Community Participation Transition After Stroke

NCT02396589 | Completed Results

• 1 other identifier: NCMRR 1611R03HD079841-01A1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is one of the most serious, disabling health conditions in the United States. Patients who undergo rehabilitation treatment for stroke have a high rate of disability. Poor outcomes for many persons with stroke may be low because of incomplete treatment. The investigators will conduct a randomized controlled trial and a process evaluation to examine the feasibility, safety, and preliminary efficacy of an enhanced rehabilitation transition program, Community Participation Transition after Stroke (COMPASS), designed to bridge inpatient rehabilitation and the home to support the performance of everyday activities.

Conditions

Stroke

Keywords

stroke rehabilitation; barriers to independence; environmental support

Outcome Measures

Primary Outcomes (1)

• Rate and Severity of Falls (Calculated With an Algorithm)

  We will explore the safety of the intervention by determining the rate and severity of falls (calculated with an algorithm). Scores are as follows: 0, those with no falls, 1, those with one fall without serious injury, 2, those with at least two falls without serious injury, and 3, those with one or more falls causing serious injury. Maximum score of three indicates an increased severity of fall. We will compare the difference in scores between groups using t-tests.

  12 months

Secondary Outcomes (4)

• Intervention Dose (Minutes)

  2 months

• Health Care Utilization, Number of Emergency Department Visits

  12 months

• Intervention Dose, Number of Treatment Sessions

  2 months

• Health Care Utilization, Days of Hospitalization

  12 months

Other Outcomes (1)

• Intervention Adherence

  9 months

Study Arms (2)

Education Group

ACTIVE COMPARATOR

Participants in the Education group receive five 90 minute tailored stroke education sessions in the home.

Behavioral: Education Group

Home Modifications Group

EXPERIMENTAL

Participants in the treatment group receive a home assessment and home modifications tailored to functional abilities (pre discharge) and then five 90 minute occupational therapy treatment sessions at home (post discharge) to improve functional abilities and community participation.

Behavioral: Home Modifications Group

Interventions

Education Group BEHAVIORAL

Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.

Education Group

Home Modifications Group BEHAVIORAL

The standardized components include assessment, identification of five problematic activities (and environmental barriers), identification of three solutions (for each problem), implementation of a solution set selected by the participant, training, and active practice of daily activities in one's own home and community.

Home Modifications Group

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥45 years old
• acute ischemic stroke, verified by a neurologist
• baseline National Institutes of Health Stroke Scale (NIHSS) ≥8
• independent in activities of daily living prior to stroke (premorbid Rankin score of ≤2)
• plan to discharge to home

You may not qualify if:

• severe terminal systemic disease that limits life expectancy to \<6 months
• previous disorder (e.g., dementia) that makes interpretation of the self-rated scales difficult or a Short Blessed Test (SBT) score of ≥9 (indicating significant cognitive impairment)
• moderate to severe aphasia, as determined by the NIHSS Best Language rating of ≥2
• residence in a congregate living facility
• not eligible for a therapeutic pass

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Susan Stark
• Organization: Washington University in St. Louis School of Medicine

sstark@wustl.edu

3142734114

Study Officials

• Susan L Stark, PhD

  Washington University School of Medicine, Program in Occupational Therapy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

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: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Professor of Neurology and Occupational Therapy

Study Record Dates

• First Submitted: March 5, 2015
• First Posted: March 24, 2015
• Study Start: January 19, 2015
• Primary Completion: December 13, 2016
• Study Completion: December 13, 2016
• Last Updated: August 27, 2025
• Results First Posted: April 12, 2024

Record last verified: 2025-08

Locations

US (1)