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Trial registered on ANZCTR


Registration number
ACTRN12618000405213
Ethics application status
Approved
Date submitted
7/03/2018
Date registered
21/03/2018
Date last updated
1/04/2019
Date data sharing statement initially provided
19/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Better Drive 2: Effect of computerised cognitive training and on-road skills training on driving safety in older adults
Scientific title
A three-arm randomised controlled trial to assess the effectiveness of cognitive training and on-road skills training on driving safety in older adults
Secondary ID [1] 294318 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ageing associated driving impairment 306958 0
Condition category
Condition code
Injuries and Accidents 306054 306054 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 306055 306055 0 0
Occupational therapy
Neurological 306056 306056 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: On-road skills training, involving driving lessons, tailored to the individuals own driving difficulties. This skills-based intervention will involve two, one-hour driver refresher training sessions within a three-week period, delivered by a qualified driving instructor. The driver-trained occupational therapist conducting all baseline on-road assessments will generate tailored written lesson plans for the driving instructor, and will train the instructor to administer the interventions. The trial blinding process requires that baseline and follow-up assessment will be undertaken by different driving instructors to those delivering driving skills instruction.

Lesson plans will be tailored to include refresher material specific to the individual, to address those areas indicated in participant assessment as requiring improvement (i.e. the components contributing to the On-road Driver Safety Rating detailed below). Instruction will be enhanced through the use of the individualised video footage feedback gathered during baseline assessment and used to illustrate the participant’s specific skill deficits. The first training session will be conducted in a dual-brake vehicle, and the second will take place in the participant’s own vehicle. Sessions will include instructor-guided driving practice using routes near or within the participant’s usual driving environment, will employ the tailored training focussed on an individual’s identified skill deficits, and involve instructor-assisted adjustment of seat and mirrors (although will not include the use of complex vehicle modifications, such as after-market spinner knobs, because of the variation it would introduce to lessons). After the lessons, participants will be given written recommendations for practice of new skills and habits over the 12 week intervention, and a logbook for self-monitoring barriers and progress in practicing these skills in their everyday driving. At the close of the 12 week period, participants will complete a questionnaire on intervention acceptability, and participant motivation and satisfaction. Qualitative and quantitative questionnaire responses and participant log data will then be examined to allow an exploration of intervention implementation.

Arm 2: Computerised cognitive training, consisting of computer-based speed of processing training (SOPT) and cognitive-motor reaction time training (CMRT) programs. This home-based computer training intervention is self-administered, with a required exposure of one to two hours per week over the 12 week intervention period. Prior to the intervention, a trained researcher will visit the participant’s home to install necessary computer software and peripherals, and instruct participants in accessing necessary websites, using project software, and safe home computer usage to minimise any risks associated with overuse. The trial coordinator will contact participants via phone on a weekly basis during the intervention phase, to provide support, to address any concerns or issues, and to encourage and monitor compliance. Participants will also log the number of hours spent and progress in training over the 12 weeks. At the close of the 12 week period, participants will complete a questionnaire on intervention acceptability, and participant motivation and satisfaction. Qualitative and quantitative questionnaire responses and participant log data will then be examined to allow an exploration of intervention implementation.

The SOPT training will employ a proprietorial computer-based brain training program (Double Decision, from BrainHQ® by Posit Science) designed to improve field of view and visual processing speed, and based on the Useful Field of View (UFOV, Trademark) task. The task will be accessed via a 3-month subscription to the program, provided without cost to participants. In this task the participant must (1) identify a briefly presented and then masked central image of a schematic vehicle, and (2) note the position, from a possible eight peripheral locations, of a simultaneously (briefly) presented and then masked road sign. The software increases background complexity and reduces presentation duration over time, to adapt to participant improvement. The CMRT training utilises a choice reaction task in which a photo of an object (belonging to a particular class e.g. vehicles) is briefly presented onscreen, in one of four quadrants corresponding the left and right hands (button press) or left and right feet (pedal press). Participants must respond as rapidly as possible to one specific example of the object class (a target), but inhibit responses to examples of non-target objects in the class (i.e. distractors). Presentation duration will be reduced to adapt to participant improvement. The object class from which targets and distractors are drawn will vary over task progress to enhance any potential generalisability of effects, and will include a wide range of everyday objects (e.g., vehicles, road signs, fruit, animals, faces, buildings, etc.).
Intervention code [1] 300559 0
Behaviour
Intervention code [2] 300633 0
Prevention
Comparator / control treatment
Arm 3: no treatment
Control group
Active

