We aim to assess the cost-effectiveness of a new health care approach for reduction of dietary salt in CKD patients, to provide a basis for widespread implementation of the new approach in CKD. To this purpose an open randomized trial in CKD…
ID
Source
Brief title
Condition
- Nephropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome: sodium intake, assessed from 24h sodium excretion,
Secondary outcome
Secondary outcomes: blood pressure, proteinuria, psychological well-being and
costs-efficiency, efficacy.
Background summary
In chronic kidney disease (CKD) morbidity, mortality, and costs are high. In
the Netherlands 750.000 patients have CKD, and 15.000 patients require dialysis
or renal transplantation, with an inflow of 2.000 patients yearly, of whom 1600
in dialysis. The
annual costs of renal replacement therapy amount to 750 million euros! Less
progression towards dialysis and less cardiovascular complications can be
achieved by even modest reduction in dietary salt. However, current care is not
effective in achieving reduction in salt intake, as over 80% of CKD patients
fail to adhere to the recommended intake of 6 grams/day. Effective new tools
for sustainable, affordable reduction of salt intake in earlier phases of CKD
are therefore needed. Recent data support the potential of behavioural
intervention for sustainable lifestyle change. We previously developed a) a
self-regulation program based on behavioural theory, and b) e-health modules
for behaviour change which creates strong synergy between regular care and
online self-care, that can partly replace time-investment of health
professionals. Pilot data demonstrated excellent acceptance of the tools, and
30 % reduction in salt intake.
Study objective
We aim to assess the cost-effectiveness of a new health care approach for
reduction of dietary salt in CKD patients, to provide a basis for widespread
implementation of the new approach in CKD. To this purpose an open randomized
trial in CKD patients is performed in Dutch university and non-university
hospitals, that addresses the superiority of the new approach.
Study design
Open randomized multi-center study in 150 CKD patients, in academic and
non-academic centres with a 3 month intervention, and 6 month follow-up
comparing the intervention with regular care.
Intervention
Two group meetings with fellow-patients, motivational interviewing, e-coaching,
blood pressure monitoring at home and ICT-based self-regulation as add-on to
regular care; control patients receive regular care.
Study burden and risks
Participation in the study is on a free-will base. Test persons will not
receive any financial support or priority for treatment of other diseases in
the clinic during this study. Test persons will visit the outpatient clinic on
a more regular base than standard patient care. During their visit blood
pressure, height, waist circumference and weight will be measured. The blood
samples will be drawn through venipuncture which forms a minimal risk /
discomfort (e.g. haematoma) 3 times in 9 months and 24-h urine will be
collected (4 times in 9 months). Test persons will fill out questionnaires
three times. During the study, Test persons in the treatment 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. Test persons participate in group meetings and use a computer
program to monitor their dietary sodium intake. A potential risk is excessive
sodium restriction. This will be closely monitored by 24-hourly urinary sodium
excretion. Sodium depletion might occur during intercurrent events (e.g.
febrile or gastro-intestinal illness, antibiotic treatment) that lead to a
decline of renal function: a sodium depleted state will then result in a more
pronounced decline of renal function due to concomitant fluid depletion. Test
persons will be instructed to contact the investigator when complaints, signs
or symptoms (e.g. light-headedness, dizziness) or concurrent illnesses occur.
Renal function and physical parameters (blood pressure) are routinely measured.
Abovementioned interaction of an intercurrent event and renal function is not
essentially different from the usual clinical situation. Usual recommendations
to monitor and counter sodium depletion, and the (dis)continuation of a
participant*s own medication will be given. Due to the close follow-up and
increased awareness of the participants, the overall risks can be considered
minimal. No further invasive measurements will be executed and therefore risks
of participation in this study are minimal.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
1. Be 18 years or older.
2. 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.)
3. 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.
4. 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).
5. Sufficient command of the Dutch language.
6. Access and ability to use the internet.
7. 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL48079.042.14 |