ENGAGE Pilot Study: Promoting Participation and Health After Stroke

University of Pittsburgh

Status: Terminated

Conditions: Stroke

Treatments: Behavioral: ENGAGE

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04019275

PRO19030256

UL1TR002345 (U.S. NIH Grant/Contract)

UL1TR001857 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

ENGAGE

Experimental group

Description:

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.

Treatment:

Behavioral: ENGAGE