Covid19RPMNCT05063812
Performance of a Remote Monitoring Program for Patients Diagnosed With COVID-19
An observational study of Covid19 and Infectious Disease, run by George Washington University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Covid19, Infectious Disease, SARS-CoV Infection
- What is being tested?
- Observational
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2020to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Laboratory-confirmed coronavirus infection
- Age >=18
- Primary language English or Spanish
Who cannot join
- Dementia
- Pregnant > 16 weeks gestation
Trial locations and contacts
1 site in 1 country.
United States1 site
The George Washington University, Department of Emergency Medicine
Washington D.C., District of Columbia, 20037
About this study
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:
- Operational parameters of program performance, such as how many patients were enrolled and how many patients completed monitoring
- Clinical course of patients, including their reported symptoms over time and clinical endpoints such as hospitalization or ICU admission
- Patient satisfaction with program
Read the 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:
- 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.
- Conditions
- Covid19, Infectious Disease, SARS-CoV Infection
- Being tested
- Observational
- Keywords
- COVID-19, Emergency Medicine, Remote Patient Monitoring
- Medical subject headings
- COVID-19, Communicable Diseases, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
All these patients have been enrolled in the COVID-19 remote patient monitoring program
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient referred
Number of patients referred
Measured: 1 year
Patients enrolled
Number of patients enrolled
Measured: 1 year
Response Rate
Patients giving at least 50% response rate over 10 days
Measured: 1 year
Flagged cases
Number of cases flagged for responses on survey
Measured: 1 year
Telehealth
Number of cases escalated to telehealth
Measured: 1 year
Patient program graduation
Number of patients who graduate from program
Measured: 1 year
Patient unenrollment
Number of patients who unenrolled and for what reason
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start21 Sep 2020
- Primary completion30 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neal Sikka, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063812
- Sponsor's protocol ID
- IRB#NCR202520
- Acronym
- RPM
- Status last verified
- Feb 2024
- First submitted
- 1 Oct 2020
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of a Remote Monitoring Program for Patients Diagnosed With COVID-19
- ClinicalTrials.gov ID
- NCT05063812
- Acronym / sponsor ID
- RPM / IRB#NCR202520
- Conditions
- Covid19, Infectious Disease, SARS-CoV Infection
- Keywords
- COVID-19, Emergency Medicine, Remote Patient Monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 1 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Operational parameters of program performance, such as how many patients were enrolled and how many patients completed monitoring
- Clinical course of patients, including their reported symptoms over time and clinical endpoints such as hospitalization or ICU admission
- 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:
- 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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Laboratory-confirmed coronavirus infection
- Age >=18
- Primary language English or Spanish
Key exclusion criteria (2 listed)
- Dementia
- Pregnant > 16 weeks gestation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalAll these patients have been enrolled in the COVID-19 remote patient monitoring program | Other | – |
Primary outcome
Patient referred
Time frame: 1 year
Number of patients referred
Patients enrolled
Time frame: 1 year
Number of patients enrolled
Response Rate
Time frame: 1 year
Patients giving at least 50% response rate over 10 days
Flagged cases
Time frame: 1 year
Number of cases flagged for responses on survey
Telehealth
Time frame: 1 year
Number of cases escalated to telehealth
Patient program graduation
Time frame: 1 year
Number of patients who graduate from program
Patient unenrollment
Time frame: 1 year
Number of patients who unenrolled and for what reason
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Infectious Disease, run by George Washington University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient referred (time frame: 1 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.