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Novel study leverages health app and electronic health records from consented patients to track long-term effects of COVID-19

Photo of doctor showing a patient something on an iPad. (Photo by Getty Images)
Researchers are using a novel health platform that links them to shared electronic health records from consented patients to track long-term effects of COVID-19. (Photo by Getty Images)

Researchers are using a novel health platform that links them to shared electronic health records from consented patients to track long-term effects of COVID-19 in a new study by The University of Texas Health Science Center at Houston (UTHealth).

UTHealth is one of eight U.S. sites for the INSPIRE trial (Innovative Support for Patients with SARS COV-2 Infections Registry), and patients will be recruited from Memorial Hermann-Texas Medical Center.

The trial is a prospective cohort study, meaning researchers will follow participants over time to observe their outcomes. Patients will partner with researchers to share their data for the study by connecting their electronic health records to the Hugo Health platform. Participants will be able to share their data directly with the research team so they can keep up with the participant’s medical developments.  Additionally, participants will receive brief follow-up surveys every three months over an 18-month period to report health status and ongoing symptoms.

“This is a very novel and important study,” said Ryan Huebinger, MD, assistant professor in the Department of Emergency Medicine at McGovern Medical School at UTHealth and co-principal investigator of the study. “Typically, in a cohort study, researchers have to physically see the patient or at least contact them, and that can result in missing people and can be costly. Using this platform is novel because we don’t have to schedule additional appointments or ask questions like ‘How long were you hospitalized?’ – we can automatically see that in their records and survey submissions.”

The study was created to help physicians learn more about the long-term symptoms of COVID-19, like brain fog, fatigue, depression, and cardiovascular issues.

“We know that there are multiple long-term symptoms of COVID, but one of the only ways to study them is through a prospective cohort trial like this to see how long the symptoms lasts, and who is affected. The first step in figuring out the problem is understanding the problem,” Huebinger said.

Mandy J. Hill, DrPH, MPH, associate professor in the Department of Emergency Medicine and co-principal investigator of the study, said it offers community members who didn’t have the virus the chance to participate in research, since only symptoms and a COVID-19 test are required.

“We’re expecting people who tested negative after having symptoms to make up about 25% of the study. That group will be our control group to be able to compare things like prevalence and risk factors,” Huebinger said.

Hill and Huebinger prioritized patient security and trial compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the federal law that protects patient health information from being disclosed without their knowledge or consent.  

“We’ve taken every step to ensure the consent process would be extremely transparent for patients, that health records will not be used for anything outside of this research study, and that the patient can withdraw their consent at any point,” Hill said.

“This study allows us to utilize a less commonly discussed aspect of HIPAA – the part that empowers people to access their health information and choose to share it in a good way, which they can fully control. This study allows willing patients to be able to use their data to help answer timely and important research questions,” Huebinger said.

“This is not going to be the last pandemic. The more information we can gather across communities now will give us a leg up when the next pandemic happens, so that we can be more prepared to take steps toward prevention,” Hill said.

Eligible patients must be at least 18, experienced symptoms of the virus, and have been tested for COVID-19 in the last four weeks. Research coordinators make the initial contact with patients in the emergency department at Memorial Hermann-TMC, inform them about the study, and coach them on how to navigate screening and enrollment. After going through rigorous screening to ensure they are eligible, patients consent through the platform on their laptop, tablet, or phone and link their patient portal to their regular hospital or clinic. Researchers hope to enroll at least 300 patients at the Houston site, while the INSPIRE trial seeks to enroll 4,800 people total.

Hill said Houston is an ideal location for a study like this, and the possibilities for what they might be able to learn are endless.

“We’re excited about our Houston site since the city is so diverse and populous – we should be able to have a pretty good representation of the general public. The INSPIRE trial is a great step toward increasing access to clinical studies outside of a clinical environment, and if we can master it, could help expand opportunities for patients to engage in research nationwide,” Hill said.

“There’s such great potential for numerous research findings to come out of this study. We could find out if people in Houston are suffering from post-COVID-19 symptoms differently than other parts of the country, whether minorities are more affected by long-hauler symptoms, and if certain interventions work better than others.”

INSPIRE is funded through a contract with the U.S. Centers for Disease Control and Prevention to study the long-term outcomes of COVID-19 infection.

Hill and Huebinger said they are working on expanding enrollment to urgent care centers in Houston.

Co-investigators for the study from the Department of Emergency Medicine include Summer Chavez, DO, MPH, an assistant professor; and Elizabeth Vidales, MPH, MBBS, a research coordinator.

Media inquiries: 713-500-3030

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