Use of Remote Patient Monitoring (RPM) Platform for COVID-19 Patient
Phase: NA
Conditions: COVID
Sponsor: Montefiore Medical Center

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Use of Remote Patient Monitoring (RPM) Platform for COVID-19 Patients
SIGNIFICANCE
COVID-19 pandemic and significant background information 
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to impact the world with 
its exponential growth and fatalities related to coronavirus disease (COVID-19). (1)  We have seen a 
global spread of the virus with the current number of reported cases exceeding 2,000,000. (2) While 
there have been other viral outbreaks in the past years (MERS, SARS, H1N1), SARS-CoV-2 has profoundly 
penetrated and impacted the world. (3)  Our healthcare systems have been stretched to their limits, 
especially in designated "hotspots," such as all boroughs of New York City.  It is clear that given the 
current outbreak of COVID-19 and previous viral contagions, a comprehensive system is necessary for 
patient care during a pandemic. The need for risk stratification of infected patients with longitudinal 
monitoring is pivotal for the current as well as future pandemic response strategies.  We believe that 
emerging technologies incorporating remote patient monitoring (RPM) will play a key role in current and 
future systems-level solutions that can rapidly and accurately identify patients who require escalation of 
care and potentially reduce the need for inpatient admission and hospital length of stay.   
 
The clinical presentation of COVID-19 patients varies widely from asymptomatic or mild illness to a more 
severe and life-threatening condition. According to published literature, most COVID-19 patients present 
with mild to moderate symptoms, approximately 14%-20% of patients develop severe symptoms that 
require hospitalization, and 5% of these patients require critical care services. (4-8)  One of the most 
troubling features of COVID-19 is the unexpected and rapid deterioration of some infected patients. An 
estimated 10% of COVID-19 patients can develop life-threatening conditions such as acute respiratory 
distress syndrome (ARDS), the treatment of which requires aggressive intervention. (9) As observed in 
other diseases, a delay in identifying clinical deterioration can result in belated therapeutic 
interventions, thereby increasing morbidity and mortality. (2,10,11).The clinical variability of symptoms 
and progression of disease makes triaging and disposition of COVID-19 patients extremely challenging.   
Similar to SARS, MERS, and H1N1, respiratory failure plays a central role in COVID-19 morbidity and 
mortality.(12,13)  The pathological data of SARS-CoV-2 is associated with patchy inflammatory cellular 
infiltration of the lung tissue. (14) Even though there are several reasons for death in COVID-19 patients, 
respiratory involvement manifested as severe cough, and shortness of breath are two early warning 
signs associated with adverse events. (15)  It is important to note that while respiratory involvement is 
an important issue for the spread and overall morbidity of these patients, there are also systemic 
responses and deterioration of other organs. (15,16).  Therefore, a comprehensive remote patient 
monitoring (RPM) system must incorporate a number of physiologic parameters in order to rapidly and 
reliably identify patients in clinical distress requiring escalation of care.   
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. Studies have demonstrated that delays in 
the identification of clinical deterioration resulting in late therapeutic interventions are associated with 
increased mortality and morbidity. (17) Strategies for identifying patients at highest risk and mobilizing 
early interventions have the potential to improve outcomes.  Patients presenting to the hospital late in 
their clinical course are challenging to manage and often require rescue interventions such as 
mechanical ventilation or extracorporeal membrane oxygenation (ECMO).  Moreover, early 
identification and subsequent intervention could mitigate disease progression, deterioration, and the 
need for more advanced therapies.  
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Lack of these predictive measures forces our healthcare system to adopt a "one-size-fits-all" model, 
which is inefficient, prohibitively expensive, and clinically ineffective in too many patients. As in the case 
of COVID-19, lack of a valid risk stratification tool and the possibility of the rapid deterioration of 
symptoms warrant continuous monitoring of non-hospitalized patients during their symptomatic phase. 
(18) The use of RPM could be instrumental in understanding and developing an algorithm for escalation 
of care and therapeutic interventions in our patient population. Moreover, during the medical surge, 
resource utilization is one of the pivotal strategies that must be considered in epidemic and pandemic 
preparedness. Appropriate resource utilization is essential to provide quality care to every patient and 
to mitigate the adverse outcomes associated with pandemics. The 4 "S' s," staff, stuff, space, and 
systems are the critical factors in pandemic preparedness and resource utilization.  
COVID-19 in the minority population 
It is readily apparent that our minority and lower socioeconomic populations are significantly more 
vulnerable in this pandemic.  COVID-19 has been shown to have higher mortality rates among the 
African-American and Hispanic populations. (19) The Bronx represents one of the most diverse 
populations in the country and has been profoundly affected by COVID-19.   An ability to monitor 
patients in an out-patient setting with wearable technology has the potential to address some of the 
historical obstacles to timely healthcare access for our patient population.  The use of continuous 
monitoring would allow us to understand the progression of SARS-CoV-2 in our community while 
providing a mechanism for intervention.  Whereas our patients may be less likely to seek medical 
attention, the use of RPM allows the medical facility to maintain a level of monitoring and provide a 
safety net in the event of clinical deterioration. 
Utilization of wearable patches for remotely monitoring COVID-19 patients
Wearable technologies are continuing to impact healthcare decision making. Fitbits, smartwatches, and 
wearable patches have become everyday devices capable of collecting physiological data such as heart 
rate, blood pressure, body temperature,  and blood oxygen saturation. (20) The utilization and success 
of wearable technologies have been demonstrated in various medical conditions, such as cancer, 
respiratory diseases, heart disorders management, and diabetic care management. (21-23)In a recently 
published study, researchers demonstrated the utilization of wearables to track the resting heart rate 
and sleep pattern to predict the incidence of influenza-like illness. (24)  The improvements in wearable 
technologies provide opportunities for clinicians to deliver patient-centered care and engage patients in 
shared decision-making. In addition, detailed, longitudinal physiologic data could provide more insight 
into the development of advanced analytical tools for a better understanding of disease development 
and progression, early detection, and intervention. Data-driven clinical decisions, coupled with advanced 
analytical methods such as artificial intelligence (AI), have the potential to revolutionize how healthcare 
is delivered and improve the outcomes. The steady stream of information provided by these wearable 
devices can be utilized for monitoring real-time disease progression and providing individualized care. 
Newly emerging and re-emergence of known and unknown pathogens have created unpredictable 
threats to global public health. In the recent period, infectious diseases such as mumps, measles, Ebola, 
and SARS have created unprecedented challenges for healthcare systems. Effective measures to limit 
the contagion include disease surveillance, hygiene measures, self-isolation, social distancing, travel 
restrictions, quarantine, and case isolation. Of all the above-described actions, case isolation (self-
isolation) and contact precautions are the most proven method in reducing the contagion and the full 
spread of the diseases.  One of the potential ways to safely implement self-isolation without impeding 
care is to develop protocols to monitor isolated patients remotely.
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Hypothesis
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.   
Specific Aims
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, we 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, we plan to compare the emergency department (ED) visits 
and inpatient admission of patients with and without wearable remote patient monitoring devices. 
Additionally, we 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 inpatient 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, inpatient 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, inpatient admissions, length of hospital stay, and 
serious adverse events. 
Objectives 
The primary purpose of the study is to compare the number of inpatient admissions between the 
monitored and non-monitored patients.
The secondary endpoints are to compare the number of ED visits, length of stay, patient satisfaction, the 
incidence of mechanical ventilation, ECMO, and serious adverse events (events requiring extended 
hospital stay). 
Methods
In this prospective observational study, we are planning to recruit COVID-19 positive patients visiting 
emergency rooms (ER) associated with  Montefiore Medical Center 
Inclusion Criteria
●
Diagnosis of COVID-19 (first-time COVID-19 diagnosis)
●
Able to read and understand English
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Able to navigate and fulfill tasks on an electronic tablet
●
21 years and older
●
 Patients that do not require an inpatient admission as per the treating physician
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Patients who are insured through Medicare
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Patients who are staying in the same household for at least 15 days
●
Exclusion Criteria
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Have never used a mobile phone or tablet in the past
●
Patients with an implanted pacemaker
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Patients with a diagnosis of hyperhidrosis
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Acute allergic reactions to the patches
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Confirmed diagnosis of  psychiatric illness  or anxiety disorder 
●
All private insurance patients
   
Recruitment Strategy 
Every day around 4 pm, the research team will generate a list of patients who were tested COVID-19 
positive and are discharged from ER without requiring inpatient admission. This list will include all the 
COVID-19 positive patients from all the emergency departments associated with Montefiore Medical 
Center. The potential patient list will be generated on every alternate day; for example, the list will be 
generated on (Monday, Wednesday, and Friday). We are only planning to enroll 5-6 patients on a single 
day. Alternate day enrollment will potentially allow us to have a balance in the number of patients in the 
intervention and the control group. Also, it helps us to streamline the study logistics.   After screening 
for inclusion and exclusion criteria, the research team will identify potential patients eligible for the 
study. 
