Status:
COMPLETED
Diabetes Management in Low-Income Hispanic Patients
Lead Sponsor:
University of Massachusetts, Worcester
Conditions:
Type 2 Diabetes
Glycemic Control
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
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 b...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT00848315
Start Date
July 1 2004
End Date
July 1 2008
Last Update
September 13 2023
Active Locations (5)
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1
Northgate Medical Center
Springfield, Massachusetts, United States, 01103
2
Brightwood Health Center
Springfield, Massachusetts, United States, 01107
3
High Street Health Center
Springfield, Massachusetts, United States, 01199
4
Plumley Village
Worcester, Massachusetts, United States, 01608