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

Completed

• Conditions: Covid19; SARS-CoV Infection; Infectious Disease

• Registration Number: NCT05063812
• Lead Sponsor: George Washington University

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2020-09-21
• Study First Submitted: 2020-10-01
• Study First Submitted QC: 2021-09-29
• Study First Posted: 2021-10-01
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-29
• Last Update Posted: 2024-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Laboratory-confirmed coronavirus infection
• Age >=18
• Primary language English or Spanish

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Exclusion Criteria

• Dementia
• Pregnant > 16 weeks gestation

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

The George Washington University, Department of Emergency Medicine; 🇺🇸 Washington, District of Columbia, United States