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

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ClinicalTrials.gov Identifier: NCT04644341
Recruitment Status : Recruiting
First Posted : November 25, 2020
Last Update Posted : February 26, 2021
Sponsor:
Collaborator:
Function Four Ltd.
Information provided by (Responsible Party):
University of Manitoba

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.


Condition or disease Intervention/treatment
COVID-19 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 Design
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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Post Discharge Tele-monitoring of COVID-19 Survivors for Long-Term Impacts and Point-of-Care
Actual Study Start Date : January 15, 2021
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : November 1, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Blood pressure [ Time Frame: Change from baseline Systolic Blood Pressure at 4 months ]
    The change of systolic blood pressure from baseline

  2. Breathing sounds average power [ Time Frame: Change from normal range at baseline and at 4 months ]
    Average power of the breathing sounds within 100 to 500 Hz

  3. Risk of aspiration [ Time Frame: Change from normal range at baseline and at 4 months ]
    risk of aspiration calculated from swallowing and breathing sounds pattern

  4. SaO2 level [ Time Frame: Change from normal range at baseline and at 4 months ]
    SaO2 level measured by pulse Oximetry


Secondary Outcome Measures :
  1. Montreal Cognitive Assessment (MoCA) [ Time Frame: Change from normal range at baseline and at 4 months ]
    Cognitive assessment


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals infected with COVID-19 with symptoms
Criteria

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:

-

Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04644341


Contacts
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Contact: Zahra Moussavi, Ph.D. (204) 474- 7023 Zahra.Moussavi@Umanitoba.ca

Locations
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Canada, Manitoba
University of Manitoba Recruiting
Winnipeg, Manitoba, Canada
Contact: Zahra Moussavi, PhD         
Sponsors and Collaborators
University of Manitoba
Function Four Ltd.
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT04644341    
Other Study ID Numbers: B2020:114 (HS24395)
First Posted: November 25, 2020    Key Record Dates
Last Update Posted: February 26, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
 Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory System Agents