COMPASS: A Novel Transition Program to Reduce Disability After Stroke
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 Design
Arms and Interventions
| 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. |
Behavioral: COMPASS
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. |
Behavioral: Stroke education
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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Outcome Measures
Primary Outcome Measures
- Reintegration to Normal Living Index (RNLI) [12 months post-stroke]
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) [12 months post-stroke]
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) [12 months post-stroke]
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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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aged ≥50 years
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acute ischemic or hemorrhagic stroke diagnosis
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independent ADLs prior to stroke (premorbid Modified Rankin Scale Score ≤2)
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plan to discharge to home
Exclusion Criteria:
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severe terminal systemic disease that limits life expectancy to < 6 months
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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)
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moderate to severe Aphasia as determined by the NIHSS Best Language rating of 2 or more
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reside in congregate living facility.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63108 |
Sponsors and Collaborators
- Washington University School of Medicine
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
- Principal Investigator: Susan Stark, PhD, Washington University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 201705047
- 1R01HD092398-01