Trial Outcomes & Findings for Use of Remote Monitoring for COVID-19 Patient (NCT NCT04425720)

NCT ID: NCT04425720

Last Updated: 2022-01-24

Results Overview

compare the number of in-patient admissions between the monitored and non-monitored patients

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 300 participants
• Primary outcome timeframe: 14 days
• Results posted on: 2022-01-24

Participant Flow

Participant milestones

Measure	Standard Of Care Patients without wearable monitoring technology undergoing routine standard of care at the hospital. Standard of Care: This group will be treated based on standard of care at our institution.	Monitored Patients who are diagnosed with COVID-19 and are undergoing self-quarantine will be closely monitored using a wearable device, and shared-clinical decisions will be made based on the monitored data and patient diary LifeSignals Biosensor 1AX\*: Shared-clinical decisions will be made based on the monitored data and patient diary. Two devices will be used to monitor data, LifeSignals Biosensor 1AX\* and a pulse oximeter.
Overall Study STARTED	150	150
Overall Study COMPLETED	150	130
Overall Study NOT COMPLETED	0	20

Reasons for withdrawal

Measure	Standard Of Care Patients without wearable monitoring technology undergoing routine standard of care at the hospital. Standard of Care: This group will be treated based on standard of care at our institution.	Monitored Patients who are diagnosed with COVID-19 and are undergoing self-quarantine will be closely monitored using a wearable device, and shared-clinical decisions will be made based on the monitored data and patient diary LifeSignals Biosensor 1AX\*: Shared-clinical decisions will be made based on the monitored data and patient diary. Two devices will be used to monitor data, LifeSignals Biosensor 1AX\* and a pulse oximeter.
Overall Study Withdrawal by Subject	0	20

Baseline Characteristics

Use of Remote Monitoring for COVID-19 Patient

Baseline characteristics by cohort

Measure	Standard Of Care n=150 Participants Patients without wearable monitoring technology undergoing routine standard of care at the hospital. Standard of Care: This group will be treated based on standard of care at our institution.	Monitored n=130 Participants Patients who are diagnosed with COVID-19 and are undergoing self-quarantine will be closely monitored using a wearable device, and shared-clinical decisions will be made based on the monitored data and patient diary LifeSignals Biosensor 1AX\*: Shared-clinical decisions will be made based on the monitored data and patient diary. Two devices will be used to monitor data, LifeSignals Biosensor 1AX\* and a pulse oximeter.	Total n=280 Participants Total of all reporting groups
Age, Customized Average Age in Years	65.50 years n=93 Participants	64 years n=4 Participants	65 years n=27 Participants
Sex: Female, Male Female	82 Participants n=93 Participants	88 Participants n=4 Participants	170 Participants n=27 Participants
Sex: Female, Male Male	68 Participants n=93 Participants	42 Participants n=4 Participants	110 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	90 Participants n=93 Participants	89 Participants n=4 Participants	179 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	60 Participants n=93 Participants	41 Participants n=4 Participants	101 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	150 participants n=93 Participants	130 participants n=4 Participants	280 participants n=27 Participants

PRIMARY outcome

Timeframe: 14 days

compare the number of in-patient admissions between the monitored and non-monitored patients

Outcome measures

Measure	Standard Of Care n=150 Participants Patients without wearable monitoring technology undergoing routine standard of care at the hospital. Standard of Care: This group will be treated based on standard of care at our institution.	Monitored n=130 Participants Patients who are diagnosed with COVID-19 and are undergoing self-quarantine will be closely monitored using a wearable device, and shared-clinical decisions will be made based on the monitored data and patient diary LifeSignals Biosensor 1AX\*: Shared-clinical decisions will be made based on the monitored data and patient diary. Two devices will be used to monitor data, LifeSignals Biosensor 1AX\* and a pulse oximeter.
Number of Monitored Versus Non-Monitored In-patient Admission	8 Participants	9 Participants

PRIMARY outcome

Timeframe: 14 days

compare the number of participants who visited Emergency Department between both arms

Outcome measures

Measure	Standard Of Care n=150 Participants Patients without wearable monitoring technology undergoing routine standard of care at the hospital. Standard of Care: This group will be treated based on standard of care at our institution.	Monitored n=130 Participants Patients who are diagnosed with COVID-19 and are undergoing self-quarantine will be closely monitored using a wearable device, and shared-clinical decisions will be made based on the monitored data and patient diary LifeSignals Biosensor 1AX\*: Shared-clinical decisions will be made based on the monitored data and patient diary. Two devices will be used to monitor data, LifeSignals Biosensor 1AX\* and a pulse oximeter.
How Many Subjects Needed to Visit the Emergency Department	14 Participants	12 Participants

PRIMARY outcome

Timeframe: 14 days

Length of stay of subject if hospitalized

Outcome measures

Measure	Standard Of Care n=150 Participants Patients without wearable monitoring technology undergoing routine standard of care at the hospital. Standard of Care: This group will be treated based on standard of care at our institution.	Monitored n=130 Participants Patients who are diagnosed with COVID-19 and are undergoing self-quarantine will be closely monitored using a wearable device, and shared-clinical decisions will be made based on the monitored data and patient diary LifeSignals Biosensor 1AX\*: Shared-clinical decisions will be made based on the monitored data and patient diary. Two devices will be used to monitor data, LifeSignals Biosensor 1AX\* and a pulse oximeter.
Length of Stay	7 days Interval 1.0 to 14.0	7 days Interval 4.5 to 9.5

PRIMARY outcome

Timeframe: 14 days

Survey given to patients who were monitored to ask about satisfaction with the program. A research associate calls enrolled subjects to determine their opinions having participated in the program.

