Atrial FibrillationNCT04715555
A Study of the Acceptability and Performance of Wearables for Atrial Fibrillation Screening in Older Adults
An observational study of Atrial Fibrillation and Paroxysmal Atrial Fibrillation, run by University of Cambridge at 1 site in United Kingdom.
Trial summary
--- Background and study aim Atrial fibrillation (AF) is an irregular heart rhythm which causes a five-fold increase in the risk of stroke. Approximately one in ten people aged over 70 have AF. If AF is recognised then the risk of stroke can be reduced by taking tablets regularly. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Atrial Fibrillation, Paroxysmal Atrial Fibrillation
- What is being tested?
- Electrocardiogram monitoring, Electrocardiogram recording and Photoplethysmogram monitoring
- Type of treatment
- Medical device
- How many people
- 130 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Feb 2023to 23 May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Potential participants for the study will be identified from amongst previous participants of the SAFER Programme (ISRCTN 16939438 and ISRCTN 72104369).
Who may be able to join
- AF screening successfully completed during the SAFER Programme
- Aged 65 years or over
- Lives in private accommodation
- Willing and able to give informed consent
Who cannot join
- Regularly sleeps on front
- Has a chest wound
- Previous reaction to, or known allergy to ECG electrodes or silicone
- Receiving palliative care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SAFER Wearables Study: A Study of the Acceptability and Performance of Wearables for Atrial Fibrillation Screening in Older Adults
--- Background and study aim
Atrial fibrillation (AF) is an irregular heart rhythm which causes a five-fold increase in the risk of stroke. Approximately one in ten people aged over 70 have AF. If AF is recognised then the risk of stroke can be reduced by taking tablets regularly. AF can be difficult to recognise as it can occur without symptoms and only intermittently. Consequently, AF is not recognised in many people, meaning they live with an increased risk of stroke. Therefore, it is important to find ways to identify AF more reliably.
Read more
Recently, wearable devices have been developed which could be useful for identifying AF. Several devices can monitor heart activity in daily life, including wristbands, smart watches and chest patch monitors. The aim of this study is to assess the acceptability and performance of wearables for use in AF screening in older adults.
The primary objective is to determine the feasibility of measuring inter-beat-intervals using a wristband. The secondary objectives are:
(i) to determine the acceptability of wearables; (ii) to determine the acceptability of the screening approach; (iii) to assess the performance of wearables for acquiring signals; (iv) to assess the performance of signal processing algorithms; and (v) to assess the performance of wearables for AF screening.
--- Who can participate?
Selected people who have previously participated in the SAFER Programme can participate in this study. The Investigators will invite previous SAFER Programme participants to also participate in this study, aiming to enrol 65 without AF, and 65 with AF.
--- What does the study involve?
Participants will be asked to wear three devices for seven days: Two wristbands (like watches), and one chest patch (like a plaster). These devices will collect measurements of their heart's activity. The Investigators will also ask participants to tell them how they found wearing the devices by completing a questionnaire. The Investigators will compare how participants found wearing each device, and how accurately each device identifies AF.
--- What are the possible benefits and risks of participating?
There will be no direct benefit to participants, although this research is intended to benefit future patients like them. Some participants may experience irritation or redness whilst wearing a chest patch - participants will be advised that if this occurs then they should remove it straightaway.
Read the detailed description
--- Where is the study run from?
The University of Cambridge.
--- Study procedures
Participants will be asked to:
- Consent: Participants will be asked to confirm their consent to take part by posting the enclosed consent form to the Investigators in a prepaid envelope.
- Device delivery: The Investigators will send participants the devices, a detailed instruction leaflet, and a questionnaire.
- Training: The Investigators will explain to participants how to wear and use the devices over the telephone, referring to the instruction leaflet.
- Wear the devices: Participants will be asked to wear the devices for seven days, going about their daily life as normal. The devices are waterproof. If a participant has chest hair then they will need to shave a small area for the chest-patch to stick to. The Investigators will ask participants to use the watch four times each day to record heart activity for 30 seconds. Participants will be asked to plug in a small hub which will send information from the devices. The Investigators will telephone participants during the study to check for any problems.
