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Shared care for patients with chronic kidney disease in nephrology and general practice.


- candidate number2906
- NTR NumberNTR1140
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-nov-2007
- Secondary IDsPV 35 (dutch kidney foundation) Department of General Practice, Nijmegen
- Public TitleShared care for patients with chronic kidney disease in nephrology and general practice.
- Scientific TitleShared care for patients with chronic kidney disease in nephrology and general practice.
- ACRONYMSHARING
- hypothesisThe 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) studiedRenal insufficiency, Hypertension, Diabetes Mellitus, Chronic kidney disease
- Inclusion criteriaPatients with hypertension and/or diabetes mellitus with an estimated glomerular filtration rate < 60 ml/min/1.73 m (MDRD).
- Exclusion criteria1. 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 receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2008
- planned closingdate1-apr-2010
- Target number of participants225
- InterventionsIn 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 outcomeA blood pressure below 130/80 mmHg or decline in blood pressure of 5 mm Hg.
- Secondary outcomePatients 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.
- TimepointsBlood sample and blood pressure when included (baseline) and after 12 months.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. N.D. Scherpbier-de Haan,
- CONTACT for SCIENTIFIC QUERIESDr. WJC Grauw de
- Sponsor/Initiator University Medical Center Nijmegen, Radboud (UMCN) Department of Nephrology
- Funding
(Source(s) of Monetary or Material Support)
Dutch Kidney Foundation (Nierstichting Nederland)
- PublicationsN/A
- Brief summaryA 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 m (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;
5. Medication;
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 m or a GFR between 30 C60 GFR /min/1.73 m 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)
- RECORD25-nov-2007 - 25-nov-2012


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