Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000372088
Ethics application status
Approved
Date submitted
28/04/2010
Date registered
10/05/2010
Date last updated
28/05/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a large-scale trial of an on-road rider development program for newly licensed motorcycle riders
Scientific title
Randomised Control Trial to evaluate the effect of VicRide on-road program for newly licensed motorcycle riders on the incidence of crashes, traffic offending behaviour and injuries
Secondary ID [1] 251678 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Road related injuries and fatals 257163 0
Condition category
Condition code
Injuries and Accidents 257312 257312 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The VicRide program involves planned on-road urban and rural rides and discussions with other newly licensed riders and the coach before and after the on-road rides. The whole session is delivered over 4 hours. The program requires five preparation exercises as well by the participant riders within 2 weeks before the ride session day so that they can effectively contribute to the discussions on the day of the ride session and to facilitate their engagement in the learning on the day. They are also required to learn the hand signals that will be used by the Coaches during rides on the session day. All the preparation should take about an hour to complete. The participants are given the Handbook at least 2 weeks before the riding session to ensure that they are prepared and sufficiently experienced to participate in all the activities in the ride session. The preparation exercises are designed for the participants to think about their own experiences in relation to motorcyclist-specific hazards, a close call, and their early rides, and their motivations for and styles of riding. They all relate to the key topics covered in the discussions on the session day. The coach facilitates discussions between on-road rides to cover four key topics: hazard perception and responding; roadcraft; inexperience and risk exposure; risk taking and motivations for riding. The program is delivered in groups of 2 or 3 riders with a qualified coach experienced as a rider and riding instructor. The coaches have also been trained specifically in this program with a particular focus on coaching strategies.
Intervention code [1] 256310 0
Prevention
Intervention code [2] 256311 0
Behaviour
Comparator / control treatment
No treatment. However the participants have the option to do the program after the trial if they wish.
Control group
Active

Outcomes
Primary outcome [1] 258311 0
Number and proportion of a composite measure of any police-recorded and self-reported crashes
Timepoint [1] 258311 0
At 12 month since the completion of the intervention (Similar timeframe overall for control group ~ 13month since the baseline interview)
Primary outcome [2] 258312 0
Frequency and severity of self-reported crashes and near misses while riding on a public road over the last 12 months as assessed by the interview.
Timepoint [2] 258312 0
At 12 month since the completion of the intervention (Similar timeframe overall for control group ~ 13month since the baseline interview)
Primary outcome [3] 258313 0
Frequency and severity of traffic offending behaviour (VicRoads data)
Timepoint [3] 258313 0
At 12 month since the completion of the intervention (Similar timeframe overall for control group ~ 13month since the baseline interview)
Secondary outcome [1] 264014 0
Frequency and severity of self-reported risk taking behaviour through a structured interview based on the Motorcycle Rider Behaviour Questionnaire.
Timepoint [1] 264014 0
Basline and at 3 and 12 month since the completion of the intervention. (Similar timeframe overall for control group ~ 4month and ~ 13month since the baseline interview)
Secondary outcome [2] 264015 0
Attitudes towards risk taking behaviour through a structured interview based on the Motorcycle Rider Behaviour Questionnaire and a self-report questionnaire developed in a UK study.
Timepoint [2] 264015 0
Basline and at 3 and 12 month since the completion of the intervention. (Similar timeframe overall for control group ~ 4month and ~ 13month since the baseline interview)
Secondary outcome [3] 264016 0
Ability to assess their own risks and riding skills (optimism bias) through a structured interview based on questions developed by a study in UK.
Timepoint [3] 264016 0
Basline and at 3 and 12 month since the completion of the intervention. (Similar timeframe overall for control group ~ 4month and ~ 13month since the baseline interview)
Secondary outcome [4] 264017 0
Ability to perceive a hazard and respond effectively thrrough a structured interview based on the Motorcycle Rider Motivation Questionnaire.
Timepoint [4] 264017 0
Basline and at 3 and 12 month since the completion of the intervention. (Similar timeframe overall for control group ~ 4month and ~ 13month since the baseline interview)
Secondary outcome [5] 264018 0
Frequency of riding errors thrrough a structured interview based on the Motorcycle Rider Behaviour Questionnaire.
Timepoint [5] 264018 0
Basline and at 3 and 12 month since the completion of the intervention. (Similar timeframe overall for control group ~ 4month and ~ 13month since the baseline interview)
Secondary outcome [6] 264019 0
Ability to avoid a crash thrrough a structured interview based on the Motorcycle Rider Behaviour Questionnaire.
Timepoint [6] 264019 0
Basline and at 3 and 12 month since the completion of the intervention. (Similar timeframe overall for control group ~ 4month and ~ 13month since the baseline interview)
Secondary outcome [7] 264020 0
Frequency and level of wearing protective clothing through a structured interview based on questions developed by a study in UK.
Timepoint [7] 264020 0
Basline and at 3 and 12 month since the completion of the intervention. (Similar timeframe overall for control group ~ 4month and ~ 13month since the baseline interview)
Secondary outcome [8] 264021 0
Nature of riding style through a structured interview based on questions developed by a study in UK.
Timepoint [8] 264021 0
Basline and at 3 and 12 month since the completion of the intervention. (Similar timeframe overall for control group ~ 4month and ~ 13month since the baseline interview)
Secondary outcome [9] 264083 0
Frequency and severity of motorcycle related injuries from insurance claim data in Victoria (Transport Accident Comission (TAC) data)
Timepoint [9] 264083 0
At 12 month since the completion of the intervention (Similar timeframe overall for control group ~ 13month since the baseline interview)
Secondary outcome [10] 314974 0
Self reported near misses
Timepoint [10] 314974 0
At 3 and 12 months following the baseline intervention
Secondary outcome [11] 314975 0
Time to first police-recorded crash date
Timepoint [11] 314975 0
Time from baseline interview date to first crash