 
The research team will call the patients in the evening and explain the purpose of the study and will 
obtain oral consent. Before calling the patient, the research team will review the EPIC notes to make 
sure their COVID results are shared and discussed with the patients.  Oral consents will serve as a 
method of patients giving consent for engaging in the study discussion. The paper consents will be 
delivered to the patients with the study materials  ( tablet, sensors SPO2, and blood pressure cuff).  
After reading the consents, patients have the opportunity to decline participation in the study and 
return the study materials.  Once patients sign the consent, patients will have two options to return the 
signed copy. Either they can take a picture of the signature page and email or text it to the research 
team, or at the end of the study, they can return the signed consents along with the tablet.  We will 
keep a registry of the consenting process, which includes date and time, and the name of the personnel 
involved in the consenting process.  For patients who email the signature, the investigator portion will 
be signed and dated on the day of receiving the email. For patients who are returning the signed 
consent with the tablet package, the investigator portion will be signed and dated on the day of 
receiving the tablet.  
Delivery and Return of the Study Materials 
The following day morning, the research staff will drop off the monitoring packages at the patient's 
preferable drop-off locations. The research team will call the patients to confirm the receiving of the 
study materials. Once the packet is delivered, the study team will share the details of the patients with 
ImagineMic, the external company which will be monitoring the patients. Once the patient completes 
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the 14 days of participation, the patient is required to return the study materials to the study team.  The 
research team will make the necessary arrangements for the return of the study materials. 
External Monitoring 
ImagineMic will be monitoring the patients for CDC recommended 14 days. (25) ImagineMIC has 
extensive monitoring experience and is providing services in different capacities and capabilities. (25) 
ImagineMic uses a secure, HIPPA compliant platform for monitoring the patients. Additionally, round 
the clock, licensed healthcare professionals continuously monitor these data from a monitoring 
intervention center. Detailed monitoring plans are explained in the submitted brochure ( Appendix-1).
Monitoring will be prematurely terminated if the patient requires inpatient hospitalization; in all other 
cases, monitoring will be continued for fourteen days. During the monitoring period, patients will have 
the opportunity to call and speak to the medical professional at the Monitoring Intervention Center and 
also can call 911 in case of a severe emergency. Additionally, submitted is the guidelines put together by 
IMagineMic regarding the treatment and transfer of COVID-19 patients from home to the emergency      
(Appendix-2)
The patients will be remotely monitored for their vital signs such as blood pressure, heart rate, SPO2, 
skin temperature, respiratory rate, two lead ECG, and accelerometer.  
All the collected physiologic data will be transmitted to a central monitoring station where it will be 
evaluated continuously by licensed healthcare workers (MD, RN, and NP) who will provide real-time 
support to the patients. Also, the research team will obtain all the data points for future analytic 
purposes. Additionally, the research team will conduct a 30 day follow up phone call to catch 
information needed in case subjects end up visiting an outside institution.
Control Group
In this study control group will be patients those patients who are COVID positive and discharged from 
the ER and are not contacted by the study team during the same study period. In order to avoid 
chronological bias, it is essential to have controls from the same period as in the intervention 
group.  The standard of care, the presentation, and the outcome of the disease are very much different 
in the surge phase of the COVID  when compared to post surge months. Hence it is crucial to avoid 
chronological bias when comparing intervention and control groups.   Additionally, in terms of 
evaluating the efficacy of the intervention, using patients from the surge period as a control  group 
could potentially impact the conclusion of the study.
Regarding the care given to the control patients, Montefiore Emergency Department has a standard of 
operating protocols for patients discharged from the emergency room. All the usual standard of care 
available for the patients discharged from the emergency room will be provided to the patients, 
including telephone consultations. The study team will not interfere or dictate the care provided to the 
control patients.  
Technology
This study will be integrating two technologies; an FDA approved proprietary body patch and a digital 
monitoring platform.  The FDA approved body patch that will be used in this study is lifesignal biosensor 
1AX*, which is capable of monitoring vital signs, including blood pressure, heart rate, temperature, 
respiratory rate. (26) These patches are also capable of generating electrocardiogram (ECG) and function 
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as an accelerometer. Additionally, an FDA approved pulse oximeter, and blood pressure monitor will be 
used to measure the peripheral oxygen saturation and blood pressure, respectively
The digital monitoring platform ImagineMic will be utilized for continuous digital monitoring of the 
physiologic measurements. (27) The vital signs generated through the biosensor patch will be 
continuously supervised at the Monitoring Intervention Center (MIC) by licensed healthcare 
professionals. These data points are monitored 24/7and alerts will be provided to patients in case an 
intervention is needed. Additionally, based on the condition of the patient, the monitoring staff will 
facilitate ambulance support if required. The schematic representation of the study proposal is depicted 
in figure 1. 
