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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
Sponsor:
Information provided by (Responsible Party):
Susan Stark, Washington University School of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: Education Group Behavioral: Home Modifications Group Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Measuring the intervention dose [ Time Frame: 2 months ]
    Calculating the intervention received by both groups (number of minutes and number of sessions delivered).

  2. 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.


Other Outcome Measures:
  1. 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).



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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ≥45 years old
  2. acute ischemic stroke, verified by a neurologist
  3. baseline National Institutes of Health Stroke Scale (NIHSS) ≥8
  4. independent in activities of daily living prior to stroke (premorbid Rankin score of ≤2)
  5. plan to discharge to home

Exclusion Criteria:

  1. severe terminal systemic disease that limits life expectancy to <6 months
  2. previous disorder (e.g., dementia) that makes interpretation of the self-rated scales difficult or a Short Blessed Test (SBT) score of ≥9 (indicating significant cognitive impairment)
  3. moderate to severe aphasia, as determined by the NIHSS Best Language rating of ≥2
  4. residence in a congregate living facility
  5. not eligible for a therapeutic pass

Information from the National Library of Medicine

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


Locations
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Susan L Stark, PhD Washington University School of Medicine, Program in Occupational Therapy

Responsible Party: Susan Stark, Assisstant Professor of Neurology and Occupational Therapy, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02396589     History of Changes
Other Study ID Numbers: NCMRR 1611R03HD079841-01A1
First Posted: March 24, 2015    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018

Keywords provided by Susan Stark, Washington University School of Medicine:
stroke rehabilitation
barriers to independence
environmental support

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases