OxCKD1 -Empowering Healthy Lifestyle Choices in Chronic Kidney Disease
Patients with kidney disease benefit from reducing the amount of salt in the food that they eat. The benefits include lower blood pressure and better kidney function. Therefore, lowering the amount of salt that is eaten could reduce the number of people who will develop kidney failure. The effect on blood pressure could also reduce the number of strokes and heart attacks. Similar benefits are also seen for people without kidney disease.
Guidelines for patients with kidney disease recommend that they lower the amount of salt that they eat, but most patients do not manage to do this. The reasons for this are not unclear, but are likely to reflect the difficulty that patients have in reducing the amount of salt in their food and the nature of the advice that they are given.
The investigators have developed a package of interventions to help patients to make healthier choices that will lower their salt intake. The package helps patients to learn about salt in food and how to avoid it. It provide practical advice on cutting down on salt using information booklets, text messages, emails, telephone calls, and a website.
Participants will be recruited from hospital kidney clinics and general practice. The investigators will randomly allocate participants to receive either the normal care that they would get or to receive the new package of interventions to help them lower salt. The package of interventions will involve patients receiving text messages, telephone calls, emails and written information. They will complete a questionnaire and collect urine samples which will can be used to measure the amount of salt that they are eating. No more than 6 visits will be required. The study is funded by the British Renal Society which is a charity that funds research to help patients with kidney disease.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||OxCKD1 - a Randomised Controlled Trial of the OxSalt1 Care Bundle to Help Renal Patients Learn How to Lower the Salt Content of Their Diets.|
- Salt intake [ Time Frame: 1 month ] [ Designated as safety issue: No ]To evaluate whether a new care bundle helps patients to reduce their salt intake.
- blood pressure [ Time Frame: 1 month, 3 months, 11 months ] [ Designated as safety issue: No ]To assess the effects of the new care bundle on blood pressure.
- urine protein [ Time Frame: 1 month, 3 months, 11 months ] [ Designated as safety issue: No ]To assess the effects of the new care bundle on urine albumin and protein levels.
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Experimental: lifestyle counselling
A package of advice and interventions to help participants reduce their salt intake.
Other: OxSalt care bundle
A care bundle consisting of a range of features to help patients to reduce their salt intake such as reminder emails, phone calls and a website.
No Intervention: Normal care
This group will receive the normal care that they would get anyway.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01552317
|Contact: Christopher A. O'Callaghan, MD PhD||+44 1865 firstname.lastname@example.org|
|Contact: Clare Camidge, RGN||+44 1865 email@example.com|
|Oxford University Hospitals NHS Trust||Recruiting|
|Oxford, Oxfordshire, United Kingdom, OX3 7LE|
|Contact: Clare Camidge, RGN +44 1865 225210 firstname.lastname@example.org|
|Principal Investigator: Christopher A. O'Callaghan, MD PhD|
|Principal Investigator:||Christopher A O'Callaghan, MD PhD||University of Oxford, UK|