The most critical factor to the success of any clinical research study is participant adherence to the study design. As the use of wearable technologies becomes more and more mainstream in clinical research, it presents unique challenges and considerations to ensure proper protocol adherence with minimal missing data. Many of these considerations have to do with the usability of the wearables and the platform required for data collection. That’s why the FDA has placed usability at the center of itsnew draft guidanceon digital health technologies (DHTs).
Drawing on ActiGraph’s 20+ years of experience supporting clinical research, including over 200 industry-sponsored trials, we’ve put together this practical guidance for optimizing wearables adherence during a study. In our experience, device specifications, protocol design, and adherence monitoring are the top three factors that sponsors should prioritize when planning a study.
Device Specifications - Design and Operation
The ways in which a wearable DHT is designed and operated are fundamental to a good user experience. The goal is to minimize user input and burden. The requirements of device charging and data upload should be first evaluated in relation to the designed data collection period. Long battery life, sufficient onboard memory capability, and passive data transfer are among the most desirable device specifications. In our experience, studies that use CentrePoint Insight Watch and Data Hub, with 30+ day device battery and passive data upload, typically have the highest adherence among those we support. Such considerations are becoming even more important for decentralized or hybrid clinical trials.
How the device looks and feels also plays an important role, especially for studies of long duration. Participants in general prefer to wear the device on the wrist as opposed to the hip, lumbar, or ankle. For wrist-worn devices, a light and thin watch style is much more desirable than a clumsy box with no interface. Not only is it more comfortable and functional, but this watch-style wearable tends to be more aesthetically pleasing and socially acceptable within participants’ daily lives.
Protocol Design – Optionality and Wear Time
Another major impact on adherence is whether the DHT is positioned as a mandatory or optional assessment in the protocol design. As DHTs are still relatively new to clinical trials, they are often included for exploratory research purposes. While it might be tempting to position an exploratory DHT use as optional in order to reduce burden and complexity, we strongly advise against such an approach. An optional assessment suggests to staff and participants that it is not important, often substantially compromising the data collection effort. It is preferable to implement the device in a sub-study to ensure adherence and hence the desired research objectives.
Similarly, the study team might be tempted to choose intermittent (few days or weeks at regular intervals) over continuous device use to minimize burden. In reality, it is often challenging to develop clear instructions for intermittent device use that participants can follow and/or remember. Intermittent use might paradoxically increase burden - for both the participants and the study personnel - rather than continuous use where the regularity helps participants to form a habit. We have found protocol designs with continuous DHT use tend to have higher adherence than those with intermittent use.
Even with the most optimal device specifications and protocol design, there will still be instances of non-adherence. The ability to monitor adherence in real time or close to real time can be the key to minimize such instances and reduce missing data. In fact, this one functionality has been the driving factor behind a variety of design specifications of our CentrePoint platform, including near real-time data upload, data processing, wear detection, and adherence reporting. The goal is to give the study team the opportunity to solve any adherence issues, whether technical or circumstantial, as soon as they arise.
These are just some of the lessons we’ve learned and improvements we have made to optimize DHT for remote data acquisition in clinical investigation. Do you agree? What else do you think is important to ensure adherence in DHT trials? Please let us know your thoughts and experiences so we can continue to advance the use of DHTs together!