In my last blog, Wearable Data Is Only Useful If It’s There: Helping You Collect Your Study Data, I described new notification and dashboard display features that give participants and site personnel the ability to view potential data collection issues and act quickly to resolve them. These features are most useful during studies with a single period of wearable data collection.  

However, there are also protocols that call for multiple different periods of data collection across the study duration. In this case, it’s common that wearable data collection periods align with a scheduled study visit. Here, I outline new features in our software platform that leverage EDC system integration to display quick and clear adherence and data collection information based on current or upcoming visit schedules. 

Defining the Visit Wear Period

Some protocol designs define a visit occurring on a specific date, but in many protocols the date can vary, and the visit will occur within a visit window. In the example below, the study design includes a wearable data collection period in the 7 days prior to the second study visit. This visit is planned to occur on day 29 in the study, but it could occur within a visit window as early as day 26 or as late as day 31.

Given this study design and visit schedule, we can identify the possible days that could include wearable data collection and turn on notifications for site personnel who want to monitor wearable data collection and wear adherence. 

To illustrate this timeline, in the picture below, we define the 7 days of wearable data collections as the “visit wear period,” which in this case will end the day before the visit takes place. The duration of the “visit wear period” is 7 days. However, the “visit wear period” will flex in sync with the “visit window.” Therefore, the “possible visit wear period” is from day 19 to day 30.It is important to note that depending on the protocol, the wearable data collection period can also occur after the planned visit. In the example below, the wearable device is provided to the participant at the visit, and the participant is asked to wear it for 7 days. We recommend that your visit wear period start the day after the participant receives the device and ends one day prior to when the participant returns the device. This way, there are no days with partial data collection in the visit wear period. 

For long running studies with large gaps in between wearable data collection periods, i.e., visit wear periods, allowing the site personnel to focus solely on participants currently in a visit wear period effectively helps them monitor for data collection issues and monitor adherence.

For instance, the example below shows participants are not scheduled to be wearing the device between week 4 and week 8, alleviating the need for site personnel supervision for device participant data collection during this period. 

EDC Integration for Accurate Visit Date Data

For the wearable adherence and data collection dashboard and notifications to be accurately timed, it is important that the actual visit date information is available in near-real time. Therefore, we created the ability to integrate with an electronic data capture (EDC) system, allowing actual visit date information to be transferred daily via an API into Ametris’ software platform.  

As illustrated below, this information will allow us to calculate the actual “visit wear periods”, as well as planned “visit wear periods”, for each participant based on their visit schedule. The system now has all the future planned visit information and is additionally receiving daily updates of actual visit data. 

Importing this information from the EDC system into our platform helps make it easier for site personnel to focus on and monitor participants that are currently in a visit wear period. In the example below, the day is June 16th, 2025. When site personnel open our platform to view the status dashboard that day, they can easily see participants currently in a visit wear period that they need to focus on. One new feature to improve visibility is the Out Of Window (OOW) that will be displayed in the Status column for participants that are not within a visit wear period. For participants with the OOW status, the “visit wear period” columns will display the information of when the next visit is planned in [ ], so that it is easy to differentiate. 

In the dashboard above, an actual visit has occurred for participant EU2096 (first row), and the participant’s visit date has been set in Week 1, and so the actual start and end date of the visit wear period are displayed. However, for participant EU1080 (last row), the actual visit associated with Week 1 has not yet occurred, therefore the information appears in [ ] and the possible date range for the visit wear period is still displayed. 

For participant US2010 (second to last row), the Week 4 visit wear period is still shown as planned, even though the current date, June 16th, is within the possible visit wear period. That is because the actual visit associated with Week 4 does not occur until after the visit wear period has been completed.  If you have the visit wear period after a scheduled visit, the user interface can provide more accurate information compared to having the visit wear period before a schedule visit. Thus, adding DHT to your study will require thinking through important implications like this when designing your study protocol. 

The Value of Accurate Wear Period Data

Here we primarily explore strategies for improving and managing data collection in complex study protocols, but it’s worth noting the added value of having access to actual visit wear periods during any study. This information enables targeted data exports specific to defined wear periods. It also supports the generation of detailed, retrospective adherence reports that not only enhance visibility into past participant behavior but also provide critical insights that can be used to refine and optimize future digital health technology (DHT) data collection efforts. 

In conclusion, we believe that we have designed a truly fit-for-purpose DHT platform that will make it easier to capture data from wearables as defined by visit structure in the study protocol. We are excited to hear your feedback on this new and improved functionality. 

This release complements our suite of tools available to help sponsors improve DHT compliance in studies, which also includes ActiTrack. ActiTrack is a service that sends daily reports on visit wear adherence by email. These reports enable the clinical team to track overall study visit wear period adherence. Combined these tools provide both the prospective and retrospective parts of data collection adherence. 

Contact us to discuss how we can support high-quality, visit-driven data collection in your next study. 

>> For more information, watch our Digital Health Monthly webinar featuring experienced digital health leaders from Pfizer, Novartis, and J&J Innovative Medicine, Real-World DHT Adherence Insights and Good Practice for Clinical Development