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Clinical Trials/NCT01688141
NCT01688141
Completed
Not Applicable

A Primary-Secondary Care Partnership to Prevent Adverse Outcomes in Chronic Kidney Disease

University Hospitals, Leicester3 sites in 1 country28,304 target enrollmentJanuary 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Kidney Disease
Sponsor
University Hospitals, Leicester
Enrollment
28304
Locations
3
Primary Endpoint
Difference in Mean CKD Register Patient eGFRs Between Groups After 3.5 Years of Study
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Chronic kidney disease (CKD) is a major public health problem with a UK prevalence of 8-10%. The study hypothesis is to ascertain if intensive primary care led disease management programmes for CKD, supported by input from secondary care specialists will slow progression of CKD, improve blood pressure control and reduce cardiovascular events in patients on CKD registers.

The investigators have partnered with Nene commissioning, a practice based commissioning group representing approximately 80 GP practices in Northamptonshire, to run this study. This will be a cluster randomised trial of an intensive, secondary care supported, CKD management programme in primary care vs normal CKD care. Randomisation will be at the level of the individual general practice. All general practices associated with Nene commissioning will be invited to participate. Randomisation of practices will be performed by the University of Leicester Clinical Trials Unit and the study will adhere to guidelines for undertaking randomised cluster trials.

The aims of the study are:

  1. To determine whether reinforcement of best practice in the management of key aspects of CKD care by clinical nurse specialists based in primary care, but with close links to colleagues from secondary care, improves clinical outcomes.
  2. To foster excellence in CKD care
  3. To improve coding of CKD and prevalence on chronic disease registers.
  4. To increase interest in, and capacity for primary care research in Northamptonshire.
  5. To implement and evaluate a new model of partnership working between primary and secondary care.

The primary outcome measures will be changes in estimated glomerular filtration rate (eGFR). Secondary outcome measures will be blood pressure control, proteinuria, incidence of cardiovascular events,other biochemical parameters, referrals to secondary care and hospitalisations and mortality.

Detailed Description

see above

Registry
clinicaltrials.gov
Start Date
January 2010
End Date
October 11, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospitals, Leicester
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • measurement of serum creatinine
  • eGFR \< 60 ml/min/1.73m2

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Difference in Mean CKD Register Patient eGFRs Between Groups After 3.5 Years of Study

Time Frame: Baseline and 3.5 years

Secondary Outcomes

  • Incidence of Cardiovascular Events(3.5 years)
  • Referrals to Secondary Care and Hospitalisations(3.5 years)
  • Other Biochemical Parameters(3.5 years)
  • Blood Pressure Control(Baseline and 3.5 years)
  • Proteinuria(3.5 years)
  • Mortality(3.5 years)

Study Sites (3)

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