Corona Virus InfectionBURDENCOVNCT04341519
Psychological Burden in ICU Survivors of Severe COVID-19 Pneumonia, Their Relatives and Their Healthcare Providers
An observational study of Corona Virus Infection and Post-traumatic Stress Disorder, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial summary
Coronavirus disease 2019 (COVID-19) is an infectious disease responsible for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The infection is highly contagious requiring restrictive and stressful measures for patients, family members and ICU healthcare providers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corona Virus Infection, Post-traumatic Stress Disorder
- What is being tested?
- PTSD and Burnout
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,464 participants
- Where
- 3 sitesFrance
- Study dates
- 6 Apr 2020to 31 Dec 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: Family members, Patients hospitalized in ICU for COVID19 infection. Healthcare providers involved in care of patients hospitalized in ICU for COVID19 infection.
Who may be able to join
- Patients:
- Age>18y
- Admission to the participating ICUs for any cause of acute respiratory failure during the COVID-19 pandemic
- Having received invasive or noninvasive mechanical ventilation
- Non-opposition to participate to the telephone interviews.
- Family members:
Show all 11Show fewer
- Age>18y
- Non-opposition to participate to the telephone interviews
- One family member per patient: the family member the most implicated in the patient's care
- Healthcare providers:
- All nurses and physicians (including those in training) in the participating ICUs during the COVID-19 pandemic
Who cannot join
- Patients:
- Language barrier to be able to respond to the telephone interview
- Cognitive disorders disabling patients to respond to the telephone interview
- Person under legal protection (1121-8 of CSP, Public Health Code) Failure to obtain the non-opposition
- Family members:
- Language barrier to be able to respond to the telephone interview
Show all 10Show fewer
- Person under legal protection (1121-8 of CSP, Public Health Code)
- Failure to obtain the non-opposition
- Healthcare providers:
- Failure to obtain the non-opposition
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
Cochin
Paris
Alaib Cariou, alain.cariou@aphp.fr
- Recruiting
Pitié Salpetrière
Paris
Aleaxndre Demoule, alexandre.demoule@aphp.fr
- Not yet recruiting
Saint-Louis Hospital
Paris, Île-de-France Region, 75010
Nancy KENTISH-BARNES, MD PHD, 142499995 ext. +33, nancy.kentish@aphp.fr
matthieu resche-rigon, MD-PhD, 142499745 ext. +33, matthieu.resche-rigon@u-paris.fr
About this study
Official title: "Psychological Burden in ICU Survivors of Severe COVID-19 Pneumonia, Their Relatives and Their Healthcare Providers" "Impact Psychologique de l'épidémie COVID-19 Chez Les Patients, Familles et Soignants de Reanimation" "BURDENCOV"
Coronavirus disease 2019 (COVID-19) is an infectious disease responsible for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The infection is highly contagious requiring restrictive and stressful measures for patients, family members and ICU healthcare providers. To avoid contagion, patient isolation has become the rule. For patients, these measures add stress to the ICU environment and deprive them of unrestricted family visits. Family members are not only left with fear but also many unanswered questions. In end-of-life situations, many family members are unable to say good-bye and unable to provide support to their loved-one throughout the process. The impact of exclusion or limited inclusion certainly needs to be explored. Moreover, ICU caregivers are having to face new challenges and to work in a unknown situation, juggling with both professional issues such as increased workload, working longer hours and safety issues, and personal issues such as child care and transport as well as family transmission of the virus.
The main objective of this study is to demonstrate that the COVID-19 pandemic, as compared to seasonal flu and community acquired pneumonia, significantly increases post-traumatic stress disorder (PTSD) in family members of critically ill patients.
PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised) during a telephone interview 90 days after ICU discharge. The IES-R is a 22-item self-report measure that assesses subjective distress caused by traumatic events. It will be compared across the three groups (COVID-19, FLU and CAP).
