Clinical trial NCT04425720: Use of Remote Monitoring for COVID-19 Patient
Official title: Use of Remote Patient Monitoring (RPM) Platform for COVID-19 Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Number of Monitored Versus Non-Monitored In-patient Admission
timeFrame: 14 days
measure: How Many Subjects Needed to Visit the Emergency Department
timeFrame: 14 days
measure: Length of Stay
timeFrame: 14 days
measure: How Many Completed the Patient Satisfaction Survey
timeFrame: 14 days
measure: How Many Subjects End up Requiring Mechanical Ventilation and ECMO
timeFrame: 14 days
measure: Serious Adverse Events
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Jonathan Leff, MD
role: PRINCIPAL_INVESTIGATOR
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