- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03485820
A Novel Transition Program to Reduce Disability After Stroke (COMPASS)
April 15, 2024 updated by: Washington University School of Medicine
COMPASS: A Novel Transition Program to Reduce Disability After Stroke
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
The proposed study investigates the efficacy and safety of a novel enhanced rehabilitation-transition program to reduce environmental barriers and improve daily activity performance and community participation.
Study Type
Interventional
Enrollment (Actual)
185
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Missouri
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Saint Louis, Missouri, United States, 63108
- Washington University School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: COMPASS
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.
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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.
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Sham Comparator: Education program
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.
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The control group will experience the same effects of time and attention in the home but no effect on the outcome of interest.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reintegration to Normal Living Index (RNLI)
Time Frame: 12 months post-stroke
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The RNLI is a disability-related quality-of life-instrument that will be 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.
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12 months post-stroke
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
In-Home Occupational Performance Evaluation (I-HOPE)
Time Frame: 12 months post-stroke
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The I-HOPE will be used to measure current activity patterns of participants, identify activities that are difficult but important to them, and identify the environmental barriers that influence those activities (person-environment fit).
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12 months post-stroke
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Stroke Impact Scale (SIS)
Time Frame: 12 months post-stroke
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The SIS is a health-related quality of life (HRQoL) measure that quantifies the impact of stroke on a client's life, via questionnaire.
59 items are measured across 8 domains, including: strength, hand function, mobility, Activities of Daily Living (ADLs) and Instrumental Activities of Daily Living (IADLs), emotion, memory, communication, and participation.
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12 months post-stroke
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Susan Stark, PhD, Washington University School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 20, 2018
Primary Completion (Actual)
February 28, 2024
Study Completion (Estimated)
May 1, 2024
Study Registration Dates
First Submitted
March 26, 2018
First Submitted That Met QC Criteria
March 26, 2018
First Posted (Actual)
April 2, 2018
Study Record Updates
Last Update Posted (Actual)
April 17, 2024
Last Update Submitted That Met QC Criteria
April 15, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201705047
- 1R01HD092398-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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