Atrial Fibrillation ParoxysmalNCT04545723
The Effect of a Case-finding App on the Detection Rate of Atrial Fibrillation in Primary Care Patients
A study testing FibriCheck in people with Atrial Fibrillation Paroxysmal, run by KU Leuven.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation Paroxysmal
- What is being tested?
- FibriCheck
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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…
About this study
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
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.
Read more
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
- Being tested
- FibriCheck
- Keywords
- atrial fibrillation, screening, FibriCheck, case finding
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibriCheckDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: FibriCheck |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks for each participant
Secondary outcomes (3)
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.
Measured: 12 months
Death
We will keep track of all-cause mortality during the study period, as well as difference in mortality between control and intervention populations.
Measured: 12 months
Compliance
We will keep track of patient compliance during the study period (e.g. minimum number of measurements with FibriCheck®).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2020
- Study startOct 2024 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: Insufficient amount of recruited practices due to workload and COVID19.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation ParoxysmalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Qompium NV
- Responsible party
- Principal investigator, Bert Vaes, KU Leuven
- Investigators
- Simon G Beerten, MD, MSc, Principal investigator, KU LeuvenTine Proesmans, MSc, Principal investigator, Qompium NVBert Vaes, MD, PhD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04545723
- Sponsor's protocol ID
- B3222020000036
- Status last verified
- Sep 2024
- First submitted
- 4 Sep 2020
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 34372905
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04545723
- Acronym / sponsor ID
- B3222020000036
- Conditions
- Atrial Fibrillation Paroxysmal
- Keywords
- atrial fibrillation, screening, FibriCheck, case finding
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient amount of recruited practices due to workload and COVID19.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Qompium NV
- Study start
- Oct 2024 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 11 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: FibriCheckIn 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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…
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FibriCheckFibriCheck 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. | Device | Intervention group |
Primary outcome
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.
3 secondary outcomes
Thromboembolic complications
Time frame: 12 months
Death
Time frame: 12 months
Compliance
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Derived from this study: PubMed 34372905Beerten 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.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon G Beerten, MD, MSc principal investigator
KU Leuven
Tine Proesmans, MSc principal investigator
Qompium NV
Bert Vaes, MD, PhD principal investigator
KU Leuven
Questions about this trial
What is this clinical trial studying?
A study testing FibriCheck in people with Atrial Fibrillation Paroxysmal, run by KU Leuven.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate of AF in patients 65 years and older (time frame: 4 weeks for each participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04545723, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.