At Home Monitoring for Patients With Covid19

Not Applicable

Active, not recruiting

• Conditions: Coronavirus
• Interventions: Device: Covidfree@home

• Registration Number: NCT04453774
• Lead Sponsor: University Health Network, Toronto

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.

Study Timeline

• Study First Submitted: 2020-05-06
• Study First Submitted QC: 2020-06-29
• Study First Posted: 2020-07-01
• Study Start: 2020-11-01
• Primary Completion: 2022-07-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-12
• Last Update Posted: 2023-05-15
• Study Completion: 2023-10-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 432

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Covi19 patients receiving intervention	Covidfree@home	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.

Primary Outcome Measures

Name	Time	Method
Number of participants with planned hospital admissions that are found to be necessary	30 days	Number of participants with planned hospital admissions that are found to be necessary
Number of participants with an unplanned hospital admissions	30 days	Number of participants with an unplanned emergency department visits leading to hospital admission

Secondary Outcome Measures

Name	Time	Method
Number of planned hospital admissions which are found to be unnecessary	30 days	Number of planned hospital admissions which are found to be unnecessary
Number of participants with an emergency department visits not resulting in hospital admission	30 days	Number of participants with an emergency department visit not resulting in a hospital admission

Trial Locations

Locations (2)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

University Health Network; 🇨🇦 Toronto, Ontario, Canada