COVID-19 Remote Monitoring

Study Overview
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Brief Summary
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The objective of the study is to assess the impact of remote cardiac and vital sign monitoring in patients with coronavirus disease (COVID-19) in the outpatient setting.

Detailed Description
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The objective of the study is to assess the impact of remote cardiac and vital sign monitoring in patients with coronavirus disease (COVID-19) in the outpatient setting. This study will enroll COVID-19 positive patients previously evaluated at Mount Sinai Hospital/Mount Sinai Health System (MSHS) and affiliated hospitals deemed appropriate for home monitoring. Patients will be monitored remotely in the outpatient setting for 1-3 weeks following diagnosis and/or treatment for COVID-19 at MSH/MSHS.

Official Title
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Remote Monitoring in Patients With Coronavirus Disease (COVID-19)

Conditions
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COVID-19, Cardiac Arrhythmias

Intervention / Treatment
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* Diagnostic Test: VitalConnect Vital Sign Patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with coronavirus and determined to be eligible for home monitoring and self-care, and either Not admitted to the hospital, and permitted to recover at home Discharged from inpatient hospitalization, during the acute recovery period 18 years old or older with the ability to understand the requirements of the study and sign the informed consent form (or able to provide over-the-phone verbal consent). Exclusion Criteria: N/A

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Interventional Model Description: This is a non-randomized study. Based on clinical assessment, patients will be provided with the following home monitoring system: VitalConnect Vital Sign Patch (San Jose, California) This patch provides continuous real-time monitoring of cardiac telemetry, heart rate, respiratory rate and oxygen saturation. Duration of monitoring is typically up to 7 days. This patch is applied to the upper left side of the chest wall, attached with a hypoallergenic adhesive material. (This device is FDA approved for this indication).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Vital Connect Patch Arm<br>This is a non-randomized study. Based on clinical assessment, patients will be provided with the following home monitoring system: VitalConnect Vital Sign Patch (FDA approved for this indication) | Diagnostic Test: VitalConnect Vital Sign Patch<br>* This patch provides continuous real-time monitoring of cardiac telemetry, heart rate, respiratory rate and oxygen saturation. Duration of monitoring is typically up to 7 days. This patch is applied to the upper left side of the chest wall, attached with a hypoallergenic adhesive material. (This device is FDA approved for this indication).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of different arrhythmias | ac rhythm in patients with COVID-19 infection following treatment/discharge from MSH | 7-14 Days | 
| Temperature | Temperature of patients with COVID-19 infection following treatment/discharge from MHS | 7-14 Days | 
| Oxygen Saturation | Oxygen saturation level in patients with COVID-19 infection following treatment/discharge from MSH | 7-14 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Cardiac Arrhythmias, Atrial Fibrillation, Telemetry