Latinos Understanding the Need for Adherence in Diabetes Using Care Coordination, Integrated Medical and Behavioral Care and E-Health

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Self identify as Hispanic/Latino ethnicity of any race

• Registered patient of federally qualified health center

• 18 years of age or older

• Type 2 diabetes with hemoglobin A1C (HbA1c) \>7.5% in past 90 days

• Approval from primary care provider

• Not currently enrolled/participating in any other diabetes intervention program(s)

Locations
United States
California
South Bay Latino Research Center
RECRUITING
Chula Vista
Contact Information
Primary
Program Manager
pmendoza@sdsu.edu
619-594-8060
Time Frame
Start Date: 2023-02-27
Estimated Completion Date: 2026-02
Participants
Target number of participants: 400
Treatments
Experimental: LUNA Group
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.
No_intervention: Care Coordination
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.
Related Therapeutic Areas
Sponsors
Leads: San Diego State University

This content was sourced from clinicaltrials.gov