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

NCT05063812 | Completed

• 1 other identifier: IRB#NCR202520
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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. 1.Operational parameters of program performance, such as how many patients were enrolled and how many patients completed monitoring
2. 2.Clinical course of patients, including their reported symptoms over time and clinical endpoints such as hospitalization or ICU admission
3. 3.Patient satisfaction with program

Conditions

Covid19; Infectious Disease; SARS-CoV Infection

Keywords

COVID-19; Emergency Medicine; Remote Patient Monitoring

Outcome Measures

Primary Outcomes (7)

• Patient referred

  Number of patients referred

  1 year

• Patients enrolled

  Number of patients enrolled

  1 year

• Response Rate

  Patients giving at least 50% response rate over 10 days

  1 year

• Flagged cases

  Number of cases flagged for responses on survey

  1 year

• Telehealth

  Number of cases escalated to telehealth

  1 year

• Patient program graduation

  Number of patients who graduate from program

  1 year

• Patient unenrollment

  Number of patients who unenrolled and for what reason

  1 year

Interventions

Observational OTHER

All these patients have been enrolled in the COVID-19 remote patient monitoring program

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be all adults enrolled in the COVID-19 Remote Monitoring Program. The investigators anticipate this population to be similar to the GW University Hospital Emergency Department patient population.

You may qualify if:

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

You may not qualify if:

• Dementia
• Pregnant \> 16 weeks gestation

Sponsors & Collaborators

• George Washington University: lead

Study Sites (1)

The George Washington University, Department of Emergency Medicine

Washington D.C., District of Columbia, 20037, United States

Location

MeSH Terms

Conditions

COVID-19; Communicable Diseases; Severe Acute Respiratory Syndrome

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Emergency Medicine

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 1, 2021
• Study Start: September 21, 2020
• Primary Completion: December 30, 2023
• Study Completion: December 31, 2023
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)