COVID-19 Virtual Care at Home

Sponsor

Lawson Health Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT04420182

Collaborator

Cardiac Arrhythmia Network of Canada (Other)

817

Enrollment

Locations

Arm

17.6

Actual Duration (Months)

163.4

Patients Per Site

9.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Covid-19	Other: Virtual Care at Home	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

817 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Prospective non-randomized cohort studyProspective non-randomized cohort study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

COVID-19 Virtual Care at Home

Actual Study Start Date :

Aug 17, 2020

Actual Primary Completion Date :

Feb 4, 2022

Actual Study Completion Date :

Feb 4, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: COVID-19 Virtual Care at Home 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	Other: Virtual Care at Home Participants will have access to the VIRTUES platform for COVID-19 Virtual Care at Home

Arm

Intervention/Treatment

Other: COVID-19 Virtual Care at Home

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

Other: Virtual Care at Home

Participants will have access to the VIRTUES platform for COVID-19 Virtual Care at Home

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Emergency Department Visits [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Mary's General Hospital	Kitchener	Ontario	Canada
2	London Health Sciences Centre	London	Ontario	Canada	N6A5A5
3	Ottawa Heart Research Institute	Ottawa	Ontario	Canada
4	Niagara Health	St. Catharines	Ontario	Canada	L2S 0A9
5	St. Joseph's Health Centre	Toronto	Ontario	Canada	M6R1B5