Community Participation Transition After Stroke (COMPASS)
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education Group
Home Modifications Group
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke rehabilitation, barriers to independence, environmental support
Eligibility Criteria
Inclusion Criteria:
- ≥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
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 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
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Education Group
Home Modifications Group
Arm Description
Participants in the Education group receive five 90 minute tailored stroke education sessions in the home.
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.
Outcomes
Primary Outcome Measures
Measuring the Safety of the intervention (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).
Secondary Outcome Measures
Measuring the intervention dose
Calculating the intervention received by both groups (number of minutes and number of sessions delivered).
Measuring health care utilization
We will also examine health care utilization (emergency department and outpatient visits, number of hospitalizations, and days hospitalized) for both groups.
Full Information
NCT ID
NCT02396589
First Posted
March 5, 2015
Last Updated
April 23, 2018
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02396589
Brief Title
Community Participation Transition After Stroke
Acronym
COMPASS
Official Title
Feasibility of a Novel Intervention to Improve Participation After Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
January 19, 2015 (Actual)
Primary Completion Date
December 13, 2016 (Actual)
Study Completion Date
December 13, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
We propose an enhanced rehabilitation transition program: Community Participation Transition after Stroke (COMPASS) is a compensatory intervention consisting of one pre-discharge and five post-discharge home visits by an occupational therapist to supplement usual care. This intervention is focused on resolving barriers to independence in daily activities and participation using environmental support and active practice of daily activities in an individual's real home (versus an idealized clinical setting). This is a new combination of evidence-based compensatory treatments delivered in a novel treatment setting (transition to home). Our long-term goal is the development of an effective intervention for a transition home designed to prevent excess disability for people living with stroke that could have an immediate effect and high public health significance.16
We will recruit 40 patients currently undergoing inpatient rehabilitation (IR) for ischemic stroke from longitudinal studies of stroke at Washington University School of Medicine (WUSM) and randomize them to receive six additional sessions of the enhanced rehabilitation transition program or attention control. Exploratory participation outcomes will be assessed by blinded evaluators at baseline, 6 months, 9 months, and 12 months after stroke.
We will test the central hypothesis that COMPASS will be acceptable, feasible, and superior to attention control on measures of participation and daily activity performance at 6 months after stroke.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke rehabilitation, barriers to independence, environmental support
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Education Group
Arm Type
Active Comparator
Arm Description
Participants in the Education group receive five 90 minute tailored stroke education sessions in the home.
Arm Title
Home Modifications Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Education Group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Home Modifications Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measuring the Safety of the intervention (rate and severity of falls (calculated with an algorithm)
Description
We will explore the safety of the intervention by determining the rate and severity of falls (calculated with an algorithm).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Measuring the intervention dose
Description
Calculating the intervention received by both groups (number of minutes and number of sessions delivered).
Time Frame
2 months
Title
Measuring health care utilization
Description
We will also examine health care utilization (emergency department and outpatient visits, number of hospitalizations, and days hospitalized) for both groups.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Measuring adherence to the intervention
Description
Interventionists will rate adherence at visit 6, as the number of recommendations implemented per recommendations suggested. Long-term adherence will be calculated as the number of recommendations used at 6 months per recommendations suggested. We will examine reasons for abandonment of strategies (resolved motor skills will not count against adherence score).
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥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
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan L Stark, PhD
Organizational Affiliation
Washington University School of Medicine, Program in Occupational Therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Community Participation Transition After Stroke
We'll reach out to this number within 24 hrs