Non-invasive Biometric Monitoring in Nursing Homes to Fight COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-30

Study Completion Date

2021-06-09

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Community-Acquired Respiratory Tract Infection Covid19

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

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LTCF residents and involved health practitioners

The intervention will take place in nursing homes, assisted living facilities and long-term care facilities (LTCF) in the United States (henceforth collectively referred to as "LTCF").

Staff who work in the participating LTCF ≥ 20 hours/week and who have direct contact with the residents are also eligible to participate and to employ the biometric monitoring equipment in their private residences.

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

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes