AUS-mTBI
Curtin UniversityDataset description
Based on similar research in other countries, feasible outcomes can be generated from population sizes as low as 37 individuals, through to large longitudinal cohorts of more than 10,000. This project aims to recruit 5000 participants across Australia during each the first and second year of recruitment. With wide recruitment we aim to have a population-based capture of adults and children who have experienced a mTBI. Custom machine learning models and related algorithms (such as RandomForests, XGBoost, etc.) will be built to analyse this high-quality dataset to predict outcomes and identify better care pathways for people following mTBI. Model robustness and uncertainty will be tested using extensive sensitivity analyses (including probabilistic sensitivity analyses) and calibration to observed trends in outcome. Baseline characteristics will be compared between men and women using Chi-square tests for categorical variables and t-tests for continuous variables. The analyses will be repeated by age, mechanism of injury, outcome (PPCS or no PPCS), nature of injury (single event or sequelae), and symptoms at presentation. All eligible participants will be included in the analyses. Analysis of data not involving machine learning models will be performed using R, SPSS or Stata V17 statistical software (StataCorp LP, College Station, Tex).Date Information
Identifiers
Source Study
Purpose:
Phase:
Trial acronym
AUS-mTBI
Trial ID
ACTRN12623000671662
Funding
University, Curtin University
Scientific enquiries
Dr Jemma Keeves
Brief Summary
This prospective interventional study will collect data pertaining to demographics, pre-injury factors, injury circumstances and concussion symptomology via online platforms for consenting participants who meet the inclusion and exclusion criteria. These data elements will be correlated with recovery, particularly time to symptom resolution, using machine learning approaches. The output from the machine learning models in the first phase of this project, will be used to revise care recommendatio .... Read more
Key Inclusion Criteria
• Consent to data collection via online platform • Aged >= 5 years • Study enrolment within 14 days of concussion injury
Key Exclusion Criteria
• Post traumatic amnesia (PTA) duration > 24 hours, indicating a more severe head injury • Loss of consciousness (LOC) > 30 minutes, indicating a more severe head injury
Can healthy volunteers participate?
No
Population
Sample Size 10000
Min. age 5 Years
Max. age No limit
Sex Both males and females
Condition category Concussion injury , Mild traumatic brain injury
Condition code Injuries and Accidents , Neurological
Intervention
Intervention code Treatment: Devices
This project will leverage and expand the validated HeadCheck application (app) into an app and website to collect data elements predictive of outcome following mTBI across all States and Territories in Australia. Participants will be followed up through their preferred online platform (app or website) to complete a concussion symptom questionnaire on day 1, 3, 7 post injury. At 2 weeks following injury, and then fortnightly until 3 months post injury (or until symptom resolution), participants .... Read more
Comparison
Control group Active
Participants recruited in phase 1 of the study and treated using the existing HeadCheck care pathways will form the control group. The treatment will be a guided recovery program through the app based on an individuals concussion symptoms and activity tolerances. The treatment program (care pathways) will provide 2 weeks of suggested activities as the treatment.
Outcomes
Outcome: Concussion symptoms as scored on the Rivermead Post-concussion Questionnaire for adults and the Post Concussion Symptom Inventory for children.Timepoint: Day 1, 3, 7, post injury, At 2 weeks following injury, and then fortnightly until 3 months post injury. 3 months following injury and then monthly for people who are still experiencing concussion-related symptoms until 12 months post injury or until symptom resolution.
Will individual participant data (IPD) for this trial be available?
yes
What data in particular will be shared?
Aggregated data can be shared upon request 12 months after the conclusion of the study.
When will data be available?
Data will be available upon request 12 months after the conclusion of the study.
Available to whom?
Case-by-case basis at the discretion of the primary sponsor.
Available for what types of analyses?
No types of analysis specified.