Covid19 Clinical Trial
Official title:
Non-invasive Biometric Monitoring for the Prevention of COVID-19 Transmission and Deaths in Nursing Homes
NCT number | NCT04548895 |
Other study ID # | HSA-001 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 30, 2020 |
Est. completion date | June 9, 2021 |
Verified date | June 2021 |
Source | Health Stream Analytics, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Avalon Health & Rehabilitation Center | Pasco | Washington |
Lead Sponsor | Collaborator |
---|---|
Health Stream Analytics, LLC |
United States,
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 |
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