Prevention of dementia by intensive vascular care
| ISRCTN | ISRCTN29711771 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29711771 |
| Secondary identifying numbers | NTR523 |
- 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
Not provided at time of registration
Contact information
Dr M. Jong-Putto, de
Scientific
Scientific
Academic Medical Center
Clinical Trial Office Neurology
H2 -233
PO Box 22660
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 5664564 |
|---|---|
| m.putto@amc.uva.nl |
Study information
| Study design | Randomised open-label triple-blind active-controlled parallel-group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Prevention of Dementia by Intensive Vascular Care |
| Study 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(s) | Received from local medical ethics committee |
| 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 |
| Primary outcome measure | Incidence of dementia |
| Secondary outcome measures | Incidence of myocardial infarction, cerebrovascular incidents and cardiovascular mortality |
| Overall study start date | 01/01/2006 |
| Overall study end date | 01/01/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 3700 |
| Participant inclusion criteria | 1. Age 70-78 years 2. No dementia 3. No other complaints with bad prognosis 4. No psychiatry |
| 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
Study participating centre
Academic Medical Center
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Sponsor information
Academic Medical Centre (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Neurology
PO Box 22660
Amsterdam
1100 DD
Netherlands
"ROR" |
https://ror.org/03t4gr691 |
|---|
Funders
Funder type
Government
Former Voluntary Fund Insurance Reserves (Reserves Voormalige Vrijwillige Ziekenfondsverzekeringen [RVVZ]) (Netherlands)
No information available
Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
Ministerie van Volksgezondheid, Welzijn en Sport
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Dutch Ministry of Health, Welfare and Sport, VWS
- Location
- Netherlands
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | |
| Other publications | post hoc analysis | 30/06/2018 | Yes | No | |
| Other publications | post hoc analysis | 01/09/2018 | 23/10/2019 | 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 |
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.
