For patients and the public
Eligibility
GP practices that are taking part in the study will identify eligible patients by using the FIND-AF tool on their practice medical records. When the tool identifies a patient as being at risk of atrial fibrillation, that patient will be deemed eligible and contacted by the practice.
No travel is required as part of the study, all taking part will be managed by post / phone from the comfort of your own home.
You do not need a mobile phone, WiFi or internet access to take part or use either of the ECG recorder devices.
People who are already diagnosed with atrial fibrillation, already take a long-term anticoagulant medicine or are in a nursing home, residential home or receiving palliative care will not be considered eligible for the study as it is considered that screening for atrial fibrillation will not benefit them.
Having a pacemaker should not cause any restrictions when recording your ECGs. The pacemaker does not interfere with recordings and if there any concerns, you can always contact the research team.
Find out more about Atrial Fibrillation
How to take part
Your GP practice will send you an invitation pack including information about the trial, a consent form and a freepost envelope, in the post. Please read this carefully before making a decision whether to take part or not, you can contact the study team to ask any questions to help you make up your mind.
If you are happy to take part, you will need to sign the consent form and return using the enclosed freepost envelope. If you received the invitation pack but have lost any part that you need please contact us and we can send you out a new one.
If you are going away (even if for a few weeks) you can still take part. Just let us know and we will post the ECG device to you when you return.
Participation in the study is entirely voluntary, patients that are contacted do not have to take part. 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 FIND-AF study you will be free to withdraw at any stage, if you decide you no longer wish to continue. Just contact the study team and let us know you have changed your mind. You do not have to tell us the reason for decision if you do not wish to do so.
The Study Process
If you are invited and choose to take part in the study, a member of the study team will contact you to make arrangements to send an ECG recording device and then a Zenicor-ECG device to your home. Both devices will be accompanied by full instructions on how to use them. Further instructions on how to use either device are available below.
You will receive a handheld Zenicor-ECG device. Both of these devices have been tested and validated for detecting atrial fibrillation and have been approved for use in the UK.
We ask that you use your ECG recorder for 2 weeks. After the 2 weeks please return the ECG recorder in the packaging provided.
Results
You and your GP practice will both receive the results of your ECG monitoring within 12 weeks of the date that the device is returned.
An easy to read summary of the results of the overall study will be published on the study website. If you are a participant and would like a copy sending to you directly, please contact the study team.
We also plan to publish the results of the study in professional medical journals and also to present them to international healthcare audiences. If the study shows this approach to AF detection appears to be successful, we will consider how to implement it on a larger scale across the United Kingdom including the feasibility of a national screening programme.
No personally identifiable information will be published or presented at any time.
The treatment
If you are found to have AF, you will be invited to attend a consultation with a healthcare professional at your GP practice. This is not part of the FIND-AF study.
The healthcare professional may discuss taking standard blood thinning (anticoagulant) medication. Anticoagulant medication significantly reduces the risk of the AF causing a stroke and heart attack. This medication is not part of the research. If you agree it is a good idea, you will be prescribed this medication (usually in the form of oral tablets). It is likely that you will need to take this for the rest of your life. As with all medication there are risks associated with taking anticoagulant medication. The most serious is an increased risk of bleeding. The healthcare professional will assess your risk of stroke and your risk of major bleeding and help you make a decision to treat based on the balance of these risks. They may also organise further investigations or other treatments.
During the COVID-19 pandemic your GP practice may conduct consultations by phone or video link. They will follow all current local guidelines.
The ECG recorder can also identify other heartbeat changes. We will tell you and your and your GP if there are any unusual changes.
Confidentiality
Protecting your personal information is very important to us. Your data will be kept confidential.
If you consent, we will store data we have collected about you on a database held on an NHS server at Leeds Teaching Hospitals NHS Trust. Only members of the study team will have access to this database.
Your GP will not pass your contact information or information used to assess your eligibility to the study team without your consent.
If you consent, we will share information about you that we have collected during the study with your GP so that we can ensure you receive the best possible healthcare as a result of the information we collect.
We will keep your data for 10 years after the end of the study. Individuals from University of Leeds and regulatory organisations may look at your medical and research records to check the accuracy of the research study. If you sign the consent form you are giving the study team permission to use your data in this way,
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 (0303 123 1113 or www.ico.org.uk) who will advise you on how to proceed.
Find out more about your data privacy
Other concerns
You retain all your usual rights as an NHS patient. Any treatment your GP provides after this study is covered by NHS indemnity.
The University of Leeds has insurance that covers if you suffer any harm as a direct consequence of your participation in this study.
Please contact the study team if you have any concerns or wish to complain about any aspect of the study.
If you remain unhappy and wish to complain formally, you can do this through the Patient advice and liaison services (PALS). To find your nearest PALS service please visit www.nhs.uk/nhs-services/hospitals/what-is-pals-patient-advice-and-liaison-service
What happens next
We would also like to investigate whether people identified as higher risk of atrial fibrillation by FIND-AF are also more likely also have other health problems.
Therefore we also offer you an optional research appointment with a clinical member of the study team. If you consent, they will discuss any symptoms you may have, listen to your heart and lungs, take an ECG, urine, blood sample and do an ultrasound scan of your heart. If there are any serious findings we will tell your GP and this may lead to further investigations or changes in your treatment.
