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

U

University of Manitoba

Status

Completed

Conditions

COVID-19

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05507190
HS25512(B2020:042

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

One arm
Experimental group
Description:
Self-management group. This pilot-study uses a one-group before-after design.
Treatment:
Other: Self-management of post COVID-19 respiratory outcomes

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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