Clinical trial NCT03485820: A Novel Transition Program to Reduce Disability After Stroke
Official title: COMPASS: A Novel Transition Program to Reduce Disability After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Hemorrhagic Stroke
Keywords: environmental modifications
activity performance
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2018-04-02
Enrollment: 185
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind, parallel-group, randomized controlled trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Reintegration to Normal Living Index (RNLI)
timeFrame: Baseline and 12 months post-stroke
Secondary outcomes:
measure: Stroke Impact Scale (SIS) - Activities of Daily Living (ADL) Domain
timeFrame: Baseline and 12 months post-stroke
measure: In-Home Occupational Performance Evaluation (I-HOPE) - Activity Score
timeFrame: Baseline and 12 months post-stroke
measure: In-Home Occupational Performance Evaluation (I-HOPE) - Performance Score
timeFrame: Baseline and 12 months post-stroke
measure: In-Home Occupational Performance Evaluation (I-HOPE) - Satisfaction Score
timeFrame: Baseline and 12-months post-stroke
measure: In-Home Occupational Performance Evaluation (I-HOPE) - Barrier Severity Score
timeFrame: Baseline and 12-months post-stroke
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Susan Stark, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.