COVID-19 Remote Monitoring

August 18, 2020 updated by: Vivek Reddy

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Vital Connect Patch Arm

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

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).

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vivek Reddy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2020

Primary Completion (Actual)

May 1, 2020

Study Completion (Actual)

May 1, 2020

Study Registration Dates

First Submitted

April 14, 2020

First Submitted That Met QC Criteria

April 14, 2020

First Posted (Actual)

April 17, 2020

Study Record Updates

Last Update Posted (Actual)

August 20, 2020

Last Update Submitted That Met QC Criteria

August 18, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 20-0932

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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