Outcomes
Primary outcome [1] 305078 0
On-road driving safety performance while accompanied by a qualified driving instructor, as indexed by a value on an On-Road Driver Safety Rating Scale. This global value is derived from scores assigned to driving domains (namely observation, head checks, indication, braking, lane positioning, gap selection, vehicle control, and speed control/acceleration). A lower global rating value indicates less safe driving. Contributing scores are assigned by a driver-trained occupational therapist observing driving from the rear seat of the vehicle, and include error counts and measures of the severity of those errors in the listed domains. This modified version of an assessment instrument originally developed by Mallon and Wood (2004) has been employed and validated in earlier research undertaken by this group (e.g. see Anstey, Eramudugolla, Kiely, & Price, under review).
Timepoint [1] 305078 0
Baseline, and 12 weeks after intervention commencement (or 12 weeks after randomisation, for participants in the control group).
Primary outcome [2] 305079 0
Number of critical errors observed in the above-listed driving domains, as recorded by the driver-trained occupational therapist during the on-road safety assessment, and contributing to the On-Road Driver Safety Rating Score.
Timepoint [2] 305079 0
Baseline, and 12 weeks after intervention commencement (or 12 weeks after randomisation, for participants in the control group).
Secondary outcome [1] 344108 0
Self- efficacy in driving, as indexed by the Adelaide Driving Self-Efficacy Scale (George, Clark & Crotty, 2007).
Timepoint [1] 344108 0
Baseline, and 12 weeks after intervention commencement (or 12 weeks after randomisation, for participants in the control group).
Secondary outcome [2] 344109 0
Off-road driver screening score, using a screening test for older drivers (DriveSafe Test; e.g. see Kay, Bundy & Clemson, 2009).
Timepoint [2] 344109 0
Baseline, and 12 weeks after intervention commencement (or 12 weeks after randomisation, for participants in the control group).
Secondary outcome [3] 344110 0
Off-road driver screening, employing the Multi-D, a task battery that generates a score related to on-road driver safety (e.g. Wood, Anstey, Kerr, Lacharez & Lord, 2008), and consisting of a central motion sensitivity task, the Cars Reaction Time test (CarsRT), a colour choice reaction time task involving foot pedals and hand (keypress) responding, and a postural sway task.
Timepoint [3] 344110 0
Baseline, and 12 weeks after intervention commencement (or 12 weeks after randomisation, for participants in the control group).
Secondary outcome [4] 344111 0
Persistence of any effects on driver safety, indexed with self-reported significant driving incidents, collected in a monthly on-line diary.
Timepoint [4] 344111 0
Month of baseline assessment, then monthly for 12 months in total.
Secondary outcome [5] 344112 0
Level of near-transfer of SOPT training, employing the score obtained on the assessment (i.e. non-adaptive) version of the UFOV® task.
Timepoint [5] 344112 0
Baseline, and 12 weeks after intervention commencement (or 12 weeks after randomisation, for participants in the control group).
Secondary outcome [6] 344113 0
Level of near-transfer of CMRT training, employing the score on the CarsRT task.
Timepoint [6] 344113 0
Baseline, and 12 weeks after intervention commencement (or 12 weeks after randomisation, for participants in the control group).

Eligibility
Key inclusion criteria
Aged 65 years or over;
Current driver (at least weekly), with a current and valid driver’s license without restrictions on driving area;
Holds valid registration and compulsory third-party vehicle insurance;
Has access to a computer with internet connection; and
Willingness to give informed consent and comply with study protocol.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Has participated in a driver education course in the previous 6 months, or
Plans to cease driving within the next 12 months; or
Has serious health conditions that could impact participation, such as
- unstable or acute medical conditions that preclude participation, or
- progressive neurological conditions, or
Uses computerised “brain training” programs regularly (once a week or more), or
Has health conditions that may be exacerbated by regular computer use.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The trial coordinator will determine eligibility prior to enrolment and consent, using a telephone questionnaire based on the inclusion/exclusion criteria. If eligible, the trial coordinator will then administer a 3-item questionnaire assessing capacity to give informed consent for trial participation. This questionnaire has been validated on cognitively impaired and healthy groups, and will identify individuals with adequate understanding and appreciation of the study risks and benefits.

Eligible participants will be enrolled and complete baseline assessment prior to allocation. The allocation sequence and assignment will be concealed from all researchers except for the trial coordinator responsible for enrolling, obtaining consent and scheduling participants, and will be revealed to the trial coordinator only after each batch of participants complete their baseline assessments.

The project statistician (who is independent from recruitment, enrolment, assessment, or allocation implementation) will assemble three separate sets of letters inside opaque envelopes marked confidential. Letter content will vary depending on condition: one-third of the envelopes will contain letters about the driving lessons followed by post-intervention assessment (on-road skills training), another third will contain letters regarding a home visit appointment for a researcher to set-up of home-based computerised cognitive training, followed by post-intervention assessments (computerised cognitive training). The remaining third will contain letters with content regarding only post-intervention assessments, but with access to on-road skills and computerised cognitive training at 12 months (waitlist control). Unique participant identifiers will be assigned to copies of letters and envelope labels as per the allocation sequence. The unique identifiers will then be matched to participant contact details (retained in a separate password-protected database) and the trial coordinator will attach relevant address labels to each envelope and phone to schedule each participant as per the envelope contents.

