Compass 3: A Novel Transition Program to Reduce Disability After Stroke

Not Applicable

Not yet recruiting

• Conditions: Stroke

• Registration Number: NCT07069660
• Lead Sponsor: Washington University School of Medicine

Brief Summary

This study evaluates a program designed to help individuals transition from inpatient rehabilitation to home following an ischemic or hemorrhagic stroke. Half of the participants will receive a stroke education program while the other half will receive an environmental modifications program.

Detailed Description

A gap in care exists at the point of transition from inpatient rehabilitation (IR) to home, when survivors encounter new environmental barriers due to the cognitive and sensorimotor sequelae of stroke. Resolving these barriers and improving independence in the community have potential to significantly improve stroke survivors' long-term morbidity.

Investigators will conduct a randomized, controlled multi-center trial (RCT) and concurrent implementation evaluation and review of process data to examine therapeutic efficacy, cost-effectiveness and implementation potential of a compensatory intervention (COMPASS) designed to improve daily activity performance and participation outcomes in persons transitioning home from inpatient rehabilitation (IR) following a stroke.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-14
• Study First Submitted QC: 2025-07-14
• Last Update Submitted: 2025-07-14
• Study First Posted: 2025-07-17
• Last Update Posted: 2025-07-17
• Study Start: 2025-08-01
• Primary Completion: 2030-03
• Study Completion: 2030-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 520

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Admission to SNF (skilled nursing facility)	From enrollment to 12 months post-discharge from inpatient rehabilitation facility	Date and days of admission to a skilled nursing facility

Trial Locations

Locations (1)

Washington University in St. Louis; 🇺🇸 St. Louis, Missouri, United States