The ASPIRED Study PISCF V4.0 09 08 2022

IRAS Project ID 304917

required to either fit it yourself at home or be fitted with it in the hospital, which will take around 15 minutes. We would ask you to continuously wear the device for up to 14 days. It is the size of a watch face, is non-invasive, water-resistant and is discreet to wear. It continuously monitors the heart for up to 14 days including during sleep, in the shower, and during moderate exercise. It does not impact on activities of everyday life such as showering, swimming and other exercise, or your choice of clothes especially in warmer weather, as it sits comfortably underneath these. In the event of you having a sudden loss of consciousness/blackout or fainting whilst wearing the heart monitor you will be required to press the button on the heart monitor after the episode. You will also be required to complete a paper symptom diary to record when one of the episodes occurred. After wearing the device for 14 days, you will return it to the device manufacturer in a pre-paid envelope for interpretation. Your research team will receive the results of your ECG recording from the manufacturer and these results will be discussed with you during a future hospital appointment. If you do wish to take some time to decide whether to take part in the study and have returned home or have been offered the opportunity to participate in the study after your hospital stay, you will be contacted by a member of the study team. If you are randomised to receive the extended mobile ECG monitoring device, you can either re-attend the hospital (travel expenses will be paid) for it to be fitted or it can be sent out to you and our study team will contact you to help you fit it yourself. Half of people who are randomised will not receive the 14-day mobile heart ECG monitor and will be investigated as normal, which may include the use of a standard heart monitor. This will allow us to clearly see what the difference in diagnosis and treatment is for the two patient groups. Whether you are randomised to receive the heart monitor or not, the rest of your clinical care today will not change. Once a month for 2 years, we will contact you either by text, email, or phone call (whichever you prefer) to complete a very brief questionnaire comprising of two questions; you will be asked whether you have had any further episodes of sudden loss of consciousness, and the number of visits to your GP for any reason (but we won’t be asking what these visits were for). You will also be asked to complete a quality-of-life questionnaire today and in one and two years asking how you are feeling, and about your day-to-day activities. Finally in one years’ time you will be asked to complete a satisfaction questionnaire. A member of your local research team will also collect information relating to the research from your hospital records over the two years of your participation. When you are taking part in this study, your data will be stored securely and in alignment with the General Data Protection Regulations and confidentially agreements. Your data will be viewed by permitted colleagues only from your local hospital team, Edinburgh Clinical Trials Unit and individuals from the trial sponsor and regulated authorities. We will seek permission from you for your local study team to hold your identifiable data for up to 15 years before it is destroyed. This is in case we wish to contact you in future to invite you to take part in future ethically approved studies looking at your health in 5-15 years from now. This is optional. If you do not wish to consent to this, your participation in this study is not affected. Today Monthly All Participants: Sign a Consent Form Complete a Questionnaire Participants: All Participants: Complete a monthly questionnaire by text, email, or phone call for 2 years Complete a yearly questionnaire by post or email for 2 years email for 2 years Participants: Sign a Consent Form Complete a monthly questionnaire by text, email, or phone call for 2 years Complete a Questionnaire Complete a yearly questionnaire by post or email for 2 years Half (50%) of Participants: Receive the mobile ECG heart monitoring to wear continuously for 14 days
Today	required to either fit it yourself at home or be fitted with it in the hospital, which will take around 15 minutes. We would ask you to continuously wear the device for up to 14 days. It is the size of a watch face, is non-invasive, water-resistant and is discreet to wear. It continuously monitors the heart for up to 14 days including during sleep, in the shower, and during moderate exercise. It does not impact on activities of everyday life such as showering, swimming and other exercise, or your choice of clothes especially in warmer weather, as it sits comfortably underneath these. In the event of you having a sudden loss of consciousness/blackout or fainting whilst wearing the heart monitor you will be required to press the button on the heart monitor after the episode. You will also be required to complete a paper symptom diary to record when one of the episodes occurred. After wearing the device for 14 days, you will return it to the device manufacturer in a pre-paid envelope for interpretation. Your research team will receive the results of your ECG recording from the manufacturer and these results will be discussed with you during a future hospital appointment. If you do wish to take some time to decide whether to take part in the study and have returned home or have been offered the opportunity to participate in the study after your hospital stay, you will be contacted by a member of the study team. If you are randomised to receive the extended mobile ECG monitoring device, you can either re-attend the hospital (travel expenses will be paid) for it to be fitted or it can be sent out to you and our study team will contact you to help you fit it yourself. Half of people who are randomised will not receive the 14-day mobile heart ECG monitor and will be investigated as normal, which may include the use of a standard heart monitor. This will allow us to clearly see what the difference in diagnosis and treatment is for the two patient groups. Whether you are randomised to receive the heart monitor or not, the rest of your clinical care today will not change. Once a month for 2 years, we will contact you either by text, email, or phone call (whichever you prefer) to complete a very brief questionnaire comprising of two questions; you will be asked whether you have had any further episodes of sudden loss of consciousness, and the number of