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INtegrative approaches for Optimizing Recognition, Management and Education of concussion at the community sports level

A randomised controlled trial, comparing the proportion of concussion diagnoses (primary outcome) in a telehealth program (intervention) to current practices (comparator), following sports-related head injuries

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000554662
Acronym
INFORMED-V
Enrollment
500
Registered
2023-05-24
Start date
2023-05-27
Completion date
2024-11-30
Last updated
2023-05-29

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

Conditions

None listed

Brief summary

Telehealth is an emerging way of assessing and managing patients, particularly after the COVID-19 pandemic. The role of telehealth in concussion diagnosis and management is not fully researched yet, therefore in this trial, we are in the first instance testing the effectiveness of the diagnostic ability of a telehealth program. This trial is running for 2 years and is available to all players in VAFA and will enrol at least 500 head-injured patients with suspected concussion. If deemed eligible, participants will be randomly allocated to either one of the following two treatment options: a) attending an online virtual video-based telehealth consultation with a neuropsychologist/ neurologist or physiotherapist which will take about 45 minutes OR b) provided with the most current and available concussion/head injury advice. There will be no restrictions on participants in terms of lifestyle or regular medications or behaviours. Regardless of which option participants are randomised to, they will be contacted on day 7 and day 14 post head injury regarding their clinical symptoms. If they attend the telehealth consultation, they will also be contacted again on day 30 to assess their satisfaction and feedback regarding the telehealth program. The primary outcome for this study is the diagnosis rate, whilst secondary outcomes include symptom improvements, RTP adherence, access to clinical specialists, and user satisfaction with the telehealth program.

Interventions

A multidisciplinary telehealth program with neuropsychologists, physiotherapists, emergency physicians, neurologists, critical care nurse, neuroscientists and sports physicians will be available to the participant. Among participants randomised to the telehealth arm, the consultation will be conducted primarily by a neuropsychologist or physiotherapist, rostered 4 half-days per week. The neuropsychologist will be co-located with a medical specialist (emergency physician or neurologist) for asses

A multidisciplinary telehealth program with neuropsychologists, physiotherapists, emergency physicians, neurologists, critical care nurse, neuroscientists and sports physicians will be available to the participant. Among participants randomised to the telehealth arm, the consultation will be conducted primarily by a neuropsychologist or physiotherapist, rostered 4 half-days per week. The neuropsychologist will be co-located with a medical specialist (emergency physician or neurologist) for assessment of symptoms related to the head injury outside the scope of possible concussion . Follow-up consultations using telehealth will be scheduled at 7 days and 14 days and may also occur at greater frequency if recommended by the assessing team. Should the telehealth team feel the need for in-person assessment and management, including physiotherapy or occupational therapy for example, this will be facilitated. Additional nurse follow-up will occur at 30 days to assess satisfaction with the telehealth program. All other standard care processes will be continued as per normal clinical practice. The telehealth consultation will be delivered via online video call by the neuropsychologist. The duration of the consult will be 45minutes. If the neuropsychologist deems that further in-person care is required, they will, with the participant’s consent, refer the participant to ED or their GP, or in the case of persistent concussive symptoms after 14 days, refer them to the Monash Turner clinic (https://www.monash.edu/turner-institute/turner-clinics). On day 30, the nurse will follow up with a telephone call. The follow-up will be less than 10 minutes unless the situation warrants further investigation. There are no specific strategies for monitoring adherence, but the episodes of intervention will be recorded.

Sponsors

Monash University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Adult patients (age >=18 years); 2. Medicare eligibility 3. Head injury sustained during sports event (either matches or training) through VAFA; 4. Concussion suspected by either club trainer, medical professionals, or players themselves 5. GCS 13-15

Exclusion criteria

1. Adolescent (<18 years) 2. Moderate or severe Traumatic Brain Injury (TBI) 3. Intracranial haemorrhage 4. GCS<13

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026