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

NCT04644341 | Unknown

• 1 other identifier: B2020:114 (HS24395)
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Montreal Cognitive Assessment (MoCA)

  Change from normal range at baseline and at 4 months

Study Arms (1)

COVID survivors

Individuals who were infected by CPVID-19 and recovered.

Combination Product: cardiovascular and respiratory systems monitoring

Interventions

cardiovascular and respiratory systems monitoring COMBINATION_PRODUCT

only one group of individuals to observe the impact of COVID-19 on their cardiovascular and respiratory systems in long term.

COVID survivors

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals infected with COVID-19 with symptoms

You may qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead
• Function Four Ltd.: collaborator

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, Canada

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Blood Circulation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

Zahra Moussavi, Ph.D.

CONTACT

(204) 474- 7023; Zahra.Moussavi@Umanitoba.ca

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2020
• First Posted: November 25, 2020
• Study Start: January 15, 2021
• Primary Completion: August 31, 2021
• Study Completion: November 1, 2021
• Last Updated: February 26, 2021

Record last verified: 2021-02

Locations

CA (1)