COVID-19 Virtual Care at Home

NCT04420182 | Completed DMC

• 1 other identifier: CTO 3210
• Study Type: interventional
• Target: 817
• Locations: 1 country
• Sites: 5

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.

Conditions

Covid-19

Keywords

COVID-19; SARS-CoV-2; VIRTUES; Virtual Care Management; Virtual Care; Patient Satisfaction; Anxiety; Emergency Visits; Oxygen Saturation; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 14 Day Patient Satisfaction Questionnaire

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

  14 days

Secondary Outcomes (2)

• Emergency Department Visits

  14 days

• 14 Day EQ-5D-5L Scores

  14 days

Study Arms (1)

COVID-19 Virtual Care at Home

OTHER

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

Interventions

Virtual Care at Home OTHER

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

COVID-19 Virtual Care at Home

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All COVID-19 positive patients of age 18 or above
• Participant must communicate in English or French language
• An email address and account

You may not qualify if:

• Unable or unwilling to provide informed consent

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Cardiac Arrhythmia Network of Canada: collaborator

Study Sites (5)

St. Mary's General Hospital

Kitchener, Ontario, Canada

Location

London Health Sciences Centre

London, Ontario, N6A5A5, Canada

Location

Ottawa Heart Research Institute

Ottawa, Ontario, Canada

Location

Niagara Health

St. Catharines, Ontario, L2S 0A9, Canada

Location

St. Joseph's Health Centre

Toronto, Ontario, M6R1B5, Canada

Location

MeSH Terms

Conditions

COVID-19; Patient Satisfaction; Anxiety Disorders

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective non-randomized cohort study

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 9, 2020
• Study Start: August 17, 2020
• Primary Completion: February 4, 2022
• Study Completion: February 4, 2022
• Last Updated: April 7, 2022

Record last verified: 2022-04

Locations

CA (5)