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NCT Number: NCT01688141

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leicester General Hospital, Leicester, Leics, United Kingdom

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About this study

see above

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Enhanced management

Other

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

Other names: CKD management

Primary outcomes

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

    Time frame: Baseline and 3.5 years

Secondary outcomes

  1. Blood Pressure Control

    Time frame: Baseline and 3.5 years

    Observation of blood pressure control over the study period via blood pressure targets

  2. Proteinuria

    Time frame: 3.5 years

    Proteinuria coding in practices

  3. Incidence of Cardiovascular Events

    Time frame: 3.5 years

    Observation of incidence of cardiovascular events over the study period

  4. Other Biochemical Parameters

    Time frame: 3.5 years

    Nature and incidence over the study period

  5. Referrals to Secondary Care and Hospitalisations

    Time frame: 3.5 years

    Data coillected from secondary care

  6. Mortality

    Time frame: 3.5 years

    data collected from secondary care

Sponsors and collaborators

Lead sponsor

University Hospitals, Leicester

Other

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2018
First posted
Sep 19, 2012
Registry last updated
Apr 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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