- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05033223
Psycho-traumatic Consequences of the COVID-19 Health Crisis Among Professionals in Emergency Services (COVER PRO LT)
26. januar 2022 opdateret af: Elisa Letellier, Hospices Civils de Lyon
Psycho-traumatic Consequences of the COVID-19 Health Crisis Among Professionals in Emergency Services and SAMU: Multicenter Cohort Study (COVid in EmeRgency PROfessionnals Long Term)
The COVID-19 outbreak has been categorized as a pandemic and declared an international public health emergency by WHO.
In this context, an exceptional mobilization and a complete reorganization of the organization of the healthcare offer was put in place.The investigators will study the psychological consequences among emergency department (ED) / SAMU (Service d'Aide Médicale Urgente) professionals exposed during the COVID-19 pandemic to high psychological stress due to work overload, changes in practices and fears of contamination.They will evaluate at 9 and 12 months after the end of the second lockdown (July December 2020), post-traumatic stress disorder (PTSD), personal and professional stress, anxiety and depression, burn-out and consumption of anxiolytic products.
This is a multi-center study and includes doctors, DE interns and nurses, other paramedics and medical regulatory assistants working in one of the ED or SAMU working during phase 3 of the COVID-19 pandemic.
It should make it possible to know the psychological load of the months following the epidemic among health professionals who worked in emergencies during this period and to understand their risk of occurrence of PTSD.
These elements are also essential to improve the management of health crises and to put in place preventive measures for health professionals, in particular in anticipation of recurrences, second wave or future new episode.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
71
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Pierre-Bénite, Frankrig, 69310
- Service d'Accueil des Urgences
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Adults
- Administrative and technical medical staff of the Hospices Civils de Lyon
- Contractual or holder
- Having participated in the COVER PRO study
- Working in one of the HCL phase 3 departments of the COVID-19 pandemic.
- Affiliated with a social security system
- Having signed an informed consent
Exclusion Criteria:
- Refusal to participate
- Major under legal protection
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Andet: Follow-up
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PCL-5 autoquestionnaire to make the PTSD diagnosis
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Existence of a Post Traumatic Stress Disorder (PTSD) at 12 months using PTSD Scale
Tidsramme: 12 months after the end of the second Lockdown (December 2020)
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: Existence of a PTSD after the end of the second lockdown using the PCL-5 scale (Post Traumatic Stress Disorder Checklist, 20 items, self-questionnaire) validated in French for PTSD screening.
The presence of a "probable PTSD" will be defined by a cut-off score of 31/80 and at least a positive response to one of the four questions asking if the symptoms were causing difficulties in relations with family, friends, work or in daily life
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12 months after the end of the second Lockdown (December 2020)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Existence of a Post Ttraumatic Stress Disorder (PTSD) 9 months using PTSD Scale
Tidsramme: 9months after the end of the second Lockdown (December 2020)
|
Existence of a PTSD after the end of the second lockdown using the PCL-5 scale (Post Traumatic Stress Disorder Checklist, 20 items, self-questionnaire) validated in French for PTSD screening.
The presence of a "probable PTSD" will be defined by a cut-off score of 31/80 and at least a positive response to one of the four questions asking if the symptoms were causing difficulties in relations with family, friends, work or in daily life
|
9months after the end of the second Lockdown (December 2020)
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Anxiety evaluation at 12 months using HAD scale
Tidsramme: 12months after the end of the second Lockdown (December 2020)
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Existence of anxious symptomatology assessed by the HAD scale.
14 items, cut-off score: 8 suspected disorder, 11: proven disorder
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12months after the end of the second Lockdown (December 2020)
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Anxiety evaluation at 9 months using HAD scale
Tidsramme: 9months after the end of the second Lockdown (December 2020)
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Existence of anxious symptomatology assessed by the HAD scale.
