Launch of a “Hearts of Athletes” research study to understand the effects of COVID-19 using Deloitte’s innovative digital platform with the support of the Joel Cornette Foundation

NEW YORK, August 9, 2021 / PRNewswire / – The Hearts of Athletes study, which is generously supported by the Joel Cornette Foundation, is now open and recruiting participants at the Duke Heart Center. Powered by Deloitte’s ConvergeHEALTH MyPath for Clinical, which runs on AWS, the study encourages athletes with and without COVID-19 to participate in the study. Secure data collection will help clinicians identify the prevalence of COVID-19-related heart inflammation in high performance athletes, and then establish associated symptoms and clinical features to support rapid and accurate diagnosis.

The Joel Cornette Foundation was created to honor Butler University basketball star Joel Cornette tragically died of a heart attack in 2016. “To carry on Joel’s legacy, we have the responsibility and the opportunity to improve lives and create opportunities for those in need,” said Christi Cornette, CEO of the Joel Cornette Foundation based in Cincinnati, Ohio. “A key part of our mission is to develop, support and provide guidance to underserved youth through education and community, but also wellness. We are honored to support the Duke Hearts study of Athletes because it truly supports this mission and we hope our involvement helps raise awareness and financially support this important study. ”

Deloitte’s ConvergeHEALTH MyPath for Clinical platform helps researchers achieve their goals by leveraging a new approach to digital clinical trials that includes innovative recruitment, enrollment, retention and event detection strategies, all in a unified digital user experience. This new approach, which does not require the athlete to be on-site at a medical facility, will help increase patient engagement and adherence, recruit a more dispersed and geographically diverse group of study participants, and to enable investigators to conduct a faster and more informed analysis.

“This study will allow us to enroll a population of young adults who prefer to engage on digital platforms and have travel limitations due to the pandemic,” said Dr. Manesh patel, head of cardiology at duke university Medicine School. “This approach has the potential to allow patients to participate wherever they are, to have a better experience, and to help physicians, researchers and others involved in the study collaborate and respond more quickly. . It could also give us the tools and a model for the future. studies.”

Why now
To date, the scientific community has lacked a large “library” containing data on the hearts of individuals who have performed at the highest levels of athletic competition. Additionally, once an athlete is finished competing at the highest level of their sport, there is little understanding and guidance on the management and medical care of the cardiovascular system in these athletes. This problem was only exacerbated with COVID-19, which posed an unprecedented public health challenge and is believed to impact the heart. Recent studies have identified inflammation of the heart – called myocarditis – as a possible side effect of COVID-19. For young adults, student athletes, and others without known cardiovascular disease, the actual incidence of myocardial involvement after COVID-19 infection and the rate of detection through different testing modalities is unknown. This has led to differential testing programs for athletes as part of a return to athletics around United States.

How it will work
As part of an innovative ‘direct to patient’ clinical trial model, athletes across the United States can identify themselves and download the iOS-based Hearts of Athletes app built on the MyPath platform for learn more about the study and decide if they want to participate. As part of this decision, they will receive clear information about the study and will have the option to consent directly in the platform. Once enrolled in the study, participants with and without COVID-19 will use their mobile devices to provide safe health information, such as symptoms and other patient-reported findings, by answering survey questions daily for 30 days. Additionally, participants will consent to have their anonymized heart images sent to the Duke Heart Center for blind analysis. NCAA collegiate athletes, professional athletes, or Olympic athletes (18 years of age or older) are eligible for the study.

The objectives of the study are to:

1. To determine the rate of COVID-19 myocarditis in athletes. This will be determined on the basis of an independent, blind-evaluated cardiovascular workup including a standard RMC with contrast.
2. Characterize the clinical features associated with COVID-19 myocarditis.
3. Determine the sensitivity of upstream data (symptoms, clinical features, ECG and echocardiogram) for the identification of COVID-19 myocarditis. Develop models that predict COVID-19 myocarditis.

“Studies like duke The Hearts of Athletes program is essential for understanding the implications of diseases like COVID-19, but also the overall cardiovascular implications of athlete behavior, ”said Brett Davis, Principal and Global Asset Leader, Deloitte Consulting LLP. “By taking this innovative decentralized digital testing approach and hosting it on AWS, Duke is able to reach a larger and more diverse set of patients faster, provide a better experience for trial participants, as well as collect richer data by enabling patients to self-report through a mobile experience practice. “

About MyPath for the clinic
MyPath for Clinical is a modular, patient-centric platform that can help accelerate the execution of digital clinical trials by taking a holistic approach to connect clinical trial participants, researchers and clinical research associates. It relies on cloud, mobile and connected technologies of modern medical devices to meet three major industry challenges: patient recruitment; patient engagement to promote retention; and protocol management. It allows:

• Personalized digital patient engagement with guidance and support throughout the clinical trial lifecycle with enhanced direct connectivity to researchers and patient communities.
• Improved patient experience through direct collection of patient data as well as a growing ecosystem of connected devices.
• Integrate data across multiple inputs, leveraging AWS with built-in analysis and reporting capabilities.
• Support for new digitally activated virtual clinical trial designs in multiple geographies.
• Advanced consent management to enable secure collection of robust real-world datasets for future clinical development.
• Support for the development of digital therapies based on a common platform and patient architecture.

MyPath for Clinical lays the foundation for the digitalization of clinical trials while improving patient and researcher engagement by providing training and resources; medication tracking and appointment management; symptom monitoring; patient-reported results and surveys; and visualization of data for patients. It also helps investigators by providing direct connectivity while organizing patient data into useful dashboards. This improves the experience for patients and researchers, and allows research teams to generate new information and provide better support to patients during a trial.

“Since our launch in 2014, ConvergeHEALTH has been particularly focused on building new innovative digital experience and data platforms that support the shift to personalized, value-based healthcare,” said Chris Zant, Principal Deloitte Consulting LLP and Managing Director of ConvergeHEALTH. “In today’s digital age, decentralized clinical trials represent an opportunity for radical change not only to advance our understanding of human health and disease, but also to make clinical trials more efficient and patient-centric. patient. “

For more information please visit: The Duke Heart Center; The Joël Cornette Foundation; ConvergeHEALTH MyPath for Clinical. The Joel Cornette Foundation is organizing the second annual JCF golf outing on August 9. All funds raised through the tournament will support the Hearts of Athletes study. To donate, please click here.

About Deloitte
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