Latinos understanding the need for adherence in diabetes (LUNA-D): a randomized controlled trial of an integrated team-based care intervention among Latinos with diabetes

We developed and tested a culturally appropriate, team-based, integrated primary care and behavioral health intervention in low income, Spanish-speaking Latinos with type 2 diabetes, at a federally qualified health center. This pragmatic randomized controlled trial included 456 Latino adults, 23-80 years, 63.7% female, with diabetes [recruitment glycosylated hemoglobin (HbA1c) >= 7.0%/53.01 mmol/mol)]. The Special Intervention occurred over 6 months and targeted improvement of HbA1c, blood pressure, and lipids. The intervention included: (i) four, same-day integrated medical and behavioral co-located visits; (ii) six group diabetes self-management education sessions addressing the cultural dimensions of diabetes and lifestyle messages; (iii) and care coordination. Usual Care participants received primary care provider led standard diabetes care, with referrals to health education and behavioral health as needed. HbA1c and lipids were obtained through electronic health records abstraction. Blood pressure was measured by trained research staff. Multi-level models showed a significant group by time interaction effect (B = -0.32, p < .01, 95% CI -0.49, -0.15), indicating statistically greater improvement in HbA1c level over 6 months in the Special Intervention group (Delta HbA1c = -0.35, p = <.01) versus Usual Care (Delta HbA1c = -0.02, p = .72). Marginally significant group by time interactions were also found for total cholesterol and diastolic blood pressure, with significant improvements in the Special Intervention group (p < .05). This culturally appropriate model of highly integrated care offers strategies that can assist with self-management goals and disease management for Latinos with diabetes in a federally qualified health center setting.