Official Title
Non-invasive Biometric Monitoring for the Prevention of COVID-19 Transmission and Deaths in Nursing Homes
Brief Summary

Solving the problem of detecting asymptomatic carriers who can transmit infection is key to protecting vulnerable residents of nursing homes and assisted living facilities, to protecting frontline workers who care for them, and to facilitating return to work (including return of nurses and medical assistants). The wearable biometric technology, if widely disseminated among vulnerable populations and the community-at-large, will help avoid the ravages of seasonal flu and other contagious illnesses, and the society will be better prepared for future waves of COVID-19 or other pandemics. Even if a vaccine is developed, due to immune senescence and immunocompromise, elderly people and those with chronic medical conditions may not be well protected by it. Continuous biomonitoring provides another layer of protection for them.

Detailed Description

1. Building the algorithm for early, pre-symptomatic DETECTION OF RESPIRATORY VIRAL
INFECTION and for predicting eventual DETERIORATION.

2. Create an APP that AUTOMATES these algorithms and clearly REPORTS ACTIONABLE RESULTS to
users, i.e., to medical professionals and citizens-at-large in near-real time. If
alerted to a possible - and likely still asymptomatic - COVID-19 infection, they can
self-isolate or be quarantined, get confirmatory COVID-19 testing done promptly, limit
transmission to others, and stay safe knowing that if they are likely to deteriorate,
the algorithm will alert the participants and their caregivers to the need to obtain
medical attention promptly.

Completed
COVID19
Community-Acquired Respiratory Tract Infection

Device: Observational measurement of biometric data. No change to health care provided.

Emfit devices will be installed once after enrollment under each participant's mattress and left to record automatically without further intervention. The participants will wear their Biostrap wristbands consistently, ideally 24 hours a day, 7 days a week, for 2 months.
A virus panel will be upon enrollment (baseline) and then every two weeks (± 3 days, or on the closest convenient sampling day if the LTCF is testing all residents on the same day) for a maximum of 5 times during the two-month period. Using polymerase chain reaction or next generation sequencing, the virus panel will detect COVID-19 and 12 other common respiratory viruses that may cause similar symptoms and similar biometric signatures. These include influenza A and B, parainfluenza types 1 through 4, respiratory syncytial virus, non-COVID coronavirus, rhinovirus, adenovirus, bocavirus and metapneumovirus.

Eligibility Criteria

Inclusion Criteria:

- Residents and staff members of U.S. LTCFs where COVID-19 transmission is actively
occurring. The LTCF medical director must agree to enroll the LTCF, and each
participant must have the capacity to agree and sign consent.

Exclusion Criteria:

- Current atrial fibrillation.

- NB: Paroxysmal atrial fibrillation is permitted if the participant is in atrial
fibrillation less than 50% of the day on most days.

- Pacemaker in place.

- Known active infection other than COVID-19.

- Dementia

Eligibility Gender
All
Eligibility Age
Minimum: N/A ~ Maximum: N/A
Countries
United States
Locations

Avalon Health & Rehabilitation Center
Pasco, Washington, United States

Martin G Frasch, Study Chair
Health Stream Analytics, LLC

Health Stream Analytics, LLC
NCT Number
Keywords
Covid-19
wearables
biometric data
MeSH Terms
COVID-19
Respiratory Tract Infections