People who find it hard to breathe because of chronic obstructive pulmonary disease have an effective, low-impact rehab program to stay healthy and out of the hospital. Very few of them use it, even though COPD is America’s fourth-leading cause of death.
Now a study at the Mayo Clinic aims to find out whether doctors can use prescription-only iPads and wearable sensors to convince more people with COPD to do the pulmonary rehab that is proved to keep them more healthy. The technology teaches patients to do their low-impact rehab at home, because history shows 70 percent of them will fail to come to a clinic for it.
The independently funded clinical study is designed to generate objective data about the effectiveness of health care software made by Novu of St. Louis Park and wearable sensors from St. Paul’s Minnesota HealthSolutions Corp. The study, doctors say, is also a glimpse into the future for the burgeoning field of mobile health (mHealth) applications.
“The technology is advancing pretty fast. So it comes down to how fast people can demonstrate evidence of predictability and accuracy and making sure that it’s safe and that we actually can achieve better results with it,” said HealthPartners vice president Dr. Kevin Ronneberg, who’s not involved in the Mayo study.
The market for smartphone and tablet apps to improve health or wellness has exploded in recent years. An article in the Journal of Medical Internet Research documented more than 60,000 health-related programs on the Apple App Store and the Google Play Store earlier this year.
In one display of commercial enthusiasm, Apple Inc. — the world’s most valuable company — opened its long news conference on new consumer gadgets last month with a presentation about an mHealth app called Airstrip. The app allows secure messaging with physicians and remote monitoring of patients, giving expectant mothers, for example, a way to read and transmit maternal and fetal heart-rate data to their doctors.
The flood of mHealth devices has been challenging regulators.
The U.S. Food and Drug Administration published new rules in 2013 in an attempt to regulate true mobile medical technology like Airstrip while limiting red tape that could strangle innovation in “wellness” programs and devices, which make up the large majority mobile health applications available today. (Airstrip Technologies has 12 different FDA approvals.)
The Federal Trade Commission is keeping a watchful eye. On Sept. 17 the commission announced a $150,000 settlement with California’s Carrot Neurotechnology in which its owners agreed to stop claiming that an app they sold on the Apple and Google stores called Ultimeyes was “scientifically shown to improve vision.”
The FTC said Ultimeyes could resume using that pitch — but only after it proved the claim using a blinded, randomized, controlled trial.
Doctors and insurance companies remain skeptical.
Health care providers and payers have been demanding more clinical data before recommending (and paying for) new medical therapies of all kinds, not just mHealth apps. But the five-star ratings system used on the Apple store (Ultimeyes gets 2.5 stars) is fundamentally at odds with traditional medical evidence.
“There are 800 diabetes apps already on the Apple store. How do we stratify which ones we would recommend to a patient?” said Dr. Chip Truwit, radiologist and chief innovation officer at Hennepin County Medical Center. “People make decisions nowadays about apps on the basis of a rating scale, zero to 5 stars, which has nothing to do with whether the thing is clinically relevant, safe, efficacious, and is going to have a positive outcome in some manner for a patient or a population of patients.”
“A lot of this will turn out to be junk obviously, but I’m sure that quite a few of these will turn out to be very useful and most of us will start to incorporate more of these recommendations in taking care of our patients,” said Dr. Dang Tran, vice president with Fairview Medical Group. “It will be really fun to see how all of this will play out.”
There are signs that the evidence for mHealth devices is coming. The National Cancer Institute recently declared that mobile health tools represent a potential “revolution” in health assessment and monitoring. The institute is now awarding Small Business Innovation Research grants for projects to validate “promising but insufficiently tested” mobile health technologies for cancer.
Mayo Clinic has staked out an ambitious position in mobile health technology. Last week, the Rochester-based national health care provider awarded its first round of $50,000 “Think Big” grants funding mHealth health tools. Mayo announced a mobile health collaboration with Apple last year.
“We expect that use of these mobile tools will grow to become the largest share of interactions between health seekers and their care teams,” said Dr. Steve Ommen, medical director of Mayo Clinic’s Center for Connected Care. “These tools can empower patients … but will require new support and analysis models before this potential is ultimately realized.”
Evidence-based medicine moves at a much different pace than most mobile technology, however.
The ongoing federally funded trial of pulmonary rehabilitation at Mayo will take at least 18 months to gather the data on the clinical effectiveness of the mHealth system designed by Novu and Minnesota HealthSolutions Corp. And as with every controlled trial, the work may end up proving the efficacy of traditional methods over the mHealth version.
But those involved say subjecting their ideas to the risk of failure is necessary to gain the data to convince doctors, insurers and the public to trust mHealth-enhanced therapies the way they do drugs or traditional devices.
“For the industry to move forward, you need to have more of these clinical trials,” said Ali Shirvani-Mahdavi, executive vice president with Novu. “I hope we are going in this direction, because it would make everybody look better, much more robust.”