Comparing Program Options for Latinos With Diabetes
Completed
Conditions studied: Diabetes Mellitus
In brief
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.
Key facts
- Study ID
- NCT03004664
- Run by
- University of New Mexico
- People needed
- 452
- Starts
- 2017-02-01
- Expected to finish
- 2023-01-30
- Last updated by the study team
- 2024-12-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patient Participants:
- Adults (men and women) who have been identified by a provider as having pre-diabetes (A1c 5.7-6.4) or diabetes (A1c 6.5 or above)
- Enter one of the two diabetes programs during the study
- Self-identify as "Latino"
- Can identify a social support or key member of their social network who will agree to participate with them
- Are not pregnant (participants who become pregnant during the study will be excluded)
- Have household income 250% of the Federal Poverty Level (FPL) or below.
- Social support participants:
- Adults
- Individuals who are identified by the patient participants as their social support
You may not qualify if…
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Prisoners
- Pregnant women
- Participants who become pregnant during the study will be excluded. At enrollment and before each data collection appointment, female patient participants will be screened to specifically exclude those who are pregnant. There is no risk to a pregnant woman or a fetus entailed in participation in this study because the study only involves data collection from individuals who have been instructed to participate in a diabetes self-management program by their provider. However, pregnant individuals will be excluded because pregnancy could impact outcomes in a way that will influence scientific analysis of diabetes self-management.
Where it is running
- One Hope Centro de Vida Health Center — Albuquerque, New Mexico, United States
- University of New Mexico Hospital — Albuquerque, New Mexico, United States
Full record on ClinicalTrials.gov
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