Apple has for years promised that its devices can help people live healthier, but it has so far produced little concrete evidence of this benefit. Many of the company’s health tools are consumer features without strong ties to the health care system, so there often isn’t a health care outcome to measure as proof.
Nevertheless, Apple has embarked on several systematic studies exploring how its devices might be used to more directly improve health conditions, and after several years, one such effort is beginning to bear fruit: a large digital asthma study launched in collaboration with Anthem, the insurer that has since changed its name to Elevance Health. The companies are now beginning to release data from the study, which hints that the tool could potentially help the millions of people who struggle with asthma avoid the worst outcomes of exacerbations.
Announced during an Apple keynote in September 2020, the 900-participant study aimed to use Apple’s sleek devices to make a dent in the staggering asthma problem — and prove the results using a gold standard randomized control trial. The intervention works by using devices and an app to encourage people to regularly reflect on symptoms and triggers and to equip them to better respond to flare-ups. New preliminary data, which is being presented this weekend at an American College of Allergy, Asthma, and Immunology conference, suggest the app helped reduce emergency department visits among people in the study on Medicaid. The control group saw an average of 0.58 visits per person per year, compared to 0.33 visits for people who used the management program. The authors calculate that one ED visit is avoided for every four Medicaid enrollees who use the intervention.
“As a result of these findings, I think it is essential that this tool be made available for patients to use and should become a key part of asthma self-management,” said Bronwyn Harris, a cardiologist who helped design the product while employed at Apple, which acquired her digital health startup for pediatric asthma in 2019. She said that based on her prior experiences she believed that simple digital tools could help but was “blown away” by the results. Harris, who is a co-author on the findings, now works at CareEvolution, which helped with the software for the study.
Whether the research will blossom into real-world products launched by any of the players involved will depend in part on health outcomes and cost savings illustrated by a deeper analysis of study data. It also remains to be seen if a broad product launch gels with each company’s current strategic priorities.
Nearly 9% of American adults have the chronic condition, in which people’s airways become blocked to the point that they have difficulty breathing. Estimates suggest that up to 60% of people with asthma don’t have the condition under control, and exacerbations are a frequent source of emergency room visits. Panagis Galiatsatos, a pulmonologist and professor at Johns Hopkins, told STAT that the main management strategy is avoiding triggers, like smoke and allergens. Because that’s often not possible, the other key piece is being prepared to quickly respond to symptoms with a doctor-prescribed action plan, which may include medication and other steps.
Apple and Anthem’s tool is designed to help keep people on track. Participants in the study received an Apple Watch and a sleep tracking mat that are used to establish baseline metrics around respiratory rate, heart rate, nighttime awakenings, and more. Harris said the devices are an “engagement hook” — when they detect that a metric is out of range, users are prompted by the app to document their symptoms, any triggers they have encountered, medication, and more. It’s not a prediction that symptoms are present, so much as a way of asking people if they feel any. The app also contains educational information, for example about lesser-known asthma triggers, and allows users to store a photo of their asthma action plan, so they can easily refer to when they feel an exacerbation coming on. Provided people log enough symptoms, they are told whether their asthma is controlled or not.
Harris said the hope is that the multi-pronged intervention encourages people to engage thoughtfully with their condition such that they’re not just hearing recommendations but discovering for themselves what contributes to whether their asthma stays under control.
The asthma study enrolled adults from Anthem’s Medicaid and commercial plans who were randomized to either receive devices and the digital app or just devices alone. The study collected data about asthma symptoms over a year, and participant claims data will be analyzed to glean impacts on health care utilization and costs. The researchers are also looking at longer term outcomes, including around Covid-19.
Richard Lee, a pulmonologist and professor at the University of California Irvine School of Medicine who led the research, said in an email that the results hint that digital tools can “potentially give patients a deeper understanding of their condition and the ability to personalize their care.”
But Lee also noted that the results are still early findings. A peer-reviewed paper is said to be coming in the future. Analyses of asthma outcomes and health care costs have not yet been completed.
By targeting asthma and Medicaid, the study honed in on a space with unmet need and a significant potential impact. All the better, if part of the goal is to explore the broad potential of digital tools.
Warris Bokhari, who is a co-author on the new results and worked as a vice president at Anthem when the project was developed, said that tackling asthma was attractive because changes in asthma control are potentially detectable very quickly. Whereas behavior change apps for slow-moving conditions like type 2 diabetes or hypertension can take years to make a difference, you can make an improvement on asthma hospitalizations relatively quickly. (Bokhari has since moved on from Elevance.)
From the start, the researchers were deliberate about wanting to recruit Medicaid enrollees who are more likely to have poor asthma outcomes, have more difficulty accessing care, and thus could potentially benefit more from the intervention. For this reason, studying asthma in that population also presented an opportunity to show how digital interventions could reduce costly care.
