ENGAGE Pilot Study: Promoting Participation and Health After Stroke

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04019275
• Collaborator: National Institutes of Health (NIH) (NIH)
• Enrollment: 32
• Locations: 3
• Arm: 1
• Anticipated Duration (Months): 40
• Patients Per Site: 10.7
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: ENGAGE Pilot Study: Promoting Participation and Health After Stroke
• Actual Study Start Date: Sep 1, 2019
• Actual Primary Completion Date: Jun 30, 2022
• Anticipated Study Completion Date: Dec 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Fidelity, indicated by score of 18 or higher out of 20 on the ENGAGE Fidelity Checklist [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 [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 [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 [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;

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Illinois at Chicago	Chicago	Illinois	United States	60612
2	Washington University	Saint Louis	Missouri	United States	63108
3	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15260

Sponsors and Collaborators

• University of Pittsburgh
• National Institutes of Health (NIH)

Investigators

• 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

Study Documents (Full-Text)

• Informed Consent Form - Feb 16, 2021

More Information

Publications

None provided.

• Responsible Party: Elizabeth R. Skidmore, PhD, OTR/L, Professor, Occupational Therapy, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT04019275
• Other Study ID Numbers: PRO19030256; UL1TR001857; UL1TR002345
• First Posted: Jul 15, 2019
• Last Update Posted: Aug 3, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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, Professor, Occupational Therapy, University of Pittsburgh: disability, rehabilitation
• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of Aug 3, 2022