OxCKD1 -Empowering Healthy Lifestyle Choices in Chronic Kidney Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Oxford
Sponsor:
Collaborator:
British Renal Society
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01552317
First received: March 1, 2012
Last updated: June 13, 2013
Last verified: June 2013

March 1, 2012
June 13, 2013
April 2012
August 2014   (final data collection date for primary outcome measure)
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.
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 as assessed by 24 hour urine sodium excretion and dietary salt analysis.
Complete list of historical versions of study NCT01552317 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
OxCKD1 -Empowering Healthy Lifestyle Choices in Chronic Kidney Disease
OxCKD1 - a Randomised Controlled Trial of the OxSalt1 Care Bundle to Help Renal Patients Learn How to Lower the Salt Content of Their Diets.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Chronic Kidney Disease
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.
  • Experimental: lifestyle counselling
    A package of advice and interventions to help participants reduce their salt intake.
    Intervention: Other: OxSalt care bundle
  • No Intervention: Normal care
    This group will receive the normal care that they would get anyway.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
August 2014
August 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female, aged 18 years or above.
  • Diagnosed with CKD and an eGFR ≥ 20 ml/min/1.73m2
  • Participant has clinically acceptable laboratory data available to confirm the diagnosis.
  • Able (in the opinion of the Investigators) and willing to comply with all study requirements.
  • Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study

Exclusion Criteria:

  • Female participants who is pregnant, lactating or planning pregnancy during the course of the study.
  • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
  • Inability to understand English or special communication needs because the interventions will use English and is not funded to deal with special communication needs.
  • Known salt losing nephropathy
Both
18 Years and older
No
Contact: Christopher A. O'Callaghan, MD PhD +44 1865 225614 clare.camidge@ouh.nhs.uk
Contact: Clare Camidge, RGN +44 1865 225210 clare.camidge@ouh.nhs.uk
United Kingdom
 
NCT01552317
OxCKD1
No
University of Oxford
University of Oxford
British Renal Society
Principal Investigator: Christopher A O'Callaghan, MD PhD University of Oxford, UK
University of Oxford
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP