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OpenTrials
Completed

NCT Number: NCT05063812

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

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

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Key information

About this study

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:

  • Patients discharged with a diagnosis of COVID-19 will be able to participate in a remote monitoring program.
  • A COVID-19 remote monitoring program will benefit patients.
  • Patients will be satisfied with their experience of a remote monitoring program and will have lower anxiety about their COVID-19 illness.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Dementia
  • Pregnant > 16 weeks gestation

Treatment and study plan

Observational

Other

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

Primary outcomes

  1. Patient referred

    Time frame: 1 year

    Number of patients referred

  2. Patients enrolled

    Time frame: 1 year

    Number of patients enrolled

  3. Response Rate

    Time frame: 1 year

    Patients giving at least 50% response rate over 10 days

  4. Flagged cases

    Time frame: 1 year

    Number of cases flagged for responses on survey

  5. Telehealth

    Time frame: 1 year

    Number of cases escalated to telehealth

  6. Patient program graduation

    Time frame: 1 year

    Number of patients who graduate from program

  7. Patient unenrollment

    Time frame: 1 year

    Number of patients who unenrolled and for what reason

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Registry information

Acronym: RPM

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 1, 2021
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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