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DEFINITIONS
Trial Review
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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.
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Scientific title
Australian Football League Brain Health Initiative: A prospective, longitudinal, player brain health research program
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Secondary ID [1]
313201
0
Nil known
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Universal Trial Number (UTN)
U1111-1319-8211
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Trial acronym
AFL BHI
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Neurodegenerative disease
336570
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Mild Traumatic Brain Injury
336276
0
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Concussion
336274
0
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Sport-Related Concussion
336275
0
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Repetitive head impacts
336277
0
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Condition category
Condition code
Injuries and Accidents
333469
333469
0
0
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Other injuries and accidents
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Neurological
332818
332818
0
0
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Other neurological disorders
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Neurological
332819
332819
0
0
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Neurodegenerative diseases
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Neurological
333079
333079
0
0
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Studies of the normal brain and nervous system
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Intervention/exposure
Study type
Observational
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Patient registry
True
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Target follow-up duration
40
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Target follow-up type
Years
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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.
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Intervention code [1]
330289
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Not applicable
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Diagnosis of neurodegenerative disease by a medical professional.
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Assessment method [1]
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Self-report as per Case Report Form collecting medical history (specifically designed for this study). Supported by the presence of neuropathology indicating neurodegenerative disease in donated brain tissue for those players who additionally consent to donate to the AFL Brain Donor Program once the program is developed and HREC approved.
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Timepoint [1]
340862
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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.
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Primary outcome [2]
340861
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Brain structure as measured by structural magnetic resonance imaging.
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Assessment method [2]
340861
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Qualitative (as evidenced by clinical read) and/or quantitative (e.g., volumetrics) changes in brain macrostructure evident on magnetic resonance imaging brain scan seen longitudinally and associated with typical brain ageing, and/or neurodegenerative change. Further advanced neuroimaging methods will be introduced from 2028 following HREC approval.
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Timepoint [2]
340861
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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.
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Primary outcome [3]
340347
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Neurocognitive performance across cognitive domains (Composite Outcome)
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Assessment method [3]
340347
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• Animals & Controlled Oral Word Association Test (COWAT) Cognigram • Multilingual Naming Test 32 (MINT-32) • Oral Symbol Digit Modalities Test (OSDMT) • Rey Adult Verbal Learning Test (RAVLT) • Rey Complex Figure Test (RCFT) • Taylor Complex Figure Test (TCFT) • Stroop Test (Golden Version) • Test of Premorbid Functioning (TOPF) • Trail Making Test (TMT) • Wechsler Adult Intelligence Scale (WAIS-IV) [select subtests - Arithmetic, Block Design, Digit Span, Matrix Reasoning, Similarities and Vocabulary] • Word Choice Test (WCT)
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Timepoint [3]
340347
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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.
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Secondary outcome [1]
445986
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Neuropsychiatric Symptoms and Psychopathology
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Assessment method [1]
445986
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The Neuropsychiatric Inventory (NPI) [Informant-Based Questionnaire]
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Timepoint [1]
445986
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Collected at 2-years, 5-years, 10-years, 20-years, 30-years and 40-years following retirement from the competition.
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Secondary outcome [2]
445981
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Athletic Identity
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Assessment method [2]
445981
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Athletic Identity Measurement Scale (AIMS) [Self-Report Questionnaire]
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Timepoint [2]
445981
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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.
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Secondary outcome [3]
445308
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Mood
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Assessment method [3]
445308
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Depression, Anxiety, & Stress Scale-21 Item (DASS21) [Self-Report Questionnaire]
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Timepoint [3]
445308
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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.
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Secondary outcome [4]
445984
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General Well Being
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Assessment method [4]
445984
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World Health Organization-5 Well-Being Index (WHO-5) [Self-Report Questionnaire]
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Timepoint [4]
445984
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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.
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Secondary outcome [5]
445975
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Pain
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Assessment method [5]
445975
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Self-report questionnaire. To be determined subject to permission approval by publisher, if not obtained prior to recruitment no pain measure will be administered initially.
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Timepoint [5]
445975
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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.
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Secondary outcome [6]
445985
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Health Behaviours
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Assessment method [6]
445985
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Health Behaviour Inventory-12 (HBI-12) [Self-Report Questionnaire]
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Timepoint [6]
445985
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Collected at 2-years, 5-years, 10-years, 20-years, 30-years and 40-years following retirement from the competition.
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Secondary outcome [7]
443776
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Concussion assessment
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Assessment method [7]
443776
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Sport Concussion Assessment Tool
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Timepoint [7]
443776
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Across playing career at BHI entry, pre-season baseline, post-injury, BHI exit.
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Secondary outcome [8]
445974
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Sleep
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Assessment method [8]
445974
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Self-report questionnaire. To be determined subject to permission approval by publisher, if not obtained prior to recruitment no sleep measure will be administered initially.
