Diabetes Management in Low-Income Hispanic Patients
United States252 participantsStarted 2004-07
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Diagnosed with T2DM (documented in the medical chart);
ā. HbA1c level \> 7.5;
ā. 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;
ā. Hispanic origin;
ā. \> 18 years old;
ā. Telephone in home or easy access to one;
ā. Able to understand and participate in the study protocol;
ā. Functionally capable of meeting the activity goals;
Exclusion criteria
ā. History of diabetic ketoacidosis
ā. Gestational diabetes
ā. Unable or unwilling to provide informed consent;
ā. Plans to move out of the area within the 12-month study period;
ā. Required intermittent glucocorticoid therapy within the past 3 months;
ā. Experienced an acute coronary event (myocardial infarction or unstable angina) within the previous 6 mos
What they're measuring
1
The primary outcome is improvement in metabolic control (HbA1c).
Timeframe: The primary outcome was evaluated at 4- and 12-months following randomization.
. Has a medical condition that precludes adherence to study dietary recommendations (e.g., Crohn's disease, ulcerative colitis, end-stage renal disease);
ā. 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.