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Managing Chronic Kidney Disease in Eastern North Carolina

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01054066
Recruitment Status : Completed
First Posted : January 22, 2010
Last Update Posted : April 12, 2012
Sponsor:
Collaborator:
The Kate B. Reynolds Charitable Trust
Information provided by (Responsible Party):
Paul Bolin, East Carolina University

Tracking Information
First Submitted Date  ICMJE January 21, 2010
First Posted Date  ICMJE January 22, 2010
Last Update Posted Date April 12, 2012
Study Start Date  ICMJE August 2008
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2010)
To determine the effect of CKD education on the behavior of the primary care physician in underserved areas in Eastern North Carolina. [ Time Frame: every 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01054066 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2010)
To assess the rate of reduction of CKD in patients in Eastern North Carolina. [ Time Frame: every 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Managing Chronic Kidney Disease in Eastern North Carolina
Official Title  ICMJE Management of Chronic Kidney Disease in Eastern North Carolina (MARKER)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Chronic Kidney Disease
Intervention  ICMJE Behavioral: Chronic Kidney Disease Education
Instituting teaching programs to manage hypertension, diabetes, anemia, proteinuria and cardiovascular disease in patients.
Other Names:
  • primary care
  • primary care clinics
  • education
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 11, 2012)
1257
Original Estimated Enrollment  ICMJE
 (submitted: January 21, 2010)
500
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01054066
Other Study ID Numbers  ICMJE 2008-317
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Paul Bolin, East Carolina University
Study Sponsor  ICMJE East Carolina University
Collaborators  ICMJE The Kate B. Reynolds Charitable Trust
Investigators  ICMJE
Principal Investigator: Paul Bolin, MD East Carolina University
PRS Account East Carolina University
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP