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

The Washington University

Status: Enrolling

Conditions: Stroke

Treatments: Behavioral: Education Program; Behavioral: COMPASS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07069660

202501232

2R01HD092398-06A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 520 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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520 participants in 2 patient groups

COMPASS intervention

Experimental group

Description:

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.

Treatment:

Behavioral: COMPASS

Education Program

Sham Comparator group

Description:

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.

Treatment:

Behavioral: Education Program