Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

COVID-19 Virtual Care at Home

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04420182
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : September 28, 2020
Sponsor:
Collaborator:
Cardiac Arrhythmia Network of Canada
Information provided by (Responsible Party):
Anthony Tang, Lawson Health Research Institute

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Covid-19 Other: Virtual Care at Home Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective non-randomized cohort study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: COVID-19 Virtual Care at Home
Actual Study Start Date : August 17, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04420182


Contacts
Layout table for location contacts
Contact: Anthony Tang, MD 519-663-3764 anthonysltang@gmail.com
Contact: Rachel Caris 519-685-8500 ext 32835 rachel.caris@lhsc.on.ca

Locations
Layout table for location information
Canada, Ontario
St. Mary's General Hospital Not yet recruiting
Kitchener, Ontario, Canada
Principal Investigator: Sindu Mohan, MD         
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A5A5
Contact: Marko Mrkobrada, MD    519-685-8500      
Principal Investigator: Marko Mrkobrada, MD         
Ottawa Heart Research Institute Recruiting
Ottawa, Ontario, Canada
Principal Investigator: Venkatesh Thiruganasambandamoorthy, MD         
Sponsors and Collaborators
Lawson Health Research Institute
Cardiac Arrhythmia Network of Canada
Layout table for additonal information
Responsible Party: Anthony Tang, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT04420182    
Other Study ID Numbers: CTO 3210
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: September 28, 2020
Last Verified: September 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anthony Tang, Lawson Health Research Institute:
COVID-19
SARS-CoV-2
VIRTUES
Virtual Care Management
Virtual Care
Patient Satisfaction
Anxiety
Emergency Visits
Oxygen Saturation
Quality of Life