Patients – taking part in the trial
Your GP practice has invited a random selection of patients aged 70 and over to take part in the trial. Any pre-existing medical conditions have not been taken into account.
For further information about AF please see the NHS Choices website.
Yes you may be able to take part. An existing diagnosis of AF will not necessarily exclude you from taking part – indeed we are particularly interested in people with an existing diagnosis of AF. However if you are taking blood thinning (anticoagulant) medication such as warfarin, edoxaban or rivaroxaban for your AF then unfortunately you will not be able to take part.
Yes you are able to take part if you currently take aspirin, clopidogrel or ticagrelor.
Yes you are able to take part if you have a pacemaker fitted. Please see the FAQ below about how to use the ECG device if you have a pacemaker.
No, you do not have to travel anywhere to take part in the trial. All aspects of taking part will be managed by post / phone.
No. You do not need to have a mobile phone, WiFi or internet access to take part in the trial or to use the ECG device.
We do not acknowledge receipt of consent as this would be very costly to do for 126,000 patients. If you do not hear from us you can assume you are part of the trial. If your practice does not offer screening for AF, and if we do not invite you to take part in any other aspect of the trial, you may not hear from us again. However please be assured that you are still part of the trial. Every patient who consents is playing a valuable part and enabling us to answer the research question.
We have been asked by a few participants how they can take part in other research studies, so thought we would share some useful links.
The National Institute for Health Research (NIHR), who fund the SAFER programme, has a website for people who want to take part in a research study.
The NIHR also have a website where you can search for studies that might interest you. There is also a link from there to sign up to be contacted about COVID-19 research studies.
More locally we are always keen to hear from people who want to get involved and support our research activities here at the University of Cambridge and also more widely at the Cambridge Biomedical Research Centre.
If you are interested in getting involved with other aspects of research, the Health Research Authority are recruiting people to sit on their NHS Research Ethics Committees.
Patients – screening for AF
Yes! The ECG device is simple to use, and previous research studies have found that patients aged 65 and over found it easy to record and transmit the ECG traces. It is a small, handheld machine that you simply rest your thumbs or index fingers on to record an ECG. There are no wires or sticky pads involved.
You will be sent full written instructions with the device which can be found here. There is an instruction video that you can watch here (please note there is no need to enter any login details or password to view the video). The research team in Cambridge will be available to answer any questions you may have about using the recorder (please see the question below ‘how do I get help’).
No. You can record the 4 ECGs whenever is convenient for you. They do not have to be recorded at the same time every day, nor spread out evenly across the day. Just whenever is most convenient for you.
It is up to you whether you want to take the ECG device with you. It is portable and can be used whilst you are out and about (bear in mind you will need to be able to sit down quietly to record an ECG). If you would prefer not to take it with you, you can simply record ECGs before leaving home and/or on your return home.
Recording one at every meal time 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.
We would like you to use the device to record 4 ECGs per day, ideally. We realise that it is easy to forget to do one, and we have some suggestions for reminders above. If you forget to record an ECG, don’t worry. Just carry on doing them as usual.
It is safe to record ECGs with the device if you have a pacemaker. As the device contains a SIM card and transmits ECGs using a mobile phone network, we advise you to take the same precautions when sending ECGs as you do when using a mobile phone. These precautions may vary depending on the pacemaker, but in general involve avoiding having the ECG device close to your body when the device is transmitting ECGs. If you have any specific questions please get in touch with us.
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.
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 device will arrive with you with a fresh set of batteries fitted. This should be more than sufficient to last for the 3 weeks of screening. 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 – see the previous FAQ ‘what should I do if I press the send button and get a message it has not been sent’ for further information.
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 trial team who will arrange to send you replacement batteries and talk you through replacing them.
You can find instructions for using the recorder here which should answer most questions. If these do not help then get in touch with the Cambridge research team, click here for contact details and we will be happy to help.
When recording an ECG 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.
At the end of the screening period you will need to return the device using the Freepost return padded envelope enclosed. Please check the device before returning it, and (if applicable) try to send any ‘unsent’ ECG recordings. Please return:
- ECG device
- Zenicor User Instructions
- Black device case
- Completed Screening Feedback Form (document B)
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.
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.
The ECG traces will be analysed once the device has been returned to the trial team. No ECGs will be reviewed before this time. The screening result will usually be available within 12 weeks of the date the device is received by the trial team. Your GP practice will inform you of your screening result (whether positive or negative), and whether any action is required.
Yes, you can take part in the trial regardless of what other AF detection initiatives you may be using (such as the AHSN initiative, or doing pulse checks). If you take part in the trial you will be free to continue with, or start, other AF detection initiatives. If you have any specific questions please get in touch with us.
Yes, you can still take part in the SAFER trial. We will ask you to exclude any patients consented to the AMALFI Study from receiving an invitation to the SAFER Trial. If you have any specific questions please get in touch with us.
Yes, you can still take part in the SAFER trial. We will ask you to exclude any patients consented to the DaRe2THINK Study from receiving an invitation to the SAFER Trial. If after completing the SAFER Trial you wish to take part in the DaRe2THINK Study, you will need to exclude patients consented to the SAFER Trial from receiving an invitation to the DaRe2THINK Study. We would ask that you do not undertake both studies at the same time. If you have any specific questions please get in touch with us.