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COVID-19 Virtual Care at Home

Primary Purpose

Covid-19

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Virtual Care at Home
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid-19 focused on measuring COVID-19, SARS-CoV-2, VIRTUES, Virtual Care Management, Virtual Care, Patient Satisfaction, Anxiety, Emergency Visits, Oxygen Saturation, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Mary's General Hospital
  • London Health Sciences Centre
  • Ottawa Heart Research Institute
  • Niagara Health
  • St. Joseph's Health Centre

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

COVID-19 Virtual Care at Home

Arm Description

VIRTUES COVID-19 Care at Home Platform The components of the platform will include: 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. Symptom logs will be entered by the patients. Feedback to the patient by the local COVID-19 care team for any action: Two-way communication between the patient and the COVID-19 care team Ability for team members to see all prior notes in order to have continuity of care Reports of these interactions are transmitted to the patient's health record Current information on COVID-19 as per the Public Health Agency of Canada

Outcomes

Primary Outcome Measures

14 Day Patient Satisfaction Questionnaire
The primary outcome measure is patient satisfaction as measured from a patient satisfaction questionnaire at 14 days.

Secondary Outcome Measures

Emergency Department Visits
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
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.

Full Information

First Posted
May 29, 2020
Last Updated
April 6, 2022
Sponsor
Lawson Health Research Institute
Collaborators
Cardiac Arrhythmia Network of Canada
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1. Study Identification

Unique Protocol Identification Number
NCT04420182
Brief Title
COVID-19 Virtual Care at Home
Official Title
COVID-19 Virtual Care at Home
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 17, 2020 (Actual)
Primary Completion Date
February 4, 2022 (Actual)
Study Completion Date
February 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
Collaborators
Cardiac Arrhythmia Network of Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19
Keywords
COVID-19, SARS-CoV-2, VIRTUES, Virtual Care Management, Virtual Care, Patient Satisfaction, Anxiety, Emergency Visits, Oxygen Saturation, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective non-randomized cohort study
Masking
None (Open Label)
Allocation
N/A
Enrollment
817 (Actual)

8. Arms, Groups, and Interventions

Arm Title
COVID-19 Virtual Care at Home
Arm Type
Other
Arm Description
VIRTUES COVID-19 Care at Home Platform The components of the platform will include: 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. Symptom logs will be entered by the patients. Feedback to the patient by the local COVID-19 care team for any action: Two-way communication between the patient and the COVID-19 care team Ability for team members to see all prior notes in order to have continuity of care Reports of these interactions are transmitted to the patient's health record Current information on COVID-19 as per the Public Health Agency of Canada
Intervention Type
Other
Intervention Name(s)
Virtual Care at Home
Intervention Description
Participants will have access to the VIRTUES platform for COVID-19 Virtual Care at Home
Primary Outcome Measure Information:
Title
14 Day Patient Satisfaction Questionnaire
Description
The primary outcome measure is patient satisfaction as measured from a patient satisfaction questionnaire at 14 days.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Emergency Department Visits
Description
The secondary outcome measures will include the number of patients that require an Emergency Department visits during the observation period of 14 days.
Time Frame
14 days
Title
14 Day EQ-5D-5L Scores
Description
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.
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
St. Mary's General Hospital
City
Kitchener
State/Province
Ontario
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A5A5
Country
Canada
Facility Name
Ottawa Heart Research Institute
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Niagara Health
City
St. Catharines
State/Province
Ontario
ZIP/Postal Code
L2S 0A9
Country
Canada
Facility Name
St. Joseph's Health Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6R1B5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

COVID-19 Virtual Care at Home

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