Back to resultsCOVID-19 Remote Monitoring
Primary Purpose
COVID-19, Cardiac Arrhythmias
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
VitalConnect Vital Sign Patch
Sponsored by
About this trial
This is an interventional screening trial for COVID-19 focused on measuring COVID-19, Cardiac Arrhythmias, Atrial Fibrillation, Telemetry
Eligibility Criteria
Inclusion Criteria:
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
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Vital Connect Patch Arm
Arm 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 (FDA approved for this indication)
Outcomes
Primary Outcome Measures
Number of different arrhythmias
ac rhythm in patients with COVID-19 infection following treatment/discharge from MSH
Temperature
Temperature of patients with COVID-19 infection following treatment/discharge from MHS
Oxygen Saturation
Oxygen saturation level in patients with COVID-19 infection following treatment/discharge from MSH
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04350476
Brief Title
COVID-19 Remote Monitoring
Official Title
Remote Monitoring in Patients With Coronavirus Disease (COVID-19)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Withdrawn
Why Stopped
closed due to lack of interest and enrollment
Study Start Date
April 17, 2020 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
May 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Vivek Reddy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Cardiac Arrhythmias
Keywords
COVID-19, Cardiac Arrhythmias, Atrial Fibrillation, Telemetry
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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).
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vital Connect Patch Arm
Arm Type
Other
Arm 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 (FDA approved for this indication)
Intervention Type
Diagnostic Test
Intervention Name(s)
VitalConnect Vital Sign Patch
Intervention Description
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 Outcome Measure Information:
Title
Number of different arrhythmias
Description
ac rhythm in patients with COVID-19 infection following treatment/discharge from MSH
Time Frame
7-14 Days
Title
Temperature
Description
Temperature of patients with COVID-19 infection following treatment/discharge from MHS
Time Frame
7-14 Days
Title
Oxygen Saturation
Description
Oxygen saturation level in patients with COVID-19 infection following treatment/discharge from MSH
Time Frame
7-14 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vivek Y Reddy, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martin Goldman, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
COVID-19 Remote Monitoring
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