Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05461521
Other study ID # RC22_0078
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 15, 2022
Est. completion date July 30, 2024

Study information

Verified date March 2024
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of the present research is to set up a large multicentric, prospective cohort of family members of patients admitted to intensive care. The data collected will concern the patients and their family members, the caregivers and the functioning of the services during the collection period. This cohort will allow: 1. to carry out a quantitative evaluation of post-traumatic stress disorder (PTSD) in a large number of family members, to determine the risk factors in relation to the characteristics of the family members, and to define a predictive model of PTSD in this population 2. to determine the factors related to the operating conditions of the resuscitation services that favor the occurrence of PTSD in the family members, 3. to create a biological bank from blood samples taken from family members, 4. to carry out a qualitative study allowing a psychological and sociological analysis of the experience of the family members concerning the hospitalization in intensive care of their loved one.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1346
Est. completion date July 30, 2024
Est. primary completion date January 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Patients : - =18 years old - Treated in the ICU with invasive mechanical ventilation for 48 hours - Having been visited by at least one family member within 72 hours of the 48th hour of intubation in intensive care - Having been informed of the study and not having objected to the use of their medical medical data prior to discharge from the ICU if they are able to receive the information the information at the time of inclusion or consent of the family member obtained for the inclusion of the patient if the patient is not able to do so at the time of at the time of inclusion Family members : - =18 years old - Identified if possible by the patient as the person to be referred or to be informed, or, in the case of a patient unable to express him/herself, identified by the caregivers as the "patient's close referent". - Understanding and speaking French - Having been informed of the study and having consented to participate in it during a visit of the patient - Inclusion between H48 and H120 post-intubation of the patient in the ICU (if the patient is still intubated at the time of inclusion) - Having given their telephone number - Being covered by a social security plan. - Only one relative of the patient is included in the study Service Professionals: All professionals in all categories and in all participating participating services who have been informed of the study and have consented to participate. Exclusion Criteria: Patients: - No family member or no family member visit - No consent to participate from family member - Organ donation planned or contemplated - Pregnant or parturient woman - Detained or deprived of liberty - Under guardianship or curator - No social security Family members : - Social context making follow-up and telephone interviews difficult (homeless, not residing in Europe or in the DOM) - Inability to give a "stable" personal cell phone number - Under guardianship or curator - Unable to communicate on the phone (hearing impairment...) Service Professionals: - Not on duty (locum tenens or interim team, only on-call) on call) - Not qualified (Physician: at least intern, nurse DE)

Study Design


Intervention

Other:
Family members of patients admitted to the ICU
At inclusion: Collection of demographic data, Anxiety-Depression Scale (HADS), Insomnia Severity Index (ISI), Resilience Insomnia Severity Index (ISI), Resilience Scale (CD RISC 10), Peritraumatic Dissociation Peritraumatic Dissociation Experience Scale (PDEQ) and MEDEC questionnaire. Venous blood sampling at 350 relatives Upon discharge of the patient (alive or deceased): Resuscitation questionnaire, HADS, ISI and PDEQ. 3 months after discharge: Demographic questionnaire, Post Traumatic Stress Disorder questionnaire (PCL-5), THS Past Trauma Experience Questionnaire, HADS experiences, HADS, ISI, CD RISC 10, MEDEC and Who- assist questionnaire (Question 2) on the use of psychoactive substances. 6 months after patient discharge: PCL-5, HADS, ISI, CD RISC 10, MEDEC, Who-assist (Question 2) and Prolonged Grief disorder (PG-13) questionnaire on bereavement if patient died in the ICU.
Health care professionals
All professionals in all categories and in all participating departments will be asked to complete questionnaires to assess the level of conflict, work stress and burn out in the units : Masclach Burnout Inventory (MBI), Job Content Questionnaire (JCQ), Ethical Decision-Making Climate Questionnaire (EDMCQ), Professional Quality Of Life scale (ProQOL), Connor-Davidson Resilience scale (CD-RISC 10), Cultural Awareness Scale (CAS).
Patients
Inclusion (at D3 after admission to the ICU): collection of demographic data Discharge from the ICU: characteristics of the stay and outcome (alive/deceased)

