COVID-19 Remote Monitoring

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-17

Study Completion Date

2020-05-01

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.

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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.

Conditions

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COVID-19 Cardiac Arrhythmias

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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).

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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)

Group Type OTHER

VitalConnect Vital Sign Patch

Intervention Type DIAGNOSTIC_TEST

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).

Interventions

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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).

Intervention Type DIAGNOSTIC_TEST

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

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).