A Novel Transition Program to Reduce Disability After Stroke

Study Overview
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Brief Summary
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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
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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.

Official Title
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COMPASS: A Novel Transition Program to Reduce Disability After Stroke

Conditions
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Ischemic Stroke, Hemorrhagic Stroke

Intervention / Treatment
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* Behavioral: COMPASS
* Behavioral: Stroke education


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-blind, parallel-group, randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COMPASS<br>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<br>* 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.<br>|
| Sham Comparator: Education program<br>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<br>* The control group will experience the same effects of time and attention in the home but no effect on the outcome of interest.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months post-stroke | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months post-stroke | 
| 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). | 12 months post-stroke | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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environmental modifications, activity performance