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Self-management of Post COVID-19 Syndrome Using Wearable Biometric Technology

Primary Purpose

COVID-19

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Self-management of post COVID-19 respiratory outcomes
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Long COVID-19, Persistent symptoms, Self-management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Post-COVID-19 ≥ 3 months after infection.
  • Mild to severe persistent respiratory symptoms
  • Access to a home internet

Exclusion Criteria:

  • History of neurological disease or mental illness
  • Inability to ambulate independently without supervision
  • Inability to complete basic tasks on a smart phone or tablet

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    One arm

    Arm Description

    Self-management group. This pilot-study uses a one-group before-after design.

    Outcomes

    Primary Outcome Measures

    Change in lung capacity
    It will be assessed using a SpiroBank Smart F/V multi parameter spirometer (MIR) at pre-post intervention and once a week in between to monitor changes. This portable spirometer, which is MDSAP approved and complaint with ATS/ERS guidelines, connects automatically via Bluetooth to an iOS & Android compatible App (MIR Spirobank). It provides real time feedback through messages and animation on smartphone, to improve personal compliance during the test. The app can generate test results PDF printout with information regarding 19 parameters of lung capacity.
    Change in dyspnea
    Modified Borg Scale (0 "best" to 10 "worse dyspnea") will be used to assess dyspnea.
    Change in fatigue
    Fatigue severity scale (0 -7 "more fatigue") will be used to measure the severity of fatigue.
    Chronic fatigue syndrome
    DePaul Symptoms Questionnaire short form (DSQ-SF) (0 "not present" - 4 "very severe")
    Health-related quality of life
    EuroQol five-dimensional questionnaire (0 "worse health" to 100 "best health")
    Postural orthostatic hypotension
    Orthostatic Stress Test (Postural transitions)
    Exercise capacity
    The 6-min walk test (6 MWT) and the one-minute sit-to-stand test

    Secondary Outcome Measures

    Symptoms change
    Participants will be ask to rate their symptoms from 0-10 using an online form (base on the baseline symptoms)
    Patient satisfaction with the study
    Participants will complete a short summary with questions regarding their satisfaction with the study

    Full Information

    First Posted
    July 28, 2022
    Last Updated
    February 22, 2023
    Sponsor
    University of Manitoba
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05507190
    Brief Title
    Self-management of Post COVID-19 Syndrome Using Wearable Biometric Technology
    Official Title
    Self-management of Post COVID-19 Syndrome Using Wearable Biometric Technology
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    December 30, 2023 (Anticipated)
    Study Completion Date
    December 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Manitoba

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The main objective of this pilot study is to evaluate the impact of a self-management intervention using wearable biometric technology on post-COVID-19 syndrome. In addition, this pilot-study will provide information regarding validity, feasibility, patient compliance and satisfaction, valuable for the design of a future large-scale study.
    Detailed Description
    This pilot-study uses a one-group before-after design. Subjects: a convenience sample of 20 adults 18 years and older in the Winnipeg Health Region with a post-COVID-19 infection (≥ 3 months since acute infection) complaining of mild to severe persistent respiratory symptoms. Intervention: using the participants' initial assessment, personal characteristics, main complaints/needs and goals, the therapist will adjust the exercise plan and personalize the recommendations (e.g. maximum heart rate) as well as instruct the patients about safety precautions (how to pace themselves, when to seek professional or emergency care). Participants will be encouraged to wear the smart shirt as much as they want during the 6 weeks (29), but at a minimum of 1-hour a day (M-F) including while performing the recommended exercises (30-45 min/3 times a week). They should self-monitor their biometric values trying to reach/stay within the target values while wearing the shirt using Hexoskin app installed on an iPad provided by the research team or on the participants' personal device if preferred. Patients will also complete an online survey reporting symptoms intensity and activities completed, 3 times a week (over 6 weeks). Participants would be able to contact the research assistant overseeing the intervention at any time of the study if they have questions or concerns (text message or email). Otherwise, they will receive a follow-up phone call every week or if a significant change in their biometrical data is identified.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COVID-19
    Keywords
    Long COVID-19, Persistent symptoms, Self-management

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    One arm
    Arm Type
    Experimental
    Arm Description
    Self-management group. This pilot-study uses a one-group before-after design.
    Intervention Type
    Other
    Intervention Name(s)
    Self-management of post COVID-19 respiratory outcomes
    Intervention Description
    Intervention: using the participants' initial assessment, personal characteristics, main complaints/needs and goals, the therapist will adjust the exercise plan and personalize the recommendations (e.g. maximum heart rate) as well as instruct the patients about safety precautions (how to pace themselves, when to seek professional or emergency care). Participants will be encouraged to wear the smart shirt as much as they want during the 6 weeks (29), but at a minimum of 1-hour a day (M-F) including while performing the recommended exercises (30-45 min/3 times a week). They should self-monitor their biometric values trying to reach/stay within the target values while wearing the shirt using Hexoskin app installed on an iPad provided by the research team or on the participants' personal device if preferred.
    Primary Outcome Measure Information:
    Title
    Change in lung capacity
    Description
    It will be assessed using a SpiroBank Smart F/V multi parameter spirometer (MIR) at pre-post intervention and once a week in between to monitor changes. This portable spirometer, which is MDSAP approved and complaint with ATS/ERS guidelines, connects automatically via Bluetooth to an iOS & Android compatible App (MIR Spirobank). It provides real time feedback through messages and animation on smartphone, to improve personal compliance during the test. The app can generate test results PDF printout with information regarding 19 parameters of lung capacity.
    Time Frame
    6 weeks
    Title
    Change in dyspnea
    Description
    Modified Borg Scale (0 "best" to 10 "worse dyspnea") will be used to assess dyspnea.
    Time Frame
    6 weeks
    Title
    Change in fatigue
    Description
    Fatigue severity scale (0 -7 "more fatigue") will be used to measure the severity of fatigue.
    Time Frame
    6 weeks
    Title
    Chronic fatigue syndrome
    Description
    DePaul Symptoms Questionnaire short form (DSQ-SF) (0 "not present" - 4 "very severe")
    Time Frame
    6 weeks
    Title
    Health-related quality of life
    Description
    EuroQol five-dimensional questionnaire (0 "worse health" to 100 "best health")
    Time Frame
    6 weeks
    Title
    Postural orthostatic hypotension
    Description
    Orthostatic Stress Test (Postural transitions)
    Time Frame
    6 weeks
    Title
    Exercise capacity
    Description
    The 6-min walk test (6 MWT) and the one-minute sit-to-stand test
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Symptoms change
    Description
    Participants will be ask to rate their symptoms from 0-10 using an online form (base on the baseline symptoms)
    Time Frame
    6 weeks
    Title
    Patient satisfaction with the study
    Description
    Participants will complete a short summary with questions regarding their satisfaction with the study
    Time Frame
    6 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Post-COVID-19 ≥ 3 months after infection. Mild to severe persistent respiratory symptoms Access to a home internet Exclusion Criteria: History of neurological disease or mental illness Inability to ambulate independently without supervision Inability to complete basic tasks on a smart phone or tablet

    12. IPD Sharing Statement

    Learn more about this trial

    Self-management of Post COVID-19 Syndrome Using Wearable Biometric Technology

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