NCT03983499

Brief Summary

The Latinos Understanding the Need for Adherence in Diabetes (LUNA-D) study, is a randomized controlled trial testing the effectiveness of an integrated behavioral health and primary care chronic care disease management intervention for low income Latino patients with type-2 diabetes mellitus (T2DM) that have 2 or more chronic health conditions. LUNA-D focuses on diabetes management and behavioral health care integration.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
456

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 16, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2018

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 12, 2019

Completed
Last Updated

June 12, 2019

Status Verified

June 1, 2019

Enrollment Period

3.4 years

First QC Date

June 7, 2019

Last Update Submit

June 10, 2019

Conditions

Type 2 DiabetesGlycemic ControlCardiovascular Risk FactorsPsychological Distress

Outcome Measures

Primary Outcomes (1)

  • HbA1c Blood Value

    The primary outcome is change in HbA1c values among non-insulin using type 2 diabetes mellitus Latino patients through a linguistically and culturally appropriate evidence-based application of a Chronic Care Model (LUNA-D).

    Repeated measures will be taken at baseline, 3-, 6-, 9-, 12-months post randomization in order to compare the rates of change over time between the two conditions (SI and UC).

Secondary Outcomes (5)

  • Body Mass Index (BMI)

    Repeated measures will be taken at baseline, 3-, 6-, 9-, 12-months post randomization in order to compare the rates of change over time between the two conditions (SI and UC).

  • Total Cholesterol

    Repeated measures will be taken at baseline, 3-, 6-, 9-, 12-months post randomization in order to compare the rates of change over time between the two conditions (SI and UC).

  • Blood Pressure (BP)

    Repeated measures will be taken at baseline, 3-, 6-, 9-, 12-months post randomization in order to compare the rates of change over time between the two conditions (SI and UC).

  • Patient Health Questionnaire (PHQ-8)

    Repeated measures will be taken at baseline, 3-, 6-, 9-, 12-months post randomization in order to compare the rates of change over time between the two conditions (SI and UC).

  • Generalized Anxiety Disorder 7-item (GAD-7)

    Repeated measures will be taken at baseline, 3-, 6-, 9-, 12-months post randomization in order to compare the rates of change over time between the two conditions (SI and UC).

Study Arms (2)

Special Intervention

EXPERIMENTAL

The special intervention (SI) arm addresses glycemic control, medication adherence, control of modifiable CVD risk factors, health behavior change, and psychosocial and cultural barriers to self-management. The SI arm consists of a collaborative care team approach with four main elements including: 1) Specialized clinical care by a medical provider; 2) Specialized behavioral health care by a behavioral health provider; 3) Group-based chronic disease self-management education by peer-leaders; 4) Intensive, proactive care coordination facilitated by a patient registry and electronic health records.

Behavioral: Special Intervention

Usual Care

NO INTERVENTION

Participants randomized to the Usual Care (UC) arm continue to see their primary care provider and receive referrals to health education. At the discretion of the provider, UC patients are screened and referred to behavioral health (BH) care.

Interventions

Special InterventionBEHAVIORAL

The components of the Special Intervention (SI) integrated design are: 1) Co-location of the clinical team; 2) Shared medical plan; 3) Clinical visits with a medical provider for management of chronic medical conditions; 4) Visits with behavioral health provider for management of psychosocial chronic conditions; 5) Care coordination; 6) Six group-health education classes and two booster sessions led by a promotora. Participants in the SI arm meet with the integrated care team in the context of a regular medical visit primarily to focus on clinical/biological aspects of the chronic medical conditions (diabetes, dyslipidemia, hypertension, obesity, etc.)

Also known as: Medical Provider clinical visits, Behavioral Health Provider counseling visits, Care Coordination, Group Health Education
Special Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • This study targets non-insulin using T2DM patients with 2 or more chronic conditions. The primary eligibility criteria are as follows:
  • Self-identify as Hispanic/Latino
  • Be a registered \& established patient of SYH
  • years of age or older
  • Have an established diagnosis of T2DM (but not currently using insulin)
  • Not currently participating in any other diabetes or CVD intervention program
  • Have 2 or more CVD risk factors (e.g., depression, anxiety, hypertension, dyslipidemia, obesity, or smoking)

You may not qualify if:

  • Individuals will be excluded if they:
  • Have plans to move out of the area in the next 12 months
  • Have pre-existing health problems so severe as to prohibit informed consent and study attendance
  • Have severe diabetes, including renal disease and/or on dialysis
  • Have severe psychosocial conditions under the care of a psychiatrist (e.g., severe depression, bipolar disorder, or schizophrenia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Bay Latino Research Center

Chula Vista, California, 91910, United States

Location

Related Publications (2)

  • Castaneda SF, Gallo LC, Garcia ML, Mendoza PM, Gutierrez AP, Lopez-Gurolla M, Roesch S, Pichardo MS, Munoz F, Talavera GA. Effectiveness of an integrated primary care intervention in improving psychosocial outcomes among Latino adults with diabetes: the LUNA-D study. Transl Behav Med. 2022 Aug 17;12(8):825-833. doi: 10.1093/tbm/ibac042.

    PMID: 35776001DERIVED

  • Talavera GA, Castaneda SF, Mendoza PM, Lopez-Gurrola M, Roesch S, Pichardo MS, Garcia ML, Munoz F, Gallo LC. 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. Transl Behav Med. 2021 Sep 15;11(9):1665-1675. doi: 10.1093/tbm/ibab052.

    PMID: 34057186DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Gregory A Talavera, MD/MPH

    SDSU

    PRINCIPAL INVESTIGATOR

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

June 7, 2019

First Posted

June 12, 2019

Study Start

July 16, 2015

Primary Completion

December 18, 2018

Study Completion

December 31, 2018

Last Updated

June 12, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)