LUNA-E: Latino Adults with Type 2 Diabetes Using Care Coordination, Integrated Medical and Behavioral Care with E-Health Support

What this Trial Is About

Researchers are evaluating a patient-centered, team-based primary care intervention enhanced with E-Health tools to improve blood sugar control and reduce psychological distress like depression and anxiety in Latino adults with type 2 diabetes. This randomized controlled trial (RCT) aims to advance diabetes care within a federally qualified health center (FQHC) setting, focusing on a population at high risk for diabetes complications. The study plans to enroll 600 participants, including 400 in the randomized trial and 200 matched controls for medical record review only. The intervention includes at least six 30-minute care coordination sessions where a care coordinator assists with appointments, medications, and access to health education videos. Participants also receive at least six 30-minute behavioral health sessions addressing stress, social support, and barriers to diabetes management. Additionally, participants have access to eight health education videos with print materials on medication adherence, self-monitoring, stress coping, nutrition, physical activity, and cultural beliefs. Two virtual integrated visits involve meetings with the care coordinator, behavioral health provider, and primary care provider to coordinate care plans. Participants will undergo biological measurements and clinical lab tests at baseline and at 3, 6, and 12 months to assess changes in blood sugar control and health behaviors. Psychological distress will also be evaluated. Medication adherence, weight, and psychosocial measures will be regularly collected. The study includes safety monitoring and follow-up over one year to evaluate outcomes such as hemoglobin A1C levels and psychological distress symptoms post-randomization.

Latinos Understanding the Need for Adherence in Diabetes Using E-Health