RecruitingNot ApplicableNCT05570734

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

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

Sponsor

San Diego State University

Enrollment

400 participants

Start Date

Feb 27, 2023

Study Type

INTERVENTIONAL

Conditions

Psychological Distress Type 2 Diabetes Glycemic Control

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

Min Age: 18 Years

Inclusion Criteria6

Self identify as Hispanic/Latino ethnicity of any race
Registered patient of federally qualified health center
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)

Exclusion Criteria5

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

Interventions

BEHAVIORALLUNA 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.

BEHAVIORALLUNA 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.

BEHAVIORALHealth 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.

BEHAVIORALVirtual 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.