Welcome.
You are being invited to take part in a research study. Before you decide whether or not to take part, it is important for you to understand why the research is being done and what it will involve. Please take time to read this information sheet carefully and discuss with others if you wish. It is up to you to decide whether or not to take part. If you decide to take part you are still free to change your mind at any time. If you decide that you do not want to take part, or to withdraw from the research at a later date, this decision will not affect the care you receive in any way.
If there is any part of this information sheet that you do not understand, or require further information about, please contact us and we will be happy to answer any questions you have. Our contact details are on the back page.
Your child has been invited to take part in a research study because they likely have asthma and/or have had breathing symptoms, with or without wheezing, during the last year. This research study aims to find out whether Digital Smart Inhaler technology can improve the quality of life of Children and Young people through better asthma control. If the study proves this technology is helpful, we will recommend that Digital Smart Inhalers be made available on the NHS. You can find out more about the technology being used in this study at www.hailie.com
No, taking part in this study is voluntary. It is entirely your choice; your decision will not impact on your child’s care. They will still be offered the full asthma review including breathing tests performed at their routine asthma review.
If you’ve provided consent to take part but change your mind, you can withdraw your consent at any time during the study by contacting a member of the study team on 0808 280 8048. Once you’ve withdrawn your consent, we will only use data collected during the study before the withdrawal.
All children with diagnosed asthma are invited for a routine yearly check-up by their GP in line with NHS policy. Some children are prescribed asthma medication and have asthma attacks but they do not have a formal diagnosis. For this study, children without a formal asthma diagnosis are also considered for a check-up.
When you bring your child for their asthma review appointment, please let the receptionist know you have arrived and also tell them whether you are interested in hearing about the digital smart inhaler study, so that we know in advance whether to discuss this part of the study with you. Please note, if you do not wish to take part in the digital smart inhaler study a Clinical Research Practitioner who does not usually work at your GP practice may still carry out your child’s asthma review on behalf of the practice.
If you and your child do not wish to take part in the study, you will only stay to complete the asthma review which takes around 15 minutes.
If you are interested, the Clinical Research Practitioner will explain the study to you and answer any questions you have. You do not have to take part if you do not want to and your child should still have their asthma review whether you join the study or not.
If you agree to take part, we will ask you to sign a consent form online using a secure e-consent portal that gives permission for our researchers to review your child’s health record and the information collected by the Digital Smart Inhaler. (This will help researchers understand whether the technology has helped you and your child to manage their asthma better). The e-consent portal is hosted by a company called Helicon Health Ltd who have been authorised to collect consent forms on behalf of the University of Leicester for the purposes of this research.
Helicon Health Ltd will need to collect the following personal information from you on the consent form:
We would also like to ask your permission to:
You can view the consent form before your appointment by vising our website at https://asthma.medicalstudy.co.uk but you will not be able to complete the form until the day of your appointment. Once you and your child have given permission to take part, the Clinical Research Practitioner will do the following:
(*pseudonymised means that we will replace information that identifies you and your childpersonally with a number).
Once you and your child have given permission to take part, the Clinical Research Practitioner willdo the following:
Please ensure you bring your smartphone with you to your appointment. If you do not have a smartphone, please tell the Clinical Research Practitioner.
The Digital Smart Inhaler app will collect and securely store online information from the sensor(s) for the researchers to view.
It will also be possible to install the Digital Smart Inhaler app on older children’s phones, if they wish (12 years and older) – you will be able to discuss and agree this with the Clinical Research Practitioner during your appointment.
The Clinical Research Practitioner will ensure everything is working properly before you go home. Joining the study will increase the review time by around 45 minutes, so you should expect the appointment to last up to 1 hour.
If you do not wish to take part in using the Digital Smart Inhaler technology, you can still participate in the research by giving your consent for researchers to access your child’s asthma medical record and use the information in their research. If you choose to do this, you will still need to sign a consent form to give your permission, but you will not need to do anything else. This will help researchers understand differences between children using the Digital Smart Inhaler technology and children who are not. They will know who your child is but they will not publish their name or anything else that could identify them in their findings.
For the next 6 months your child will use their inhalers as normal at home but keep the Digital Smart Inhaler sensor attached. The sensor will beep and the app will send you notifications at set times to remind your child to take their Preventer medication.