visits to your GP for any reason (but we won’t be asking what these visits were for). You will also be asked to complete a quality-of-life questionnaire today and in one and two years asking how you are feeling, and about your day-to-day activities. Finally in one years’ time you will be asked to complete a satisfaction questionnaire. A member of your local research team will also collect information relating to the research from your hospital records over the two years of your participation. When you are taking part in this study, your data will be stored securely and in alignment with the General Data Protection Regulations and confidentially agreements. Your data will be viewed by permitted colleagues only from your local hospital team, Edinburgh Clinical Trials Unit and individuals from the trial sponsor and regulated authorities. We will seek permission from you for your local study team to hold your identifiable data for up to 15 years before it is destroyed. This is in case we wish to contact you in future to invite you to take part in future ethically approved studies looking at your health in 5-15 years from now. This is optional. If you do not wish to consent to this, your participation in this study is not affected. Today Monthly All Participants: Sign a Consent Form Complete a Questionnaire Participants: All Participants: Complete a monthly questionnaire by text, email, or phone call for 2 years Complete a yearly questionnaire by post or email for 2 years email for 2 years Participants: Sign a Consent Form Complete a monthly questionnaire by text, email, or phone call for 2 years Complete a Questionnaire Complete a yearly questionnaire by post or email for 2 years Half (50%) of Participants: Receive the mobile ECG heart monitoring to wear continuously for 14 days Half (50%) of Participants: Receive the mobile ECG heart monitoring to wear continuously for 14 days Monthly
All Participants: Sign a Consent Form Complete a Questionnaire	All Participants: Complete a monthly questionnaire by text, email, or phone call for 2 years Complete a yearly questionnaire by post or email for 2 years
required to either fit it yourself at home or be fitted with it in the hospital, which will take around 15 minutes. We would ask you to continuously wear the device for up to 14 days. It is the size of a watch face, is non-invasive, water-resistant and is discreet to wear. It continuously monitors the heart for up to 14 days including during sleep, in the shower, and during moderate exercise. It does not impact on activities of everyday life such as showering, swimming and other exercise, or your choice of clothes especially in warmer weather, as it sits comfortably underneath these. In the event of you having a sudden loss of consciousness/blackout or fainting whilst wearing the heart monitor you will be required to press the button on the heart monitor after the episode. You will also be required to complete a paper symptom diary to record when one of the episodes occurred. After wearing the device for 14 days, you will return it to the device manufacturer in a pre-paid envelope for interpretation. Your research team will receive the results of your ECG recording from the manufacturer and these results will be discussed with you during a future hospital appointment. If you do wish to take some time to decide whether to take part in the study and have returned home or have been offered the opportunity to participate in the study after your hospital stay, you will be contacted by a member of the study team. If you are randomised to receive the extended mobile ECG monitoring device, you can either re-attend the hospital (travel expenses will be paid) for it to be fitted or it can be sent out to you and our study team will contact you to help you fit it yourself. Half of people who are randomised will not receive the 14-day mobile heart ECG monitor and will be investigated as normal, which may include the use of a standard heart monitor. This will allow us to clearly see what the difference in diagnosis and treatment is for the two patient groups. Whether you are randomised to receive the heart monitor or not, the rest of your clinical care today will not change. Once a month for 2 years, we will contact you either by text, email, or phone call (whichever you prefer) to complete a very brief questionnaire comprising of two questions; you will be asked whether you have had any further episodes of sudden loss of consciousness, and the number of visits to your GP for any reason (but we won’t be asking what these visits were for). You will also be asked to complete a quality-of-life questionnaire today and in one and two years asking how you are feeling, and about your day-to-day activities. Finally in one years’ time you will be asked to complete a satisfaction questionnaire. A member of your local research team will also collect information relating to the research from your hospital records over the two years of your participation. When you are taking part in this study, your data will be stored securely and in alignment with the General Data Protection Regulations and confidentially agreements. Your data will be viewed by permitted colleagues only from your local hospital team, Edinburgh Clinical Trials Unit and individuals from the trial sponsor and regulated authorities. We will seek permission from you for your local study team to hold your identifiable data for up to 15 years before it is destroyed. This is in case we wish to contact you in future to invite you to take part in future ethically approved studies looking at your health in 5-15 years from now. This is optional. If you do not wish to consent to this, your participation in this study is not affected. Today Monthly All Participants: Sign a Consent Form Complete a Questionnaire Participants: All Participants: Complete a monthly questionnaire by text, email, or phone call for 2 years Complete a yearly questionnaire by post or email for 2 years email for 2 years Participants: Sign a Consent Form Complete a monthly questionnaire by text, email, or phone call for 2 years Complete a Questionnaire Complete a yearly questionnaire by post or email for 2 years Half (50%) of Participants: Receive the mobile ECG heart monitoring to wear continuously for 14 days Half (50%) of Participants: Receive the mobile ECG heart monitoring to wear continuously for 14 days	All Participants: Complete a monthly questionnaire by text, email, or phone call for 2 years Complete a yearly questionnaire by post or email for 2 years email for 2 years

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