- Being tested
- PTSD, Burnout
- Medical subject headings
- Coronavirus Infections, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTSDBehavioural
family members: post-traumatic stress disorder (PTSD) related symptoms assessed by Impact of Event Scale Revised (IES-R) at 90 days
Patients:
post-traumatic stress disorder (PTSD) related symptoms assessed by Impact of Event Scale Revised (IES-R) at 90 days
BurnoutBehavioural
Symptoms of burnout as assessed by the Maslash Burnout Inventory
| Study group | Role | What they receive |
|---|---|---|
| Family members | * Age>18y
* Non-opposition to participate to the telephone interviews
* One family member per patient: the family member the most implicated in the patient's care
3 groups of Family members will be enrolled in the study corresponding to patients with COVID-19, patients with seasonal flu and patients with community acquired pneumonia (See below). 1 family member per patient will be recruited. Receives: Behavioral: PTSD | |
| Patients | Patients:
* Age>18y
* Admission to the participating ICUs for any cause of acute respiratory failure during the COVID-19 pandemic
* Having received invasive or noninvasive mechanical ventilation
* Non-opposition to participate to the telephone interviews.
3 groups of patients will be enrolled in the study: patients with COVID-19, patients with seasonal flu and patients with community acquired pneumonia.
* COVID group : Patients admitted to the ICU for acute respiratory failure and having a positive 2019-nCOV RT PCR in a respiratory / nasal swab sample (GROUP COVID-19)
* Group FLU : patients admitted to the ICU for acute respiratory failure and having a confirmed influenza pneumonia
* Group CAP (Community-acquired pneumonia) : patients admitted to the ICU for acute respiratory failure and having a clinically or microbiologically documental community acquired pneumonia with negative COVID-19 and Influenza PCRs. Receives: Behavioral: PTSD | |
| healthcare providers | Two months after the official end of the COVID-19 peak in France, the local investigator will receive a set of 100 questionnaires. He/she will be responsible for proposing survey participation to volunteer healthcare providers. Those who are interested will be given the information letter and the questionnaires in an envelope. Once completed anonymously, they will seal the envelope and give it to the local investigator who will then send us all completed questionnaires by registered post. Receives: Behavioral: Burnout |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Family members sup 22
Proportion of Family members with IES-R> 22 PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised) during a telephone interview 90 days after ICU discharge of corresponding patient. It si a scale ranging from 0 to 88.
Weiss, DS.; Marmar, CR. The impact of event scale - revised. In: Wilson, JP.; Keane, TM., editors.Assessing psychological trauma and PTSD. New York: Guilford Press; 1997. p. 399-411
Measured: 90 days
Secondary outcomes (11)
PTSD Family members
Among Family members PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised)
Measured: 90 days
PTSD Patients
Among Patients PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised)
Measured: 90 days
PTSD healthcare providers
Among healthcare providers PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised)
Measured: 2 months after official end of the Covid-19 peak
HADS Family members
Among Family members Symptoms of anxiety and depression using the HADS scale
Measured: 90 days
HADS Patients
Among Patients Symptoms of anxiety and depression using the HADS scale
Measured: 90 days
SF36 Patients
Among Patients Mental and physical health-related quality of life as assessed by the SF36
Measured: 90 days
Questionnaire Family members
Among Family members Questionnaire describing their experience of the patient's ICU hospitalization
Measured: 90 days
Questionnaire Patients
Among Patients Questionnaire describing their experience of the patient's ICU hospitalization
Measured: 90 days
Questionnaire healthcare providers
Among healthcare providers Questionnaire describing their experience of the patient's ICU hospitalization
Measured: 2 months after official end of the Covid-19 peak
MBI healthcare providers
Among healthSymptoms of burnout on MBI scale as assessed by the Maslash Burnout Inventorycare providers
Measured: 2 months after official end of the Covid-19 peak
Karasec instrument healthcare providers
Job Strain as assessed by the Karasec instrument
Measured: 2 months after official end of the Covid-19 peak
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start6 Apr 2020
- Primary completion30 Nov 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Corona Virus InfectionStudies 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
- 1,464 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elie AZOULAY, MD PhD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04341519
- Sponsor's protocol ID
- APHP200389
- Acronym
- BURDENCOV
- Status last verified
- Oct 2020
- First submitted
- 7 Apr 2020
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Azoulay E, Resche-Rigon M, Megarbane B, Reuter D, Labbe V, Cariou A, Geri G, Van der Meersch G, Kouatchet A, Guisset O, Bruneel F, Reignier J, Souppart V, Barbier F, Argaud L, Quenot JP, Papazian L, Guidet B, Thiery G, Klouche K, Lesieur O, Demoule A, Guitton C, Capellier G, Mourvillier B, Biard L, Pochard F, Kentish-Barnes N. Association of COVID-19 Acute Respiratory Distress Syndrome With Symptoms of Posttraumatic Stress Disorder in Family Members After ICU Discharge. JAMA. 2022 Mar 15;327(11):1042-1050. doi: 10.1001/jama.2022.2017.
