Emergency Department (ED) Self-Monitoring Pilot COVID-19

NCT ID: NCT04462783

Last Updated: 2021-07-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-30
• Study Completion Date: 2021-11-30

Brief Summary

This feasibility study is being conducted to understand how discharged emergency department patients who were tested for the SARS-CoV-2 virus (COVID-19) engage with a symptom-tracking web application. Study participants that are enrolled in the study will be asked to enter daily information about their health into the CovidX web application (app.). In addition, patients will answer questions regarding anxiety levels, use a pulse oximeter to record information (if you own one or are given one).

The investigators predict that participants will be able to engage with the CovidX web application over several days to weeks for the purposes of symptom tracking, and may have decreased anxiety over the study period.

Conditions

COVID; Covid-19; SARS-CoV 2

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patient's symptom data without pulse oximeter

Some patients may not be given a pulse oximeter to enter heart rate and O2 saturation into the CovidX application.

Group Type: EXPERIMENTAL

Symptoms entered into the CovidX application

Intervention Type: OTHER

Participants are asked to enter symptoms into the CovidX application at least daily for 30 days. Additionally, they will enter demographic information and some survey information will be collected.

Patient's symptom data with a pulse oximeter

Some patients will be given (or may have) a pulse oximeter in order to enter heart rate and O2 saturation data into the CovidX application.

Group Type: EXPERIMENTAL

Symptoms entered into the CovidX application

Intervention Type: OTHER

Participants are asked to enter symptoms into the CovidX application at least daily for 30 days. Additionally, they will enter demographic information and some survey information will be collected.

Interventions

Symptoms entered into the CovidX application

Participants are asked to enter symptoms into the CovidX application at least daily for 30 days. Additionally, they will enter demographic information and some survey information will be collected.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Reported symptoms of viral illness during ED encounter
• Tested for SARS-CoV-2 (COVID-19) during ED encounter
• Discharged home from the Emergency Department

Exclusion Criteria

• Prisoners
• Residents of congregate living facilities who are already being monitored
• Baseline oxygen requirement
• Patients whose primary goals of care are palliative
• Pregnant women

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vironix Health Incorporated

UNKNOWN

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Kathleen Li

Adjunct Clinical Lecturer in Emergency Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathleen Li, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Other Identifiers

HUM00181946

Identifier Type: -

Identifier Source: org_study_id