Use of Remote Monitoring for COVID-19 Patient

Study Overview
=================
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.

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

Conditions
-----------------
COVID

Intervention / Treatment
-----------------
* Device: LifeSignals Biosensor 1AX*
* Other: Standard of Care


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Of Care<br>Patients without wearable monitoring technology undergoing routine standard of care at the hospital. | Other: Standard of Care<br>* This group will be treated based on standard of care at our institution.<br>|
| Experimental: Monitored<br>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 | Device: LifeSignals Biosensor 1AX*<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Monitored Versus Non-Monitored In-patient Admission | compare the number of in-patient admissions between the monitored and non-monitored patients | 14 days | 
| How Many Subjects Needed to Visit the Emergency Department | compare the number of participants who visited Emergency Department between both arms | 14 days | 
| Length of Stay | Length of stay of subject if hospitalized | 14 days | 
| How Many Completed the Patient Satisfaction Survey | 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. | 14 days | 
| How Many Subjects End up Requiring Mechanical Ventilation and ECMO | How often does a subject end up getting mechanical ventilation or ECMO | 14 days | 
| Serious Adverse Events | events requiring extended hospital stay | 14 days |