PubMed 35179564
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Psychological Burden in ICU Survivors of Severe COVID-19 Pneumonia, Their Relatives and Their Healthcare Providers" "Impact Psychologique de l'épidémie COVID-19 Chez Les Patients, Familles et Soignants de Reanimation" "BURDENCOV"
- ClinicalTrials.gov ID
- NCT04341519
- Acronym / sponsor ID
- BURDENCOV / APHP200389
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,464 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 6 Apr 2020 (actual)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 10 Apr 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.
Coronavirus disease 2019 (COVID-19) is an infectious disease responsible for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The infection is highly contagious requiring restrictive and stressful measures for patients, family members and ICU healthcare providers. To avoid contagion, patient isolation has become the rule. For patients, these measures add stress to the ICU environment and deprive them of unrestricted family visits. Family members are not only left with fear but also many unanswered questions. In end-of-life situations, many family members are unable to say good-bye and unable to provide support to their loved-one throughout the process. The impact of exclusion or limited inclusion certainly needs to be explored. Moreover, ICU caregivers are having to face new challenges and to work in a unknown situation, juggling with both professional issues such as increased workload, working longer hours and safety issues, and personal issues such as child care and transport as well as family transmission of the virus.
The main objective of this study is to demonstrate that the COVID-19 pandemic, as compared to seasonal flu and community acquired pneumonia, significantly increases post-traumatic stress disorder (PTSD) in family members of critically ill patients.
PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised) during a telephone interview 90 days after ICU discharge. The IES-R is a 22-item self-report measure that assesses subjective distress caused by traumatic events. It will be compared across the three groups (COVID-19, FLU and CAP).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Family members | – | Behavioral: PTSD* Age>18y * Non-opposition to participate to the telephone interviews * One family member per patient: the family member the most implicated in the patient's care 3 groups of Family members will be enrolled in the study corresponding to patients with COVID-19, patients with seasonal flu and patients with community acquired pneumonia (See below). 1 family member per patient will be recruited. |
| Patients | – | Behavioral: PTSDPatients: * Age>18y * Admission to the participating ICUs for any cause of acute respiratory failure during the COVID-19 pandemic * Having received invasive or noninvasive mechanical ventilation * Non-opposition to participate to the telephone interviews. 3 groups of patients will be enrolled in the study: patients with COVID-19, patients with seasonal flu and patients with community acquired pneumonia. * COVID group : Patients admitted to the ICU for acute respiratory failure and having a positive 2019-nCOV RT PCR in a respiratory / nasal swab sample (GROUP COVID-19) * Group FLU : patients admitted to the ICU for acute respiratory failure and having a confirmed influenza pneumonia * Group CAP (Community-acquired pneumonia) : patients admitted to the ICU for acute respiratory failure and having a clinically or microbiologically documental community acquired pneumonia with negative COVID-19 and Influenza PCRs. |
| healthcare providers | – | Behavioral: BurnoutTwo months after the official end of the COVID-19 peak in France, the local investigator will receive a set of 100 questionnaires. He/she will be responsible for proposing survey participation to volunteer healthcare providers. Those who are interested will be given the information letter and the questionnaires in an envelope. Once completed anonymously, they will seal the envelope and give it to the local investigator who will then send us all completed questionnaires by registered post. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Family members, Patients hospitalized in ICU for COVID19 infection. Healthcare providers involved in care of patients hospitalized in ICU for COVID19 infection.
