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N/A N=23,357 Randomized Prevention

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

Chronic Kidney Disease

Enrolled (actual)
23,357
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Difference in Mean CKD Register Patient eGFRs Between Groups After 3.5 Years of Study — -2.00; -2.29 mean average eGFR change/mL/min/1.73 m^2

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Enhanced management (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University Hospitals, Leicester
Primary completion
Jan 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Difference in Mean CKD Register Patient eGFRs Between Groups After 3.5 Years of Study
-2.00; -2.29
SECONDARY
Blood Pressure Control
6834; 7137; 7460; 7295
SECONDARY
Proteinuria
627; 982; 1947; 2110
SECONDARY
Incidence of Cardiovascular Events
SECONDARY
Other Biochemical Parameters
SECONDARY
Referrals to Secondary Care and Hospitalisations
SECONDARY
Mortality

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.

Eligibility Criteria

Inclusion Criteria

  • measurement of serum creatinine
  • eGFR < 60 ml/min/1.73m2
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01688141). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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