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Timepoint [8]
445974
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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.
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Secondary outcome [9]
446266
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Player movement
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Assessment method [9]
446266
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Catapult metrics
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Timepoint [9]
446266
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Data collected in all matches throughout career.
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Secondary outcome [10]
446265
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Player performance
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Assessment method [10]
446265
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Champion Data metrics e.g. Frequency of select skill execution, and match-related situational factors
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Timepoint [10]
446265
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Data collected in all matches throughout career.
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Secondary outcome [11]
445977
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Alcohol Use
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Assessment method [11]
445977
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Alcohol Use Disorder Identification Test (AUDIT) [Self Report Questionnaire]
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Timepoint [11]
445977
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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.
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Secondary outcome [12]
445307
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Repetitive Head Impact Exposure as measured by instrumented mouthguards.
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Assessment method [12]
445307
0
Wearable accelerometers (instrumented mouthguards) to measure both frequency and magnitude
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Timepoint [12]
445307
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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.
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Secondary outcome [13]
445979
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Quality of Life
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Assessment method [13]
445979
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World Health Organization Quality of Life BREF (WHOQOL-BREF) [Self-Report Questionnaire]
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Timepoint [13]
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.
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Secondary outcome [14]
445978
0
Substance Use
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Assessment method [14]
445978
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Drug Use Disorders Identification Test (DUDIT) [Self-Report Questionnaire]
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Timepoint [14]
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.
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Secondary outcome [15]
445976
0
Fatigue
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Assessment method [15]
445976
0
Self-report questionnaire. To be determined subject to permission approval by publisher, if not obtained prior to recruitment no pain measure will be administered initially.
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Timepoint [15]
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.
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Secondary outcome [16]
445980
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Childhood Trauma
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Assessment method [16]
445980
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Adverse Childhood Events Questionnaire (ACE-Q) [Self-Report Questionnaire]
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Timepoint [16]
445980
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Collected once during exit from the professional competition (exit).
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Secondary outcome [17]
445983
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Psychosocial Stressors
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Assessment method [17]
445983
0
Recent Life Change Questionnaire (RLCQ) [Self-Rated Questionnaire]
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Timepoint [17]
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.
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Secondary outcome [18]
445982
0
Subjective Cognitive Decline
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Assessment method [18]
445982
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Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) [Informant-Based Questionnaire]
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Timepoint [18]
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.
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Secondary outcome [19]
445987
0
Rating of Cognitive Function in Daily Activities
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Assessment method [19]
445987
0
Cognitive function as measured by "Informant Questionnaire on Cognitive decline in the Elderly"
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Timepoint [19]
445987
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Collected at 2-years, 5-years, 10-years, 20-years, 30-years and 40-years following retirement from the competition.
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
None
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/05/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
3000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
317646
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Commercial sector/Industry
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Name [1]
317646
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Australian Football League
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Address [1]
317646
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Country [1]
317646
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Australian Football League
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Address
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Country
Australia
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Secondary sponsor category [1]
320761
0
None
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Name [1]
320761
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Address [1]
320761
0
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Country [1]
320761
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316345
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Bellberry Human Research Ethics Committee B
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Ethics committee address [1]
316345
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https://bellberry.com.au/
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Ethics committee country [1]
316345
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Australia
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Date submitted for ethics approval [1]
316345
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13/11/2024
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Approval date [1]
316345
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07/03/2025
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Ethics approval number [1]
316345
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2024-10-1388
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Summary
Brief summary
The AFL Brain Health Initiative is a prospective, longitudinal clinical research program designed to monitor player brain health across the lifespan, and explore both protective contributors and risk factors for long-term brain health. The research design therefore aims to answer key questions regarding the prevention, diagnosis and management of sport-related concussion (SRC) and repetitive head impacts, and potentially enable identification of players at risk of poorer outcomes following retirement to inform education and intervention to reduce risks.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Catherine Willmott
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Address
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c/o Australian Football League, 140 Harbour Esplanade, Docklands VIC 3008
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Country
137598
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Australia
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Phone
137598
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+61 498666397
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Fax
137598
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Email
137598
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[email protected]
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Contact person for public queries
Name
137599
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Catherine Willmott
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Address
137599
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c/o Australian Football League, 140 Harbour Esplanade, Docklands VIC 3008
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Country
137599
0
Australia
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Phone
137599
0
+61 498666397
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Fax
137599
0
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Email
137599
0
[email protected]
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Contact person for scientific queries
Name
137600
0
Catherine Willmott
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Address
137600
0
c/o Australian Football League, 140 Harbour Esplanade, Docklands VIC 3008
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Country
137600
0
Australia
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Phone
137600
0
+61 498666397
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Fax
137600
0
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Email
137600
0
[email protected]
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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?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Ethical 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.
Download to PDF