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

NCT04715555 | Active Not Recruiting

• 3 other identifiers: IRAS 283812FS/20/20/3462620/EM/0255
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Atrial Fibrillation; Paroxysmal Atrial Fibrillation

Keywords

Wearable Electronic Devices; Electrocardiography, Ambulatory; Photoplethysmography; Arrhythmias, Cardiac; Diagnostic Screening Programs; Ergonomics

Outcome Measures

Primary Outcomes (1)

• The performance of each wrist-worn wearable approach for identifying AF participants

  Sensitivity and specificity

  7 days

Secondary Outcomes (15)

• The time for which participants report wearing the wearables

  7 days

• The number of wrist-ECG recordings taken by participants

  7 days

• The proportion of participants in whom AF was observed, who recorded a wrist-ECG signal during an AF episode

  7 days

• Participant-reported experiences of wearing the wearables

  Day 8

• Device packs lost in transit

  Day 1, end of participation

Study Arms (2)

Atrial Fibrillation

Participants with a diagnosis of atrial fibrillation (AF) who exhibited AF in previous AF screening (as part of the SAFER Programme).

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).

Device: Electrocardiogram monitoring; Device: Electrocardiogram recording; Device: Photoplethysmogram monitoring; Other: Feedback questionnaire

Interventions

Electrocardiogram monitoring DEVICE

Continuous monitoring using a wearable, single-lead electrocardiography (ECG) device affixed to the chest.

Atrial Fibrillation; Non-Atrial Fibrillation

Electrocardiogram recording DEVICE

Intermittent electrocardiogram (ECG) recordings taken using a wearable device on the wrist.

Atrial Fibrillation; Non-Atrial Fibrillation

Photoplethysmogram monitoring DEVICE

Photoplethysmogram monitoring using a wearable device on the wrist.

Atrial Fibrillation; Non-Atrial Fibrillation

Feedback questionnaire OTHER

A questionnaire to collect feedback on participants' experiences of wearing the devices.

Atrial Fibrillation; Non-Atrial Fibrillation

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential participants for the study will be identified from amongst previous participants of the SAFER Programme (ISRCTN 16939438 and ISRCTN 72104369).

You may qualify if:

• AF screening successfully completed during the SAFER Programme
• Aged 65 years or over
• Lives in private accommodation
• Willing and able to give informed consent

You may not qualify if:

• Regularly sleeps on front
• Has a chest wound
• Previous reaction to, or known allergy to ECG electrodes or silicone
• Receiving palliative care

Sponsors & Collaborators

• University of Cambridge: lead
• City, University of London: collaborator
• University of Leicester: collaborator

Study Sites (1)

University of Cambridge

Cambridge, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter H Charlton, MEng, PhD

  University of Cambridge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: British Heart Foundation Research Fellow

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 20, 2021
• Study Start: February 2, 2023
• Primary Completion: May 23, 2025
• Study Completion: May 23, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Data will be made available within 12 months of the study ending. It will made available indefinitely via an online repository.
• Access Criteria: None planned

Locations

GB (1)