Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Improving Recruitment and Retention for Diabetes Self-Management Education and Support by Bridging Clinical-Community Linkages and Supplemental Diabetes Education Technology: A Socio-Ecological Approach
This randomized clinical trial aims to examine the effectiveness of utilizing CHWs (community health workers) and supplemental diabetes education technology to improve DSMES (diabetes self-management education and support) participation, retention, engagement, and clinical outcomes in adults in Jefferson County, AL living with diabetes. The main questions this study aims to answer are as follows: 1) Is the utilization of a multi-directional recruitment model via partnerships with community health workers and local primary care providers versus traditional recruitment methods (including using flyers, word of mouth, and media ads) effective in increasing recruitment and retention of people living with diabetes into a pharmacist-led DSMES program? 2) Is the utilization of the HICO Health Mobile application and provider dashboard as a supplementary tool alongside a standard DSMES curriculum effective at improving patient participation, retention, engagement, and clinical outcomes in a pharmacist-led DSMES program versus standard DSMES alone in Jefferson County, AL? After eligibility screenings and enrollment, participants will be randomized into two groups: one group will receive standard DSMES programming based on the 7 Self Care Behaviors and one group will receive standard DSMES programming and access to HICO Health, a diabetes-related mobile health application. The study team plans to evaluate whether a CHW- recruitment strategy will lead to an increase in referral and enrollment and whether incorporating the HICO Health application will lead to better retention, engagement, and clinical outcomes in terms of HbA1C levels. This novel project will utilize continued stakeholder engagement, community health workers, and diabetes-related technology which we hope will increase the uptake and retention of participants in DSMES in Jefferson County, AL.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | March 2025 |
Est. primary completion date | February 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Must be a resident of Jefferson County, Alabama - Must have an ICD-10 diagnosis of diabetes - Must have a primary care provider - Must be able to read, write, and converse in English - Must own and be able to utilize a smartphone with internet access - Must be willing to visit MedsPLUS Consulting in downtown Birmingham on 3 separate occasions (transportation may be provided, if approved). - Must be willing to attend and participate in five, two-hour education sessions over the course of 10 weeks Exclusion Criteria: - Currently enrolled in a diabetes-related study - Currently enrolled in a lifestyle change program - Does not have or cannot get access to a home blood glucose monitor - Does not have or cannot get access to a smartphone with internet access |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
MedsPLUS Consulting | Jenkins Public Health Consulting LLC, Lister Hill Center for Health Policy, National Institutes of Health (NIH) |
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Referrals from Study Stakeholders | Number of referrals from study stakeholders to DSMES programs in Jefferson County, AL. | 3 months | |
Primary | Number of Participants Enrolled in DSMES Study | Number of Participants Enrolled in DSMES Study | 3 months | |
Primary | Number of DSMES Sessions Attended by Participants | Number of DSMES sessions attended | 2 months | |
Primary | Number of DSMES Participants with at Least 80% Session Retention | Number of participants completing 4 of 5 DSMES sessions | 2 months | |
Primary | Change in HbA1C of Participants | Change in HbA1C | Baseline, 3 months, and 6 months | |
Secondary | Change in Self-Care Knowledge | Measure change in diabetes self-care knowledge utilizing the Diabetes Self-Management Questionnaire a 16-question survey broken down into 4 sub-scales (glucose management, dietary control, physical activity, and healthcare use). The rating scale utilizes a 4-point Likert scale ranging from 0 to 3 (where 0 means it does not apply to the participant and 3 means it applies to the participant very much). For each sub-scale, the minimum score is zero and the maximum score is 10, and higher scores are indicative of better self-care. Additionally, there is one item that requires participants to rate their perceived self-care using the 4-point Likert scale indicated above. | 6 months | |
Secondary | App Engagement | Number of participants who used app at least two times a week during the intervention | 6 months |
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