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| ID | Type | Description | Link |
|---|---|---|---|
| METC 2014/075 | Other Identifier | Medical Ethics Committee, UMCG | |
| 837001005 | Other Grant/Funding Number | ZonMW |
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| Name | Class |
|---|---|
| Dutch Kidney Foundation | OTHER |
| Leiden University Medical Center | OTHER |
| St. Antonius Hospital | OTHER |
| Ziekenhuisgroep Twente |
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The purpose of this study is to evaluate the effects and efficacy of dietary sodium restriction by mean of a new healthcare approach in patients with chronic kidney disease. The test persons in the intervention group are actively supported to adhere to a restricted sodium diet with a structured self-regulation program to implement sodium recommendations that are in current guidelines.
The intervention entails two group meetings with fellow-patients, motivational interviewing, e-coaching and ICT-based self-regulation as add-on to regular care. The intervention consists of a baseline measurement (T0), followed by a preparation phase of 2-3 weeks duration before the first group meeting. The first group meeting is followed by the action phase with a second group meeting in 9-11 weeks. During the action phase, test persons are stimulated to use the special self-regulation computer program, monitor their dietary sodium intake on this website and receive e-coaching from their personal coach. Test persons in the control group receive standard care. After 3 months in study (T1), all test persons visit the outpatient clinic for measurements and data collection. The half year long maintenance phase starts after this timepoint, test persons in the intervention group can continue the use of the special website and get feedback from their coach at 3, 4, 5, 6 months. After 9 months of total study duration (T2), data collection and measurements take place.
At each timepoint blood and 24-hourly urine is collected, test persons fill out questionnaires. The intervention group collects after 5 weeks in study an additional 24-hourly urine collection to assess dietary compliance and enable feedback.
Cost-efficacy and implementation analysis will be conducted after study closure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention SUBLIME | Experimental | Intervention group |
|
| Control | No Intervention | Regular care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention SUBLIME | Behavioral | Intervention: dietary sodium restriction supported by 2 group meetings, structured self-regulation computer program, e-coaching. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 24-hourly urinary sodium excretion | up to 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | 0, 3, 9 months | |
| Psychological well-being | Psychological well-being will be assessed with multiple choice questionnaires in all 150 participants. | 0, 3, 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Tertiary: effect of sodium restriction on cardiorenal biomarkers | 0, 3 or 9 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerjan J Navis, MD PhD | University Medical Center Groningen | Study Chair |
| Paul JM Van der Boog, MD PhD | Leiden University Medical Center | Principal Investigator |
| Sandra Van Dijk, PhD | Leiden University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuisgroep Twente | Almelo | Overijssel | 7609PP | Netherlands | ||
| University Medical Center Groningen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34164803 | Derived | 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. | |
| 31955921 | Derived | Humalda JK, Klaassen G, de Vries H, Meuleman Y, Verschuur LC, Straathof EJM, Laverman GD, Bos WJW, van der Boog PJM, Vermeulen KM, Blanson Henkemans OA, Otten W, de Borst MH, van Dijk S, Navis GJ; SUBLIME Investigators. A Self-management Approach for Dietary Sodium Restriction in Patients With CKD: A Randomized Controlled Trial. Am J Kidney Dis. 2020 Jun;75(6):847-856. doi: 10.1053/j.ajkd.2019.10.012. Epub 2020 Jan 16. |
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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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| OTHER |
| TNO | OTHER |
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| Cost-effectiveness | Cost-effectiveness will be calculated from data derived from questionnaires on health care use (contacts with health care professionals, change in medication) in all participants. | After study closure |
| Groningen |
| Provincie Groningen |
| 9700RB |
| Netherlands |
| Leiden University Medical Center | Leiden | South Holland | 2333ZA | Netherlands |
| St. Antonius | Nieuwegein | Utrecht | 3435CM | Netherlands |
| 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 |