COVID-19 Remote Monitoring

Not Applicable

Withdrawn

• Conditions: COVID-19; Cardiac Arrhythmias
• Interventions: Diagnostic Test: VitalConnect Vital Sign Patch

• Registration Number: NCT04350476
• Lead Sponsor: Vivek Reddy

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-04-14
• Study Start: 2020-04-17
• Study First Posted: 2020-04-17
• Primary Completion: 2020-05-01
• Study Completion: 2020-05-01
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-18
• Last Update Posted: 2020-08-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients diagnosed with coronavirus and determined to be eligible for home monitoring and self-care, and either

  1. Not admitted to the hospital, and permitted to recover at home
  2. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vital Connect Patch Arm	VitalConnect Vital Sign Patch	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)

Primary Outcome Measures

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