Latinos Understanding the Need for Adherence in Diabetes (LUNA-D)

San Diego State University

Status: Completed

Conditions: Glycemic Control; Cardiovascular Risk Factors; Type 2 Diabetes; Psychological Distress

Treatments: Behavioral: Special Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03983499

NR014866

Details and patient eligibility

About

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.

Full 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.

Enrollment: 456 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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456 participants in 2 patient groups

Special Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Special Intervention

Usual Care

No Intervention group

Description:

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.