Data

AUS-mTBI

Curtin University

Dataset 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).
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Source Study

Trial acronym

AUS-mTBI

Trial ID

ACTRN12623000671662

Purpose

Treatment

Phase

Not Applicable

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 ....
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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 ....
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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.

Study Protocol: Not Available
Data Dictionary: Not Available

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.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au