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).
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
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