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

Primary Purpose

Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diabetes LIVE JustICE
Enhanced Education
Sponsored by
Louise Reagan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 1 focused on measuring Vulnerable Population, Diabetes Self-Management Education and Support (DSMES), Diabetes Survival Skills (DSS), innovation, technology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of ConnecticutRecruiting
  • University of ConnecticutRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Demographics
Demographic data (race/ethnicity, marital status, income (categorical), educational attainment, employment, age, sex, and disease duration).
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)
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)
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)
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)
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)
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)
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).
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).
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.
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.
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.
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.
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.
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.
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
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
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
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
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
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
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 24, 2022
Last Updated
September 18, 2023
Sponsor
Louise Reagan
Collaborators
American Diabetes Association
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1. Study Identification

Unique Protocol Identification Number
NCT05286892
Brief Title
Diabetes Learning in Virtual Environments Just in Time for Community Reentry
Acronym
LIVE JustICE
Official Title
Diabetes Learning in Virtual Environments Just In Time for Community reEntry (Diabetes LIVE JustICE)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 30, 2023 (Actual)
Primary Completion Date
November 15, 2024 (Anticipated)
Study Completion Date
November 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Louise Reagan
Collaborators
American Diabetes Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Keywords
Vulnerable Population, Diabetes Self-Management Education and Support (DSMES), Diabetes Survival Skills (DSS), innovation, technology

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Diabetes LIVE JustICE
Intervention Description
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
Intervention Name(s)
Enhanced Education
Intervention Description
See control group description above
Primary Outcome Measure Information:
Title
Demographics
Description
Demographic data (race/ethnicity, marital status, income (categorical), educational attainment, employment, age, sex, and disease duration).
Time Frame
baseline
Title
Potential Confounding Effects
Description
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)
Time Frame
week 1
Title
Potential Confounding Effects
Description
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)
Time Frame
week 2
Title
Potential Confounding Effects
Description
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)
Time Frame
week 3
Title
Potential Confounding Effects
Description
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)
Time Frame
week 4
Title
Potential Confounding Effects
Description
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)
Time Frame
week 5
Title
Potential Confounding Effects
Description
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)
Time Frame
week 6
Title
Metabolic Indicator
Description
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).
Time Frame
baseline
Title
Metabolic Indicator
Description
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).
Time Frame
week 12
Title
Diabetes Knowledge
Description
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.
Time Frame
baseline
Title
Diabetes Knowledge
Description
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.
Time Frame
week 6
Title
Diabetes Knowledge
Description
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.
Time Frame
week 12
Title
Diabetes-Related Emotional Distress
Description
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.
Time Frame
baseline
Title
Diabetes-Related Emotional Distress
Description
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.
Time Frame
week 6
Title
Diabetes-Related Emotional Distress
Description
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.
Time Frame
week 12
Title
Self-management behaviors
Description
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
Time Frame
baseline
Title
Self-management behaviors
Description
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
Time Frame
week 6
Title
Self-management behaviors
Description
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
Time Frame
week 12
Title
Perceived Support for Diabetes Management
Description
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
Time Frame
baseline
Title
Perceived Support for Diabetes Management
Description
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
Time Frame
week 6
Title
Perceived Support for Diabetes Management
Description
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
Time Frame
week 12
Title
Perceived Competence Scale
Description
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.
Time Frame
baseline
Title
Perceived Competence Scale
Description
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.
Time Frame
week 6
Title
Perceived Competence Scale
Description
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.
Time Frame
week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals will be eligible to participate if they: have Type 1 or 2 diabetes are age 18 and older can speak and understand English have been released directly from one of five Connecticut prisons to supervised community housing or parole
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lousie Reagan, PhD
Phone
860-486-0593
Email
louise.reagan@uconn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen Walsh, ScD
Phone
860-486-0544
Email
stephen.walsh@uconn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lousie Reagan, PhD
Organizational Affiliation
University of Connecticut
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut
City
Storrs
State/Province
Connecticut
ZIP/Postal Code
06269-0001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louise A Reagan, PhD
Phone
860-874-5644
Email
louise.reagan@uconn.edu
Facility Name
University of Connecticut
City
Storrs
State/Province
Connecticut
ZIP/Postal Code
06269
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louise A Reagan, PhD
Phone
860-874-5644
Email
louise.reagan@uconn.edu
First Name & Middle Initial & Last Name & Degree
Stephen J Walsh, ScD
Phone
8608745644
Email
louise.reagan@uconn.edu
First Name & Middle Initial & Last Name & Degree
Louise A Reagan, PhD
First Name & Middle Initial & Last Name & Degree
Stephen J Walsh, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
1. Summary of data outputs and/or resources that the proposed research will generate: The PIs are committed to the open and timely dissemination of research outcomes. We expect that the proposed project will produce the following data: Raw study data, protocols, processed data, quantitative measures and qualitative self-reported data. Data analysis programs in the format of SPSS, SAS, and R. Proposed repository for data sharing: The materials, data, and protocols from the research will be made available to researchers who are interested in reproducing the work and developing original research based on our work. We will prepare our dataset in accordance with the requirements for NIDDK data repository datasets and associated documentation for submission to the NIDDK Information Network(DKnet) in accordance with the Guidelines for NIDDK DKnet data set preparation.
IPD Sharing Time Frame
Data generated from the proposed study would be shared and available to the participating study investigators no later than 6 months post publication or 18 months from the award end date of November 1, 2024.
IPD Sharing Access Criteria
We also intend to make results available to the community of scientists interested in diabetes self-management education and behavioral research, correctional health research, and virtual environments upon request to avoid unintentional duplication of research. Furthermore, we will welcome collaboration with others who could make use of the study protocols developed in the proposed study. Deidentified datasets will be made readily available for sharing with other qualified researchers after major publications have been accepted
Citations:
PubMed Identifier
19648129
Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
27077019
Citation
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Results Reference
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Citation
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Citation
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