Feasibility of a Novel Intervention to Improve Participation After Stroke
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Rate and Severity of Falls (Calculated With an Algorithm)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Rate and Severity of Falls (Calculated With an Algorithm)
Time Frame: 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 Outcomes
- Intervention Dose, Number of Treatment Sessions(2 months)
- Health Care Utilization, Number of Emergency Department Visits(12 months)
- Intervention Dose (Minutes)(2 months)
- Health Care Utilization, Days of Hospitalization(12 months)
Investigators
Susan Stark
Assisstant Professor of Neurology and Occupational Therapy
Washington University School of Medicine