OxCKD1 -Empowering Healthy Lifestyle Choices in Chronic Kidney Disease (OxCKD1)

December 2, 2014 updated by: University of Oxford

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

201

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7LE
        • Oxford University Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Salt intake
Time Frame: 1 month
To evaluate whether a new care bundle helps patients to reduce their salt intake.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood pressure
Time Frame: 1 month, 3 months, 11 months
To assess the effects of the new care bundle on blood pressure.
1 month, 3 months, 11 months
urine protein
Time Frame: 1 month, 3 months, 11 months
To assess the effects of the new care bundle on urine albumin and protein levels.
1 month, 3 months, 11 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

British Renal Society

Investigators

  • Principal Investigator: Christopher A O'Callaghan, MD PhD, University of Oxford, UK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

March 1, 2012

First Submitted That Met QC Criteria

March 8, 2012

First Posted (Estimate)

March 13, 2012

Study Record Updates

Last Update Posted (Estimate)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OxCKD1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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