COVID-19 has wreaked havoc around the globe, with more than 310,000 fatalities occurring in the United States alone. While much has been learned about the virus since it was first detected, the long-term effects on the health of coronavirus survivors may take years to understand. To find some answers, investigators from the Yale School of Medicine and partners across the country are launching a nationwide study of patients who were infected.
INSPIRE (Innovative Support for Patients with SARS COV-2 Infections Registry) is a Centers for Disease Control and Prevention-funded project led by Yale University with Rush University Medical Center; the University of Washington; the University of Texas Health Science Center at Houston; the University of Texas Southwestern Medical Center; the University of California, Los Angeles; the University of California, San Francisco; and Thomas Jefferson University. They will track 4,800 individuals to assess the longitudinal outcomes of infections on various age groups over a two-year period.
With a philosophy that views participants as part of the team — ensuring patients’ involvement, engagement, and control over their data — researchers will look closely at healthcare utilization, ongoing clinical events, and physical and mental function, including neurocognitive function and fatigue.
INSPIRE participants will register using the Hugo platform, a health data system that honors individuals’ HIPAA right to access their own health information and collects health data on their behalf, while maintaining the highest degree of confidentiality. This will allow essential, large-scale data gathering.
“Every day we learn something new about COVID-19, often to find out that what we believed to be true last month is no longer the case,” said Arjun Venkatesh, MD, MBA, MHS, associate professor in the Department of Emergency Medicine at the Yale School of Medicine and co-principal investigator at the Yale University site. “The INSPIRE registry provides the opportunity to elucidate broader patient-oriented and centered outcomes of COVID-19 and take a long-term view likely to define the legacy of this pandemic in the US.”
“This disease will be with us for years to come and understanding the impact on the health of survivors will be essential to our understanding of how to treat it,” said Erica Spatz, MD, a preventive cardiologist and associate professor in the Section of Cardiovascular Medicine, a health services researcher at the Center for Outcomes Research and Evaluation (CORE) at the Yale School of Medicine, and co-principal investigator at Yale. “We are working with a phenomenal group of researchers from across the country and with Hugo Health to put together a virtual community that will enable research participants to fully engage with us as partners to advance our understanding of the ongoing impact of COVID-19.”
The INSPIRE Study Team has partnered with Yale New Haven Health (YNHH) to share study details with patients and promote enrollment in the study. “YNHH has supported the Connecticut community by making high quality COVID-19 testing accessible across the state,” said Christian Pettker, MD, professor of obstetrics, gynecology, and reproductive sciences, and associate chief quality officer at Yale Medicine. “In addition to caring for patients with COVID-19, we are also helping them understand the long-term effects of this disease through registries like INSPIRE, our specialty clinics, and our Post-COVID-19 Recovery Program.”
Recruitment for the INSPIRE study began December 1, with expected enrollment of 3,600 COVID-19 survivors and 1,200 control subjects. The INSPIRE study team’s enrollment goals will greatly benefit from its partnership with YNHH testing services as they have established numerous fixed and mobile testing sites throughout Connecticut and have conducted more than 500,000 COVID-19 tests to date. The study will gather information through ongoing surveys and will not require participants to see a physician.
A community advisory board is planned, made up of participants and researchers, to inform the overall and likely evolving direction of the study.