ENGAGE Pilot Study: Promoting Participation and Health After Stroke

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.

Study Overview

• Status: Terminated
• Conditions: Stroke
• Intervention / Treatment: Behavioral: ENGAGE

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 Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago
  • Missouri
    • Saint Louis, Missouri, United States, 63108
      • Washington University
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15260
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fidelity, Indicated by Score of 18 or Higher Out of 20 on the ENGAGE Fidelity Checklist	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	week 7
Acceptability, Indicated by Score 24 or Higher Out of 32 on the Client Satisfaction Questionnaire	Number of participants attaining >= 90% satisfaction; satisfaction is rated on 8 items with a 4-point Likert-type scale, 4 indicating very high satisfaction. Items are summed with total score ranging from 8 indicating poor satisfaction to 32 indicating very high satisfaction.	week 7
Adverse Events, Defined as Reported Injuries or Injurious Falls		week 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohen's d Effect Size of the Change From Week 1 to Week 7 in PROMIS Ability to Participate in Social Roles	The PROMIS Ability to Participate in Social Roles scale measures difficulty participating in social roles and activities. Eight items are rated on a Liker-type scale from 1=always having difficulty to 5=never having difficulty. Raw total scores (range 8 to 40) are converted to standardized T-scores with a population mean of 50, with a standard deviation of 10. Higher T-scores are associated with less difficulty. A T-score of 40 is considered subclinical difficulty with ability to participate in social roles and activities. A Cohen's d=.20 is considered a small effect size, d=.50 is considered a medium effect size, and d=.80 is considered a large effect size. A positive Cohen's d effect size indicates a higher score at week 7 than week 1. A negative Cohen's d effect size indicates a higher score at week 1 than week 7.	week 1 vs week 7

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• 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 record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: July 11, 2019
• First Submitted That Met QC Criteria: July 11, 2019
• First Posted (Actual): July 15, 2019

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: disability, rehabilitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: PRO19030256; UL1TR002345 (U.S. NIH Grant/Contract); UL1TR001857 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No