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

San Diego State University

Status: Enrolling

Conditions: Glycemic Control; Type 2 Diabetes; Psychological Distress

Treatments: Behavioral: LUNA Behavioral Health; Behavioral: LUNA Care Coordination; Behavioral: Virtual Integrated Visits; Behavioral: Health Education Videos

Study type: Interventional

Funder types: Other

Identifiers

NCT05570734

R01MD015080

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Self identify as Hispanic/Latino ethnicity of any race
2. Registered patient of federally qualified health center
3. 18 years of age or older
4. Type 2 diabetes with hemoglobin A1C (HbA1c) >7.5% in past 90 days
5. Approval from primary care provider
6. Not currently enrolled/participating in any other diabetes intervention program(s)

Exclusion criteria

1. Actively being treated for cancer or Parkinson's Disease
2. Pregnant or nursing (temporary exclusion, may qualify 6-months postpartum)
3. Have plans to move out of the area in the next 12 months
4. Have other existing mental or physical health problems so severe as to prohibit informed consent and participation
5. Have severe diabetes complications (e.g., renal disease, or on dialysis)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

LUNA Group

Experimental group

Description:

The LUNA Group is a culturally appropriate, E-Health enhanced, patient-centered, team-care model that includes: 1) care coordination by a Care Coordinator (CC) trained in electronic health records (EHR) clinical decision support and health promotion methods; 2) visits with a specially trained Behavioral Health Provider (BHP) with knowledge of diabetes and psychosocial aspects of diabetes; 3) care integration with primary care provider (PCP) implemented using the clinical decision support dashboard and/or synchronous communication during visits; and 4) a video adapted, evidence-based diabetes self-management education and support curriculum delivered through a learning management system.

Treatment:

Behavioral: Health Education Videos

Behavioral: Virtual Integrated Visits

Behavioral: LUNA Care Coordination

Behavioral: LUNA Behavioral Health

Care Coordination

No Intervention group

Description:

The Care Coordination group applies the current methods of the federally qualified health center (FHQC) Patient Centered Medical Home initiative. Participants assigned to the care coordination group will continue with their regular medical visits with their primary care provider. In addition, they will receive care coordination and brief targeted health education provided by a specially trained medical assistant/care coordinator. This will involve 1 or more brief sessions with a care coordinator to provide health education, assist with appointments and referrals, and review medications. The care coordinator will work closely with their primary care provider. The care coordinator will also assist with referrals to behavioral health that may be initiated by the primary care provider.