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| Name | Class |
|---|---|
| British Renal Society | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | A package of advice and interventions to help participants reduce their salt intake. |
|
| Normal care | No Intervention | This group will receive the normal care that they would get anyway. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OxSalt care bundle | Other | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour Urinary Sodium Excretion | To evaluate whether a new care bundle helps patients to reduce their salt intake. | 1 month |
| 24-hour Urinary Salt Excretion | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour Urinary Sodium Excretion | 3 months | |
| 24-hour Urinary Salt Excretion | 3 months | |
| 24-hour Urinary Sodium Excretion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher A O'Callaghan, MD PhD | University of Oxford, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oxford University Hospitals NHS Trust | Oxford | Oxfordshire | OX3 7LE | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37254243 | Derived | O'Callaghan CA, Camidge C, Thomas R, Reschen ME, Maycock AJ, Lasserson DS, Fox RA, Thomas NPB, Shine B, James T. Evaluation of a Simple Low-cost Intervention to Empower People with CKD to Reduce Their Dietary Salt Intake: OxCKD1, a Multicenter Randomized Controlled Trial. Kidney360. 2023 Jul 1;4(7):890-898. doi: 10.34067/KID.0000000000000160. Epub 2023 May 31. | |
| 34164803 |
| Label | URL |
|---|---|
| University of Oxford Department of Medicine website | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Normal Care | This group will receive the normal care that they would get anyway. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Normal Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 24-hour Urinary Sodium Excretion | To evaluate whether a new care bundle helps patients to reduce their salt intake. | Posted | Mean | Standard Deviation | mmol/day | 1 month |
|
Adverse event data were collected during the primary study period which was from the date of consent to the end of the one month period during which participants were either randomized to the intervention or to normal routine care (the control group). Further adverse event data was also collected from those participants who attended for further invited assessments at 3 or 11 months following randomization.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | University of Oxford | +441865287794 | chris.ocallaghan@ndm.ox.ac.uk |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| 11 months |
| 24-hour Urinary Salt Excretion | 11 months |
| 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. |
This group will receive the normal care that they would get anyway. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 24-hour urinary sodium excretion | Mean | Standard Deviation | mmol/day |
|
| 24-hour urinary salt excretion | Mean | Standard Deviation | grams/ day |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 24-hour Urinary Salt Excretion | Posted | Mean | Standard Deviation | grams/ day | 1 month |
|
|
|
| Secondary | 24-hour Urinary Sodium Excretion | 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. | Posted | Mean | Standard Deviation | mmol/day | 3 months |
|
|
|
| Secondary | 24-hour Urinary Salt Excretion | 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. | Posted | Mean | Standard Deviation | grams/ day | 3 months |
|
|
|
| Secondary | 24-hour Urinary Sodium Excretion | 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. | Posted | Mean | Standard Deviation | mmol/day | 11 months |
|
|
|
| Secondary | 24-hour Urinary Salt Excretion | 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. | Posted | Mean | Standard Deviation | grams/ day | 11 months |
|
|
|
| 0 |
| 96 |
| 0 |
| 96 |
| 0 |
| 96 |
| EG001 | Normal Care | This group will receive the normal care that they would get anyway. | 0 | 97 | 0 | 97 | 0 | 97 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |