Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000464369
Ethics application status
Approved
Date submitted
8/03/2017
Date registered
30/03/2017
Date last updated
30/03/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial to investigate driving test performance for people with recently diagnosed Alzheimer's Disease.
Scientific title
A randomised controlled trial to determine the effect of location of assessment and number of assessments on driving test performance of people with recently diagnosed dementia of the Alzheimer's type.
Secondary ID [1] 285008 0
None
Universal Trial Number (UTN)
U1111-1159-4534
Trial acronym
No acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 292518 0
Condition category
Condition code
Neurological 292823 292823 0 0
Alzheimer's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants completed a standard driver assessment which included
A. Off-road test (up to 90 minutes), and
B. On-road (approximately 45 minutes) testing in either a local-area or open-area.
Three groups of participants were exposed to different driver assessment protocols as follows:
Group 1: Received off-road test on day 1, on-road-open-area license test on day 2 and an on-road-local-area license test on day 3.
Group 2: Received off-road test on day 1, on-road-open-area license test on day 2 and an on-road-open-area license test on day 3 (a local-area test was then conducted if required as well).
Group 3: Received off-road test on day 1, an on-road-local-area license test on day 2 and an on-road-open-area license test on day 3.
The duration between the tests on each of the three days varied for the participants, which is usual clinical practice. It is important that the three tests are not conducted on the same day due to participant fatigue, but there are no reasons that there should be a set duration for undertaking the tests. The timing of the tests usually corresponds to the availability of the participant, the researcher/ occupational therapy driver assessor and the driving instructor. The assessments were conducted over an 8 week period.
Three qualified occupational therapy driver assessors undertook the testing, all conducted face-to-face. A rotating system was used to ensure therapists were not biased from the results of the off-road assessment as to the possible outcome of the on-road assessment. For the first client the tasks were rotated through as follows:
Therapist A- off road
Therapist B- first on road
Therapist C- second on road
Therapist A- conducted the third on road (if required) and collated reports, make final recommendation and feedback to client. For the second client the system started with Therapist B and rotated through, and so on. The therapists were blind to the test results of the client as they proceeded. Only the final therapist who was required to collate the test results and make a final report saw all the client data.
The assessments were conducted as per usual clinical practice which was either at the Driving Clinic at Austin Health or La Trobe University for the off-road test, and on regular roads for the on-road tests.
During the off-road assessment, participants are assessed on The OT-DORA Battery (Unsworth et al., 2011) which is a standardised assessment battery developed by investigators Unsworth and Russell. The Battery takes approximately 90 minutes to administer and is conducted in a clinic room. The participant answers questions about their need for car driving and medical history, and then undergoes comprehensive assessment of sensory, physical and cognitive skills required for driving. Seventeen subtests are administered. For example, visual acuity is measured in OT-DORA using the Snellen Chart, motor impairment is screened using The Motricity Index (Collin & Wade, 1990), and visual construction skills are assessed using the OT-Drive Home Maze Test (Krishnasamy & Unsworth, 2011).
During the on-road assessment, the participant undertakes the drive in a dual controlled vehicle with the driving instructor responsible for the vehicle safely in the front passenger seat and the occupational therapy driver assessor in the rear of the vehicle and is responsible for documenting the test and determining the outcome. In an on-road-open-area test, the driving instructor directs the client to follow a set route which commences and finishes at the Driving Clinic. The occupational therapists uses a standard protocol to document driver behaviours and to describe any driving instructor interventions. The protocol includes 211 expected behaviours at nominated points along the route including checking mirrors and signalling prior to turning. In an on-road-local-area test, the client commences and finishes the drive from their home. The client is asked to self-navigate to familiar locations that are agreed upon such as the local shops and medical clinic. The protocol for the local area assessment allows space for detailing the locations driven to as well as driver behaviours and instructor interventions.
Intervention code [1] 289843 0
Other interventions
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292688 0
Outcome: Number of participants who passed or failed their driver license.
Assessments:
A. Off-road assessment (using the OT-DORA Battery, Unsworth et al, 2011).
B. On-road assessment which took two forms:
1. open-area license assessment with a directed route and scoring of manoeuvres performed.
2. local area license assessment with a self-directed route and scoring of manoeuvres performed.
Timepoint [1] 292688 0
Assessment A time point: Baseline (prior to on-road assessment B).
Assessment B time point: Between 1 and 8 weeks after Assessment A.
Secondary outcome [1] 309509 0
Nil
Timepoint [1] 309509 0
Nil

