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

NCT04545723 | Withdrawn

• 1 other identifier: B3222020000036
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atrial Fibrillation Paroxysmal

Keywords

atrial fibrillation; screening; FibriCheck; case finding

Outcome Measures

Primary Outcomes (1)

• Detection rate of AF in patients 65 years and older

  The detection rate of AF in both the control and intervention group will be calculated after 4 weeks. A significant difference in both groups will be noted. Compared with previous studies of similar design (32-34), we will realistically assume a 2-fold increase in the detection rate of AF in the intervention group to be significant.

  4 weeks for each participant

Secondary Outcomes (3)

• Thromboembolic complications

  12 months

• Death

  12 months

• Compliance

  12 months

Study Arms (2)

Control group

NO INTERVENTION

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

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.

Device: FibriCheck

Interventions

FibriCheck DEVICE

FibriCheck is a smartphone application that measures hearth rhythm using the phone's built-in camera. It is able to detect aberrant rhythms, such as atrial fibrillation.

Intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• The patient is 65 years or older.
• 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.
• If the patient will be prescribed the FibriCheck® app, he/she signs the relevant patient consent form

You may not qualify if:

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

Sponsors & Collaborators

• KU Leuven: lead
• Qompium NV: collaborator

Related Publications (1)

• 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.

  PMID: 34372905 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Simon G Beerten, MD, MSc

  KU Leuven

  PRINCIPAL INVESTIGATOR

• Tine Proesmans, MSc

  Qompium NV

  PRINCIPAL INVESTIGATOR

• Bert Vaes, MD, PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: September 11, 2020
• Study Start: October 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share