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临床试验/NCT04375709
NCT04375709Unknown不适用

Health-related Quality of Life (HRQOL) and Physical Performance in Individuals After COVID-19 Induced Hospitalisation and the Impact of a Standard Care Follow-up Program: a Longitudinal Observational Cohort Study

Kantonsspital Winterthur KSW1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年3月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Health-related quality of life; EuroQoL (EQ-5D-5L)

研究概览

简要总结

This study aims to observe the long-term health-related quality of life (HRQOL) and physical performance in individuals hospitalized due to a COVID-19 infection. Therefore, data is extracted from a study-site standard aftercare program which has been adjusted for this patient population. This comprehensive aftercare program includes education sessions and physical exercise. A second aim is to observe adherence and feasibility to the program and if indicated compare the clinical data and outcomes from patients following the program with patients denying to participate in guided exercise and education sessions.

It is expected that patients hospitalized due to COVID-19 infection show a reduction in physical performance and HRQOL directly after discharge. The severity of illness is hypothesized to be associated with a reduction as well in HRQOL and physical performance after one-year post-discharge.

详细描述

Currently, the U.S. National Library of Medicine (April 2nd) reports 282 studies registered investigating the COVID-19 infection. According to the present knowledge the COVID-19, also known as novel type Coronavirus or SARS-CoV-2 (severe acute respiratory syndrome-Coronavirus-2), belongs to a large family of viruses consist-ing of hundreds of variations and subtypes of this virus (World Health Organisation (WHO)/emergencies, April 2nd 2020). These types of virus' can cause respiratory and gastrointestinal symptoms ranging from a mild cold to pneumonia. The clinical manifestation of this novel type of Coronavirus - COVID-19 - was found to cause more severe pneumonia or severe acute respiratory syndrome such as the acute respiratory distress syndrome (ARDS). According to the data of Arabi and colleagues (2020) average age in Chinese affected individuals were 60, 40% had comorbid conditions, 42% required invasive mechanical ventilation and the mortality rate was at 62%. Epidemiological information from other countries is not yet published. According to the WHO in the Europe Region, 503730 cases and 33617 deaths were reported since January 25th 2020. In the 8,5 million populated countries of Switzerland, the number of confirmed cases raised to 23'574 and 756 deaths (Bundesamt für Gesundheit) Situationsbericht, April 9th). According to this report, the incidence of infection and hospitalization is highest in individuals aged 50 and older with a higher presence registered in men. Nevertheless, a certain number of affected individuals is between 20 and 50 years which is in accordance with the number presented from large studies in China (50.7%-55.1%). Among the 23'674 positive tested 2730 are currently hospitalized. Among these 280 individuals require mechanically assisted ventilation, meaning health care at an intensive care unit (status April 2nd).

In this acute situation of the pandemic, there is an enormous urge to finding a vaccine or medications to release or prevent severe symptoms and complications due to the new virus. Therefore, in the listed studies keen interest is on drug interventions to stop the expansion of this virus. However, knowledge on long-term consequences of physical condition and psychological state is unknown. Although, taking into account the clinical manifestation observed in the severe cases negative long-term consequences have to be expected as described in the following paragraph.

Up to date knowledge exist on the clinical manifestation which varies from asymptomatic to severe disease with approximately 80% of the cases found to present an asymptomatic carrier.

Thus, about 13.8% to 35% is suffering a severe course including dyspnoea, respiratory frequency ≥30/minute, desaturation of blood oxygen (≤93%) and or lung infiltrates >50% of the lung within 24-48 hours. Further signs of hospitalized individuals are fever, cough, myalgia, fatigue and sputum production. In literature, the clinical picture is described as bilateral pneumonia or acute respiratory distress syndrome which leads to a severe organ failure of the lung. These patients require oxygen therapy with invasive (17%) or non-invasive (14%) mechanically assisted ventilation. And the higher probability of preloaded organ dysfunctions due to co-morbidities most often high blood pressure (13%), diabetes (4-6%) and COPD (1-5%) has to be taken into account.

According to the WHO report and Lai et al (2020) between 6.1% to 28%, respectively, were found to be in a critical stage. Acute respiratory failure, septic shock and/ or multiple organ failure defined this stage. According to a retrospective analysis from a large population in Wuhan, these patients require intensive care with most of them presenting (multi) organ failure with acute respiratory distress (ARDS, 67%), acute kidney injury (29%), cardiac injury (23%), and liver dysfunction (29%). These patients require invasive or non-invasive mechanical ventilation. The mortality rate for critically ill COVID-19 patients varies from 1-4% to 4.3% according to large studies reported by Lai et al. (2020).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Hospitalized at the Kantonsspital Winterthur (KSW) due to COVID-19 infection (laboratory-confirmed),
  • with or without mechanically assisted ventilation
  • being at risk to obtain severe illness caused by the COVID-19*
  • individuals without defined risk factors but requiring oxygenation during hospitalisation
  • Agree to general consent or specific consent to subsequent use of his/her personal health data for research purpose
  • German-speaking

排除标准

  • Presence of mental disability or impairments to reasoning or judgment
  • Individuals who are immunocompromised due to medical treatment
  • A documented objection of subsequent use of personal health data
  • Specific exclusion criteria for presence at the hospital (for evaluation and training); criteria will be verified during the phone-based screening process. After two weeks of a COVID-19 positive diagnosis and with four entire days the patient reports no signs of:
  • fever >37.3° C
  • sore throat,
  • cough (productive or non-productive)
  • common cold
  • Also, treatment-based immunocompromised patients are excluded for on-site evaluation and training.

结局指标

主要结局

Health-related quality of life; EuroQoL (EQ-5D-5L)

时间窗: 01.04.2020 - 30.05.2021

Self-managed questionnaire on functional status, anxiety, pain and independence in daily living; The EuroQoL includes a five item scale and a visual analog scale from 0-100 in order to quantify perception of current health. The five item scale includes ordinary scores from 0-5. Lower numbers equal less problems and better quality of life. For the visual analog scale a higher number represents a better health status perceived.

6-minute walk test

时间窗: 01.04.2020 - 30.05.2021

6-minute walk test measures the distance acquired during six minutes walking, it quantifies the physical performance, dyspnoea and endurance.

次要结局

  • Jamar dynamometer(01.04.2020 - 30.05.2021)
  • Hospital Anxiety and Depression Scale (HADS)(01.04.2020 - 30.05.2021)
  • revised Impact of Event Scale (IES-R)(01.04.2020 - 30.05.2020)
  • Mini-Nutritional Assessment (MNA)(01.04.2020 - 30.05.2021)
  • Spirometry (bed-side)(01.04.2020 - 30.05.2021)
  • Post-Covid Functional Scale (PCFS)(01.04.2020 - 30.05.2021)
  • modified Medical Research Council Dyspnoea Scale (mMRC Dyspnoea)(01.04.2020 - 30.05.2021)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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