Community Participation Transition After Stroke

Study Overview
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Brief Summary
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Stroke is one of the most serious, disabling health conditions in the United States. Patients who undergo rehabilitation treatment for stroke have a high rate of disability. Poor outcomes for many persons with stroke may be low because of incomplete treatment. The investigators will conduct a randomized controlled trial and a process evaluation to examine the feasibility, safety, and preliminary efficacy of an enhanced rehabilitation transition program, Community Participation Transition after Stroke (COMPASS), designed to bridge inpatient rehabilitation and the home to support the performance of everyday activities.

Detailed Description
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We propose an enhanced rehabilitation transition program: Community Participation Transition after Stroke (COMPASS) is a compensatory intervention consisting of one pre-discharge and five post-discharge home visits by an occupational therapist to supplement usual care. This intervention is focused on resolving barriers to independence in daily activities and participation using environmental support and active practice of daily activities in an individual's real home (versus an idealized clinical setting). This is a new combination of evidence-based compensatory treatments delivered in a novel treatment setting (transition to home). Our long-term goal is the development of an effective intervention for a transition home designed to prevent excess disability for people living with stroke that could have an immediate effect and high public health significance.16 We will recruit 40 patients currently undergoing inpatient rehabilitation (IR) for ischemic stroke from longitudinal studies of stroke at Washington University School of Medicine (WUSM) and randomize them to receive six additional sessions of the enhanced rehabilitation transition program or attention control. Exploratory participation outcomes will be assessed by blinded evaluators at baseline, 6 months, 9 months, and 12 months after stroke. We will test the central hypothesis that COMPASS will be acceptable, feasible, and superior to attention control on measures of participation and daily activity performance at 6 months after stroke.

Official Title
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Feasibility of a Novel Intervention to Improve Participation After Stroke

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: Education Group
* Behavioral: Home Modifications Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥45 years old acute ischemic stroke, verified by a neurologist baseline National Institutes of Health Stroke Scale (NIHSS) ≥8 independent in activities of daily living prior to stroke (premorbid Rankin score of ≤2) plan to discharge to home Exclusion Criteria: severe terminal systemic disease that limits life expectancy to <6 months previous disorder (e.g., dementia) that makes interpretation of the self-rated scales difficult or a Short Blessed Test (SBT) score of ≥9 (indicating significant cognitive impairment) moderate to severe aphasia, as determined by the NIHSS Best Language rating of ≥2 residence in a congregate living facility not eligible for a therapeutic pass

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Education Group<br>Participants in the Education group receive five 90 minute tailored stroke education sessions in the home. | Behavioral: Education Group<br>* Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.<br>|
| Experimental: Home Modifications Group<br>Participants in the treatment group receive a home assessment and home modifications tailored to functional abilities (pre discharge) and then five 90 minute occupational therapy treatment sessions at home (post discharge) to improve functional abilities and community participation. | Behavioral: Home Modifications Group<br>* The standardized components include assessment, identification of five problematic activities (and environmental barriers), identification of three solutions (for each problem), implementation of a solution set selected by the participant, training, and active practice of daily activities in one's own home and community.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring the Safety of the intervention (rate and severity of falls (calculated with an algorithm) | We will explore the safety of the intervention by determining the rate and severity of falls (calculated with an algorithm). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring the intervention dose | Calculating the intervention received by both groups (number of minutes and number of sessions delivered). | 2 months | 
| Measuring health care utilization | We will also examine health care utilization (emergency department and outpatient visits, number of hospitalizations, and days hospitalized) for both groups. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke rehabilitation, barriers to independence, environmental support