Clinical trial NCT05570734: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Glycemic Control
Psychological Distress
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Hemoglobin A1C (HbA1c) Blood Value
timeFrame: 6-months post randomization
measure: Psychological Distress - Depression
timeFrame: 6-months post randomization
measure: Psychological Distress - Anxiety
timeFrame: 6-months post randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: South Bay Latino Research Center
state: California
Study officials:
affiliation: San Diego State University
name: Gregory A Talavera, MD/MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: San Diego State University
name: Linda C Gallo, PHD
role: PRINCIPAL_INVESTIGATOR
References: