To Participate

This page is relevant for patients recruited at The Alfred hospital. Below is the information as stated in the Plain Language Statement for patients. To participate, you will need to be contacted by a researcher from our research team. Please contact us for any inquiries.

1. Introduction

You are invited to take part in this research project. This project aims to track cognitive recovery (that is, recovery of thinking skills and function of the brain), following a mild brain injury.

This Plain Language Statement contains detailed information about the research project.  Its purpose is to explain to you as openly and clearly as possible all the procedures involved in this project before you decide whether or not to take part in it.

Please read this Plain Language Statement carefully. Feel free to ask any questions about any information in the Statement. You may also wish to discuss the project with a relative or friend or your local health worker.

Participation in this research is voluntary. If you do not wish to take part, you do not have to. If you decide you want to take part in the research project, you will be asked to sign the consent section. By signing it you are telling us that you:

• Understand what you have read;
• Consent to take part in the research project;
• Consent to be involved in the procedures described;
• Consent to the use of your personal and health information as described.

You will be given a copy of this Participant Information and Consent Form to keep.

2. What is the purpose of this research project?

Mild brain injury is the most common form of traumatic brain injury. Despite how common mild brain injury is, we know little about the trajectory of cognitive recovery during the first three months of recovery. The overall aim of this project is to be able to track cognitive recovery in patients with mild brain injury using smartphones. Around 450 people will be taking part in this study. We will be recruiting patients with mild head injury, patients with non-head-related mild injury, and healthy controls.

The results of this research will be used by Evelyn Chen as part of her doctoral thesis.

3. What does participation in this research project involve?

Participation in this study will involve two components: (1) Completion of a short online survey, and (2) Download and use of a freely available smartphone application designed for this study.

(1) You will complete a short online questionnaire (approximately 15 minutes) at the initial assessment time point, and at 1, 2 and 3 months. These questionnaires help us to confirm what type of symptoms you might have experienced following brain injury, how your mood has been, and how you feel about your health. As we wish to examine the links between alcohol, smoking, drug use and cognition, patients will also complete questionnaires that ascertain how often and for how long you have been having alcohol, smoking cigarettes, and using illicit drugs. You will not be asked to detail specific instances of substance use. Only typical patterns of use will be asked. You will also complete a short online survey (2-3 minutes) on your mood twice a week.

(2) You will download and use a freely available smartphone application designed for this study. You will be able to access a video that will guide you on how to download and use the application. A researcher will also contact you to provide instructions over the phone. You will complete short cognitive tasks using your smartphone twice a week for a period of three months. Each session will run for approximately 15 minutes. There will be rest breaks approximately every minute during the cognitive tasks. The cognitive tasks will present images of letters displayed on your smartphone app, and you will be asked to make judgments about the images that you see. We will measure your reaction time/and or accuracy as you press buttons on your phone to indicate your responses. We will show you what the images look like, explain exactly what judgments you need to make, and give you some time to practise before we start.

Patients with mild head injury will be recruited at the time of presentation to hospital following the head injury. We will then contact you again about 1 week after your injury to ascertain if you would still like to participate in the study, and to provide instructions regarding assessment. Patients with non-head-related injury and healthy controls will complete assessment (both questionnaires and smartphone cognitive tasks) for the 3-month period. If you do not respond to the smartphone application and/or online questionnaires during the 3-month period, a researcher will contact you to find out what the reason may be and to provide assistance with using the application and/or questionnaires if required. If you decided to take part in the study, and have changed your mind since, you are free to withdraw from the project at any stage.

4. Possible Benefits

You will not receive direct clinical benefit from participation in the study. The cognitive tasks you perform on the app are not currently diagnostic or prognostic in terms of the severity or recovery of your injury. The aim of the research is to investigate if this type of remote cognitive monitoring is a valid and reliable indicator of recovery progress. However, prior to this validation, we cannot provide diagnostic information or information predicting extent of recovery to patients. An indirect benefit is the opportunity to help yourself and patients with mild head injury by contributing to understanding the trajectory of cognitive recovery following head injury, and how it can be better managed in the future. 

5. Possible Risks

You might experience minor mental fatigue, particularly in the early periods of recovery when you are completing the cognitive tasks. There are plenty of rest breaks in between cognitive tasks, and you are free to take as many breaks as required.

Participating in this research may present a minimal risk for patients who report use of illicit drugs in the unlikely event that such information were to be subpoenaed by a court of law. For the purposes of the research, patients are not asked to detail specific instances of illicit drug use. They are specifically instructed to provide only typical patterns of use with regard to frequency of drug use. All data (including information on drug use) is collated and reported as group averages and identifying information never accompanies its storage or presentation. Given these conditions, we believe that reporting such information presents a very minimal risk.

6. Do I have to take part in this research project?

Participation in any research project is entirely 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 a later stage. Alternatively, if we think that participation in the study is having any unforeseen negative consequences for you, you will be withdrawn from the study at that time. 

Your decision whether to take part or not to take part, or to take part and then withdraw, will not affect your routine treatment, your relationship with those treating you or your relationship with The Alfred hospital.

Before you make your decision, a member of the research team will be available so that you can ask any questions you have about the research project. You can ask for any information you want. Sign the Consent Form only after you have had a chance to ask your questions and have received satisfactory answers.

7. How will I be informed of the final results of this research project?

When the research project has been completed, a report of the results will be available to all patients. We will ask you when the study ends, if you would like to receive a copy of this report.

8. Confidentiality and Disclosure of Information

Any information obtained in connection with this project that can identify you will remain confidential and will only be used for the purpose of this research. It will only be disclosed with your permission, or in compliance with the law. We plan to discuss and publish the results of the study, however, only group data will be published. In any publication, information will be provided in such a way that you cannot be identified. When data sets are provided to consortia or journal repositories, any personal or medical information that may potentially identify you (e.g., date of birth, address, medical conditions) will be removed before the data set is provided. Your responses from the web-based questionnaires and data collected via the app will be uploaded to separate secure password protected locations, and will be stored securely for a maximum of seven years. These two datasets will only be linked by a unique anonymous ID code generated when you install the app. Data submitted using the app will be automatically date and time stamped, but no geo-location data will be collected from your phone. Although your email address will be stored with data collected via web-based questionnaires, only the project researchers will be able to access this information. All your data will be confidential to project researchers, except in the unlikely event it is required by law (e.g., subpoena).

If there was any adverse event that occurred to you during the study, we will discuss this and the appropriate treatment of the event with your treating clinician unless you choose not to allow us to do so.

9. Can I access research information kept about me?

In accordance with the Victorian Information Privacy Act and hospital policy, you have the right to access the information collected and stored by the researchers about you.

10. Is this research project approved?

The ethical aspects of this research project have been approved by the Human Research Ethics Committee of the Alfred Hospital.

This project will be carried out according to the National Statement on Ethical Conduct in Human Research (2007) produced by the National Health and Medical Research Council of Australia. This statement has been developed to protect the interests of people who agree to participate in human research studies.

11. New Information Arising During the Project

During the research project, new information about the risks and benefits of the project may become known to the researchers. If this occurs, you will be told about this new information. This may mean that you can no longer participate in this research. If this occurs, the person supervising the research will stop your participation. In all cases, you will be offered all available care to suit your needs and medical condition if applicable.