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COVID-19 Remote Monitoring

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04350476
Enrollment
0
Registered
2020-04-17
Start date
2020-04-17
Completion date
2020-05-01
Last updated
2020-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrhythmias, COVID-19

Keywords

COVID-19, Cardiac Arrhythmias, Atrial Fibrillation, Telemetry

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.

Interventions

DIAGNOSTIC_TESTVitalConnect 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).

Sponsors

Vivek Reddy
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Intervention 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).

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of different arrhythmias7-14 Daysac rhythm in patients with COVID-19 infection following treatment/discharge from MSH
Temperature7-14 DaysTemperature of patients with COVID-19 infection following treatment/discharge from MHS
Oxygen Saturation7-14 DaysOxygen saturation level in patients with COVID-19 infection following treatment/discharge from MSH

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026