The Rise of Remote EKG Monitoring
The COVID-19 era is one of exceptional innovation. The pandemic is acting as a catalyst for the adoption of technological advancements that will continue to drive improvements in healthcare even after the pandemic has passed. There are several examples of this in the realm of clinical trials, including the increased use of personal mobile devices for patient-collected, remote ECG/EKG reads.
Upon the onset of the pandemic, the FDA issued new guidance that enabled AliveCor to expand the use of KardiaMobile 6L to help physicians measure and monitor QT intervals in patients. There was greater than usual demand for ECG/EKG testing at the time because certain drugs being tested for the treatment of COVID-19 were known to have dangerous heart rhythm side effects, including prolonged QT (Figure 1).
At-Home EKG Testing Benefits Patients
There are several benefits to using KardiaMobile 6L over traditional ECG/EKG testing methods. For patients, there is the benefit of increased safety as they can administer the test themselves at home. For the ECG/EKG technicians that would otherwise facilitate the testing, there are the benefits of decreased risk of exposure, reduced use of scarce personal protective equipment (PPE), and time better spent on the “front lines.”
Figure 1: With the KardiaMobile6L, clinical trial patients administer their own ECG/EKG testing from the comfort of home.
In addition to pandemic-time safety, there are other benefits of at-home, patient-administered ECG/EKG collection. People are more relaxed and comfortable at home, which can lead to improved data quality (similar to countering the white coat effect by collecting blood pressure data at home).
Also, sometimes patients experience conditions like atrial fibrillation at home, but the symptoms pass by the time they get to the testing site. With personal ECG/EKG devices, patients can document their experiences without ever going to the doctor. Remote management and remote patient monitoring are trends that are here to stay following COVID-19.
Virtual Trial Tech Enables Study Continuity
In a recent industry survey, when asked, What changes are you making to existing trial models to address the challenges of the COVID-19 pandemic? 82% of clinical trial professionals reported that their organizations were adopting virtual trial technologies. Devices such as the KardiaMobile 6L have been instrumental to the continuation of clinical trials during this extraordinary time and will continue to be a critical ingredient in safe, efficient, and high-quality studies through and after the pandemic.
Ellen Street is the Executive Vice President of Cardiac Safety at ERT