February 4, 2022
Digital health platforms: Considerations for study design and the IRB
Clinical Trials & Research
September 23, 2022
Are you experiencing low retention and adherence rates, resulting in incomplete datasets and delayed study timelines? Are your study staff bogged down with phone calls and scheduling visits in order to follow up with participants?
Participant adherence to the protocol (i.e., completing study tasks) is crucial to a study’s success. In conventional, centralized clinical study designs, though, participants often have to travel to study sites to provide data. In addition, staff spend enormous amounts of time making sure they get through the protocol.
Digital clinical trial and research (DCTR) technology enables decentralized study models, which can allow you to collect more continuous real-world data and reach participants where they are. Instead of endless phone calls, you can let technology handle the busy work.
By improving participant adherence with the four steps that we’ve outlined below, you can reduce gaps and increase the accuracy of participant data, and avoid underpowered studies.
Calling participants to remind them to complete study tasks and scheduling follow-up visits are time-consuming for personnel. Using DCTR technology, you can automate notifications and reminders to participants based on different characteristics (e.g., incomplete survey, device not syncing). These forms of participant outreach are especially impactful in decentralized study models when study tasks, like remote surveys, can be completed without going to a clinic.
If, for example, you need participants to complete a survey six weeks after their in-clinic visit, you may need to remind participants to do so. Instead of having staff call each participant at the six-week mark, set up a notification that gets automatically sent to them. You can even schedule reminders to go to participants that haven’t completed the survey within a week of the initial notification.
Through automated notifications and reminders, you can reduce gaps in your participant data and help ensure that tasks are completed at the proper time. Meanwhile, your staff can direct their efforts towards high-value activities and may only need to call participants that need extra assistance. This is particularly helpful when employing digital surveys and protocols that allow participants to complete study tasks wherever they are.
Clearly communicating study expectations and providing value back to your participants can significantly improve adherence and retention. While you probably inform participants about what to expect during the consent process, it can be helpful to remind them of what comes next throughout the course of your study with dashboards. You can also use these dashboards as an engagement tool by returning results to participants and providing educational information.
Consider a complex protocol that requires participants to provide a saliva sample, complete surveys every month, use a wearable device daily, and perform an active task weekly. Rather than relying on a participant’s memory or needing staff to walk them through the protocol each week, what if the participant could log in to an app and immediately see their progress in a visual dashboard? Not only would they be reminded of what comes next, but by incorporating a return of results dashboard, the participant can remain engaged in the study and receive value back through a genetic ancestry report derived from their saliva sample.
Returning results, providing educational resources, and generally engaging with participants through dashboards is a high value, low lift method of increasing participant adherence. Participants are able to have greater insight into your study and their own health information without extra effort required from your staff.
The application of gamified, engaging dashboards can be extended to incentives or rewards systems to further increase participant adherence. Through DCTR technology, you can automatically update participant-facing dashboards and trigger delivery of incentives based on their completion of study tasks.
For a longitudinal study using activity data, you might wish to encourage your participants to consistently wear and sync their wearable device throughout your study. If you incorporate a participant-facing dashboard that tracks their progress through increasing levels of rewards, your participants are more likely to continue through the protocol. For example, they could receive a gift card after wearing and syncing their device at least 25 of the first 30 days. The dashboard could then unlock a new level, encouraging them to continue this practice over the next 30 days to receive another gift card.
Engaging with participants through automated rewards systems can ultimately help limit attrition without requiring staff attention. By accomplishing this in conjunction with engaging dashboards, your participants may even be eager to complete tasks in order to reach the next threshold.
Providing in-depth data (e.g., physical activity, sleep, daily heart rate) in conventional clinical study designs is burdensome on participants. Asking them to actively provide this information is time-consuming for the participant and results in less reliable data. By allowing participants to connect their wearable devices (e.g., smartwatch, fitness tracker) to your study platform, you can easily gather continuous real-world data while they go about their daily lives. In addition, wearable devices can serve as an engagement tool. Displaying these data for participants in dashboards and having them interact with their own devices keeps participants involved in your study.
What if you want to collect sleep data, for example? You could ask a participant to self-report their sleep habits and risk recall bias. You could have your participants come in person for a controlled sleep study, which is highly disruptive to their lives. Or they could connect a device that they already own and wear on a normal basis, and passively share their data with you. Additionally, you have the option to provide devices to participants who do not have their own.
Passive data collection through wearables not only provides flexibility for your participants, but also improves the accuracy of the data. Participants can remain engaged in the study through their own health data while relieving the burden on them to provide the information, ultimately increasing adherence and retention.