Diabetes Learning in Virtual Environments Just in Time for Community Reentry

Diabetes Mellitus, Type 2 Clinical Trial

— LIVE JustICE  

Official title:

Diabetes Learning in Virtual Environments Just In Time for Community reEntry (Diabetes LIVE JustICE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05286892
• Other study ID #: H21-0144
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2023
• Est. completion date: November 15, 2024

Study information

• Verified date: September 2023
• Source: University of Connecticut
• Contact: Lousie Reagan, PhD
• Phone: 860-486-0593
• Email: louise.reagan[@]uconn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: November 15, 2024
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Intervention

Other:
• 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.
• Enhanced Education
See control group description above

Locations

Country	Name	City	State
United States	University of Connecticut	Storrs	Connecticut
United States	University of Connecticut	Storrs	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Louise Reagan	American Diabetes Association

Country where clinical trial is conducted

United States, 

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* Note: There are 55 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demographics	Demographic data (race/ethnicity, marital status, income (categorical), educational attainment, employment, age, sex, and disease duration).	baseline
Primary	Potential Confounding Effects	We will send weekly text messages to experimental group participants. 1. In the past week, how many minutes did you talk to someone about your diabetes self-management? Multiple choice: minutes 2. Do you have anything else to tell us? (open-ended)	week 1
Primary	Potential Confounding Effects	We will send weekly text messages to experimental group participants. 1. In the past week, how many minutes did you talk to someone about your diabetes self-management? Multiple choice: minutes 2. Do you have anything else to tell us? (open-ended)	week 2
Primary	Potential Confounding Effects	We will send weekly text messages to experimental group participants. 1. In the past week, how many minutes did you talk to someone about your diabetes self-management? Multiple choice: minutes 2. Do you have anything else to tell us? (open-ended)	week 3
Primary	Potential Confounding Effects	We will send weekly text messages to experimental group participants. 1. In the past week, how many minutes did you talk to someone about your diabetes self-management? Multiple choice: minutes 2. Do you have anything else to tell us? (open-ended)	week 4
Primary	Potential Confounding Effects	We will send weekly text messages to experimental group participants. 1. In the past week, how many minutes did you talk to someone about your diabetes self-management? Multiple choice: minutes 2. Do you have anything else to tell us? (open-ended)	week 5
Primary	Potential Confounding Effects	We will send weekly text messages to experimental group participants. 1. In the past week, how many minutes did you talk to someone about your diabetes self-management? Multiple choice: minutes 2. Do you have anything else to tell us? (open-ended)	week 6
Primary	Metabolic Indicator	Metabolic control will be measured as glycosylated hemoglobin (HbA1c) through central laboratory measures (Quest Labs) [78], indicating average glucose levels over the prior three months. The reliability and validity of the lab measures are improved by utilizing a central laboratory for sample analysis (Quest Labs).	baseline
Primary	Metabolic Indicator	Metabolic control will be measured as glycosylated hemoglobin (HbA1c) through central laboratory measures (Quest Labs) [78], indicating average glucose levels over the prior three months. The reliability and validity of the lab measures are improved by utilizing a central laboratory for sample analysis (Quest Labs).	week 12
Primary	Diabetes Knowledge	Diabetes knowledge will be measured by the 10 item Spoken Knowledge in Low Literacy for Diabetes scale (SKILLD).51 It takes less than 10 minutes to administer. Coefficients of internal reliability for the SKILLD have been reported at 0.72 (Kuder Richardson Coefficient of reliability) When used to evaluate knowledge in a population of incarcerated persons with diabetes, Cronbach's alpha was 0.6520-.0.70 respectively.7,6 Content validity was confirmed in previous research by experts in correctional health.	baseline
