NCT07069660

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
520

participants targeted

Target at P75+ for not_applicable stroke

Timeline
48mo left

Started Sep 2025

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress13%
Sep 2025Mar 2030

First Submitted

Initial submission to the registry

July 14, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 17, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

September 29, 2025

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2030

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

4.5 years

First QC Date

July 14, 2025

Last Update Submit

February 12, 2026

Conditions

Keywords

occupational therapystrokeadultsenvironmental modifications

Outcome Measures

Primary Outcomes (1)

  • Admission to SNF (skilled nursing facility)

    Date and days of admission to a skilled nursing facility

    From enrollment to 12 months post-discharge from inpatient rehabilitation facility

Study Arms (2)

COMPASS intervention

EXPERIMENTAL

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.

Behavioral: COMPASS

Education Program

SHAM COMPARATOR

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.

Behavioral: Education Program

Interventions

COMPASSBEHAVIORAL

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.

COMPASS intervention

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

Education Program

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Missouri

Columbia, Missouri, 65211, United States

NOT YET RECRUITING

Washington University in St. Louis

St Louis, Missouri, 63110, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Susan Stark, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Stark, PhD

CONTACT

Brianna Holden, OTR/L

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2025

First Posted

July 17, 2025

Study Start

September 29, 2025

Primary Completion (Estimated)

March 31, 2030

Study Completion (Estimated)

March 31, 2030

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Final de-identified data will be preserved and shared with the public via WashU Research Data, an institutional repository managed by the Washington University in St. Louis Libraries. Datasets submitted to the data repository undergo curation prior to publication to ensure that the data are functioning, in the appropriate format, and well documented to facilitate long-term FAIRness (findable, accessible, interoperable and reusable). Submissions receive digital object identifiers minted with DataCite, and the library will retain the deposits for a minimum of 10 years.

Locations