The study, involving 476 patients recruited through 18 health systems, was done on a completely virtual platform, with researchers communicating with and collecting data from patients through an mHealth app and online portal. It may serve as a model for future clinical studies.
Researchers at Henry Ford Health are celebrating the results of a multi-institutional heart failure study that was conducted entirely on a virtual care platform, saying it could be the model for future clinical studies.
Some 476 patients were enrolled in the study through 18 participating health systems between March 2020 and February 2021 – during the height of the pandemic, when every effort was being made to reduce in-person treatments. Researchers connected with study participants through an mHealth app and online portal, where they communicated with patients and collected data from surveys and Fitbit devices. Medications used in the study were mailed to the participant's home.
“What this study demonstrated is that you can execute a virtual clinical trial with greater efficiency than a traditional, in-person trial,” David Lanfear, MD, an advanced heart failure specialist at Henry Ford Health and one of eight authors of a report on the study recently published in Nature Medicine, said in a press release. “This could lead to more people getting involved in medical research because of the convenience of participating from home and the potential for lower costs and faster results.”
The study sought to test the value of a sodium-glucose co-transporter 2 inhibitor (SGLT2i), a newer class of drugs used in heart failure treatment and shown to improve clinical outcomes. It also looked at how these drugs could be applied to patients at home, how it might affect their quality of life, how patients could report their own data and observations through a connected health channel, and how patient-reported outcomes might affect treatment and results.
"The costs of conducting clinical trials have risen substantially over time, leading to calls for novel study designs to generate the evidence needed to guide care," Lanfear and his colleagues said in the report. "A large component (up to 50%) of these costs is the burden of data collection on sites, which have nearly quadrupled from 1990 to 2010. The ongoing Coronavirus Disease 2019 (COVID-19) global pandemic further highlighted the challenges of traditional study designs that depend on in-person visits and resource-intense data acquisition and verification. In response to the growing demands to make clinical trials more pragmatic, novel study designs have been implemented, from leveraging existing registries for data collection to the use of electronic health records to identify, enroll, randomize and follow-up eligible patients. Although the innovation of eliminating in-person clinical trial visits has been proposed, it has not, to our knowledge, been tested on a large scale."
Lanfear and his colleagues said the virtual study may have been "the first randomized drug study of its kind in cardiology." It could also set the bar for clinical studies by eliminating geographical barriers to patient recruitment, allowing healthcare organizations to find the right participants no matter where they live. And the platform allows researchers to better understand how patients are affected at home, and in their daily lives and routines, while gathering biometric and other data in real time.
“Improving symptom burden is one of our main goals for managing heart failure patients,” he said in the press release. “Clearly, what this study showed is that these agents have meaningful impact on patients within just weeks of starting treatment, which we were able to prove using a virtual research approach.”
The platform also reduces barriers to participation for patients. Lanfear noted enrollment for this study was roughly five times faster that in traditional in-person heart failure clinical trials.
Eric Wicklund is the associate content manager and senior editor for Innovation, Technology, and Pharma for HealthLeaders.