CLICK HERE TO PARTICIPATE NOW
ABOUT THE STUDY
The purpose of the Genetics of Pharmacoresistant Epilepsy (GenPhEp) Study is to improve our understanding of why a person may fail to become (and stay) seizure free with initial trials of antiseizure medications.
The GenPhEp study aims to identify the genetic basis of why medications work for some people but not others, and why some medications cause side effects and others do not.
To do this, researchers are seeking adults who have a diagnosis of Epilepsy or recurrent seizures to participate in our study. We are looking for participants with any type of Epilepsy, including from a brain tumour, injury, or whether the diagnosis is related to another condition, to help us find out how to predict the right (and wrong) medications for a person with epilepsy from the beginning.
WHO IS RUNNING THE SURVEY?
The GenPhEp Study is a collaborative project conducted by researchers from QIMR Berghofer Medical Research Institute, a not-for-profit research institute located in Brisbane, the Queensland University of Technology, and the University of Melbourne.
This research project has been approved by the Human Research Ethics Committee of the QIMR Berghofer Medical Research Institute (QIMRB-HREC).
WHAT DIFFERENCE CAN I MAKE BY PARTICIPATING?
Participating in this study can make important contributions to improving outcomes for individuals who experience Epilepsy and their families.
The benefits of the research will include:
1) Insight into epilepsy biology and anti-epileptic drug (AED) mechanisms of action;
2) Development of patient profiles that predict the right (and wrong) AED to treat a person with epilepsy; and
3) Discovery of novel targets to develop new AEDs for those people whose seizures are not adequately controlled by current AEDs.
WHAT DOES THE SURVEY INVOLVE?
If you choose to participate, we will ask you to fill in an online survey about your experiences with Epilepsy, including symptoms, seizures, medications, and emotional impacts. This is the core survey.
The survey also has additional modules that ask you about your experiences with other conditions that are known to impact individuals with epilepsy, like mood, sleep, memory, and headaches. These modules are optional.
We will also ask permission to access your Medicare Benefits Schedule (MBS) and Pharmaceutical Benefits Scheme (PBS) claims information through Services Australia. Providing MBS and PBS access is optional. You can still participate if you choose not to provide access.
We may also ask you to supply us with a sample of saliva, which we will use to extract DNA to look for genetic factors that influence Epilepsy and Anti-Epileptic medication response.
We are able to reimburse participants with a $30 gift card to show our appreciation of the time and effort given in completing the survey and donating a saliva sample.
HOW LONG DOES IT TAKE?
Registering your participation in the study can require as little as 5 minutes of your time.
Completing the core survey can take 15-30 minutes to complete, but it can take longer, while the additional optional modules might take up to an extra 20-30 minutes.
We may contact you after the core survey is completed to discuss if you would like to donate a saliva sample. If you agree to give a saliva sample, we will send you a sample collection kit through the post. Saliva samples can be collected in the privacy of your own home at a time that suits you. Providing a sample is easy and takes about 5-10 minutes. The saliva sample is sent back to us through the post using a pre-paid envelope.
I AM READY TO PARTICIPATE – WHAT NEXT?
- Click the blue ‘CLICK HERE TO PARTICIPATE NOW’ button at the top of screen
- Enter your contact details
- Read the study information sheet
- Consent to the study
- Complete the online survey
- Donate a saliva sample in a provided collection kit and return it to our laboratory in Brisbane using a pre-paid package
CONTACT US
You may find that the answers to your questions are listed in our Frequently Asked Questions Section below.
If you require any further general queries about the GenPhEp Study, please see our contact details below:
Email: epilepsy@qimrberghofer.edu.au
Call: 1800 257 179
Write to: Locked Bag 2000, Royal Brisbane Hospital, Herston, QLD, 4029, AUSTRALIA
FREQUENTLY ASKED QUESTIONS
WHO CAN PARTICIPATE?
Researchers are seeking adults who live in Australia who have a diagnosis of epilepsy, or recurrent seizures, to participate in our study. We are looking for participants with any type of Epilepsy, including from a brain tumour, injury, or whether the diagnosis is related to another condition have taken anti-epileptic medications.
