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For Young People
We would like to invite you to take part in a research study. Research helps us to find out answers to questions.
This is some information about the research study. When you have read it, or listened to it being read to you, you can ask us as many questions as you like. You and your family can then decide whether or not you would like to take part.
Why is this study being done?
Some people can get wheezy or have a cough due to asthma. We want to use a new test that might be able to tell us if people are more likely to cough and wheeze. To do that we need to see if children with asthma can use the test, and if it gives us useful information.
Why have I been invited to take part?
You have been invited to take part because you have asthma, and are aged 6 years to 15 years
Do I have to take part?
No. You do not have to take part. It is up to you and your family to decide if you want to take part. Your doctor will not mind if you don’t want to take part.
What will happen if I take part?
If you decide to take part in this study, you will be asked to: Keep all your appointments with your doctor and Try to remember how many asthma attacks you have had
Will taking part help me?
On We can’t promise that the study will help you. However, the information collected from this study may help to improve the way in which young patients asthma might be helped in the future.
Will anything about the study upset me?
We don’t think so. Blowing into the machine can be a bit tricky but we will try to teach you to be gentle with it.
What if something goes wrong?
If you have any worries about this study please speak to your family, or doctor or nurse.
What if I don’t want to carry on with the research?
If at any time you don’t want to be part of the study any more, just tell your family, doctor or nurse. You don't have to give a reason and they will not be cross with you.
Will anyone else know I am doing this?
The only people who will know that you are taking part in this study will be the team of doctors, nurses and researchers looking after you, your parent or legal guardian and your family doctor.
What do I have to do now?
Talk to your family about taking part in this study, they will be able to help you to decide. You can also talk to the doctors and nurses who are looking after you.
Thank you
We would like to invite you to take part in a research study.
Before you decide if you want to join, it’s important that you understand why the research is being done and what it would involve for you. Please read this information sheet carefully, and talk to your parents, family, friends, doctor or nurse if you wish.If you choose not to take part, this will not affect the care you receive.
What is the purpose of this study?
This study aims to collect information on chemicals in the breath in children and young people with asthma. We don’t have any tests that are good at predicting if a person might have an asthma attack in the next few months. A company that we have started working with (called Applied Nanodetectors) have developed a machine that can measure chemicals in the breath of adults with asthma; we want to see if this works in children and teenagers.
Why have I been invited to take part?
You have been invited to take part because you have asthma and You are aged 12 years to 15 years 364 days, inclusive, and
Do I have to take part?
No. It is up to you and your family to decide whether to join the study. We will describe the study and go through this information sheet with you. If you and your family decide to join the study, your parents/guardians will need to sign a consent form to show that you want to take part and there is a place on the form for you to sign as well if you want to. You are free to stop taking part at any time during the study, without giving a reason. If you decide to stop, this will not affect the care you will receive.
What will happen to me if I take part?
If you decide to take part in this trial, you will be asked to: Keep all appointments with your doctor Try to record how many asthma attacks you have in the next few months
What will happen to the samples taken in this study?
The information collected by the breath device in the study will be written into a spreadsheet and stored safely in the hospital computer. During the study we will also collect information about you (e.g. your age, gender), your medical history including details of your medical condition and treatment. We will collect this information from your medical records from the time you enter the study for a period of up to approximately 6 months after you used the device.
Will any genetic tests be done?
No.
What will happen if I don’t want to carry on with the study?
You are free to leave the study at any time without giving a reason, and this will not affect the standard of care you receive. If you choose to withdraw from the study, we will delete the information on samples we collected up until you decided to withdraw.
What are the possible benefits of taking part?
There may be no direct benefit to you from taking part in this study. But it might make asthma care a bit better in the future.
What are the possible risks of taking part?
We don’t anticipate any risks from taking part in this study. We won’t change how we treat your asthma on the basis of the numbers we get from the device.
Will anyone else know I am doing this?
The only people who will know that you are taking part in this study will be the team of doctors, nurses and researchers looking after you, we won’t share the information with anyone else.
What if there is a problem or something goes wrong?
If you have any worries about this study please speak to your family or doctor or nurse.
What if relevant new information becomes available?
If we get new information concerning the study that is applicable to you, your study doctor will discuss this with you. If you decide to continue in the study your study doctor may ask you to sign an updated Informed Consent Form.
Who is organising and funding the study?
This study is a collaborative project involving Great Ormond Street Hospital and Applied Nanodetectors. This research is funded by the UK Research and Innovation. The study is being run by Great Ormond Street Hospital. Your doctor will not be paid for including you in this trial.
Who has reviewed the study?
Before any research is allowed to start, it has to be checked by a group of people called a Research Ethics Committee to protect the safety, rights, wellbeing, and dignity of participants.
Further information and contact details
If you have any questions or concerns about your disease or this research study, please discuss them with your study doctor.
Hospital Contact Details
Study Doctor: insert name Research Nurse: insert name Emergency (24 hours)
Please take as much time as you need to make a decision and then let your study doctor or research nurse know what you have decided.
Thank you for reading this information sheet
