Clarksdale Diabetes and Metabolism Clinic CHEC Study | NCT00791453

Studies
Clarksdale Diabetes and Metabolism Clinic CHEC Study

NCT00791453

Sponsor

University of Mississippi Medical Center

Status

Completed

Last Update Posted

May 12, 2009Estimated

Enrollment

55Actual

Phase

Not provided

Conditions

Diabetes

Interventions

Education

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

ID	Type	Description	Link
NO1-LM-6-3502

Status Module

Record Verification Date

May 2009

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 2008

Primary Completion Date

Feb 2009Actual

Completion Date

Feb 2009Actual

First Submitted Date

Jan 28, 2008

First Submission Date that Met QC Criteria

Nov 12, 2008

First Posted Date

Nov 14, 2008Estimated

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

May 11, 2009

Last Update Posted Date

May 12, 2009Estimated

Name	Class
National Library of Medicine (NLM)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will involve established clinic patients. The Rapid Estimate of Adult Literacy in Medicine will be administered during patients' regular clinic visits. Patients will then be referred to the Consumer Health Education Center (CHEC)by healthcare providers who will fill out a referral form. The form will be given the the CHEC health educator who will assist patients in finding literacy-appropriate health information. BMI and Hgb A1c values will be compared after 3 months and 6 months to baseline values. It is hypothesized that objective assessment of patient use of literacy-appropriate, health information from the Clarksdale Diabetes and Metabolism Clinic CHEC will improve Hgb A1c and BMI values among patients.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

55Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
I		Established patients at the Clarksdale Diabetes and Metabolism Center	Behavioral: Education

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Education	Behavioral	Patients will receive literacy appropriate health information.	I

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hgb A1C and BMI measurements will improve		3 and 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Established patients of the Clarksdale Diabetes and Metabolism Clinic between the ages of 18 and 64.

Exclusion Criteria:

Individuals who are not established patients of the clinic and are not between the ages of 18 and 64.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Established patients at a diabetes clinic.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jacinda B. Roach, PhD	The University of Mississippi Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Mississippi Medical Center		Jackson	Mississippi	39216	United States

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004522	Educational Status

Ancestor Terms

ID	Term
D012959	Socioeconomic Factors
D011154	Population Characteristics

Browse Leaves

Not provided

Browse Branches

Not provided