- Questionnaire: Participants will be asked to complete a questionnaire on the devices after wearing them.
- Return devices: At the end, the Investigators will telephone participants and arrange a courier to pick up the devices and questionnaire from their home (which the Investigators will arrange and pay for).
Participants will be given an instruction leaflet with further details of each step.
- Being tested
- Electrocardiogram monitoring, Electrocardiogram recording, Photoplethysmogram monitoring, Feedback questionnaire
- Keywords
- Wearable Electronic Devices, Electrocardiography, Ambulatory, Photoplethysmography, Arrhythmias, Cardiac, Diagnostic Screening Programs, Ergonomics
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrocardiogram monitoringDevice
Continuous monitoring using a wearable, single-lead electrocardiography (ECG) device affixed to the chest.
Electrocardiogram recordingDevice
Intermittent electrocardiogram (ECG) recordings taken using a wearable device on the wrist.
Photoplethysmogram monitoringDevice
Photoplethysmogram monitoring using a wearable device on the wrist.
Feedback questionnaireOther
A questionnaire to collect feedback on participants' experiences of wearing the devices.
| Study group | Role | What they receive |
|---|---|---|
| Atrial Fibrillation | Participants with a diagnosis of atrial fibrillation (AF) who exhibited AF in previous AF screening (as part of the SAFER Programme). Receives: Device: Electrocardiogram monitoring; Device: Electrocardiogram recording; Device: Photoplethysmogram monitoring; Other: Feedback questionnaire | |
| Non-Atrial Fibrillation | Participants without a diagnosis of atrial fibrillation (AF) who have previously undergone AF screening (as part of the SAFER Programme). Receives: Device: Electrocardiogram monitoring; Device: Electrocardiogram recording; Device: Photoplethysmogram monitoring; Other: Feedback questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
The performance of each wrist-worn wearable approach for identifying AF participants
Sensitivity and specificity
Measured: 7 days
Secondary outcomes (15)
The time for which participants report wearing the wearables
Duration of time, expressed as median (lower, upper quartiles)
Measured: 7 days
The number of wrist-ECG recordings taken by participants
Median (lower, upper quartiles)
Measured: 7 days
The proportion of participants in whom AF was observed, who recorded a wrist-ECG signal during an AF episode
Percentage
Measured: 7 days
Participant-reported experiences of wearing the wearables
Feedback obtained from questionnaires (including some responses provided on a Likert Scale with options 'Strongly agree', 'Agree', 'Neither agree nor disagree', 'Disagree', and 'Strongly disagree').
Measured: Day 8
Device packs lost in transit
The number for both outward and return legs
Measured: Day 1, end of participation
The time for which each device attempts to record signals
The time from the wearable being first applied to the time of either it being finally removed, or its battery running out (whichever occurs first). Expressed as median (lower, upper quartiles)
Measured: 7 days
The time for which wearable signals are acquired
Duration of time, and proportion of recording time, expressed as median (lower, upper quartiles). 'Wearable signal' is defined as a non-flat-line signal.
Measured: 7 days
The proportion of recording time for which wearable signals are of high quality
Percentage, expressed as median (lower, upper quartiles)
Measured: 7 days
The proportion of recording time for which high quality wearable signals are acquired at different times of day
Percentages, expressed as median (lower, upper quartiles)
Measured: 7 days
The agreement between interbeat-intervals (IBIs) provided by IBI wristbands, and derived from reference ECG chest-patch signals
Limits of Agreement technique (consisting of the bias and limits of agreement)
Measured: 7 days
The agreement between ECG features derived from wrist-ECGs and reference ECG chest-patch signals.
