Back to resultsA Novel Transition Program to Reduce Disability After Stroke (COMPASS)
Primary Purpose
Ischemic Stroke, Hemorrhagic Stroke
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
COMPASS
Stroke education
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Stroke focused on measuring environmental modifications, activity performance
Eligibility Criteria
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.
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
COMPASS
Education program
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Reintegration to Normal Living Index (RNLI)
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.
Secondary Outcome Measures
Stroke Impact Scale (SIS)
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 and Instrumental Activities of Daily Living (ADLs/IADLs), emotion, memory, communication, and participation.
In-Home Occupational Performance Evaluation (I-HOPE)
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).
Full Information
NCT ID
NCT03485820
First Posted
March 26, 2018
Last Updated
July 17, 2023
Sponsor
Washington University School of Medicine
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT03485820
Brief Title
A Novel Transition Program to Reduce Disability After Stroke
Acronym
COMPASS
Official Title
COMPASS: A Novel Transition Program to Reduce Disability After Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 20, 2018 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Hemorrhagic Stroke
Keywords
environmental modifications, activity performance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-blind, parallel-group, randomized controlled trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
185 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COMPASS
Arm Type
Experimental
Arm Description
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.
Arm Title
Education program
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
COMPASS
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Stroke education
Intervention Description
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 Information:
Title
Reintegration to Normal Living Index (RNLI)
Description
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.
Time Frame
12 months post-stroke
Secondary Outcome Measure Information:
Title
Stroke Impact Scale (SIS)
Description
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 and Instrumental Activities of Daily Living (ADLs/IADLs), emotion, memory, communication, and participation.
Time Frame
12 months post-stroke
Title
In-Home Occupational Performance Evaluation (I-HOPE)
Description
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).
Time Frame
12 months post-stroke
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Stark, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31577356
Citation
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.
Results Reference
derived
Learn more about this trial
A Novel Transition Program to Reduce Disability After Stroke
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