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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04644341
• Other study ID #: B2020:114 (HS24395)
• Status: Recruiting
• Start date: January 15, 2021
• Est. completion date: November 1, 2021

Study information

• Verified date: February 2021
• Source: University of Manitoba
• Contact: Zahra Moussavi, Ph.D.
• Phone: (204) 474- 7023
• Email: Zahra.Moussavi[@]Umanitoba.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 1, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• COVID-19

Intervention

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.

Locations

Country	Name	City	State
Canada	University of Manitoba	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Function Four Ltd.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure	The change of systolic blood pressure from baseline	Change from baseline Systolic Blood Pressure at 4 months
Primary	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
Primary	Risk of aspiration	risk of aspiration calculated from swallowing and breathing sounds pattern	Change from normal range at baseline and at 4 months
Primary	SaO2 level	SaO2 level measured by pulse Oximetry	Change from normal range at baseline and at 4 months
Secondary	Montreal Cognitive Assessment (MoCA)	Cognitive assessment	Change from normal range at baseline and at 4 months