February 4, 2022
Digital health platforms: Considerations for study design and the IRB
Clinical Trials & Research
February 10, 2022
In the U.S., health disparities and the exclusion of individuals from underrepresented and underserved communities from clinical research are prevalent across disease states:
These examples are a few of many that highlight the importance of active and thoughtful inclusion of underrepresented and underserved populations in clinical research. Digital health platforms are a powerful way to meet this need.
Digital health platforms like CareEvolution’s MyDataHelps™ have the potential to enable clinical research in diverse populations, removing barriers that exist with in-person studies. In-person research is often limited to participants with healthcare access, work-day flexibility, and the means to travel to their healthcare provider’s location. Digital clinical research opens up new routes of enrollment and data collection that reduces the burden of participation and meets participants where they are. MyDataHelps™ enables participant enrollment through a number of easily accessible means, including publicly shareable QR codes, study-specific PIN numbers, and custom HTML email invitations. In addition, a digital clinical study can still present a high-touch model to participants as needed—MyDataHelps™ has a coordinator enrollment mode that allows participants to enroll with a shared device. With a variety of enrollment options, people can elect to participate in a research study from their home, community center, church, etc., simply by using their email or scanning a QR code posted in a public location. They can also provide data using their smartphones or computers when it is convenient to them and without ever needing to travel to a doctor’s office.
An often cited concern for digital clinical research is technology access. However, as of February 2021, 85% of Americans own a smartphone (97% own a cell phone of any kind) and 77% have a desktop or laptop computer. American adult dependency on a smartphone for internet access (i.e., no traditional broadband service) is even down to 15%. In addition, technology usage among some underrepresented populations indicates many of these communities good candidates for participating in digital clinical studies – 85% of SGM people use social media in some capacity and 91% of people with a physical or mental disability use a smartphone or tablet. Collectively, these data point to the potential reach of digital health platforms being wide.
Americans own a smartphone
Americans own a cell phone
Americans own a desktop or laptop computer
SGM people use social media
People with a physical or mental disability use a smartphone or tablet
There are a number of top-tier research studies that have demonstrated the wide reach of digital health platforms. Let’s consider first the All of Us Research Program, a federally-funded national research effort whose goal is “to help build one of the most diverse health databases in history”. Their community outreach and partnerships, including the use of the MyDataHelps™ platform, has yielded over 460,000 participants, 80+% of which belong to a category that is underrepresented in biomedical research. All of Us consents participants, collects participant provided information through surveys, connects to electronic health records, enables remote DNA sampling, and queries physical activity data all through our health app.
Similar to All of Us, the RURAL study uses MyDataHelps™ to fill the existing gap in data that includes people in the rural south by electronically consenting individuals, collecting survey data on health and lifestyle, and tracking Fitbit physical activity all within our platform. These communities show higher incidences of heart, lung, blood, and sleep disorders, but research in these areas for rural populations has not been prioritized in the past. RURAL is committed to bridging the “rural research gap” and expanding the reach of their study, even providing smartphones and wearable technology to those without access, ultimately enrolling approximately 4,000 participants all from underrepresented rural communities.
Last but not least, let’s go back to the final health disparities example listed in the beginning of this article – Black and American Indian/Alaska Native mothers are 2-3 times more likely to die from pregnancy-related complications than white mothers. CareEvolution has partnered with Scripps Research as a consortium member to launch the PowerMom study, which is powered by MyDataHelps™. PowerMom enrolls, monitors, and communicates with pregnant participants through our mobile health platform in order to reduce the barriers seen with clinic-based studies and enable research that will help us understand what leads to a healthy pregnancy for every pregnant person. The first iteration of PowerMom initially enrolled over 4,500 diverse pregnant participants and reached all 50 states—we are excited to support the relaunch of this important research effort through the MyDataHelps™ digital clinical trial and research platform.
The opportunity digital health platforms provide for inclusive clinical research is remarkable, but what about the 15% of Americans that don’t have a smartphone or easy access to the internet? Is there a risk of furthering the exclusion of certain demographics if a digital health platform isn’t implemented thoughtfully? While cell phone ownership doesn’t vary greatly by demographic, the same cannot be said for smartphone ownership. Fewer Americans in the following categories own smartphones: aged 65+, high school or less education, and those earning less than $30,000/year.
To compound access issues, the adoption of technology for health-related purposes may vary by demographic. Rural Americans show lower broadband adoption, and a recent study found that for people aged 54+, Black and Hispanic users were less likely to utilize the internet for health information or health management. Information gathering efforts among Latino, Somali, and Native Hawaiian Pacific Islander communities illuminated some cross-cutting themes that are important to consider for purposeful inclusion of underrepresented populations in clinical research:
Ultimately, digital health platforms represent a significant catalyst in the new frontier of decentralized clinical research. We should also recognize that these new tools can positively influence our ability to prioritize diversity and inclusion rather than that be an afterthought. We are proud of the innovative tools such as MyDataHelps™ that contribute to broadening participation but that must be coupled with community engagement efforts and strategies for mitigating the digital divide, which are crucial for proper implementation.
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