Wearable, sensor-based digital health technologies (DHTs) can provide clinical researchers with valuable insight into the physical activity, movement behavior, and sleep of study participants – with data collected remotely from the comfort of their own homes. Once your team has decided to leverage DHTs in this way, what should you look for in a technology partner to ensure the successful collection of meaningful, patient-centered digital measures?
Incorporating remote DHT assessments into a clinical trial comes with many operational challenges. To help you prepare to overcome these hurdles, we’ve put together a short list of important, yet often overlooked, questions to discuss with any wearable technology partner prior to your study.
1. What is your experience managing DHT operations in large-scale clinical trials?
It’s important to work with a technology partner that has experience navigating the complexities of DHT deployment and data management. They should have the ability to guide your study team from beginning to end in order to ensure all aspects of the technology are meeting your research needs.
Every step of that process must be done effectively in order for a DHT assessment to provide valuable digital clinical measures of a treatment’s impact on the participant.
2. Will the devices work in each geographic region of my study?
Just because a DHT is medical-grade doesn’t necessarily mean it’s cleared to be shipped to all the countries where it will be used. In some cases, this can be mitigated by adjusting the use of the DHT based on the countries that will accept it. Keep in mind that regional regulations, such as restrictions on GPS or Bluetooth, are frequently changing.
Be mindful of the fact that participants don’t always stay in the same time zone throughout the study, or in some cases, even throughout the day. Due to privacy restrictions on DHTs, GPS time-syncing is not always an option.
3. How do you manage and process raw data?
When people say they want raw data, they don’t always understand what that means when it comes to actigraphy. The size of the data can be massive, and more information does not always equal more value. The complexity of managing this volume of data is often underestimated, and selecting and processing algorithms can become overwhelming. A cost analysis should be conducted with consideration as to what data is actually needed.
Ask the technology partner if the calculation of the data has been separated from the collection of the data. The differentiation allows for flexibility with adaptable, clinically validated algorithms.
4. What happens if there is an issue with data collection?
The robustness of the wireless channel and cellular signal should be considered because every time data is transferred, it creates an opportunity for error. If there is an issue with data collection, does data collection stop, or is data overwritten? (Sufficient non-volatile DHT memory is strongly preferred.)
Find out if the technology partner understands database lock. If they do not have this capability, you could encounter issues if new data comes into the database after the study is over.
5. What happens to data at the end of the study?
Archiving the raw data at the end of the study is necessary to have the option to apply new algorithms later.
In addition, giving the site the ability to share data back to participants at the end of a study engages them and helps them better understand how the technology is informing decisions. Such feedback does not necessarily have to include the actual endpoint being studied.