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Trial registered on ANZCTR


Registration number
ACTRN12610000065099
Ethics application status
Approved
Date submitted
13/01/2010
Date registered
20/01/2010
Date last updated
15/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
ROARI – Road Accident Rehabilitation Initiative
Scientific title
Effectiveness of rehabilitation physician intervention for those at risk of long term complications determined by screening, in the return to work rates and usual activities at 3 months for mild-moderate and 6 months for severe injury post road accident.
Secondary ID [1] 1307 0
None
Universal Trial Number (UTN)
Trial acronym
ROARI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Motor vehicle accident injuries 256521 0
Condition category
Condition code
Physical Medicine / Rehabilitation 256691 256691 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An early assessment and treatment by a rehabilitation physician (1 hour consultation to identify and manage rehabilitation issues such as identification of injuries and pain management)
Intervention code [1] 255798 0
Early detection / Screening
Intervention code [2] 255855 0
Rehabilitation
Comparator / control treatment
Usual treatment (by general practitioner), the number of reviews deemed appropriate by the general practitioner
Control group
Active

Outcomes
Primary outcome [1] 257581 0
Return to work (full or suitable duties) rates via a questionnaire
Timepoint [1] 257581 0
3 months for mild-moderate and 6 months for severe injury post road accident from baseline
Secondary outcome [1] 262827 0
Return to driving (questionnaire)
Timepoint [1] 262827 0
week 6, week 12 and week 26 from baseline
Secondary outcome [2] 262828 0
Return to usual activities (determined by phone interview and the Short Form 12 (SF-12) Health Survey)
Timepoint [2] 262828 0
week 6, week 12 and week 26 from baseline
Secondary outcome [3] 262829 0
Physical /Functional Measure: Modified Barthels Index
Timepoint [3] 262829 0
week 6, week 12 and week 26 from baseline
Secondary outcome [4] 262830 0
Psychological & health measures: Depression Anxiety Stress Scales (DASS-21), Orebro Muscoskeletal Pain Questionnaire (OMPQ) (Modified) for attitude to pain (this includes an Experienced Pain Index created from 2 items of the OMPQ by multiplying average pain intensity during the last 3 months (scored out of 10) by pain frequency (scored out of 10))
Timepoint [4] 262830 0
week 6, week 12 and week 26 from baseline
Secondary outcome [5] 262831 0
Medication, alcohol and drug utilization: alcohol use disorders identification test (Interview andthe 'Cut-Annoyed-Guilty-Eye' [CAGE] questions)
Timepoint [5] 262831 0
week 6, week 12 and week 26 from baseline
Secondary outcome [6] 262832 0
Health services utilization (questionnaire)
Timepoint [6] 262832 0
week 6, week 12 and week 26 from baseline

Eligibility
Key inclusion criteria
- Adults (aged 18 or over presenting to the emergency department following road trauma
- Able to provide informed consent
- Willingness to participate in and comply with the study.
- Deemed suitable by medical team for consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Patients who have suffered a severe traumatic brain injury as defined by 1 of the following:
- Glasgow Coma Score of 8 or lower
- Loss of consciousness for more than 24 hours
- Post-traumatic amnesia of 7 or more days.
* Patients experiencing spinal cord injury
* Those unable to read, speak or write English language:
- Severe deafness and unable to hold a phone conversation
- No fixed abode
- No phone
- Overseas tourist leaving Australia within 18 months
- Those with preexisting cognitive impairment who are unable to identify a person responsible or next-of-kin.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomized to either the intervention or control arm this will be done by selecting a sealed envelope from a prepared box.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
At each site, patients will be stratified by using the Abbreviated Injury Score (AIS) into either severe (greater than 2) or mild / moderate (2 or less) (to prevent an uneven distribution of injury severity into either group) .
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/10/2010
Actual
18/10/2010
Date of last participant enrolment
Anticipated
Actual
1/04/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
180
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2387 0
2010
Recruitment postcode(s) [2] 2388 0
2217
Recruitment postcode(s) [3] 2389 0
2145
Recruitment postcode(s) [4] 2390 0
2170

Funding & Sponsors
Funding source category [1] 256286 0
Government body
Name [1] 256286 0
Motor Accidents Association
Country [1] 256286 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital
Address
Sacred Heart Rehabilitation Service
170 Victoria Street,
Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 251611 0
None
Name [1] 251611 0
Address [1] 251611 0
Country [1] 251611 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258420 0
St Vincent's Human Research Ethics Committee (HREC)
Ethics committee address [1] 258420 0
Ethics committee country [1] 258420 0
Australia
Date submitted for ethics approval [1] 258420 0
15/03/2010
Approval date [1] 258420 0
15/07/2010
Ethics approval number [1] 258420 0

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

Contacts
Principal investigator
Name 30691 0
A/Prof Steven Faux
Address 30691 0
St Vincent's Hospital Sacred Heart Rehabilitation Service 170 Victoria Street, Darlinghurst NSW 2010 Sydney
Country 30691 0
Australia
Phone 30691 0
61283829516
Fax 30691 0
61283829431
Email 30691 0
sfaux@stvincents.com.au
Contact person for public queries
Name 13938 0
Dea Irwin
Address 13938 0
St Vincent's Hospital
Sacred Heart Rehabilitation Service
170 Victoria Street, Darlinghurst NSW 2010
Sydney
Country 13938 0
Australia
Phone 13938 0
+61 2 8382 9516
Fax 13938 0
Email 13938 0
dirwin@stvincents.com.au
Contact person for scientific queries
Name 4866 0
A/Prof Steven Faux
Address 4866 0
St Vincent's Hospital
Sacred Heart Rehabilitation Service
170 Victoria Street, Darlinghurst NSW 2010
Sydney
Country 4866 0
Australia
Phone 4866 0
+61 2 8382 9516
Fax 4866 0
Email 4866 0
sfaux@stvincents.com.au

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.