INFORMEDTBI
Clinical trials in the diagnosis and management of concussions
Frequently Asked Questions
Click on the icon to download the "Participant Information Sheet/Consent Form"
What is the purpose of this research?
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. After two years at the conclusion of the trial, the research findings will be emailed to all participants with the aggregate summary data findings.
What does participation in this research involve?
You will be participating in a randomised controlled research project. Sometimes we do not know which treatment is best for treating a condition. To find out we need to compare different treatments. We put people into groups and give each group a different treatment. The results are compared to see if one is better. To try to make sure the groups are the same, each participant is put into a group by chance (random).
You have a one in two chance of being allocated to the telehealth program. The program is meant to assess whether telehealth increases the number of diagnoses.
This research project has been designed to make sure the researchers interpret the results in a fair and appropriate way and avoids study doctors or participants jumping to conclusions.
There are no additional costs associated with participating in this research project, nor will you be paid. All tests and medical care required as part of the research project will be provided to you free of charge.
Given the study is conducted via telehealth, there are no costs expected to be incurred by the participant.
It is desirable that your local doctor be advised of your decision to participate in this research project. If you have a local doctor, we strongly recommend that you inform them of your participation in this research project.
How do I sign up?
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Check you eligible for the study:​​​​
a. Between the ages of 18-50
b. Sustained a suspected concussion within the last seven days
2. Visit the "study enrolment" tab on this website and fill out the "expression of interest forms"​
3. One of our research nurses will be in contact with you to fill out the initial screening documents
4. You will be randomised into the "standard care" group or the "telehealth" group
Standard Care
Telehealth
5. After you have been allocated into a group, our research nurses will organise a time to call you for your day 7 check and telehealth appointment (if applicable)
Do I have to take part in this research?
Participation in any research project is voluntary. If you do not wish to take part, you do not have to. If you decide to take part and later change your mind, you are free to withdraw from the project at any stage.
If you do decide to take part, you will be given a Participant Information and Consent Form to sign and you will be given a copy to keep.
What are the alternatives to participation?
You do not have to take part in this research project to receive treatment. Other options are available; these include sourcing available evidence regarding what to do with concussion and suspected concussion or see your GP.
Your research nurse will discuss these options with you before you decide whether or not to take part in this research project. You can also discuss the options with your local doctor.
Please note that this program cannot clear you of concussion. Players are required to follow existing guidelines, including the need to “obtain a written medical clearance from a Medical Practitioner (i.e. General Practitioner, Sports Doctor, Neurologist) to return to training and playing. The medical clearance must state that the player has been cleared from a concussion injury”
What are the possible benefits in participating?
We cannot guarantee or promise that you will receive any benefits from this research; however, possible benefits may include:
In the telehealth group, earlier, more accurate and more personalised diagnosis of concussion, as well as access to our online resources relating to concussion.
In the standard of care group, introduction to online resources relating to concussion.
What are the possible risks or disadvantages in participating?
If you become upset or distressed as a result of your participation in the research, the study doctor will be able to arrange for counselling or other appropriate support. Any counselling or support will be provided by qualified staff who are not members of the research project team. This counselling will be provided free of charge.
Can I have other treatments whilst participating in this study?
Whilst you are participating in this research project, you may not be able to take some or all of the medications or treatments you have been taking for your condition or for other reasons. It is important to tell your study doctor and the study staff about any treatments or medications you may be taking, including over-the-counter medications, vitamins or herbal remedies, acupuncture or other alternative treatments. You should also tell your study doctor about any changes to these during your participation in the research project. Your study doctor should also explain to you which treatments or medications need to be stopped for the time you are involved in the research project.
What I withdraw from this research project?
If you decide to withdraw from the project, please notify a member of the research team before you withdraw. This notice will allow that person or the research supervisor to discuss any health risks or special requirements linked to withdrawing.
If you do withdraw your consent during the research project, the study doctor and relevant study staff will not collect additional personal information from you and all exsiting data will be deleted.
What will happen to information about me?
By signing the consent form you consent to the study doctor and relevant research staff collecting and using personal information about you for the research project. Any information obtained in connection with this research project that can identify you will remain confidential.
If eligible, you will be randomised by the critical care nurse who is doing the phone triage and you will be assigned a study number. The Research Coordinator will compile a study enrolment log, which will link the study number to your name. Subsequent data will be identified by the study number. The video consultations will not be recorded to maximise your security and privacy. The enrolment log and study data will be kept separately. Your follow-up details will be collected including name, address and contact telephone numbers for the purpose of contacting you for subsequent reviews. The contact details will be forwarded to the coordinating centre. Study data will be entered into The Alfred Hospital Red-Cap database specifically designed for the study with restricted access via authenticated login using an email address and password combination. Furthermore, to further protect your privacy, your contact details (i.e.: name, phone number, email etc) will be kept electronically in a secured database in Red-Cap separately to your clinical information.
The study number will hold the clinical information data, and as such your symptoms cannot be directly related to your name. There will be no hard copies stored physically. The data will be retained indefinitely.
Your information will only be used for the purpose of this research project and it will only be disclosed with your permission, except as required by law.
Information about you will NOT be obtained from your health records held at this and other health services for the purpose of this research.
It is anticipated that the results of this research project will be published and/or presented in a variety of forums. In any publication and/or presentation, information will be provided in such a way that you cannot be identified, except with your permission. Only aggregate data, that cannot be traced back to the individual participant will be presented.
Information about your participation in this research project will NOT be recorded in your health records. It is however encouraged that you discuss the outcomes of your involvement in this trial with your club trainers, medical personnel and your GP.
In accordance with relevant Australian and Victorian privacy and other relevant laws, you have the right to request access to your information collected and stored by the research team. You also have the right to request that any information with which you disagree be corrected. Please contact the study team member named at the end of this document if you would like to access your information.
Any information obtained for the purpose of this research project described in this Section 15 that can identify you will be treated as confidential and securely stored. It will be disclosed only with your permission, or as required by law.