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SodiUm Burden Lowered by Lifestyle Intervention: Self-Management and E-health Technology (SUBLIME)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02132013
Recruitment Status : Completed
First Posted : May 6, 2014
Last Update Posted : May 13, 2016
Sponsor:
Collaborators:
Dutch Kidney Foundation
Leiden University Medical Center
St. Antonius Hospital
Ziekenhuisgroep Twente
TNO
Information provided by (Responsible Party):
prof.dr. G.J. Navis, University Medical Center Groningen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Unspecified Complication of Kidney Transplant Behavioral: Intervention SUBLIME Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SodiUm Burden Lowered by Lifestyle Intervention: Self-Management and E-health Technology
Study Start Date : June 2014
Actual Primary Completion Date : December 2015

Arm Intervention/treatment
Experimental: Intervention SUBLIME
Intervention group
Behavioral: Intervention SUBLIME
Intervention: dietary sodium restriction supported by 2 group meetings, structured self-regulation computer program, e-coaching.

No Intervention: Control
Regular care



Primary Outcome Measures :
  1. 24-hourly urinary sodium excretion [ Time Frame: up to 9 months ]

Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: 0, 3, 9 months ]
  2. Psychological well-being [ Time Frame: 0, 3, 9 months ]
    Psychological well-being will be assessed with multiple choice questionnaires in all 150 participants.

  3. Cost-effectiveness [ Time Frame: After study closure ]
    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.


Other Outcome Measures:
  1. Tertiary: effect of sodium restriction on cardiorenal biomarkers [ Time Frame: 0, 3 or 9 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be 18 years or older.
  • Have chronic kidney disease (CKD stage 1-3, CKD 4 if eGFR is not lower than 25 mL/min/1.73m2, or be a renal transplant recipient.)
  • Have a urinary sodium excretion during at least the last 2 subsequent visits of more than 130 mmol per day, or one last urinary sodium excretion of more than 150 mmol per day.
  • Have a systolic blood pressure higher than 135 mmHg, diastolic blood pressure higher than 85 mmHg or a well-controlled blood pressure by treatment with antihypertensives including RAAS-blockade (ACE-inhibitor or ARB).
  • Sufficient command of the Dutch language.
  • Access and ability to use the internet.
  • Written informed consent.

Exclusion Criteria:

  • eGFR < 25 ml/min/1.73m2 or an anticipated need for predialysis work-up within the time frame of the study.
  • Unstable disease: defined as rapid, persistent, progressive renal function loss (e.g. > 6 mL/min/1.73m2 per year), not from acute, intermittent origin.
  • Blood pressure > 170 mmHg systolic or > 100 mmHg diastolic during medical treatment
  • Blood pressure < 95 mmHg systolic not responding to withdrawal of antihypertensives.
  • Cardiovascular event (myocardial infarction, cerebrovascular accident) < 6 months ago.
  • Renal transplantation <1 year ago.
  • Medical conditions that are likely to interfere with completion of the study (such as progressive malignancy or other debilitating illness) at the discretion of the nephrologist.
  • Every patient who has participated in the ESMO study (regardless whether intervention or control) cannot participate in the current study.
  • Current participation in any clinical trial that might interfere with SUBLIME trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02132013


Locations
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Netherlands
Ziekenhuisgroep Twente
Almelo, Overijssel, Netherlands, 7609PP
St. Antonius
Nieuwegein, Utrecht, Netherlands, 3435CM
Leiden University Medical Center
Leiden, Zuid Holland, Netherlands, 2333ZA
University Medical Center Groningen
Groningen, Netherlands, 9700RB
Sponsors and Collaborators
University Medical Center Groningen
Dutch Kidney Foundation
Leiden University Medical Center
St. Antonius Hospital
Ziekenhuisgroep Twente
TNO
Investigators
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Study Chair: Gerjan J Navis, MD PhD University Medical Center Groningen
Principal Investigator: Paul JM Van der Boog, MD PhD Leiden University Medical Center
Principal Investigator: Sandra Van Dijk, PhD Leiden University Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: prof.dr. G.J. Navis, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT02132013    
Other Study ID Numbers: NL48079.042.14
METC 2014/075 ( Other Identifier: Medical Ethics Committee, UMCG )
837001005 ( Other Grant/Funding Number: ZonMW )
First Posted: May 6, 2014    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency