Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000046101
Ethics application status
Approved
Date submitted
20/12/2018
Date registered
14/01/2019
Date last updated
24/01/2020
Date data sharing statement initially provided
14/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Injury profiles of female Australian Rules Football players: a survey of Geelong and South-Western Victoria
Scientific title
Injury profiles of female Australian Rules Football players: a survey of Geelong and South-Western Victoria
Secondary ID [1] 296710 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Australian Rules Football (ARF)- related injury 310562 0
Condition category
Condition code
Injuries and Accidents 309275 309275 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The condition of interest is an Australian Rules Football (ARF) related injury and participants will be invited to participate upon presentation at an Emergency Department (ED) department or Urgent Care Centre (UCC) in either Geelong or in the South Western region of Victoria. In the first stage (Study One) both males and females will be asked to participate as males are required to enable comparison between males and female injury types. Data for Study One will be extracted from participants' medical records and will indicate the number and type of injuries sustained.

Six-to-ten weeks following an ARF-related injury and ED or UCC presentation, each female patient (or person caring for a female child) will be contacted by letter or SMS and asked to describe the impact of the injury via a questionnaire (Study Two). Patients will access the questionnaire using a link to the web-based questionnaire. The questionnaire will take approximately 5 minutes to complete.
Intervention code [1] 313020 0
Diagnosis / Prognosis
Comparator / control treatment
Males will act as the comparison group for Study One and will not participate in Study Two.
Control group
Active

Outcomes
Primary outcome [1] 308251 0
Number of injuries sustained by female ARF players who present to emergency departments (EDs) and urgent care centers (UCCs) in Geelong and South-Western Victoria. Data will be extracted from medical records.
Timepoint [1] 308251 0
On presentation at either a specified ED or UCC
Primary outcome [2] 318514 0
Type of injuries sustained by female ARF players who present to emergency departments (EDs) and urgent care centers (UCCs) in Geelong and South-Western Victoria. Data will be extracted from medical records.
Timepoint [2] 318514 0
On presentation at either a specified ED or UCC
Secondary outcome [1] 354419 0
Number of injuries sustained by male ARF players who present to emergency departments (EDs) and urgent care centers (UCCs) in Geelong and South-Western Victoria. Data will be extracted from medical records.
Timepoint [1] 354419 0
On presentation at a specified ED or UCC
Secondary outcome [2] 354420 0
Follow-up healthcare requirements for female ARF players who present to EDs and UCCs (i.e the number of appointments with a specific health professional as assessed by investigator designed questionnaire completed by participants)
Timepoint [2] 354420 0
6-10 weeks post presentation at a specified ED or UCC
Secondary outcome [3] 354421 0
Determine the economic impact of injuries sustained by female ARF players who present to EDs and UCCs from a health sector and societal perspective. Economic impact will be assessed using a participant-completed investigator-designed questionnaire and health provider and participant costs calculated based on responses.
Timepoint [3] 354421 0
6-10 weeks post presentation at a specified ED or UCC
Secondary outcome [4] 354422 0
Impact of injuries sustained by female ARF players who present to EDs and UCCs regarding their ability to play football. Impact will be assessed using a participant-completed investigator-designed questionnaire.
Timepoint [4] 354422 0
6-10 weeks post presentation at a specified ED or UCC
Secondary outcome [5] 365202 0
Types of injuries sustained by male ARF players who present to emergency departments (EDs) and urgent care centers (UCCs) in Geelong and South-Western Victoria. Data will be extracted from medical records.
Timepoint [5] 365202 0
On presentation at a specified ED or UCC
Secondary outcome [6] 365224 0
Impact of injuries sustained by female ARF players who present to EDs and UCCs regarding their ability to work or attend school/place of study. Impact will be assessed using a participant-completed investigator-designed questionnaire.
Timepoint [6] 365224 0
6-10 weeks post presentation at a specified ED or UCC

Eligibility
Key inclusion criteria
Study One: Presentation with an ARF-related injury at an ED in one of the 3 Geelong Hospitals or an ED or Urgent Care Centre in the South Western Region.

Study two: females who presented with an ARF-related injury at an ED in one of the 3 Geelong Hospitals or an ED or Urgent Care Centre in the South Western Region.
Minimum age
2 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data for Studies One and Two will be analysed with descriptive statistics. De-identified records will be summarised using descriptive statistics (mean ± standard deviation for continuous variables, and frequencies and percentages for categorical variables). Stratification will be based upon demographic factors such as gender, age and injury type. Chi-square tests will be used to compare proportions.

