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ENGAGE Pilot Study: Promoting Participation and Health After Stroke

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ClinicalTrials.gov Identifier: NCT04019275
Recruitment Status : Not yet recruiting
First Posted : July 15, 2019
Last Update Posted : July 17, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Elizabeth R. Skidmore, PhD, OTR/L, University of Pittsburgh

Brief Summary:
This is a multi-site single-arm community-based pilot study examining the feasibility, acceptability, safety, and estimated effects of the ENGAGE intervention, a community-based intervention to promote community participation after stroke. The study will also characterize variances in changes in community participation outcomes. These findings will provide the pilot data needed to inform a multi-site randomized controlled clinical trial.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: ENGAGE Not Applicable

Detailed Description:

Significant advancements in acute medical management have shifted stroke from an acute condition with a high prevalence of mortality to a chronic condition with high prevalence of morbidity. One of the leading causes of chronic illness and disability worldwide, stroke results in residual sensorimotor, cognition, and communication impairments. These impairments reduce over time, but few people have complete restoration of function. Hence, people with stroke-related disability do not resume pre-stroke levels of community participation (education; paid or volunteer work; civic, social, and religious activities; and leisure). Low levels of community participation are associated with inactivity, sedentary behavior, and social isolation, each contributors to cardiovascular disease, diabetes, obesity, pulmonary conditions, depression - and secondary stroke. These consequences are particularly problematic for people with low income who have limited resources.

Investigators at the University of Pittsburgh, Washington University, and the University of Illinois at Chicago have designed a self-management training program that uses social learning, motivational interviewing, and guided discovery to help people with mild to moderate stroke-related disability resume community participation, and to develop a strong network of social support. However, the combination of these elements has yet to be studied in people with chronic stroke-related disability who live with low income - one of the most vulnerable segments of the population. By partnering with the Community Research Fellows Program at Washington University and the Community PARTners Program at the University of Pittsburgh, this multi-site team seeks to design and implement a culturally-responsive program to promote community participation among people with stroke-related disability and low income. This new collaboration is the next logical step in the development and examination of community-based interventions to promote self-management and community participation after stroke.

The overall purpose of this research study is to examine the feasibility, safety, and acceptability of a multi-site community-based intervention to promote self-management of community participation after stroke, with a particular focus on the needs of people with low income. The study will also characterize variances in intervention response.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ENGAGE Pilot Study: Promoting Participation and Health After Stroke
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Arm Intervention/treatment
Experimental: ENGAGE
The intervention blends social learning, guided discovery, and skill training to promote community participation after stroke. The intervention is delivered in a group format and comprises group learning activities and individual action planning activities that address barriers to community participation after stroke.
Behavioral: ENGAGE
ENGAGE blends social learning, guided discovery and skill training focused on community participation




Primary Outcome Measures :
  1. Fidelity, indicated by score of 18 or higher out of 20 on the ENGAGE Fidelity Checklist [ Time Frame: week 7 ]
    number of sessions attaining >= 90% adherence to protocol; an independent evaluator will assess a random 20% of sessions using the ENGAGE Fidelity Checklist; the Checklist has 20 items, each rated as 2=exceptional, 1=adherent, 0=not adherent

  2. Acceptability, indicated by score 24 or higher out of 32 on the Client Satisfaction Questionnaire [ Time Frame: week 7 ]
    number of participants attaining >= 90% satisfaction; satisfaction is rated on 8 items with a 4-point likert scale, 4 indicating very high satisfaction; items are summed with total a total score of 32 indicating very high satisfaction;

  3. Adverse Events, defined as reported injuries or injurious falls [ Time Frame: week 7 ]
    <3% of participants reporting adverse events; investigators will tally the number of participants reporting injuries or injurious falls during the 6 week intervention;


Secondary Outcome Measures :
  1. Change in PROMIS Ability to Participate in Social Roles from week 1 to week 7 [ Time Frame: week 1 vs week 7 ]
    Cohen's d effect size of change >.20; the PROMIS measure is 8 items rated on a 5-point likert scale; 5=never any difficulty; scores are summed, with total scores 40 indicating high ability to participate;



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ages 18 and older
  • chronic stroke (minimum 3 months)
  • community-dwelling
  • mild to moderate stroke-related disability (NIHSS<=16)
  • restrictions in community participation (ACS <80% of pre-stroke activities)
  • low income (uninsured or underinsured)
  • able to provide written informed consent

Exclusion Criteria:

  • currently receiving rehabilitation serves
  • dementia diagnosis
  • severe aphasia (BDAE=0 or 1)
  • current major depressive disorder (unless treated and in partial remission)
  • current bipolar or psychotic disorder
  • substance abuse within 3 months

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): NCT04019275


Contacts
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Contact: Elizabeth R Skidmore, PhD 412-383-6617 skidmore@pitt.edu
Contact: Laura F Waterstram, MOT 412-383-1055 lfw11@pitt.edu

Locations
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United States, Illinois
University of Illinois at Chicago Not yet recruiting
Chicago, Illinois, United States, 60612
Contact: Joy Hammel, PhD    312-996-3513    hammel@uic.edu   
United States, Missouri
Washington University Not yet recruiting
Saint Louis, Missouri, United States, 63108
Contact: Carolyn Baum, PhD    314-286-1618    baumc@wustl.edu   
United States, Pennsylvania
University of Pittsburgh Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15260
Contact: Elizabeth R Skidmore, PhD    412-383-6617    skidmore@pitt.edu   
Contact: Laura F Waterstram, MOT    412-383-1055    lfw11@pitt.edu   
Sponsors and Collaborators
University of Pittsburgh
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Elizabeth R Skidmore, PhD University of Pittsburgh
Principal Investigator: Carolyn Baum, PhD Washington University School of Medicine
Principal Investigator: Joy Hammel, PhD University of Illinois at Chicago

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Responsible Party: Elizabeth R. Skidmore, PhD, OTR/L, Professor, Occupational Therapy, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04019275     History of Changes
Other Study ID Numbers: PRO19030256
UL1TR001857 ( U.S. NIH Grant/Contract )
UL1TR002345 ( U.S. NIH Grant/Contract )
First Posted: July 15, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Elizabeth R. Skidmore, PhD, OTR/L, University of Pittsburgh:
disability, rehabilitation

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