Compass 3: A Novel Transition Program to Reduce Disability After Stroke
NCT ID: NCT07069660
Last Updated: 2025-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
520 participants
INTERVENTIONAL
2025-09-29
2030-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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COMPASS intervention
COMPASS is a complex intervention that combines 2 evidence-based treatment strategies at a new point of care (transition from inpatient rehabilitation). The objective of home visits by an occupational therapy (OT) practitioner is to remediate barriers in the home and community that influence daily activities and community participation.
COMPASS
The data from the baseline assessment will be used to develop an environmental modification intervention plan. Environmental modifications will be installed before discharge if possible. Problem areas addressed are participant specific (tailored), but the process to identify and address the target area is systematic. All participants will receive identical intervention components. The standardized components include assessment, identification of problematic activities (and environmental barriers), identification of solutions for each problem, implementation of solution set selected by the participant, training, and active practice of daily activities in one's own home and community.
Education Program
A research team member will deliver the program in accordance with "Evidence-Based Educational Guidelines for Stroke Survivors after Discharge Home." Topics may include stroke symptoms, risk factors and preventing stroke recurrence.
Education Program
The control group will experience the same effects of time and attention in the home but no effect on the outcome of interest.
Interventions
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COMPASS
The data from the baseline assessment will be used to develop an environmental modification intervention plan. Environmental modifications will be installed before discharge if possible. Problem areas addressed are participant specific (tailored), but the process to identify and address the target area is systematic. All participants will receive identical intervention components. The standardized components include assessment, identification of problematic activities (and environmental barriers), identification of solutions for each problem, implementation of solution set selected by the participant, training, and active practice of daily activities in one's own home and community.
Education Program
The control group will experience the same effects of time and attention in the home but no effect on the outcome of interest.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
55 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Susan Stark, PhD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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University of Missouri
Columbia, Missouri, United States
Washington University in St. Louis
St Louis, Missouri, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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202501232
Identifier Type: -
Identifier Source: org_study_id
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