Diabetes Management in Low-Income Hispanic Patients

This study has been completed.
Sponsor:
Information provided by:
University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT00848315
First received: February 19, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00848315

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
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 20, 2014