Stress Disorders, Post-TraumaticFAMENCT05461521
Improving FAMily Members' Experience in the ICU
An observational study of Stress Disorders, Post-Traumatic and Family Members, run by Nantes University Hospital at 56 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Family Members
- What is being tested?
- Family members of patients admitted to the ICU, Health care professionals and Patients
- How many people
- 1,346 participants
- Where
- 56 sitesin 2 countries
- Study dates
- 15 Dec 2022to 13 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Family members : 1346 family members of 1346 patients admitted to the ICU and treated with invasive mechanical ventilation will be included in the research. Only one person among the patient's family members will be concerned by the study. The inclusion window will be 72 hours, starting from the 48th hour after the patient's intubation in the ICU and ending at the 120th hour after intubation. Patients: 1346 patients treated with invasive mechanical ventilation will be included in this research. Information about the study will be given to the patient at the same time as to the family member if the patient is conscious, or as soon he is able to receive the information. Caregivers: All professionals in all categories and in all participating departments will be asked to complete questionnaires to assess the level of stress and burn out in the units. Participation in the study will be participation in the study will be offered to them at the beginning of the study in the department.
Who may be able to join
- 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 :
Show all 14Show fewer
- ≥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.
Who cannot join
- 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
Show all 16Show fewer
- 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)
Trial locations and contacts
56 sites in 2 countries.
56 sites in 2 countries
France55 sites
CH Angoulême
Angoulême, France, 16000
Hôpital Privé d'Antony
Antony, France, 92160
CH d'Argenteuil
Argenteuil, France, 95100
CH de Bastia
Bastia, France, 20600
CH Beauvais
Beauvais, France, 60000
Hôpital Nord Franche Comté
Belfort, France, 90015
CH de Béthune
Beuvry, France, 62660
APHP Hôpital Avicenne
Bobigny, France, 9300
CHU de Bordeaux - Hôpital Saint-André
Bordeaux, France, 33000
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, France, 33076
AP-HP Hôpital Ambroise Paré
Boulogne, France, 92104
CH de Boulogne-sur-Mer
Boulogne-sur-Mer, France, 62231
CHU de Brest
Brest, France, 29609
CH de Chartres
Chartres, France, 28000
CH de Cholet
Cholet, France, 49300
CHU Clermont-Ferrand - Centre Jean Perrin
Clermont-Ferrand, France, 63000
CHU Clermont-Ferrand - Hôpital Gabriel Montpied
Clermont-Ferrand, France, 63003
CH de Dieppe
Dieppe, France, 76200
CHU de Dijon
Dijon, France, 21033
CH de Fréjus - Saint Raphaël
Fréjus, France, 83608
APHP Hôpital Raymond Poincaré
Garches, France, 92380
CHU de Grenoble Alpes
Grenoble, France, 38043
GHEF- Site de Marne de la Vallée
Jossigny, France, 77600
CHD Vendée
La Roche-sur-Yon, France, 85000
CH de la Rochelle
La Rochelle, France, 17019
CH Versailles - Hôpital André Mignot
Le Chesnay, France, 78150
CH du Mans
Le Mans, France, 72000
CHU de Lille - Hôpital Roger Salengro
Lille, France, 59045
GHB Sud - Hôpital de Lorient
Lorient, France, 56322
CHU De Lyon - Hôpital Edouard Herriot
Lyon, France, 69437
AP-HM - Hôpital Nord
Marseille, France, 13915
Hôpital Privé Jacques Cartier
Massy, France, 91300
GHI le Raincy Montfermeil
Montfermeil, France, 93370
CHU de Montpellier - Hôpital Lapeyronie
Montpellier, France, 34295
CHU de Montpellier - Hôpital Saint-Eloi
Montpellier, France, 34295
CHU de Nantes
Nantes, France, 44000
Clinique Ambroise Paré
Neuilly-sur-Seine, France, 45100
CHR d'Orléans
Orléans, France, 45100
APHP Hôpital Saint-Louis
Paris, France, 75010
APHP Hôpital Cochin
Paris, France, 75013
APHP Hôpital La Pitié Salpêtrière
Paris, France, 75013
APHP Hôpital Tenon
Paris, France, 75020
APHP Hôpital Saint-Antoine
Paris, France, 75571
CHI Poissy
Poissy, France, 78300
CH René Dubos
Pontoise, France, 95300
CH de Saint-Lô
Saint-Lô, France, 50000
CH de Saint-Nazaire
Saint-Nazaire, France, 44600
Hôpital du Pays Salonais
Salon-de-Provence, France, 13300
CH de Bassin de Thau
Sète, France, 34200
CH de Saint-Malo
St-Malo, France, 35403
Hôpital Foch
Suresnes, France, 92150
CH de Tourcoing - Hôpital Guy Chatiliez
Tourcoing, France, 59208
Ch Bretagne Atlantique - site de Vannes
Vannes, France, 59300
CH de Vichy
Vichy, France, 03200
Institut Gustave Roussy
Villejuif, France, 94805
About this study
Official title: Post-traumatic Stress Disorder in Relatives of Patients Admitted to the ICU: a Multicenter, Observational, Prospective Study (FAME Observational)
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:
- 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
- to determine the factors related to the operating conditions of the resuscitation services that favor the occurrence of PTSD in the family members,
- to create a biological bank from blood samples taken from family members,
- 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.
- Conditions
- Stress Disorders, Post-Traumatic, Family Members
- Being tested
- Family members of patients admitted to the ICU, Health care professionals, Patients
- Keywords
- Family Members of a Patient Hospitalized in Intensive Care
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family members of patients admitted to the ICUOther
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 professionalsOther
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).
PatientsOther
Inclusion (at D3 after admission to the ICU): collection of demographic data Discharge from the ICU: characteristics of the stay and outcome (alive/deceased)
| Study group | Role | What they receive |
|---|---|---|
| Family members of patients admitted to the ICU | Not described Receives: Other: Family members of patients admitted to the ICU | |
| Health care professionals | Not described Receives: Other: Health care professionals | |
| Patients | Not described Receives: Other: Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 3 months after the patient's discharge from the ICU
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.
Measured: at 3 months after the patient's discharge from the ICU
Secondary outcomes (7)
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),
Measured: at inclusion, at the patient's discharge from the ICU, 3 and 6 months after the patient's discharge from the ICU
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
Measured: 6 months after the patient's discharge from the ICU
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)
Measured: at inclusion, at the patient's discharge from the ICU, 3 and 6 months after the patient's discharge from the ICU
Assessing the psychological impact of a family member stay in intensive care
Proportion of resilient relatives assessed by Resilience Scale (CD RISC 10)
Measured: at inclusion, at the patient's discharge from the ICU, 3 and 6 months after the patient's discharge from the ICU
Assessing the psychological impact of a family member stay in intensive care
Proportion of relatives who developed peri-traumatic dissociation experiences (PDEQ)
Measured: at inclusion, at the patient's discharge from the ICU, 3 and 6 months after the patient's discharge from the ICU
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
Measured: at 6 months after the patient's death in intensive care
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
Measured: at 3 and 6 months after discharge of the patient from the intensive care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start15 Dec 2022
- Primary completion30 Jan 2024
- Study completion13 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,346 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris, Assistance Publique Hopitaux De Marseille
- Responsible party
- Sponsor
- Investigators
- Jean REIGNIER, PU-PH, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461521
- Sponsor's protocol ID
- RC22_0078
- Acronym
- FAME
- Status last verified
- Sep 2024
- First submitted
- 4 Jul 2022
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-traumatic Stress Disorder in Relatives of Patients Admitted to the ICU: a Multicenter, Observational, Prospective Study (FAME Observational)
- ClinicalTrials.gov ID
- NCT05461521
- Acronym / sponsor ID
- FAME / RC22_0078
- Conditions
- Stress Disorders, Post-Traumatic, Family Members
- Keywords
- Family Members of a Patient Hospitalized in Intensive Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,346 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris, Assistance Publique Hopitaux De Marseille
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 13 Sep 2024 (actual)
- First posted
- 18 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- to determine the factors related to the operating conditions of the resuscitation services that favor the occurrence of PTSD in the family members,
- to create a biological bank from blood samples taken from family members,
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Family members of patients admitted to the ICU | – | Other: Family members of patients admitted to the ICU |
| Health care professionals | – | Other: Health care professionals |
| Patients | – | Other: Patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Family members : 1346 family members of 1346 patients admitted to the ICU and treated with invasive mechanical ventilation will be included in the research. Only one person among the patient's family members will be concerned by the study. The inclusion window will be 72 hours, starting from the 48th hour after the patient's intubation in the ICU and ending at the 120th hour after intubation. Patients: 1346 patients treated with invasive mechanical ventilation will be included in this research. Information about the study will be given to the patient at the same time as to the family member if the patient is conscious, or as soon he is able to receive the information. Caregivers: All professionals in all categories and in all participating departments will be asked to complete questionnaires to assess the level of stress and burn out in the units. Participation in the study will be participation in the study will be offered to them at the beginning of the study in the department.
Key inclusion criteria (14 listed)
- ≥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
- ≥18 years old
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family members of patients admitted to the ICUAt 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. | Other | Family members of patients admitted to the ICU |
| Health care professionalsAll 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). | Other | Health care professionals |
| PatientsInclusion (at D3 after admission to the ICU): collection of demographic data Discharge from the ICU: characteristics of the stay and outcome (alive/deceased) | Other | Patients |
Primary outcome
To determine the factors associated with post-traumatic stress disorder (PTSD) in family members of patients admitted to the ICU, and.
Time frame: at 3 months after the patient's discharge from the ICU
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.
To define a predictive model of PTSD in this population
Time frame: at 3 months after the patient's discharge from the ICU
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.
7 secondary outcomes
Assessing the psychological impact of a family member stay in intensive care
Time frame: at inclusion, at the patient's discharge from the ICU, 3 and 6 months after the patient's discharge from the ICU
Assessing the psychological impact of a family member stay in intensive care
Time frame: 6 months after the patient's discharge from the ICU
Assessing the psychological impact of a family member stay in intensive care
Time frame: at inclusion, at the patient's discharge from the ICU, 3 and 6 months after the patient's discharge from the ICU
Assessing the psychological impact of a family member stay in intensive care
Time frame: at inclusion, at the patient's discharge from the ICU, 3 and 6 months after the patient's discharge from the ICU
Assessing the psychological impact of a family member stay in intensive care
Time frame: at inclusion, at the patient's discharge from the ICU, 3 and 6 months after the patient's discharge from the ICU
Assessing the psychological impact of a family member stay in intensive care
Time frame: at 6 months after the patient's death in intensive care
To identify the impact on the consumption of care and medical procedures of PTSD in family members of patients admitted to the ICU
Time frame: at 3 and 6 months after discharge of the patient from the intensive care unit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean REIGNIER, PU-PH principal investigator
Nantes University Hospital
56 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Disorders, Post-Traumatic and Family Members, run by Nantes University Hospital at 56 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in France, Guadeloupe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the factors associated with post-traumatic stress disorder (PTSD) in family members of patients admitted to the ICU, and. (time frame: at 3 months after the patient's discharge from the ICU). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.