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
  Purpose

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.


Condition Intervention
Chronic Kidney Disease
Other: OxSalt care bundle

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 200
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)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01552317

Contacts
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

Locations
United Kingdom
Oxford University Hospitals NHS Trust Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 7LE
Contact: Clare Camidge, RGN    +44 1865 225210    clare.camidge@ouh.nhs.uk   
Principal Investigator: Christopher A. O'Callaghan, MD PhD         
Sponsors and Collaborators
University of Oxford
British Renal Society
Investigators
Principal Investigator: Christopher A O'Callaghan, MD PhD University of Oxford, UK
  More Information

Additional Information:
No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01552317     History of Changes
Other Study ID Numbers: OxCKD1
Study First Received: March 1, 2012
Last Updated: June 13, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Oxford:
chronic kidney disease

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on September 22, 2014