Primary	Diabetes Knowledge	Diabetes knowledge will be measured by the 10 item Spoken Knowledge in Low Literacy for Diabetes scale (SKILLD).51 It takes less than 10 minutes to administer. Coefficients of internal reliability for the SKILLD have been reported at 0.72 (Kuder Richardson Coefficient of reliability) When used to evaluate knowledge in a population of incarcerated persons with diabetes, Cronbach's alpha was 0.6520-.0.70 respectively.7,6 Content validity was confirmed in previous research by experts in correctional health.	week 6
Primary	Diabetes Knowledge	Diabetes knowledge will be measured by the 10 item Spoken Knowledge in Low Literacy for Diabetes scale (SKILLD).51 It takes less than 10 minutes to administer. Coefficients of internal reliability for the SKILLD have been reported at 0.72 (Kuder Richardson Coefficient of reliability) When used to evaluate knowledge in a population of incarcerated persons with diabetes, Cronbach's alpha was 0.6520-.0.70 respectively.7,6 Content validity was confirmed in previous research by experts in correctional health.	week 12
Primary	Diabetes-Related Emotional Distress	Distress will be measured with PAID (Problem Areas in Diabetes) scale, 52with 20 items using a 6-point Likert scale; higher scores indicate higher levels of distress. Internal consistency >0.902.	baseline
Primary	Diabetes-Related Emotional Distress	Distress will be measured with PAID (Problem Areas in Diabetes) scale, 52with 20 items using a 6-point Likert scale; higher scores indicate higher levels of distress. Internal consistency >0.902.	week 6
Primary	Diabetes-Related Emotional Distress	Distress will be measured with PAID (Problem Areas in Diabetes) scale, 52with 20 items using a 6-point Likert scale; higher scores indicate higher levels of distress. Internal consistency >0.902.	week 12
Primary	Self-management behaviors	Self-management behaviors will be assessed using the Summary of Diabetes Self-Care Activities (SDSCA) .53 This 11-item questionnaire assesses the frequency of health behaviors over the last week, including diet, exercise, blood sugar testing, foot care, and smoking. The instrument has acceptable internal consistency	baseline
Primary	Self-management behaviors	Self-management behaviors will be assessed using the Summary of Diabetes Self-Care Activities (SDSCA) .53 This 11-item questionnaire assesses the frequency of health behaviors over the last week, including diet, exercise, blood sugar testing, foot care, and smoking. The instrument has acceptable internal consistency	week 6
Primary	Self-management behaviors	Self-management behaviors will be assessed using the Summary of Diabetes Self-Care Activities (SDSCA) .53 This 11-item questionnaire assesses the frequency of health behaviors over the last week, including diet, exercise, blood sugar testing, foot care, and smoking. The instrument has acceptable internal consistency	week 12
Primary	Perceived Support for Diabetes Management	The 12-item Diabetes Support Scale assesses social support in a diabetes internet intervention and has demonstrated internal consistency 0.90-0.93, and construct validity	baseline
Primary	Perceived Support for Diabetes Management	The 12-item Diabetes Support Scale assesses social support in a diabetes internet intervention and has demonstrated internal consistency 0.90-0.93, and construct validity	week 6
Primary	Perceived Support for Diabetes Management	The 12-item Diabetes Support Scale assesses social support in a diabetes internet intervention and has demonstrated internal consistency 0.90-0.93, and construct validity	week 12
Primary	Perceived Competence Scale	The 4-item PCS assesses the degree to which participants feel confident of meeting the challenges of DSM. A person's score on the PCS is calculated by averaging responses on the four-item 7-poins Likert scale with higher scores indicating higher perceived competence. Alpha reliabilities have been reported as above 0.80.	baseline
Primary	Perceived Competence Scale	The 4-item PCS assesses the degree to which participants feel confident of meeting the challenges of DSM. A person's score on the PCS is calculated by averaging responses on the four-item 7-poins Likert scale with higher scores indicating higher perceived competence. Alpha reliabilities have been reported as above 0.80.	week 6
Primary	Perceived Competence Scale	The 4-item PCS assesses the degree to which participants feel confident of meeting the challenges of DSM. A person's score on the PCS is calculated by averaging responses on the four-item 7-poins Likert scale with higher scores indicating higher perceived competence. Alpha reliabilities have been reported as above 0.80.	week 12