Covid-19NCT04420182
COVID-19 Virtual Care at Home
A study testing Virtual Care at Home in people with Covid-19, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 5 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid-19
- What is being tested?
- Virtual Care at Home
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 817 participants
- Where
- 5 sitesCanada
- Study dates
- 17 Aug 2020to 4 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All COVID-19 positive patients of age 18 or above
- Participant must communicate in English or French language
- An email address and account
Who cannot join
- Unable or unwilling to provide informed consent
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
St. Mary's General Hospital
Kitchener, Ontario
London Health Sciences Centre
London, Ontario, N6A5A5
Ottawa Heart Research Institute
Ottawa, Ontario
Niagara Health
St. Catharines, Ontario, L2S 0A9
St. Joseph's Health Centre
Toronto, Ontario, M6R1B5
About this study
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
- Being tested
- Virtual Care at Home
- Keywords
- COVID-19, SARS-CoV-2, VIRTUES, Virtual Care Management, Virtual Care, Patient Satisfaction, Anxiety, Emergency Visits, Oxygen Saturation, Quality of Life
- Medical subject headings
- COVID-19, Patient Satisfaction, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Care at HomeOther
Participants will have access to the VIRTUES platform for COVID-19 Virtual Care at Home
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Virtual Care at Home |
What is being measured
The primary outcome is the main question the study is designed to answer.
14 Day Patient Satisfaction Questionnaire
The primary outcome measure is patient satisfaction as measured from a patient satisfaction questionnaire at 14 days.
Measured: 14 days
Secondary outcomes (2)
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.
Measured: 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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start17 Aug 2020
- Primary completion4 Feb 2022
- Study completion4 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective non-randomized cohort study
- Masking
- None (open label)
- Enrolment
- 817 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Cardiac Arrhythmia Network of Canada
- Responsible party
- Principal investigator, Anthony Tang, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04420182
- Sponsor's protocol ID
- CTO 3210
- Status last verified
- Apr 2022
- First submitted
- 29 May 2020
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Virtual Care at Home
- ClinicalTrials.gov ID
- NCT04420182
- Acronym / sponsor ID
- CTO 3210
- Conditions
- Covid-19
- Keywords
- COVID-19, SARS-CoV-2, VIRTUES, Virtual Care Management, Virtual Care, Patient Satisfaction, Anxiety, Emergency Visits
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 817 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Cardiac Arrhythmia Network of Canada
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 4 Feb 2022 (actual)
- Study completion
- 4 Feb 2022 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective non-randomized cohort study
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Virtual Care at Home | Other | Other: Virtual Care at HomeVIRTUES 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All COVID-19 positive patients of age 18 or above
- Participant must communicate in English or French language
- An email address and account
Key exclusion criteria (1 listed)
- Unable or unwilling to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Care at HomeParticipants will have access to the VIRTUES platform for COVID-19 Virtual Care at Home | Other | COVID-19 Virtual Care at Home |
Primary outcome
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.
2 secondary outcomes
Emergency Department Visits
Time frame: 14 days
14 Day EQ-5D-5L Scores
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Care at Home in people with Covid-19, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
14 Day Patient Satisfaction Questionnaire (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.