Community Participation Transition After Stroke "COMPASS"

Recruiting

Phase N/A Results N/A

Trial Description

Stroke is one of the most serious, disabling health conditions in the United States. Patients who undergo rehabilitation treatment for stroke have a high rate of disability. Poor outcomes for many persons with stroke may be low because of incomplete treatment. The investigators will conduct a randomized controlled trial and a process evaluation to examine the feasibility, safety, and preliminary efficacy of an enhanced rehabilitation transition program, Community Participation Transition after Stroke (COMPASS), designed to bridge inpatient rehabilitation and the home to support the performance of everyday activities.

Detailed Description

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.

Conditions

Interventions

  • Education Group Behavioral
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Education Group
    Description: Participants in the Education group receive five 90 minute tailored stroke education sessions in the home.
  • Home Modifications Group Behavioral
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Home Modifications Group
    Description: 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.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Measuring the Safety of the intervention (rate and severity of falls (calculated with an algorithm) 12 months Yes
Secondary Measuring the intervention dose 2 months No
Secondary Measuring health care utilization 12 months No

Sponsors