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ISRCTN
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ISRCTN29711771
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DOI
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10.1186/ISRCTN29711771
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Prevention of Dementia by Intensive Vascular Care
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Scientific title
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Acronym
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Pre-DIVA
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Serial number at source
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NTR523
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Study hypothesis
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To investigate if interventions aimed at vascular risk factors reduce the incidence of dementia or the burden of functional disability in elderly.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Received from local medical ethics committee
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Study design
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Randomised open label triple blind active controlled parallel group trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Dementia, Vascular complaints
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Participants - inclusion criteria
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1. Age: 70-78 years
2. No dementia
3. No other complaints with bad prognosis
4. No psychiatry
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Participants - exclusion criteria
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1. Diagnosis of dementia
2. Any factor that limits the probability of successful follow up (e.g. alcoholism, imminent emigration)
3. Any factor that limits life expectancy to less than 2 years
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Anticipated start date
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01/01/2006
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Anticipated end date
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01/01/2013
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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3700
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Interventions
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Intensive vascular care for elderly people (aged 70 through 78 years) by nurse practitioners in general practice compared to regular care.
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Primary outcome measure(s)
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Incidence of dementia
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Secondary outcome measure(s)
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Incidence of myocardial infarction, cebrovascular incidents and cardiovascular mortality.
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Sources of funding
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1. Former Voluntary Fund Insurance Reserves (Reserves Voormalige Vrijwillige Ziekenfondsverzekeringen [RVVZ]) (Netherlands)
2. Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
3. Ministry of Public Health, Welfare and Sport (Ministerie van Volksgezondheid, Welzijn en Sport [VWS]) (Netherlands)
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Trial website
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Publications
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1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21930719
2. 2012 substudy results in http://www.ncbi.nlm.nih.gov/pubmed/22664551
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Contact name
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Dr
M.
Jong-Putto, de
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Address
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Academic Medical Center
Clinical Trial Office Neurology
H2 -233
P.O. Box 22660
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City/town
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Amsterdam
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Zip/Postcode
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1100 DD
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Country
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Netherlands
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Tel
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+31 (0)20 5664564
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Email
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m.putto@amc.uva.nl
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Sponsor
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Academic Medical Centre (Netherlands)
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Address
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Department of Neurology
P.O. Box 22660
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City/town
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Amsterdam
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Zip/Postcode
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1100 DD
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Country
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Netherlands
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Date applied
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14/02/2006
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Last edited
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24/08/2012
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Date ISRCTN assigned
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14/02/2006
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