Screening for atrial fibrillation using economical and accurate technology
| ISRCTN | ISRCTN17495003 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17495003 |
| Secondary identifying numbers | N/A |
- Submission date
- 29/06/2016
- Registration date
- 10/08/2016
- Last edited
- 23/03/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Atrial fibrillation (AF) is a common heart condition, affecting millions of people worldwide. The heart consists of two upper chambers (atria) and two lower chambers (ventricles). Inside the right atrium, a cluster of cells (sinus node) are responsible for firing electrical signals into the heart muscle causing the heart to beat regularly (sinus rhythm). When a person is suffering from AF, the normal signals from the sinus node do not work properly, causing other parts of the atria to fire chaotically. These uncoordinated signals cause the heart to beat irregularly and often very fast (arrhythmia). People with AF have a significantly higher risk of having a stroke, and so it is important to accurately diagnose it as soon as possible. At the moment there is no UK screening programme for AF. Several relatively low cost devices with good accuracy now exist which can be used to pick up AF. These measure the electrical heart trace or pulse over short time periods (less than a few minutes) and can also be used in GP surgeries to screen for AF. The aim of this study is to test the accuracy of four different devices (a blood pressure meter, a hand-held device, a heart rate monitor belt and a wearable heartbeat recording device) by comparing them to the current best way of detecting AF (gold standard), a 12-lead ECG. The study also aims to find out how people feel about using the devices, in terms of comfort and ease of use.
Who can participate?
Adults aged 65 and over who are able to read and speak English.
What does the study involve?
Participants attend a single appointment at their GP surgery, during which a nurse performs the screening tests using the devices in a random order (this should take a couple of minutes per device). The devices are non-invasive (they fit on the skin): one device uses the pulses detected while a blood pressure reading is taken; the second device records an electrical trace of the heart by simply holding the device with the fingertips; the third device uses a heart rate monitor belt (used by athletes) that straps comfortably to the chest to obtain electrical pulse signals; and the fourth device also attaches to the chest using two gel electrodes (sticky pads which conduct electricity). Participants then go on to have a standard ECG test, in which 12 electrodes are attached to the body to measure the electrical activity of the heart. The results of this test are then interpreted by a panel of cardiologists (heart doctors). Participants are then asked to rate the devices for comfort and ease of use. The accuracy of each of the devices is determined by comparing the results of each test to the ECG (which is the best known way of detecting AF).
What are the possible benefits and risks of participating?
Participants who are found to have AF benefit from being given this information so that they can be treated. There are no notable risks involved with participating. Although in rare cases, some participants may have some minor skin irritation after having an ECG taken (caused by the electrode gel).
Where is the study run from?
Highfield Health, Southampton (UK)
When is the study starting and how long is it expected to run for?
November 2011 to May 2017
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Mark Lown
m.lown@soton.ac.uk
Contact information
Public
Primary Care and Population Sciences
Aldermoor Health Centre
Addermoor Close
Southampton
SO165ST
United Kingdom
| Phone | +44 2380 595000 |
|---|---|
| m.lown@soton.ac.uk |
Study information
| Study design | Diagnostic accuracy case-control study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | GP practice |
| Study type | Diagnostic |
| Participant information sheet | ISRCTN17495003_PIS_29Jun16_V2.docx |
| Scientific title | Screening for Atrial Fibrillation using Economical and Accurate TechnologY (SAFETY) – a pilot study |
| Study acronym | SAFETY |
| Study objectives | The aim of this study to assess the accuracy of a novel algorithm using a Bluetooth heart rate monitor belt and a wearable heart rate monitor to detect Atrial Fibrillation compared with a standard 12-Lead ECG. The accuracy will be compared to two existing devices: WatchBP (a blood pressure meter) and AliveCor (ahand-held ECG device). |
| Ethics approval(s) | London - City & East REC, 30/06/2016, ref: 16/LO/1173 |
| Health condition(s) or problem(s) studied | Atrial Fibrillation |
| Intervention | Each participant will attend their GP surgery for one visit. Each participant will be tested using 4 devices in random sequence, followed by a standard 12 lead ECG. Each test is performed immediately after the preceding test, with no wash out period in between. AliveCor: This involves the participant to hold fingers on electrodes for 30s while a single lead ECG trace is obtained. WatchBP: This involves a blood pressure measurement to be taken (automated) just like any other blood pressure measurement. Polar Heart rate monitor belt: This involves wearing a polar heart rate monitor belt which will obtain heartbeat intervals which will be used by a smartphone app. FirstbeatBodyguard2: This involves having two gel-electrodes placed on the chest and have the firstbeat bodyguard2 device attached which will record heartbeat intervals for a few minutes. Participants then undergo a standard 12 lead ECG, the result of which is read by a panel of cardiologists. The diagnostic accuracy of each device is then determined through comparison with the results of the 12 lead ECG. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Diagnostic accuracy of WatchBP, AliveCor, Polar heart rate monitor belt (with diagnostic algorithm), Firstbeat Bodyguard2 (with diagnostic algorithm) are determined through comparison with the 12-lead ECG reference test at the study visit. |
| Secondary outcome measures | 1. Comfort is measured using a visual analogue scale immediately after all tests are completed 2. Ease of use for each device is measured using a visual analogue scale immediately after all tests are completed |
| Overall study start date | 01/01/2016 |
| Completion date | 31/12/2017 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 421 |
| Total final enrolment | 418 |
| Key inclusion criteria | AF Participants: 1. Aged 65 years an over 2. Coded as AF on their GP records Control participants: 1. Aged 65 years an over 2. No known AF |
| Key exclusion criteria | All participants: 1. Aged under 65 2. Permanent pacemaker in situ 3. Dementia / lacking in capacity 4. Previous moderate or severe skin reaction to electrode gel |
| Date of first enrolment | 01/09/2016 |
| Date of final enrolment | 31/08/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Southampton
SO171BJ
United Kingdom
Sponsor information
University/education
University Road
Southampton
Southampton
SO171BJ
England
United Kingdom
| Phone | +44 2380 595000 |
|---|---|
| rgoinfo@soton.ac.uk | |
"ROR" |
https://ror.org/01ryk1543 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V2 | 29/06/2016 | 10/08/2016 | No | Yes |
| Protocol article | protocol | 13/01/2017 | Yes | No | |
| Results article | results | 15/10/2018 | 23/08/2019 | Yes | No |
| Other publications | qualitative study | 18/03/2020 | 23/03/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN17495003_PIS_29Jun16_V2.docx
- Uploaded 10/08/2016
Editorial Notes
23/03/2020: Publication reference added.
23/08/2019: Publication reference and total final enrolment number added.
21/02/2018: Publication reference added.
