February 4, 2022
Digital health platforms: Considerations for study design and the IRB
Clinical Trials & Research
October 21, 2022
Research Electronic Data Capture (REDCap) is an EDC web-based application developed by Vanderbilt University to collect data for clinical research. It’s widely used by many non-profit organizations and Academic Medical Centers (AMCs), and REDCap excels in running conventional studies. However, using REDCap in collaboration with MyDataHelps™ can unlock new potential in digital clinical studies.
MyDataHelps™ connects to electronic health records (EHR) and wearable devices in an easy-to-use, straightforward manner. This will give you access to novel biomarkers—complete, real-world, actionable data collected in a participant-friendly environment. In addition, MyDataHelps™ streamlines survey delivery and participant engagement and management. Ultimately, you can boost the power of your study by complementing your existing REDCap protocol. There is no need to reinvent the wheel—you can just upgrade it.
Readily available wearable device data has unlocked the use of critical digital biomarkers in clinical research. Common sensor measurements have a well-known correlation to general health—increased physical activity, lower resting heart rate, and proper sleep typically suggest improved physiologic status. By including these biomarkers in studies, researchers can examine new correlations between sensor data and clinical outcome assessments.
Augmenting your existing REDCap data collection with wearable device data through MyDataHelps™ can provide more complete, real-world data. In a participant-mediated design, participants can elect to share their smartwatch, fitness tracker, or health app data with your study, including:
Integrating real-world EHR data is a new and powerful instrument for incorporating more complete data into your research studies. Through MyDataHelps™, participants are able to mediate the exchange of their EHR and claims data from various payers and providers. This allows researchers to gain access to reliable and contextualized data while simultaneously giving participants insight into their own health information. By doubling as a personal health record, these EHR and claims data can also facilitate participant engagement.
MyDataHelps™ can connect to 80% of all United States healthcare delivered annually. By complementing your existing REDCap study with EHR and claims data, your participants can mediate your access to a robust dataset, including:
Augmenting a REDCap protocol with MyDataHelps™ further benefits a decentralized clinical study by optimizing the participant experience. REDCap surveys are often designed to be completed by study coordinators during an in-clinic visit. Through MyDataHelps™—with its robust electronic clinical outcome assessments (eCOA) solution, including participant-reported outcomes (ePROs) and performance outcomes (PerfOs) / active tasks—participants are able to provide their information more readily (e.g., from the comfort of their home). MyDataHelps™ also enables remote engagement with participants through ecological momentary assessments (EMAs) and just-in-time adaptive interventions (JITAI).
The collection of eCOA / ePROs through MyDataHelps™ and its seamless integration with wearable device and EHR data—or complementing REDCap survey data with wearables and EHR—ultimately yields a more complete dataset. These data can then be used to automatically trigger actions (e.g., participant and coordinator notifications) within MyDataHelps™ based on a participant’s individual behavior. This takes the burden off of study staff to lead participants through the study protocol.
Seamless data transfer between REDCap and MyDataHelps™
MyDataHelps™ surveys are easy to design and can be launched in a well-developed user interface in a matter of minutes. Researchers can also transfer data between REDCap and MyDataHelps™. By leveraging the import tool within MyDataHelps™, a user can seamlessly manage and launch an existing REDCap survey within the app. MyDataHelps™ webhooks can also be used to send data back to REDCap through their Application Programming Interface (API).