Official Title
Use of Remote Patient Monitoring (RPM) Platform for COVID-19 Patient
Brief Summary

The central hypothesis motivating this study is that remote patient monitoring (RPM) of infectious disease patients can efficiently facilitate self-isolation. Additionally, RPM can assist in more rapid identification of patients at risk, facilitate detection of patient deterioration, and enable early interventions, all of which play a vital role in resource utilization and outcomes.

Detailed Description

Aim-I To develop and test a clinical care pathway that can be utilized in similar epidemic
conditions in the future. To study this aim, the investigators will be using the COVID-19
medical surge as a condition to evaluate the framework of delivering care through remote
patient monitoring. The success of this care delivery model will be evaluated on ease of
model implementation, patient satisfaction, clinical outcomes, and the utilization of shared
decision making.

Aim-II To evaluate remote patient monitoring for appropriate resource utilization in epidemic
and pandemic conditions. To evaluate this aim, the investigators plan to compare the
emergency department (ED) visits and in-patient admission of patients with and without
wearable remote patient monitoring devices. Additionally, the investigators will compare the
number of patients that required critical interventions (mechanical ventilation and ECMO)
during the hospital stay.

Aim III To evaluate the utilization of wearable technology for upfront predictions of
patients that would require in-patient admissions. To evaluate this aim, 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. The comparison group will be patients undergoing routine standard of care at
the hospital. ED visits, in-patient hospital admissions, and patient satisfaction will be the
outcome measures compared between the two groups.

Aim IV To evaluate the association between early identification of critical, abnormal vital
signs and the prevention of serious adverse events. To evaluate this aim, patients in the
monitored group and non-monitored group will be compared for ED visits, in-patient
admissions, length of hospital stay, and serious adverse events.

Completed
COVID

Device: 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.

Other: Standard of Care

This group will be treated based on standard of care at our institution.

Eligibility Criteria

Inclusion Criteria:

- Covid-19 positive patient

- Does not require in-patient admission

Exclusion Criteria:

- Allergic to sensor patch

- Has implanted pacemaker

- Has excessive sweating

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 90 Years
Countries
United States
Locations

Montefiore Medical Center
Bronx, New York, United States

Jonathan Leff, MD, Principal Investigator
Montefiore Medical Center

Montefiore Medical Center
NCT Number