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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04548895
• Other study ID #: HSA-001
• Status: Completed
• Start date: December 30, 2020
• Est. completion date: June 9, 2021

Study information

• Verified date: June 2021
• Source: Health Stream Analytics, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 9, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Community-Acquired Respiratory Tract Infection
• Covid19
• Respiratory Tract Infections

Intervention

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.

Locations

Country	Name	City	State
United States	Avalon Health & Rehabilitation Center	Pasco	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Health Stream Analytics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of quality signals obtained out of all monitoring time for each device	Feasibility assessment	8 weeks from first enrollment
Primary	Predictive characteristics of the algorithm for respiratory tract infection	Algorithm development, sensitivity, specificity, positive and negative predictive value at different lead times ahead of symptom onset	2 months

External Links

•   At least 55,000 or more than 40% of currently over 120,000 deaths from COVID-19 were residents and workers at nursing homes and other long-term care facilities for older adults in the United States.