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

Disabilities Multiple Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05792852
• Other study ID #: 2022-1393
• Secondary ID: UL1TR002003
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: January 31, 2025

Study information

• Verified date: May 2024
• Source: University of Illinois at Chicago
• Contact: Joy Hammel, PhD
• Phone: (312) 996-3513
• Email: hammel[@]uic.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disabilities Multiple

Intervention

Behavioral:
• ENGAGE
ENGAGE is a group intervention designed to improve social participation within the context of the COVID-19 pandemic.

Locations

Country	Name	City	State
United States	University of Illinois Chicago	Chicago	Illinois

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Social Participation	PROMIS Ability to Participate in Social Roles (Cohen's d=/> .2)	8 weeks