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

NCT04462783 | Withdrawn

• 1 other identifier: HUM00181946
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

coronavirus

Outcome Measures

Primary Outcomes (3)

• Change in the percent of participants using the CovidX web application (app) on 50% or greater of days

  baseline, up to 30 days

• Average compliance rate with daily symptom tracking by day 30

  Day 30

• Recruitment rate

  The proportion of patients approached for the study who enroll

  through study completion an average of 1 year

Secondary Outcomes (4)

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety short form 4a

  completed at baseline (enrollment), up to 30 days

• Change in Coronavirus Anxiety Scale

  completed at baseline (enrollment), up to 30 days

• CovidX web application usability and utility measured adapted by mHealth App Usability Questionnaire

  30 days

• Differences in CovidX web application engagement between patients who do and do not receive a pulse oximeter

  30 days

Study Arms (2)

Patient's symptom data without pulse oximeter

EXPERIMENTAL

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

Other: Symptoms entered into the CovidX application

Patient's symptom data with a pulse oximeter

EXPERIMENTAL

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.

Other: Symptoms entered into the CovidX application

Interventions

Symptoms entered into the CovidX application 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; Patient's symptom data without pulse oximeter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead
• Vironix Health Incorporated: collaborator

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Kathleen Li, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Clinical Lecturer in Emergency Medicine

Model Details: Some patients will have pulse oximeters or be given one and provide data from these.

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 8, 2020
• Study Start: June 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: July 1, 2021

Record last verified: 2021-06