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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05063812
Other study ID # IRB#NCR202520
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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