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NCT04581863 · ClinicalTrials.gov registry record · NA
COVID-19 Watch + COVID-19 Pulse
A NA study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- NA
- Development phase
- 2,097
- Enrollment target
NCT04581863: Completed NA study, sponsored by University of Pennsylvania.
NCT04581863 is a NA study that has completed, run by University of Pennsylvania. The registered enrollment target is 2,097 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04581863, a NA study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- NA
- Development phase
- 2,097 participants
- Enrollment target
Study Summary
The clinical guidance for 90 percent of infected COVID-19 adult patients who do not meet eligibility for inpatient admission is to self-isolate. To support these patients, alternatives to in-person care are needed to manage an unpredictable clinical course; identify and intercept patients rapidly deteriorating at home, prevent viral spread during in-person visits; and minimize future surges in emergency departments (EDs). In addition, fingertip pulse oximeters have been proposed to improve in-home early detection of respiratory deteriorations but are untested and the operational infrastructure to support large-scale monitoring is limited. While telemedicine has been widely adopted during the pandemic as an alternative to conventional outpatient care, limited telemedicine access may be exacerbating observed disparities for Black and Latino patients. In our health system, Black and Latino patients used video-visits 15 percent less often than white patients. Text messaging and phone calls may improve healthcare access for communities of color, but the evidence for these telecommunication modalities to be effective and improve equity are limited. The University of Pennsylvania Health System (UPHS) developed and deployed COVID Watch to improve access to health care for COVID-19 patients who are self-isolating at home. COVID Watch sends twice-daily, scheduled text messages to assess patients for shortness of breath using a clinical algorithm to determine whether patients need an urgent escalation to a team of dedicated, on-call nurses within one hour. These nurses are supported by an on-call team of clinicians who can conduct urgent phone or video assessments. Patients can also trigger the algorithmic assessment independent of the scheduled messages. As of May 21, 2020, COVID Watch has managed 3,628 COVID-19 patients at home, of which 1,295 are confirmed COVID-19 positive; of these, 61 percent are Black or Latino, higher than the proportion of all UPHS COVID-19 positive
Interventions
- DEVICE pulse oximeter
- OTHER COVID Watch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,097 participants |
| Start Date | 2020-11-30 |
| Est. Completion | 2022-05-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04581863
The ClinicalTrials.gov registry entry for NCT04581863 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 2,097 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which pulse oximeter is the first listed.
NCT04581863 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04581863 about?
NCT04581863 is a clinical study titled "COVID-19 Watch + COVID-19 Pulse". The clinical guidance for 90 percent of infected COVID-19 adult patients who do not meet eligibility for inpatient admission is to self-isolate. To support these patients, alternatives to in-person care are needed to manage an unpredictable clinical course; identify and intercept patients rapidly de...
What is the current status of trial NCT04581863?
This trial is currently completed. It is a NA study. The enrollment target is 2,097 participants. The study started on 2020-11-30. Estimated completion is 2022-05-31.
What interventions are being tested in trial NCT04581863?
The interventions under investigation include: pulse oximeter (DEVICE), COVID Watch (OTHER).
Who is sponsoring clinical trial NCT04581863?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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