E-Health Intervention for Type 2 Diabetes

(LUNA-E Trial)

Overseen By Program Manager

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: San Diego State University

Disqualifiers: Cancer, Parkinson's, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 months

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new e-health program aimed at improving blood sugar control and reducing stress, anxiety, and depression in people with Type 2 diabetes. It compares two groups: one receiving usual care with extra support from a care coordinator, and another with added digital tools and education specifically for Latino patients. The trial is ideal for Hispanic or Latino individuals diagnosed with Type 2 diabetes who have struggled to manage their blood sugar levels (HbA1c over 7.5%) in the past three months. As an unphased trial, this study provides a unique opportunity to contribute to innovative research tailored to the community's needs.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your primary care provider.

What prior data suggests that this E-Health intervention is safe for improving glycemic control and psychological distress in Latinos with Type 2 Diabetes?

Studies have shown that the LUNA Group's approach is generally safe for participants, focusing on managing healthcare and mental well-being. Participants receive assistance with scheduling appointments and taking medications, and they gain a better understanding of their health.

For the LUNA Behavioral Health component, research indicates that the program is culturally sensitive and well-liked. Although specific safety details are not provided, similar programs are typically safe and well-accepted.

LUNA Care Coordination also offers help with health education and appointments. Research has not identified any major safety concerns with this type of care.

Overall, these treatments emphasize support and education, which are generally low-risk and well-tolerated. Participants can expect a supportive environment aimed at improving their health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these innovative approaches to managing Type 2 diabetes because they integrate modern technology and personalized care into treatment. The LUNA Behavioral Health approach stands out by using an E-Health enhanced, patient-centered model that includes real-time care coordination, specialized behavioral health support, and interactive self-management education delivered through a video-based learning system. This method is distinct from traditional treatments, which often rely solely on medication and periodic doctor visits, by actively engaging patients in their health management using digital tools and tailored education. Meanwhile, the LUNA Care Coordination arm builds on current care models by enhancing the role of care coordinators who assist patients with health education, appointment scheduling, and medication management, ensuring a seamless and supportive healthcare experience. These approaches aim to empower patients and potentially improve health outcomes by making care more accessible, personalized, and proactive.

What evidence suggests that this trial's treatments could be effective for Type 2 Diabetes?

Research has shown that the LUNA Group, a culturally tailored online health program, holds promise for improving diabetes care among Latinos. In this trial, participants in the LUNA Group will receive a combination of care coordination and mental health support. Studies suggest this approach can better manage blood sugar levels and reduce feelings of depression and anxiety. Participants in the Care Coordination arm will receive help with appointments, referrals, and medication management, which has improved emotional well-being. Overall, these programs use technology and personalized care to support better diabetes management. ^{1 2 4 6 7}

Who Is on the Research Team?

Gregory A Talavera, MD/MPH

Principal Investigator

San Diego State University

Linda C Gallo, PHD

Principal Investigator

San Diego State University

Are You a Good Fit for This Trial?

This trial is for Hispanic/Latino adults with Type 2 diabetes and poor blood sugar control (HbA1c >8%). Participants must be registered at a qualifying health center, not in other diabetes programs, and have their doctor's approval. Exclusions include severe diabetes complications, current cancer or Parkinson's treatment, plans to move soon, severe health issues preventing consent, or being pregnant/nursing.

Inclusion Criteria

Registered patient of federally qualified health center

Self identify as Hispanic/Latino ethnicity of any race

Approval from primary care provider

Exclusion Criteria

Pregnant or nursing (temporary exclusion, may qualify 6-months postpartum)

Have other existing mental or physical health problems so severe as to prohibit informed consent and participation

You are planning to move away from the area within the next year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a patient-centered, team-based, primary care intervention with E-Health enhancements to improve glycemic control and psychological distress

6 months

Visits at baseline, 3 months, 6 months, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Health Education Videos
• LUNA Behavioral Health
• LUNA Care Coordination
• Virtual Integrated Visits

Trial Overview The LUNA-E study is testing a patient-centered care approach using virtual visits, coordinated care management, integrated medical and behavioral support alongside educational videos. This randomized trial aims to improve blood sugar levels and reduce psychological distress among participants.

How Is the Trial Designed?

Group I: LUNA Group Experimental Treatment 4 Interventions

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.

Group II: Care Coordination Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

San Diego State University

Lead Sponsor

Trials

182

Recruited

119,000+

Published Research Related to This Trial

A culturally tailored, integrated care intervention for low-income, Spanish-speaking Latinos with type 2 diabetes significantly improved HbA1c levels over 6 months, showing a greater reduction compared to usual care (ΔHbA1c = -0.35 vs. ΔHbA1c = -0.02).

The intervention also led to improvements in total cholesterol and diastolic blood pressure, indicating that this model of care can effectively support diabetes management and self-care in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Latinos understanding the need for adherence in diabetes (LUNA-D): a randomized controlled trial of an integrated team-based care intervention among Latinos with diabetes. Talavera, GA., Castañeda, SF., Mendoza, PM., et al.[2022]

Latinos experience higher rates of diabetes and related complications, and existing health information technology (HIT) tools for diabetes management may not be effectively utilized by this group, especially those with low literacy or limited English proficiency.

The development of a novel 'eNavigator' role aims to enhance the adoption of HIT among Latinos, which could help improve diabetes self-management and reduce health care disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Closing the gap: eliminating health care disparities among Latinos with diabetes using health information technology tools and patient navigators. López, L., Grant, RW.[2022]

The Innovative Care for Chronic Conditions framework was developed to improve chronic care management specifically for low-income, uninsured Mexican Americans with Type 2 diabetes, highlighting the importance of addressing health disparities.

