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Effect of health informatics approaches on concussion symptoms through an app-guided recovery program

AUS-mTBI: Effect of implementing novel health informatics approaches on concussion symptoms through an app-guided recovery program for people with mild TBI

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000671662
Acronym
AUS-mTBI
Enrollment
170
Registered
2023-06-21
Start date
2024-07-22
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Curtin University
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
5 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• Consent to data collection via online platform • Aged >= 5 years • Study enrolment within 14 days of concussion injury

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026