COVID-19 Virtual Care at Home

Not Applicable

Completed

• Conditions: Covid-19
• Interventions: Other: Virtual Care at Home

• Registration Number: NCT04420182
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-29
• Study First Submitted QC: 2020-06-05
• Study First Posted: 2020-06-09
• Study Start: 2020-08-17
• Primary Completion: 2022-02-04
• Study Completion: 2022-02-04
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-06
• Last Update Posted: 2022-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 817

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
COVID-19 Virtual Care at Home	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.

Trial Locations

Locations (5)

St. Mary's General Hospital; 🇨🇦 Kitchener, Ontario, Canada

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

Ottawa Heart Research Institute; 🇨🇦 Ottawa, Ontario, Canada

Niagara Health; 🇨🇦 St. Catharines, Ontario, Canada

St. Joseph's Health Centre; 🇨🇦 Toronto, Ontario, Canada