Differences between the prevalence and type of injuries for females and males will be assessed with the chi-squared statistic and considered significant if p < 0.05.

Healthcare related costs will be determined for ED or UCC presentations, hospital admissions and any subsequent investigations and/or treatments. Societal costs will be determined by loss of income or expenses associated with the injury including subsequent healthcare appointments, investigations or treatments for the injured person and his/her carer.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
14/01/2019
Actual
14/01/2019
Date of last participant enrolment
Anticipated
Actual
31/10/2019
Date of last data collection
Anticipated
31/03/2020
Actual
Sample size
Target
1500
Accrual to date
Final
1500
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12542 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [2] 12544 0
St John of God Hospita, Geelong - Geelong
Recruitment hospital [3] 12545 0
Southwest Health Care - Warrnambool - Warrnambool
Recruitment hospital [4] 12546 0
Portland District Health - Portland
Recruitment hospital [5] 12548 0
Moyne Health Services - Port Fairy
Recruitment hospital [6] 12549 0
Terang & Mortlake Health Service - Terang
Recruitment hospital [7] 12550 0
South West Healthcare - Camperdown - Camperdown
Recruitment hospital [8] 12551 0
Lorne Community Hospital - Lorne
Recruitment hospital [9] 12552 0
Timboon & District Healthcare Service - Timboon
Recruitment hospital [10] 12553 0
Colac Area Health - Colac
Recruitment hospital [11] 12564 0
Epworth Hospital Geelong - Waurn Ponds
Recruitment hospital [12] 12565 0
Apollo Bay Hospital - Apollo Bay
Recruitment postcode(s) [1] 24924 0
3220 - Geelong
Recruitment postcode(s) [2] 24925 0
3280 - Warrnambool
Recruitment postcode(s) [3] 24926 0
3305 - Portland
Recruitment postcode(s) [4] 24928 0
3284 - Port Fairy
Recruitment postcode(s) [5] 24929 0
3264 - Terang
Recruitment postcode(s) [6] 24930 0
3260 - Camperdown
Recruitment postcode(s) [7] 24931 0
3232 - Lorne
Recruitment postcode(s) [8] 24932 0
3268 - Timboon
Recruitment postcode(s) [9] 24933 0
3250 - Colac
Recruitment postcode(s) [10] 24943 0
3216 - Waurn Ponds
Recruitment postcode(s) [11] 24944 0
3233 - Apollo Bay

Funding & Sponsors
Funding source category [1] 301290 0
Commercial sector/Industry
Name [1] 301290 0
The Australian Football League Research Board
Country [1] 301290 0
Australia
Primary sponsor type
University
Name
Deakin University Geelong
Address
75 Pigdons Road, Waurn Ponds, Victoria, 3216
Country
Australia
Secondary sponsor category [1] 300941 0
Hospital
Name [1] 300941 0
Barwon Health
Address [1] 300941 0
Bellerine Street, Geelong, Victoria, 3220
Country [1] 300941 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302031 0
Barwon Health’s Human Research Ethics Committee
Ethics committee address [1] 302031 0
Ethics committee country [1] 302031 0
Australia
Date submitted for ethics approval [1] 302031 0
Approval date [1] 302031 0
07/11/2018
Ethics approval number [1] 302031 0
Reference 18/178

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

Contacts
Principal investigator
Name 88902 0
Dr Stephen Gill
Address 88902 0
Barwon Centre for Orthopaedic Research & Education (B-CORE)
St John of God Hospital Geelong
Myers St, Geelong, Victoria, Australia, 3220
Country 88902 0
Australia
Phone 88902 0
+61 3 52150902
Fax 88902 0
Email 88902 0
[email protected]
Contact person for public queries
Name 88903 0
Stephen Gill
Address 88903 0
Barwon Centre for Orthopaedic Research & Education (B-CORE)
St John of God Hospital Geelong
Myers St, Geelong, Victoria, Australia, 3220
Country 88903 0
Australia
Phone 88903 0
+61 3 52150902
Fax 88903 0
Email 88903 0
[email protected]
Contact person for scientific queries
Name 88904 0
Stephen Gill
Address 88904 0
Barwon Centre for Orthopaedic Research & Education (B-CORE)
St John of God Hospital Geelong
Myers St, Geelong, Victoria, Australia, 3220
Country 88904 0
Australia
Phone 88904 0
+61 3 52150902
Fax 88904 0
Email 88904 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


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.