Community Participation Transition After Stroke

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Behavioral: Education Group; Behavioral: Home Modifications Group

• Registration Number: NCT02396589
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-01-19
• Study First Submitted: 2015-03-05
• Study First Submitted QC: 2015-03-23
• Study First Posted: 2015-03-24
• Primary Completion: 2016-12-13
• Study Completion: 2016-12-13
• Results First Submitted: 2021-10-18
• Status Verified: 2023-10
• Results First Submitted QC: 2023-10-26
• Last Update Submitted: 2023-10-26
• Results First Posted: 2024-04-12
• Last Update Posted: 2024-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. ≥45 years old
2. acute ischemic stroke, verified by a neurologist
3. baseline National Institutes of Health Stroke Scale (NIHSS) ≥8
4. independent in activities of daily living prior to stroke (premorbid Rankin score of ≤2)
5. plan to discharge to home

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Exclusion Criteria

1. severe terminal systemic disease that limits life expectancy to <6 months
2. 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)
3. moderate to severe aphasia, as determined by the NIHSS Best Language rating of ≥2
4. residence in a congregate living facility
5. not eligible for a therapeutic pass

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education Group	Education Group	Participants in the Education group receive five 90 minute tailored stroke education sessions in the home.
Home Modifications Group	Home Modifications Group	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.

Primary Outcome Measures

Name	Time	Method
Rate and Severity of Falls (Calculated With an Algorithm)	12 months	We will explore the safety of the intervention by determining the rate and severity of falls (calculated with an algorithm). Scores are as follows: 0, those with no falls, 1, those with one fall without serious injury, 2, those with at least two falls without serious injury, and 3, those with one or more falls causing serious injury. Maximum score of three indicates an increased severity of fall. We will compare the difference in scores between groups using t-tests.

Secondary Outcome Measures

Name	Time	Method
Intervention Dose, Number of Treatment Sessions	2 months	The does of the intervention as measured by amount of treatment minutes received by both groups. The total number of treatment sessions was calculated for each participant and the average is reported here.
Health Care Utilization, Number of Emergency Department Visits	12 months	We analyzed health care utilization by examining the number of emergency department visits, outpatient physical and occupational therapy visits, and doctor visits. The total number of each was calculated for each participant and the average is reported here.
Intervention Dose (Minutes)	2 months	The does of the intervention as measured in minutes received by both groups. The number of minutes reported is the average of the total for each participant in each group.
Health Care Utilization, Days of Hospitalization	12 months	We analyzed health care utilization by examining the number of days participants in each group spent in the hospital. The total number of days was calculated for participants in each group and the average is reported here.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States