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

Part of paid clinical trials in Chula Vista, California.

Sponsor
San Diego State University
Study ID
NCT05570734
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LUNA Care Coordination — BEHAVIORAL
    Participants in this group will have 6 or more 30-minute care coordination sessions with the LUNA Care Coordinator. The LUNA Care Coordinator will assist with appointments and referrals, medications, and assist with accessing the health education videos. They will work closely with the participant's primary care provider and the LUNA Behavioral Health Provider.
  • LUNA Behavioral Health — BEHAVIORAL
    Participants in this group will have 6 or more 30-minute behavioral health sessions with the LUNA Behavioral Health Provider. The LUNA Behavioral Health Provider will screen and address life stressors, social support, and health care use. The purpose of these sessions is to check on participant's progress with their care plan. The behavioral health sessions will involve discussion of issues that may interfere with optimal diabetes self-management. The LUNA Behavioral Health Provider will help participants overcome any potential barriers to managing their diabetes by setting goals and helping to address life stress or other issues that may be interfering with their diabetes self-management.
  • Health Education Videos — BEHAVIORAL
    Participants in this group will have access to eight 20 to 30-minute health education video sessions with corresponding print material and activities to reinforce what they learn. The health education videos focus on medication adherence, self-monitoring, stress and coping, nutrition, physical activity and culturally driven beliefs and values.
  • Virtual Integrated Visits — BEHAVIORAL
    Participants in this group will have two virtual integrated visits with the LUNA care team. Through video conferencing, they will meet at the same time with the LUNA Care Coordinator, the LUNA Behavioral Health Provider, and their primary care provider to ensure an integrated care plan.

Study Details

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).

Key Dates

Start date
Feb 27, 2023
Status verified
Jan 2025
Primary completion
Aug 31, 2025
Completion
Feb 28, 2026

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Hemoglobin A1C (HbA1c) Blood Value [ Time Frame: 6-months post randomization ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
South Bay Latino Research CenterChula VistaCalifornia91910
Paulina M Mendoza, MPH
[email protected]
619-594-8060
Gregory A Talavera, MD
[email protected]
619-594-8044

Find similar trials in Chula Vista, CA

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
South Bay Latino Research Center· Chula Vista, CA

Related Studies