Community Participation Transition After Stroke (COMPASS)

The Washington University

Status: Completed

Conditions: Stroke

Treatments: Behavioral: Home Modifications Group; Behavioral: Education Group

Study type: Interventional

Funder types: Other

Identifiers

NCT02396589

NCMRR 1611R03HD079841-01A1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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15 participants in 2 patient groups

Education Group

Active Comparator group

Description:

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

Treatment:

Behavioral: Education Group

Home Modifications Group

Experimental group

Description:

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.

Treatment:

Behavioral: Home Modifications Group