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A randomised controlled trial to investigate driving test performance for people with recently diagnosed Alzheimer's Disease.

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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000464369
Acronym
No acronym
Enrollment
43
Registered
2017-03-30
Start date
2013-09-10
Completion date
2016-12-15
Last updated
2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Annette Moxey
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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).

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026