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

Official title

Latinos Understanding the Need for Adherence in Diabetes Using Care Coordination, Integrated Medical and Behavioral Care and E-Health

Overview

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.

Interventions

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

Primary outcome measures

• Hemoglobin A1C (HbA1c) Blood Value [Time frame: 6-months post randomization]
• Psychological Distress - Depression [Time frame: 6-months post randomization]
• Psychological Distress - Anxiety [Time frame: 6-months post randomization]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• South Bay Latino Research Center — Chula Vista

Identifiers

NCT: NCT05570734 · R01MD015080

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