You will be asked to make sure your child is taking their preventer medication at home, not at school during the study, so that the sensor data is regularly uploading to the app on your phone. We will also provide a sensor for your child’s rescue mediation that is kept at home. If you usually leave a rescue medication with your child’s school this is fine, but we will not provide an additional sensor for this. If your child is away from home without you at any time and needs to take their preventer medication with them, don’t worry – the sensor will store data for long periods of time. The data will then automatically upload to the app once it comes back within range of your phone again. You do not need to keep the sensor close to your phone all the times.
The only other things you’ll need to do are:
We will contact you after 3 months to see how you are getting on with everything. You will be able to call us at any time if you have any problems, and we might call you if we identify any issues with the technology. If you lose or damage a Digital Smart Inhaler sensor during the study, please contact us and we will arrange for a replacement to be sent out to you by post. Our contact details are on the back page. Please keep this information sheet safe so that you can refer to it later.
In 6 months, at the end of the study, we will contact you to let you know the study has ended and invite you attend another asthma review appointment. This appointment is an optional part of the research study but a clinical review to check that the treatment and monitoring is working to improve your child’s asthma is also good clinical care. You will be advised that you can stop using the Digital Smart Inhaler sensor and that your child can continue taking their inhaler medication without the sensor, in the same way they did before the study. You may continue to use the monitoring unsupervised by the research team until the sensor battery runs out if you wish.
You will also be asked to complete an end of study survey which will be emailed to you. If you do not have an email address, a printed copy of the survey will be sent to you by post with a pre-paid envelop so that you can complete and return it. The survey will ask you some final questions about your experience of the study in general and the Digital Smart Inhaler asthma monitoring.
The Clinical Research Practitioner at your asthma review appointment will help you uninstall the Digital Smart Inhaler app from your smartphone if you wish or you can call us if you need assistance to do this. You do not need to return the Digital Smart Inhaler sensors to us but they should be recycled in an environmentally friendly way at your local recycling site.
(Please note: continuing to use the sensor after the end of the study is fine but no one from the research team will be looking at any data received, and the sensor will run out of battery and stop working after 12 months of use).
Additionally, we might ask you and your child if you would like to take part in a focus group or interview where you will have the opportunity to share what it was like to take part in the study and comment on the use of the Digital Smart Inhaler technology. By agreeing to take part you will help us to improve the care we provide to children with asthma throughout the UK. This is optional and not a requirement of taking part in the study. You may be asked to travel to a Leicester location where the focus group/interview will take place. We will ask your permission to make video or audio recordings of the session. Recordings will be stored securely at the University of Leicester and will be transcribed by either the research team or by an approved transcribing company that will have a confidentiality agreement in place. Recordings will be deleted as soon as they have been transcribed. You will be reimbursed for any travel expenses. More details will be provided at the end of the study, if you give permission for us to contact you about this.
The Digital Smart Inhaler technology is called Hailie® and it has been created by a company called Adherium (NZ) Ltd and is supplied to the study by Adherium Europe Limited.
Hailie® is already in use in the UK and other countries but it is not yet available to people in the UK from GPs with an NHS prescription. It is completely safe to use and has all the necessary CE registration marks. You can find out more information about Hailie® by going to their website www.hailie.com.
You may find using the Digital Smart Inhaler technology helps you and your child manage their asthma better while they are taking part in the study, but because we are testing this as part of the research, we cannot guarantee you will see any improvements. This means there may be no benefits for your child but what we learn may benefit other children and young people in the future.
There are no disadvantages with taking part except the small amount of time it will take you to open the app occasionally, attach the sensor to medication refills and complete the survey at the end of the study.
There is minimal risk associated with this kind of study but in the extremely unlikely event that something does go wrong and your child is harmed during the research and this is due to someone‘s negligence then you may have grounds for a legal action for compensation against the University of Leicester but you may have to pay your legal costs.
Should you wish to complain or have any concerns about the way you have been approached or treated in connection with the study, you should ask to speak to a member of the study team on 0808 280 8048 who will do their best to answer your questions. If you remain unhappy and wish to address your concerns or complaints on a formal basis, you should contact the University’s Research Governance Office [email protected].
