Diabetes Management in Low-Income Hispanic Patients

Study Overview
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Brief Summary
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The overall goal of this randomized clinical trial (RCT) is to test the efficacy of a culturally- and literacy-tailored cognitive-behavioral intervention designed to enhance adherence to diabetes self-management behaviors and improve glycemic control among low-income Hispanic individuals with type 2 diabetes mellitus.

Detailed Description
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Patients are randomly assigned to a Usual Care condition or to the Cognitive Behavioral Intervention condition. The unit of randomization and analysis is the patient. The intervention is implemented by a nutritionist, a nurse diabetes educator and an assistant, and patients are encouraged to bring a family member or friend living in the same household to facilitate home-based support for the intervention. The intervention emphasizes patients' ethnic preferences and traditions (e.g., adapting ethnic recipes to meet dietary goals) and the use of available community resources (e.g., available areas for exercise), and is delivered utilizing strategies and materials appropriate for low-literate/illiterate pts.

Official Title
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Diabetes Management in Low-Income Hispanic Patients

Conditions
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Type 2 Diabetes, Glycemic Control

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with T2DM (documented in the medical chart); HbA1c level > 7.5; Currently treated with diet, oral hypoglycemics or insulin. If currently on insulin, must have a history of prior therapy with diet alone or oral hypoglycemic agents; Hispanic origin; > 18 years old; Telephone in home or easy access to one; Able to understand and participate in the study protocol; Functionally capable of meeting the activity goals; Understands and can provide informed consent (English or Spanish; for illiterate pts we will require that a representative of the pt also understands and signs the consent form on behalf of the pt); Physician approval to participate in the study. Exclusion Criteria: History of diabetic ketoacidosis Gestational diabetes Unable or unwilling to provide informed consent; Plans to move out of the area within the 12-month study period; Required intermittent glucocorticoid therapy within the past 3 months; Experienced an acute coronary event (myocardial infarction or unstable angina) within the previous 6 mos Has a medical condition that precludes adherence to study dietary recommendations (e.g., Crohn's disease, ulcerative colitis, end-stage renal disease); Has a medical or psychiatric illness (i.e., dementia, psychiatric hospitalization or suicidality within past 5 years or takes an atypical neuroleptic medication). We will not exclude individuals with a diagnosis of depression or pts taking anti-depressants.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>Usual Care that the Type 2 Diabetes Patients usually receive at the health centers. | |
| Experimental: 2<br>Cognitive Behavioral Intervention | Behavioral: Cognitive Behavioral Intervention<br>* The intervention emphasizes patients' ethnic preferences and traditions (e.g., adapting ethnic recipes to meet dietary goals) and the use of available community resources (e.g., available areas for exercise), and is delivered utilizing strategies and materials appropriate for low-literate/illiterate patients.<br>* Other names: Diabetes Self-Management;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome is improvement in metabolic control (HbA1c). |  | The primary outcome was evaluated at 4- and 12-months following randomization. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of the intervention |  | 4- and 12-months following the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive behavioral intervention, low literate/illiterate Hispanic patients