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

Covid19 Clinical Trial

— ISO-BK  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04677478
• Other study ID #: APHP200227
• Status: Not yet recruiting
• Start date: December 2020
• Est. completion date: January 2022

Study information

• Verified date: December 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Matthieu Resche-Rigon
• Phone: +3342499742
• Email: matthieu.resche-rigon[@]univ-paris-diderot.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Tuberculosis

Intervention

Other:
• Impact of respiratory isolation on quality of life
Semi-structured interviews

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life using semi-structured interview.	Quality of life will be assessed using semi-structured interview.	at 28 days respiratory isolation
Primary	Quality of life using 36-Item Short Form Health Survey (SF-36)	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.	at 28 days respiratory isolation
Primary	Quality of life using State-Trait Anxiety Inventory (STAY) A+B scale	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.	at 28 days respiratory isolation
Primary	Quality of life using Beck Depressive Inventory (BDI) -13	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.	at 28 days respiratory isolation