NCT05570734 · San Diego State University
Latinos Understanding the Need for Adherence in Diabetes Using E-Health
(LUNA-E)
What this study is about
Latinos Understanding the Need for Adherence in Diabetes using Care Coordination, Integrated Medical and Behavioral Care and E-Health (LUNA-E) is a randomly assigned 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).
View original scientific description
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).
Interventions
BEHAVIORAL
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.
BEHAVIORAL
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.
BEHAVIORAL
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.
BEHAVIORAL
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 measures
Hemoglobin A1C (HbA1c) Blood Value
Time frame: 6-months post randomization
Change glycemic control among Latino patients with type 2 diabetes through an innovative patient centered, team-based, highly integrated primary care intervention (LUNA-E).
Psychological Distress - Depression
Time frame: 6-months post randomization
Change psychological distress (depression symptoms) among Latino patients with type 2 diabetes via the LUNA-E intervention. The Personal Health Questionnaire-8 (PHQ-8) will be used to assess depression symptomatology. Response options range from not at all (0) to nearly every day (3). Item scores are summed (range 0-24) with higher scores indicating more severe depression symptoms.
Psychological Distress - Anxiety
Time frame: 6-months post randomization
Change psychological distress (anxiety symptoms) among Latino patients with type 2 diabetes via the LUNA-E intervention. The Generalized Anxiety Disorder Questionnaire (GAD-7) will be used to measure anxiety symptomatology. Response options range from not at all (0) to nearly every day (3). Item scores are summed (range 0-21) with higher scores indicating more severe anxiety symptoms.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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)
Exclusion criteria
- 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)
Where
- Chula Vista, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 17, 2025 · Source of record for eligibility and locations