The study aims to improve the existing screening procedure for car drivers with dementia. It validates the current testing procedure and the decision procedure regarding fitness to drive. This is supposed to be beneficial to the safety of the driver…
ID
Source
Brief title
Condition
- Dementia and amnestic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The aim of the proposed study is to investigate how well the test procedure can
predict fitness to drive, how long this prediction is valid, and what is the
relation between the test procedure, the on road driving test and the daily
driving behaviour. Also, an important objective is the validation of the
procedure to assess fitness to drive for patients with cognitive impairment as
was developed in FitCI. The study should result in a new test procedure for
dementia patients with better criteria for fitness to drive, which allows more
focus on functional performance of individual patients. This test procedure
will in time be implemented in the Dutch policy procedures. Discussions with
the Dutch licence agency and the ministery of Infrastructure and the
Environment should result in more specific plans with regard to
responsibilities and the road to implementation. Possibly, patients will be
tested in mobility centers.
Furthermore, the results could provide a framework for medical and paramedical
workers on how to inform dementia patients and their families about the
possibilities and barriers for independent car driving (Brouwer, 2012).
Secondary outcome
Other questions to be answered during this study are:
- How can the driving performance and driving behaviour of patients with a CDR
of max 0,5 and a relatively unimpaired cognitive functioning on domains outside
memory and language be described in het period of 1 to 3 years after the first
driving test?
- Which patient characteristics are related to a decrease in driving
performance and driving behaviour?
- Can we develop a hazard perception test with a response method that is better
suited for the target group than the hazard perception test that was developed
in FitCI?
- Can we develop an Intelligent Transport System (ITS)-application that can
support drivers with dementia during the driving task?
Background summary
In the Netherlands, about 250.000 people are suffering from dementia. It is
expected that this number will be doubled in 2040. Research shows that car
drivers with dementia have an increased risk of being involved in a road crash;
this risk is about the same as the risk of driving under influence of alcohol
or drugs. However, in early stages of dementia, the majority of drivers can
still drive safely. This is the reason why Dutch drivers with (very) mild
dementia are still considered fit to drive, at least when they perform
adequately on a number of neuropsychological tests and on an on-the-road
driving test carried out by the Dutch Licence Agency CBR. The
neuropsychological tests have recently been developed in FitCI: a joint
research programme by SWOV, RuG, UMCG and CBR. De driving licence can be
renewed for 1, 2 or 3 years, depending on the results of the neuropsychological
tests and the on-the-road driving test.
Although the practical driving test is carefully constructed, it is a
momentarily measurement in specific circumstances. We would like to know
whether the results of the neurpsychological tests and the driving test are
good predictors of daily driving behaviour. Also, we would like to validate the
results with a new patient group. Finally, given the progressive nature of
dementia, we would like to know for how long this prediction is valid.
Study objective
The study aims to improve the existing screening procedure for car drivers with
dementia. It validates the current testing procedure and the decision procedure
regarding fitness to drive. This is supposed to be beneficial to the safety of
the driver, his passengers (if applicable) and other road users. Furthermore,
the study may decrease the chance that the licence is withdrawn unneccesarily,
and thus independent mobility may be maintained for a longer time. This is
considered beneficial for the car driver and his family. The aim of the study
is also that the driving test will not be necessary anymore for some groups of
patients.
Study design
The duration of the study is three years. During this period, 120 car drivers
with (very) mild dementia and 40 car drivers without dementia symptoms are
followed for two years. All 160 participants take part in the FitCI test
procedure three times: at the start of the project and after that every 6 to 8
months. The FitCI procedure includes an interview with the participant and
partner, a neuropsychological examination and a test drive in a driving
simulator. Furthermore, at the start of the project and in the end of the
research period, and possibly once in between, a practical on-the-road driving
test will be carried out. In order to observe day-to-day driving behaviour, an
in-car device will be mounted in the participant's own car. This device
collects camera footage and registers driving parameters. The main research
question is whether participants who have been qualified for license renewal
are indeed safe drivers during the whole period for which the licence renewal
applies.
Study burden and risks
Participants will visit SWOV three times in a 2-year period, to participate in
neuropsychological tests and test drive in the simulator. This takes about 3
hours per visit; breaks will be held whenever the participant feels the need.
During each visit, an in-car device with camera's will be installed in the
participants' car and will stay there for two months. After two months, the
researchers will make an appointment with the participants to uninstall the
device.
After the first and the last testing day, and possibly once in between, an
appointment will be made on a separate day with the licence agency (CBR) for
the on road driving test. The on road driving test takes one hour of the
participants' time. Persons with (very) mild dementia (CDR 0.5 en CDR 1) will
generally be asked to participate shortly after having received the diagnosis.
Participation has the advantage of having a comprehensive driving evaluation
without direct consequences for their driving license, including an on road
test by the CBR. However, the results of the on-road test can labelled as
official if a subject asks for it. This could occur in case he/she performed
adequately on the on-road test; in that case the license will be renewed for a
year. In case the subject failed the on-road test, he or she will, depending on
the performance, be advised to take driving lessons and have an official
examination afterwards, or to stop driving and handing in the license. This
advice will not be reported to the CBR however. Besides, persons with CDR=0.5
and a positive result in the on-road test, have the advantage that the
neuropsychological assessment which is essential for an extension of the
driving license longer than a year is without costs for them. In all cases the
results of the examination will be discussed with the subjects and families.
While driving the driving simulator it is possible that the participant will
suffer from 'simulator sickness'. We will inform the participant beforehand
that this is possible. During the driving simulator tests, the physical
well-being of the participants is being monitored carefully. If the participant
is not feeling well, the simulator is stopped immediately. The driving
simulator-part of the study will be terminated for this participant. When the
participant is feeling well enough to go home, he/she is allowed to do so.
Bezuidenhoutseweg 62
Den Haag 2594 AW
NL
Bezuidenhoutseweg 62
Den Haag 2594 AW
NL
Listed location countries
Age
Inclusion criteria
Older than 50 years
Very mild or mild dementie (CDR <= 0,5 or CDR <= 1)
Has a valid driving licence, or had a valid driving licence until recently
Has the intention to keep on driving
Exclusion criteria
Stroke
Visual acuity < 0.5
Other serious disorders with consequences for fitness to drive
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL56827.078.16 |