Diabetes Learning in Virtual Environments Just in Time for Community Reentry

Part of paid clinical trials in Storrs, Connecticut.

Sponsor
Louise Reagan
Study ID
NCT05286892
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Diabetes LIVE JustICE — OTHER
    Diabetes LIVE JustICE will be an adaptation of the current Diabetes LIVE persistent multi-user online virtual environment built on the Unreal Engine (Epic Games, Inc., Cary, NC) that allows users to talk to each other in real-time and participate in instructor-led synchronous sessions. Users can access the virtual environment through IOS/Android devices. Instructors can show learning material such as Google Docs and PowerPoint. The LIVE JustICE community will contain a community center, a tranquility center, and a message board. This will be an interactive community where participants will communicate in real-time on their mobile device or, if preferred, using their computer via text or audio chat. Access to LIVE will allow participants to utilize resources and links in the application, leave a message on the message board for the diabetes educators, or engage with other participants. Research team members will add and trial gaming activities to the VE during this feasibility study.
  • Enhanced Education — OTHER
    See control group description above

Study Details

The proposed study will use a randomized clinical trial design with non-equivalent control group and longitudinal design to evaluate the feasibility, acceptability, and preliminary effects of the Diabetes LIVE JustICE application. The design will incorporate repeated measures at 0, 6, and 12 weeks. Outcome variables will include recruitment assessments, participation, engagement, user experience, and measures proximally related to behavior change - e.g., diabetes knowledge, diabetes-related distress, diabetes self-care, and social support and clinical outcomes -e.g., glycemic control. Focus group interviewing will be conducted to evaluate acceptability among intervention group participants.

Key Dates

Start date
Apr 30, 2023
Status verified
Jul 2025
Primary completion
Nov 15, 2026
Completion
Dec 15, 2026

Study Design

Enrollment
128 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Control
    Participants randomized to the control group will receive enhanced pre-release diabetes education with registered or licensed practical nurse-delivered diabetes education about medications and insulin administration supplemented with the literacy tailored diabetes education packets used in the principal investigator's prior research.
  • Experimental: Intervention
    Because eight avatars plus the educator avatar are allowed in the VE classroom at one time, we will cap enrollment for the feasibility study to allow for CHW and CDE training and the opportunity to work together during LIVE JustICE sessions. The DSMES will consist of six synchronous 1-hour education sessions and an hour support session for participants living in supervised community housing in the experimental group. We will run the six-week series sequentially a total of eleven times over 18 months. LIVE JustICE sessions will be held conveniently for participants, and days/times rotated if needed.

Primary Outcome Measure

Demographics [ Time Frame: baseline ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of ConnecticutStorrsConnecticut06269
Louise A Reagan, PhD
[email protected]
18608745644
Stephen J Walsh, ScD
[email protected]
8608745644
Louise A Reagan, PhD (PRINCIPAL_INVESTIGATOR)
Stephen J Walsh, PhD (SUB_INVESTIGATOR)
University of ConnecticutStorrs MansfieldConnecticut06269-0001
Louise A Reagan, PhD
[email protected]
8608745644

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By research site
University of Connecticut· Storrs, CTUniversity of Connecticut· Storrs Mansfield, CT

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