Diabetes Management in Low-Income Hispanic Patients
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Glycemic Control |
Behavioral: Cognitive Behavioral Intervention |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) |
| Official Title: | Diabetes Management in Low-Income Hispanic Patients |
- The primary outcome is improvement in metabolic control (HbA1c). [ Time Frame: The primary outcome was evaluated at 4- and 12-months following randomization. ] [ Designated as safety issue: No ]
- Efficacy of the intervention [ Time Frame: 4- and 12-months following the intervention ] [ Designated as safety issue: No ]
| Enrollment: | 252 |
| Study Start Date: | July 2004 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: 1
Usual Care that the Type 2 Diabetes Patients usually receive at the health centers.
|
|
|
Experimental: 2
Cognitive Behavioral Intervention
|
Behavioral: Cognitive Behavioral 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 patients.
Other Name: Diabetes Self-Management
|
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 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, Massachusetts | |
| Brightwood Health Center | |
| Springfield, Massachusetts, United States, 01107 | |
| High Street Health Center | |
| Springfield, Massachusetts, United States, 01199 | |
| Northgate Medical Center | |
| Springfield, Massachusetts, United States, 01103 | |
| Family Health Center | |
| Worcester, Massachusetts, United States, 01610 | |
| Plumley Village | |
| Worcester, Massachusetts, United States, 01608 | |
| Principal Investigator: | Milagros C Rosal, PhD | University of Massachusetts, Worcester |
More Information
No publications provided by University of Massachusetts, Worcester
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Milagros C. Rosal, PhD, Associate Professor of Medicine, University of Massachusetts Medical School |
| ClinicalTrials.gov Identifier: | NCT00848315 History of Changes |
| Other Study ID Numbers: | 1R18DK65985 |
| Study First Received: | February 19, 2009 |
| Last Updated: | February 19, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Massachusetts, Worcester:
|
cognitive behavioral intervention low literate/illiterate Hispanic patients |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013