The Effect of a Case-finding App on the Detection Rate of Atrial Fibrillation in Primary Care Patients

Catholic University (KU) of Leuven

Status: Withdrawn

Conditions: Atrial Fibrillation Paroxysmal

Treatments: Device: FibriCheck

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04545723

B3222020000036

Details and patient eligibility

About

Atrial fibrillation is a cardiac arrhythmia commonly encountered in a primary care setting. Current screening is limited to pulse palpation and ECG confirmation when an irregular pulse is found. Paroxysmal atrial fibrillation will, however, still be difficult to pick up. With the advent of smartphones, screening could be more cost-efficient by making use of simple applications, lowering the need for intensive screening to discover (paroxysmal) atrial fibrillation.

This cluster randomized trial will examine the effect of using a smartphone-based application such as FibriCheck® on the detection rate of atrial fibrillation in a Flemish general practice population. This study will be conducted in 22 primary care practices across the Flanders region of Belgium and will last 12 months. Patients above 65 years of age will be divided in control and intervention groups on the practice level. The control group will be subjected to standard opportunistic screening only, while the intervention group will be prescribed the FibriCheck® app on top of this opportunistic screening. The difference in detection rate between control and intervention groups will be calculated at the end of the study.

The investigators will use the online platform INTEGO for pseudonymized data collection and analysis, and risk calculation.

Smartphone applications might offer a way to cost-effectively screen for (paroxysmal) atrial fibrillation in a primary care setting. This could open the door for the update of future screening guidelines.

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. The patient is 65 years or older.
2. The patient has an electronic medical record (EMR) in the practice. This EMR contains all the patient information, for instance regarding medical history and medication and is managed by the general practitioner.
3. If the patient will be prescribed the FibriCheck® app, he/she signs the relevant patient consent form

Exclusion criteria

1. The patient has already been diagnosed with AF.
2. The patient is already under anticoagulant therapy.
3. The patient has a pacemaker. Active pacing during measurements influences the results obtained with the FibriCheck® app (26).
4. The patient is unable to use the FibriCheck® application independently due to cognitive disorders, functional limitations, visual impairments...

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Control group

No Intervention group

Description:

In every cluster designated as a control group, patients aged 65 or older will be selected according to the inclusion criteria. The difference here is that patients will be given the standard opportunistic screening instead: pulse palpation and a 12-lead ECG when an irregular rhythm is found. This is current best practice.

Intervention group

Active Comparator group

Description:

In every cluster designated as an intervention group, patients aged 65 or older will be selected according to the inclusion criteria. Within this group, high-risk patients will be identified using the CHARGE-AF score, and will be prescribed the FibriCheck® app.

Treatment:

Device: FibriCheck