Clinical trial NCT05507190: 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
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: Long COVID-19
Persistent symptoms
Self-management
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2022-08-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in lung capacity
timeFrame: 6 weeks
measure: Change in dyspnea
timeFrame: 6 weeks
measure: Change in fatigue
timeFrame: 6 weeks
measure: Chronic fatigue syndrome
timeFrame: 6 weeks
measure: Health-related quality of life
timeFrame: 6 weeks
measure: Postural orthostatic hypotension
timeFrame: 6 weeks
measure: Exercise capacity
timeFrame: 6 weeks
Secondary outcomes:
measure: Symptoms change
timeFrame: 6 weeks
measure: Patient satisfaction with the study
timeFrame: 6 week
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Riverview Health Centre
state: Manitoba
Study officials:
References: