CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 28,304 enrolled
Drug / intervention
Enhanced managementother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01688141
NCT01688141N/ACompleted

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

University Hospitals, Leicester·interventional·Posted Sep 19, 2012·Updated Apr 8, 2020

In Brief

A clinical study evaluating Enhanced management for Chronic Kidney Disease. Completed, enrolled 28,304 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 19, 2012
Enrollment StartJan 1, 2010
Primary CompletionJan 1, 2014
Study CompletionOct 11, 2018
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 13.8 years ago

Interventions

Enhanced managementother

Specialist nurses providing enhanced CKD management using NICE guidelines and enhanced access to secondary care.