The allocation sequence will be saved in password protected files and stored on a secure server until the end of the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Prior to study commencement, the project statistician will develop a list of unique random numeric participant identifiers. These will be forwarded to the trial coordinator, and will be consecutively assigned to participants as they are successively enrolled in the study. Assigned participant identifiers and the age and gender of the participant to which they have been attached, will be returned to the statistician following baseline assessment, to assign allocation to the control or to one of the two intervention conditions, using the strategy outlined below.

The project statistician will use a computer generated randomisation list to assign group allocations to participant identification codes. The allocation sequence will be stratified by age group (65-75 years of age, 76+ years of age) and gender, because prior research has demonstrated that age is correlated with driving safety, driving patterns differ across gender, and females are generally underrepresented in driving research.

The randomisation list will be generated using the adaptive minimisation technique described by Pocock and Simon (1975) using Subject Randomization System (SRS; an R package) to allocate participants to equally-sized groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size estimation/power analysis: Based on effects observed in our previous trial of tailored driving lessons and a non-randomised trial of the effect of SOPT training on driver screening measures, a sample of 40 individuals per group will be sufficient to detect a 1-point change in the on-road driver safety rating score, and a one-third change in the number of critical driving errors, with 80% power. The expected rate of attrition will not be more than 5% (based on previous trial), so a total sample of 126 is required (42 per group).

Analyses will be conducted on an intention-to-treat (ITT) basis, with missing data imputed in sensitivity analyses. Latent change score analysis will be used to compare SOPT group with control group performance, and driver training group with control group performance, examining group differences in change (improvement) on the primary outcome measures, the on-road driver safety rating score and the number of critical driving errors.

As there are two primary outcomes, analyses will minimise type I error rates introduced by multiple testing by adjusting for the False Discovery Rate with a q-value = .05 (Benjamini and Hochberg, 1995).

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/05/2018
Actual
Date of last participant enrolment
Anticipated
31/07/2018
Actual
Date of last data collection
Anticipated
30/06/2019
Actual
Sample size
Target
126
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW

Funding & Sponsors
Funding source category [1] 298909 0
Other
Name [1] 298909 0
NRMA-ACT Road Safety Trust
Country [1] 298909 0
Australia
Primary sponsor type
University
Name
The Australian National University
Address
Centre for Research on Ageing, Health and Wellbeing
Research School of Population Health
ANU College of Health & Medicine
54 Mills Road
The Australian National University
Acton ACT 2601
Country
Australia
Secondary sponsor category [1] 298123 0
Other
Name [1] 298123 0
Neuroscience Research Australia
Address [1] 298123 0
Margarete Ainsworth Building
Barker Street
Randwick NSW 2031
Country [1] 298123 0
Australia
Secondary sponsor category [2] 298490 0
University
Name [2] 298490 0
University of New South Wales
Address [2] 298490 0
School of Psychology
University of New South Wales
UNSW Sydney NSW 2052
Country [2] 298490 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299851 0
ANU Human Research Ethics Committee
Ethics committee address [1] 299851 0
Ethics committee country [1] 299851 0
Australia
Date submitted for ethics approval [1] 299851 0
17/10/2017
Approval date [1] 299851 0
01/12/2017
Ethics approval number [1] 299851 0
2017/429
Ethics committee name [2] 299856 0
UNSW Human Research Ethics Committee
Ethics committee address [2] 299856 0
Ethics committee country [2] 299856 0
Australia
Date submitted for ethics approval [2] 299856 0
07/03/2018
Approval date [2] 299856 0
Ethics approval number [2] 299856 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81770 0
Prof Kaarin Anstey
Address 81770 0
Address 1: Centre for Research on Ageing, Health and Wellbeing,
54 Mills Road,
The Australian National University,
Acton ACT 2601.

Address 2: Neuroscience Research Australia,
Margarete Ainsworth Building,
Barker Street,
Randwick NSW 2031.
Country 81770 0
Australia
Phone 81770 0
+61 2 9399 1019
Fax 81770 0
Email 81770 0
[email protected]
Contact person for public queries
Name 81771 0
Maria Borzycki
Address 81771 0
Centre for Research on Ageing, Health and Wellbeing
54 Mills Road
The Australian National University
Acton ACT 2601
Country 81771 0
Australia
Phone 81771 0
+61 2 6125 1457
Fax 81771 0
Email 81771 0
[email protected]
Contact person for scientific queries
Name 81772 0
Kaarin Anstey
Address 81772 0
Address 1: Centre for Research on Ageing, Health and Wellbeing,
54 Mills Road,
The Australian National University,
Acton ACT 2601.

Address 2: Neuroscience Research Australia,
Margarete Ainsworth Building,
Barker Street,
Randwick NSW 2031.
Country 81772 0
Australia
Phone 81772 0
+61 2 9399 1019
Fax 81772 0
Email 81772 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Study has been withdrawn prior to the first participant enrolment; described RCT data collection will not be proceeding therefore no individual participant data will be available


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.