Latinos Understanding the Need for Adherence in Diabetes Using E-Health
NCT ID: NCT05570734
Last Updated: 2025-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
400 participants
INTERVENTIONAL
2023-02-27
2026-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
ALL
No
Sponsors
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San Diego State University
OTHER
Responsible Party
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Gregory Talavera
Professor
Principal Investigators
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Gregory A Talavera, MD/MPH
Role: PRINCIPAL_INVESTIGATOR
San Diego State University
Linda C Gallo, PHD
Role: PRINCIPAL_INVESTIGATOR
San Diego State University
Locations
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South Bay Latino Research Center
Chula Vista, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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