- New York’s Mount Sinai Hospital is reporting positive results from its mHealth study on asthma patients, though nagging questions remain on patient engagement.
In a study published in Nature Biotechnology, Mount Sinai researchers claimed success with the Asthma Mobile Health Study, in which the hospital used Apple’s ResearchKit platform and an mHealth app to collaborate with thousands of asthma patients around the country through their iPhones.
“We critically assessed the feasibility, strengths, and limitations of a smartphone-based study and found that this methodology is particularly suitable for studies of short duration that require rapid enrollment across diverse geographical locations, frequent data collection and real-time feedback to participants,” Yvonne Chan, MD, PhD, director of digital health and personalized medicine at the Icahn Institute for Genomics and Multiscale Biology at Mount Sinai and principal investigator of the study, said in a press release. “Our study demonstrates the power of mobile health tools to scale and accelerate clinical research so that we can derive the evidence needed to inform clinical practice and improve patient care.”
“The … study represents the coming together of academia and industry to benefit from the ubiquity of smartphones and harness the power of citizen-science to modernize the clinical research process,” added Eric Schadt, PhD, the Jean C. and James W. Crystal Professor of Genomics at the Icahn School of Medicine at Mount Sinai and founding director of the Icahn Institute for Genomics and Multiscale Biology.
Those involved with the project said the data gleaned from participants was comparable to other studies, at a fraction of the cost for a typical clinical research study. In one instance, researchers were able to link a spike in daily asthma symptoms in participants living in Washington to an outbreak of wildfires in that state.
“We now have the ability to capture rich research data from thousands of individuals, to better characterize ‘real world’ patterns of disease, wellness, and behavior,” said Schadt, the paper’s senior author. “This approach provides a more comprehensive and accurate view of our patients that was not feasible in the past due to logistical limitations and prohibitive costs.”
While being hailed for its ability to gather data from a large population of scattered and diverse asthma patients – a key component of an effective population health program – the study still raises questions about its sustainability.
Launched in March 2015 amid the first wave of projects on ResearchKit, the study reported nearly 50,000 downloads by iPhone users. Yet of that number, only 7,593 people (roughly 15 percent) completed the online informed consent process to take part in the study.
According to researchers, 85 percent of that group completed at least one survey during the six-month study, and 2,317 people – about 30 percent of the original participants – filled out more than one survey.
Those types of percentages offer fuel to critics who say clinical studies need a more reliable platform, as well as those who favor a platform that includes Android-based smartphones, which are more prevalent in underserved populations.
Despite the criticism, dozens of ResearchKit projects are underway, both here and in other parts of the globe.
In an interview with mHealthIntelligence.com in April 2015, one month after launching the study, Chan said the Mount Sinai team was thrilled with the interest in the app – including 35,000 downloads during the first four days that the app was available.
“These are pretty staggering numbers as far as clinical research is concerned,” she said. “Beyond the sheer large sample size, we are also canvassing a large geographical region. Essentially, anyone in the U.S. that meets our criteria and has an iPhone and internet connectivity can be a participant.”
“In traditional studies, participants need to have proximity to where the consenting process takes place, causing the results to be very localized,” she pointed out. “There is a chance that a clinic might have multiple locations, but it is not this large in scope. That is really exciting for so many reasons. We get such a better sampling across the land.”
This past January, another of the original ResearchKit studies, the Stanford University School of Medicine’s MyHeart Counts project, also reported positive results.
“The ultimate goals of the MyHeart Counts study are to provide real-world evidence of both the physical activity patterns most beneficial to people and the most effective behavioral motivation approaches to promote healthy activity,” Michael McConnell, MD, a professor of cardiovascular medicine at Stanford and co-lead author of the study, said in a press release..
“Traditional research on physical activity and cardiovascular health has been based on people writing down what they remembered doing,” he added. “Mobile devices let us measure more directly people’s activity patterns throughout the day.”
Following that report, published in the December 2016 issue of JAMA Cardiology, Stanford researchers unveiled an updated MyHeart Counts app with AI and analytics tools. Officials said they hope to give participants more directed feedback and apply precision medicine to the ongoing study.
“[This] lets us begin to customize feedback to users, and also discover which types of information might be most useful or motivating for different groups,” Abby King, PhD, a professor of medicine and health research and policy at Stanford who designed the coaching module, said in a press release.
“The most unique thing about the new version is its ability to randomize patients and intervene,” added Euan Ashley, DPhil, MRCP, an associate professor of cardiovascular medicine and genetics at Stanford and the principal investigator for the MyHeart Counts study. Those interventions, he said, “will give researchers a handle on whether a particular intervention for an individual is prompting a change in behavior for the better.”
At Mount Sinai, meanwhile, officials expect to continue their work with ResearchKit as well.
“Mount Sinai has a long history of embracing new technologies to enhance patient care, and I’m delighted to see that tradition continuing with this mobile health study,” Dennis S. Charney, MD, the Anne and Joel Ehrenkranz Dean of the Icahn School of Medicine at Mount Sinai, said in a release. “We look forward to building on this work to serve new patient populations and to dramatically increase the amount of research data we can mine for discoveries that will ultimately improve healthcare for people around the world.”