Researchers at the Duke Heart Center in Durham, North Carolina, are recruiting avid athletes both with and without COVID-19, in a study looking into how the virus impacts their hearts. The research (using the Deloitte ConvergeHEALTH MyPath for Clinical platform), aims to identify the prevalence of COVID-related heart inflammation in high-end athletes, then establish symptoms and clinical features to help promote timely, accurate diagnosis.
The study is backed by the Joel Cornette Foundation, named after the Butler University basketball player who succumbed to a heart attack five years ago. According to researchers, the use of the Deloitte platform will enable the team to increase patient engagement and adherence, recruit from a geographically dispersed and diverse pool, and conduct analysis more efficiently and effectively, through digital technology that enables research to be conducted remotely.
"This study will enable us to enroll a population of young adults that prefer to engage on digital platforms and have travel limitations due to the pandemic," said study lead Manesh Patel, chief of cardiology at Duke University School of Medicine. "This approach has the potential to allow patients to participate from wherever they are, have a better experience, and helps the physicians, investigators and others involved in the study collaborate and respond more quickly; it could also give us the tools and a template for future studies."
According to researchers, to date, there has been no significant “library” of data on the cardiological health of high-end athletes. Further, once such athletes are done competing at the highest levels of their sport, there has been little information or guidance on management and care of their hearts.
Unsurprisingly, the relative lack of data has carried over to data on how the COVID-19 virus might impact the hearts of athletes. Recent studies have identified inflammation of the heart (myocarditis) as a possible side effect of COVID-19.
In a direct-to-patient study model, athletes from across the US (collegiate, professional, and Olympic athletes 18 or older are eligible) can self-identify and download the Hearts of Athletes app to learn more and decide whether they are interested in participation. The process is designed to present potential participants with information about the study and consent directly in the platform.
After enrollment, participants (either with COVID-19 or without) use the app to securely enter their health data, symptoms, and other info, answering survey questions each day for 30 days. Enrollees also consent to share de-identified cardiac images with the Duke Heart Center team for blinded analysis.
According to researchers, the objectives are:
- Determining the rate of COVID-19 myocarditis in athletes
- Characterizing clinical features associated with COVID-19 myocarditis
- Ascertaining the sensitivity of upstream data (symptoms, clinical features, ECG, and echocardiogram) for the identification of COVID-19 myocarditis.
"Studies like Duke's Hearts of Athletes program are critical for understanding the implications of diseases like COVID-19, but also the overall cardiovascular implications of athlete behavior," said Brett Davis, principal and Global Assets leader with Deloitte Consulting. "By taking this innovative decentralized digital trial approach, and hosting it on AWS, Duke is able to reach a broader and more diverse set of patients quicker, deliver a better experience for trial participants, as well as collect richer data by enabling patients to self-report through a convenient mobile experience.”
MyPath for Clinical is a modular platform engineered to help accelerate digital trial execution, through technology that connects participants, investigators, and clinical research associates. It uses cloud, mobile, and wearables technologies to promote better patient recruitment, patient engagement, and protocol management.
