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

Primary Purpose

Atrial Fibrillation Paroxysmal

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FibriCheck
Sponsored by
KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Atrial Fibrillation Paroxysmal focused on measuring atrial fibrillation, screening, FibriCheck, case finding

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts 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…

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    Control group

    Intervention group

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Thromboembolic complications
    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.
    Death
    We will keep track of all-cause mortality during the study period, as well as difference in mortality between control and intervention populations.
    Compliance
    We will keep track of patient compliance during the study period (e.g. minimum number of measurements with FibriCheck®).

    Full Information

    First Posted
    September 4, 2020
    Last Updated
    September 2, 2023
    Sponsor
    KU Leuven
    Collaborators
    Qompium NV
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04545723
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2024 (Anticipated)
    Primary Completion Date
    January 2024 (Anticipated)
    Study Completion Date
    March 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    KU Leuven
    Collaborators
    Qompium NV

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrial Fibrillation Paroxysmal
    Keywords
    atrial fibrillation, screening, FibriCheck, case finding

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    8765 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm 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.
    Arm Title
    Intervention group
    Arm Type
    Active Comparator
    Arm 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.
    Intervention Type
    Device
    Intervention Name(s)
    FibriCheck
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Detection rate of AF in patients 65 years and older
    Description
    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.
    Time Frame
    4 weeks for each participant
    Secondary Outcome Measure Information:
    Title
    Thromboembolic complications
    Description
    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.
    Time Frame
    12 months
    Title
    Death
    Description
    We will keep track of all-cause mortality during the study period, as well as difference in mortality between control and intervention populations.
    Time Frame
    12 months
    Title
    Compliance
    Description
    We will keep track of patient compliance during the study period (e.g. minimum number of measurements with FibriCheck®).
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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…
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tine Proesmans, MSc
    Phone
    +32476856148
    Email
    tine.proesmans@fibricheck.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Simon G Beerten, MD, MSc
    Phone
    +32479723648
    Email
    simon.beerten@kuleuven.be
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Simon G Beerten, MD, MSc
    Organizational Affiliation
    KU Leuven
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Tine Proesmans, MSc
    Organizational Affiliation
    Qompium NV
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Bert Vaes, MD, PhD
    Organizational Affiliation
    KU Leuven
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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.
    Citations:
    PubMed Identifier
    34372905
    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.
    Results Reference
    derived

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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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