Limits of Agreement technique (consisting of the bias and limits of agreement)
Measured: 7 days
The performance of an algorithm to detect AF from wrist-ECG signals
sensitivity and specificity
Measured: 7 days
The performance of an algorithm to detect possible AF from IBI wristband signals
Sensitivity and specificity
Measured: 7 days
The proportion of possible AF episodes detected from IBI wristband signals for which the reference ECG exhibited a verified AF episode lasting for ≥ 90 seconds from the start time of the possible episode
Percentage, expressed as median (lower, upper quartiles)
Measured: 7 days
The agreement between AF burden estimates obtained from wrist devices and the reference ECG chest-patch
Limits of Agreement technique (consisting of the bias and limits of agreement)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start2 Feb 2023
- Primary completion23 May 2025 (estimated)
- Study completion23 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Collaborators
- City, University of London, University of Leicester
- Responsible party
- Principal investigator, Peter Charlton, University of Cambridge
- Investigators
- Peter H Charlton, MEng, PhD, Principal investigator, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715555
- Sponsor's protocol ID
- IRAS 283812
- Other IDs
- FS/20/20/34626, 20/EM/0255
- Status last verified
- Apr 2025
- First submitted
- 14 Jan 2021
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The following data from individual participants will be anonymised and shared: * Participant characteristics * Quantitative questionnaire data (providing feedback on the wearable devices) * Device data including physiological signals, physiological parameters, and technical parameters.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAFER Wearables Study: A Study of the Acceptability and Performance of Wearables for Atrial Fibrillation Screening in Older Adults
- ClinicalTrials.gov ID
- NCT04715555
- Acronym / sponsor ID
- IRAS 283812
- Keywords
- Wearable Electronic Devices, Electrocardiography, Ambulatory, Photoplethysmography, Arrhythmias, Cardiac, Diagnostic Screening Programs, Ergonomics
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Collaborators
- City, University of London, University of Leicester
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 23 May 2025 (estimated)
- Study completion
- 23 May 2025 (estimated)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
--- Background and study aim
Atrial fibrillation (AF) is an irregular heart rhythm which causes a five-fold increase in the risk of stroke. Approximately one in ten people aged over 70 have AF. If AF is recognised then the risk of stroke can be reduced by taking tablets regularly. AF can be difficult to recognise as it can occur without symptoms and only intermittently. Consequently, AF is not recognised in many people, meaning they live with an increased risk of stroke. Therefore, it is important to find ways to identify AF more reliably.
Recently, wearable devices have been developed which could be useful for identifying AF. Several devices can monitor heart activity in daily life, including wristbands, smart watches and chest patch monitors. The aim of this study is to assess the acceptability and performance of wearables for use in AF screening in older adults.
The primary objective is to determine the feasibility of measuring inter-beat-intervals using a wristband. The secondary objectives are:
(i) to determine the acceptability of wearables; (ii) to determine the acceptability of the screening approach; (iii) to assess the performance of wearables for acquiring signals; (iv) to assess the performance of signal processing algorithms; and (v) to assess the performance of wearables for AF screening.
--- Who can participate?
Selected people who have previously participated in the SAFER Programme can participate in this study. The Investigators will invite previous SAFER Programme participants to also participate in this study, aiming to enrol 65 without AF, and 65 with AF.
--- What does the study involve?
Participants will be asked to wear three devices for seven days: Two wristbands (like watches), and one chest patch (like a plaster). These devices will collect measurements of their heart's activity. The Investigators will also ask participants to tell them how they found wearing the devices by completing a questionnaire. The Investigators will compare how participants found wearing each device, and how accurately each device identifies AF.
--- What are the possible benefits and risks of participating?
There will be no direct benefit to participants, although this research is intended to benefit future patients like them. Some participants may experience irritation or redness whilst wearing a chest patch - participants will be advised that if this occurs then they should remove it straightaway.
Detailed description
--- Where is the study run from?
The University of Cambridge.
--- Study procedures
Participants will be asked to:
- Consent: Participants will be asked to confirm their consent to take part by posting the enclosed consent form to the Investigators in a prepaid envelope.
- Device delivery: The Investigators will send participants the devices, a detailed instruction leaflet, and a questionnaire.
- Training: The Investigators will explain to participants how to wear and use the devices over the telephone, referring to the instruction leaflet.
- Wear the devices: Participants will be asked to wear the devices for seven days, going about their daily life as normal. The devices are waterproof. If a participant has chest hair then they will need to shave a small area for the chest-patch to stick to. The Investigators will ask participants to use the watch four times each day to record heart activity for 30 seconds. Participants will be asked to plug in a small hub which will send information from the devices. The Investigators will telephone participants during the study to check for any problems.
