Blog 10 - Participant Centric Wearables
Our tenth and final blog for 2020 examines commonly held participant fears about using wearable technology in Clinical Trials, and how Verisense was designed to reduce these and increase Participant compliance.
The use of connected digital technology in Clinical Trials has grown significantly this century. Marra et al, (2020) (1), outlined the growth from just eight trials in 2000, to over 1,100 trails in 2018 at a CAGR of 34%. This trend is expected to continue and research undertaken by Intel (2) expects that by 2025, 70% of Clinical Trials will involve digital sensors. More and more, Sponsor’s resistance to change and fears over data security, compliance, increased site burden and interoperability of multiple systems are being allayed.
One area of continuing concern lies in the adoption of technology by Clinical Trial participants, and the fear that the increased complexity of integrating further technology on the participants end, may ultimately affect participation and compliance. A 2020 study by Polhemus et al (3) found that “access to connected devices, time and effort required to learn to use the trial’s technology, and carrying an additional phone or mobile device dedicated to trial activities as the top challenges or burdens patients face” when using technology in clinical trials.
The question of participant burden was top of mind for the Shimmer team when designing the Verisense platform. Anecdotal feedback from stakeholders in the industry had identified numerous issues for participants using wearable sensors in Clinical Trials. The major issue centred on participant compliance to wearing the sensor. Any actions that required the participant to take off the sensor ran the risk of the sensor not being put back on and compliance protocols being breached.
A key mantra for the use of Verisense is that it reduces participant burden to the minimum, removing potential pain points where the sensor may need to be removed. We believe this is achieved in the design of the Verisense platform.
Long Lasting Battery – The Verisense battery can reach up to 6 months continuous use in some select modes. In most standard studies, users are experiencing a minimum of 2 months continuous battery life. With this extended battery life users do not need to take any regular actions, such as recharging the battery. In the case of trials spreading over many months, batteries can be changed on site visits by site staff, or even by the participant depending on the frequency of scheduled site visits. The process of changing batteries is quick and simple as demonstrated here.
Automated Data Upload – The Verisense System can be configured to upload data to the AWS hosting platform once daily, every second day or weekly. All data upload is automated, and requires no interaction from the user. The Verisense app on the base station (Android phone) acts as a communication gateway to receive data from the sensor and subsequently uploads this data via Cellular or Wi-Fi networks. All the participants are required to do is ensure the base station is powered on throughout. The participant is also asked to keep the base station in an area of the home where they spend a minimum of 1 hour each day, typically living room or bedroom in most cases.
IP67 Waterproof Rating – With an IP67 rating the Verisense sensor can withstand most standard exposures to water such as showering, bathing or washing dishes. More extreme water activities such as swimming are not advised.
All the above features eliminate the need for the participant to remove the sensor or have any physical interaction with the sensor or related accessories. The steps required for the participant to take part in a Trial involving wearables are reduced to the absolute minimum; simply wear the sensor and nothing more. We belief these features will go a long way to both enhancing participation and increasing the compliance rate. Early feedback from users suggests we are on the right track.
1 - Marra, C., Chen, J.L., Coravos, A. et al. Quantifying the use of connected digital products in clinical research. npj Digit. Med. 3, 50 (2020). https://doi.org/10.1038/s41746-020-0259-x
2 - Jansen, Y. and Thornton, G. (2020) Wearables & Big Data In Clinical Trials — Where Do We Stand? Clinical Leader. https://www.clinicalleader.com/doc/wearables-big-data-in-clinical-trials-where-dowe-stand-0001
3 - Polhemus AM, Kadhim H, Barnes S, et al. Accelerating Adoption of Patient-Facing Technologies in Clinical Trials: A Pharmaceutical Industry Perspective on Opportunities and Challenges. Therapeutic Innovation & Regulatory Science. 2019;53(1):8-24. doi:10.1177/2168479018801566
