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

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ClinicalTrials.gov Identifier: NCT04545723
Recruitment Status : Not yet recruiting
First Posted : September 11, 2020
Last Update Posted : August 2, 2021
Sponsor:
Collaborator:
Qompium NV
Information provided by (Responsible Party):
Bert Vaes, KU Leuven

Study Description
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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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Paroxysmal Device: FibriCheck Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8765 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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
Estimated Study Start Date : January 2022
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control group
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.
Active Comparator: Intervention group
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
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.


Outcome Measures
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Primary Outcome Measures :
  1. Detection rate of AF in patients 65 years and older [ Time Frame: 4 weeks for each participant ]
    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.


Secondary Outcome Measures :
  1. Thromboembolic complications [ Time Frame: 12 months ]
    We will track incidence of transient ischemic attack or ischemic stroke during the study period, in addition to the eventual difference between both study populations.

  2. Death [ Time Frame: 12 months ]
    We will keep track of all-cause mortality during the study period, as well as difference in mortality between control and intervention populations.

  3. Compliance [ Time Frame: 12 months ]
    We will keep track of patient compliance during the study period (e.g. minimum number of measurements with FibriCheck®).


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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…
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04545723


Contacts
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Contact: Tine Proesmans, MSc +32476856148 tine.proesmans@fibricheck.com
Contact: Simon G Beerten, MD, MSc +32479723648 simon.beerten@kuleuven.be

Sponsors and Collaborators
KU Leuven
Qompium NV
Investigators
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Principal Investigator: Simon G Beerten, MD, MSc KU Leuven
Principal Investigator: Tine Proesmans, MSc Qompium NV
Principal Investigator: Bert Vaes, MD, PhD KU Leuven
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bert Vaes, Professor, KU Leuven
ClinicalTrials.gov Identifier: NCT04545723    
Other Study ID Numbers: B3222020000036
First Posted: September 11, 2020    Key Record Dates
Last Update Posted: August 2, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data will be available upon reasonable request. The trial's dataset will be held at the University of Leuven, Belgium, and can be shared upon contacting the principal investigator.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bert Vaes, KU Leuven:
atrial fibrillation
screening
FibriCheck
case finding
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes