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

Not Applicable

Recruiting

• Conditions: Psychological Distress; Glycemic Control; Type 2 Diabetes
• Interventions: Behavioral: LUNA Care Coordination; Behavioral: LUNA Behavioral Health; Behavioral: Health Education Videos; Behavioral: Virtual Integrated Visits

• Registration Number: NCT05570734
• Lead Sponsor: San Diego State University

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).

Detailed Description

LUNA-E will help advance our understanding of optimal approaches to diabetes healthcare services in a large, growing, US population at high risk for diabetes and related complications. If shown effective, LUNA-E has high potential for broad scaling and dissemination due to its community partnered approach, use of technology, and implementation within a large, exemplar federally qualified health center (FQHC) environment. The study's total sample size is 600, with 400 consented and enrolled in the randomized controlled trial (RCT). An additional 200 participants will be identified for medical records review and will not undergo study related activities.

The RCT (Arms 1 and 2) targets 400 Latino patients with type 2 diabetes from a local FQHC pool of registered patients. The eligibility criteria are: 1) Latino ethnicity of any race; 2) registered patient of FQHC; 3) \> 18 years; 4) type 2 diabetes with hemoglobin A1C (HbA1c) \>7.5% in past 90 days; 5) provider approval; 6) not participating in any other diabetes intervention. Biological measurements will be taken at baseline, 3-, 6-, and 12-months to detect changes in glycemic control. Clinical lab measures, medication adherence, weight, health behaviors and psychosocial measures will also be obtained across the study.

For Arm 3,the research team will work with the FQHC IT to query all patients with type 2 diabetes and then identify 200 matched controls, using propensity score matching as guided by the study statistician. Selection criteria will occur after the study has completed recruitment. Only de-identified data will be obtained from the medical records for these individuals. De-identified data will be provided by the FQHC IT department.

Study Timeline

• Study First Submitted: 2022-09-15
• Study First Submitted QC: 2022-10-04
• Study First Posted: 2022-10-07
• Study Start: 2023-02-27
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-17
• Primary Completion: 2025-08
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Self identify as Hispanic/Latino ethnicity of any race
2. Registered patient of federally qualified health center
3. 18 years of age or older
4. Type 2 diabetes with hemoglobin A1C (HbA1c) >7.5% in past 90 days
5. Approval from primary care provider
6. Not currently enrolled/participating in any other diabetes intervention program(s)

Exclusion Criteria

1. Actively being treated for cancer or Parkinson's Disease
2. Pregnant or nursing (temporary exclusion, may qualify 6-months postpartum)
3. Have plans to move out of the area in the next 12 months
4. Have other existing mental or physical health problems so severe as to prohibit informed consent and participation
5. Have severe diabetes complications (e.g., renal disease, or on dialysis)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LUNA Group	LUNA Behavioral Health	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.
LUNA Group	Health Education Videos	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.
LUNA Group	LUNA Care Coordination	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.
LUNA Group	Virtual Integrated Visits	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.

Primary Outcome Measures

Name	Time	Method
Psychological Distress - Depression	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	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.
Hemoglobin A1C (HbA1c) Blood Value	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).

Trial Locations

Locations (1)

South Bay Latino Research Center; 🇺🇸 Chula Vista, California, United States