OxCKD1 -Empowering Healthy Lifestyle Choices in Chronic Kidney Disease

Study Overview
=================
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.

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.

Conditions
-----------------
Chronic Kidney Disease

Intervention / Treatment
-----------------
* Other: OxSalt care bundle


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lifestyle counselling<br>A package of advice and interventions to help participants reduce their salt intake. | Other: OxSalt care bundle<br>* 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.<br>|
| No Intervention: Normal care<br>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 | 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 | To assess the effects of the new care bundle on blood pressure. | 1 month, 3 months, 11 months | 
| urine protein | To assess the effects of the new care bundle on urine albumin and protein levels. | 1 month, 3 months, 11 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic kidney disease