A Novel Transition Program to Reduce Disability After Stroke

NCT03485820 | Completed Results

• 2 other identifiers: 2017050471R01HD092398-01
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates a program designed to help individuals transition home from inpatient rehabilitation 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

Ischemic Stroke; Hemorrhagic Stroke

Keywords

environmental modifications; activity performance

Outcome Measures

Primary Outcomes (1)

• Reintegration to Normal Living Index (RNLI)

  The RNLI is a disability-related quality-of life-instrument used to measure participants' satisfaction with their home and community participation and has been validated on a population of community-dwelling individuals with chronic conditions. It uses an 11-item, 10 point scale, with higher scores indicating greater reintegration to normal living. The sum score is divided by 110 and then multiplied by 100 to obtain an adjusted score. Adjusted scores range from 0 to 100, with higher scores indicating greater reintegration to normal living.

  Baseline and 12 months post-stroke

Secondary Outcomes (5)

• Stroke Impact Scale (SIS) - Activities of Daily Living (ADL) Domain

  Baseline and 12 months post-stroke

• In-Home Occupational Performance Evaluation (I-HOPE) - Activity Score

  Baseline and 12 months post-stroke

• In-Home Occupational Performance Evaluation (I-HOPE) - Performance Score

  Baseline and 12 months post-stroke

• In-Home Occupational Performance Evaluation (I-HOPE) - Satisfaction Score

  Baseline and 12-months post-stroke

• In-Home Occupational Performance Evaluation (I-HOPE) - Barrier Severity Score

  Baseline and 12-months post-stroke

Study Arms (2)

COMPASS

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. The treatment will include a set of 1 predischarge and four 75-minute postdischarge visits. The intervention is followed by 2 booster sessions.

Behavioral: COMPASS

Education program

SHAM COMPARATOR

An OT practitioner will deliver the program in accordance with "Evidence-Based Educational Guidelines for Stroke Survivors after Discharge Home." Topic order is determined by participants. Four 75-minute sessions will be provided. Topics may include stroke symptoms, risk factors and preventing stroke recurrence, nutrition, managing emotions, sleep, pain. Written materials from the National Stroke Association and the American Stroke Association are provided.

Behavioral: Stroke education

Interventions

COMPASS 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 three 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

Stroke education BEHAVIORAL

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

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged ≥50 years
• acute ischemic or hemorrhagic stroke diagnosis
• independent ADLs prior to stroke (premorbid Modified Rankin Scale Score ≤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 Short Blessed Test (SBT) score of 10 or less (indicating significant cognitive impairment)
• moderate to severe Aphasia as determined by the NIHSS Best Language rating of 2 or more
• reside in congregate living facility.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63108, United States

Location

Related Publications (4)

• Krauss MJ, Somerville E, Poiter C, Bollinger RM, Holden BM, Blenden G, Kretzer D, Stark SL. Functional performance of patients with stroke during inpatient rehabilitation: a cross-sectional study of home and access visits. BMC Health Serv Res. 2025 Jan 7;25(1):34. doi: 10.1186/s12913-024-12167-6.

  PMID: 39773227 DERIVED

• Bollinger RM, Krauss MJ, Somerville EK, Holden BM, Blenden G, Hollingsworth H, Keleman AA, Carter A, McBride TD, Barker AR, Yan Y, Stark SL. Rehabilitation Transition Program to Improve Community Participation Among Stroke Survivors: A Randomized Clinical Trial. JAMA Netw Open. 2024 Oct 1;7(10):e2437758. doi: 10.1001/jamanetworkopen.2024.37758.

  PMID: 39374016 DERIVED

• Krauss MJ, Holden BM, Somerville E, Blenden G, Bollinger RM, Barker AR, McBride TD, Hollingsworth H, Yan Y, Stark SL. Community Participation Transition After Stroke (COMPASS) Randomized Controlled Trial: Effect on Adverse Health Events. Arch Phys Med Rehabil. 2024 Sep;105(9):1623-1631. doi: 10.1016/j.apmr.2024.05.015. Epub 2024 May 19.

  PMID: 38772517 DERIVED

• Somerville E, Minor B, Keglovits M, Yan Y, Stark S. Effect of a Novel Transition Program on Disability After Stroke: A Trial Protocol. JAMA Netw Open. 2019 Oct 2;2(10):e1912356. doi: 10.1001/jamanetworkopen.2019.12356.

  PMID: 31577356 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Hemorrhagic Stroke

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Susy Stark
• Organization: Washington University in St. Louis

sstark@wustl.edu

3142734114

Study Officials

• Susan Stark, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• 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: SPONSOR

Model Details: Single-blind, parallel-group, randomized controlled trial

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 2, 2018
• Study Start: January 9, 2018
• Primary Completion: December 20, 2023
• Study Completion: February 28, 2024
• Last Updated: August 27, 2025
• Results First Posted: March 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)