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临床试验/NCT01688141
NCT01688141已完成不适用

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

University Hospitals, Leicester5 个研究点 分布在 1 个国家目标入组 28,304 人开始时间: 2010年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
28,304
试验地点
5
主要终点
Difference in Mean CKD Register Patient eGFRs Between Groups After 3.5 Years of Study

研究概览

简要总结

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.

详细描述

see above

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 未提供

结局指标

主要结局

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

时间窗: Baseline and 3.5 years

次要结局

  • 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)

研究者

发起方
University Hospitals, Leicester
申办方类型
Other
责任方
Sponsor

研究点 (5)

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