- Questionnaire: Participants will be asked to complete a questionnaire on the devices after wearing them.
- Return devices: At the end, the Investigators will telephone participants and arrange a courier to pick up the devices and questionnaire from their home (which the Investigators will arrange and pay for).
Participants will be given an instruction leaflet with further details of each step.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atrial Fibrillation | – | Device: Electrocardiogram monitoring, Device: Electrocardiogram recording, Device: Photoplethysmogram monitoring, Other: Feedback questionnaireParticipants with a diagnosis of atrial fibrillation (AF) who exhibited AF in previous AF screening (as part of the SAFER Programme). |
| Non-Atrial Fibrillation | – | Device: Electrocardiogram monitoring, Device: Electrocardiogram recording, Device: Photoplethysmogram monitoring, Other: Feedback questionnaireParticipants without a diagnosis of atrial fibrillation (AF) who have previously undergone AF screening (as part of the SAFER Programme). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Potential participants for the study will be identified from amongst previous participants of the SAFER Programme (ISRCTN 16939438 and ISRCTN 72104369).
Key inclusion criteria (4 listed)
- AF screening successfully completed during the SAFER Programme
- Aged 65 years or over
- Lives in private accommodation
- Willing and able to give informed consent
Key exclusion criteria (4 listed)
- Regularly sleeps on front
- Has a chest wound
- Previous reaction to, or known allergy to ECG electrodes or silicone
- Receiving palliative care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrocardiogram monitoringContinuous monitoring using a wearable, single-lead electrocardiography (ECG) device affixed to the chest. | Device | Atrial Fibrillation, Non-Atrial Fibrillation |
| Electrocardiogram recordingIntermittent electrocardiogram (ECG) recordings taken using a wearable device on the wrist. | Device | Atrial Fibrillation, Non-Atrial Fibrillation |
| Photoplethysmogram monitoringPhotoplethysmogram monitoring using a wearable device on the wrist. | Device | Atrial Fibrillation, Non-Atrial Fibrillation |
| Feedback questionnaireA questionnaire to collect feedback on participants' experiences of wearing the devices. | Other | Atrial Fibrillation, Non-Atrial Fibrillation |
Primary outcome
The performance of each wrist-worn wearable approach for identifying AF participants
Time frame: 7 days
Sensitivity and specificity
15 secondary outcomes
The time for which participants report wearing the wearables
Time frame: 7 days
The number of wrist-ECG recordings taken by participants
Time frame: 7 days
The proportion of participants in whom AF was observed, who recorded a wrist-ECG signal during an AF episode
Time frame: 7 days
Participant-reported experiences of wearing the wearables
Time frame: Day 8
Device packs lost in transit
Time frame: Day 1, end of participation
The time for which each device attempts to record signals
Time frame: 7 days
The time for which wearable signals are acquired
Time frame: 7 days
The proportion of recording time for which wearable signals are of high quality
Time frame: 7 days
The proportion of recording time for which high quality wearable signals are acquired at different times of day
Time frame: 7 days
The agreement between interbeat-intervals (IBIs) provided by IBI wristbands, and derived from reference ECG chest-patch signals
Time frame: 7 days
The agreement between ECG features derived from wrist-ECGs and reference ECG chest-patch signals.
Time frame: 7 days
The performance of an algorithm to detect AF from wrist-ECG signals
Time frame: 7 days
The performance of an algorithm to detect possible AF from IBI wristband signals
Time frame: 7 days
The proportion of possible AF episodes detected from IBI wristband signals for which the reference ECG exhibited a verified AF episode lasting for ≥ 90 seconds from the start time of the possible episode
Time frame: 7 days
The agreement between AF burden estimates obtained from wrist devices and the reference ECG chest-patch
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: Yes. The following data from individual participants will be anonymised and shared: * Participant characteristics * Quantitative questionnaire data (providing feedback on the wearable devices) * Device data including physiological signals, physiological parameters, and technical parameters.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter H Charlton, MEng, PhD principal investigator
University of Cambridge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Paroxysmal Atrial Fibrillation, run by University of Cambridge at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The performance of each wrist-worn wearable approach for identifying AF participants (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.