Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000508370
Ethics application status
Approved
Date submitted
5/04/2017
Date registered
7/04/2017
Date last updated
10/04/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of speed of processing training on older driver screening measures
Scientific title
Effect of speed of processing training on older driver screening measures
Secondary ID [1] 291622 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Driving safety 302744 0
Condition category
Condition code
Other 302261 302261 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Self-administered home-based, computerised speed of processing training using online commercial product "Double Decision" in the BrainHQ suite of cognitive training software. Double Decision involves viewing a scene on the computer and identifying an image that appears briefly at the centre of the scene (either a car or truck). At the same time, the participant must also note the location of a briefly appearing peripheral figure at one of eight possible locations around the central image. During training, the speed of presentation of the images is adaptively reduced (between 500ms and 17ms), depending on the participant's accuracy, and the background is made more visually complex. Training on the Double Decision task results in participants becoming faster at accurately identifying and locating the images. Participants allocated to the intervention arm were asked to complete 10 hours of training over 5 weeks, at 2 hours per week. Researchers conducted weekly phone follow-up of each participant during the intervention in order to provide technical and motivational support. The phone follow-ups were also aimed at maintaining adherence to the intervention, with the researcher using basic motivational techniques such as encouraging training, normalising difficulties, providing advice regarding impediments to training, and reinforcing importance.
Intervention code [1] 297695 0
Other interventions
Comparator / control treatment
No contact (no treatment) control participants
Control group
Active

Outcomes
Primary outcome [1] 301676 0
change in speed of processing on Useful Field of View test (UFOV)
Timepoint [1] 301676 0
at completion of 5weeks (or 10hrs) training (or matched test-retest interval for control group)
Secondary outcome [1] 333535 0
Trail Making Test B
Timepoint [1] 333535 0
at completion of 5weeks (or 10hrs) training (or matched test-retest interval period for control group)
Secondary outcome [2] 333536 0
Maze Test (part of OT-DORA battery)
Timepoint [2] 333536 0
at completion of 5weeks (or 10hrs) training (or matched test-retest interval for controls)
Secondary outcome [3] 333537 0
Hazard Perception Test
Timepoint [3] 333537 0
at completion of 5weeks (or 10hrs) training (or matched test-retest interval for controls)
Secondary outcome [4] 333538 0
Colour Choice reaction time test "Cars RT" (part of Multi-D battery)
Timepoint [4] 333538 0
at completion of 5weeks (or 10hrs) training (or matched test-retest interval for controls)
Secondary outcome [5] 333539 0
visual motion sensitivity "Dot motion test" (part of Multi-D battery)
Timepoint [5] 333539 0
at completion of 5weeks (or 10hrs) training (or matched test-retest interval for controls)
Secondary outcome [6] 333540 0
DriveSafe Intersection knowledge test
Timepoint [6] 333540 0
at completion of 5weeks (or 10hrs) training (or matched test-retest interval for controls)
Secondary outcome [7] 333541 0
Road law knowledge test (part of OT-DORA battery)
Timepoint [7] 333541 0
at completion of 5weeks (or 10hrs) training (or matched test-retest interval for controls)

Eligibility
Key inclusion criteria
current full driver’s license
aged over 65
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
history of neurological, psychiatric or major medical illness
history of health issues that may be impacted by regular computer usage (e.g., 2 hours per week for 5 weeks)
no access to a home computer with internet connection

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/12/2014
Date of last participant enrolment
Anticipated
Actual
31/03/2016
Date of last data collection
Anticipated
Actual
16/05/2016
Sample size
Target
50
Accrual to date
Final
53
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 295509 0
Other Collaborative groups
Name [1] 295509 0
ARC Centre of Excellence in Population Ageing Research
Country [1] 295509 0
Australia
Funding source category [2] 296116 0
Government body
Name [2] 296116 0
National Health and Medical Research Council
Country [2] 296116 0
Australia
Primary sponsor type
University
Name
Australian National University
Address
Centre for Research on Ageing, Health and Wellbeing
Research School of Population Health
Building 54, Mills Road
Australian National University
Acton, ACT 0200
Country
Australia
Secondary sponsor category [1] 295013 0
None
Name [1] 295013 0
Address [1] 295013 0
Country [1] 295013 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296836 0
Human Research Ethics Committee, Australian National University
Ethics committee address [1] 296836 0
Research Integrity & Compliance
Research Services Division
Level 2, Birch Building 36
Science Road, ANU
The Australian National University
Acton ACT 2601
Ethics committee country [1] 296836 0
Australia
Date submitted for ethics approval [1] 296836 0
Approval date [1] 296836 0
02/01/2013
Ethics approval number [1] 296836 0
2012/322

Summary
Brief summary
Computerised training for cognitive enhancement is of great public interest, however, there is as yet insufficient data on whether, and how, such training leads to changes in everyday activity that relies on the trained cognitive function. Speed of processing training is a commercial software that has been examined in a number of large trials, particularly in the context of ageing and driving safety. This pilot study aims to examine whether online speed of processing training in healthy older drivers will lead to improvement in other measures known to be associated with driving safety.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72178 0
Prof Kaarin Anstey
Address 72178 0
Centre for Research on Ageing, Health and Wellbeing
The Australian National University
Building 54 Mills Road, Acton, ACT 0200
Country 72178 0
Australia
Phone 72178 0
+61 2 6125 8410
Fax 72178 0
Email 72178 0
[email protected]
Contact person for public queries
Name 72179 0
Dr Ranmalee Eramudugolla
Address 72179 0
Centre for Research on Ageing, Health and Wellbeing
The Australian National University
Building 54 Mills Road, Acton, ACT 0200
Country 72179 0
Australia
Phone 72179 0
+61 2 6125 1456
Fax 72179 0
Email 72179 0
[email protected]
Contact person for scientific queries
Name 72180 0
Dr Ranmalee Eramudugolla
Address 72180 0
Centre for Research on Ageing, Health and Wellbeing
The Australian National University
Building 54 Mills Road, Acton, ACT 0200
Country 72180 0
Australia
Phone 72180 0
+61 2 6125 1456
Fax 72180 0
Email 72180 0
[email protected]

No information has been provided regarding IPD availability


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.