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

• Sponsor: George Washington University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05063812
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Anticipated Duration (Months): 27.3
• Patients Per Site Per Month: 18.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Covid19; Infectious Disease; SARS-CoV Infection	Other: Observational

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 Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Other
• Time Perspective: Retrospective
• Official Title: Performance of a Remote Monitoring Program for Patients Diagnosed With COVID-19
• Actual Study Start Date: Sep 21, 2020
• Anticipated Primary Completion Date: Jun 30, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Outcome Measures

Primary Outcome Measures

1. Patient referred [1 year]

   Number of patients referred

2. Patients enrolled [1 year]

   Number of patients enrolled

3. Response Rate [1 year]

   Patients giving at least 50% response rate over 10 days

4. Flagged cases [1 year]

   Number of cases flagged for responses on survey

5. Telehealth [1 year]

   Number of cases escalated to telehealth

6. Patient program graduation [1 year]

   Number of patients who graduate from program

7. Patient unenrollment [1 year]

   Number of patients who unenrolled and for what reason

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Laboratory-confirmed coronavirus infection

• Age >=18

• Primary language English or Spanish

Exclusion Criteria:

• Dementia

• Pregnant > 16 weeks gestation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The George Washington University, Department of Emergency Medicine	Washington	District of Columbia	United States	20037

Sponsors and Collaborators

• George Washington University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Neal Sikka, Professor of Emergency Medicine, George Washington University
• ClinicalTrials.gov Identifier: NCT05063812
• Other Study ID Numbers: IRB#NCR202520
• First Posted: Oct 1, 2021
• Last Update Posted: Dec 1, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Neal Sikka, Professor of Emergency Medicine, George Washington University: COVID-19; Emergency Medicine; Remote Patient Monitoring
• Additional relevant MeSH terms: COVID-19; Communicable Diseases; Infections; Severe Acute Respiratory Syndrome

Study Results

No Results Posted as of Dec 1, 2021