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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 : December 8, 2020
Sponsor:
Collaborator:
Cardiac Arrhythmia Network of Canada
Information provided by (Responsible Party):
Anthony Tang, Lawson Health Research Institute

Tracking Information
First Submitted Date  ICMJE May 29, 2020
First Posted Date  ICMJE June 9, 2020
Last Update Posted Date December 8, 2020
Actual Study Start Date  ICMJE August 17, 2020
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2020)		 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 5, 2020)		 28 Day Patient Satisfaction Questionnaire [ Time Frame: 28 days ]
The primary outcome measure is patient satisfaction as measured from a patient satisfaction questionnaire at 28 days.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2020)
  • 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 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2020)
  • Emergency Department Visits [ Time Frame: 28 days ]
    The secondary outcome measures will include the number of patients that require an Emergency Department visits during the observation period of 28 days.
  • 28 Day EQ-5D-5L Scores [ Time Frame: 28 days ]
    The secondary outcome measures will include the health status measures of the EuroQuality of Life Five Dimensions (EQ-5D-5L) at 28 days. Scoring is Level 1 to 5 for each dimension; higher scores meaning worse health status.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE COVID-19 Virtual Care at Home
Official Title  ICMJE COVID-19 Virtual Care at Home
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Prospective non-randomized cohort study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Covid-19
Intervention  ICMJE Other: Virtual Care at Home
Participants will have access to the VIRTUES platform for COVID-19 Virtual Care at Home
Study Arms  ICMJE 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
Intervention: Other: Virtual Care at Home
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 5, 2020)		 2000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Anthony Tang, MD 519-663-3764 anthonysltang@gmail.com
Contact: Rachel Caris 5192811712 rachel.caris@lhsc.on.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04420182
Other Study ID Numbers  ICMJE CTO 3210
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anthony Tang, Lawson Health Research Institute
Study Sponsor  ICMJE Lawson Health Research Institute
Collaborators  ICMJE Cardiac Arrhythmia Network of Canada
Investigators  ICMJE Not Provided
PRS Account Lawson Health Research Institute
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP