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NCT03004664 · ClinicalTrials.gov registry record
Comparing Program Options for Latinos With Diabetes
A clinical trial, sponsored by University of New Mexico.
- Completed
- Registry status
- 452
- Enrollment target
NCT03004664: Completed study, sponsored by University of New Mexico.
NCT03004664 is a clinical trial that has completed, run by University of New Mexico. The registered enrollment target is 452 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03004664 has completed, sponsored by University of New Mexico.
- COMPLETED
- Registry status
- 452 participants
- Enrollment target
Study Summary
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 pati
Primary Outcome
Improvement in diabetes knowledge measured through change in scores on The Diabetes Knowledge Questionnaire \[DKQ\])
Interventions
- BEHAVIORAL Support Empowerment Model
- BEHAVIORAL The Chronic Care Model
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 452 participants |
| Start Date | 2017-02-01 |
| Est. Completion | 2023-01-30 |
What the finished NCT03004664 record still lists
NCT03004664 is an observational study that tracks outcomes without assigning an intervention. The registered 452 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which Support Empowerment Model is the first listed.
NCT03004664 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03004664 about?
NCT03004664 is a clinical study titled "Comparing Program Options for Latinos With Diabetes". 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...
What is the current status of trial NCT03004664?
This trial is currently completed. The enrollment target is 452 participants. The study started on 2017-02-01. Estimated completion is 2023-01-30.
What interventions are being tested in trial NCT03004664?
The interventions under investigation include: Support Empowerment Model (BEHAVIORAL), The Chronic Care Model (BEHAVIORAL).
Who is sponsoring clinical trial NCT03004664?
This trial is sponsored by University of New Mexico, which has 168 total clinical trials registered on ClinicalTrials.gov.
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