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

NCT ID: NCT07069660

Last Updated: 2025-11-25

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

520 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-29

Study Completion Date

2030-03-31

Brief Summary

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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

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Group Type EXPERIMENTAL

COMPASS

Intervention Type BEHAVIORAL

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.

Group Type SHAM_COMPARATOR

Education Program

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status NOT_YET_RECRUITING

Washington University in St. Louis

St Louis, Missouri, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Susan Stark, PhD

Role: CONTACT

(314)935-2551

Brianna Holden, OTR/L

Role: CONTACT

(314)935-2501

Facility Contacts

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Rachel Wolpert, PhD

Role: primary

573-884-2418

Susan Stark

Role: primary

314-935-2500

Other Identifiers

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2R01HD092398-06A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

202501232

Identifier Type: -

Identifier Source: org_study_id

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