NCT05792852

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 31, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

April 24, 2025

Status Verified

April 1, 2025

Enrollment Period

2.8 years

First QC Date

March 27, 2023

Last Update Submit

April 21, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Social Participation

    8 weeks

Study Arms (1)

ENGAGE

EXPERIMENTAL

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

Interventions

ENGAGEBEHAVIORAL

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

ENGAGE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois Chicago

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Interventions

engage 8200

Study Officials

  • Joy Hammel, PhD

    University of Illinois Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joy Hammel, PhD

CONTACT

Jessica Kersey, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 27, 2023

First Posted

March 31, 2023

Study Start

April 1, 2023

Primary Completion

January 31, 2026

Study Completion

January 31, 2026

Last Updated

April 24, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations