Comparing Program Options for Latinos With Diabetes
Public ClinicalTrials.gov record NCT03004664. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Patient-Centered Framework to Test the Comparative Effectiveness of Culturally and Contextually Appropriate Program Options for Latinos With Diabetes From Low-Income Households
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
BACKGROUND AND SIGNIFICANCE: Diabetes is a national health problem, yet Latinos from low-income households are at greater risk. Although guidelines recommend that patients learn self-management strategies, many people are not able to do so effectively and cannot control their diabetes. Studies show that culturally competent self-management programming can help, but patients in preliminary research indicated that not all programs sufficiently respect patients' cultural values or account for their socio-economic limitations. STUDY AIMS: This project will compare two models for culturally competent diabetes self-management programming. The hypothesis is that the program model that best considers patient culture and accommodates patient socio-economic circumstances will have the best outcomes. COMPARATORS: 2 diabetes self-management program models used by many Latino patients from low-income households in Albuquerque, New Mexico 1. The Diabetes Self-Management Support Empowerment Model 2. The Chronic Care Model STUDY POPULATION: Patients will be 240 individuals who consider themselves to be Latino and who are from low-income households. In addition, 240 patients will identify a corresponding social support to participate with them. Outcomes will be measured based on the 240 patient participants. Social support data will be measured as a covariate to understand patient outcomes. PRIMARY OUTCOME: Improved capacity for diabetes self-management measured as diabetes knowledge and patient activation or the ability to put that knowledge into action. SECONDARY OUTCOME: Successful diabetes self-management measured through reduced A1c, BMI and depression. Patient stress levels will also be measured using testing of hair samples to identify levels of cortisol as a biological marker for chronic stress. METHODS: Statistical calculations will be conducted to make sure that the things being compared are differences in program design and not differences in individual patient characteristics. This study will compare whether the programs improve diabetes health knowledge, ability to act, and A1c, BMI, depression and stress control, and determine which program is the best.
Study identification
- NCT ID
- NCT03004664
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 452 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2017
- Primary completion
- Mar 16, 2021
- Completion
- Jan 29, 2023
- Last update posted
- Dec 16, 2024
2017 – 2023
United States locations
- U.S. sites
- 2
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| One Hope Centro de Vida Health Center | Albuquerque | New Mexico | 87108 | — |
| University of New Mexico Hospital | Albuquerque | New Mexico | 87131 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03004664, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 16, 2024 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03004664 live on ClinicalTrials.gov.