The choice required navigating the particulars of state-by-state bureaucracies, and came with several challenges, like ensuring that educational content met Medicaid standards for readability and that the study didn’t max out incentives that plans are allowed to give out to members.
The early returns appear to bear out the value of putting in this effort.
“[It] shows the importance of representation from underserved populations in clinical trials, which is needed to ensure that any benefits of digital health innovation can be realized by all,” Jordan Silberman, a co-author and director of clinical analytics and research at Elevance, said in an email.
Indeed, despite the opportunity to improve access and care, Medicaid populations are sometimes ignored by health tech startups. Abner Mason, CEO of Medicaid-focused SameSky Health and who advocates for more health tech for vulnerable populations, said there are a number of reasons that lower-income people aren’t included in the design of tech solutions. For example, fee-based reimbursements for Medicaid care can be low and there’s a sense that for people who are struggling financially, health takes a backseat to other concerns.
Moreover, there’s a persistent — and controversial — concern that many people simply cannot afford smartphones if they are not provided for free.
The researchers believe such thinking is naive.
“At what point do you start addressing, you know, as much of the addressable market as possible?” said Bokhari. “This is how people should be thinking about digital health, and the skepticism around deploying digital tools in Medicaid is completely inappropriate.”
In a curious wrinkle, the early results show that the study’s commercial population saw no improvement on emergency department visits. Harris said analyses of health outcomes and costs may reveal impact, but the early results suggest that for better-resourced populations, “the low-hanging fruit isn’t there.”
Robert Rudin, a senior information scientist at RAND Corporation who has developed and studied several digital asthma interventions, agreed that the focus on Medicaid is significant. But he notes that the intervention is more complex than others he has seen, and that the study design will make it hard to know what element is doing the work in the event that it’s successful. Moreover, given how intricate the intervention is, it may be hard to sustain for long periods of time.
One of Rudin’s collaborators, physician and researcher Wilson Pace underscored this concern.
“Their system is pretty intense — most remote patient monitoring systems for asthma find that weekly or twice weekly interactions are plenty to catch exacerbations early,” he wrote in an email. “Even with that level of contact most people find these apps are difficult to maintain.”
Rudin also expressed concern that the intervention in the study operates entirely independently of other care. While the designers view that as an advantage that makes the tools cheaply scalable, it may be a missed opportunity to reinforce important relationships.
Getting a high-profile study like this approved by both Apple and Anthem was a significant challenge, but it may be even more complicated for the product to end up on the market. People involved in the design suggested a lightweight version of the tool could be incorporated into Apple’s existing health offering, much how it offers menstrual cycle tracking features that are useful to only some users. Elevance could similarly ramp up a similar intervention to its members with asthma as part of a more integrated care offering.
Still, it’s unclear that the will to launch more broadly exists. Many of the leaders who launched this study have moved on from their respective companies.
Apple has shown continued skittishness around launching too aggressively into anything that might be construed as health care, preferring to stick to features for consumers and letting developers and other partners carry the burden of adapting its devices and software tools for ongoing care. The asthma study was not included in the 59-page white paper Apple published about its many health efforts last year. Sources told STAT they were certain that positive results from the asthma study would prompt a conversation within the company about what to do next with the technology.
Apple did not respond to a request for comment and always declines to discuss its future product plans.
The process of launching an asthma management tool at a payer like Elevance, meanwhile, requires navigating extensive bureaucracy. Mason said that after a successful pilot, it’s often incumbent on health tech companies to push payers to expand. Without Apple leading the charge, such momentum may not exist.
Silberman’s statement provided by Elevance did not discuss the company’s plans for the intervention going forward but affirmed that “digital health technologies offer a new set of tools that may help patients manage chronic conditions and improve wellbeing.”
Rajeev Ronanki, who was chief digital officer at Elevance at the time the study was launched, said that with a positive outcome in hand, a process of exploring how to expand access to the tool should commence. However, he said sometimes tools that show promising results in smaller tests might not be adopted because on examination, they may not easily or cost-effectively scale to a much broader population. He pointed to marketing costs that a company must put behind new offerings as a potential impediment to adoption. He also noted that the calculus is different in commercial populations where members turn over more often.
Moreover, payers have sophisticated methods calculating potential return on investment and Apple Watches and sleep tracking mats are costly tools to offer to large populations without assurance that the costs will be offset.
The researchers last year published a detailed protocol of the study, which is in part a way of leaving breadcrumbs behind for others to follow should the work die on the vine.
Rudin said that it’s too early to pass judgment on the significance of the data without a full peer-reviewed study, but he suggested that if the results bear out, the ambitious work undertaken by Apple and Elevance may inspire others.
“If you show that there’s a potential to do this, even if it’s done using a Cadillac product,” he said, “well, maybe it’ll motivate some further studies to see if the same thing can be done with the Honda Civic level product.”