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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07069660
Acronym
COMPASS 3
Enrollment
520
Registered
2025-07-17
Start date
2025-09-29
Completion date
2030-03-31
Last updated
2026-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

occupational therapy, stroke, adults, environmental modifications

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.

Interventions

BEHAVIORALCOMPASS

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.

BEHAVIORALEducation Program

The control group will experience the same effects of time and attention in the home but no effect on the outcome of interest.

Sponsors

Washington University School of Medicine
Lead SponsorOTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Admission to SNF (skilled nursing facility)From enrollment to 12 months post-discharge from inpatient rehabilitation facilityDate and days of admission to a skilled nursing facility

Countries

United States

Contacts

CONTACTSusan Stark, PhD
sstark@wustl.edu(314)935-2551
CONTACTBrianna Holden, OTR/L
barkocyb@wustl.edu(314)935-2501
PRINCIPAL_INVESTIGATORSusan Stark, PhD

Washington University School of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026