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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05507190
• Other study ID #: HS25512(B2020:042
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2024
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Other:
• Self-management of post COVID-19 respiratory outcomes
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.

Locations

Country	Name	City	State
Canada	Riverview Health Centre	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks
Primary	Change in dyspnea	Modified Borg Scale (0 "best" to 10 "worse dyspnea") will be used to assess dyspnea.	6 weeks
Primary	Change in fatigue	Fatigue severity scale (0 -7 "more fatigue") will be used to measure the severity of fatigue.	6 weeks
Primary	Chronic fatigue syndrome	DePaul Symptoms Questionnaire short form (DSQ-SF) (0 "not present" - 4 "very severe")	6 weeks
Primary	Health-related quality of life	EuroQol five-dimensional questionnaire (0 "worse health" to 100 "best health")	6 weeks
Primary	Postural orthostatic hypotension	Orthostatic Stress Test (Postural transitions)	6 weeks
Primary	Exercise capacity	The 6-min walk test (6 MWT) and the one-minute sit-to-stand test	6 weeks
Secondary	Symptoms change	Participants will be ask to rate their symptoms from 0-10 using an online form (base on the baseline symptoms)	6 weeks
Secondary	Patient satisfaction with the study	Participants will complete a short summary with questions regarding their satisfaction with the study	6 week