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A Self-care Intervention for Latino Adults With Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00263835
First Posted: December 9, 2005
Last Update Posted: March 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  Purpose
The purpose of this study is to modify and evaluate a culturally appropriate intervention that is designed to improve diabetes self-care practices by enhancing the self-efficacy, empowerment and diabetes knowledge among Latino adults over the age of 55 years.

Condition Intervention Phase
Diabetes Hypertension Behavioral: Empowerment Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Self-care Intervention for Latino Adults With Diabetes

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Change in hemoglobin A1c.

Secondary Outcome Measures:
  • Change in blood pressure, cholesterol, and weight.

Estimated Enrollment: 300
Study Start Date: October 2004
Estimated Study Completion Date: May 2006
Detailed Description:
It is recognized that Latinos with diabetes experience substantially worse process and outcomes of care. To address this problem, the goal of the proposed study is to modify and evaluate a culturally appropriate intervention designed to improve diabetes self-care practices by enhancing the self-efficacy, empowerment, and diabetes-specific knowledge among Latino adults over the age of 55 years. Specific aims of the project are: 1) to modify an existing empowerment intervention to improve self-care skills among Latinos with diabetes; 2) to test the effect of a patient-centered culturally-tailored intervention that focuses on increasing self-efficacy, knowledge about diabetes care, and self-care skills among Latinos with diabetes on: a) biophysiological endpoints such as glycemic control; b) self-efficacy, diabetes-specific knowledge, and self-care behaviors; c) psychosocial endpoints such as quality of life; and d) total costs and cost-effectiveness of care; and 3) to test the effect of the intervention on compliance with indicators of good process of diabetes care. To evaluate the effectiveness of the intervention, the research team will conduct a controlled clinical trial that will randomize 300 Latino adults over the age of 55 years with diabetes who are cared for in 4 public clinics affiliated with the Martin Luther King/Drew University Medical Center. Randomization will occur at the patient level. The primary endpoints for the trial will be: 1) differences in glycemic control as reflected by mean difference in hemoglobin A1c over time for the intervention versus usual care control group; and 2) difference in diabetes-specific quality of life over time. The trial will also measure a number of important secondary endpoints both before and after exposure to the intervention: self-efficacy, knowledge about diabetes, self-care behaviors, diabetes-specific symptoms, quality of life, low density lipoprotein levels, blood pressure, weight, quality of care, and costs. Variables that are likely to modify the effectiveness of the intervention will also be examined, including acculturation, language, insurance status, and social support. These data will provide the needed information to evaluate both the effectiveness and the cost effectiveness of the patient-centered intervention among Latino adults with diabetes. In summary, by modifying and testing an empowerment intervention that focuses on the patient, we hope to arm Latino adults with diabetes with the needed self-efficacy, knowledge, and self-care skills to have the best possible glycemic control and process of health care regardless of the resources available in their care setting.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Self-Identify as having diabetes, be 55 years of age or older, Latino/a and have a hemoglobing A1c of 8% or greater.

Exclusion Criteria:

Non diabetic, under 55, non Latino/a, a hemoglobin A1c of less than 8%.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00263835


Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Carol M Mangione, M.D., MSPH University of California, Los Angeles
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00263835     History of Changes
Other Study ID Numbers: DK59527 (completed)
5R01DK059527-04 ( U.S. NIH Grant/Contract )
First Submitted: December 7, 2005
First Posted: December 9, 2005
Last Update Posted: March 2, 2010
Last Verified: March 2010

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases