Overview

This trial is active, not recruiting.

Condition chronic kidney disease
Treatment enhanced management
Sponsor University Hospitals, Leicester
Start date January 2010
End date January 2014
Trial size 28304 participants
Trial identifier NCT01688141, Shelton

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(No Intervention)
Usual care
(Active Comparator)
Practices randomised to the intervention group will be offered an enhanced level of CKD disease management led by clinical nurse specialists based on an intervention previously piloted in high risk patients. Here, high risk patients identified will be invited to a CKD clinic for tailored management of bp and proteinuria and referral as needed.
enhanced management CKD management
Specialist nurses providing enhanced CKD management using NICE guidelines and enhanced access to secondary care.

Primary Outcomes

Measure
difference in mean CKD register patient eGFRs between groups after 3.5 years of study
time frame: 3.5 years

Secondary Outcomes

Measure
blood pressure control
time frame: 3.5 years
proteinuria
time frame: 3.5 years
incidence of cardiovascular events
time frame: 3.5 years
other biochemical parameters
time frame: 3.5 years
referrals to secondary care and hospitalisations
time frame: 3.5 years
mortality
time frame: 3.5 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - measurement of serum creatinine - eGFR < 60 ml/min/1.73m2

Additional Information

Official title A Primary-Secondary Care Partnership to Prevent Adverse Outcomes in Chronic Kidney Disease
Principal investigator Nigel Brunskill, PhD
Description see above
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University Hospitals, Leicester.