Clinical trial NCT02396589: Community Participation Transition After Stroke
Official title: Feasibility of a Novel Intervention to Improve Participation After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke rehabilitation
barriers to independence
environmental support
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2015-03-24
Enrollment: 15
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Rate and Severity of Falls (Calculated With an Algorithm)
timeFrame: 12 months
Secondary outcomes:
measure: Intervention Dose (Minutes)
timeFrame: 2 months
measure: Health Care Utilization, Number of Emergency Department Visits
timeFrame: 12 months
measure: Intervention Dose, Number of Treatment Sessions
timeFrame: 2 months
measure: Health Care Utilization, Days of Hospitalization
timeFrame: 12 months
Other outcomes:
measure: Intervention Adherence
timeFrame: 9 months
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine, Program in Occupational Therapy
name: Susan L Stark, PhD
role: PRINCIPAL_INVESTIGATOR
References: