COVID19NCT04432922
Perceptions, Representations and Experiences of Septic Isolation of Hospitalized Patients for COVID-19 Infection
An observational study of COVID19, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
Trial summary
The aim of this study is to analyze the perceptions, representations and experiences of septic isolation of patients hospitalized for COVID-19 infection. This analysis could lead to better understanding and communication between the medical profession and patients in septic isolation in hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID19
- What is being tested?
- Hospitalized Patients for COVID-19 Infection
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2020to 15 Nov 2020
- 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: The study will be provided to Covid 19 participants during their hospitalization or upon discharge from hospitalization
Who may be able to join
- Major patients
- Living in metropolitan France during the SARS-CoV2 pandemic
- Being or having been hospitalized in isolation contact and droplet for a COVID-19 infection (proven or suspected)
- Being in the process of leaving hospital
- Ready for No Opposition for Participation in the Protocol
Who cannot join
- Patients under guardianship or curatorship
- Patients unable to give free and informed consent;
- Patients under safeguarding justice
- Hospitalized patients on oxygen therapy with speech dyspnea
Trial locations and contacts
1 site in 1 country.
France1 site
Centre hospitalier intercommunal de Villeneuve St Georges
Villeneuve-Saint-Georges, 94190
About this study
Official title: Perceptions, Representations and Experiences of Septic Isolation of Hospitalized
The aim of this study is to analyze the perceptions, representations and experiences of septic isolation of patients hospitalized for COVID-19 infection.
This analysis could lead to better understanding and communication between the medical profession and patients in septic isolation in hospital. It would also provide patient-specific responses to their expectations, as to their families.
Read the detailed description
SARS-Cov2 is a new virus responsible for the COVID-19 pandemic. For the first time, it was observed in Wuhan, China in December 2019. For this previously unknown contagious disease, which can cause severe respiratory infections, isolation precautions in hospitals and public places are one of the cornerstones for fighting this pandemic.
Hospital isolation precautions have been present since the 19th century as a means to control the spread of infections. Septic isolation includes contact isolation, droplets and air. Isolation precautions must be prescribed by a physician. To our knowledge, there are few studies about the impact of septic isolation on hospitalized patients at both the psychological level and the relationship with doctors.
This study could enable a better understanding and communication between the medical profession and patients in septic isolation during hospitalization. It could also provide patient-specific responses to their expectations.
- Conditions
- COVID19
- Being tested
- Hospitalized Patients for COVID-19 Infection
- Keywords
- Septic isolation, perception, questionnaire
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospitalized Patients for COVID-19 InfectionOther
Face to face semi-directed interviews about perceptions, representations and experiences of septic isolation, including nine opened-questions.
What is being measured
The primary outcome is the main question the study is designed to answer.
To highlight the perceptions, representations and experiences of septic isolation of patients hospitalized for COVID-19 infection
Measured: 1 day
Secondary outcomes (1)
to identify key elements to improve the medical discourse on septic isolation among patients
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start1 Nov 2020
- Primary completion15 Nov 2020
- Study completion15 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID19Studies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04432922
- Sponsor's protocol ID
- ISOCOV
- Status last verified
- Jun 2023
- First submitted
- 15 Jun 2020
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perceptions, Representations and Experiences of Septic Isolation of Hospitalized
- ClinicalTrials.gov ID
- NCT04432922
- Acronym / sponsor ID
- ISOCOV
- Conditions
- COVID19
- Keywords
- Septic isolation, perception, questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 15 Nov 2020 (actual)
- Study completion
- 15 Nov 2020 (actual)
- First posted
- 16 Jun 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 aim of this study is to analyze the perceptions, representations and experiences of septic isolation of patients hospitalized for COVID-19 infection.
This analysis could lead to better understanding and communication between the medical profession and patients in septic isolation in hospital. It would also provide patient-specific responses to their expectations, as to their families.
Detailed description
SARS-Cov2 is a new virus responsible for the COVID-19 pandemic. For the first time, it was observed in Wuhan, China in December 2019. For this previously unknown contagious disease, which can cause severe respiratory infections, isolation precautions in hospitals and public places are one of the cornerstones for fighting this pandemic.
Hospital isolation precautions have been present since the 19th century as a means to control the spread of infections. Septic isolation includes contact isolation, droplets and air. Isolation precautions must be prescribed by a physician. To our knowledge, there are few studies about the impact of septic isolation on hospitalized patients at both the psychological level and the relationship with doctors.
This study could enable a better understanding and communication between the medical profession and patients in septic isolation during hospitalization. It could also provide patient-specific responses to their expectations.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be provided to Covid 19 participants during their hospitalization or upon discharge from hospitalization
Key inclusion criteria (5 listed)
- Major patients
- Living in metropolitan France during the SARS-CoV2 pandemic
- Being or having been hospitalized in isolation contact and droplet for a COVID-19 infection (proven or suspected)
- Being in the process of leaving hospital
- Ready for No Opposition for Participation in the Protocol
Key exclusion criteria (4 listed)
- Patients under guardianship or curatorship
- Patients unable to give free and informed consent;
- Patients under safeguarding justice
- Hospitalized patients on oxygen therapy with speech dyspnea
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 |
|---|---|---|
| Hospitalized Patients for COVID-19 InfectionFace to face semi-directed interviews about perceptions, representations and experiences of septic isolation, including nine opened-questions. | Other | – |
Primary outcome
To highlight the perceptions, representations and experiences of septic isolation of patients hospitalized for COVID-19 infection
Time frame: 1 day
1 secondary outcome
to identify key elements to improve the medical discourse on septic isolation among patients
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID19, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To highlight the perceptions, representations and experiences of septic isolation of patients hospitalized for COVID-19 infection (time frame: 1 day). 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 7 Jun 2023.