E-Health Intervention for Type 2 Diabetes

(LUNA-E Trial)

Overseen by Linda C Gallo, PHD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: San Diego State University

Disqualifiers: Cancer, Parkinson's, Pregnancy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial uses a team-based healthcare approach with online tools to help Latino patients with type 2 diabetes manage their condition. The goal is to improve blood sugar control and reduce stress and anxiety related to diabetes.

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 data supports the effectiveness of this treatment for Type 2 Diabetes?

Research shows that tailored e-health interventions, especially those involving community health workers and culturally appropriate education, improve diabetes management in Latino populations. These programs enhance patient engagement and adherence, leading to better health outcomes like improved blood sugar control. ^{1 2 3 4 5}

Is the E-Health Intervention for Type 2 Diabetes safe for humans?

The research articles do not provide specific safety data for the E-Health Intervention for Type 2 Diabetes, but they suggest that eHealth interventions, including those using digital health navigators and community health workers, are generally feasible and usable for diabetes management. ^{3 4 5 6 7}

How is the LUNA Behavioral Health and LUNA Care Coordination treatment different from other treatments for type 2 diabetes?

The LUNA treatment is unique because it is an e-health intervention specifically tailored for Latinos with type 2 diabetes, incorporating cultural, linguistic, and educational adaptations to improve adherence and outcomes. It uses community health workers and technology to provide personalized support and education, addressing barriers like technology literacy and involving family in the care process. ^{4 5 8 9 10}

Research Team

Gregory A Talavera, MD/MPH

Principal Investigator

San Diego State University

Linda C Gallo, PHD

Principal Investigator

San Diego State University

Eligibility Criteria

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

Approval from primary care provider

Self identify as Hispanic/Latino ethnicity of any race

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.

Trial Timeline

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

Treatment Details

Interventions

• Health Education Videos (Behavioural Intervention)
• LUNA Behavioral Health (Behavioural Intervention)
• LUNA Care Coordination (Behavioural Intervention)
• Virtual Integrated Visits (Behavioural Intervention)

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.

Participant Groups

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+

William Tong

San Diego State University

Chief Executive Officer since 2023

PhD in Chemistry from Iowa State University

Ramin Farzaneh-Far

San Diego State University

Chief Medical Officer since 2024

MD

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Integrating education, group support, and case management for diabetic Hispanics. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

A Chronic Care Management Framework Bridging Clinic, Home, and Community Care in a Mexican American Population. [2022]

3. England 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

Eliminating disparities among Latinos with type 2 diabetes: Effective eHealth strategies. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Digital healthcare equity in primary care: implementing an integrated digital health navigator. [2023]

7. Canada pubmed.ncbi.nlm.nih.gov

Exchanges in a Virtual Environment for Diabetes Self-Management Education and Support: Social Network Analysis. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

e-Health Interventions for Community-Dwelling Type 2 Diabetes: A Scoping Review. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Innovative Diabetes Interventions in the U.S. Hispanic Population. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Social Support for Diabetes Self-Management via eHealth Interventions. [2022]