Prevention of dementia by intensive vascular care

ISRCTN	ISRCTN29711771
DOI	https://doi.org/10.1186/ISRCTN29711771
Protocol serial number	NTR523
Sponsor	Academic Medical Centre (Netherlands)
Funders	Former Voluntary Fund Insurance Reserves (Reserves Voormalige Vrijwillige Ziekenfondsverzekeringen [RVVZ]) (Netherlands), Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands), Ministerie van Volksgezondheid, Welzijn en Sport

Submission date: 14/02/2006
Registration date: 14/02/2006
Last edited: 03/08/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr M. Jong-Putto, de
Scientific

Academic Medical Center
Clinical Trial Office Neurology
H2 -233
PO Box 22660
Amsterdam
1100 DD
Netherlands

Phone	+31 (0)20 5664564
Email	m.putto@amc.uva.nl

Study information

Primary study design	Interventional
Study design	Randomised open-label triple-blind active-controlled parallel-group trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Prevention of Dementia by Intensive Vascular Care
Study acronym	Pre-DIVA
Study objectives	To investigate if interventions aimed at vascular risk factors reduce the incidence of dementia or the burden of functional disability in elderly.
Ethics approval(s)	Received from local medical ethics committee
Health condition(s) or problem(s) studied	Dementia, Vascular complaints
Intervention	Intensive vascular care for elderly people (aged 70 through 78 years) by nurse practitioners in general practice compared to regular care.
Intervention type	Other
Primary outcome measure(s)	Incidence of dementia
Key secondary outcome measure(s)	Incidence of myocardial infarction, cerebrovascular incidents and cardiovascular mortality
Completion date	01/01/2013

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	3700
Key inclusion criteria	1. Age 70-78 years 2. No dementia 3. No other complaints with bad prognosis 4. No psychiatry
Key exclusion criteria	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
Date of first enrolment	01/01/2006
Date of final enrolment	01/01/2013

Locations

Countries of recruitment

Netherlands

Study participating centre

Academic Medical Center

Amsterdam
1100 DD
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	-

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	substudy results	01/06/2012		Yes	No
Results article	results	01/12/2012		Yes	No
Results article	results	20/08/2016		Yes	No
Results article	substudy results	01/07/2017		Yes	No
Results article	results	01/08/2017		Yes	No
Results article	results	01/05/2018		Yes	No
Results article	results	01/09/2019	08/06/2020	Yes	No
Results article	results	01/08/2019	22/10/2020	Yes	No
Results article	post hoc analysis	02/08/2022	03/08/2022	Yes	No
Other publications	post hoc analysis	30/06/2018		Yes	No
Other publications	post hoc analysis	01/09/2018	23/10/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

03/08/2022: Publication reference added.
22/10/2020: Publication reference added.
08/06/2020: Publication reference added.
23/10/2019: Publication reference added.
02/11/2018: Publication reference added.
02/07/2018: Publication reference added.
12/06/2017: Publication reference added.
12/05/2017: Publication reference added.
01/08/2016: Publication reference added.