Diabetes Learning in Virtual Environments Just in Time for Community Reentry

NCT ID: NCT05286892

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-30
• Study Completion Date: 2026-12-15

Brief Summary

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.

Detailed Description

Among incarcerated persons, the rate of diabetes is almost 50% higher (9%) than the general population (6.5%) when matched for sex, age, race, and Hispanic origin. The burden of diabetes is carried forward post-incarceration, with 95% of incarcerated persons reentering the community with minimal health-related skills stemming from high-security environments with constrained self-care. These individuals lack critical knowledge and skills for diabetes self-management (DSM) regarding what foods to eat, how to control the formerly incarcerated person's blood sugar, and how and when to take insulin. Furthermore, the Principal Investigator's research in correctional institutions has demonstrated significant diabetes knowledge deficits related to treating potentially life-threatening hypo/hyperglycemia. A1C, a measure of metabolic control and predictive for diabetes complications, was suboptimal for the majority of participants. Furthermore, these returning citizens have cognitive impairment and lower literacy than those living in community households across age, sex, and educational attainment. The formerly incarcerated have higher hospitalization rates for short-term diabetes complications seven days' post-prison release compared to matched controls. Prevention is possible with Diabetes Self-Management Education and Support (DSMES) and diabetes survival skills (DSS). DSS refers to hypoglycemia and sick day management, insulin administration, and consistent nutrition habits, among other behaviors to prevent acute diabetes issues (hypo/hyperglycemia), and hospitalizations. At a minimum, incarcerated persons transitioning to the community have a critical need for DSS and support.

There have been efforts to examine the effect of engaging incarcerated persons in blood glucose monitoring on glycemic control. Still, those released from incarceration have not benefitted from the decades of research that have resulted in improved outcomes. As a first step to filling this gap, the research team developed a literacy-tailored 6-week theory-based DSS intervention. The research team tested the feasibility and acceptability of the DSS intervention in incarcerated men between 6 to 9 months of transitioning from state prisons to supervised community housing or parole. The Principal Investigator found improvements in diabetes knowledge and diabetes-related distress in both groups and outcome expectancy with the treatment group. Analysis of focus group data revealed acceptance of the literacy-tailored DSS education, a need for skill-based videos, and ongoing support upon release. After an analysis of the research team's retention rate and feasibility data, the research team identified the haphazard process of releasing individuals to supervised community housing as a significant contributor to retention for the research team's in-person pre-release DSS intervention.

Consequently, the primary investigator recognized a critical need to make the literacy-tailored DSS and ongoing DSMES widely accessible to returning citizens with diabetes after release to supervised housing via synchronous and asynchronous remote options. Based on the evidence that virtual environments (VE) may lead to superior learning and experience for the participants and can promote social and educational interaction via repetition, practice, feedback, and application,24,25 the research team aims to leverage the research team's collective experience with diabetes Learning in Virtual Environments (LIVE) a diabetes educator-led, DSMES in a VE26-28 to develop the Diabetes LIVE JustICE (Just In time for Community reentry) intervention using an iterative participant engaged process. Because persons living in supervised community housing do not have access to reliable private computers but do have access to mobile devices, the research team will develop Diabetes LIVE JustICE as a mobile application. The Principal Investigator's goal is to recruit a sample of vulnerable incarcerated persons with multimorbidity, including diabetes on the transition to supervised community living to develop and test the feasibility and acceptability of a multi-user virtual diabetes community (Diabetes LIVE JustICE). This platform allows users to talk to each other in real-time and participate in instructor-led education sessions and facilitated support sessions accessed through IOS/Android mobile devices. The specific aims of this study are to:

1. Examine feasibility and acceptability of the Diabetes LIVE JustICE application by tracking the following outcomes: recruitment rate, participation rates (number of log-ins, time spent in mobile application, retention) engagement (materials accessed), and the user experience (usability, usefulness, satisfaction, and attitudes toward use of Diabetes LIVE JustICE).

2. Examine the preliminary short-term effects of Diabetes LIVE JustICE compared to usual pre-release diabetes care supplemented with low literacy diabetes education materials on the following outcomes: A1C, diabetes knowledge, diabetes self-care, diabetes-related emotional distress, social support, and perceived competence.

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Enhanced Education

Intervention Type: OTHER

See control group description above

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.

Group Type: EXPERIMENTAL

Diabetes LIVE JustICE

Intervention Type: 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.

Interventions

Diabetes LIVE JustICE

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.

Intervention Type: OTHER

Enhanced Education

See control group description above

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Individuals will be eligible to participate if they:

1. have Type 1 or 2 diabetes

2. are age 18 and older

3. can speak and understand English

4. have been released directly from one of five Connecticut prisons to supervised community housing or parole

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Diabetes Association

OTHER

Sponsor Role: collaborator

Louise Reagan

OTHER

Sponsor Role: lead

Responsible Party

Louise Reagan

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lousie Reagan, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Connecticut

Locations

University of Connecticut

Storrs, Connecticut, United States

Site Status: RECRUITING

University of Connecticut

Storrs Mansfield, Connecticut, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lousie Reagan, PhD

Role: CONTACT

louise.reagan@uconn.edu

860-486-0593

Stephen Walsh, ScD

Role: CONTACT

stephen.walsh@uconn.edu

860-486-0544

Facility Contacts

Louise A Reagan, PhD

Role: primary

louise.reagan@uconn.edu

18608745644

Stephen J Walsh, ScD

Role: backup

louise.reagan@uconn.edu

8608745644

Louise A Reagan, PhD

Role: primary

louise.reagan@uconn.edu

8608745644

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Other Identifiers

H21-0144

Identifier Type: -

Identifier Source: org_study_id