Improving the Health and Social Participation of People With Disabilities From Underrepresented Groups Post COVID

Feasibility of ENGAGE to Address Social Isolation Related to the COVID-19 Pandemic

This is a single-arm community-based feasibility study examining recruitment, retention, adherence, and satisfaction with ENGAGE, a community-based intervention designed to address pandemic-related social isolation among people with disabilities. We will also examine preliminary, within-group effects on social participation. The findings of this study will inform a larger trial to examine intervention efficacy.

Study Overview

• Status: Recruiting
• Conditions: Disabilities Multiple
• Intervention / Treatment: Behavioral: ENGAGE

Detailed Description

Social isolation has been shown to negatively affect physical and mental health, particularly among people with disabilities. Social isolation among people with disabilities has been exacerbated by the COVID-19 pandemic. Even now, people with disabilities remain hesitant to return to social and community activities due to ongoing risk of severe cases and death. Yet, we do not have strong models of intervention designed to address this problem.

ENGAGE is an intervention that may address this gap. ENGAGE was designed to address social and community participation among people with stroke. We have since conducted qualitative research to inform adaptation of ENGAGE to meet the needs of a broader range of people with disabilities related to participation in the context of the ongoing COVID-19 pandemic. This study is the next step in testing and refining the adapted intervention protocol. At the end of this study, we will have a finalized adapted intervention protocol ready for large-scale efficacy testing.

• Study Type: Interventional
• Enrollment (Estimated): 21
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joy Hammel, PhD; Phone Number: (312) 996-3513; Email: hammel@uic.edu
• Study Contact Backup: Name: Jessica Kersey, PhD; Email: jmkersey@uic.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • University of Illinois Chicago
      • Contact: Joy Hammel, PhD; Phone Number: (312) 996-3513; Email: hammel@uic.edu
      • Contact: Jessica Kersey, PhD

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Self-identify as disabled
• Report problems with social participation
• Speak English
• Live in a community setting

Exclusion Criteria:

• Severe communication impairment limiting ability to verbally indicate interest in participation

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; ENGAGE uses social learning, guided problem-solving and applied skill training to promote social participation among people with disabilities within the context of the COVID-19 pandemic. This is a group intervention using a self-management framework.	Behavioral: ENGAGE; ENGAGE is a group intervention designed to improve social participation within the context of the COVID-19 pandemic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Feasibility	Recruitment (5-7 participants per group recruited within one month), retention (80% of participants complete follow up assessments), adherence (80% of participants complete the intervention group	8 weeks
Intervention Satisfaction	Client Satisfaction Questionnaire-8: 8-item scale of intervention satisfaction with a 32-point scale (higher scores indicate greater satisfaction). We will establish adequate acceptability if we achieve a mean score of 24 or greater.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social Participation	PROMIS Ability to Participate in Social Roles (Cohen's d=/> .2)	8 weeks

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Joy Hammel, PhD, University of Illinois Chicago

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: March 27, 2023
• First Submitted That Met QC Criteria: March 27, 2023
• First Posted (Actual): March 31, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 21, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2022-1393; UL1TR002003 (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
• product manufactured in and exported from the U.S.: No