Fitness trackers such as the Fitbit and Apple Watch have become an integral part of life for millions of Americans. More than one in five U.S. adults (21%) regularly using a smartwatch or fitness tracker, according to a 2020 study by Pew Research. The wearable data collected by today’s consumer devices has the potential to fundamentally change health research by providing unprecedented real-time insight into key participant wellness metrics. The physiological and activity data gathered by these devices is being analyzed by researchers seeking to understand and find treatments for diseases. For example, researchers are using data from wearable fitness trackers to track diseases such as Covid-19 by measuring changes in a wearer’s heart rate, sleep, and activity level.
Unlike data from electronic health records (EHRs) or clinical data registries that are typically captured from patient encounters at a particular point in time, wearable data is always on, and can provide a steady stream of real-time health information that can offer a more complete picture of overall wellness. Adding this information to more traditional research data sources can help accelerate research efforts while enhancing the accuracy of the findings.
But there are challenges to using wearable data in medical research, many of which revolve around personal privacy, consent, and trust. Accessing wearable data requires tight interaction between researcher and participants. Given this added complexity, we recommend the following five strategies research teams aiming to add wearable measurements into the data mix.
Researchers can begin by helping participants understand why they want to access wearable data for a study, and what type of data access the individual is consenting to give. The process should address concerns with clear and complete information about what data is being collected, how it will be stored, who will have access to it, and how it will be used — along with any associated risks and responsibilities. In essence, everything a participant needs to know both to support the decision to participate in the study and share their wearable data should be outlined in clear and concise language.
The eConsent form used for The National Institutes of Health (NIH) All of Us Research Program is an excellent example of a user-friendly digital document. The form is presented as a FAQ, explaining in simple terms what All of Us is, how long it will last, what data and blood samples will be required of participants, what data will be gathered from fitness trackers and other sources, how the data will be used, any potential risks to joining the study, and much more. eConsent should be presented in a way that encourages understanding and absorption.
eConsent facilitates this process by delivering information in various media formats, including audio and video, to accommodate different learning styles and promote consumption and understanding. The result is a more informed participant who is more comfortable and trusting of the study and its use of wearable data.
Any effort to gain consent to access wearable data will fail if the process of connecting a personal device to the research database is too difficult. To ensure participants don’t drop out of the study, researchers must make wearable data collection easy and intuitive. To that end, wearables such as biosensors automatically collect and transmit wearer data. Other types of medical wearables include clothing with embedded sensors (which may measure heart rate, heart rate variability, electrocardiography (EKG) or breathing rate) and headbands (for electroencephalograms and electromyographies).
If possible, provide a self-service digital interface that guides participants through the process of connecting their wearables and medical devices. This effort should be a one-time request of the participant, allowing ongoing data collection to occur automatically after the connection is established. A digital connectivity platform such as Vibrent Health’s Participant Experience Manager can deliver the user experience necessary to facilitate data connectivity and collection.
Many research studies that access wearable data provide participants with trackers to use, and Fitbit units tend to be the devices of choice. In fact, 70% of the participants engaged in research studies leveraging Vibrent Health’s Participant Experience Manager platform use Fitbit devices.
However, researchers need to understand that Fitbit isn’t the only game in town. There is a sizeable and growing set of participants that elect to use their own trackers for data collection in research initiatives. Researchers must be able to collect data from Apple Health, Apple Watch, Google Fit, Samsung Health, and more in addition to Fitbit to ensure comprehensive device compatibility and to maximize participant inclusion. Each platform may present its own hardware, software, device, connectivity and security challenges, along with different levels of data governance and standardization.
Further, integrating with (and providing support for) this diverse array of platforms can be difficult because these activities are staff-intensive and may require a wide range of IT skills. A connectivity tool like Vibrent Health’s Participant Experience Manager provides comprehensive platform compatibility, removing this burden from your research team.
Even if a self-service interface for eConsent and wearable device connectivity is available, participants need an easy way to reach a human if they become confused or require support. Researchers should provide a direct line to the study team or platform provider – not a contracted third party – to answer questions and help participants get connected. Providing this personal touch is instrumental in building and maintaining trust.
A big part of ensuring continued trust and engagement in a research effort is delivering information back to participants that they may find valuable. This process is called “return of information” and can include benchmarking data that shows how a participant’s tracking measures compare to others in the research cohort or a breakdown of how an entire participant group responded to survey questions. For example, the NIH All of UsResearch Program is based on sharing information on health and habits collected by the study with all participants. This transparency helps foster a sense of inclusion and builds trust and interest in the Institutes’ research.
Given the “growing public demand that research participants receive all of their results,” as Vanderbilt University Medical Center writes, researchers are well-positioned to be able to use return of information as an effective tool for recruiting trial participants. Over the long run, educating the public about medical research should help ease the arduous and costly process of clinical trial recruitment.
The health data collected by today’s wearable technologies has the potential to fundamentally change clinical research by providing unprecedented real-time insight into key participant wellness metrics.
Possible applications are endless, including an increased understanding of disease variability and responses to treatment. However, the potential issues associated with consolidating and accessing wearable data are significant. Researchers need to understand the increased complexity and variability involved with wearable data as well as the enhanced interaction necessary between researcher and participants, whether through return of information or ongoing communication through digital tools.
Researchers can get access to this valuable data now – but the first step is to find a collaborator with experience in wearable data connectivity. Research teams should also aim to learn from the best practices, experiences, and results of other research programs that have successfully leveraged wearable data to date.
To learn more about eConsent in the digital age, watch our recent GenomeWeb webinar, eConsent in the Era of Digital Health, Genomics, and Wearables: What We Can Learn from the NIH’s All of Us Research Program, available on-demand now.
Ready to learn how collaborating with Vibrent Health can enable you to streamline eConsent and connectivity for wearable data collection for your study? Request a pilot.
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