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Trial registered on ANZCTR


Registration number
ACTRN12625000346471
Ethics application status
Approved
Date submitted
27/03/2025
Date registered
23/04/2025
Date last updated
23/04/2025
Date data sharing statement initially provided
23/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Australian Football League Brain Health Initiative: monitoring player brain health.
Scientific title
Australian Football League Brain Health Initiative: A prospective, longitudinal, player brain health research program
Secondary ID [1] 313201 0
Nil known
Universal Trial Number (UTN)
U1111-1319-8211
Trial acronym
AFL BHI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Concussion 336274 0
Sport-Related Concussion 336275 0
Mild Traumatic Brain Injury 336276 0
Repetitive head impacts 336277 0
Neurodegenerative disease 336570 0
Condition category
Condition code
Neurological 332818 332818 0 0
Other neurological disorders
Neurological 332819 332819 0 0
Neurodegenerative diseases
Neurological 333079 333079 0 0
Studies of the normal brain and nervous system
Injuries and Accidents 333469 333469 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
40
Target follow-up type
Years
Description of intervention(s) / exposure
The AFL BHI is a prospective, longitudinal, observational clinical research program in which current and retired AFL and AFLW players are offered the opportunity to participate.

CURRENT PLAYERS: Data for current players will be collected at draft into the competition (entry), annual pre-season baseline assessment and following concussion (if any) throughout their playing career, and upon retirement (exit) from the competition. Secondary data collection will involve concussion measures (baseline and sideline assessment tools, computerised tests, match video footage), some neurocognitive test measures, self-report questionnaires) - as they form part of routine clinical care of players they will take no additional time to complete. Primary data collection will involve additional self-report questionnaires, neurocognitive testing and the completion of a case report form. Current players will also have the option to consent to an MRI brain scan at entry and exit only, as well as the option to wear an instrumented mouthguard throughout training and matches. The total time taken for primary measures is as follows: additional questionnaires 20 min, MRI scan 1.5 hours (including travel), instrumented mouthguard 30 min for initial scan, and 5 min pre-post training/match. Consent will also be requested for access to concussion screening data from 2019 which will not take additional participant time.

RETIRED PLAYERS: Once current players retire from the competition, they will then participate as retired players. Additionally, retired players can consent to participate in the BHI from 2026/7 onwards, even though they did not participate as current players. Data for retired players will be collected at 2, 5, 10, 20, 30 and 40 years from the point of retirement (exit) from the competition. Data collection will involved limited concussion measures (computerised tests), neurocognitive test measures, self-report questionnaires, informant based questionnaires, case report form and MRI brain scan as an optional add-on. The total time taken for these measures is as follows: computerised tests 15 min, neurocognitive test measures 2 hours, self questionnaires 30 min, informant based questionnaires 10 min, and optional MRI brain scan 1,5 hours (inc. travel time). Consent will also be requested for access to concussion screening data from 2019 which will not take additional participant time.
Intervention code [1] 330289 0
Not applicable
Comparator / control treatment
A group of demographically matched elite athletes who participate in non-contact sports, and are otherwise not exposed to repetitive head impacts, will be recruited from 2029 onwards as a comparison group to retired professional Australian football players. The assessment they undertake, including the frequency and time taken will mirror that of the AFL/AFLW RETIRED player cohort.
Control group
Active

