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Screening for atrial fibrillation in the over-75s with handheld ECG devices

Mass screening for atrial fibrillation in the over-75s using handheld devices integrated with a central monitoring service: A pilot study of feasibility and preliminary efficacy

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000184875
Enrollment
200
Registered
2021-02-22
Start date
2021-05-25
Completion date
2022-06-30
Last updated
2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Patient-led screening for atrial fibrillation (AF) using handheld mobile electrocardiogram (ECG) devices at their homes may help in detecting AF. However, there is no established system to facilitate the diagnosis and management of AF when a suspected case is detected. Therefore, we aim to study whether we can implement an AF screening program using handheld mobile ECG devices integrated with a cardiac centre at Westmead Hospital, New South Wales, that is able to confirm the diagnosis and facilitate appropriate management of new AF. Participants are given a handheld mobile ECG device and they will receive training in using the device. They will involve in the study for a period of 12 months. Participants randomised to the intervention group will commence monitoring straight away while participants in the control group will wait for 6 months to receive the handheld ECG device. During the waiting period, they see their general practitioners (GPs) for usual care. Participants record a 30-second daily ECG on weekdays. ECGs will be automatically transmitted to Westmead Cardiology Department and monitored by trained technicians. Participants and their GPs will be notified of ECG abnormality and GPs can access support from cardiologists involved in this research. The primary outcome at 6-month follow-up (or when AF is diagnosed, whichever occurs first) is the proportion of participants’ reporting being very satisfied/satisfied that their heart rhythm was being monitored in the past 6 months in the intervention group compared to the control group.

Interventions

Participants will acquire a single-lead electrocardiogram (ECG) trace by placing minimum one finger of each hand on each small touchpad (3cm x 3cm) of the device for 30 seconds once daily on weekdays (12 months for intervention group and 6 months for waitlist group). The device is connected to their mobile phone wirelessly and an ECG trace will appear on the mobile phone confirming that the participant has recorded their ECG. Participants confirm their identity and ECG will be transmitted to a c

Participants will acquire a single-lead electrocardiogram (ECG) trace by placing minimum one finger of each hand on each small touchpad (3cm x 3cm) of the device for 30 seconds once daily on weekdays (12 months for intervention group and 6 months for waitlist group). The device is connected to their mobile phone wirelessly and an ECG trace will appear on the mobile phone confirming that the participant has recorded their ECG. Participants confirm their identity and ECG will be transmitted to a central monitoring system automatically. Participants will receive printed instructions on “how to download the Kardia app into their mobile phone” and “how to set up an account to use the app” when they receive the handheld ECG device. We will also send participants a mobile text message with a weblink that will take them to a training video produced by the device manufacturer (AliveCor Kardia). Participants can click on the weblink to watch the short video. In addition, study personnel will call each participant to support and help the participant overcome any technical difficulties and test run the device to make sure all participants can acquire an ECG and answer any questions participants may have. The above training and interaction will take approximately 30 – 60 minutes per participant. The intervention program will commence upon successful transmission of first ECG from each participant. Participants will receive daily notification to do their ECG. If no ECG is received for three consecutive days, our central review process will identify this, and a study personnel will then contact the participants by phone, text message or email. At 6-month follow up or upon diagnosis of atrial fibrillation (whichever occurs first), participants will be invited to participate in a survey and one-to-one interview to assess their satisfaction and feedback about their experience in the program.

Sponsors

Westmead Applied Research Centre, University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
75 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1) Community-dwelling people aged 75 or older 2) Have a smartphone that is able to operate AliveCor Kardia system 3) Be able to understand instructions in English

Exclusion criteria

1) Having documented diagnosis of AF 2) Having an implantable pacemaker or defibrillator, or both 3) Dementia 4) Inability to provide informed consent 5) Medical illness with anticipated life expectancy < 3 months

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 13, 2026