Managing Chronic Kidney Disease in Eastern North Carolina | NCT01054066

Studies
Managing Chronic Kidney Disease in Eastern North Carolina

NCT01054066

Sponsor

East Carolina University

Status

Completed

Last Update Posted

Apr 12, 2012Estimated

Enrollment

1,257Actual

Phase

Not Applicable

Conditions

Chronic Kidney Disease

Interventions

Chronic Kidney Disease 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

Status Module

Record Verification Date

Apr 2012

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

Aug 2008

Primary Completion Date

May 2011Actual

Completion Date

May 2011Actual

First Submitted Date

Jan 21, 2010

First Submission Date that Met QC Criteria

Jan 21, 2010

First Posted Date

Jan 22, 2010Estimated

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

Apr 11, 2012

Last Update Posted Date

Apr 12, 2012Estimated

Name	Class
The Kate B. Reynolds Charitable Trust	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

The purpose of this program is to educate primary care physicians in four underserved clinics in eastern North Carolina about chronic kidney disease.

Detailed Description

The Division of Nephrology within the Brody School of Medicine recently form a center to focus attention on the needs of patients with kidney disease in eastern North Carolina. It is estimated that more than 40 million Americans have or at risk for CKD. The estimate for CKD in eastern North Carolina is exacerbated by poor access to health care. The mission of the East Carolina University Center for the Study and Treatment of Kidney Disease (ECCKD) is to increase education and awareness, improve treatment and outcomes through research, and better serve patients with CKD in eastern North Carolina.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,257Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chronic Kidney Disease Education	Behavioral	Instituting teaching programs to manage hypertension, diabetes, anemia, proteinuria and cardiovascular disease in patients.		primary care primary care clinics education

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine the effect of CKD education on the behavior of the primary care physician in underserved areas in Eastern North Carolina.		every 6 months

Secondary Outcomes

Measure	Description	Time Frame
To assess the rate of reduction of CKD in patients in Eastern North Carolina.		every 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary care clinics in eastern North Carolina with a high penetration of chronic kidney disease, risk factors for chronic kidney disease and poverty.

Accepts Healthy Volunteers

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
Paul Bolin, MD	East Carolina University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
East Carolina University		Greenville	North Carolina	27834	United States

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D002318	Cardiovascular Diseases
D006973	Hypertension
D000740	Anemia

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011320	Primary Health Care
D004522	Educational Status

Ancestor Terms

ID	Term
D003191	Comprehensive Health Care
D010346	Patient Care Management
D006298	Health Services Administration
D012959	Socioeconomic Factors

Browse Leaves

Not provided

Browse Branches

Not provided