Outcomes
Primary outcome [1] 340347 0
Neurocognitive performance across cognitive domains (Composite Outcome)
Timepoint [1] 340347 0
Data from select neurocognitive measures will be collected at baseline [entry to professional competition], annual pre-season, and post-concussion. Comprehensive neurocognitive testing will be undertaken upon retirement [exiting the professional competition], and following retirement at 2-years, 5-years, 10-years with the intention to continue follow-up at 20-years, 30-years and 40-years.
Primary outcome [2] 340861 0
Brain structure as measured by structural magnetic resonance imaging.
Timepoint [2] 340861 0
Data collected at baseline [entry to professional competition], upon retirement [exiting the professional competition] and following retirement at 2-years, 5-years, 10-years with the intention to continue follow-up at 20-years, 30-years and 40-years.
Primary outcome [3] 340862 0
Diagnosis of neurodegenerative disease by a medical professional.
Timepoint [3] 340862 0
Data collected via the CRF at baseline [entry to professional competition], upon retirement [exiting the professional competition] and following retirement at 2-years, 5-years, 10-years with the intention to continue follow-up at 20-years, 30-years and 40-years. Neuropathology data collected at autopsy.
Secondary outcome [1] 443776 0
Concussion assessment
Timepoint [1] 443776 0
Across playing career at BHI entry, pre-season baseline, post-injury, BHI exit.
Secondary outcome [2] 445307 0
Repetitive Head Impact Exposure as measured by instrumented mouthguards.
Timepoint [2] 445307 0
Data will be purposefully collected during training sessions (AFL pre-season Nov-Feb; AFLW pre-season May-Jul) and matches (AFL season Mar-Sep; AFLW season Aug to Dec) throughout the player's professional career.
Secondary outcome [3] 445308 0
Mood
Timepoint [3] 445308 0
Collected during draft into the professional competition (entry), annual pre-season baseline assessment, post-concussion (if any), upon retirement (exit) from the competition, and at 2-years, 5-years, 10-years, 20-years, 30-years and 40-years following retirement from the competition.
Secondary outcome [4] 445974 0
Sleep
Timepoint [4] 445974 0
Collected during draft into the professional competition (entry), annual pre-season baseline assessment, post-concussion (if any), upon retirement (exit) from the competition, and at 2-years, 5-years, 10-years, 20-years, 30-years and 40-years following retirement from the competition.
Secondary outcome [5] 445975 0
Pain
Timepoint [5] 445975 0
Collected during draft into the professional competition (entry), annual pre-season baseline assessment, post-concussion (if any), upon retirement (exit) from the competition, and at 2-years, 5-years, 10-years, 20-years, 30-years and 40-years following retirement from the competition.
Secondary outcome [6] 445976 0
Fatigue
Timepoint [6] 445976 0
Collected during draft into the professional competition (entry), annual pre-season baseline assessment, post-concussion (if any), upon retirement (exit) from the competition, and at 2-years, 5-years, 10-years, 20-years, 30-years and 40-years following retirement from the competition.
Secondary outcome [7] 445977 0
Alcohol Use
Timepoint [7] 445977 0
Collected during draft into the professional competition (entry), upon retirement (exit) from the competition, and at 2-years, 5-years, 10-years, 20-years, 30-years and 40-years following retirement from the competition.
Secondary outcome [8] 445978 0
Substance Use
Timepoint [8] 445978 0
Collected during draft into the professional competition (entry), upon retirement (exit) from the competition, and at 2-years, 5-years, 10-years, 20-years, 30-years and 40-years following retirement from the competition.
Secondary outcome [9] 445979 0
Quality of Life
Timepoint [9] 445979 0
Collected during draft into the professional competition (entry), upon retirement (exit) from the competition, and at 2-years, 5-years, 10-years, 20-years, 30-years and 40-years following retirement from the competition.
Secondary outcome [10] 445980 0
Childhood Trauma
Timepoint [10] 445980 0
Collected once during exit from the professional competition (exit).
Secondary outcome [11] 445981 0
Athletic Identity
Timepoint [11] 445981 0
Collected during draft into the professional competition (entry), upon retirement (exit) from the competition, and at 2-years, 5-years, 10-years, 20-years, 30-years and 40-years following retirement from the competition.
Secondary outcome [12] 445982 0
Subjective Cognitive Decline
Timepoint [12] 445982 0
Collected upon retirement (exit) from the competition, and at 2-years, 5-years, 10-years, 20-years, 30-years and 40-years following retirement from the competition.
Secondary outcome [13] 445983 0
Psychosocial Stressors
Timepoint [13] 445983 0
Collected upon retirement (exit) from the competition, and at 2-years, 5-years, 10-years, 20-years, 30-years and 40-years following retirement from the competition.
Secondary outcome [14] 445984 0
General Well Being
Timepoint [14] 445984 0
Collected upon retirement (exit) from the competition, and at 2-years, 5-years, 10-years, 20-years, 30-years and 40-years following retirement from the competition.
Secondary outcome [15] 445985 0
Health Behaviours
Timepoint [15] 445985 0
Collected at 2-years, 5-years, 10-years, 20-years, 30-years and 40-years following retirement from the competition.
Secondary outcome [16] 445986 0
Neuropsychiatric Symptoms and Psychopathology
Timepoint [16] 445986 0
Collected at 2-years, 5-years, 10-years, 20-years, 30-years and 40-years following retirement from the competition.
Secondary outcome [17] 445987 0
Rating of Cognitive Function in Daily Activities
Timepoint [17] 445987 0
Collected at 2-years, 5-years, 10-years, 20-years, 30-years and 40-years following retirement from the competition.
Secondary outcome [18] 446265 0
Player performance
Timepoint [18] 446265 0
Data collected in all matches throughout career.
Secondary outcome [19] 446266 0
Player movement
Timepoint [19] 446266 0
Data collected in all matches throughout career.

