Active not recruitingOBSERVATIONAL

A Study of the Acceptability and Performance of Wearables for Atrial Fibrillation Screening in Older Adults

This study explores how well wearable devices, such as smartwatches and chest patches, can detect a common heart condition called atrial fibrillation (AF) in older adults. AF is an irregular heartbeat that significantly increases the risk of stroke, and finding it early can help reduce this risk with medication. Many people don't know they have AF because it often has no symptoms or comes and goes. Researchers want to see if these devices can reliably identify AF. The study also aims to understand how comfortable and easy older adults find these devices to use in their daily lives. By doing this, the study hopes to develop better ways to screen for AF and help prevent strokes in the future.

At a glance

Status

Active not recruiting

Sponsor

University of Cambridge

Enrolment target

130

Start

02 Feb 2023

Estimated completion

23 May 2025

Atrial Fibrillation Paroxysmal Atrial Fibrillation

What is this study about?

This study is all about improving how we find atrial fibrillation (AF) – a type of irregular heartbeat – in older people. AF is quite common, especially if you're over 70, and it can increase your risk of having a stroke by a lot. The good news is that if AF is found, taking regular medication can significantly lower that stroke risk.

However, AF can be tricky to spot because it often doesn't cause any symptoms, or symptoms might come and go. This means many people have AF without even knowing it, leaving them at a higher risk of stroke. That's why scientists are looking for better and more reliable ways to check for AF. Lately, wearable gadgets like smartwatches and small patches you wear on your chest have been invented that can keep an eye on your heart. This study wants to see how well these devices work in real life and how easy and comfortable older adults find them to use.

The main goal is to understand if these wearables can accurately measure your heartbeat and if they can effectively screen for AF. The study will also ask participants about their experiences wearing the devices, to understand what people like and don't like. The hope is that the results from this study will help us find AF earlier in more people, ultimately helping to prevent strokes.

Key takeaways

Study aims to find better ways to detect irregular heartbeats (AF).
Uses wearable devices like smartwatches and chest patches.
Participation involves wearing devices for seven days and completing a questionnaire.
Results could help prevent strokes in future patients.
Suitable for older adults who have participated in the SAFER Programme.

Who may be eligible?

To be able to join this study, you must have been part of an earlier program called the SAFER Programme and had your heart checked for AF during that time. You also need to be 65 years old or older and live in your own home.

It's important that you are willing and able to understand what the study involves and give your permission (consent) to take part.

You cannot join the study if you usually sleep on your tummy, have any open wounds on your chest, or have previously had a bad reaction or allergy to materials used in heart-monitoring patches (like silicone). If you are receiving care aimed at making you comfortable in your final stages of life (palliative care), you also won't be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have you previously taken part in the SAFER Programme and had AF screening?
Are you 65 years old or older?
Do you live in your own home (not in a care facility)?
Are you comfortable understanding and signing a consent form?
Do you not have an existing chest wound or allergy to sticky patches?
Are you able to sleep on your back or side (not your front)?

Answer every question to see your result.

What does participation involve?

If you're invited to take part, here’s what you can expect:

First, you'll need to confirm you want to join by sending back a signed consent form in a special pre-paid envelope. Then, the researchers will send you the devices, along with clear instructions and a questionnaire.

A team member will call you to explain how to wear and use the devices, going through the instruction leaflet with you. You'll then be asked to wear three different devices for seven days: two wristbands (like watches) and one small patch on your chest. These devices will quietly record your heart's activity as you go about your normal daily life. They are waterproof, so you don't need to take them off for showers. If you have chest hair, you might need to shave a small area for the chest patch to stick properly. You'll also need to use one of the wristwatches four times a day for 30 seconds to record your heart activity.

The researchers will provide a small hub that you plug in, which will send the information from your devices to them. They will call you during the week to make sure everything is going smoothly and answer any questions. After wearing the devices for seven days, you'll fill out the questionnaire about your experience. Finally, the researchers will arrange and pay for a courier to pick up all the devices and your completed questionnaire from your home.

Potential risks and benefits

There won't be any direct health benefits to you from taking part in this study. However, the information gathered from your participation could help other people in the future by improving how we find and treat atrial fibrillation. A minor risk is that the chest patch might cause some skin irritation or redness; if this happens, you should remove it straight away. You are free to stop participating in the study at any time without giving a reason.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of Cambridge
Verified postcode
Cambridge, United Kingdom

Common questions

What is atrial fibrillation (AF)?

AF is an irregular heartbeat that can increase your risk of stroke. Finding it early can help manage this risk.

What are 'wearable devices'?

These are small gadgets, like smartwatches or chest patches, that you wear to monitor your heart activity throughout the day.

How long will I need to wear the devices?

You will be asked to wear them for seven days continuously.

Do I have to pay for anything?

No, the study will cover all costs, including sending devices to you and arranging their pick-up.

Will I get my results from the devices?

The study aims to improve screening methods for future patients. There will be no direct benefit or results provided to you.