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Trial record 49 of 52 for:    Developmental Disabilities | Recruiting Studies | NIH

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 : June 7, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
This study evaluates a program designed to help individuals transition home from inpatient rehabilitation following an ischemic or hemorrhagic stroke. Half of the participants will receive a stroke education program while the other half will receive an environmental modifications program.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Hemorrhagic Stroke Behavioral: COMPASS Behavioral: Stroke education Not Applicable

Detailed Description:
A gap in care exists at the point of transition from inpatient rehabilitation (IR) to home, when survivors encounter new environmental barriers due to the cognitive and sensorimotor sequelae of stroke. Resolving these barriers and improving independence in the community have potential to significantly improve stroke survivors' long-term morbidity. The proposed study investigates the efficacy and safety of a novel enhanced rehabilitation-transition program to reduce environmental barriers and improve daily activity performance and community participation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single-blind, parallel-group, randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: COMPASS
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 occupational therapy (OT) practitioner 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.
Behavioral: COMPASS
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • aged ≥50 years
  • acute ischemic or hemorrhagic stroke diagnosis
  • independent ADLs prior to stroke (premorbid Modified Rankin Scale Score ≤2)
  • plan to discharge to home

Exclusion Criteria:

  • severe terminal systemic disease that limits life expectancy to < 6 months
  • previous disorder (e.g. dementia) that makes interpretation of the self-rated scales difficult or SBT score of 10 or less (indicating significant cognitive impairment)
  • moderate to severe Aphasia as determined by the NIHSS Best Language rating of 2 or more
  • reside in congregate living facility.

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): NCT03485820


Contacts
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Contact: Emily Somerville, OTD 314-273-4117 somervillee@wustl.edu
Contact: Brittany Minor, MSOT 314-273-4116 bminor@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63108
Contact: Megan Baldenweck, BA    314-273-4115    meganbaldenweck@wustl.edu   
Contact: Emily Somerville, OTD    314-273-4117    somervillee@wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Susan Stark, PhD Washington University School of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03485820     History of Changes
Other Study ID Numbers: 201705047
1R01HD092398-01 ( U.S. NIH Grant/Contract )
First Posted: April 2, 2018    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Washington University School of Medicine:
environmental modifications
activity performance
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases