Digital clinical trial solutions have unlocked a world of personalized real-time interactions with participants. Throughout the course of a research study, researchers can collect digital biomarkers from wearables, instantaneously deliver surveys, and—with these patient-reported outcomes in a centralized system—enable a real-time, adaptive response to this real-world data.
Through ecological momentary assessments (EMAs) delivered to a participant via a digital health platform, researchers are more likely to collect momentary, daily, accurate data. These data can also be gathered without increasing staff burden using this technology. Just-in-time adaptive interventions (JITAIs) use individual participant data—collected through EMAs, wearable devices, or otherwise—to promote behavior change or achieve a clinical outcome with efficiency.
Higher quality data and more effective interventions
The days of traditional study protocols are behind us. With digital technology, longitudinal collection of participant-reported outcomes (PROs) doesn’t have to be done in large chunks that result in cognitive overload and rely on participant recall. Interventions don’t have to be in response to events that happened days or weeks in the past.
EMAs are a low-burden way to get high quality, real-time, longitudinal data. Collecting information from participants in the moment helps alleviate the impact of recall bias, making your data more accurate. In addition, digital technology allows you to get more data by delivering EMAs more frequently (e.g., daily).
Attempting to get in-the-moment data through traditional study means—daily phone calls or frequent clinic visits—would be nearly impossible. With digital technology, however, researchers can deliver EMAs at a cadence that more easily captures data in the moment and uses personalized messaging to yield high completion rates.
A mental health study incorporating EMAs through MyDataHelps™, for example, was able to achieve completion rates consistently above 80% for daily mood scores, compared to their previous 53% completion rate for this type of daily assessment. The team then uses this trending data for each participant to deliver individualized behavioral interventions in how that participant can improve their mental health—go for a run, practice better sleep hygiene, or read a resource.
Providing real-time feedback through JITAIs is more likely to result in behavioral change, and participants are better able to identify how interventions are impacting their health. Consider a cardiac rehabilitation study aiming to facilitate rehab outside of the clinic. Using data from wearable devices, the digital research technology automatically sends a notification to participants when their device data indicates they aren’t reaching their activity goals. The notification is personalized, using the participant’s first name and individual data to deliver the intervention at the time most appropriate for them.
Improve the participant experience
What is good for science isn’t always good for the participant. EMAs and JITAIs that aren’t optimally implemented can end up burdening the participant with too many requests and turn the participant off from continued participation in the study. When EMAs and JITAIs are optimized, though, high quality data and an improved participant experience can go hand in hand. In-the-moment data collection and nudges infuse personalization into the participant experience.
These interactions with participants, even though automated, can include messaging tailored to each participant, from simply including their first name to adjusting an intervention based on the local weather forecast. This personalization helps the participant feel connected to the study, and spreading out these interactions over time helps increase engagement.
EMAs and JITAIs can also tie nicely together to really enhance the participant experience. An asthma study, for example, used physiological data from a wearable device to send an alert to a participant when their measurements deviated from baseline values—a JITAI—and prompted them to complete an EMA regarding their symptoms and triggers at the time of the deviation. This personalized interaction with the participant was then able to inform the educational materials they were provided.
In addition to increasing engagement, spreading out participant interactions through EMAs and JITAIs lowers the burden on participants. While this strategy alleviates recall bias from a scientific perspective, it also helps prevent the participant from experiencing cognitive overload when trying to remember months worth of events and completing multiple PROs at one time. EMAs and JITAIs reach participants where they are, allowing them to complete PROs or incorporate a study intervention without a clinic visit.
Lower the burden on your study team
Utilizing EMAs might make some study teams nervous. They may worry they will spend even more time calling participants to keep them engaged and to ensure completeness of data. However, the automation that comes with using digital technology to enable EMAs and JITAIs actually reduces burden on study personnel.
EMAs and JITAIs help limit the time study staff spend on follow-up visits, phone calls, or other outreach activities, particularly during a longitudinal study. These automated interactions allow staff to redirect their efforts towards high-value activities instead. High-value activities might still include outreach to participants, but researchers can focus on participants that need extra assistance.
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