Mobile Phone Research Feasible in Patient Study

Ken Terry

March 16, 2017

Researchers at the Icahn School of Medicine at Mount Sinai in New York City say they have shown the feasibility of using mobile phones to perform a remote, large-scale research study on asthma patients, including recruitment, consent, and enrollment.

Yu-Feng Yvonne Chan, MD, PhD, associate professor, genetics and genomic sciences, and associate professor, emergency medicine, at Icahn School of Medicine at Mount Sinai in New York City, and colleagues published their initial results online March 13 in Nature Biotechnology.

With the aid of Apple's ResearchKit, an open-source framework for mobile research, the investigators established a secure bidirectional data flow with 7953 US participants who had downloaded a free iPhone app from the Apple Store. The researchers used the mobile connections to collect longitudinal data on a subset of the users over a 6-month study period. They included information on patient characteristics, asthma symptoms, and the effects on those symptoms of factors such as heat, pollen, and wildfires.

The app for the Asthma Mobile Health Study was downloaded nearly 50,000 times in the first 6 months it was available, which coincided with the study period. Of these downloads, 40,683 were in the United States. After the researchers applied rigorous participation criteria, including a diagnosis of asthma and an asthma medication, they enrolled 7953 people in the study.

In addition to an intake questionnaire, the researchers asked participants to fill out daily and weekly surveys of various kinds. Of the enrollees, 6470 (85%) responded to at least one survey; these people were the "baseline user" cohort. The study also included a "robust user" cohort of 2317 participants. These people were free from other lung diseases and congestive heart failure, did not smoke more than 10 packs of cigarettes per year, and completed at least five daily or weekly surveys during the study period. Finally, there was a subset of 175 participants known as the "milestone users," who completed a 6-month milestone survey.

The steep drop-off in user retention parallels that of many other mobile apps, the researchers note. In many cases, this reflects the users' "psychosocial-behavioral needs," they write. In addition, participants were not given any monetary incentives.

The users of the asthma health app tended to be younger, wealthier, more educated, and more often male than the asthma patients in a much larger asthma population studied by the Centers for Disease Control and Prevention (CDC), the study notes. Lead study author Yu-Feng Yvonne Chan, MD, PhD, told Medscape Medical News that was to be expected, considering that the participants were all iPhone users.

Baseline users had a higher rate of hospitalization (6%) and emergency-department visits (11%) in the 6 months before enrollment than the CDC rates (2% and 8%, respectively). Of the baseline users, 47% reported symptoms twice or more a week, and 29% most days or daily. Thirty-seven percent of baseline users reported the use of oral steroids to treat an asthma exacerbation. Similar distributions were observed in robust and milestone users.

Using Global Initiative for Asthma (GINA) criteria to assess asthma symptom control, 43%, 44%, and 42% of baseline users, robust users, and milestone users, respectively, reported uncontrolled asthma.

Dr Chan, who is director of digital health and personalized medicine at the Icahn School of Medicine at Mount Sinai, said that it was not clear why the study participants reported being in worse health than those in the CDC population. She told Medscape Medical News that it is difficult to enroll people in vulnerable populations using traditional trial recruitment methods. "Maybe people who have severe disease that is poorly controlled have mobility issues that prevent them from meeting with study coordinators or can't take time off from their jobs," she surmised. In either case, she said, they would be able to participate in a study using their mobile phones.

To check on the quality of data, the researchers compared participants' reported asthma control upon study enrollment with their reported daily and nightly asthma symptoms, quick-relief inhaler usage, controller-medicine usage, and peak flow measures during their participation in the study. "Patients' daily survey responses for the aforementioned four parameters were all found to be significantly associated with the GINA control levels calculated based on questionnaires from robust users reporting daily and nightly symptoms," the study said.

Of the robust users, 1621 submitted at least one peak flow measurement during the study period. "As expected, patients with well-controlled asthma, and who were male and tall had higher average peak flows during the study period," the researchers noted.

The percentage of people with uncontrolled asthma dropped from 42% to 24% (Wilcoxon signed-rank test, P < .0001) among the 173 milestone users who reported their asthma control had improved during the study period. Although Dr Chan believes that the educational materials and alerts in the app probably contributed to this outcome, she noted that the number of milestone users was very small and that selection bias may have had an effect.

The asthma app also included a "doctor dashboard" that summarized the data most useful to physicians, Dr Chan observed. Some study participants showed this summary to doctors on their phones during visits, she said.

Following the study period, she added, Mount Sinai piloted a method of sending alerts from the app into its Epic electronic health record. To avoid bombarding doctors with too much data, the researchers set the threshold for the alerts fairly low: for example, if the peak flow rate for a patient dipped below 40% of the patient's clinical best on a good day, their physician received an alert. Mount Sinai doctors liked this, she said.

Overall, Dr Chan said, mobile studies have some significant strengths that traditional trial methods lack. "With traditional trial methods, we examine the relationship of isolated variables in a very artificial environment, in a near vacuum. We're now able to look at the human being in a very holistic way. Because of that, [mobile studies] could yield the most useful, generalizable results."

Although this was an observational study, Dr Chan said the same methods could be used in randomized controlled trials, but that traditional trial methods would continue to be important, as well. "For us to reach as much of the population as possible, we should give people a choice. Whatever suits their preference or circumstance better, they should choose that. So in the end, we have a much more representative sampling of the population, and their adherence to the protocol will be better too, because we eliminate the pain or the friction of participating in research."

Mount Sinai provided funding for this study.

One coauthor reports being a coinvestigator in this study, chair of the department of genetics and genomics sciences, and director of the Icahn Institute for Genomics and Multiscale Biology; and serves as an uncompensated advisory board member and is administratively responsible for the medical school's collaboration with LifeMap Solutions; one coauthor reports being a coinvestigator in this study and the director of biomedical informatics at the Icahn School of Medicine at Mount Sinai. Both hold equity in the form of stock options in LifeMap Solutions, a privately held company. The remaining coauthors have disclosed no relevant financial relationships.

Nat Biotechnol. Published online March 13, 2017. Abstract

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