Back to resultsSodiUm Burden Lowered by Lifestyle Intervention: Self-Management and E-health Technology (SUBLIME)
Primary Purpose
Chronic Kidney Disease, Unspecified Complication of Kidney Transplant
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Intervention SUBLIME
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease
Eligibility 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.
Sites / Locations
- Ziekenhuisgroep Twente
- St. Antonius
- Leiden University Medical Center
- University Medical Center Groningen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention SUBLIME
Control
Arm Description
Intervention group
Regular care
Outcomes
Primary Outcome Measures
24-hourly urinary sodium excretion
Secondary Outcome Measures
Blood pressure
Psychological well-being
Psychological well-being will be assessed with multiple choice questionnaires in all 150 participants.
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.
Full Information
NCT ID
NCT02132013
First Posted
May 2, 2014
Last Updated
May 12, 2016
Sponsor
University Medical Center Groningen
Collaborators
Dutch Kidney Foundation, Leiden University Medical Center, St. Antonius Hospital, Ziekenhuisgroep Twente, TNO
1. Study Identification
Unique Protocol Identification Number
NCT02132013
Brief Title
SodiUm Burden Lowered by Lifestyle Intervention: Self-Management and E-health Technology
Acronym
SUBLIME
Official Title
SodiUm Burden Lowered by Lifestyle Intervention: Self-Management and E-health Technology
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen
Collaborators
Dutch Kidney Foundation, Leiden University Medical Center, St. Antonius Hospital, Ziekenhuisgroep Twente, TNO
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Unspecified Complication of Kidney Transplant
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention SUBLIME
Arm Type
Experimental
Arm Description
Intervention group
Arm Title
Control
Arm Type
No Intervention
Arm Description
Regular care
Intervention Type
Behavioral
Intervention Name(s)
Intervention SUBLIME
Intervention Description
Intervention: dietary sodium restriction supported by 2 group meetings, structured self-regulation computer program, e-coaching.
Primary Outcome Measure Information:
Title
24-hourly urinary sodium excretion
Time Frame
up to 9 months
Secondary Outcome Measure Information:
Title
Blood pressure
Time Frame
0, 3, 9 months
Title
Psychological well-being
Description
Psychological well-being will be assessed with multiple choice questionnaires in all 150 participants.
Time Frame
0, 3, 9 months
Title
Cost-effectiveness
Description
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.
Time Frame
After study closure
Other Pre-specified Outcome Measures:
Title
Tertiary: effect of sodium restriction on cardiorenal biomarkers
Time Frame
0, 3 or 9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerjan J Navis, MD PhD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Paul JM Van der Boog, MD PhD
Organizational Affiliation
Leiden University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sandra Van Dijk, PhD
Organizational Affiliation
Leiden University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ziekenhuisgroep Twente
City
Almelo
State/Province
Overijssel
ZIP/Postal Code
7609PP
Country
Netherlands
Facility Name
St. Antonius
City
Nieuwegein
State/Province
Utrecht
ZIP/Postal Code
3435CM
Country
Netherlands
Facility Name
Leiden University Medical Center
City
Leiden
State/Province
Zuid Holland
ZIP/Postal Code
2333ZA
Country
Netherlands
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9700RB
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
34164803
Citation
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.
Results Reference
derived
PubMed Identifier
31955921
Citation
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.
Results Reference
derived
Learn more about this trial
SodiUm Burden Lowered by Lifestyle Intervention: Self-Management and E-health Technology
We'll reach out to this number within 24 hrs