At Home Monitoring for Patients With Covid19
Primary Purpose
Coronavirus
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Covidfree@home
Sponsored by
About this trial
This is an interventional health services research trial for Coronavirus focused on measuring telemedicine, clinical care, predictive modeling, epidemiology, hospitalization
Eligibility Criteria
Inclusion Criteria
- Patients who tested positive for Covid19
- Patients experiencing symptoms of Covid19 and have been deemed to likely have Covid19
Exclusion Criteria
- Does not speak English
- Unable to use a mobile smartphone and smart watch
- Unable to complete questionnaires on own
- Significant comorbid condition that would confound symptoms and sensor readings
- Deemed palliative with goals of care being comfort measures only
Sites / Locations
- Sunnybrook Health Sciences Centre
- University Health Network
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Covi19 patients receiving intervention
Arm Description
We will collect self-reported symptoms via a questionnaire, temperature and oxygen saturation will be entered by the patient and passive near continuous sensing of heart rate, audio for cough detection, respiratory rate, cough and physical activity from a smart watch. The smart watch then transmits this sensor data to the paired smartphone.
Outcomes
Primary Outcome Measures
Number of participants with an unplanned hospital admissions
Number of participants with an unplanned emergency department visits leading to hospital admission
Number of participants with planned hospital admissions that are found to be necessary
Number of participants with planned hospital admissions that are found to be necessary
Secondary Outcome Measures
Number of participants with an emergency department visits not resulting in hospital admission
Number of participants with an emergency department visit not resulting in a hospital admission
Number of planned hospital admissions which are found to be unnecessary
Number of planned hospital admissions which are found to be unnecessary
Full Information
NCT ID
NCT04453774
First Posted
May 6, 2020
Last Updated
May 12, 2023
Sponsor
University Health Network, Toronto
Collaborators
Sunnybrook Health Sciences Centre, University of Toronto
1. Study Identification
Unique Protocol Identification Number
NCT04453774
Brief Title
At Home Monitoring for Patients With Covid19
Official Title
Covidfree@Home: At Home Monitoring Using Mobile Devices for Patients With Covid19
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
October 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto
Collaborators
Sunnybrook Health Sciences Centre, University of Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The vast majority of individuals with Covid19 have mild illness that can be managed in the outpatient setting. A small but significant number of these people will deteriorate and require hospitalization. Symptoms are a poor - and possibly late - indicator for deterioration. While people who have died, and/or been cared for in the ICU or hospital have been well characterized, there remains a dearth of information about the clinical course of people in the outpatient setting. Most notably, it is not known when to escalate to hospital care. The consequence of non-escalation when needed is significant patient morbidity and mortality, of escalation when not needed is unnecessarily overwhelmed hospitals. Technologies for clinical management and early diagnostics for severe Covid19 infection will address this challenge.
The research goal of this study is to use real-time remote patient monitoring to detect which patients with Covid19 are at risk of deterioration to bring to hospital, while at the same ensuring the worried will receive reassurance so they stay at home. The clinical goal is to help clinicians provide excellent care using ubiquitous mobile phones.
Detailed Description
People with COVID infection recovering at home or in long-term care are at high risk of hospitalization and death, a reservoir of the disease, and the source of any second wave. Three important gaps still besiege their well-being and, consequently, the well-being of all of us. First, we cannot yet accurately predict the approximately 10% who deteriorate and need hospitalization. Deterioration happens quick and without warning. Delayed detection of deterioration worsens patient outcomes. Second, COVID patients feel terrified and alone. This leads them to come to EDs when not indicated, to have poor mental health and to risk violating physical distancing rules. Third, the health of people with COVID cannot be improved without having a means of studying and understanding what they are going through. None of these gaps are being filled by public health.
It is imperative that Ontario have an effective and safe outpatient care and research strategy for people with COVID isolated at home and in long term care to survive this COVID pandemic.
The investigators are building a mobile smartwatch/smartphone application to create a scalable safe virtual system that meets the care needs of COVID patients at home and in long term care (including reassurance when they are doing well), that uses continuous symptom, heart rate, respiratory rate, cough and other monitoring to predict who needs to go to hospital in real time and that provides a research platform to learn how to further improve and preserve their health.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus
Keywords
telemedicine, clinical care, predictive modeling, epidemiology, hospitalization
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
432 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Covi19 patients receiving intervention
Arm Type
Experimental
Arm Description
We will collect self-reported symptoms via a questionnaire, temperature and oxygen saturation will be entered by the patient and passive near continuous sensing of heart rate, audio for cough detection, respiratory rate, cough and physical activity from a smart watch. The smart watch then transmits this sensor data to the paired smartphone.
Intervention Type
Device
Intervention Name(s)
Covidfree@home
Intervention Description
Mobile phone, Covidfree@home app, thermometer, pulse oximeter, smart watch
Primary Outcome Measure Information:
Title
Number of participants with an unplanned hospital admissions
Description
Number of participants with an unplanned emergency department visits leading to hospital admission
Time Frame
30 days
Title
Number of participants with planned hospital admissions that are found to be necessary
Description
Number of participants with planned hospital admissions that are found to be necessary
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Number of participants with an emergency department visits not resulting in hospital admission
Description
Number of participants with an emergency department visit not resulting in a hospital admission
Time Frame
30 days
Title
Number of planned hospital admissions which are found to be unnecessary
Description
Number of planned hospital admissions which are found to be unnecessary
Time Frame
30 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Patients who tested positive for Covid19
Patients experiencing symptoms of Covid19 and have been deemed to likely have Covid19
Exclusion Criteria
Does not speak English
Unable to use a mobile smartphone and smart watch
Unable to complete questionnaires on own
Significant comorbid condition that would confound symptoms and sensor readings
Deemed palliative with goals of care being comfort measures only
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Wu
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N3M5
Country
Canada
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2Cr
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
At Home Monitoring for Patients With Covid19
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