At Home Monitoring for Patients With Covid19

NCT04453774 | Completed

• 1 other identifier: 3185
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 2

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.

Conditions

Coronavirus

Keywords

telemedicine; clinical care; predictive modeling; epidemiology; hospitalization

Outcome Measures

Primary Outcomes (2)

• Number of participants with an unplanned hospital admissions

  Number of participants with an unplanned emergency department visits leading to hospital admission

  30 days

• 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 Outcomes (2)

• Number of participants with an emergency department visits not resulting in hospital admission

  30 days

• Number of planned hospital admissions which are found to be unnecessary

  30 days

Study Arms (1)

Covi19 patients receiving intervention

EXPERIMENTAL

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.

Device: Covidfree@home

Interventions

Covidfree@home DEVICE

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

Covi19 patients receiving intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who tested positive for Covid19
• Patients experiencing symptoms of Covid19 and have been deemed to likely have Covid19

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Sunnybrook Health Sciences Centre: collaborator
• University of Toronto: collaborator

Study Sites (2)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location

University Health Network

Toronto, Ontario, M5G 2Cr, Canada

Location

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Robert Wu

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General Internal Medicine Site Director

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: July 1, 2020
• Study Start: November 1, 2020
• Primary Completion: July 1, 2022
• Study Completion: June 1, 2024
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)