Use of Remote Monitoring 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.
Brief Title
Use of Remote Monitoring for COVID-19 Patient
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.
Completion Date
Completion Date Type
Actual
Conditions
COVID
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
Inclusion Criteria
Inclusion Criteria:

* Covid-19 positive patient
* Does not require in-patient admission

Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Submit Date
Maximum Age
90 Years
Minimum Age
18 Years
NCT Id
NCT04425720
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2020-11824
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Use of Remote Patient Monitoring (RPM) Platform for COVID-19 Patient
Primary Outcomes
Outcome Description
compare the number of in-patient admissions between the monitored and non-monitored patients
Outcome Measure
Number of Monitored Versus Non-Monitored In-patient Admission
Outcome Time Frame
14 days
Outcome Description
compare the number of participants who visited Emergency Department between both arms
Outcome Measure
How Many Subjects Needed to Visit the Emergency Department
Outcome Time Frame
14 days
Outcome Description
Length of stay of subject if hospitalized
Outcome Measure
Length of Stay
Outcome Time Frame
14 days
Outcome Description
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 Measure
How Many Completed the Patient Satisfaction Survey
Outcome Time Frame
14 days
Outcome Description
How often does a subject end up getting mechanical ventilation or ECMO
Outcome Measure
How Many Subjects End up Requiring Mechanical Ventilation and ECMO
Outcome Time Frame
14 days
Outcome Description
events requiring extended hospital stay
Outcome Measure
Serious Adverse Events
Outcome Time Frame
14 days
Start Date
Start Date Type
Actual
Status Verified Date
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
90
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jonathan Leff
Investigator Email
jleff@montefiore.org
Investigator Phone