Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618001684213
Ethics application status
Approved
Date submitted
9/10/2018
Date registered
12/10/2018
Date last updated
12/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Functional Outcomes following a Road Traffic Crash
Scientific title
Functional Outcomes following a Road Traffic Crash
Secondary ID [1] 296297 0
Nil known
Universal Trial Number (UTN)
U1111-1221-9541
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Injuries due to a road traffic crash 309976 0
Condition category
Condition code
Injuries and Accidents 308748 308748 0 0
Fractures
Injuries and Accidents 308749 308749 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
12
Target follow-up type
Months
Description of intervention(s) / exposure
Queensland residents (aged 18 to 64 years) injured in a road traffic crash in Queensland in the 28 days prior to the day of baseline data collection. Participants will complete questions on vocational, quality of life, pain, disability, psychosocial wellbeing, sleep, physical activity and sedentary behaviour outcomes at baseline (within 28 days post road traffic crash), and 6 and 12 months post baseline (via self-report questionnaire). In addition, participants will complete questions on vocational outcomes at 1, 2, 3, 4, 5, and 9 months post baseline. A sub-set of participants will have their physical activity and sedentary behaviour objectively measured at baseline, 6 and 12 months.
Intervention code [1] 312626 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307734 0
Return to work status (yes/no). Self-report question on questionnaire: "Since your road traffic crash, did you return to work at any time?"
Timepoint [1] 307734 0
Baseline, 6 and 12 months
Secondary outcome [1] 352693 0
Time to return to work. Self-report question on questionnaire: “If you have returned to work, what was the date on which you returned to work?”
Timepoint [1] 352693 0
Baseline, 1, 2, 3, 4, 5, 6, 9 and 12 months
Secondary outcome [2] 352694 0
Absenteeism. Self-report. WHO Health and Work Performance Questionnaire.
Timepoint [2] 352694 0
Baseline, 1, 2, 3, 4, 5, 6, 9 and 12 months
Secondary outcome [3] 352695 0
Presenteeism. Self-report. WHO Health and Work Performance Questionnaire.
Timepoint [3] 352695 0
Baseline, 1, 2, 3, 4, 5, 6, 9 and 12 months
Secondary outcome [4] 352696 0
Job performance. Self-report. WHO Health and Work Performance Questionnaire.
Timepoint [4] 352696 0
Baseline, 1, 2, 3, 4, 5, 6, 9 and 12 months
Secondary outcome [5] 352697 0
Effect of injury on productivity. Self-report. Work Productivity and Activity Impairment Questionnaire.
Timepoint [5] 352697 0
Baseline, 1, 2, 3, 4, 5, 6, 9 and 12 months
Secondary outcome [6] 352698 0
Return to Work Self-Efficacy Scale. Self-report questionnaire.
Timepoint [6] 352698 0
Baseline, 6 and 12 months
Secondary outcome [7] 352699 0
WHO Disability Assessment Schedule 2.0. Self-report questionnaire.
Timepoint [7] 352699 0
Baseline, 6 and 12 months
Secondary outcome [8] 352700 0
Örebro Musculoskeletal Pain Screening Questionnaire. Self-report questionnaire.
Timepoint [8] 352700 0
Baseline, 6 and 12 months
Secondary outcome [9] 352798 0
Health-related quality of life. Short Form-12. Self-report questionnaire.
Timepoint [9] 352798 0
Baseline, 6 and 12 months
Secondary outcome [10] 352799 0
Health-related quality of life. EQ-5D-5L. Self-report questionnaire.
Timepoint [10] 352799 0
Baseline, 6 and 12 months
Secondary outcome [11] 352800 0
Global Perceived Effect scale. 1 self-report item on questionnaire.
Timepoint [11] 352800 0
Baseline, 6 and 12 months
Secondary outcome [12] 352801 0
Total activity time in the last week, measured by the Active Australia Questionnaire.
Timepoint [12] 352801 0
Baseline, 6 and 12 months
Secondary outcome [13] 352802 0
Average time spent sitting on a weekday in the last week (1 item from the IPAQ).
Timepoint [13] 352802 0
Baseline, 6 and 12 months
Secondary outcome [14] 352810 0
Total physical activity (light+moderate+vigorous) time, measured by the activPAL monitor in a sub-set of participants.
Timepoint [14] 352810 0
Baseline, 6 and 12 months
Secondary outcome [15] 352811 0
Sitting time, measured by the activPAL monitor in a sub-set of participants.
Timepoint [15] 352811 0
Baseline, 6 and 12 months

Eligibility
Key inclusion criteria
Sustained an injury as a result of a road traffic crash in Queensland and has sought advice from a medical practitioner or other healthcare provider
Diagnosis of injury and recruitment must be within 28 days of the road traffic crash
Queensland resident aged 18 to 64 years
Proficient in English language
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Road traffic crash did not involve a motorised vehicle
Severe injuries (including severe traumatic brain injury, spinal cord injury, extensive burns or multiple amputations)
Injury required hospitalisation for more than 10 days
Injury was a result of intentional self-harm
Dementia or significant cognitive impairment that affects ability to provide informed consent

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Random sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/10/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
297
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 12141 0
The Townsville Hospital - Douglas

Funding & Sponsors
Funding source category [1] 300889 0
University
Name [1] 300889 0
RECOVER Injury Research Centre, The University of Queensland
Country [1] 300889 0
Australia
Primary sponsor type
University
Name
RECOVER Injury Research Centre, The University of Queensland
Address
RECOVER Injury Research Centre, The University of Queensland, Oral Health Centre, Herston Rd, Herston QLD 4006
Country
Australia
Secondary sponsor category [1] 300457 0
None
Name [1] 300457 0
None
Address [1] 300457 0
None
Country [1] 300457 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301662 0
Townsville Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 301662 0
Ethics committee country [1] 301662 0
Australia
Date submitted for ethics approval [1] 301662 0
24/05/2018
Approval date [1] 301662 0
17/07/2018
Ethics approval number [1] 301662 0
HREC/18/QTHS/131
Ethics committee name [2] 301663 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [2] 301663 0
Ethics committee country [2] 301663 0
Australia
Date submitted for ethics approval [2] 301663 0
18/09/2018
Approval date [2] 301663 0
24/09/2018
Ethics approval number [2] 301663 0
2018001693

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

Contacts
Principal investigator
Name 87706 0
A/Prof Venerina Johnston
Address 87706 0
RECOVER Injury Research Centre, The University of Queensland, Oral Health Centre, Herston Rd, Herston QLD 4006
Country 87706 0
Australia
Phone 87706 0
+61 07 3346 4859
Fax 87706 0
Email 87706 0
[email protected]
Contact person for public queries
Name 87707 0
Venerina Johnston
Address 87707 0
RECOVER Injury Research Centre, The University of Queensland, Oral Health Centre, Herston Rd, Herston QLD 4006
Country 87707 0
Australia
Phone 87707 0
+61 07 3346 4859
Fax 87707 0
Email 87707 0
[email protected]
Contact person for scientific queries
Name 87708 0
Venerina Johnston
Address 87708 0
RECOVER Injury Research Centre, The University of Queensland, Oral Health Centre, Herston Rd, Herston QLD 4006
Country 87708 0
Australia
Phone 87708 0
+61 07 3346 4859
Fax 87708 0
Email 87708 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.