Recruiting

Stroke Education & Environmental Modifications

Sponsor:

Washington University School of Medicine

Code:

NCT07069660

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

COMPASS

Education Program

Study Details

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.

Conditions

Stroke

Study ID

NCT07069660

Start date

Sep 29, 2025

Status verified date

Feb, 2026

Completion date

Mar 31, 2030

Anticipated

Primary completion date

Mar 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

520 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

sham comparator: 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.

Interventions

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.

Primary outcome measure

  • Admission to SNF (skilled nursing facility) [ Time Frame: From enrollment to 12 months post-discharge from inpatient rehabilitation facility ]

Central Contacts and Locations

Central contacts

Susan Stark, PhD

(314)935-2551sstark@wustl.edu

Brianna Holden, OTR/L

(314)935-2501barkocyb@wustl.edu

Locations

Washington University in St. Louis

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Susan Stark

314-935-2500sstark@wustl.edu

More Information

Sponsor

Washington University School of Medicine

Last update posted

Feb 13, 2026

Last verified

Feb, 2026

Keywords

  • occupational therapy
  • stroke
  • adults
  • environmental modifications

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-02-13.