Recruiting

E-Health

Sponsor:

San Diego State University

Code:

NCT05570734

Conditions

Type 2 Diabetes

Glycemic Control

Psychological Distress

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

LUNA Care Coordination

LUNA Behavioral Health

Health Education Videos

Virtual Integrated Visits

Study Details

Brief 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).

Conditions

Type 2 Diabetes

Glycemic Control

Psychological Distress

Study ID

NCT05570734

Start date

Feb 27, 2023

Status verified date

Jan, 2025

Completion date

Feb, 2026

Anticipated

Primary completion date

Aug, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

LUNA Care Coordination

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

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

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

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.

Primary outcome measure

  • Hemoglobin A1C (HbA1c) Blood Value [ Time Frame: 6-months post randomization ]
  • Psychological Distress - Depression [ Time Frame: 6-months post randomization ]
  • Psychological Distress - Anxiety [ Time Frame: 6-months post randomization ]

Central Contacts and Locations

Central contacts

Locations

South Bay Latino Research Center

Recruiting

Chula Vista, California, United States, 91910

Contacts

Paulina M Mendoza, MPH

619-594-8060pmendoza@sdsu.edu

Gregory A Talavera, MD

619-594-8044gtalavera@sdsu.edu

More Information

Sponsor

San Diego State University

Last update posted

Jan 17, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by San Diego State University on 2025-01-17.