Yes, we are interested in adults who have ever had a diagnosis of epilepsy, or recurrent seizures, in their lifetime.
Yes, if you have been diagnosed with Epilepsy and only had one seizure, you are eligible for the study.
Yes, we are interested in your experiences with seizures even if you have not received a diagnosis of epilepsy.
Yes, we would like to hear from people about their experiences when their medication is working as well as any times when their medication isn’t working, so we can look at the full picture.
Yes, even though this is a genetics study, you don’t need to have a family member with epilepsy or seizures to participate in this study.
No. We thank you for your interest and consideration in our research study. The medications used in epilepsy treatment may sometimes be used to treat many other conditions such as migraine, nerve pain, post-operative pain relief, restless legs syndrome, bipolar disorder, dystonia, Parkinson’s disease, Crohns disease, PTSD, and Mood disorder. Unfortunately these medical conditions are not within the scope of our research.
To show our appreciation for the time and effort given by participants in the GenPhEp Study, each participant will receive an e-gift card to the value of $30 at the end of their participation in the study.
There is no direct clinical benefit to participants. This is not a treatment-based study or clinical trial.
WHAT IS THE PROCESS OF PARTICIPATING?
| · Reading and understanding the study information sheet; |
| · Providing consent for participating in the study; |
| · Providing consent for researchers to access your MBS and PBS records [optional]; |
| · Providing contact information; |
| · Completing the online survey; and if eligible |
| · Donating a saliva sample |
After completing the core survey, you may be asked to donate a saliva sample.
Researchers will send a saliva collection kit together with a pre-paid return envelope to selected participants.
We will extract DNA from the saliva to allow us to investigate genetic factors that influence anti-epileptic medications and their tolerability, and ultimately develop diagnostics that can tailor the best treatment for epilepsy patients.
CONFIDENTIALITY AND GENETIC DATA STORAGE
Study participation is strictly confidential. All patient information provided will be maintained in accordance with the Commonwealth Privacy Act (1988) and National Health and Medical Research Council (NHMRC) Guidelines.
Your personal details, survey data and genetic information will all be stored in separate, firewalled password protected databases, and the only link between your personal details and your other data is your participant identification number.
The databases and samples are stored separately – the data collection team can only access your personal and survey information, analysts can only access your survey information and genetic data, and laboratory staff can only access your biological sample and DNA. This separation protects the confidentiality of participants.
When results are published, no individual results are included.
Participant DNA will be stored at QIMR Berghofer Medical Research Institute.
This research is not designed to provide any clinical results to participants. The study does not undertake individual analysis of each sample provided, but rather analyses all samples together.
If you have a personal interest in obtaining a genetic test, we suggest you consider contacting a genetic testing entity that can provide such testing.
We want to provide as much feedback as possible to participants about the study.
In the consent form, we will ask you if you would like to receive study updates. If you agree, we will send updates via email during the study.
A copy of the GenPhEp Participant Information Sheet and Consent Form can be found here.
In this study, we are not conducting clinical genetic testing. We are also not providing participants any personal or family information from the research. Because of this, under the current Australian guidelines you do not need to disclose to Insurers that you participated in this study. For further information, refer to this summary article discussing insurance and genetic research, as well as Section 10.3 of the Financial Services Council policy on genetic testing and research (fsc.org.au).
PROVIDING A SALIVA SAMPLE
Please wait half an hour after smoking, drinking, eating, chewing gum, or brushing your teeth before you provide your saliva sample.
If you are having trouble producing a sample, please visualise squeezing a half-lemon.
Please note that any volume is useful, even with bubbles.
If you are still unable to produce a sample, take a teaspoon of water, vigorously swish it around in your mouth and add that to the tube.
If you find the saliva collection kit is not suitable for you to use, please let us know as there are other sample collection options available that we can provide. Please call or email us using the contact details below if this is an issue.
Even if your saliva sample is discoloured in the tube (e.g., lipstick, food scraps or blood), there is still plenty of your DNA in the tube for us to extract and use. Please return it to us and if we need you to provide another sample we will be in contact.
Please find instructions on how to provide a saliva sample into the tube here
Alternatively, please watch the instructional video here: