|- candidate number||2906|
|- NTR Number||NTR1140|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||25-nov-2007|
|- Secondary IDs||PV 35 (dutch kidney foundation) Department of General Practice, Nijmegen|
|- Public Title||Shared care for patients with chronic kidney disease in nephrology and general practice.|
|- Scientific Title||Shared care for patients with chronic kidney disease in nephrology and general practice.|
|- hypothesis||The hypothesis is that patients with chronic kidney disease will meet treating goals better when they are treated in a shared care model by a general practitioner, a practice nurse and with online consultation of a nephrologist.|
|- Healt Condition(s) or Problem(s) studied||Renal insufficiency, Hypertension, Diabetes Mellitus, Chronic kidney disease|
|- Inclusion criteria||Patients with hypertension and/or diabetes mellitus with an estimated glomerular filtration rate < 60 ml/min/1.73 m² (MDRD). |
|- Exclusion criteria||1. Patients with serious medical or psychiatric conditions or drug or alcohol abuse;|
2. patients under specialist care for chronic kidney disease in the last year;
3. analphabetism or not being able to read/understand Dutch language (including cognitive disorders);
4. participation in another intervention trial within 30 days before the start of the study.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2008|
|- planned closingdate||1-apr-2010|
|- Target number of participants||225|
|- Interventions||In intervention practices patients will be treated conform a shared care model by a practice nurse, a GP and a nephrologist. A treatment protocol and web based consultation will be part of this shared care model. |
Goals are optimal management of cardiovascular risk.
|- Primary outcome||A blood pressure below 130/80 mmHg or decline in blood pressure of 5 mm Hg.|
|- Secondary outcome||Patients with hypertension: BMI, stop smoking, course of eGFR, lipids, proteinuria, SCORE riskscore
Patients with diabetes mellitus: BMI, stop smoking, course of eGFR, proteinuria, glyHb, fasting bloodglucose, lipids, UKPDS riskscore.
|- Timepoints||Blood sample and blood pressure when included (baseline) and after 12 months.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. N.D. Scherpbier-de Haan, |
|- CONTACT for SCIENTIFIC QUERIES||Dr. WJC Grauw de|
|- Sponsor/Initiator ||University Medical Center Nijmegen, Radboud (UMCN) Department of Nephrology|
(Source(s) of Monetary or Material Support)
|Dutch Kidney Foundation (Nierstichting Nederland)|
|- Brief summary||A randomized controlled trial will be performed: 9 GP practices will be randomised to control or intervention. Patients with hypertension and/or diabetes mellitus with an estimated glomerular filtration rate < 60 ml/min/1.73 m² (MDRD)will be included in the study with a minimum of 20 and a maximum of 28 patients per practice.|
The patients in intervention practices will be monitored:
1. Cardiovascular risk (smoking, blood pressure, cardiovascular co-morbidity);
2. Laboratory: creatinine, ureum, sodium, potassium, calcium, phosphate, Hb, MCV, lipids, fasting glucose, glyHb;
3. Urine: albumin, protein, creatinine;
4. Important co morbidity;
6. UKPDS or SCORE riskengine score.
After 12 months this monitoring will be repeated.
The intervention patients will be treated by GP and practice nurse according to a shared care model. Patients with a GFR < 30 ml/min/1.73 m² or a GFR between 30 ¨C60 GFR /min/1.73 m² and proteinuria will be presented to a nephrologist by web based consultation.
In control practices of the NMP project patients will receive usual care (according to the diabetes- and cardiovascular risk-guidelines of the Dutch College of General Practitioners).
|- Main changes (audit trail)|
|- RECORD||25-nov-2007 - 25-nov-2012|