Condition category
Mental and Behavioural Disorders
Date applied
14/02/2006
Date assigned
14/02/2006
Last edited
12/06/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M. Jong-Putto, de

ORCID ID

Contact details

Academic Medical Center
Clinical Trial Office Neurology
H2 -233
PO Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 5664564
m.putto@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR523

Study information

Scientific title

Prevention of Dementia by Intensive Vascular Care

Acronym

Pre-DIVA

Study hypothesis

To investigate if interventions aimed at vascular risk factors reduce the incidence of dementia or the burden of functional disability in elderly.

Ethics approval

Received from local medical ethics committee

Study design

Randomised open-label triple-blind active-controlled parallel-group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Incidence of dementia

Secondary outcome measures

Incidence of myocardial infarction, cerebrovascular incidents and cardiovascular mortality

Overall trial start date

01/01/2006

Overall trial end date

01/01/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 70-78 years
2. No dementia
3. No other complaints with bad prognosis
4. No psychiatry

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

3700

Participant 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

Recruitment start date

01/01/2006

Recruitment end date

01/01/2013

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Center
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Centre (Netherlands)

Sponsor details

Department of Neurology
PO Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Former Voluntary Fund Insurance Reserves (Reserves Voormalige Vrijwillige Ziekenfondsverzekeringen [RVVZ]) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Alternative name(s)

Netherlands Organisation for Health Research and Development

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

Funder name

Ministerie van Volksgezondheid, Welzijn en Sport

Alternative name(s)

Dutch Ministry of Health, Welfare and Sport, VWS

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

Netherlands

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21930719
2012 substudy results in: http://www.ncbi.nlm.nih.gov/pubmed/22664551
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27474376
2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28488553
2017 substudy results in: http://www.ncbi.nlm.nih.gov/pubmed/28596452

Publication citations

  1. Results

    Ligthart SA, Richard E, van Gool WA, Moll van Charante EP, Cardiovascular risk management in community-dwelling elderly: opportunities for prevention., Eur J Prev Cardiol, 2012, 19, 6, 1365-1372, doi: 10.1177/1741826711422979.

  2. Substudy results

    Ligthart SA, Richard E, Fransen NL, Eurelings LS, Beem L, Eikelenboom P, van Gool WA, Moll van Charante EP, Association of vascular factors with apathy in community-dwelling elderly individuals., Arch. Gen. Psychiatry, 2012, 69, 6, 636-642, doi: 10.1001/archgenpsychiatry.2011.1858.

  3. Results

    van Charante EP, Richard E, Eurelings LS, van Dalen JW, Ligthart SA, van Bussel EF, Hoevenaar-Blom MP, Vermeulen M, van Gool WA, Effectiveness of a 6-year multidomain vascular care intervention to prevent dementia (preDIVA): a cluster-randomised controlled trial, Lancet, 2016, pii: S0140-6736(16)30950-3, doi: 10.1016/S0140-6736(16)30950-3.

Additional files

Editorial Notes

12/06/2017: Publication reference added. 12/05/2017: Publication reference added. 01/08/2016: Publication reference added.