Community Participation Transition After Stroke

Stroke Clinical Trial

— COMPASS  

Official title:

Feasibility of a Novel Intervention to Improve Participation After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02396589
• Other study ID #: NCMRR 1611R03HD079841-01A1
• Status: Completed
• Phase: N/A
• Start date: January 19, 2015
• Est. completion date: December 13, 2016

Study information

• Verified date: October 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 13, 2016
• Est. primary completion date: December 13, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intervention Adherence	Adherence to the intervention will be measured by examine the number of recommendations implemented per recommendations suggested. Long-term adherence will be calculated as the number of recommendations used at 9 months per recommendations suggested.	9 months
Primary	Rate and Severity of Falls (Calculated With an Algorithm)	We will explore the safety of the intervention by determining the rate and severity of falls (calculated with an algorithm). Scores are as follows: 0, those with no falls, 1, those with one fall without serious injury, 2, those with at least two falls without serious injury, and 3, those with one or more falls causing serious injury. Maximum score of three indicates an increased severity of fall. We will compare the difference in scores between groups using t-tests.	12 months
Secondary	Intervention Dose (Minutes)	The does of the intervention as measured in minutes received by both groups. The number of minutes reported is the average of the total for each participant in each group.	2 months
Secondary	Health Care Utilization, Number of Emergency Department Visits	We analyzed health care utilization by examining the number of emergency department visits, outpatient physical and occupational therapy visits, and doctor visits. The total number of each was calculated for each participant and the average is reported here.	12 months
Secondary	Intervention Dose, Number of Treatment Sessions	The does of the intervention as measured by amount of treatment minutes received by both groups. The total number of treatment sessions was calculated for each participant and the average is reported here.	2 months
Secondary	Health Care Utilization, Days of Hospitalization	We analyzed health care utilization by examining the number of days participants in each group spent in the hospital. The total number of days was calculated for participants in each group and the average is reported here.	12 months