Clinical trial NCT04545723: The Effect of a Case-finding App on the Detection Rate of Atrial Fibrillation in Primary Care Patients
Official title: The Effect of a Case-finding App on the Detection Rate of Atrial Fibrillation Compared with Opportunistic Screening in Primary Care Patients: Protocol for a Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Atrial Fibrillation Paroxysmal
Keywords: atrial fibrillation
screening
FibriCheck
case finding
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Qompium NV
First posted: 2020-09-11
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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.


Eligibility criteria: 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...

Primary outcomes:
measure: Detection rate of AF in patients 65 years and older
timeFrame: 4 weeks for each participant
Secondary outcomes:
measure: Thromboembolic complications
timeFrame: 12 months
measure: Death
timeFrame: 12 months
measure: Compliance
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: KU Leuven
name: Simon G Beerten, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Qompium NV
name: Tine Proesmans, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven
name: Bert Vaes, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beerten SG, Proesmans T, Vaes B. The effect of a case-finding app on the detection rate of atrial fibrillation compared with opportunistic screening in primary care patients: protocol for a cluster randomized trial. Trials. 2021 Aug 9;22(1):525. doi: 10.1186/s13063-021-05497-x.