At Home Monitoring for Patients With Covid19

Coronavirus Clinical Trial

Official title:

Covidfree@Home: At Home Monitoring Using Mobile Devices for Patients With Covid19

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04453774
• Other study ID #: 3185
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: October 1, 2023

Study information

• Verified date: May 2023
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 432
• Est. completion date: October 1, 2023
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infections

Intervention

Device:
• Covidfree@home
Mobile phone, Covidfree@home app, thermometer, pulse oximeter, smart watch

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University Health Network, Toronto	Sunnybrook Health Sciences Centre, University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with an unplanned hospital admissions	Number of participants with an unplanned emergency department visits leading to hospital admission	30 days
Primary	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	30 days
Secondary	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	30 days
Secondary	Number of planned hospital admissions which are found to be unnecessary	Number of planned hospital admissions which are found to be unnecessary	30 days