Tele-monitoring of COVID-19 Survivors for Long-Term Impacts

Post Discharge Tele-monitoring of COVID-19 Survivors for Long-Term Impacts and Point-of-Care

To confront the COVID-19 pandemic hospitals need to maximize bed availability and minimize the duration of patients' stay as much as possible. Given the constraints, physicians are neither able to investigate the long-term effects of COVID-19 nor able to optimize extended treatments beyond the hospital. Physicians also do not have time to keep patients mobile and lucid during their hospital stays, resulting in longer recovery periods and further complications for patients. The investigators propose the development of a tele-monitoring solution for the long-term monitoring of COVID-19 survivors. Such a solution will help save significant healthcare costs by reducing the number of plausible future hospitalizations due to patient complications, providing valuable insights to various stakeholders from doctors to policymakers on the long-term effects of COVID-19, and improving patient care and treatment.

Using our team's existing bio-instrumentation technologies and years of experience, the investigators propose to develop a custom-designed miniaturized monitoring system capable of recording pulse oximetry (blood's oxygen level), blood pressure, heart rate and breathing and swallowing sounds. This solution will be non-invasive, easy to implement and will not require an assistant physically present. The system will be augmented by regular videoconferencing sessions with a medical practitioner. The frequency of the connection can be modified depending on the patient's condition and medical history in consultation with our team's physician.

By running the proposed project on a large scale, the expected outcomes will be: 1) collection of reliable and objective information on the long-term impacts of COVID-19, 2) developing an all-in-one technology for future applications, 3) collection of objective and actionable information that can be used to optimize care and treatment plans for patients, 4) better care and treatment for all strata of society regardless of the remoteness of the residence, and 5) improved mental health and recovery of patients.

Study Overview

• Status: Unknown
• Conditions: COVID-19
• Intervention / Treatment: Combination product: cardiovascular and respiratory systems monitoring

Detailed Description

To confront the COVID-19 pandemic hospitals need to maximize bed availability and minimize the duration of patients' stay as much as possible. Given the constraints, physicians are neither able to investigate the long-term effects of COVID-19 nor able to optimize extended treatments beyond the hospital. Physicians also do not have time to keep patients mobile and lucid during their hospital stays, resulting in longer recovery periods and further complications for patients. The investigators propose the development of a tele-monitoring solution for the long-term monitoring of COVID-19 survivors. Such a solution will help save significant healthcare costs by reducing the number of plausible future hospitalizations due to patient complications, providing valuable insights to various stakeholders from doctors to policymakers on the long-term effects of COVID-19, and improving patient care and treatment.

Using our team's existing bio-instrumentation technologies and years of experience, the investigators will develop a custom-designed miniaturized monitoring system capable of recording pulse oximetry (blood's oxygen level), blood pressure, heart rate and breathing and swallowing sounds. This solution will be non-invasive, easy to implement and will not require an assistant physically present. The system will be augmented by regular videoconferencing sessions with a medical practitioner. The frequency of the connection can be modified depending on the patient's condition and medical history in consultation with our team's physician.

By running the proposed project on a large scale, the expected outcomes will be: 1) collection of reliable and objective information on the long-term impacts of COVID-19, 2) developing an all-in-one technology for future applications, 3) collection of objective and actionable information that can be used to optimize care and treatment plans for patients, 4) better care and treatment for all strata of society regardless of the remoteness of the residence, and 5) improved mental health and recovery of patients.

The goal of this project is to provide COVID-19 survivors a point-of-care facility by using an interactive virtual program to measure 4 main vital biological signals (blood pressure, heart rate, pulse oximetry, and respiratory sounds (that include both tracheal and lung breathing and swallowing sounds) and assess cognitive status of individuals remotely at their own home. The specific objectives are:

1. Assemble the existing and medically approved blood pressure and pulse oximetry miniaturized non-invasive devices along with a digital stethoscope, all to be connected to a smart phone operated by a custom-designed app to collect and store data on secure servers of the PI. One secure server is dedicated to the contact information of the patients and their unique codes, and another physically separate server is dedicated to patients' data after anonymizing.
2. Schedule videoconferencing sessions for a Research Assistant (RA) to interact with the patient regularly to help with recording the signals remotely and assess the cognitive and mood of the patients at their home.
3. Evaluate the above program on 20 COVID-19 patients for a period of 4 months.
4. Analyse the collected data during the 4 months observation period, and identify any consistent pattern of the long-term effect of COVID-19.
5. Disseminate the results in both scientific and public events, and plan future studies.

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada
      • Recruiting
      • University of Manitoba
      • Contact: Zahra Moussavi, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Individuals infected with COVID-19 with symptoms

Description

Inclusion Criteria:

• Age >18 years,
• MoCA > 15
• Clinically diagnosed with COVID-19 and have had symptoms for a minimum of 5 days
• Must speak and understand English
• Must have wifi Internet and an smart phone

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COVID survivors; Individuals who were infected by CPVID-19 and recovered.	Combination product: cardiovascular and respiratory systems monitoring; only one group of individuals to observe the impact of COVID-19 on their cardiovascular and respiratory systems in long term.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	The change of systolic blood pressure from baseline	Change from baseline Systolic Blood Pressure at 4 months
Breathing sounds average power	Average power of the breathing sounds within 100 to 500 Hz	Change from normal range at baseline and at 4 months
Risk of aspiration	risk of aspiration calculated from swallowing and breathing sounds pattern	Change from normal range at baseline and at 4 months
SaO2 level	SaO2 level measured by pulse Oximetry	Change from normal range at baseline and at 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montreal Cognitive Assessment (MoCA)	Cognitive assessment	Change from normal range at baseline and at 4 months

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: Function Four Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Anticipated): August 31, 2021
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: November 14, 2020
• First Submitted That Met QC Criteria: November 24, 2020
• First Posted (Actual): November 25, 2020

Study Record Updates

• Last Update Posted (Actual): February 26, 2021
• Last Update Submitted That Met QC Criteria: February 24, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Respiratory System Agents
• Other Study ID Numbers: B2020:114 (HS24395)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Once we collect data and they are useful, we plan to share the anonymized data on our website after receiving Ethics Board's approval.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No