Enhanced management
OtherSpecialist nurses providing enhanced CKD management using NICE guidelines and enhanced access to secondary care.
Other names: CKD management
NCT Number: NCT01688141
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Leicester General Hospital, Leicester, Leics, United Kingdom
see above
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Specialist nurses providing enhanced CKD management using NICE guidelines and enhanced access to secondary care.
Other names: CKD management
Time frame: Baseline and 3.5 years
Time frame: Baseline and 3.5 years
Observation of blood pressure control over the study period via blood pressure targets
Time frame: 3.5 years
Proteinuria coding in practices
Time frame: 3.5 years
Observation of incidence of cardiovascular events over the study period
Time frame: 3.5 years
Nature and incidence over the study period
Time frame: 3.5 years
Data coillected from secondary care
Time frame: 3.5 years
data collected from secondary care
University Hospitals, Leicester
Other
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.
Published trials that share one or more normalized conditions with this study.
NCT05021835
Cardiovascular Risk, Chronic Disease
Birmingham, Alabama, United States
View Trial DetailsNCT07195747
Arterial Occlusive Diseases, Arteriosclerosis
São Paulo, Brazil
View Trial DetailsNCT05254002
Chronic Disease, Chronic Kidney Disease
Surprise, Arizona, United States
View Trial DetailsNCT02579655
Brain Diseases, Cardiovascular Diseases
Calgary, Alberta, Canada
View Trial Details