Community Diabetes Education Program Evaluation "Code Eva... | NCT00151190

Studies
Community Diabetes Education Program Evaluation "Code Evaluation"

NCT00151190

Sponsor

The University of Texas Health Science Center, Houston

Status

Completed

Last Update Posted

Jan 11, 2010Estimated

Enrollment

180

Phase

Phase 3

Conditions

Diabetes Mellitus

Interventions

Education for diabetes self-management

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2005

Primary Completion Date

Not provided

Completion Date

Aug 2006

First Submitted Date

Sep 6, 2005

First Submission Date that Met QC Criteria

Sep 6, 2005

First Posted Date

Sep 8, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2010

Last Update Posted Date

Jan 11, 2010Estimated

Name	Class
The Institute for Faith Health Research of Dallas	UNKNOWN

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180

Name	Type	Description	Arm Group Labels	Other Names
Education for diabetes self-management	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HbA1c, Triglycerides, Cholesterol, Urine Microalbumin, Blood Pressure,

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

people with no health insurance

Exclusion Criteria:

people with any type of health insurance coverage

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
DAN CULICA, MD, PhD	UTHSC School Public Health at Houston	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Central Dallas Ministries Community Health Services Clinic		Dallas	Texas	75246	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23748855	Derived	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.
23453178

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D012959	Socioeconomic Factors
D011154	Population Characteristics