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Activity Trackers Enlisted in Clinical Health Trials

Consumer activity trackers like Fitbit are increasing becoming a tool used by researchers in clinical trials that look at activities that could stop diseases from progressing or recurring.

(TNS) -- When UCSF prostate cancer patient Joe Casserly agreed to participate in a clinical trial, researchers handed him a Fitbit.

“What I loved about the Fitbit, or any kind of device like this, is it gave me quantitative data for what I’m doing,” said Casserly, 58, of San Francisco, an IT asset manager for a large architectural and engineering firm.

Consumer activity trackers like Fitbit are increasing becoming a tool used by researchers in clinical trials like Casserly’s, which look at activities that could stop diseases from progressing or recurring.

More than 100 studies listed on the federal government’s trial-tracking website feature Fitbits, with smaller numbers relying on the Apple Watch or Jawbone, Garmin, Pebble and other devices.

Wearables have made their way into the precision-oriented world of clinical trials in part because patients like them, they’re easy to use and more convenient for participants than coming to a clinic to be monitored. While the devices may lack clinical-grade accuracy, particularly when it comes to heart-rate technology and tracking calorie burning, they are considered far more accurate that self-reported data.

Casserly, who had not used an activity monitor before, became a convert. “Once (the trial) was over, I turned it in and bought myself one,” he said.

Wearable health devices are big business, and their popularity gives researchers another way to monitor patients participating in a wide range of trials. Researchers are using them to study sleep patterns among adolescents, physical rehabilitation of heart patients, the relationship between activity and epilepsy in children and ways to reduce the risk of falling among seniors.

The U.S. wearable health care market, estimated at $2 billion in 2014, is expected to jump to more than $41 billion in 2020, driven primarily by the need to track such medical conditions as obesity, diabetes, sleep disorders and cardiovascular disease, according to data from Soreon Research.

A survey released in May by the Association of Clinical Research Organizations described the use of wearables as “a huge opportunity” for increased efficiency and convenience in clinical trials.

Oakland’s Samuel Merritt University, in collaboration with San Francisco State University, is using the devices to study mobility in patients with multiple sclerosis. Meanwhile, UCSF is involved in a number of trials using health-tracking wearables, particularly with cancer patients.

June Chan, UCSF professor of epidemiology, biostatistics and urology, said researchers are going beyond standard activity tracking. Chan is recruiting prostate cancer patients for a more complex trial using wearables that synch with a custom app to deliver personalized exercise sessions.

“Not only is the wearable a motivational tool for the participant and a device for collecting objective heart-rate data for research, but it is syncing with a custom-made app,” she said.

While some trials rely on existing wearables, other trials are testing prototypes that could help people better manage their health, such as monitoring pain or helping patients comply with their medication regimens, said Harry Wang, senior director of research at the Dallas market research and consulting firm Parks Associates.

Wang said there’s still debate over how valuable the data from Fitbits and other consumer monitoring devices will be. “This is in the very early stages of exploring and determining how much value this consumer data will have and how much it adds to the clinical trial process,” he said.

Fitbit is betting on the value of its information. The San Francisco company announced last month that with its Fitabase research, it has collected more than 2 billion bits of Fitbit data on behalf of research customers.

“Supporting the research community is critical to our efforts as we continue to grow as a digital health company,” said Amy McDonough, vice president and general manager of Fitbit Group Health, in a statement.

Still, concerns over privacy and accuracy continue.

Fitbit is involved in a class-action lawsuit regarding the accuracy of its heart-rate monitoring. The study by the Association of Clinical Research Organizations, which represents medical researchers, urged federal regulators to offer more guidance for using the devices in trials, particularly when it comes to data security and privacy.

But Jeff Moroso of Pacifica, who was diagnosed with colon cancer in 2013, didn’t hesitate to participate in a UCSF trial that used Fitbit to monitor his activity.

“Anything I can do for UCSF by the way of research, I’m on it,” he said. “I like helping out. There’s known research that shows the more exercise you get after cancer, the longer you’ll live.”

While the study gave patients a secure sign-in to access their data, the 71-year-old retired contractor said he doesn’t care if anyone finds out that he logs more than 10,000 steps a day — often more than three times that.

“I don’t have anything to hide,” Moroso said.

©2016 the San Francisco Chronicle, Distributed by Tribune Content Agency, LLC.