TuberculosisISO-BKNCT04677478
Impact of the Respiratory Isolation on the Quality of Life in Patients Hospitalized for Tuberculosis or COVID-19
An observational study of Tuberculosis and Covid19, run by Assistance Publique - Hôpitaux de Paris.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis, Covid19
- What is being tested?
- Impact of respiratory isolation on quality of life
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated for tuberculosis or COVID-19 and placed in respiratory isolation.
Who may be able to join
- 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.
Who cannot join
- Patient deprived of their rights
- Patient under tutorship or guardianship or under the protection of a conservator
- Tuberculosis without respiratory isolation
Trial locations and contacts
No sites are listed yet.
About this study
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
- Being tested
- Impact of respiratory isolation on quality of life
- Medical subject headings
- Tuberculosis, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impact of respiratory isolation on quality of lifeOther
Semi-structured interviews
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life using semi-structured interview.
Quality of life will be assessed using semi-structured interview.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at 28 days respiratory isolation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study startDec 2020 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677478
- Sponsor's protocol ID
- APHP200227
- Acronym
- ISO-BK
- Status last verified
- Dec 2020
- First submitted
- 15 Dec 2020
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Respiratory Isolation on the Quality of Life in Patients Hospitalized for Tuberculosis or COVID-19
- ClinicalTrials.gov ID
- NCT04677478
- Acronym / sponsor ID
- ISO-BK / APHP200227
- Conditions
- Tuberculosis, Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 21 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated for tuberculosis or COVID-19 and placed in respiratory isolation.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Patient deprived of their rights
- Patient under tutorship or guardianship or under the protection of a conservator
- Tuberculosis without respiratory isolation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Impact of respiratory isolation on quality of lifeSemi-structured interviews | Other | – |
Primary outcome
Quality of life using semi-structured interview.
Time frame: 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)
Time frame: 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.
Quality of life using State-Trait Anxiety Inventory (STAY) A+B scale
Time frame: 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 Beck Depressive Inventory (BDI) -13
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis and Covid19, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthieu Resche-Rigon (+3342499742, matthieu.resche-rigon@univ-paris-diderot.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life using semi-structured interview. (time frame: at 28 days respiratory isolation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2020.