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

Sponsor

University of Illinois at Chicago (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05792852

Collaborator

National Center for Advancing Translational Sciences (NCATS) (NIH)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Disabilities Multiple	Behavioral: ENGAGE	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

21 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Oct 31, 2023

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Feasibility [8 weeks]
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
Satisfaction [8 weeks]
Client Satisfaction Questionnaire-8 (item average of 3 or greater)

Secondary Outcome Measures

Social Participation [8 weeks]
PROMIS Ability to Participate in Social Roles (Cohen's d=/> .2)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Illinois Chicago	Chicago	Illinois	United States	60612

Sponsors and Collaborators

University of Illinois at Chicago
National Center for Advancing Translational Sciences (NCATS)

Investigators

Principal Investigator: Joy Hammel, PhD, University of Illinois Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Joy M Hammel, Professor, University of Illinois at Chicago

ClinicalTrials.gov Identifier:

NCT05792852

Other Study ID Numbers:

2022-1393
UL1TR002003

First Posted:

Mar 31, 2023

Last Update Posted:

Mar 31, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 31, 2023