Community Participation Transition After Stroke

NCT ID: NCT02396589

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-19
• Study Completion Date: 2016-12-13

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Education Group

Participants in the Education group receive five 90 minute tailored stroke education sessions in the home.

Group Type: ACTIVE_COMPARATOR

Education Group

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Home Modifications Group

Intervention Type: BEHAVIORAL

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.

Interventions

Education Group

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.

Intervention Type: BEHAVIORAL

Home Modifications Group

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Susan Stark

Assisstant Professor of Neurology and Occupational Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan L Stark, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine, Program in Occupational Therapy

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Other Identifiers

NCMRR 1611R03HD079841-01A1

Identifier Type: -

Identifier Source: org_study_id