Diabetes Management in Low-Income Hispanic Patients

Type 2 Diabetes Clinical Trial

Official title:

Diabetes Management in Low-Income Hispanic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00848315
• Other study ID #: 1R18DK065985
• Status: Completed
• Phase: Phase 2
• Start date: July 2004
• Est. completion date: July 2008

Study information

• Verified date: September 2023
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: July 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Diagnosed with T2DM (documented in the medical chart);

2. HbA1c level > 7.5;

3. 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;

4. Hispanic origin;

5. > 18 years old;

6. Telephone in home or easy access to one;

7. Able to understand and participate in the study protocol;

8. Functionally capable of meeting the activity goals;

9. 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);

10. Physician approval to participate in the study.

Exclusion Criteria:

1. History of diabetic ketoacidosis

2. Gestational diabetes

3. Unable or unwilling to provide informed consent;

4. Plans to move out of the area within the 12-month study period;

5. Required intermittent glucocorticoid therapy within the past 3 months;

6. Experienced an acute coronary event (myocardial infarction or unstable angina) within the previous 6 mos

7. Has a medical condition that precludes adherence to study dietary recommendations (e.g., Crohn's disease, ulcerative colitis, end-stage renal disease);

8. 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Glycemic Control
• Type 2 Diabetes

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.

Locations

Country	Name	City	State
United States	Brightwood Health Center	Springfield	Massachusetts
United States	High Street Health Center	Springfield	Massachusetts
United States	Northgate Medical Center	Springfield	Massachusetts
United States	Family Health Center	Worcester	Massachusetts
United States	Plumley Village	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is improvement in metabolic control (HbA1c).		The primary outcome was evaluated at 4- and 12-months following randomization.
Secondary	Efficacy of the intervention		4- and 12-months following the intervention