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NCT00151190 Clinical Trial

Community Diabetes Education Program Evaluation "Code Evaluation"

Diabetes Mellitus Clinical Trial

Official title:
Community Diabetes Education Program Evaluation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00151190
Other study ID # HSC-SPH-05-0092
Secondary ID
Status Completed
Phase Phase 3
First received September 6, 2005
Last updated January 7, 2010
Start date April 2005
Est. completion date August 2006

Study information
Verified date January 2010
Source The University of Texas Health Science Center, Houston
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 180
Est. completion date August 2006
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- people with no health insurance

Exclusion Criteria:

- people with any type of health insurance coverage

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Behavioral:
• Education for diabetes self-management

Locations
Country Name City State
United States Central Dallas Ministries Community Health Services Clinic Dallas Texas

Sponsors (2)
Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston The Institute for Faith Health Research of Dallas

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c, Triglycerides, Cholesterol, Urine Microalbumin, Blood Pressure,
Secondary Patients' attitudes and knowledge about diabetes self-management, American Diabetes Association standards of care.
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