Diabetes Management in Low-Income Hispanic Patients

Completed · Phase 2

Conditions studied: Type 2 Diabetes, Glycemic Control

In brief

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.

Key facts

Study ID

NCT00848315

Run by

University of Massachusetts, Worcester

People needed

252

Starts

2004-07-01

Expected to finish

2008-07-01

Last updated by the study team

2023-09-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Northgate Medical Center — Springfield, Massachusetts, United States
• Brightwood Health Center — Springfield, Massachusetts, United States
• High Street Health Center — Springfield, Massachusetts, United States
• Plumley Village — Worcester, Massachusetts, United States
• Family Health Center — Worcester, Massachusetts, United States

Full record on ClinicalTrials.gov

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