A Novel Transition Program to Reduce Disability After Stroke

Ischemic Stroke Clinical Trial

— COMPASS  

Official title:

COMPASS: A Novel Transition Program to Reduce Disability After Stroke

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03485820
• Other study ID #: 201705047
• Secondary ID: 1R01HD092398-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 20, 2018
• Est. completion date: May 2024

Study information

• Verified date: April 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 185
• Est. completion date: May 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhagic Stroke
• Ischemic Stroke
• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 (ADLs) and Instrumental Activities of Daily Living (IADLs), emotion, memory, communication, and participation.	12 months post-stroke
Secondary	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