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临床试验/NCT04584450
NCT04584450已完成不适用

Investigation of Validity and Reliability of Post-COVID-19 Functional Status Scale

Hacettepe University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年9月2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
100
试验地点
1
主要终点
Post-COVID-19 Functional Status Scale (Turkish version)

研究概览

简要总结

The new type of Coronavirus (SARS-CoV-2) epidemic puts great pressure on health systems around the world. A large number of people are hospitalized in intensive care units due to acute respiratory distress syndrome due to SARS-CoV-2. Common symptoms seen with SARS-CoV-2 include fever, cough, and dyspnea, as well as pneumonia, severe acute respiratory distress syndrome, renal failure, and even death. Many patients develop mild to moderate disease without pneumonia. The respiratory condition of some patients continues to worsen gradually and develop acute respiratory distress syndrome, which usually requires mechanical ventilation support.

Exercise capacity and health status of individuals who survived severe acute respiratory distress syndrome are lower than the general population. Persistent physical, cognitive, and psychosocial disorders can be seen in people who have survived acute respiratory distress syndrome.

Given the clinical and radiological heterogeneity of COVID-19, it is important to have a simple tool for the disease to monitor the course of symptoms and the impact of symptoms on patients' functional status.

Klok FA et al. developed the Post-COVID-19 Functional Status Scale (PCFS). PCFS can be evaluated for functional sequelae after discharge from the hospital, at 4 and 8 weeks after discharge, to directly monitor recovery, and at 6 months. The aim of this study is to investigate the validity and reliability of PCFS in Turkish population. Research permission to investigate the validity and reliability of PCFS in the Turkish population was obtained from the developer of the PCFS.

研究设计

研究类型
Observational
观察模型
Other
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

  • clinically stable,
  • being 18 years of age or older,
  • having education level at least primary school,
  • whose local language is Turkish,
  • being discharged after COVID-19
  • giving consent on a voluntary basis.

排除标准

  • having an unstable clinical condition,
  • being stayed in intensive care,
  • having severe neuromuscular and musculoskeletal problems,
  • not being able to cooperate to fill questionnaires,
  • having a cognitive problem,
  • not being able to read,
  • not being willing to participate in the study.

结局指标

主要结局

Post-COVID-19 Functional Status Scale (Turkish version)

时间窗: Through study completion, an average of 1 year

It has been proposed as a tool to measure the full spectrum of functional outcomes following COVID-19. Post-COVID-19 Functional Status scale was reported to be used to monitor functional status. Scoring varies between 0-4. The expression 0 in PCFS indicates that there is no functional limitation. Grade 4 describes patients with severe functional limitations that require assistance with activities of daily living.

次要结局

  • Evaluation of daily living activities(Through study completion, an average of 1 year)
  • Assessment of the structural validity of the Post-COVID-19 Functional Status Scale(Through study completion, an average of 1 year)
  • Dyspnea assessment(Through study completion, an average of 1 year)

研究者

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

Ebru Calik Kutukcu

Assoc. Prof.

Hacettepe University

研究点 (1)

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