ENGAGE Pilot Study: Promoting Participation and Health After Stroke

Stroke Clinical Trial

Official title:

ENGAGE Pilot Study: Promoting Participation and Health After Stroke

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04019275
• Other study ID #: PRO19030256
• Secondary ID: UL1TR001857UL1TR
• Status: Terminated
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: December 30, 2022

Study information

• Verified date: February 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: December 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• ENGAGE
ENGAGE blends social learning, guided discovery and skill training focused on community participation

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Washington University	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Adverse Events, Defined as Reported Injuries or Injurious Falls		week 7
Secondary	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