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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Disabilities Multiple

Intervention / Treatment
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* Behavioral: ENGAGE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ENGAGE<br>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<br>* ENGAGE is a group intervention designed to improve social participation within the context of the COVID-19 pandemic.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Satisfaction | Client Satisfaction Questionnaire-8 (item average of 3 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 |