OxCKD1 -Empowering Healthy Lifestyle Choices in Chronic Kidney Disease (OxCKD1)
Primary Purpose
Chronic Kidney Disease
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
OxSalt care bundle
Sponsored by

About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring chronic kidney disease
Eligibility 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
Sites / Locations
- Oxford University Hospitals NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
lifestyle counselling
Normal care
Arm Description
A package of advice and interventions to help participants reduce their salt intake.
This group will receive the normal care that they would get anyway.
Outcomes
Primary Outcome Measures
Salt intake
To evaluate whether a new care bundle helps patients to reduce their salt intake.
Secondary Outcome Measures
blood pressure
To assess the effects of the new care bundle on blood pressure.
urine protein
To assess the effects of the new care bundle on urine albumin and protein levels.
Full Information
NCT ID
NCT01552317
First Posted
March 1, 2012
Last Updated
December 2, 2014
Sponsor
University of Oxford
Collaborators
British Renal Society
1. Study Identification
Unique Protocol Identification Number
NCT01552317
Brief Title
OxCKD1 -Empowering Healthy Lifestyle Choices in Chronic Kidney Disease
Acronym
OxCKD1
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.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
Collaborators
British Renal Society
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
chronic kidney disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
201 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lifestyle counselling
Arm Type
Experimental
Arm Description
A package of advice and interventions to help participants reduce their salt intake.
Arm Title
Normal care
Arm Type
No Intervention
Arm Description
This group will receive the normal care that they would get anyway.
Intervention Type
Other
Intervention Name(s)
OxSalt care bundle
Intervention Description
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.
Primary Outcome Measure Information:
Title
Salt intake
Description
To evaluate whether a new care bundle helps patients to reduce their salt intake.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
blood pressure
Description
To assess the effects of the new care bundle on blood pressure.
Time Frame
1 month, 3 months, 11 months
Title
urine protein
Description
To assess the effects of the new care bundle on urine albumin and protein levels.
Time Frame
1 month, 3 months, 11 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher A O'Callaghan, MD PhD
Organizational Affiliation
University of Oxford, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oxford University Hospitals NHS Trust
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
34164803
Citation
McMahon EJ, Campbell KL, Bauer JD, Mudge DW, Kelly JT. Altered dietary salt intake for people with chronic kidney disease. Cochrane Database Syst Rev. 2021 Jun 24;6(6):CD010070. doi: 10.1002/14651858.CD010070.pub3.
Results Reference
derived
Links:
URL
http://www.ndm.ox.ac.uk
Description
University of Oxford Department of Medicine website
Learn more about this trial
OxCKD1 -Empowering Healthy Lifestyle Choices in Chronic Kidney Disease
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