COMPASS: Home transition program to reduce disability after stroke
Compass 3: A Novel Transition Program to Reduce Disability After a Stroke
NA · Washington University School of Medicine · NCT07069660
This program will test whether a home-focused environmental modifications intervention helps people aged 55 and older returning home from inpatient stroke rehabilitation do everyday activities better than a standard stroke education program.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 520 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine (other) |
| Locations | 2 sites (Columbia, Missouri and 1 other locations) |
| Trial ID | NCT07069660 on ClinicalTrials.gov |
What this trial studies
Researchers will run a randomized, controlled multi-center trial comparing a compensatory environmental modifications intervention (COMPASS) to a standard stroke education program for people discharged home after an ischemic or hemorrhagic stroke. Participants are randomized at discharge from inpatient rehabilitation and the study collects outcomes on daily activity performance, participation, cost-effectiveness, and implementation processes. A concurrent implementation evaluation and process-data review will examine how the intervention is delivered, barriers to uptake, and potential scalability. The trial is conducted at sites in Missouri and targets adults who were independent before their stroke and able to consent.
Who should consider this trial
Good fit: Ideal candidates are adults aged 55 or older with a recent ischemic or hemorrhagic stroke who were independent before the stroke and plan to be discharged to home from inpatient rehabilitation and can give informed consent.
Not a fit: Patients with severe cognitive or communication impairments that prevent informed consent or completion of study activities, those living in congregate care, or those with life expectancy under six months are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the COMPASS approach could increase independence in daily activities and reduce long-term disability for people returning home after stroke.
How similar studies have performed: Smaller single-site and pilot studies of home modifications and compensatory occupational therapy approaches have shown promising improvements in function, but this multi-center randomized trial tests broader effectiveness and implementation potential.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged ≥55 years at the time of screening * Acute stroke diagnosis (IS or ICH) verified by the stroke team or medical record * Independent in activities of daily living (ADLs) prior to stroke (premorbid Modified Rankin Scale score ≤2) * Plan to discharge to home from an IR * Capable of giving informed consent which includes compliance with the requirements and duration of participation as listed in the Informed Consent Form (ICF). Exclusion Criteria: * Life expectancy \<6 months * Cognitive impairment that the participant's stroke team or a research team member believes impairs their ability to provide informed consent or make reasoned choice including the interpretation of the self-rated scales * Any communication problem that would prevent study completion * Residence in a congregate living facility * Not eligible for a therapeutic pass * Residence outside of the designated catchment area (specific catchment distance to be determined by each site) * Site investigator's judgment that the participant would not be able to complete research procedures or interventions * Participation in another research study that in the site investigator's judgment could interfere or conflict with this research study's assessments or interventions
Where this trial is running
Columbia, Missouri and 1 other locations
- University of Missouri — Columbia, Missouri, United States (NOT_YET_RECRUITING)
- Washington University in St. Louis — St Louis, Missouri, United States (RECRUITING)
Study contacts
- Principal investigator: Susan Stark, PhD — Washington University School of Medicine
- Study coordinator: Susan Stark, PhD
- Email: sstark@wustl.edu
- Phone: (314)935-2551
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stroke, occupational therapy, stroke, adults, environmental modifications