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

Study Overview
=================
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.

Official Title
-----------------
SodiUm Burden Lowered by Lifestyle Intervention: Self-Management and E-health Technology

Conditions
-----------------
Chronic Kidney Disease, Unspecified Complication of Kidney Transplant

Intervention / Treatment
-----------------
* Behavioral: Intervention SUBLIME


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention SUBLIME<br>Intervention group | Behavioral: Intervention SUBLIME<br>* Intervention: dietary sodium restriction supported by 2 group meetings, structured self-regulation computer program, e-coaching.<br>|
| No Intervention: Control<br>Regular care | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hourly urinary sodium excretion |  | up to 9 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |