Resilience-Based Diabetes Self-Management Education (RB-DSME) for African Americans
United States284 participantsStarted 2020-01-25
Plain-language summary
African Americans are twice as likely to have type 2 diabetes as non-Hispanic Whites and are less likely to engage in effective diabetes self-management. There is a critical need for intensive lifestyle interventions that address the distress inherent in having the disease and the unique stressors faced by African Americans that may worsen diabetes-related health outcomes. Our program, Resilience-Based Diabetes Self-Management Education and Support, integrates resilience resources with diabetes self-management skills to enable African-American patients to manage the daily demands of the disease and improve long-term adherence to healthy lifestyle choices, thereby reducing the negative health burden of diabetes.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria: Participants must:
* be African American;
* be diagnosed with T2DM;
* be 18 years of age or older;
* have an A1C of 6.5 or higher; and
* not be currently participating in another T2DM management program.
Exclusion Criteria: Individuals will be excluded if they:
* are pregnant/lactating;
* have medical conditions for which changes in diet and/or physical activity would be contraindicated (e.g., hospitalization for heart disease during the past 6 months, diagnosed heart failure, kidney failure, or peripheral vascular disease requiring special diets and/or restricted physical activity severe enough to preclude walking three times per week, or active tuberculosis); or
* use glucocorticoid containing medication.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically designed for African Americans with Type 2 Diabetes — given my background and situation, is this the kind of program my doctor thinks could be a good fit for my care plan?
2The study tracks A1C levels and depressive symptoms over 6, 12, and even 24 months, which is a long commitment — how would participating in something like this fit alongside my current diabetes treatment, and would it replace or add to what I'm already doing?
3Since this trial is listed as 'active not recruiting,' does that mean there's no way to join it now, and are there similar resilience-based or diabetes self-management education programs I could still access?
4The study is measuring depressive symptoms as a primary outcome alongside blood sugar control — does my doctor think the emotional and mental health side of managing my diabetes is something we should be addressing more directly, regardless of this trial?
5This is listed as Phase NA, which often applies to behavioral or educational studies rather than drug trials — what does my doctor think the evidence says so far about whether resilience-focused diabetes education programs actually help improve A1C or mood in people like me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in glycosylated hemoglobin (A1C) at 6 months
Timeframe: Baseline and 6 months
2
Change from baseline in glycosylated hemoglobin (A1C) at 12 months
Timeframe: Baseline and 12 months
3
Change from baseline in glycosylated hemoglobin (A1C) at 24 months
Timeframe: Baseline and 24 months
4
Change from baseline in depressive symptoms at 6 months
Timeframe: Baseline and 6 months
5
Change from baseline in depressive symptoms at 12 months
Timeframe: Baseline and 12 months
6
Change from baseline in depressive symptoms at 24 months