NCT03983499

Latinos Understanding the Need for Adherence in Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 456 (actual)
• Sponsor: San Diego State University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Latinos Understanding the Need for Adherence in Diabetes (LUNA-D) study, is a randomized controlled trial testing the effectiveness of an integrated behavioral health and primary care chronic care disease management intervention for low income Latino patients with type-2 diabetes mellitus (T2DM) that have 2 or more chronic health conditions. LUNA-D focuses on diabetes management and behavioral health care integration.

Detailed description

LUNA-D proposes to test the ability of a fully integrated behavioral health and primary care diabetes management intervention in a federally-qualified community health care setting to improve multiple clinical and behavioral outcomes. LUNA-D will recruit non-insulin using adult type two diabetes mellitus (T2DM) patients with two or more chronic diseases. Half will be randomized to the Special Intervention (SI) arm and half to the Usual Care (UC) arm. The SI is an intensive intervention including fully integrated clinical visits with a medical provider (MP) co-located with a behavioral health counselor (BHC) and peer-led evidence-based group health education sessions and proactive care coordination. Usual Care is represented by passive appointments with the primary care physician and passive referrals to behavioral health and traditional health education. Biological measurements will be taken at baseline, 3-, 6-, 9- 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.

Conditions

• Type 2 Diabetes
• Glycemic Control
• Cardiovascular Risk Factors
• Psychological Distress

Interventions

Type	Name	Description
BEHAVIORAL	Special Intervention	The components of the Special Intervention (SI) integrated design are: 1) Co-location of the clinical team; 2) Shared medical plan; 3) Clinical visits with a medical provider for management of chronic medical conditions; 4) Visits with behavioral health provider for management of psychosocial chronic conditions; 5) Care coordination; 6) Six group-health education classes and two booster sessions led by a promotora. Participants in the SI arm meet with the integrated care team in the context of a regular medical visit primarily to focus on clinical/biological aspects of the chronic medical conditions (diabetes, dyslipidemia, hypertension, obesity, etc.)

Timeline

• Start date: 2015-07-16
• Primary completion: 2018-12-18
• Completion: 2018-12-31
• First posted: 2019-06-12
• Last updated: 2019-06-12

Locations

1 site across 1 country: United States