Community Diabetes Education Program Evaluation "Code Evaluation"

This study has been completed.

Sponsor:

Collaborator:

The Institute for Faith Health Research of Dallas

Information provided by:

The University of Texas Health Science Center, Houston

ClinicalTrials.gov Identifier:

NCT00151190

First received: September 6, 2005

Last updated: January 7, 2010

Last verified: January 2010

History of Changes

Purpose

The study is intended to determine the effectiveness and efficiency of a community diabetes education program administered by a community health worker in a low-cost community clinic. We expect an improvement in overall glycemic control in the experimental group of at least 20%. We also expect to document improvement in diabetes self-management skills, quality of life and an increase in achievement of ADA standards of care4 in the experimental group.

Condition	Intervention	Phase
Diabetes Mellitus	Behavioral: Education for diabetes self-management	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label
Official Title:	Community Diabetes Education Program Evaluation

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:

HbA1c, Triglycerides, Cholesterol, Urine Microalbumin, Blood Pressure,

Secondary Outcome Measures:

Patients' attitudes and knowledge about diabetes self-management, American Diabetes Association standards of care.


Estimated Enrollment:	180
Study Start Date:	April 2005
Estimated Study Completion Date:	August 2006

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

people with no health insurance

Exclusion Criteria:

people with any type of health insurance coverage

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: NCT00151190

Locations


United States, Texas
Central Dallas Ministries Community Health Services Clinic
Dallas, Texas, United States, 75246

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

The Institute for Faith Health Research of Dallas

Investigators


Principal Investigator:	DAN CULICA, MD, PhD	UTHSC School Public Health at Houston

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Prezio EA, Balasubramanian BA, Shuval K, Cheng D, Kendzor DE, Culica D. Evaluation of quality improvement performance in the Community Diabetes Education (CoDE) program for uninsured Mexican Americans: results of a randomized controlled trial. Am J Med Qual. 2014 Mar-Apr;29(2):124-34. doi: 10.1177/1062860613489165. Epub 2013 Jun 7.

Prezio EA, Cheng D, Balasubramanian BA, Shuval K, Kendzor DE, Culica D. Community Diabetes Education (CoDE) for uninsured Mexican Americans: a randomized controlled trial of a culturally tailored diabetes education and management program led by a community health worker. Diabetes Res Clin Pract. 2013 Apr;100(1):19-28. doi: 10.1016/j.diabres.2013.01.027. Epub 2013 Feb 28. Review.


ClinicalTrials.gov Identifier:	NCT00151190 History of Changes
Other Study ID Numbers:	HSC-SPH-05-0092
Study First Received:	September 6, 2005
Last Updated:	January 7, 2010
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:


Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases

ClinicalTrials.gov processed this record on September 26, 2016

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