跳至主要内容
临床试验/NCT05507190
NCT05507190已完成不适用

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

University of Manitoba2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Change in lung capacity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Change in lung capacity

时间窗: 6 weeks

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

时间窗: 6 weeks

Modified Borg Scale (0 "best" to 10 "worse dyspnea") will be used to assess dyspnea.

Change in fatigue

时间窗: 6 weeks

Fatigue severity scale (0 -7 "more fatigue") will be used to measure the severity of fatigue.

Chronic fatigue syndrome

时间窗: 6 weeks

DePaul Symptoms Questionnaire short form (DSQ-SF) (0 "not present" - 4 "very severe")

Health-related quality of life

时间窗: 6 weeks

EuroQol five-dimensional questionnaire (0 "worse health" to 100 "best health")

Postural orthostatic hypotension

时间窗: 6 weeks

Orthostatic Stress Test (Postural transitions)

Exercise capacity

时间窗: 6 weeks

The 6-min walk test (6 MWT) and the one-minute sit-to-stand test

次要结局

  • Symptoms change(6 weeks)
  • Patient satisfaction with the study(6 week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Diana C Sanchez-Ramirez, PhD

Assistant professor

University of Manitoba

研究点 (2)

Loading locations...

相似试验