The purpose of the AMALFI study is to see whether wearing a new home monitor called a Zio Patch, which can give a continuous heart trace reading for 2 weeks, will increase the number of people we can detect with atrial fibrillation. Diagnosing atrial fibrillation is normally done using an electrocardiogram (ECG) which catches the heart rate at a single point in time. However, as atrial fibrillation may only be happening some of the time this test might not always detect atrial fibrillation if by chance the heart is beating regularly when the ECG is done. The hope is that using the Zio Patch would allow more people to be put on the right treatment at an earlier stage and so bring down their risk of having a stroke.
The AMALFI study has been designed and is run by researchers at the University of Oxford’s Clinical Trial Service Unit and the Division of Cardiovascular Medicine, which are world-leading centres for this type of work. The study is led by Professor Louise Bowman and Professor Barbara Casadei and involves local cardiology and General Practice specialists as well as partnership work with many other local doctors, nurses and healthcare professionals.
The study has been approved by an independent Research Ethics Committee, which includes medical professionals and members of the general public. The Ethics Committee has reviewed all the study documentation as well as checking that the question the study is hoping to answer is important enough to warrant the research being undertaken.
AMALFI has been designed by the University of Oxford, who will run the study independently of any funders. The funding itself comes through the NHS funded Biomedical Research Centre & National Institute for Health Research with additional support from iRhythm, who are donating the Zio Patches free of charge.
No. Participation in the study is entirely voluntary. Choosing not to take part will not affect your future medical care or your statutory rights in any way. However, if you decide to help, many people around the UK may benefit from this research in years to come.
If you do choose to take part in the AMALFI study you will be free to withdraw at any stage, if you decide you no longer wish to continue. Just contact the study team by telephone, email or post, let us know you have changed your mind and we will remove your details from our contact list. You do not have to tell us the reason for decision if you do not wish to do so.
If you choose to participate in the AMALFI study you will be assigned to one of two study groups – one group who will wear the patch and the other will not.
The first group will be sent a Zio Patch monitor by post. If you are in this group you will then need to stick the Zio Patch on to your chest over your heart. Instructions will come with the patch explaining how to apply it - it is quick and easy to do. If required, a video is also available here showing what the patch looks like and how it can be put on. After 2 weeks, the patch should be removed and returned using the packaging provided. When the results have been analysed, a report will be sent to your own GP. You can either contact them for the results or they may ask you to come in for an appointment to discuss the findings.
Half of the people who agree to take part in the study will not have to wear the patch. We understand some people may be disappointed having volunteered to take part if they do not receive the Zio Patch. However, the only way we can know if this approach to screening is worthwhile is by having an even mix of people wearing and not wearing the patch. The information you are providing will be just as important to the study and the wider community as those who do wear the patch.
If you would like to take part in the AMALFI study, the first step is to complete the consent form and questionnaire that provides us with some background information on your health. You will find these included in the pack. These need to be returned in the freepost envelope included.
If you choose to join the study, we will contact you to let you know which group you have been assigned to.
If you have any questions about the process at any time or need help with any of the information you can contact the study team.
The AMALFI study has been designed to see if using the Zio Patch, will increase the number of people detected early with atrial fibrillation and therefore to bring down their risk of having a stroke. To do this we hope to recruit around 2,500 people, half of whom will be asked to wear a patch and half of whom won’t need to. The reason for this approach is because we need to compare different treatments to find out which one is best for patients, so we divide participants into groups and give each group a different treatment. The groups are then compared to see if one treatment is better. In AMALFI, we will count how many people are diagnosed with atrial fibrillation over the next 5 years and analyse if there was any difference between those who had a patch and those who didn’t.
The only difference between the two groups in AMALFI is the patch, which will only be worn in the early stages of the trial. After this, everyone’s medical care in both groups will be as normal. We do ask that you give us permission to access your medical records (from your GP surgery and NHS Digital) so we can see what happens to you over the next few years. We will ask your GP for information 3 times in the next 5 years. We will also request information from NHS Digital both during this time and for up to a further 20 years. To do this, identifiable data (NHS number and date-of-birth) will be supplied by the AMALFI team to NHS Digital, and used to trace and link to Hospital Episode Statistics and Office of National Statistics mortality data for each person taking part. This is so that we can see if there are longer-term benefits of screening for atrial fibrillation. The end of the trial will be the date of the final data download.
We would like to know if you move address or change GP so we can continue to be in contact with you - if you have an email address this would be a very good way for us to stay in touch. However, if you change your mind and would like not to be contacted again, just let us know using the contact details here.
When the main analysis (taken from 2.5 and 5 years) has been completed, we will inform you and your GP of the results. We plan to publish the results of the study in professional medical journals and also to present them to international healthcare audiences. No personally identifiable information will be published or presented at any time. If the study shows this approach to screening appears to be successful and cost-effective we will consider how to implement screening on a larger scale across the United Kingdom including the feasibility of a national screening programme.
Sometimes during long term studies new information comes to light that might affect the current treatment you are receiving. If this does happen we will tell you and your GP and let you know how it might impact on your involvement in the study.
You retain all your usual rights as an NHS patient.
The University of Oxford, as Sponsor, has appropriate insurance in place in the unlikely event that you suffer any harm as a direct consequence of your participation in this study.
NHS indemnity operates in respect of any clinical treatment provided by your GP as a result of taking part in this study.
If you do have any concern about taking part or if you wish to complain about any aspect of the way in which you have been approached or treated during the course of this study, you should contact the AMALFI research team, by calling Freephone 0808 164 5080 or by email using email@example.com. Alternatively you may contact the University of Oxford Clinical Trials and Research Governance (CTRG) office on 01865 572224, or the head of CTRG, email firstname.lastname@example.org.
Yes, protecting your personal information is very important to us. Personal information from the patch will only be shared with your GP so that we can ensure you receive the best possible healthcare as a result of the information we collect. We will also need to access your medical data from GP and NHS Digital. All information will be held securely in a database by the study team on computer servers managed by the University of Oxford and used only for the medical research purposes outlined in this study. We plan to keep the data we collected about you for least 25 years after the end of the study, but this will not be identifiable. By signing the consent form to take part you are giving our team permission to use your data in this way. For more information see the Data Usage tab. If at any stage you are concerned about how your data has been used or want to raise a complaint about data handling, you can contact the Independent Information Commissioner’s Office, who will advise you on how to proceed.