Key inclusion criteria (11 listed)
- Patients:
- Age>18y
- Non-opposition to participate to the telephone interviews
- One family member per patient: the family member the most implicated in the patient's care
- All nurses and physicians (including those in training) in the participating ICUs during the COVID-19 pandemic
Key exclusion criteria (10 listed)
- Patients:
- Language barrier to be able to respond to the telephone interview
- Person under legal protection (1121-8 of CSP, Public Health Code)
- Failure to obtain the non-opposition
- Failure to obtain the non-opposition
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 |
|---|---|---|
| PTSDfamily members: post-traumatic stress disorder (PTSD) related symptoms assessed by Impact of Event Scale Revised (IES-R) at 90 days Patients: post-traumatic stress disorder (PTSD) related symptoms assessed by Impact of Event Scale Revised (IES-R) at 90 days | Behavioural | Family members, Patients |
| BurnoutSymptoms of burnout as assessed by the Maslash Burnout Inventory | Behavioural | healthcare providers |
Primary outcome
PTSD Family members sup 22
Time frame: 90 days
Proportion of Family members with IES-R> 22 PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised) during a telephone interview 90 days after ICU discharge of corresponding patient. It si a scale ranging from 0 to 88. Weiss, DS.; Marmar, CR. The impact of event scale - revised. In: Wilson, JP.; Keane, TM., editors.Assessing psychological trauma and PTSD. New York: Guilford Press; 1997. p. 399-411
11 secondary outcomes
PTSD Family members
Time frame: 90 days
PTSD Patients
Time frame: 90 days
PTSD healthcare providers
Time frame: 2 months after official end of the Covid-19 peak
HADS Family members
Time frame: 90 days
HADS Patients
Time frame: 90 days
SF36 Patients
Time frame: 90 days
Questionnaire Family members
Time frame: 90 days
Questionnaire Patients
Time frame: 90 days
Questionnaire healthcare providers
Time frame: 2 months after official end of the Covid-19 peak
MBI healthcare providers
Time frame: 2 months after official end of the Covid-19 peak
Karasec instrument healthcare providers
Time frame: 2 months after official end of the Covid-19 peak
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
- Derived from this study: PubMed 35179564Azoulay E, Resche-Rigon M, Megarbane B, Reuter D, Labbe V, Cariou A, Geri G, Van der Meersch G, Kouatchet A, Guisset O, Bruneel F, Reignier J, Souppart V, Barbier F, Argaud L, Quenot JP, Papazian L, Guidet B, Thiery G, Klouche K, Lesieur O, Demoule A, Guitton C, Capellier G, Mourvillier B, Biard L, Pochard F, Kentish-Barnes N. Association of COVID-19 Acute Respiratory Distress Syndrome With Symptoms of Posttraumatic Stress Disorder in Family Members After ICU Discharge. JAMA. 2022 Mar 15;327(11):1042-1050. doi: 10.1001/jama.2022.2017.
- 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.
Elie AZOULAY, MD PhD principal investigator
APHP
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corona Virus Infection and Post-traumatic Stress Disorder, run by Assistance Publique - Hôpitaux de Paris at 3 sites 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 11 inclusion and 10 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 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Contact Nancy KENTISH-BARNES, PhD (142499995 ext. +33, nancy.kentish@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Family members sup 22 (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04341519, which also lists 1 linked publication.
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 6 Oct 2020.