NCT00151190

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P25-P50 for phase_3 diabetes-mellitus

Timeline
Completed

Started Apr 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

January 11, 2010

Status Verified

January 1, 2010

First QC Date

September 6, 2005

Last Update Submit

January 7, 2010

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

Education for diabetes self-managementBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • people with no health insurance

You may not qualify if:

  • people with any type of health insurance coverage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Dallas Ministries Community Health Services Clinic

Dallas, Texas, 75246, United States

Location

Related Publications (2)

  • 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.

    PMID: 23748855DERIVED

  • 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.

    PMID: 23453178DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • DAN CULICA, MD, PhD

    UTHSC School Public Health at Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

April 1, 2005

Study Completion

August 1, 2006

Last Updated

January 11, 2010

Record last verified: 2010-01

Locations

US(1)