While you and your child are taking part in the study, your contact details will be made available to the researchers so that they can contact you to arrange the details of your research study appointments. On the consent form, you can also choose to be informed about the results of the trial. If you consent for this to happen, we will store your contact details securely, separately from your research data, and we will only use them for the purposes you have chosen. Your contact details will be destroyed once they have been used for the purpose that you have agreed to. The study is taking place for nine months. Anonymised research data will be stored for 10 years after the study has finished.
Only with your permission, authorised and medically qualified researchers from the University of Leicester will have access to your child’s NHS health record as part of this study. They will also have access to the data collected by the Digital Smart Inhaler technology. They will know who your child is but they will not publish their name or anything else that could identify them in their findings.
This is a Small Business Research Initiative (SBRI) funded study and is being administered by Adherium Europe Ltd who have employed Helicon Health Limited to securely process the study consent forms and provide copies to you, your GP and researchers at the University of Leicester. Helicon Health Ltd will also support you with any technical issues during the study. Helicon Health Ltd will not have access to your child’s NHS health record. They will only have access to the personal details you provide on the consent form for yourself and your child, and the Hailie® Web Portal. Helicon Health Ltd will ensure all your personal information is kept safe and is not shared with anyone other than authorised study team members for the purpose of carrying out the research. They will also ensure your information is not used for commercial purposes and that all your personal data is safely destroyed 12 months after the study has finished.
Adherium Europe Ltd is providing the Hailie® Digital Smart Inhaler technology for the Study. Adherium will not have access to any personal information that could directly identify you or your child. They will be responsible for collecting and processing the data collected by the Hailie® Digital Smart Inhaler technology, but they will do this using a unique identification number, not your child’s name. Adherium Europe will safely destroy any data it holds 15 years after the study has finished.
Only Helicon Health Ltd and the researchers at the University of Leicester will be able to identify your child using the unique identification number
Only authorised and qualified medical professionals will have access to your child’s medical record as part of this study.
You should be aware that we have a professional and ethical duty to act on concerns for your and your child’s safety and welfare. If we identify welfare issues, such as deteriorating illness or concerns of abuse, we may need to report these to your GP, your hospital team, or social services. We will tell you if we do this’.
We will need to use information from you and your child’s medical records and data collected from the smart inhaler for this research project.
This information will include your name and contact details (postal address, telephone number and email address), your child’ name, DOB, medication and asthma health records.
People will use this information to do the research or to check your records to make sure that the research is being done properly.
People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead.
We will keep all information about you safe and secure.
Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study
You can find out more about how we the University of Leicester use your information:
The results will be presented to NHS decision makers, at scientific meetings and published in medical journals and asthma websites. A plain language summary will also be published on the study website asthma.medicalstudy.co.uk which families will be able to access. Your child will not be identifiable in any report or publication.
You will be asked to complete an Informed Consent Form via an e-consent portal at your initial asthma review appointment and to opt-in to a variety of research options by placing your initials within the Yes or No box. This will confirm you understand how your data will be processed, protected and reviewed for research purposes.
This research is being conducted by Dr Erol Gaillard at the University of Leicester. Dr Gaillard is an Associate Professor, Senior Lecturer in Child Health and Honorary Consultant in Paediatric Respiratory Medicine at the Leicester Institute for Lung Health. He is based at the National Institute for Health Research, Leicester Respiratory Biomedical Research Unit, University of Leicester, PO Box 65, Robert Kilpatrick Clinical Sciences Building, Leicester Royal Infirmary, Leicester, LE2 7LX.
The research is being funded by the UK Small Business Research Initiative SBRI Healthcare sbrihealthcare.co.uk. The SBRI are funding the research but will not be part of study conduct, data analysis and interpretation manuscript writing or dissemination of results.ses.
All research that involves NHS patients, information from NHS medical records or uses NHS premises must be approved by an NHS research ethics committee. This research was approved by the East Midlands – Nottingham 1 Research Ethics Committee. Approval means that the committee is satisfied that your rights will be respected and that you will be given sufficient information on which to make an informed decision.
Thank you very much for taking the time to read this information.
A member of the study team will be available at your child’s asthma review to answer any questions and to take consent if you agree to participate. We have included an information sheet designed to help younger children understand the study. You can read this with your child before deciding whether to take part.
Chief Investigator – Dr. Erol Gaillard (Associate Professor and Honorary Consultant Respiratory Paediatrician)
Telephone: +44 (0)116 2587763
Email: [email protected]
In partnership with:
