Updates on the Wearables Study for Patients

The ongoing wearables study is enrolling transplant patients and their household members to wear smart watches that measure biometrics, such as heart rate, heart rate variability, blood pressure, sleep and respiratory patterns, activity, and saturating oxygen levels. Algorithms are being applied to the data streams from these devices. These algorithms set baselines for each patient and then monitor the data for changes in the physiological parameters that may be indicators of infections.
There are many underlying physiological signs of infection that could be detected by wearable health devices, such as increasing temperature and heart rate. These changes often begin to occur before clinical symptoms present.
As an example, generally an increase in heart rate of 8.5 beats per minute equates to your temperature rising by 1oC. While this can occur through rigorous physical activities, large increases in heart rate are not generally sustained for long periods of 12 or more hours unless an infection or some other physiological processes are occurring. Studies in the general population have demonstrated early infection detection capabilities of wearable devices days before clinical presentation of infection such as influenza, and SARS-CoV-2 (which causes COVID-19 disease). Due to being immunosuppressed transplant patients are at a high risk for contracting and experiencing complications from infections, but have been shown to benefit from early intervention. Receiving care early on during the infection process is associated with better outcomes and fewer hospitalizations.
The wearables device in transplant household studies are look at many factors, such as type of solid organ transplant, pre- and post-transplant medication, and post-transplant complications, to determine the impact that these factors have on the infection detection algorithms. Thus patient recruitment includes the collection of background health information to be linked with the wearable sensor data.
For the existing studies patients and household members are recruited through an existing study protocol in specific transplant sites. Once consented and enrolled in the study they are shipped the smart watches wearable. Household members are part of the study wearables to examine if intra-household spread has the potential to be prevented through early self-isolation or distancing. Patients and household members would be asked to wear the health wristwatches as often as possible throughout the day to create steady streams of data. Additionally, everyone would be asked to complete a very brief symptoms questionnaire (about 1 min) once daily through a smartphone app. The study protocol is intended to be minimally invasive so as not to add excess burden onto participating families.
The first phase of the study for 35-40 days is observational to determine how effective the existing early infection detection algorithms are in the transplant population. These analysis arel determining the optimal sensitivity of the algorithms to maximize early detection while being able to minimize false alarms. The second phase of the study will be to alert non-transplanted family members in real-time when the algorithms detect a period of potential infection, while the transplanted individuals trigger alerts are sent to the clinical care team for continued monitoring to assess if the trigger is real. This study is meant to be an added resource for the high-risk transplant population that can supplement standard care. It does not act as a replacement for any aspects of standard transplant care. We anticipate that if these studies are successful we may be able to roll them out to broader transplant populations through the use of newer transplant specific algorithms with remote enrolling and consent through the Stanford MyPHD study.
Posted on: January 12, 2021, by :
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