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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04548895
Recruitment Status : Not yet recruiting
First Posted : September 16, 2020
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Health Stream Analytics, LLC

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.


Condition or disease Intervention/treatment
Covid19 Community-Acquired Respiratory Tract Infection Device: Observational measurement of biometric data. No change to health care provided.

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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Non-invasive Biometric Monitoring for the Prevention of COVID-19 Transmission and Deaths in Nursing Homes
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : February 26, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nursing Homes

Group/Cohort Intervention/treatment
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.

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.





Primary Outcome Measures :
  1. Proportion of quality signals obtained out of all monitoring time for each device [ Time Frame: 8 weeks from first enrollment ]
    Feasibility assessment

  2. Predictive characteristics of the algorithm for respiratory tract infection [ Time Frame: 2 months ]
    Algorithm development, sensitivity, specificity, positive and negative predictive value at different lead times ahead of symptom onset


Biospecimen Retention:   Samples With DNA
Nasal swabs will be taken at five time points to test for virus presence.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04548895


Contacts
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Contact: Martin G Frasch, MD, PhD 206-705-3381 martin@healthstreamanalytics.com

Sponsors and Collaborators
Health Stream Analytics, LLC
Investigators
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Study Chair: Martin G Frasch Health Stream Analytics, LLC
Additional Information:
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Responsible Party: Health Stream Analytics, LLC
ClinicalTrials.gov Identifier: NCT04548895    
Other Study ID Numbers: HSA-001
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Health Stream Analytics, LLC:
COVID-19
wearables
biometric data
Additional relevant MeSH terms:
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Respiratory Tract Infections
Infection
Respiratory Tract Diseases