Eligibility
Key inclusion criteria
Over 18 years of age; current Australian football player who is a listed player at the professional level (AFLM or AFLW) of the competition, or retired professional Australian football player (AFLM or AFLW) who has competed in at least one professional Australian football match; sufficient English proficiency to enable player to provide informed consent and complete testing; has demonstrated capacity to provide informed consent; resides within Australia and (for retired players) are able to nominate General Practitioner (GP) for management of medical care if required upon consenting to the BHI.
Elite athletes who have participated in non-contact sports (e.g., tennis, athletics, swimming, track), and who are retired from the elite non-contact sport will be recruited as a comparison group to participating retired players with recruitment commencing in 2029 subject to an appropriate Human Research Ethics Committee (HREC) amendment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The BHI has multiple primary and secondary aims, with several research questions within each aim. Analytic plans for short-term aims (Years 1-5) will be outlined in a stand-alone Statistical Analysis Plan (SAP), with specifications for mid-term and long-term research questions appended as the study evolves. This longitudinal cohort study also has numerous sub-studies embedded; analytic methods to assess these research questions will be defined when these cohorts are established. The volume and rigor of data collected also invite ad hoc analytics to investigate trends and establish the need for any additional
research questions, given how the scientific landscape will evolve through the duration of this study.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 317646 0
Commercial sector/Industry
Name [1] 317646 0
Australian Football League
Country [1] 317646 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Australian Football League
Address
Country
Australia
Secondary sponsor category [1] 320761 0
None
Name [1] 320761 0
Address [1] 320761 0
Country [1] 320761 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316345 0
Bellberry Human Research Ethics Committee B
Ethics committee address [1] 316345 0
Ethics committee country [1] 316345 0
Australia
Date submitted for ethics approval [1] 316345 0
13/11/2024
Approval date [1] 316345 0
07/03/2025
Ethics approval number [1] 316345 0
2024-10-1388

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

Contacts
Principal investigator
Name 137598 0
A/Prof Catherine Willmott
Address 137598 0
c/o Australian Football League, 140 Harbour Esplanade, Docklands VIC 3008
Country 137598 0
Australia
Phone 137598 0
+61 498666397
Fax 137598 0
Email 137598 0
[email protected]
Contact person for public queries
Name 137599 0
Catherine Willmott
Address 137599 0
c/o Australian Football League, 140 Harbour Esplanade, Docklands VIC 3008
Country 137599 0
Australia
Phone 137599 0
+61 498666397
Fax 137599 0
Email 137599 0
[email protected]
Contact person for scientific queries
Name 137600 0
Catherine Willmott
Address 137600 0
c/o Australian Football League, 140 Harbour Esplanade, Docklands VIC 3008
Country 137600 0
Australia
Phone 137600 0
+61 498666397
Fax 137600 0
Email 137600 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Whilst there may be consideration of IPD sharing in the future, sharing of data over the first 4 years of the BHI research program development is not currently contemplated.



What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24577Ethical approval    ApprovalLetter-HREC2024-10-1388.pdf



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.