sprouts participants received 12 weeks of weekly 90-minute culturally tailored gardening, nutrition, and cooking classes after school. Questionnaire data examining dietary determinants were obtained at baseline and post-intervention. Results After the 12-week program, LA Sprouts participants compared with controls improved scores for identification of vegetables (+11% vs. +5%; P=.001), nutrition and gardening knowledge (+14.5% vs. −5.0%; P =.003), and were more likely to garden at home (+7.5% vs. −4.4%; P=.003). Conclusions The LA Sprouts program positively impacted a number of determinants of dietary behaviors, which suggest possible mechanisms by which gardening and nutrition education act to improve dietary intake and health outcomes. PMID:26453367