Chronic Kidney Disease
Conditions
Keywords
chronic kidney disease
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.
Interventions
OTHEROxSalt 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.
Sponsors
British Renal Society
University of Oxford
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24-hour Urinary Sodium Excretion | 1 month | To evaluate whether a new care bundle helps patients to reduce their salt intake. |
| 24-hour Urinary Salt Excretion | 1 month | — |
Secondary
| Measure | Time frame |
|---|---|
| 24-hour Urinary Sodium Excretion | 3 months |
| 24-hour Urinary Salt Excretion | 3 months |
Countries
United Kingdom
Participant flow
Pre-assignment details
Note. 201 participants were enrolled into the study following informed consent. Following informed consent, there was a 1-month period of normal routine care after which participants reattended and were randomized to the intervention or to normal routine care (the control group). Only 193 participants attended for randomization.
Participants by arm
| Arm | Count |
|---|---|
| Intervention A package of advice and interventions to help participants reduce their salt intake.
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. | 96 |
| Normal Care This group will receive the normal care that they would get anyway. | 97 |
| Total | 193 |
Baseline characteristics
| Characteristic | Total | Normal Care | Intervention |
|---|---|---|---|
| 24-hour urinary salt excretion | 7.6 grams/ day STANDARD_DEVIATION 3.3 | 7.8 grams/ day STANDARD_DEVIATION 3.4 | 7.3 grams/ day STANDARD_DEVIATION 3.1 |
| 24-hour urinary sodium excretion | 129 mmol/day STANDARD_DEVIATION 56 | 134 mmol/day STANDARD_DEVIATION 58 | 125 mmol/day STANDARD_DEVIATION 53 |
| Age, Continuous | 63.7 years STANDARD_DEVIATION 11.7 | 64.2 years STANDARD_DEVIATION 10.5 | 63.3 years STANDARD_DEVIATION 12.8 |
| Race/Ethnicity, Customized African | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Any other Asian background | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Any other ethnic group | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Any other mixed background | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Any other White background | 8 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized British | 170 Participants | 86 Participants | 84 Participants |
| Race/Ethnicity, Customized Caribbean | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Irish | 4 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Pakistani | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White and Asian | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White and Black African | 1 Participants | 1 Participants | 0 Participants |
| Region of Enrollment United Kingdom | 193 participants | 97 participants | 96 participants |
| Sex: Female, Male Female | 97 Participants | 48 Participants | 49 Participants |
| Sex: Female, Male Male | 96 Participants | 49 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 96 | 0 / 97 |
| other Total, other adverse events | 0 / 96 | 0 / 97 |
| serious Total, serious adverse events | 0 / 96 | 0 / 97 |
Outcome results
Primary
24-hour Urinary Salt Excretion
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | 24-hour Urinary Salt Excretion | 5.4 grams/ day | Standard Deviation 2.8 |
| Normal Care | 24-hour Urinary Salt Excretion | 6.9 grams/ day | Standard Deviation 3.1 |
Primary
24-hour Urinary Sodium Excretion
To evaluate whether a new care bundle helps patients to reduce their salt intake.
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | 24-hour Urinary Sodium Excretion | 93 mmol/day | Standard Deviation 48 |
| Normal Care | 24-hour Urinary Sodium Excretion | 119 mmol/day | Standard Deviation 52 |
Secondary
24-hour Urinary Salt Excretion
Time frame: 3 months
Population: The primary study period was 1 month after randomization to the intervention or to normal routine care (the control group). Participants were invited to further assessment 3 months following randomization and 69 in the control group and 65 in the intervention group undertook this.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | 24-hour Urinary Salt Excretion | 5.9 grams/ day | Standard Deviation 2.4 |
| Normal Care | 24-hour Urinary Salt Excretion | 6.6 grams/ day | Standard Deviation 3.1 |
Secondary
24-hour Urinary Salt Excretion
Time frame: 11 months
Population: The primary study period was 1 month after randomization to the intervention or to normal routine care (the control group). Participants were invited to further assessment 11 months following randomization and 16 in the control group and 44 in the intervention group undertook this.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | 24-hour Urinary Salt Excretion | 6.2 grams/ day | Standard Deviation 2.4 |
| Normal Care | 24-hour Urinary Salt Excretion | 7.1 grams/ day | Standard Deviation 3.4 |
Secondary
24-hour Urinary Sodium Excretion
Time frame: 3 months
Population: The primary study period was 1 month after randomization to the intervention or to normal routine care (the control group). Participants were invited to further assessment 3 months following randomization and 69 in the control group and 65 in the intervention group undertook this.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | 24-hour Urinary Sodium Excretion | 100 mmol/day | Standard Deviation 41 |
| Normal Care | 24-hour Urinary Sodium Excretion | 113 mmol/day | Standard Deviation 52 |
Secondary
24-hour Urinary Sodium Excretion
Time frame: 11 months
Population: The primary study period was 1 month after randomization to the intervention or to normal routine care (the control group). Participants were invited to further assessment 11 months following randomization and 16 in the control group and 44 in the intervention group undertook this.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | 24-hour Urinary Sodium Excretion | 106 mmol/day | Standard Deviation 41 |
| Normal Care | 24-hour Urinary Sodium Excretion | 121 mmol/day | Standard Deviation 58 |