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

NCT04545723 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-09-20

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Qompium NV

    collaborator INDUSTRY

  • KU Leuven

    lead OTHER

Principal Investigators

  • Simon G Beerten, MD, MSc · KU Leuven

  • Tine Proesmans, MSc · Qompium NV

  • Bert Vaes, MD, PhD · KU Leuven

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-31
Primary Completion
2024-11-30
Completion
2024-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04545723 on ClinicalTrials.gov