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

ABSTRACT: 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. Fidelity is being addressed and measured across several domains.Feasibility indications to date are positive. Although the protocol has some limitations, we expect to learn enough about the intervention, delivery and effects to support a larger trial with a more stringent design and enhanced statistical power.ClinicalTrials.gov ID NCT00985283.

SUBMITTER: Cutchin MP

PROVIDER: S-EPMC2797508 | biostudies-literature | 2009 Dec

REPOSITORIES: biostudies-literature

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

Cutchin Malcolm P MP Coppola Susan S Talley Vibeke V Svihula Judie J Catellier Diane D Shank Kendra Heatwole KH

BMC geriatrics 20091203

<h4>Background</h4>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 ...[more]

PMID: 19958547

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Project description:Regarding demographic changes in Germany it can be assumed that the number of elderly and the resulting need for long term care is increasing in the near future. It is not only an individual's interest but also of public concern to avoid a nursing home admission. Current evidence indicates that preventive home visits can be an effective way to reduce the admission rate in this way making it possible for elderly people to stay longer at home than without home visits. As the effectiveness and cost-effectiveness of preventive home visits strongly depends on existing services in the social and health system existing international results cannot be merely transferred to Germany. Therefore it is necessary to investigate the effectiveness and cost-effectiveness of such an intervention in Germany by a randomized controlled trial.The trial is designed as a prospective multi-center randomized controlled trial in the cities of Halle and Leipzig. The trial includes an intervention and a control group. The control group receives usual care. The intervention group receives three additional home visits by non-physician health professionals (1) geriatric assessment, (2) consultation, (3) booster session. The nursing home admission rate after 18 months will be defined as the primary outcome. An absolute risk reduction from a 20% in the control-group to a 7% admission rate in the intervention group including an assumed drop out rate of 30% resulted in a required sample size of N = 320 (n = 160 vs. n = 160). Parallel to the clinical outcome measurement the intervention will be evaluated economically. The economic evaluation will be performed from a society perspective.To the authors' knowledge for the first time a trial will investigate the effectiveness and cost-effectiveness of preventive home visits for people aged 80 and over in Germany using the design of a randomized controlled trial. Thus, the trial will contribute to the existing evidence on preventive home visits especially in Germany.

Project description:Preoperative physical exercise is emerging as a growing field of research globally. There are still challenges in recruiting vulnerable older people, and time constraints in preoperative cancer care to consider. We therefore evaluated the feasibility of short-term supervised home-based exercise in older people prior to colorectal cancer surgery. This feasibility study was conducted between September 2016 and June 2018. People ≥70 years scheduled for colorectal cancer surgery were recruited and randomized to an intervention group receiving supervised home-based physical exercise at a high level of estimated exertion or a standard care group following the standard preoperative path. The exercise (respiratory, strength, and aerobic) consisted of 2-3 supervised sessions a week in the participants' homes, for at least 2-3 weeks or until surgery, and a self-administered exercise program in between. The primary outcome was process feasibility, including aspects specifically related to recruitment rate, compliance to the intervention, and acceptability. The secondary outcome was scientific feasibility including treatment safety, description of dose level and response, and estimation of treatment results. Twenty-three participants were included (recruitment rate 35%). A median of 6 supervised sessions was conducted over a 17-day exercise period. Compliance with the supervised sessions was 97%, and participants found the intervention acceptable. Concerning the self-administered exercise, a median of 19 inspiratory muscle training, 6 functional strength, and 8.5 aerobic sessions were reported. Challenges reported by program instructors were time constraints and difficulties in achieving high exercise intensities on the Borg CR-10 scale. A statistically significant between-group difference was only found in inspiratory muscle strength, favoring the intervention group (p<0.01). A short-term preoperative supervised home-based physical exercise intervention can be conducted, with respect to compliance and acceptability, in older people with similar physical status as in this study prior to colorectal cancer surgery. However, modifications are warranted with respect to improving recruitment rates and achieving planned intensity levels prior to conducting a definitive trial.

Project description:BackgroundThis feasibility study is intended to assess the acceptability of home-based task-specific reach-to-grasp (RTG) training for people with stroke, and to gather data to inform recruitment, retention, and sample size for a definitive randomized controlled trial.Methods/designThis is to be a randomized controlled feasibility trial recruiting 50 individuals with upper-limb motor impairment after stroke. Participants will be recruited after discharge from hospital and up to 12 months post-stroke from hospital stroke services and community therapy-provider services. Participants will be assessed at baseline, and then electronically randomized and allocated to group by minimization, based on the time post-stroke and extent of upper-limb impairment. The intervention group will receive 14 training sessions, each 1 hour long, with a physiotherapist over 6 weeks and will be encouraged to practice independently for 1 hour/day to give a total of 56 hours of training time per participant. Participants allocated to the control group will receive arm therapy in accordance with usual care. Participants will be measured at 7 weeks post-randomization, and followed-up at 3 and 6 months post-randomization. Primary outcome measures for assessment of arm function are the Action Research Arm Test (ARAT) and Wolf Motor Function Test (WMFT). Secondary measures are the Motor Activity Log, Stroke Impact Scale, Carer Strain Index, and health and social care resource use. All assessments will be conducted by a trained assessor blinded to treatment allocation. Recruitment, adherence, withdrawals, adverse events (AEs), and completeness of data will be recorded and reported.DiscussionThis study will determine the acceptability of the intervention, the characteristics of the population recruited, recruitment and retention rates, descriptive statistics of outcomes, and incidence of AEs. It will provide the information needed for planning a definitive trial to test home-based RTG training.Trial registration isrctnISRCTN56716589.

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

Publications

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

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