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临床试验/NCT04677478
NCT04677478Unknown不适用

Impact of the Respiratory Isolation on the Quality of Life in Patients Hospitalized for Tuberculosis or COVID-19

Assistance Publique - Hôpitaux de Paris0 个研究点目标入组 20 人开始时间: 2020年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
主要终点
Quality of life using Beck Depressive Inventory (BDI) -13

研究概览

简要总结

The respiratory isolation could have a harmful impact on the well-being of patients, especially in a psychological point of view such as anxiety and depression disorders or through the relationship with medical team and/or relatives but also in terms of informations.

The evaluation of the impact of respiratory isolation in patients hospitalized for tuberculosis or COVID-19 could allow to identify the different kinds of problems encountered by these patients (physical, psychological, sociological, informations, ...) in order to adapt the environment for efficient care and to improve patient's well-being.

The purpose of this research is to evaluate the psychological impact of the respiratory isolation on the quality of life in patients hospitalized for tuberculosis or COVID-19.

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

  • Patient who are more than 18 years old hospitalized in respiratory isolation for tuberculosis or COVID-
  • Patient able to understand questions and to communicate verbally with investigators.
  • Patient who has given his consent.

排除标准

  • Patient deprived of their rights
  • Patient under tutorship or guardianship or under the protection of a conservator
  • Tuberculosis without respiratory isolation

结局指标

主要结局

Quality of life using Beck Depressive Inventory (BDI) -13

时间窗: at 28 days respiratory isolation

It is a self-rated scale. each item is made up of 4 sentences corresponding to 4 degrees of intensity of increase in a symptom: from 0 to 3. The overall score is obtained by adding the scores of the 13 items. The range of the scale is 0 to 39.

Quality of life using State-Trait Anxiety Inventory (STAY) A+B scale

时间窗: at 28 days respiratory isolation

The State-Trait Anxiety Inventory is a self-rated scale. Each type of anxiety has its own scale of 20 different questions that are scored. STAY-YA and STAY-YB Scores range from 20 to 80. A higher score is higher anxiety.

Quality of life using semi-structured interview.

时间窗: at 28 days respiratory isolation

Quality of life will be assessed using semi-structured interview.

Quality of life using 36-Item Short Form Health Survey (SF-36)

时间窗: at 28 days respiratory isolation

Quality of life will be assessed using SF-36. SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting. Items are grouped into three categories: functional status, well-being, overall health assessment. The scores for the different items are coded and then summed and transformed linearly on a scale ranging from 0 to 100.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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