This appointment is not a replacement for any of your routine medical appointments. Should you have any symptoms you are concerned about, you should ask for a review with your GP.
Using the Zenicor-ECG device
When to use it
The small handheld device is easy to use. It is portable and can be used while out and about if needed, but you will need to sit somewhere quiet. It is best to be relaxed and sitting down. If you have just exercised vigorously it is advisable to take a few minutes to relax before you start to record an ECG.
We ask that you record an ECG 2 times per day at any time of day that is convenient for you, for 2 weeks, and also if you feel that your heart is beating irregularly.
Recording one at breakfast plus another before going to bed is one way to help you remember to record them. Alternatively, some people set reminders on their mobile phone. If you wish, you can also use the tally chart given to you with your ECG device. This will help you keep track of the number of ECGs recorded each day. You do not have to use the tally chart if you do not want to, it is up to you. If you use it you do not have to return it with your device.
If you do forget to record an ECG, do not worry, just carry on as usual and try to use one of the useful reminders above.
It is very important that if at any point you have symptoms you are concerned about, that you seek medical help in the same way that you usually would, for example by calling 111 or 999, or visiting your GP. Do not wait for the results of your ECG monitoring. If you are feeling well enough to record ECGs please continue to do so. The ECG data will not be affected by an illness you may have or symptoms you may be experiencing. If you are feeling unwell and not able to record ECGs, please don’t worry. Just start recording again as soon as you feel able to do so.
The study team will call you during the 2 weeks to see how you are getting on.
How to use it
You take an ECG recording by placing your thumbs or index fingers on the silver metal bits (electrodes) on either side of the device. No wires or sticky pads are required.
You have to hold your fingers on the electrodes for 30 seconds and an audio signal will play when the recording is complete. You then press the send button on the device so that the ECG is sent to a secure portal. The ECG is sent over a 2G mobile network so you do not need an internet connection to use the device.
Sometimes the device does not immediately register that you have placed your thumbs or fingers on the contact points, and does not start recording. This is usually because the skin on the hands is dry. You can achieve better connection with the electrodes (contact points) by washing and drying your hands prior to recording, to dampen the skin. However do not use hand cream or lotion before recording, as this makes the connection between the electrodes and the skin worse.
There is a patient video which shows the device in use and highlights good recording technique - watch the video
Read the printed user instructions supplied with the ECG device
Recording clear ECG traces helps to ensure you get a definitive screening result. Following the key points below will help to record clear traces. Wherever possible:
- keep both thumbs or fingers in light contact with the electrodes for the entire measurement, do not press
- avoid using hand cream before recording
- do not move your thumbs or fingers whilst recording
- do not talk, cough or laugh whilst recording
- remain relaxed and still whilst recording – preferably sitting down with your hands resting in your lap or on a table
- ensure your skin is not too dry – you can achieve a better connection with the electrodes by making sure the skin is damp (not wet). Washing and drying your hands as usual prior to recording is a good way to ensure this. Do not use hand cream or lotion.
- be relaxed and sitting down when recording the ECG. If you have just exercised vigorously it is advisable to take a few minutes to relax before you start to record an ECG.
It is okay to repeat an ECG if you mistakenly move or cough (for example) during a recording.
If you have any questions about how to use the Zenicor ECG device please contact the study team. We are happy to answer any questions and talk you through the ECG recording process.
Mobile signal and batteries
If you press the send button and get a message saying the ECG has not been sent, this usually happens when there is a poor mobile signal (as the device uses an inbuilt SIM card to transmit the ECGs). There is no need to worry. Continue to record ECGs as normal. The ECGs will be stored safely on the device until they are sent. If it keeps failing to send, please do not continue trying to send the ECGs after each recording. This will help preserve the battery life. When you are in a location with a stronger mobile signal you can try and press the send button again. If the device is able to pick up a mobile signal all stored ECGs will be transmitted. The strength of mobile signal appears in the top right hand corner of the screen whilst the device is transmitting.
The batteries should be more than sufficient to last for the 2 weeks of ECG monitoring. However if you are in a location with a poor mobile signal and the device is slow / unable to transmit ECGs, this will drain the batteries more quickly. In this situation continue to record ECGs as normal. When the device is switched on by pressing the Start button, the battery levels are indicated in the top right hand corner of the screen. If this indicates battery levels of 1 or 2 bars, the batteries will need replacing. Please contact the study team who will arrange to send you replacement batteries and talk you through replacing them.
Returning your device
At the end of the 2 week ECG monitoring period you will need to return the device using the Freepost return padded envelope provided. Please check the device before returning it, and (if applicable) try to send any ‘unsent’ ECG recordings.
Each device has a unique serial number and is registered to a particular participant. When the device is returned, any unsent ECGs are uploaded to the system. The device is then disconnected from that participant before cleaning and preparing it for allocation to another participant. There is no need to include your name or other details when returning the device.
Please return:
- ECG device
- Zenicor User Instructions
- Black device case
- Return recorder note
Put these items in the Freepost return padded envelope provided and securely seal the envelope. Post the Freepost return envelope in any post box. No stamps are needed and there is no need to take it to the post office. Please do not take it to your GP practice.