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
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring Long COVID-19, Persistent symptoms, Self-management
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
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
NCT ID
NCT05507190
First Posted
July 28, 2022
Last Updated
February 22, 2023
Sponsor
University of Manitoba
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
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Self-management of Post COVID-19 Syndrome Using Wearable Biometric Technology
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