Locations

Country Name City State
France CH Angoulême Angoulême
France Hôpital Privé d'Antony Antony
France CH d'Argenteuil Argenteuil
France CH de Bastia Bastia
France CH Beauvais Beauvais
France Hôpital Nord Franche Comté Belfort
France CH de Béthune Beuvry
France APHP Hôpital Avicenne Bobigny
France CHU de Bordeaux - Hôpital Pellegrin Bordeaux
France CHU de Bordeaux - Hôpital Saint-André Bordeaux
France AP-HP Hôpital Ambroise Paré Boulogne
France CH de Boulogne-sur-Mer Boulogne-sur-Mer
France CHU de Brest Brest
France CH de Chartres Chartres
France CH de Cholet Cholet
France CHU Clermont-Ferrand - Centre Jean Perrin Clermont-Ferrand
France CHU Clermont-Ferrand - Hôpital Gabriel Montpied Clermont-Ferrand
France CH de Dieppe Dieppe
France CHU de Dijon Dijon
France CH de Fréjus - Saint Raphaël Fréjus
France APHP Hôpital Raymond Poincaré Garches
France CHU de Grenoble Alpes Grenoble
France GHEF- Site de Marne de la Vallée Jossigny
France CHD Vendée La Roche-sur-Yon
France CH de la Rochelle La Rochelle
France CH Versailles - Hôpital André Mignot Le Chesnay
France CH du Mans Le Mans
France CHU de Lille - Hôpital Roger Salengro Lille
France GHB Sud - Hôpital de Lorient Lorient
France CHU De Lyon - Hôpital Edouard Herriot Lyon
France AP-HM - Hôpital Nord Marseille
France Hôpital Privé Jacques Cartier Massy
France GHI le Raincy Montfermeil Montfermeil
France CHU de Montpellier - Hôpital Lapeyronie Montpellier
France CHU de Montpellier - Hôpital Saint-Eloi Montpellier
France CHU de Nantes Nantes
France Clinique Ambroise Paré Neuilly-sur-Seine
France CHR d'Orléans Orléans
France APHP Hôpital Cochin Paris
France APHP Hôpital La Pitié Salpêtrière Paris
France APHP Hôpital Saint-Antoine Paris
France APHP Hôpital Saint-Louis Paris
France APHP Hôpital Tenon Paris
France CHI Poissy Poissy
France CH René Dubos Pontoise
France CH de Saint-Lô Saint-Lô
France CH de Saint-Malo Saint-Malo
France CH de Saint-Nazaire Saint-Nazaire
France Hôpital du Pays Salonais Salon-de-Provence
France CH de Bassin de Thau Sète
France Hôpital Foch Suresnes
France CH de Tourcoing - Hôpital Guy Chatiliez Tourcoing
France Ch Bretagne Atlantique - site de Vannes Vannes
France CH de Vichy Vichy
France Institut Gustave Roussy Villejuif
Guadeloupe CHU La Guadeloupe Pointe-à-Pitre France

Sponsors (3)

Lead Sponsor Collaborator
Nantes University Hospital Assistance Publique - Hôpitaux de Paris, Assistance Publique Hopitaux De Marseille

