Clinical trial NCT04019275: ENGAGE Pilot Study: Promoting Participation and Health After Stroke
Official title: ENGAGE Pilot Study: Promoting Participation and Health After Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Keywords: disability, rehabilitation
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2019-07-15
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Fidelity, Indicated by Score of 18 or Higher Out of 20 on the ENGAGE Fidelity Checklist
timeFrame: week 7
measure: Acceptability, Indicated by Score 24 or Higher Out of 32 on the Client Satisfaction Questionnaire
timeFrame: week 7
measure: Adverse Events, Defined as Reported Injuries or Injurious Falls
timeFrame: week 7
Secondary outcomes:
measure: Cohen's d Effect Size of the Change From Week 1 to Week 7 in PROMIS Ability to Participate in Social Roles
timeFrame: week 1 vs week 7
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Elizabeth R Skidmore, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Carolyn Baum, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Illinois at Chicago
name: Joy Hammel, PhD
role: PRINCIPAL_INVESTIGATOR
References: