"No benefit" shown by digital health monitoring in large study

A large six-month randomised control trial has found that remote monitoring devices offer no short term benefit in health costs or outcomes for patients that monitor their health with connected devices. The trial of 160 patients with either hypertentsion, diabetes, or arrhythmia, issued them with an iPhone 4 and a device with which to monitor their condition. Commenting on the trial, study author and noted digital health advocate Dr. Eric Topol said “It was a bit disappointing, but remember, this was the first multisensor trial that’s ever been reported, so in that respect it was a pioneering effort".

The results are in for the Scripps Translational Science Institute’s Wired For Health study, and there’s no sugar-coating it: they’re disappointing for those working in digital health. The six-month randomized control trial found no short-term benefit in health costs or outcomes for patients monitoring their health with connected devices.

“It was a bit disappointing, but remember, this was the first multisensor trial that’s ever been reported, so in that respect it was a pioneering effort,” study author and STSI Director Dr. Eric Topol told MobiHealthNews. “And you know, it was very difficult because we had these three different sensors, glucose, blood pressure, and heart rhythm, and a lot of patients had all three problems or two of them, and had to have a dashboard created. There are a lot of logistical challenges there.”

Scripps recruited 160 patients with either hypertension, diabetes, or arrhythmia and randomized them into an intervention group and a control group. Members of the intervention group were issued an iPhone 4 and a connected device: for those with hypertension, a Withings blood pressure monitor, a Sanofi IBGStar blood glucose meter for those with diabetes, or an AliveCor ECG for those with arrhythmia. The study took place in 2013 and 2014.

In order to make data from their connected devices available to their physicians and their family members, intervention group participants also had access to Qualcomm Life’s HealthyCircles care coordination and management platform.

The study looked at claims data, to see whether one group cost more than the other, as well as outcomes data like blood pressure and HbA1C. They found no difference between the two groups. The only meaningful difference the study found was related to health self-management. Patients who monitored their health were less likely to attribute health outcomes to chance than those who didn’t monitor their health. Topol said several different surveys showed the monitoring patients had a better sense of wellbeing and felt more control over their health.

“We learned a lot, but the fact that it wasn’t a positive trial, with respect to reducing economic burden is probably not so surprising because we only followed the people for six months, and many would project that you need much more follow-up and a much larger sample size to be able to show the burden,” Topol said. “The good part is we didn’t add any burden economically. A lot of people thought, if people have access to their data they’re going to end up tapping more into medical resources. Well, we certainly didn’t see that. So that was encouraging, but obviously we would have liked to reduce the need for emergency rooms and office visits and hospitalizations. That could still be out there, but this is just the beginning of studying that question.”

There are a few possible explanations for the failure of digital health devices to impact outcomes or costs in this trial. One is that the trial only tested for short-term outcomes and healthcare costs after six months. It’s possible that this technology can have an effect over the longer term. Another is that this study more or less tested the effect of monitoring itself, although there were nurses and coaches made available to participants.

Topol also pointed out all the ways the technology has advanced since this study. Better data visualizations and monitoring that is passive, rather than requiring manual logging action on the part of the patient, could go a long way.

“I think the key here is that it’s the first foray into this multi-sensor smartphone world and we need to do a lot more randomized trials that are bigger and better. Hopefully I and many others will do this in the future,” he said.