14 items, cut-off score: 8 suspected disorder, 11: proven disorder
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9months after the end of the second Lockdown (December 2020)
|
|
Depression evaluation at 12 months using HAD scale
Tidsramme: 12months after the end of the second Lockdown (December 2020)
|
Existence of depression symptomatology assessed by the HAD scale.
14 items, cut-off score: 8 suspected disorder, 11: proven disorder
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12months after the end of the second Lockdown (December 2020)
|
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Depression evaluation at 9 months using HAD scale
Tidsramme: 9months after the end of the second Lockdown (December 2020)
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Existence of depression symptomatology assessed by the HAD scale.
14 items, cut-off score: 8 suspected disorder, 11: proven disorder
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9months after the end of the second Lockdown (December 2020)
|
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Presence of a Burn out at 12 months using the Maslach Burnot Inventory (MBI) scale
Tidsramme: 12months after the end of the second Lockdown (December 2020)
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Burnout characterized by the Maslach burnout inventory scale.
All MBI items are scored using a 7 level frequency ratings from "never" to "daily."
The MBI has three component scales: emotional exhaustion (9 items), depersonalization (5 items) and personal achievement (8 items).
Each scale measures its own unique dimension of burnout.
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12months after the end of the second Lockdown (December 2020)
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Presence of a Burn out at 9 months using the MBI scale
Tidsramme: 9months after the end of the second Lockdown (December 2020)
|
Burnout characterized by the Maslach burnout inventory scale.
All MBI items are scored using a 7 level frequency ratings from "never" to "daily."
The MBI has three component scales: emotional exhaustion (9 items), depersonalization (5 items) and personal achievement (8 items).
Each scale measures its own unique dimension of burnout.
|
9months after the end of the second Lockdown (December 2020)
|
|
Work-related stress measured using Karasek questionnaire at 12 months
Tidsramme: 12months after the end of the second Lockdown (December 2020)
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Work-related stress measured using Karasek questionnaire at 12 months
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12months after the end of the second Lockdown (December 2020)
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Work-related stress measured using Karasek questionnaire at 9 months
Tidsramme: 9months after the end of the second Lockdown (December 2020)
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Work-related stress measured using Karasek questionnaire at 9 months
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9months after the end of the second Lockdown (December 2020)
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Consumption of psychoactive substances at 12 months
Tidsramme: 12months after the end of the second Lockdown (December 2020)
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Change in the consumption of psychoactive substances at 12 months
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12months after the end of the second Lockdown (December 2020)
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Percentage of patients with psychological Support at 12 months
Tidsramme: 12months after the end of the second Lockdown (December 2020)
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Percentage of patients who benefit from a psychological support at 12 months
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12months after the end of the second Lockdown (December 2020)
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Mean number of days of sick leave at 12 months
Tidsramme: 12months after the end of the second Lockdown (December 2020)
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Mean number of days of sick leave at 12 months
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12months after the end of the second Lockdown (December 2020)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
12. oktober 2021
Primær færdiggørelse (Faktiske)
16. januar 2022
Studieafslutning (Faktiske)
16. januar 2022
Datoer for studieregistrering
Først indsendt
1. september 2021
Først indsendt, der opfyldte QC-kriterier
1. september 2021
Først opslået (Faktiske)
2. september 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. januar 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. januar 2022
Sidst verificeret
1. januar 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Patologiske processer
- Coronavirus infektioner
- Coronaviridae infektioner
- Nidovirales infektioner
- RNA-virusinfektioner
- Virussygdomme
- Infektioner
- Luftvejsinfektioner
- Luftvejssygdomme
- Lungebetændelse, viral
- Lungebetændelse
- Lungesygdomme
- Sygdomsegenskaber
- Traumer og stressor-relaterede lidelser
- COVID-19
- Nødsituationer
- Stresslidelser, traumatiske
- Stresslidelser, posttraumatisk
Andre undersøgelses-id-numre
- 69HCL21_0311
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