Latinos Understanding the Need for Adherence in Diabetes (LUNA-D)
Type 2 Diabetes, Glycemic Control, Cardiovascular Risk Factors
About this trial
This is an interventional treatment trial for Type 2 Diabetes
Eligibility Criteria
Inclusion Criteria:
This study targets non-insulin using T2DM patients with 2 or more chronic conditions. The primary eligibility criteria are as follows:
- Self-identify as Hispanic/Latino
- Be a registered & established patient of SYH
- 18 years of age or older
- Have an established diagnosis of T2DM (but not currently using insulin)
- Not currently participating in any other diabetes or CVD intervention program
- Have 2 or more CVD risk factors (e.g., depression, anxiety, hypertension, dyslipidemia, obesity, or smoking)
Exclusion Criteria:
Individuals will be excluded if they:
- Are pregnant or planning to get pregnant (temporary exclusion, may qualify 6-months postpartum)
- Have plans to move out of the area in the next 12 months
- Have pre-existing health problems so severe as to prohibit informed consent and study attendance
- Have severe diabetes, including renal disease and/or on dialysis
- Have severe psychosocial conditions under the care of a psychiatrist (e.g., severe depression, bipolar disorder, or schizophrenia)
Sites / Locations
- South Bay Latino Research Center
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Special Intervention
Usual Care
The special intervention (SI) arm addresses glycemic control, medication adherence, control of modifiable CVD risk factors, health behavior change, and psychosocial and cultural barriers to self-management. The SI arm consists of a collaborative care team approach with four main elements including: 1) Specialized clinical care by a medical provider; 2) Specialized behavioral health care by a behavioral health provider; 3) Group-based chronic disease self-management education by peer-leaders; 4) Intensive, proactive care coordination facilitated by a patient registry and electronic health records.
Participants randomized to the Usual Care (UC) arm continue to see their primary care provider and receive referrals to health education. At the discretion of the provider, UC patients are screened and referred to behavioral health (BH) care.