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Trial registered on ANZCTR


Registration number
ACTRN12623000671662
Ethics application status
Approved
Date submitted
8/05/2023
Date registered
21/06/2023
Date last updated
8/09/2024
Date data sharing statement initially provided
21/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of health informatics approaches on concussion symptoms through an app-guided recovery program
Scientific title
AUS-mTBI: Effect of implementing novel health informatics approaches on concussion symptoms through an app-guided recovery program for people with mild TBI
Secondary ID [1] 308780 0
nil
Universal Trial Number (UTN)
U1111-1287-1666
Trial acronym
AUS-mTBI
Linked study record
The current study is a parent study of ACTRN12623000259640. The data from trial ACTRN12623000259640 will be analysed with the data from this current trial to inform the predicitve model of recovery for people with mild TBI.

Health condition
Health condition(s) or problem(s) studied:
Mild traumatic brain injury 328722 0
Concussion injury 328731 0
Condition category
Condition code
Neurological 325732 325732 0 0
Other neurological disorders
Injuries and Accidents 326845 326845 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 with persistent symptoms will be prompted to complete questionnaires to assess concussion symptoms and quality of life, as well as reporting if they have returned to their pre-injury levels of physical activity, sport, work and/or study. These same questions will be administered monthly from 3 months following injury for people who are still experiencing concussion-related symptoms until symptom resolution.

In Phase 1 of the study (approx. first 12 months of data collection), participants will be treated using the established care pathways in the HeadCheck app. The established care pathways are the tasks and activities that participants are instructed to do within the app based on their symptom severity. An example of the tasks and activities that form part of the established care pathways within the app are 'See a GP/health professional if you feel any of your symptoms are getting worse or you see any of these symptoms: 1. Change in behavious, 2. Vomitnig, 3. Worsening headache, 4. Double vision, 5. Excessive drowsiness', 'Do 1-2 hours of work/study/school at home', 'Do gentle physical activitiy' or 'Read about what to do following a head knock' . Phase 1 data will then be used to inform a revision of the care pathways that will be built into the HeadCheck app and administered to participants in Phase 2 in year 2 of the study. The revised care pathways will be informed by the machine learning analysis of which factors predict symptom resolution, in conjunction with consensus from the AUS-mTBI Steering Committee. An example of a change in the pathway may be for someone who has distinct grouping of vestibular symptoms as a result of their concussion, they may be advised to seek timely input from a vestibular physiotherapist, as well as general advice from their GP. In app analytics will be used to monitor adherence to the activities suggested to participants through the app intervention.

The AUS-mTBI Steering Committee consists of: expert researchers in traumatic brain injury, neuroscientists, data scientists, neuropsychologist, sports physicians, people with lived experience of concussion, people from Aboriginal and Torres Strait Islander background, Emergency Physicians, Occupational Therapists, registry and data linkage experts.
Intervention code [1] 325233 0
Treatment: Devices
Comparator / control treatment
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.
Control group
Active

Outcomes
Primary outcome [1] 333581 0
Concussion symptoms as scored on the Rivermead Post-concussion Questionnaire for adults and the Post Concussion Symptom Inventory for children.
Timepoint [1] 333581 0
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.
Secondary outcome [1] 417640 0
Quality of life meausred by the Quality of Life after Brain Injury - Overall Score (QOLIBRI-OS) questionnaire.
Timepoint [1] 417640 0
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.

Eligibility
Key inclusion criteria
• Consent to data collection via online platform
• Aged >= 5 years
• Study enrolment within 14 days of concussion injury
Minimum age
5 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
n/a
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
All participants recruited in the first year of the study will be enrolled into the 'control group', using the established treatment pathways within the Headcheck app. Participants in the second year of the study will form the 'treatment group', with treatment pathways revised based on the findings of the first year of the study regarding predictors of persistent post concussion symptoms (PPCS). The time to symptom resolution will be compared between the treatment group and control group at the conclusion of the study to evaluate the revised treatment pathways trialled in year 2 by the treatment group.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
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).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2024
Actual
22/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10000
Accrual to date
53
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 312998 0
University
Name [1] 312998 0
Curtin University
Country [1] 312998 0
Australia
Funding source category [2] 313802 0
Charities/Societies/Foundations
Name [2] 313802 0
Perron Institute for Neurological Research and Translation
Country [2] 313802 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
The Curtin Health Innovation and Research Institute (CHIRI)
Building 305 Curtin University
Kent St, Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 315633 0
None
Name [1] 315633 0
Address [1] 315633 0
Country [1] 315633 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312261 0
Alfred Hospital Human Research Ethics Committee
Ethics committee address [1] 312261 0
55 Commercial Rd
Prahran 3004 VIC
Ethics committee country [1] 312261 0
Australia
Date submitted for ethics approval [1] 312261 0
03/05/2023
Approval date [1] 312261 0
07/07/2023
Ethics approval number [1] 312261 0

Summary
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 recommendations provided through the app. To evaluate the efficacy of the revised care pathway, the time to symptom resolution from the original HeadCheck recovery pathways will be compared to the revised care recommendations in the second phase of the project. Ongoing data collection will form the AUS-mTBI Registry that will enable additional research projects to be undertaken using the collected data to inform clinical decision making, patient care and optimal healthcare for people with mTBI.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124026 0
Prof Melinda Fitzgerald
Address 124026 0
Curtin University
Level 3, Sarich Neuroscience Institute
8 Verdun st, Nedlands WA 6009
Country 124026 0
Australia
Phone 124026 0
+61 08 64570514
Fax 124026 0
Email 124026 0
[email protected]
Contact person for public queries
Name 124027 0
Jemma Keeves
Address 124027 0
Curtin University
Level 3, Sarich Neuroscience Institute
8 Verdun st, Nedlands WA 6009
Country 124027 0
Australia
Phone 124027 0
+61 0422869759
Fax 124027 0
Email 124027 0
[email protected]
Contact person for scientific queries
Name 124028 0
Jemma Keeves
Address 124028 0
Curtin University
Level 3, Sarich Neuroscience Institute
8 Verdun st, Nedlands WA 6009
Country 124028 0
Australia
Phone 124028 0
+61 0422869759
Fax 124028 0
Email 124028 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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 (start and end dates)?
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.
How or where can data be obtained?
Access subject to approvals by Principal Investigator, Melinda Fitzgerald ([email protected])


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.