App stores are exploding with programs designed to help people monitor their health using a smart phone. But the majority of these apps merely make it easier for patients to record health measures, such as weight or blood pressure. It’s unclear if they actually significantly improve health behavior.
Joseph Cafazzo, a biomedical engineer at the University Health Network, in Toronto, and collaborators have developed apps that do much more. Their apps interface wirelessly with medical devices—including a blood-pressure monitor and a blood-sugar monitor—and offer suggestions based on the readings. They found that people using the programs lowered their blood pressure and were more vigilant about monitoring and testing their blood sugar.
One of the most interesting findings was that doctors seemed to play no role in the change. “It was solely patients becoming responsible for their own care,” says Cafazzo, who heads the university’s Centre for Global eHealth Innovation.
Cafazzo’s efforts were partly a result of the growing use of smart phones as medical tools, as well as an increase in remote and home monitoring devices that are moving medicine outside the doctor’s office.
But unlike many existing monitoring systems, Cafazzo sees his work bringing greater responsibility to the patient. “The goal of classic home monitoring is to collect information and deliver it to the doctor, who has to analyze and act on it, then return that information to the patient,” he says. “It’s not really self-care.”
In a yearlong clinical trial of the system involving 110 patients with diabetic hypertension, Cafazzo and colleagues had some people use the app and a home blood-pressure monitor, while others used only a monitor. Those who used the app had a drop in systolic blood pressure of 10 millimeters of mercury, on average, which would reduce the risk of cardiac events by about 25 percent. Those who used just the conventional pressure monitor saw no reduction in blood pressure.
Physicians didn’t significantly alter patients’ medication or treatment regimens during the course of the study, so researchers say any changes in health must have been solely due to the monitoring app and related changes in patient behavior, such as new eating patterns and better medication compliance. “Just giving the monitor isn’t enough,” says Cafazzo. “Active telemonitoring keeps patients engaged.”
The app highlights trends in blood-pressure readings and detects when people forget to take their measurements, reminding them with an automated phone call. Giving patients self-monitoring tools makes them aware of their health stats on a daily basis, rather than just in the week before a doctor’s appointment, says Cafazzo. This is especially relevant for hypertension, which doesn’t usually have detectable symptoms.
A second project focused on adolescents with diabetes, a challenging population for doctors because teens are transitioning from being cared for by their parents to being responsible for their own care. Researchers worked with Apple to create an app that is compatible with a blood-sugar monitor. The app reminds users to check their blood sugar and rewards users with iTunes certificates for healthy behavior. If it detects a string of low measurements, it will ask users what they think caused the trend. Teens who used the app checked their blood sugar twice as often as those who didn’t.
Cafazzo hopes self-monitoring tools like these will be instrumental in changing how chronic conditions, such as diabetes and hypertension, are managed. These conditions represent a huge financial burden on health-care systems. “Primary care isn’t the best place for chronic disease management,” says Cafazzo. “It should go back to nurses and the patients themselves.”
For both apps, researchers won approval from Health Canada (similar to the U.S. Food and Drug Administration) to run the clinical trials. As smart-phone apps become increasingly sophisticated, incorporating external sensors and intelligence to make recommendations to users, this type of approval will become more and more important. Cafazzo says they spent more money running the clinical trial than on developing the technology.
In July, the FDA announced its intentions to regulate smart-phone apps that are used as an accessory to a medical device already regulated by the FDA, or that use attachments, sensors, or other devices to transform the phone into a medical device.
Cafazzo’s team plans to create a similar app for kids with asthma. He also hopes to collaborate with a company to commercialize the two existing apps. A limited version of the diabetes-monitoring app is currently available in the Apple app store; it doesn’t include automated blood-sugar monitoring but encourages users to test themselves regularly.
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