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

Health Stream Analytics

Status: Completed

Conditions: Community-Acquired Respiratory Tract Infection; Covid19

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

Study type: Observational

Funder types: Industry

Identifiers

NCT04548895

HSA-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

26 participants in 1 patient group

LTCF residents and involved health practitioners

Description:

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.

Treatment:

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