Community health workers are crucial in delivering services that tackle social determinants of health, leading to promising outcomes and suggesting that this framework can be replicated in various settings to enhance chronic care management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Chronic Care Management Framework Bridging Clinic, Home, and Community Care in a Mexican American Population. Zolezzi, M., Lopez, J., Mitchell-Bennet, L., et al.[2022]

The study analyzed social support exchanges in a virtual environment for type 2 diabetes self-management, revealing that emotional and appraisal support networks were the largest and most active, indicating the effectiveness of virtual communities in providing these types of support.

Participants who engaged in emotional support were also likely to exchange appraisal and instrumental support, suggesting that these virtual environments can foster interconnected support networks that enhance diabetes self-management outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exchanges in a Virtual Environment for Diabetes Self-Management Education and Support: Social Network Analysis. Pérez-Aldana, CA., Lewinski, AA., Johnson, CM., et al.[2021]

Culturally tailored diabetes self-management education (DSME) effectively improves glycemic control and health outcomes in Mexican Americans, as shown in a study with 165 participants in a rural Texas community.

Adding a nurse case manager (NCM) to the DSME program increased attendance rates, although both groups showed similar improvements in diet, physical activity, and clinical outcomes, indicating the need for further research on the NCM's impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating education, group support, and case management for diabetic Hispanics. Brown, SA., García, AA., Winter, M., et al.[2021]

Hispanics in the U.S. are at a significantly higher risk for type 2 diabetes and experience worse health outcomes, highlighting the need for targeted interventions for this group.

Successful interventions for underserved Hispanics with type 2 diabetes include both live and technology-based approaches that are culturally tailored, involve multimodal delivery, and maintain some level of human interaction, suggesting that personalized and engaging methods are key to improving health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovative Diabetes Interventions in the U.S. Hispanic Population. Fortmann, AL., Savin, KL., Clark, TL., et al.[2022]

An integrated digital health navigator program successfully increased patient portal enrollment among individuals with type II diabetes, enrolling 121 patients (30.9%) during the pilot study.

The program notably improved portal usage among underrepresented groups, with enrollment rising from 30% to 42% for Hispanic/Latinx patients and from 49% to 61% for Black patients, highlighting its potential to reduce digital disparities in healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital healthcare equity in primary care: implementing an integrated digital health navigator. Rodriguez, JA., Charles, JP., Bates, DW., et al.[2023]

Information technology (IT) interventions can effectively improve diabetes self-management among Latinos, but there is a lack of studies specifically targeting this population, highlighting the need for tailored approaches that consider their unique socio-cultural and linguistic characteristics.

Incorporating community health workers (CHWs) into eHealth programs can enhance technology literacy and patient engagement, leading to better outcomes in managing type 2 diabetes among Latinos, especially when interventions are designed to include family and community support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eliminating disparities among Latinos with type 2 diabetes: Effective eHealth strategies. López, L., Tan-McGrory, A., Horner, G., et al.[2021]

E-health interventions, particularly multimodal approaches that combine treatment advice, patient monitoring, and adherence reminders, have been shown to effectively control blood glucose levels in individuals with type 2 diabetes, based on a review of 81 studies.

Mobile devices are the most commonly used platforms for delivering e-health services, highlighting their importance in diabetes self-care management, although the usability of these interventions remains a topic of debate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

e-Health Interventions for Community-Dwelling Type 2 Diabetes: A Scoping Review. Seo, HJ., Kim, SY., Sheen, SS., et al.[2021]

eHealth interventions have shown significant improvements in self-management behaviors and clinical outcomes, particularly in lowering HbA1c levels for individuals with type 2 diabetes.

Successful implementation of eHealth support requires attention to participant preferences, technology usability, and the availability of support personnel, making it a valuable addition to traditional clinical care for chronic disease management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social Support for Diabetes Self-Management via eHealth Interventions. Vorderstrasse, A., Lewinski, A., Melkus, GD., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8442567/

Latinos understanding the need for adherence in diabetes ... Hispanics/Latinos (hereafter Latinos) are disproportionately at-risk for type 2 diabetes [1] and have poor diabetes medication adherence [2], ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05570734

Latinos Understanding the Need for Adherence in ... 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) ...

3. ctv.veeva.com ctv.veeva.com/study/latinos-understanding-the-need-for-adherence-in-diabetes-using-e-health

Latinos Understanding the Need for Adherence in Diabetes ... If shown effective, LUNA-E has high potential for broad scaling and dissemination due to its community partnered approach, use of technology, ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05570734/latinos-understanding-the-need-for-adherence-in-diabetes-using-e-health

Latinos Understanding the Need for Adherence in ... ... Behavioral Care and E-Health (LUNA-E) is a randomized controlled trial (RCT) that will test the effectiveness a patient-centered, team-based ...

5. app.dimensions.ai app.dimensions.ai/details/grant/grant.3625349

Latinos Understanding the Need for Adherence in Diabetes The study aims are to: 1) improve glycemic control, 2) improve cardiovascular risk profiles, 3) decrease psychological distress, and 4) evaluate the patient and ...

6. trialx.com trialx.com/clinical-trials/listings/277621/latinos-understanding-the-need-for-adherence-in-diabetes-using-e-health/

Latinos Understanding the Need for Adherence in ... LUNA-E will help advance our understanding of optimal approaches to diabetes healthcare services in a large, growing, US population at high ...

7. researchgate.net researchgate.net/publication/352009980_Latinos_understanding_the_need_for_adherence_in_diabetes_LUNA-D_a_randomized_controlled_trial_of_an_integrated_team-based_care_intervention_among_Latinos_with_diabetes

Latinos understanding the need for adherence in diabetes ... Latinos understanding the need for adherence in diabetes (LUNA-D): a randomized controlled trial of an integrated team-based care intervention among Latinos ...