Eligibility
Key inclusion criteria
- Victorian Probationary/Restricted licence holders
- Have ridden 500km - 3000km in at least 12 separate rides on public roads since obtaining the learner permit.
- Own a motorcycle (minimum of 125cc) that is not a scooter
- Have ridden in metropolitan areas with posted speed limits 40-70km/h
- Have ridden in country roads with posted speed limits 80-90km.h
- Able to accelerate up to and maintain the posted speed limit on all roads
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- An unrestricted motorcycle licence holder
- A rider with less than 500km riding experience
- A rider without a motorcycle licence
- A rider who does not own a motorcycle with a minimum of 125cc and that is not a scooter
- A rider without basic motorcycle riding skills

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects are recruited using two methods. 1.Subjects are recruited via information provided to them by licensing authorities and consent online at a study website; or 2. after receiving a mailed letter (as per previous group) alerting them about the study (and allowing them to opt out), those eligible are phoned by research staff and invited to participate. After screening, and consent, all participants complete a baseline interview administered by a trained telephone interviewer using a CATI system. After the interview, participants are allocated to intervention group using an automatic simple randomisation system built into the CATI software. The interviewers and interviewees are blinded to the group assignment until the end of the baseline interview when the randomisation process occurs.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was via a simple automatic process in-built into CATI software. No stratification or blocking used.
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
Safety/efficacy
Statistical methods / analysis
1. All analyses will be conducted on an intention-to-treat (ITT) basis. They will however exclude patients who withhold or withdraw consent to the use of their data.
2. All tests are two-sided and the nominal level of alpha will be 5%.
3. P-value will not be adjusted for multiplicity
4. All statistical analyses will be unadjusted except where indicated.
5. No sub-group analysis will be implemented
6. Multiple imputation method will be used to impute missing secondary outcomes of self-reported crashes and self-reported near crashes if more than 10% of missing is observed in each of the two outcomes. However, when data are missing because the riders withdrawn from the study before the completion of interviews 2 or 3 then no imputation will be performed.
7. Data screening will be conducted to determine outlier and missing data treatment on case by case basis for all variables.
8. The number of observations used in the analysis will be reported.

Sample size calculations assumed a composite crash outcome (at least one police-recorded crash or self-reported crash) of 22% after 12 months, based on previous studies reporting crash rates in novice motorcyclists or drivers. Assuming a 15% drop-out rate, 2400 riders were required for statistical power of 88% (a=0.05) to detect an absolute reduction in crash outcome of 5.5% (a relative reduction of 25%).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/05/2010
Actual
25/10/2010
Date of last participant enrolment
Anticipated
Actual
30/10/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
2400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2860 0
3062
Recruitment postcode(s) [2] 2861 0
3137
Recruitment postcode(s) [3] 2862 0
3820
Recruitment postcode(s) [4] 2863 0
3550

Funding & Sponsors
Funding source category [1] 256880 0
Commercial sector/Industry
Name [1] 256880 0
VicRoads
Country [1] 256880 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The George Institute
Address
Level 7, 341 George Street Sydney NSW 2000
Country
Australia
Secondary sponsor category [1] 256152 0
None
Name [1] 256152 0
Address [1] 256152 0
Country [1] 256152 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258886 0
The University Of Sydney Human Research Ethics Committee
Ethics committee address [1] 258886 0
Ethics committee country [1] 258886 0
Australia
Date submitted for ethics approval [1] 258886 0
Approval date [1] 258886 0
22/02/2010
Ethics approval number [1] 258886 0
12467

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

Contacts
Principal investigator
Name 31051 0
Prof Rebecca Ivers
Address 31051 0
The George Institute for Global Health
Level 13, 321 Kent St, Sydney 2000 NSW Australia
Country 31051 0
Australia
Phone 31051 0
+61414726975
Fax 31051 0
Email 31051 0
[email protected]
Contact person for public queries
Name 14298 0
Professor Rebecca Ivers
Address 14298 0
Level 7, 341 George Street, Sydney NSW 2000
Country 14298 0
Australia
Phone 14298 0
+61 2 9657 0361
Fax 14298 0
+61 2 9657 0301
Email 14298 0
[email protected]
Contact person for scientific queries
Name 5226 0
Professor Rebecca Ivers
Address 5226 0
Level 7, 341 George Street, Sydney NSW 2000
Country 5226 0
Australia
Phone 5226 0
+61 2 9657 0361
Fax 5226 0
+61 2 9657 0301
Email 5226 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.