Outcome measures

Measure	Standard Of Care n=130 Participants Patients without wearable monitoring technology undergoing routine standard of care at the hospital. Standard of Care: This group will be treated based on standard of care at our institution.	Monitored Patients who are diagnosed with COVID-19 and are undergoing self-quarantine will be closely monitored using a wearable device, and shared-clinical decisions will be made based on the monitored data and patient diary LifeSignals Biosensor 1AX\*: Shared-clinical decisions will be made based on the monitored data and patient diary. Two devices will be used to monitor data, LifeSignals Biosensor 1AX\* and a pulse oximeter.
How Many Completed the Patient Satisfaction Survey	84 Participants	—

PRIMARY outcome

Timeframe: 14 days

Population: As only those monitored were surveyed, the following results only reflect one of the arms. There is no reason to conduct a satisfaction survey on individuals who received standard of care because they would not be aware of the monitoring option.

How often does a subject end up getting mechanical ventilation or ECMO

Outcome measures

Measure	Standard Of Care n=130 Participants Patients without wearable monitoring technology undergoing routine standard of care at the hospital. Standard of Care: This group will be treated based on standard of care at our institution.	Monitored Patients who are diagnosed with COVID-19 and are undergoing self-quarantine will be closely monitored using a wearable device, and shared-clinical decisions will be made based on the monitored data and patient diary LifeSignals Biosensor 1AX\*: Shared-clinical decisions will be made based on the monitored data and patient diary. Two devices will be used to monitor data, LifeSignals Biosensor 1AX\* and a pulse oximeter.
How Many Subjects End up Requiring Mechanical Ventilation and ECMO	0 Participants	—

PRIMARY outcome

Timeframe: 14 days

events requiring extended hospital stay

Outcome measures

Measure	Standard Of Care n=150 Participants Patients without wearable monitoring technology undergoing routine standard of care at the hospital. Standard of Care: This group will be treated based on standard of care at our institution.	Monitored n=130 Participants Patients who are diagnosed with COVID-19 and are undergoing self-quarantine will be closely monitored using a wearable device, and shared-clinical decisions will be made based on the monitored data and patient diary LifeSignals Biosensor 1AX\*: Shared-clinical decisions will be made based on the monitored data and patient diary. Two devices will be used to monitor data, LifeSignals Biosensor 1AX\* and a pulse oximeter.
Serious Adverse Events	2 Participants	1 Participants

Adverse Events

Standard Of Care

Serious events: 2 serious events

Other events: 8 other events

Deaths: 2 deaths

Monitored

Serious events: 1 serious events

Other events: 9 other events

Deaths: 1 deaths

Serious adverse events

Measure	Standard Of Care n=150 participants at risk Patients without wearable monitoring technology undergoing routine standard of care at the hospital. Standard of Care: This group will be treated based on standard of care at our institution.	Monitored n=130 participants at risk Patients who are diagnosed with COVID-19 and are undergoing self-quarantine will be closely monitored using a wearable device, and shared-clinical decisions will be made based on the monitored data and patient diary LifeSignals Biosensor 1AX\*: Shared-clinical decisions will be made based on the monitored data and patient diary. Two devices will be used to monitor data, LifeSignals Biosensor 1AX\* and a pulse oximeter.
Respiratory, thoracic and mediastinal disorders Death	1.3% 2/150 • Number of events 2 • Up to 17 days after admission As this is a novel pandemic, there are limited resources available for accurate identification of patients at high risk for respiratory failure and other adverse events. Subjects who were repeatedly admitted into the hospital will count as an adverse event. Death will count as a serious adverse event.	0.77% 1/130 • Number of events 1 • Up to 17 days after admission As this is a novel pandemic, there are limited resources available for accurate identification of patients at high risk for respiratory failure and other adverse events. Subjects who were repeatedly admitted into the hospital will count as an adverse event. Death will count as a serious adverse event.

Other adverse events

Measure	Standard Of Care n=150 participants at risk Patients without wearable monitoring technology undergoing routine standard of care at the hospital. Standard of Care: This group will be treated based on standard of care at our institution.	Monitored n=130 participants at risk Patients who are diagnosed with COVID-19 and are undergoing self-quarantine will be closely monitored using a wearable device, and shared-clinical decisions will be made based on the monitored data and patient diary LifeSignals Biosensor 1AX\*: Shared-clinical decisions will be made based on the monitored data and patient diary. Two devices will be used to monitor data, LifeSignals Biosensor 1AX\* and a pulse oximeter.
Infections and infestations Repeated Admission	5.3% 8/150 • Number of events 8 • Up to 17 days after admission As this is a novel pandemic, there are limited resources available for accurate identification of patients at high risk for respiratory failure and other adverse events. Subjects who were repeatedly admitted into the hospital will count as an adverse event. Death will count as a serious adverse event.	6.9% 9/130 • Number of events 9 • Up to 17 days after admission As this is a novel pandemic, there are limited resources available for accurate identification of patients at high risk for respiratory failure and other adverse events. Subjects who were repeatedly admitted into the hospital will count as an adverse event. Death will count as a serious adverse event.

Additional Information

Dr. Jonathan Leff

Montefiore Medical Center

Phone: 7189204316

Email: jleff@montefiore.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place