ENGAGE Pilot Study: Promoting Participation and Health After Stroke

NCT04019275 | Terminated Results

• 3 other identifiers: PRO19030256UL1TR001857UL1TR002345
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 3

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.

Conditions

Stroke

Keywords

disability, rehabilitation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Cohen's d Effect Size of the Change From Week 1 to Week 7 in PROMIS Ability to Participate in Social Roles

  week 1 vs week 7

Study Arms (1)

ENGAGE

EXPERIMENTAL

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

Interventions

ENGAGE BEHAVIORAL

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

ENGAGE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (3)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Washington University

St Louis, Missouri, 63108, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

engage 8200

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

The ENGAGE Fidelity Checklist was not finalized due to changes in procedures during the COVID pandemic. Thus, while 4 of 24 sessions involving 9 participants were assessed for fidelity, and all 4 sessions met criteria for fidelity, the method for assessing fidelity was still in development and was only applied to a limited sample of sessions. Data pertaining to this should be interpreted with caution.

Results Point of Contact

• Title: Elizabeth Skidmore
• Organization: University of Pittsburgh

skidmore@pitt.edu

412-383-6620

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Occupational Therapy

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 15, 2019
• Study Start: September 1, 2019
• Primary Completion: June 30, 2022
• Study Completion: December 30, 2022
• Last Updated: February 21, 2024
• Results First Posted: June 23, 2023

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)