In addition to remote monitoring, the monitoring team will collect the data about their daily clinical 
symptoms, including cough, myalgia, difficulty in breathing, and any other clinically significant 
symptoms.  Additionally, at the end of the monitoring period (14days), a personal well-being 
questionnaire will be administered to those patients who experience no adverse events.  
Cost and Reimbursement 
There will be no cost for the patient to participate in this study. The department of the anesthesiology    
(grant fund) and ImagineMic (company monitoring the patients) will share the cost of the wearables. 
The cost of the monitoring will be billed to the insurance company by ImagineMic. Patients will not be 
reimbursed for participating in the study. 
Data Collection and Storage
All the study data will be collected on a paper case report form (CRF), which will be entered into the 
computer database. All the data points will be collected and managed using RedCap electronic data 
capture tools.  All the electronic files will be saved in a password-protected computer in the research 
office.  Additionally, de-identified continuous monitoring data will be shared with the Montefiore Center 
for Health and Data Innovation team for additional analysis. 
DSMB
The first DSMB meeting will be conducted after the completion of 50% of the enrollment. The safety of 
the RPM will be the only outcome discussed during the DSMB meetings. Additionally, all the adverse 
events associated with the RPM will be reported to the DSMB and the IRB. In the event of serious 
adverse events, the termination or the continuation of the study will be at the discretion of the IRB. No 
interim analysis will be conducted, and the efficacy of the study will not be discussed at the DSMB 
meetings.
Statistical Analysis
In this prospective observational study, we are evaluating the efficacy of continuous monitoring in 
preventing inpatient admissions. A sample size of 300 patients is targeted for enrollment; 150 in the 
monitoring and 150 in the non-monitoring group. The sample size calculation is based on the 
hypothesized reduction of 10% inpatient admission between the two groups; 15% admission in the non-
monitoring group and 5% in the monitoring group, 80% statistical power, and 20% type –II error.
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All continuous variables will be summarized using the following descriptive statistics: mean, standard 
deviation, median, maximum, and minimum. The frequency and percentages will be reported for all 
categorical variables. No interim analysis will be performed. Quantitative variables will be compared 
using parametric or non-parametric t-test. A Chi-square test will be used for the comparison of 
categorical outcomes. All significance tests will be two-tailed, and values of P <0.05 will be considered 
statistically significant.   
Risks and Benefits
Risks associated with this study are minimal.   Complications from pulse oximeters and the LifeSignal 
Biosensor 1AX* are exceedingly rare. Complications that may occur in this study include feeling a small 
pinch when the monitors are placed and perhaps a small irritation to the skin. Subjects will be asked to 
provide personal information (PHI). All attempts will be made to keep the PHI confidential within the 
limits of the law. All the study documents will be kept in a locked file cabinet in the research office. 
Electronic files will be password protected. Informed consent will clearly state that by participating in 
this study, the patient’s personal information will be shared with an external monitoring agency.
The potential benefits of remote monitoring are at the patient, provider, and hospital level. One of the 
most important benefits for the patient is that during the self-isolating, and self-quarantine period, RPM 
can potentially provide peace of mind and daily assurance about their condition. In addition, enrolled 
patients will be able to instantly connect to their provider without any additional visit to the ED or clinic. 
These remote interactions could play a significant role in preventing the spread of the disease. At the 
provider level, because of the real-time availability of patient data, providers can deliver high-quality 
healthcare to a higher number of patients. Also, providers could use continuous physiological data 
points in risk stratifying and identifying patients with evidence of clinical deterioration and the need for 
care escalation.  At the hospital level, RPM can potentially reduce the need for inpatient hospitalization 
during the surge period. Additionally, RPM may allow earlier discharge of hospitalized patients, thereby 
generating space for new admissions. Finally, the hospital could potentially incorporate RPM as one of 
the key strategies of future preparedness for similar outbreaks.      
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IP admission directly without ED 
visit
Monitoring Intervention
Unit
(Doctors NP, Nurses)
Monitoring
SPo2
Temperature
Respiration rate 
EKG (optional)
Blood pressure
Heart rate
Online Symptoms Diary
COVID-19 
suspected 
cases
Testing 
Confirmation
Negative patients will be advised 
to follow up with their PCP
Out-Patient Positive 
cases 
Treatment and Remote 
Monitoring  
Recommendations based on the 
daily monitoring 
Physician Identification of 
worsening symptoms  
Continue home quarantine  
Contacting COVID hotline and 
follow recommendations
Feeling worsening of the symptoms  
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IRB NUMBER: 2020-11824
IRB APPROVAL DATE: 07/08/2020