Montana State University researchers have developed a new medical device aimed at improving the safety and experience of clinical trial participants, particularly those in rural areas. The device, called TrialWear, is a wearable electronic patch that links to essential information about patients’ clinical trial requirements through a scannable code. When a patient enters a medical facility, the device prompts them via text message to show the code to healthcare providers.
Elizabeth Johnson, assistant professor in MSU’s Mark and Robyn Jones College of Nursing and inventor of TrialWear, explained that this technology addresses gaps in communication between research teams and local hospitals. According to Johnson, these gaps can result in patients being removed from potentially lifesaving trials if local care decisions conflict with study protocols. She noted that most clinical trial participants are recruited from large urban hospitals due to limited coordination with rural sites.
“Without clinical trial participants, we cannot get new drugs to bedside,” Johnson said. “When surveyed, most people here in the U.S. are willing to go on a clinical trial. But only a small fraction may get to be on a clinical trial due to lack of access or safety issues. We’re looking to narrow that gap.”
Johnson also pointed out that participating in trials can offer access to treatments for patients who have exhausted other options. However, if healthcare providers unknowingly administer medications that interact negatively with ongoing trials, patients may lose their eligibility.
Historically, paper cards have been used by patients for this purpose but are often misplaced. TrialWear instead provides digital access to up-to-date information about medications and trial guidelines through an online database. The concept was inspired by technologies used for tracking aid among refugee populations.
After feedback from more than 300 patients during prototype testing over several years, the team finalized the design in July. With assistance from MSU’s Technology Transfer Office, plans are underway for commercialization so hospitals can distribute TrialWear patches directly to eligible patients. Bozeman-based A&E Design is handling packaging development.
Funding for the project has come from multiple sources including federal agencies such as the National Science Foundation and National Institutes of Health; professional organizations like the American Nurses Association; university grants; and economic development initiatives. The team recently applied for additional funding from the National Cancer Institute to expand partnerships with academic medical centers nationwide.
Collaboration has been central throughout development: Johnson worked alongside faculty and students from engineering and business backgrounds at MSU as well as specialists at MIT who helped refine components of the device.
Initial versions were designed as bracelets but were changed after studies showed nurses focused attention on patients’ chests rather than wrists during care interactions—prompting redesign into a chest-worn patch now reduced in size and made waterproof.
Eric Sproles, director of MSU’s Geospatial Core Facility—which contributed geolocation technology—explained his team adapted package-tracking software so alerts would trigger when users entered any medical facility within defined regions.
“In terms of addressing and improving rural health care, there’s definitely a geospatial component to it that’s quite powerful,” Sproles said. “I feel incredibly honored to be a part of this work.”
He added: “This effort really speaks to the value of collaboration and innovation, and how getting motivated people together can lead to a great outcome. That’s something MSU really excels at, is connecting people with different types of expertise to solve real-world problems.”
Community members interested in learning more or participating in final testing can contact Johnson at elizabeth.johnson37@montana.edu.
