A Novel Transition Program to Reduce Disability After Stroke

Not Applicable

Completed

Conditions: Ischemic Stroke
Hemorrhagic Stroke

Registration Number: NCT03485820

Lead Sponsor: Washington University School of Medicine

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 185

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reintegration to Normal Living Index (RNLI)	Baseline and 12 months post-stroke	The RNLI is a disability-related quality-of life-instrument 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. It uses an 11-item, 10 point scale, with higher scores indicating greater reintegration to normal living. The sum score is divided by 110 and then multiplied by 100 to obtain an adjusted score. Adjusted scores range from 0 to 100, with higher scores indicating greater reintegration to normal living.

Secondary Outcome Measures

Name	Time	Method
In-Home Occupational Performance Evaluation (I-HOPE) - Satisfaction Score	Baseline and 12-months post-stroke	The In-Home Occupational Performance Evaluation (I-HOPE) satisfaction score is a mean rating of up to 10 participant-prioritized activities on a scale of 1 (not satisfied at all with their performance of the activity) to 5 (very satisfied with their performance of the activity). Higher mean scores indicate more satisfaction with self-rated activity performance.
In-Home Occupational Performance Evaluation (I-HOPE) - Barrier Severity Score	Baseline and 12-months post-stroke	The In-Home Occupational Performance Evaluation (I-HOPE) barrier severity score is a total sum of barrier ratings (0=independent with/without a device, 1=stand-by assistance needed, 2=minimum assistance needed, 3=moderate assistance needed, 4=maximum assistance needed, 5=no activity ) for all identified barriers across up to 10 prioritized activities. Multiple barriers could be identified for each prioritized activity. Higher sum scores indicate a greater need for assistance/less independence for completion of functional activities. There is no maximum score.
Stroke Impact Scale (SIS) - Activities of Daily Living (ADL) Domain	Baseline and 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. The Activities of Daily Living (ADL) domain was used to measure daily activity performance. The scale ranges from 0 to 100, with higher scores indicating less difficulty.
In-Home Occupational Performance Evaluation (I-HOPE) - Activity Score	Baseline and 12 months post-stroke	The In-Home Occupational Performance Evaluation (I-HOPE) activity score measures current activity patterns of participants across 44 activities. The score ranges from 0 to 1.0, with a higher score indicating fewer problematic activities for the participant.
In-Home Occupational Performance Evaluation (I-HOPE) - Performance Score	Baseline and 12 months post-stroke	The In-Home Occupational Performance Evaluation (I-HOPE) performance score is a mean rating of up to 10 participant-prioritized activities on a scale from 1 (unable to perform the activity at all) to 5 (able to perform the activity without difficulty). Higher mean scores indicate better functional ability to perform tasks without difficulty.

Trial Locations

Locations (1): Washington University School of Medicine
🇺🇸
Saint Louis, Missouri, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States