Community Participation Transition After Stroke (COMPASS)
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|ClinicalTrials.gov Identifier: NCT02396589|
Recruitment Status : Completed
First Posted : March 24, 2015
Last Update Posted : April 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Behavioral: Education Group Behavioral: Home Modifications Group||Not Applicable|
We propose an enhanced rehabilitation transition program: Community Participation Transition after Stroke (COMPASS) is a compensatory intervention consisting of one pre-discharge and five post-discharge home visits by an occupational therapist to supplement usual care. This intervention is focused on resolving barriers to independence in daily activities and participation using environmental support and active practice of daily activities in an individual's real home (versus an idealized clinical setting). This is a new combination of evidence-based compensatory treatments delivered in a novel treatment setting (transition to home). Our long-term goal is the development of an effective intervention for a transition home designed to prevent excess disability for people living with stroke that could have an immediate effect and high public health significance.16
We will recruit 40 patients currently undergoing inpatient rehabilitation (IR) for ischemic stroke from longitudinal studies of stroke at Washington University School of Medicine (WUSM) and randomize them to receive six additional sessions of the enhanced rehabilitation transition program or attention control. Exploratory participation outcomes will be assessed by blinded evaluators at baseline, 6 months, 9 months, and 12 months after stroke.
We will test the central hypothesis that COMPASS will be acceptable, feasible, and superior to attention control on measures of participation and daily activity performance at 6 months after stroke.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Feasibility of a Novel Intervention to Improve Participation After Stroke|
|Actual Study Start Date :||January 19, 2015|
|Actual Primary Completion Date :||December 13, 2016|
|Actual Study Completion Date :||December 13, 2016|
Active Comparator: Education Group
Participants in the Education group receive five 90 minute tailored stroke education sessions in the home.
Behavioral: Education Group
Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.
Experimental: Home Modifications Group
Participants in the treatment group receive a home assessment and home modifications tailored to functional abilities (pre discharge) and then five 90 minute occupational therapy treatment sessions at home (post discharge) to improve functional abilities and community participation.
Behavioral: Home Modifications Group
The standardized components include assessment, identification of five problematic activities (and environmental barriers), identification of three solutions (for each problem), implementation of a solution set selected by the participant, training, and active practice of daily activities in one's own home and community.
- Measuring the Safety of the intervention (rate and severity of falls (calculated with an algorithm) [ Time Frame: 12 months ]We will explore the safety of the intervention by determining the rate and severity of falls (calculated with an algorithm).
- Measuring the intervention dose [ Time Frame: 2 months ]Calculating the intervention received by both groups (number of minutes and number of sessions delivered).
- Measuring health care utilization [ Time Frame: 12 months ]We will also examine health care utilization (emergency department and outpatient visits, number of hospitalizations, and days hospitalized) for both groups.
- Measuring adherence to the intervention [ Time Frame: 6 months ]Interventionists will rate adherence at visit 6, as the number of recommendations implemented per recommendations suggested. Long-term adherence will be calculated as the number of recommendations used at 6 months per recommendations suggested. We will examine reasons for abandonment of strategies (resolved motor skills will not count against adherence score).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02396589
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Susan L Stark, PhD||Washington University School of Medicine, Program in Occupational Therapy|