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

• Conditions: Tuberculosis; Covid19

• Registration Number: NCT04677478
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-12
• Study Start: 2020-12
• Study First Submitted: 2020-12-15
• Study First Submitted QC: 2020-12-18
• Last Update Submitted: 2020-12-18
• Study First Posted: 2020-12-21
• Last Update Posted: 2020-12-21
• Primary Completion: 2022-01
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Patient who are more than 18 years old hospitalized in respiratory isolation for tuberculosis or COVID-19.
2. Patient able to understand questions and to communicate verbally with investigators.
3. Patient who has given his consent.

Exclusion Criteria

1. Patient deprived of their rights
2. Patient under tutorship or guardianship or under the protection of a conservator
3. Tuberculosis without respiratory isolation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life using Beck Depressive Inventory (BDI) -13	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	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.	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)	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.