Comparing Program Options for Latinos With Diabetes

NCT03004664 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 452

Last updated 2024-12-17

No results posted yet for this 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 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.

Conditions

Interventions

BEHAVIORAL

Support Empowerment Model

The DSMS combines a series of clinically informed group didactic sessions that use a patient self-determination approach to empower patients to take control of their own diabetes health with follow-up supports to sustain self-management gains achieved during the sessions.

BEHAVIORAL

The Chronic Care Model

the CCM focuses on addressing social determinants of health by meeting the medical, cultural, and linguistic needs of patients through integration of cultural norms and social relationships from the patient population into program design

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER
  • University of New Mexico

    lead OTHER

Principal Investigators

  • Janet M Page-Reeves, Ph.D. · University of New Mexico School of Medicine

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2021-03-17
Completion
2023-01-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03004664 on ClinicalTrials.gov