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

NCT04677478 | Unknown

• 1 other identifier: APHP200227
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tuberculosis; Covid19

Outcome Measures

Primary Outcomes (4)

• Quality of life using semi-structured interview.

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

  at 28 days respiratory isolation

• 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

• 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

• 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

Interventions

Impact of respiratory isolation on quality of life OTHER

Semi-structured interviews

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated for tuberculosis or COVID-19 and placed in respiratory isolation.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Tuberculosis; COVID-19

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Matthieu Resche-Rigon

CONTACT

+3342499742; matthieu.resche-rigon@univ-paris-diderot.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 21, 2020
• Study Start: December 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: December 21, 2020

Record last verified: 2020-12