|- candidate number||9506|
|- NTR Number||NTR2917|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-mei-2011|
|- Secondary IDs||300020016 ZonMw|
|- Public Title||Effects of Selfmonitoring on Outcome of Chronic Kidney Disease.|
|- Scientific Title||Effecten van het zelf monitoren van zoutinname op de uitkomst van de behandeling van patienten met een chronische nierziekte.|
|- hypothesis||The intervention, optimal selfmanagement conditions for applying to saltrestriction, improves treatment of hypertension in patients with chronic kidney disease.|
|- Healt Condition(s) or Problem(s) studied||Hypertension, Selfmanagement, Blood pressure, Psychologic factors, Chronic kidney disease, Kidney|
|- Inclusion criteria||1. Age at least 18 years;|
2. Creatinin clearance between 90 and 20 ml/min/1.73m2;
3. Systolic bloodpressure higher than 135/85 mm Hg or a normal bloodpressure with antihypertensive treatment (at least 1 RAAS blockade);
4. Command of the Dutch language.
|- Exclusion criteria||1. Renal transplant;|
2. Acute renal failure;
3. Diabetes type 1;
4. Insulin dependent diabetes type 2;
5. Rapidly progressive glomerulonephritis;
6. Malignancy less than 5 years before inclusion;
7. A cardiovascular event less than 6 months before inclusion;
8. Participation in other clinical trials in which using medicine is part of the trial procedures;
9. Blood pressure higher than 180/100 mmHg;
10. Blood pressure lower than 125/75 mmHg.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2011|
|- planned closingdate||1-sep-2013|
|- Target number of participants||150|
|- Interventions||Two-arm multicenter open randomized controlled trial. Intervention period of 3 months, follow-up 6 months.|
Control and intervention group: All patients are informed about a sodium (salt) restricted diet (< 5 grams salt/day) and instructed how to achieve this. All patients are instructed in home blood pressure measurement and provided with a validated blood pressure measurement device.
Intervention group: In addition to the general procedure, patients in the intervention group receive instructions and materials for self monitoring of the sodium intake. This is established by measuring sodium in their 24 hour urine (Medimate Multireader) and by monitoring their salt intake by dietary diaries. In addition to this they receive nurse-led self-regulation assistance.
|- Primary outcome||1. Changes in sodium intake;|
2. Changes in blood pressure.
|- Secondary outcome||1. Creatinine clearance;|
3. Antihypertensive medication;
4. Psychological outcome measures.
|- Timepoints||1st year: Literature study, focus group interviews, fine tuning design, training motivational interviewing, preparing RCT, pilot logistics, fine-tuning design, finalizing baseline questionnaire;|
2nd year: Recruitment of patients, recording baseline data, start intervention;
3rd year: Follow up measures (at 3 months and 6 months), start analyzing data;
4rd year: Analyzing data and reporting findings.
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Dr. S. Dijk, van|
|- CONTACT for SCIENTIFIC QUERIES||Dr. S. Dijk, van|
|- Sponsor/Initiator ||Hans Mak Instituut, Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, Dutch Kidney Foundation (Nierstichting Nederland)|
|- Brief summary||The purpose of the current study is to develop, test, and evaluate a self-management care model regarding CKD patients’ salt intake in order to enhance health outcomes and autonomy. For this purpose, a multicenter open randomized controlled trial will be conducted. We will randomize 150 CKD patients having a systolic blood pressure above the target value of 140 mm Hg despite antihypertensive treatment to one of the two study conditions for three months:|
1. A control condition in which patients receive care as usual and the possibility to home blood pressure measurement (HBPM);
2. An intervention condition in which above this patients self-measure their sodium levels and keep a diary about their salt intake. This is embedded in a nurse-led self-management approach in which patients receive motivational interviewing to set and obtain appropriate goals. Furthermore, tailored behavioral modules will be available.
At the end of the study we will analyze baseline and follow-up data (3 months and 6 months) to determine whether the intervention condition was superior to the usual care condition regarding primary and secondary outcomes. In this study, we will not only reveal potential effects of the intervention: In the preparation and evaluation process in-depth knowledge will be obtained about patients’ CKD beliefs, needs and self-perceived skills regarding self-management and how these compare to attitudes of health care workers. Finally, we will develop a set of recommendations about implementation of self-management for CKD patients.
|- Main changes (audit trail)||2-nov-2014: During the study period the following amendments have been made regarding the inclusion and exclusion criteria as requested by the ESMO study group: Additional inclusion criteria: (a) proteinuria > 0.2 g/L or 0.3 g/24 h; (b) last two sodium measurements > 120 mmol/24 h. Changed exclusion criteria: (c) Having undergone renal transplantation < 1 year ago (instead of ‘having undergone renal transplantation at any time’); (d) Being diagnosed with diabetes type II is no longer a reason for exclusion; (e) A creatinine clearance of > 90 ml/min/1.73m2 is allowed if patients are treated for their kidney disease by an internist. The new criterion is ‘a creatinine clearance > 20 ml/min/1.73 m2’ (instead of ‘creatinine clearance between 90 and 20 ml/min/1.73m2’).
These amendments have been approved by the medical ethical committee.
In addition, the last follow-up measurement of the last patient has been obtained in August 2014, and the contact person for public queries is S. van Dijk of the Leiden University Medical Center.
Addendum to clear up confusion about the trial and some changes:
On September 1st 2009 the ESMO project started with a group meeting of the project
team and with the start of preparatory work to develop the ESMO self-management
On June 24th 2010 permission of the Medical Ethical Committee was obtained for the
whole study (focus groups, questionnaire study and the randomized controlled trial;
reference number P10.056).
On June 6th 2011 the randomized trial was started, upon delivery of the first informed
consent of the first participant.
On January 31th 2013 written permission was provided by the Medical Ethical Commis-
sion of the Leiden University Medical Center to adapt the inclusion criteria. See for an
overview of the changes the table in attachment 1.
On August 1st 2014 the randomized trial was finished by obtaining the last follow-up
measurement of the last patient (the last informed consent form of the last patient had
been reveived on March 11th 2014).-EB
|- RECORD||26-mei-2011 - 15-apr-2016|