Last month, executives at Apple, Anthem—the second largest health insurer in the U.S.—and the University of California, Irvine (UCI) announced a new study that examines how the use of everyday devices, like the Apple Watch and iPhone, may help individuals with asthma better self-manage their condition for improved clinical outcomes. The virtual study is being conducted by UCI, and healthcare IT company CareEvolution is the study technology partner responsible for building the study app and enabling collection of the study data.
The two-year, randomized controlled study will enroll participants from Anthem-affiliated health plans who have been clinically diagnosed with asthma. Nearly 25 million Americans are currently diagnosed with some form of the chronic condition, and, when uncontrolled, asthma can lead to permanent lung damage, hospitalizations and even premature death, researchers and clinical leaders said in the September announcement. Additionally, nearly 1.8 million emergency department visits each year are counted as a result of asthma attacks.
Researchers involved in the study say their primary goal to investigate clinical changes in outcomes associated with the use of the new digital tools in self-management of asthma. Additionally, the study will aim to explore if data collected from everyday use devices such as the iPhone and Apple Watch can help predict asthma exacerbation or serve as potential digital biomarkers of asthma control. Put another way, “This project combines the brainpower and clinical expertise of UCI Health, the reach and commitment to good health of Anthem, and the digital savvy of Apple,” Steve Goldstein, M.D., Ph.D., vice chancellor for health affairs at UCI, says in a recent interview with Healthcare Innovation. “Clearly at the largest level, this study is about how can we use everyday devices like the Apple Watch and the iPhone to one day help people with asthma manage the condition so they have fewer flare-ups. And the larger concept, of course, is to make it easier for patients to manage their health using digital solutions,” he adds.
Researchers importantly point out that while there is no cure for asthma, studies have shown that many people can improve their symptoms and reduce exacerbation risk through self-management behaviors including avoiding triggers – such as pollen, mold or smoke – medication adherence, and correct inhaler technique. However, they add, asthma self-management is often far from ideal, with some data suggesting that less than 50 percent of individuals with asthma are well-controlled. Scalable and effective solutions are needed to empower patients to improve asthma self-management and reduce the need for costly asthma care, they contend.
For this study, eligible participants will be invited to enroll, and participants who choose to enroll in the study will receive a Beddit Sleep Monitor and an Apple Watch. To investigate the impact of digital intervention on asthma symptoms and healthcare utilization, the active group of the study will have access to the digital asthma tool, designed for the study. The digital asthma tool includes daily symptom and trigger tracking to provide awareness of asthma control and personalized nudges based on changes in signals from their Apple Watch including activity, heart rate, the new blood oxygen feature and other health metrics. Participants will also receive timely curated education materials and prescription refill resources.
To date, there haven’t been many, if any studies that would be a precursor to this current one on the usage of smartphones for asthma self-management, notes Daniela Bota, M.D., Ph.D., vice dean of clinical research at the UCI School of Medicine, who adds that using wearables and moving the line from using smartphones as a utility for communication to being able to maintain your health is a relatively new concept. The element that Bota thinks has been missing is figuring out how to get the data from the wearables—which sometimes can be immense amounts of data—into a system that becomes medically manageable and will provide both the patients and the physicians with valuable information on which they can act.
Bota explains that phase one of the study, which included 100 patient subjects, has actually been completed already as researchers are set to start analyzing that data. Phase two will have close to 1,000 participants, which Bota says is a credit to Anthem for having “an amazing database of people who are diagnosed with this condition all over the country.” She further notes that because the study is virtual, patients don’t need to go to study sites in person as they typically would, meaning the participant repository can extend to all over the U.S. This is where Anthem’s expertise came in, says Bota: they were able to identify the people who might be potentially eligible, while UCI makes sure that the people who are considered for the study understand what a clinical research project is, how it would impact their day-to-day lives, how it will impact their health, and the overall importance in participating in clinical research.
Goldstein notes that Anthem and UCI have actually brainstormed together for a few years prior to this study came to fruition about how they can work together to improve the health of large groups of people by using the insurer’s large data set and knowledge, and UCI’s clinical expertise. “This is the first [study] out of the gate, because it felt like it hit those parameters—having a big impact for many people. We know what it's like to have a disease exacerbation. We know that with enough information we can find a way to stop a flare-up before you need to be in an ER, or before you go from an ER to a hospital bed. So it just seemed like a sweet spot for the bigger goal,” he says.
Of course, with studies of this nature, one of the key considerations for researchers is how to ensure that patients’ data will only be used for the purposes of medical research. Bota notes that there has been plenty of time and effort spent around this question. “This clinical trial has been evaluated by our institutional review board (IRB) and it has an IRB approval. In addition to that, we have multiple check-in points on the data safety, assuring that we do not have any data breaches, and assuring that the data circulates in the appropriate way between the participants in the study,” she says. To this end, officials from UCI and Anthem noted in their announcement, “Designed with patient privacy in mind, the study offers the participants complete control over their data, and transparency into how the data will be used and shared. Data will be stored on the participants’ device and shared through a direct, encrypted connection with CareEvolution.”
Ultimately, while there is never any guarantee of success, Bota and Goldstein feel that some degree of achievement has already been accomplished since they were able to complete “phase one of a study that has not been conducted before using a partnership that was not tried and true before,” Bota contends. “We have answered the question that this type of study can be done, can be managed, and can be operational,” she adds. “It’s hard to say what the final results will [look like] because this is a learning experience and every clinical trial builds knowledge for the next clinical trial. So in my opinion, there aren’t any negative clinical trials; there are just clinical trials that teach us what the next step for us to take is.”
More broadly, Goldstein believes that the study aligns with the future of healthcare in which the patient has increasing control over his or her health experience. “That’s one part of this, and another part is in the whole area of personalized health is. I call them the four Ps— preventing and predicting disease, personalized care, and then expanding that to the wellness of populations. The way we do that, and the way we get to a future where people are being cared for in their homes, or in their communities, is [through] this type of work.”