COVID-19 Virtual Care at Home

April 6, 2022 updated by: Anthony Tang, Lawson Health Research Institute

This multicentre prospective cohort trial is designed to demonstrate effectiveness and efficiency of a virtual care model for the management of COVID-19 patients isolating at home. The investigators have reoriented existing technology and networks for this research project. The investigators are amplifying our existing virtual care platform VIRTUES, combining it with home monitoring of COVID-19 patients, to provide real-time evidence, harmonize data collection, and share data provincially to mitigate the impact of the rapid spread of the virus. The study will facilitate early detection of complications associated with the disease, treatment and management of COVID-19 patients at home. The research will be conducted provincially in Ontario.

This initiative will provide evidence to inform clinical and health system management and public health response to COVID-19 patients isolating at home.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

817

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Kitchener, Ontario, Canada
        • St. Mary's General Hospital
      • London, Ontario, Canada, N6A5A5
        • London Health Sciences Centre
      • Ottawa, Ontario, Canada
        • Ottawa Heart Research Institute
      • St. Catharines, Ontario, Canada, L2S 0A9
        • Niagara Health
      • Toronto, Ontario, Canada, M6R1B5
        • St. Joseph's Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All COVID-19 positive patients of age 18 or above
  • Participant must communicate in English or French language
  • An email address and account

Exclusion Criteria:

  • Unable or unwilling to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: COVID-19 Virtual Care at Home

VIRTUES COVID-19 Care at Home Platform

The components of the platform will include:

  1. Vital sign monitoring, including O2 saturation with a home-based pulse oximeter, temperature and respiratory rate performed three times per day (a notification to do this will be sent from the app), with the option of doing assessments more frequently if needed. Study patients will be provided monitoring devices to collect this data.
  2. Symptom logs will be entered by the patients.

  3. Feedback to the patient by the local COVID-19 care team for any action:

    1. Two-way communication between the patient and the COVID-19 care team
    2. Ability for team members to see all prior notes in order to have continuity of care
    3. Reports of these interactions are transmitted to the patient's health record
  4. Current information on COVID-19 as per the Public Health Agency of Canada
Other: Virtual Care at Home
Participants will have access to the VIRTUES platform for COVID-19 Virtual Care at Home

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
14 Day Patient Satisfaction Questionnaire
Time Frame: 14 days
The primary outcome measure is patient satisfaction as measured from a patient satisfaction questionnaire at 14 days.
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emergency Department Visits
Time Frame: 14 days
The secondary outcome measures will include the number of patients that require an Emergency Department visits during the observation period of 14 days.
14 days
14 Day EQ-5D-5L Scores
Time Frame: 14 days
The secondary outcome measures will include the health status measures of the EuroQuality of Life Five Dimensions (EQ-5D-5L) at 14 days. Scoring is Level 1 to 5 for each dimension; higher scores meaning worse health status.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Collaborators

Cardiac Arrhythmia Network of Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2020

Primary Completion (Actual)

February 4, 2022

Study Completion (Actual)

February 4, 2022

Study Registration Dates

First Submitted

May 29, 2020

First Submitted That Met QC Criteria

June 5, 2020

First Posted (Actual)

June 9, 2020

Study Record Updates

Last Update Posted (Actual)

April 7, 2022

Last Update Submitted That Met QC Criteria

April 6, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTO 3210

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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