Eligibility
Key inclusion criteria
1. Diagnosis of Alzheimer’s Disease,
2. English-speaking
3. Current holder of an unconditional driver licence,
4. Have driven within the last 3 months,
5. Medically fit-to-drive according to the medical guidelines (Austroads, 2012).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previously undertaken any occupational therapy driver assessment, or driving test with a VicRoads assessor in the last 3 years,
2. History of other medical conditions which may simultaneously impact on driving performance, such as stroke, Parkinson’s disease, or amputation.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random Numbers Table
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size was calculated using the results from the previous study by our team (Lovell & Russell, 2005) and assuming a pass rate of 25% in the on-road assessment following the standard route and a 60% pass rate in subsequent local area assessment when the assessments are undertaken in that order. The minimal group size for which there was an 80% chance of rejecting the null hypothesis at p= 0.05 was calculated as 20. The unknown in the current study, as there has been no research published on this topic, is the improvement in performance when the assessment following the standard route is undertaken after the local area assessment. Treating the outcome of the open area assessment from each group as independent groups and using the Fisher exact test to compare means, we estimated that we needed 20 participants in each of the three groups (total sample size of 60).
Data from off-road and on-road assessments were analysed using descriptive statistics, chi square and generalized linear mixed effects (GLME) modelling.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/09/2013
Date of last participant enrolment
Anticipated
Actual
15/12/2016
Date of last data collection
Anticipated
Actual
30/01/2017
Sample size
Target
60
Accrual to date
Final
43
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2736 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment postcode(s) [1] 8450 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 295831 0
Charities/Societies/Foundations
Name [1] 295831 0
Alzheimers Australia - Dementia Research Foundation
Country [1] 295831 0
Australia
Primary sponsor type
Individual
Name
Annette Moxey
Address
Alzheimer's Australia Dementia Research Foundation
42 Macquarie St, Barton ACT 2600
Country
Australia
Secondary sponsor category [1] 294712 0
Individual
Name [1] 294712 0
Michael Woodward
Address [1] 294712 0
Alzheimer's Australia VIC
98 Riversdale Rd, Hawthorn VIC 3122
Country [1] 294712 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297132 0
CQUniversity Human Research Ethics Committee
Ethics committee address [1] 297132 0
Ethics committee country [1] 297132 0
Australia
Date submitted for ethics approval [1] 297132 0
Approval date [1] 297132 0
18/08/2015
Ethics approval number [1] 297132 0
H15-08-185
Ethics committee name [2] 297133 0
La Trobe University Human Research Ethics Committee
Ethics committee address [2] 297133 0
Ethics committee country [2] 297133 0
Australia
Date submitted for ethics approval [2] 297133 0
Approval date [2] 297133 0
12/12/2012
Ethics approval number [2] 297133 0
12-109
Ethics committee name [3] 297134 0
Austin Health Human Research Ethics Committee
Ethics committee address [3] 297134 0
Ethics committee country [3] 297134 0
Australia
Date submitted for ethics approval [3] 297134 0
11/10/2012
Approval date [3] 297134 0
18/12/2012
Ethics approval number [3] 297134 0
H2012/04855

Summary
Brief summary
Cognitive impairment, as experienced in people with Alzheimer’s Disease, a common cause of dementia, is an important factor leading to driving cessation. Making decisions regarding fitness-to-drive based on a diagnosis of dementia or dementia severity alone in the absence of rigorous assessment can lead to premature driving cessation or continuation of unsafe driving. Many people who are suspected of having, or have a new diagnosis of Alzheimer’s Disease, are referred for an occupational therapy driver assessment. While a portion of drivers with early Alzheimer's Disease will need to relinquish driving, there is also a need to support those who can drive safely to continue to do so for as long as possible. Since driving is an over-learned skill, it may be possible for some individuals with Alzheimer’s Disease to continue to drive safely for some time after a diagnosis and undergo periodic re-assessment to ensure the continued safety of the individual and the community. A driving assessment involves both off-road and on-road components. The purpose of the off-road component is to identify strengths and weaknesses that may impact on driving and to screen out clients who are unsuitable to progress to an on-road assessment. During the on-road assessment, an occupational therapy driver assessor observes driver behaviour and performance. The outcome for the purpose of this research is classified as pass or fail.
While some people with Alzheimer’s Disease may perform poorly on the unfamiliar (open/standard) test route, performance may be significantly improved if tested in their local area leading to a recommendation for local-area-only licence. Drivers who do not pass an open area assessment may therefore undergo a local-area-only licence. There is little research evidence concerning the performance of drivers with Alzheimer's Disease on initial versus subsequent testing and if improved performance is related to the area the assessment is undertaken in, or related to a practice effect. Additionally, it’s not clear if performance in both these testing locations is affected by whether the client has navigational problems. Clients tested in their local area need to self-navigate. However, clients tested in an open area are generally directed by the driving instructor.
This study determined the effect of: (1) location of assessment and ordering of the tests (local area test first or second); (2) opportunity to undertake a second test, and; (3) navigational difficulties on the performance of people with Alzheimer’s Disease on an on-road driver assessment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50034 0
Prof Carolyn Unsworth
Address 50034 0
Occupational Therapy
School of Health, Medical & Applied Sciences
Central Queensland University Melbourne campus,
120 Spencer St, Melbourne, VIC, 3000
Country 50034 0
Australia
Phone 50034 0
+61 3 9616 0504
Fax 50034 0
Email 50034 0
c.unsworth@cqu.edu.au
Contact person for public queries
Name 50035 0
Prof Carolyn Unsworth
Address 50035 0
Occupational Therapy
School of Health, Medical & Applied Sciences
Central Queensland University Melbourne campus,
120 Spencer St, Melbourne, VIC, 3000
Country 50035 0
Australia
Phone 50035 0
+61 3 9616 0504
Fax 50035 0
Email 50035 0
c.unsworth@cqu.edu.au
Contact person for scientific queries
Name 50036 0
Prof Carolyn Unsworth
Address 50036 0
Occupational Therapy
School of Health, Medical & Applied Sciences
Central Queensland University Melbourne campus,
120 Spencer St, Melbourne, VIC, 3000
Country 50036 0
Australia
Phone 50036 0
+61 3 9616 0504
Fax 50036 0
Email 50036 0
c.unsworth@cqu.edu.au

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Results publications and other study-related documents

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