COVID-19 Remote Monitoring

NCT04350476 | Withdrawn FDA Device

• 1 other identifier: GCO 20-0932
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COVID-19; Cardiac Arrhythmias

Keywords

COVID-19; Cardiac Arrhythmias; Atrial Fibrillation; Telemetry

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Vital Connect Patch Arm

OTHER

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

Interventions

VitalConnect Vital Sign Patch 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).

Vital Connect Patch Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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).

You may not qualify if:

• N/A

Sponsors & Collaborators

• Vivek Reddy: lead

MeSH Terms

Conditions

COVID-19; Arrhythmias, Cardiac; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vivek Y Reddy, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Martin Goldman, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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).

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 17, 2020
• Study Start: April 17, 2020
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: August 20, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share