Dr. David Albert of AliveCor explains how patient-collected data can solve some of the problems facing clinical trials during the COVID-19 pandemic, as well as the long-term outlook on changes in data collection for clinical research.
The AliveCor KardiaMobile 6L is a 6-lead device for patient-collected ECG/EKG reads.
AliveCor received the FDA’s approval for emergency use of the KardiaMobile 6L. Some drugs being tested as treatments for COVID-19 may cause QT prolongation, potentially leading to a serious cardiac arrhythmia. The KardiaMobile 6L is capable of monitoring QTc and able to keep people safe while they’re using experimental COVID-19 treatments.
Taking ECGs in hospitals treating patients with coronavirus requires staff to sterilize the machine and use personal protective equipment, when those resources may be better used on the “front lines” in hospitals. Now, using the KardiaMobile 6L, patients are able to complete their own ECGs / EKGs without having to use valuable PPE or put ECG/ EKG techs at risk.
There are increasing demands from sponsors who want to do virtual trials or conduct trials within unique venues, like refugee camps. In these cases, the KardiaMobile 6L can provide a solution to measure the potential impacts of a treatment on a patient’s QT interval.
The KardiaMobile technology has proven that a person if trained correctly and with practice, can collect clinical-quality ECGs at home by themselves. It’s also been demonstrated that this technology can be used even in difficult populations.
COVID-19 has been the greatest catalyst to change in primary care; for example, telemedicine has become a standard way of providing care. Patients have responded positively to it. This sentiment will likely carry over into the clinical research industry.
People are more relaxed and comfortable at home, which can lead to improved data (similar to the white coat effect in collecting blood pressure data at home.) Sometimes patients may experience conditions like atrial fibrillation at home; by the time they get to the hospital or doctor, it’s passed. 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.
“Digital health” is just becoming health. The smartphone is now incorporated into every part of our lives; that’s going to become the principal entry point for many people into healthcare. Smart devices keep becoming more and more sophisticated, and we’ll continue to see more remote monitoring and attempts to prevent illness by catching issues early and encouraging changes in lifestyle and healthcare.