Latinos Understanding the Need for Adherence in Diabetes Using E-Health

NCT05570734 | Recruiting DMC

• 1 other identifier: R01MD015080
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Type 2 Diabetes; Glycemic Control; Psychological Distress

Outcome Measures

Primary Outcomes (3)

• Hemoglobin A1C (HbA1c) Blood Value

  Change glycemic control among Latino patients with type 2 diabetes through an innovative patient centered, team-based, highly integrated primary care intervention (LUNA-E).

  6-months post randomization

• Psychological Distress - Depression

  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.

  6-months post randomization

• Psychological Distress - Anxiety

  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.

  6-months post randomization

Study Arms (2)

LUNA Group

EXPERIMENTAL

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.

Behavioral: LUNA Care Coordination; Behavioral: LUNA Behavioral Health; Behavioral: Health Education Videos; Behavioral: Virtual Integrated Visits

Care Coordination

NO 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.

Interventions

LUNA Care Coordination BEHAVIORAL

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 Group

LUNA Behavioral Health BEHAVIORAL

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.

LUNA Group

Health Education Videos BEHAVIORAL

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.

LUNA Group

Virtual Integrated Visits BEHAVIORAL

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.

LUNA Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self identify as Hispanic/Latino ethnicity of any race
• Registered patient of federally qualified health center
• 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)

You may not qualify if:

• Actively being treated for cancer or Parkinson's Disease
• 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)

Sponsors & Collaborators

• San Diego State University: lead

Study Sites (1)

South Bay Latino Research Center

Chula Vista, California, 91910, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Gregory A Talavera, MD/MPH

  San Diego State University

  PRINCIPAL INVESTIGATOR

• Linda C Gallo, PHD

  San Diego State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Program Manager

CONTACT

619-594-8060; pmendoza@sdsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: October 7, 2022
• Study Start: February 27, 2023
• Primary Completion: August 1, 2025
• Study Completion: February 1, 2026
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)