Performance of a Remote Monitoring Program for Patients Diagnosed With COVID-19

Covid19 Clinical Trial

— RPM  

Official title:

Performance of a Remote Monitoring Program for Patients Diagnosed With COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05063812
• Other study ID #: IRB#NCR202520
• Status: Completed
• Start date: September 21, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The GW Medical Faculty Associates recently launched a remote monitoring program for patients diagnosed with COVID-19. Patients are provided with a home pulse oximeter and thermometer. Participants complete daily surveys about their symptoms and vital signs and are escalated to receive phone calls and video visits if responses are abnormal.

Investigators would like to complete a study of the program to understand:

1. Operational parameters of program performance, such as how many patients were enrolled and how many patients completed monitoring

2. Clinical course of patients, including their reported symptoms over time and clinical endpoints such as hospitalization or ICU admission

3. Patient satisfaction with program

Description:

The SARS-CoV-2 that emerged in late 2019 has been noted to have a wide range of presentations, from asymptomatic and mild cases to those requiring intubation, ECMO, and critical care. As it is a novel pathogen, clinicians and scientists are only beginning understand when and who will require hospital-based resources such as oxygen, hospitalization, or ICU admission. The Medical Faculty Associates (MFA) COVID-19 Remote Monitoring Program (RPM) was developed to provide a daily touchpoint for patients during their COVID-19 course, including ready connection to paramedics and physicians when needed. The program was launched with the goal of identifying clinical decompensation early, maximizing available healthcare capacity, and minimizing nosocomial COVID-19 spread and healthcare worker exposure.

Investigators would like to perform analyses to test multiple hypotheses, including:

1. Patients discharged with a diagnosis of COVID-19 will be able to participate in a remote monitoring program.

2. A COVID-19 remote monitoring program will benefit patients.

3. Patients will be satisfied with their experience of a remote monitoring program and will have lower anxiety about their COVID-19 illness.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 31, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Laboratory-confirmed coronavirus infection

• Age >=18

• Primary language English or Spanish

Exclusion Criteria:

• Dementia

• Pregnant > 16 weeks gestation

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Covid19
• Infections
• Infectious Disease
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

Other:
• Observational
All these patients have been enrolled in the COVID-19 remote patient monitoring program

Locations

Country	Name	City	State
United States	The George Washington University, Department of Emergency Medicine	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
George Washington University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient referred	Number of patients referred	1 year
Primary	Patients enrolled	Number of patients enrolled	1 year
Primary	Response Rate	Patients giving at least 50% response rate over 10 days	1 year
Primary	Flagged cases	Number of cases flagged for responses on survey	1 year
Primary	Telehealth	Number of cases escalated to telehealth	1 year
Primary	Patient program graduation	Number of patients who graduate from program	1 year
Primary	Patient unenrollment	Number of patients who unenrolled and for what reason	1 year