Psychological Impact of COVID-19 Outbreak on Caregivers (PSY-CO-ICU)

• ClinicalTrials.gov Identifier: NCT04511780
• Recruitment Status: Not yet recruiting
• First Posted: August 13, 2020
• Last Update Posted: December 19, 2020
• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Information provided by (Responsible Party): Centre Hospitalier Universitaire de Nīmes

Tracking Information

• First Submitted Date: August 12, 2020
• First Posted Date: August 13, 2020
• Last Update Posted Date: December 19, 2020
• Estimated Study Start Date: January 2021
• Estimated Primary Completion Date: September 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 12, 2020)

Post-Traumatic Stress Disorder [ Time Frame: 3-6 month after the Covid-19 outbreak ]

PCL - 5 (Post-Traumatic Stress Disorder Checklist Scale, version DSM-5)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 12, 2020)

• anxiety and depression [ Time Frame: 3-6 month after the Covid-19 outbreak ]
  HADS scale (Hospital Anxiety and Depression Scale)
• Burn out [ Time Frame: 3-6 month after the Covid-19 outbreak ]
  Score MBI (Burn out syndrome)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Psychological Impact of COVID-19 Outbreak on Caregivers
• Official Title: Psychological Impact of COVID-19 Outbreak on Caregivers Involved in Intensive Care Unit Patient Management: Impact on the Occurrence of Post-traumatic Stress Disorder, Anxiety, Depression and Burn Out Syndrome

Brief Summary

Based on the experience of previous pandemics, countries reacted by applying different upgrade strategies to prevent or delay the widespread of the disease. Therefore, measures such as border closure, school closure, restrict social gathering (even shutdown of workplaces), limit population movements, and confinement meaning quarantines at the scale of cities or regions. In public hospitals, several measures have been decided to concentrate the power of care on potential wave of admissions of patients with severe forms of Covid-19. In this purpose, the number of available beds in Intensive Care Units (ICU) has been increased by two-fold and scheduled non-emergency surgical procedure have been cancelled. That means:

1. For the most severe patients, new personals (physician such as anesthesiologists, nurses of other units) have been transferred in ICUs.
2. For the less severe patients, personals of non-busy units have been transferred in busier ones.

All these measures lead to major daily-life change sets that could be stressful. In the general population, it has been well documented that quarantine or confinement or isolation could lead to the occurrence of Post-Traumatic Stress Disorder (PTSD) syndrome in about 30% overall population. Importantly, high depressive symptoms have been reported in 9% of hospital staff. Numerous symptoms have been reported after quarantine or isolation such as emotional disturbance, depression, stress, low mood, irritability, insomnia, and post-traumatic stress symptoms.

In hospital setting, few studies have been performed for assessing the psychological impact of quarantine and isolation. However, two studies reported a high prevalence of burn-out syndrome (BOS) in ICU physician and PTSD syndrome and depression in ICU nurses. As the consequences of all the measures decided and applied during Covid-19 pandemic could be important on caregivers, the present study primarily aims at assessing the prevalence of PTSD syndrome in a large population of caregivers implied or not in Intensive Care Units. The secondary objective were 1) to assess the prevalence of severe depression and anxiety and BOS 2) to isolate potential factors associated with PTSD, severe depression, anxiety or BOS.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Caregivers (doctors senior and junior, nurses, aid nurses) involved in the staff (permanent or transient, full or partial time) of ICU patients during Covid-19 outbreak

Condition

• Critical Illness
• Covid19
• Stress Disorders, Post-Traumatic

Intervention

Other: questionnaire filling

assessment of post-traumatic stress, anxiety and burn out

Study Groups/Cohorts

Caregivers

• Caregivers (doctors senior and junior, nurses, aid nurses) involved in the staff (permanent or transient, full or partial time) of ICU patients during Covid-19 outbreak

Intervention: Other: questionnaire filling

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: August 12, 2020): 5000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2022
• Estimated Primary Completion Date: September 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Caregivers (doctors senior and junior, nurses, aid nurses) involved in the staff (permanent or transient, full or partial time) of ICU patients during Covid-19 outbreak
• Approved to participate

Exclusion Criteria:

• Participation refusal
• No internet connection for responding to the questionnaire with REDCAP file

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Jean Yves LEFRANT; +33466683331; jean.yves.lefrant@chu-nimes.fr

• Listed Location Countries: France

Administrative Information

• NCT Number: NCT04511780
• Other Study ID Numbers: Local/2020/JYL-03
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Centre Hospitalier Universitaire de Nīmes
• Study Sponsor: Centre Hospitalier Universitaire de Nīmes
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jean Yves LEFRANT; CHU de Nîmes

• PRS Account: Centre Hospitalier Universitaire de Nīmes
• Verification Date: December 2020