Countries where clinical trial is conducted

France,  Guadeloupe, 

Outcome

Type Measure Description Time frame Safety issue
Other Qualitative study To deepen the understanding of the mechanisms leading to post-traumatic stress disorder in relatives of patients admitted to the ICU
Semi-structured interviews conducted by a psychologist or a sociologist
Population concerned by the interviews:
relatives of non deceased patients (n= 20)
bereaved relatives (patient who died in intensive care) (n= 20)
nurses (n= 20) and intensive care physicians (n= 20).
3 to 4 months after the patient's death or discharge of the patient from the intensive care unit
Other FAME ICU Team (FIT) study to determine the individual and organizational (unit-related) factors associated with the risk of burnout among service professionals, and to identify a possible association between the presence of burnout and the ethical climate in which the professional working in the unit operates burnout and the ethical climate in which the professional working in the resuscitation.
Scales completed by caregivers :
Maslach Burnout Inventory (MBI) for the assessment of burnout
Job Content Questionnaire (JCQ) for the assessment of job stress months").
Ethical Decision-Making Climate Questionnaire (EDMCQ) for the evaluation of the ethical climate
Professional Quality Of Life scale (ProQOL) for the assessment of quality of life at work
Connor-Davidson Resilience scale (CD-RISC 10) to assess resilience
Cultural Awareness Scale (CAS)
at the beginning of the study in the department
Other FAME Bio-bank: Analysis of molecular signatures of PTSD The main objective is to provide a prediction of the risk of PTSD that is as close as possible to to the individuals concerned. to the inclusion
Primary To determine the factors associated with post-traumatic stress disorder (PTSD) in family members of patients admitted to the ICU, and. The primary endpoint is the proportion of family members who developed PTSD 3 months after the patient's discharge from the ICU assessed by the Post-traumatic stress disorder CheckList (PCL-5) version Diagnostic and Statistical Manual of Mental Disorders (DSM-5) scale. This scale consists of 20 items on the symptoms of PTSD according to the DSM-5 criteria. Each item is rated from 0 ("not at all") to 4 ("extremely"). The maximum score is 80. at 3 months after the patient's discharge from the ICU
Primary To define a predictive model of PTSD in this population The primary endpoint is the proportion of family members who developed PTSD 3 months after the patient's discharge from the ICU assessed by the Post-traumatic stress disorder CheckList (PCL-5) version Diagnostic and Statistical Manual of Mental Disorders (DSM-5) scale. This scale consists of 20 items on the symptoms of PTSD according to the DSM-5 criteria. Each item is rated from 0 ("not at all") to 4 ("extremely"). The maximum score is 80. at 3 months after the patient's discharge from the ICU
Secondary Assessing the psychological impact of a family member stay in intensive care Proportion of family members who developed symptoms of anxiety and depression assessed by the Hospital Anxiety and Depression Scale (HADS), at inclusion, at the patient's discharge from the ICU, 3 and 6 months after the patient's discharge from the ICU
Secondary Assessing the psychological impact of a family member stay in intensive care Proportion of family members who developed PTSD 6 months after discharge from the assessed by the PCL-5 scale 6 months after the patient's discharge from the ICU
Secondary Assessing the psychological impact of a family member stay in intensive care Proportion of relatives who developed severe insomnia assessed by the Insomnia Severity Index (ISI) at inclusion, at the patient's discharge from the ICU, 3 and 6 months after the patient's discharge from the ICU
Secondary Assessing the psychological impact of a family member stay in intensive care Proportion of resilient relatives assessed by Resilience Scale (CD RISC 10) at inclusion, at the patient's discharge from the ICU, 3 and 6 months after the patient's discharge from the ICU
Secondary Assessing the psychological impact of a family member stay in intensive care Proportion of relatives who developed peri-traumatic dissociation experiences (PDEQ) at inclusion, at the patient's discharge from the ICU, 3 and 6 months after the patient's discharge from the ICU
Secondary Assessing the psychological impact of a family member stay in intensive care Proportion of relatives who developed prolonged grief assessed by the Prolonged Grief disorder (PG-13) questionnaire at 6 months after the patient's death in intensive care
Secondary To identify the impact on the consumption of care and medical procedures of PTSD in family members of patients admitted to the ICU Proportion of relatives who used psychoactive substances assessed by the Who-assist questionnaire (Question 2 of the questionnaire), Consumption of care and medical procedures by relatives (MEDEC questionnaire at 3 and 6 months after discharge of the patient from the intensive care unit
See also
  Status Clinical Trial Phase
Recruiting NCT05620381 - Health and Sleep Assessment After the Strasbourg Attacks of December 11, 2018
Completed NCT02856412 - Improving Mind/Body Health and Functioning With Integrative Exercise N/A
Recruiting NCT05400200 - PTSD and Self-regulation: Coping, Emotional Regulation and Cognitive Control and Their Relationships to Symptom Management N/A
Not yet recruiting NCT06088303 - Enhancing PTSD Treatment Outcomes by Improving Patient-Provider Communication N/A
Not yet recruiting NCT03652922 - Propranolol Reactivation Mismatch (PRM) Treatment for PTSD Phase 4
Completed NCT02875912 - Prospective Evaluation of Family Care Rituals in the ICU N/A
Completed NCT01589575 - Anxiety and Depression in Relatives of Critically Ill Patients: Spouses Versus Other Close Relatives N/A
Completed NCT00990106 - Augmentation Trial of Prazosin for Post-Traumatic Stress Disorder (PTSD) N/A
Completed NCT01291368 - Sedation Influence on Delirium and Post-traumatic Stress-disorder as a Result of Hospitalization in Intensive Care N/A
Active, not recruiting NCT00657787 - Development of a Post-Traumatic Stress Disorder (PTSD) Population Registry for Veterans
Completed NCT00880152 - Mindfulness Based Stress Reduction for Posttraumatic Stress Disorder: A Pilot Study N/A
Completed NCT00835627 - Treatment Trial for Psychogenic Nonepileptic Seizures Phase 4
Completed NCT01365247 - Concurrent Treatment for Substance Dependent Individuals With Post-Traumatic Stress Disorder (PTSD) N/A
Completed NCT00419029 - Motivational Interviewing to Engage Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans in Mental Health Treatment N/A
Completed NCT00514956 - Effect of Emotional Freedom Technique and Diaphragmatic Breathing on Post Traumatic Stress Disorder (PTSD) Phase 1
Completed NCT00333710 - Evaluating a Telehealth Treatment for Veterans With Hepatitis C and PTSD N/A
Completed NCT01120847 - Post Traumatic Stress Disorder (PTSD), Sleep Disordered Breathing And Genetics: Effects On Cognition
Completed NCT00069225 - Brain Structure and Function Before and After Treatment for Post-Traumatic Stress Disorder N/A
Completed NCT00055354 - Acupuncture for the Treatment of Post-Traumatic Stress Disorder (PTSD) N/A
Completed NCT00186212 - Alternative Support for Rural and Isolated Women in an HMO Phase 3