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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04916275
Other study ID # Local/2020/COVID/JYL IC-04
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 27, 2021
Est. completion date August 31, 2021

Study information

Verified date October 2021
Source Centre Hospitalier Universitaire de Nimes
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Nursing home staff face multiple stresses during the Covid-19 pandemic including personal risk of infection, risk of transmission of the virus to residents and relatives, and risk of witnessing end-of-life scenarios under difficult contexts (absence of families). The hypothesis of this study is that the Covid-19 period is associated with an incidence of more than 30% of post-traumatic stress in nursing home staff.


Recruitment information / eligibility

Status Completed
Enrollment 501
Est. completion date August 31, 2021
Est. primary completion date August 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Professional working in a nursing home in Occitanie - Professional agreeing to participate - Professional in a nursing home for at least 3 months - Professional able to read French - Profession with an internet connection Exclusion Criteria: - The subject is in a period of exclusion determined by a previous study - The subject refuses to participate - The subject has already been included into the study - It is impossible to give the subject informed information - The subject is under safeguard of justice or state guardianship - The subject is unable to express consent

Study Design


Intervention

Other:
Cognitive tests
Optional tests: Corsi block-tapping task, Stroop test and Iowa gambling task

Locations

Country Name City State
France CHU de Montpellier Montpellier
France CHU de Nîmes, Hôpital Universitaire Carémeau Nimes
France CHU de Toulouse Toulouse

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other Optional assessment of work memory abnormalities associated with symptoms of post-traumatic stress disorder, anxiety and depression Corsi block-tapping task - score ranging from 0(good memory) -18(bad memory) Day 0
Other Optional assessment of cognitive flexibility abnormalities associated with symptoms of post-traumatic stress disorder, anxiety and depression Corsi block-tapping task - score ranging from 0(good memory) -18(bad memory) Day 0
Other Optional assessment of decision-making abnormalities associated with symptoms of post-traumatic stress disorder, anxiety and depression Iowa Gambling Task - score ranes from -14 to +40 Day 0
Primary To assess the prevalence of post-traumatic stress disorder (PTSD) in the context of the COVID-19 health crisis Posttraumatic Stress Disorder Checklist Scale (PCL-5) scale, where the recommended cut-off threshold for screening is 44 Day 0
Secondary Prevalence of depression in the context of the COVID-19 health crisis Hospital Anxiety and Depression Scale (HADS) scale, using a cut-off above 7 Day 0
Secondary Prevalence of burn out in the context of the COVID-19 health crisis Masslach Burn out Inventory (MBI) questionnaire where high scores for the professional burnout and depersonalization sections and a low score for the personal accomplishments section will signal burn out Day 0
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