Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Psychological Burden in ICU Survivors of Severe COVID-19 Pneumonia, Their Relatives and Their Healthcare Providers (BURDENCOV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04341519
Recruitment Status : Recruiting
First Posted : April 10, 2020
Last Update Posted : October 6, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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. 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).


Condition or disease Intervention/treatment
Corona Virus Infection Post-traumatic Stress Disorder Behavioral: PTSD Behavioral: Burnout

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1464 participants
Observational Model: Cohort
Time Perspective: Prospective
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"
Actual Study Start Date : April 6, 2020
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.

Behavioral: PTSD

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


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.
Behavioral: PTSD

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


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.
Behavioral: Burnout
Symptoms of burnout as assessed by the Maslash Burnout Inventory




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. PTSD Family members [ Time Frame: 90 days ]
    Among Family members PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised)

  2. PTSD Patients [ Time Frame: 90 days ]
    Among Patients PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised)

  3. PTSD healthcare providers [ Time Frame: 2 months after official end of the Covid-19 peak ]
    Among healthcare providers PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised)

  4. HADS Family members [ Time Frame: 90 days ]
    Among Family members Symptoms of anxiety and depression using the HADS scale

  5. HADS Patients [ Time Frame: 90 days ]
    Among Patients Symptoms of anxiety and depression using the HADS scale

  6. SF36 Patients [ Time Frame: 90 days ]
    Among Patients Mental and physical health-related quality of life as assessed by the SF36

  7. Questionnaire Family members [ Time Frame: 90 days ]
    Among Family members Questionnaire describing their experience of the patient's ICU hospitalization

  8. Questionnaire Patients [ Time Frame: 90 days ]
    Among Patients Questionnaire describing their experience of the patient's ICU hospitalization

  9. Questionnaire healthcare providers [ Time Frame: 2 months after official end of the Covid-19 peak ]
    Among healthcare providers Questionnaire describing their experience of the patient's ICU hospitalization

  10. MBI healthcare providers [ Time Frame: 2 months after official end of the Covid-19 peak ]
    Among healthSymptoms of burnout on MBI scale as assessed by the Maslash Burnout Inventorycare providers

  11. Karasec instrument healthcare providers [ Time Frame: 2 months after official end of the Covid-19 peak ]
    Job Strain as assessed by the Karasec instrument



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Family members, Patients hospitalized in ICU for COVID19 infection. Healthcare providers involved in care of patients hospitalized in ICU for COVID19 infection.
Criteria

Inclusion Criteria:

  • 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:

  • 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

Exclusion Criteria:

  • 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
  • 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04341519


Contacts
Layout table for location contacts
Contact: Nancy KENTISH-BARNES, PhD 142499995 ext +33 nancy.kentish@aphp.fr
Contact: Matthieu RESCHE-RIGON, MD PhD 142499742 ext +33 matthieu.resche-rigon@u-paris.fr

Locations
Layout table for location information
France
Saint-Louis Hospital Not yet recruiting
Paris, Ile De France, France, 75010
Contact: Nancy KENTISH-BARNES, MD PHD    142499995 ext +33    nancy.kentish@aphp.fr   
Contact: matthieu resche-rigon, MD-PhD    142499745 ext +33    matthieu.resche-rigon@u-paris.fr   
Cochin Recruiting
Paris, France
Contact: Alaib Cariou       alain.cariou@aphp.fr   
Pitié Salpetrière Recruiting
Paris, France
Contact: Aleaxndre Demoule       alexandre.demoule@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Layout table for investigator information
Principal Investigator: Elie AZOULAY, MD PhD APHP
Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04341519    
Other Study ID Numbers: APHP200389
First Posted: April 10, 2020    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronavirus Infections
Severe Acute Respiratory Syndrome
Pneumonia
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Trauma and Stressor Related Disorders
Mental Disorders
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections