A Novel Transition Program to Reduce Disability After Stroke (COMPASS)
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|ClinicalTrials.gov Identifier: NCT03485820|
Recruitment Status : Recruiting
First Posted : April 2, 2018
Last Update Posted : April 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Stroke Hemorrhagic Stroke||Behavioral: COMPASS Behavioral: Stroke education||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||156 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Single-blind, parallel-group, randomized controlled trial|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||COMPASS: A Novel Transition Program to Reduce Disability After Stroke|
|Actual Study Start Date :||January 18, 2018|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
COMPASS is a complex intervention that combines 2 evidence-based treatment strategies at a new point of care (transition from inpatient rehabilitation). The objective of home visits by an OT provider is to remediate barriers in the home and community that influence daily activities and community participation. The treatment will include a set of 1 predischarge and four 75-minute postdischarge visits. The intervention is followed by 2 booster sessions.
The data from the baseline assessment will be used to develop an environmental modification intervention plan. Environmental modifications will be installed before discharge if possible. Problem areas addressed are participant specific (tailored), but the process to identify and address the target area is systematic. All participants will receive identical intervention components. The standardized components include assessment, identification of problematic activities (and environmental barriers), identification of three solutions (for each problem), implementation of solution set selected by the participant, training, and active practice of daily activities in one's own home and community.
Sham Comparator: Education program
An OT practitioner will deliver the program in accordance with "Evidence-Based Educational Guidelines for Stroke Survivors after Discharge Home." Topic order is determined by participants. Four 75-minute sessions will be provided. Topics may include stroke symptoms, risk factors and preventing stroke recurrence, nutrition, managing emotions, sleep, pain. Written materials from the National Stroke Association and the American Stroke Association are provided.
Behavioral: Stroke education
The control group will experience the same effects of time and attention in the home but no effect on the outcome of interest.
- Reintegration to Normal Living Index (RNLI) [ Time Frame: 12 months post-stroke ]The RNLI is a disability-related quality-of life-instrument that will be used to measure participants' satisfaction with their home and community participation and has been validated on a population of community-dwelling individuals with chronic conditions.
- Stroke Impact Scale (SIS) [ Time Frame: 12 months post-stroke ]The SIS is a health-related quality of life (HRQoL) measure that quantifies the impact of stroke on a client's life, via questionnaire. 59 items are measured across 8 domains, including: strength, hand function, mobility, ADLs/IADLs, emotion, memory, communication, and participation.
- In-Home Occupational Performance Evaluation (I-HOPE) [ Time Frame: 12 months post-stroke ]The I-HOPE will be used to measure current activity patterns of participants, identify activities that are difficult but important to them, and identify the environmental barriers that influence those activities (person-environment fit).
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): NCT03485820
|Contact: Megan Baldenweck, BAemail@example.com|
|Contact: Emily Somerville, OTDfirstname.lastname@example.org|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|Saint Louis, Missouri, United States, 63108|
|Contact: Megan Baldenweck, BA 314-273-4115 email@example.com|
|Contact: Emily Somerville, OTD 314-273-4117 firstname.lastname@example.org|
|Principal Investigator:||Susan Stark, PhD||Washington University School of Medicine|