Type 2 Diabetes Clinical Trial
Official title:
Latinos Understanding the Need for Adherence in Diabetes Using Care Coordination, Integrated Medical and Behavioral Care and E-Health
Latinos Understanding the Need for Adherence in Diabetes using Care Coordination, Integrated Medical and Behavioral Care and E-Health (LUNA-E) is a randomized controlled trial (RCT) that will test the effectiveness a patient-centered, team-based, primary care intervention with E-Health enhancements in improving glycemic control (primary outcome, hemoglobin A1C level) and psychological distress (secondary outcome; depression, anxiety symptoms).
LUNA-E will help advance our understanding of optimal approaches to diabetes healthcare services in a large, growing, US population at high risk for diabetes and related complications. If shown effective, LUNA-E has high potential for broad scaling and dissemination due to its community partnered approach, use of technology, and implementation within a large, exemplar federally qualified health center (FQHC) environment. The study's total sample size is 600, with 400 consented and enrolled in the randomized controlled trial (RCT). An additional 200 participants will be identified for medical records review and will not undergo study related activities. The RCT (Arms 1 and 2) targets 400 Latino patients with type 2 diabetes from a local FQHC pool of registered patients. The eligibility criteria are: 1) Latino ethnicity of any race; 2) registered patient of FQHC; 3) > 18 years; 4) type 2 diabetes with hemoglobin A1C (HbA1c) >7.5% in past 90 days; 5) provider approval; 6) not participating in any other diabetes intervention. Biological measurements will be taken at baseline, 3-, 6-, and 12-months to detect changes in glycemic control. Clinical lab measures, medication adherence, weight, health behaviors and psychosocial measures will also be obtained across the study. For Arm 3,the research team will work with the FQHC IT to query all patients with type 2 diabetes and then identify 200 matched controls, using propensity score matching as guided by the study statistician. Selection criteria will occur after the study has completed recruitment. Only de-identified data will be obtained from the medical records for these individuals. De-identified data will be provided by the FQHC IT department. ;
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