Clinical validation. That’s what every digital health and mobile health startup, with money to spare for research, wants to shoot for. After all, the proof is in the pudding, right? But studies have unexpected results and that’s what appears to have greeted Medisafe, whose app tracks medication adherence levels and reminds people to take their prescriptions, when it ventured to gather real-world evidence about its mobile health tool.
Last week saw the release of a JAMA Internal Medicine study that examined Boston, Massachusetts-based Medisafe’s app and its impact on outcomes for patients with uncontrolled hypertension. While the app improved medication adherence, there was only a slight downward tick in high blood pressure in the group using the app versus the control group that didn’t. But the exercise also showed the limitations of studies requiring people to download and use apps.
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The research, which was funded by Medisafe, examined 411 participants, all of whom had uncontrolled hypertension and were taking one to three antihypertensive medications. The patients were put in two categories: 202 were in the control group, while 209 were given instructions on how to download and utilize the Medisafe app.
The study lasted twelve weeks.
At the end of that time period, the researchers found patients using the Medisafe app reported a small improvement in self-reported medication adherence. However, there wasn’t much of a difference between the two groups’ blood pressure at the end of the study. The app users’ mean systolic blood pressure decreased by 10.6 mm Hg, compared to 10.1 mm Hg among the control group.
In a phone interview, Jon Michaeli, Medisafe’s executive vice president of strategic partnerships, weighed in on the research and results.
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“We decided to essentially try a study that used a surrogate outcome,” Michaeli said. In this case, that surrogate endpoint is the blood pressure measurement.
“We did that because frankly, to look at a chronic condition like hypertension, it could be five, ten years before you know if the patient is going to develop these conditions,” he added.
Michaeli said the Boston-based company was hopeful it would see app users’ blood pressure decrease more than the control group. And to be fair, the blood pressure of the Medisafe users did drop slightly more than that of the non-app users.
But he noted those results came from research that had its own limitations.
First, the researchers can’t force people to download the app. Michaeli said at least 30 people who were included in the app using group didn’t actually download Medisafe. Still, their blood pressure values were lumped in with those of the app users. This may have brought up the average blood pressure of the group.
The study indicated participants reported a small improvement in adherence. But as Michaeli pointed out, patients utilized the Morisky medication adherence scale, which is self-reported, to measure any changes.
In a separate commentary on the study, two doctors (and non-study authors) noted mobile health technologies seem to be most effective when the patient data is sent to and used by healthcare professionals. Michaeli had some thoughts on this, too.
“It’s not as if we’re saying Medisafe is a standalone technology solution,” he said. “We are certainly planning on working with others to support the patient and increase adherence even more.”
Dr. Raj Khandwalla, director of cardiovascular education at Cedars-Sinai Medical Care Foundation and assistant professor at Cedars-Sinai Heart Institute, said remote monitoring is challenging, that it’s hard to truly improve patient outcomes.
But he also touched on a few positives from the study.
“There was a trend toward increasing adherence,” he said in a phone interview. “I think that’s really a hopeful sign that tools like this may one day move the needle when it comes to improving hypertension control.”
Though Medisafe is constantly considering improvements to its app, Michaeli said it does not plan on fundamentally altering its approach based on the data from the JAMA Internal Medicine study.
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