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Recruiting NCT05792852

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

No phase Interventional Disabilities Multiple

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ENGAGE.
Who it may be relevant to
Registry conditions: Disabilities Multiple. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

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

Primary outcome measures

  • Intervention Feasibility [Time frame: 8 weeks]
  • Intervention Satisfaction [Time frame: 8 weeks]
Secondary outcome measures (1)
  • Social Participation [Time frame: 8 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Illinois Chicago — Chicago

Identifiers

NCT: NCT05792852 · 2022-1393 · UL1TR002003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