Intensive Care UnitFAMILY-COVIDNCT04872049
Assessment of SARS-CoV-2 Effect on Post-traumatic Stress of Patients Hospitalized in Intensive Care Unit
An observational study of Intensive Care Unit and SARS-CoV2, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Patients admitted to the intensive care unit develop psychiatric disorders, such as anxiety, depression or post-traumatic stress disorder, which can be prolonged. During the COVID crisis, the presence of relatives in the intensive care unit was reduced and this, in a lasting way. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit, SARS-CoV2
- How many people
- 264 participants
- Where
- 1 siteFrance
- Study dates
- 27 Apr 2021to 27 Oct 2021
- 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 admitted more than 2 days (48 hours) in Intensive care unit between 01/01/2020 and 06/30/2020i, infected or not with SARS-CoV-2;
Who may be able to join
- Major patients (above 18 years old)
- Admitted in intensive care unit
- Hospitalized more than 2 days (48 hours)
- Between 01/01/2020 and 06/30/2020
- Whether SARS-CoV-2 positive or negative
Who cannot join
- Minor patient
- Protected major (under safeguardship, curatorship or guardianship)
- Patient opposition
Trial locations and contacts
1 site in 1 country.
France1 site
GH Pitié Salpêtrière - Charles Foix
Paris, Île-de-France Region, 75013
About this study
Official title: Assessment of SARS-CoV-2 Effect on Post-traumatic Stress of Patients Hospitalized in Intensive Care
Patients admitted to the intensive care unit develop psychiatric disorders, such as anxiety, depression or post-traumatic stress disorder, which can be prolonged.
During the COVID crisis, the presence of relatives in the intensive care unit was reduced and this, in a lasting way.
The hypothesis is that there is a difference in the experience of the stay in the intensive care unit whether or not one is affected by SARS-CoV-2 and that this difference is likely to have an impact on the long-term outcome of the patients and their relatives.
Read the detailed description
The stay in the ICU is a complex and often traumatic experience for patients. Patients often develop psychiatric disorders such as anxiety, depression or post-traumatic stress disorder after an ICU stay. These symptoms can be prolonged over time, resulting in a decrease in quality of life and a potential cost in care.
In the epidemic context of the COVID crisis, the presence of family members in the intensive care unit was reduced to its most extreme portion, with sometimes an almost total impossibility of visiting a loved one. This situation, although it has become less strict, has lasted for a long time. The patient can only exchange with them with difficulty, despite the extremely trying situation that is resuscitation. Moreover, there is a stress factor linked to the infectious risk for the relatives and for the relatives with regard to COVID-19, in particular within the framework of family clusters with sometimes several hospitalized subjects within the same family.
Of course, means of communication have been put in place with relatives, but these means do not seem to be equivalent to the presence of one's relatives.
The investigators therefore hypothesize that there is a difference in the experience of the stay in the intensive care unit whether or not one is affected by SARS-CoV-2 and that this difference is likely to have an impact on the long-term outcome of patients and their relatives.
- Conditions
- Intensive Care Unit, SARS-CoV2
- Keywords
- SARS-CoV-2, Post-traumatic stress, Anxiety, Depression, Covid-19, Intensive-care
- Medical subject headings
- Anxiety Disorders, Depression, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of post-traumatic stress at 1 year
Prevalence of post-traumatic stress in patients treated in intensive care at 1 year diagnosed with an IES-r> 33 depending on whether they are SARS-CoV-2 positive or not.
(IES-r: Impact of Event Scale - Revised scale, minimum value: 0, maximum value: 88, higher score indicates a worse outcome)
Measured: 12 months from hospitalization
Secondary outcomes (3)
Level of depression at 1 year
Assessed by the Center for Epidemiologic Studies Depression scale (CES-D, minimum value: 0, maximum value: 60, higher score indicates a worse outcome)
Measured: 12 months from hospitalization
Perceived interest of the proposed communication tools at 1 year
Semi-structured interviews
Measured: 12 months from hospitalization
Level of quality of life at 1 year
Assessed by EQ-5D (EuroQol 5Dimension scale, minimum value: 0, maximum value: 100, higher score indicates a better outcome)
Measured: 12 months from hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start27 Apr 2021
- Primary completion27 Oct 2021 (estimated)
- Study completion27 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care UnitStudies 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
- Cross-sectional
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire FAZILLEAU, Study director, Assistance Publique - Hôpitaux de ParisArthur Dr JAMES, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872049
- Sponsor's protocol ID
- APHP200450
- Other IDs
- 2020-A03430-39
- Acronym
- FAMILY-COVID
- Status last verified
- Apr 2021
- First submitted
- 29 Apr 2021
- Last updated
- 17 May 2021
- 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 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of SARS-CoV-2 Effect on Post-traumatic Stress of Patients Hospitalized in Intensive Care
- ClinicalTrials.gov ID
- NCT04872049
- Acronym / sponsor ID
- FAMILY-COVID / APHP200450
- Conditions
- Intensive Care Unit, SARS-CoV2
- Keywords
- SARS-CoV-2, Post-traumatic stress, Anxiety, Depression, Covid-19, Intensive-care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 27 Oct 2021 (estimated)
- Study completion
- 27 Oct 2021 (estimated)
- First posted
- 4 May 2021 (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.
Patients admitted to the intensive care unit develop psychiatric disorders, such as anxiety, depression or post-traumatic stress disorder, which can be prolonged.
During the COVID crisis, the presence of relatives in the intensive care unit was reduced and this, in a lasting way.
The hypothesis is that there is a difference in the experience of the stay in the intensive care unit whether or not one is affected by SARS-CoV-2 and that this difference is likely to have an impact on the long-term outcome of the patients and their relatives.
Detailed description
The stay in the ICU is a complex and often traumatic experience for patients. Patients often develop psychiatric disorders such as anxiety, depression or post-traumatic stress disorder after an ICU stay. These symptoms can be prolonged over time, resulting in a decrease in quality of life and a potential cost in care.
In the epidemic context of the COVID crisis, the presence of family members in the intensive care unit was reduced to its most extreme portion, with sometimes an almost total impossibility of visiting a loved one. This situation, although it has become less strict, has lasted for a long time. The patient can only exchange with them with difficulty, despite the extremely trying situation that is resuscitation. Moreover, there is a stress factor linked to the infectious risk for the relatives and for the relatives with regard to COVID-19, in particular within the framework of family clusters with sometimes several hospitalized subjects within the same family.
Of course, means of communication have been put in place with relatives, but these means do not seem to be equivalent to the presence of one's relatives.
The investigators therefore hypothesize that there is a difference in the experience of the stay in the intensive care unit whether or not one is affected by SARS-CoV-2 and that this difference is likely to have an impact on the long-term outcome of patients and their relatives.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted more than 2 days (48 hours) in Intensive care unit between 01/01/2020 and 06/30/2020i, infected or not with SARS-CoV-2;
Key inclusion criteria (5 listed)
- Major patients (above 18 years old)
- Admitted in intensive care unit
- Hospitalized more than 2 days (48 hours)
- Between 01/01/2020 and 06/30/2020
- Whether SARS-CoV-2 positive or negative
Key exclusion criteria (3 listed)
- Minor patient
- Protected major (under safeguardship, curatorship or guardianship)
- Patient opposition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of post-traumatic stress at 1 year
Time frame: 12 months from hospitalization
Prevalence of post-traumatic stress in patients treated in intensive care at 1 year diagnosed with an IES-r> 33 depending on whether they are SARS-CoV-2 positive or not. (IES-r: Impact of Event Scale - Revised scale, minimum value: 0, maximum value: 88, higher score indicates a worse outcome)
3 secondary outcomes
Level of depression at 1 year
Time frame: 12 months from hospitalization
Perceived interest of the proposed communication tools at 1 year
Time frame: 12 months from hospitalization
Level of quality of life at 1 year
Time frame: 12 months from hospitalization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
- 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.
Claire FAZILLEAU study director
Assistance Publique - Hôpitaux de Paris
Arthur Dr JAMES, MD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Intensive Care Unit and SARS-CoV2, run by Assistance Publique - Hôpitaux de Paris 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 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 17 May 2021. 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?
Results are not available in the source record.
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?
Prevalence of post-traumatic stress at 1 year (time frame: 12 months from hospitalization). 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 17 May 2021.