CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,097 enrolled
Drug / intervention
pulse oximeter +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04581863
NCT04581863N/ACompleted

Randomized Trial of Adding Pulse Oximetry to an Automated Text-messaging Program for Remotely Monitoring Patients at Home With COVID-19

University of Pennsylvania·interventional·Posted Oct 9, 2020·Updated Nov 24, 2023

In Brief

A clinical study evaluating pulse oximeter and COVID Watch for Covid19. Completed, enrolled 2,097 participants across 1 site.

Detailed 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 patients that are Black or Latino (55 percent).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCovid19
CountriesUnited States

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedOct 9, 2020
Enrollment StartNov 30, 2020
Primary CompletionFeb 5, 2021
Study CompletionMay 31, 2022
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 5.7 years ago

Interventions

pulse oximeterdevice

Patients will be prompted twice daily to text their oxygen saturation level after walking in place for 1 minute. If the oxygen saturation is \>3% lower than than the baseline first O2 sat measurement, or if it falls below an absolute level of 90%, the patient will receive an immediate call from the same on-call RN's for COVID Watch and undergo the same triage protocol .

COVID Watchother

Enrolled patients receive text-based assessments, two times a day for 14 days and escalates care to a nurse via telemedicine for any reported worsening of symptoms not severe enough to recommend going to the ED immediately.