An interventional study of PREMREA program in PTSD - Post Traumatic Stress Disorder, sponsored by Almaviva Sante. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Almaviva Sante · Not applicable, Interventional, and Health services research
Hospitalisation in intensive care is always traumatic and can lead to a long rehabilitation process, slowed down by symptoms of anxiety and/or depression, and/or post-traumatic stress disorder (PTSD). These psychiatric disorders, or post-intensive care syndrome (PICS), can persist for several years after hospitalisation in intensive care and cause functional disability. They are associated with the use of psychotropic drugs and mental health services, and impair health-related quality of life.
This research is based on the hypothesis that the traumatic nature of intensive care hospitalisation can be reduced by implementing programmes to improve intensive care hospitalisation conditions, promoting changes in the practices of all healthcare professionals involved in intensive care.
IPREA3 study (Kalfon et al, 2017) demonstrated that implementation of a tailor-made, multi-component programme, led by a doctor/non-medical caregiver significantly reduced the overall discomfort score (derived from the IPREA questionnaire) perceived by patients hospitalised in an intensive care unit with sufficient experience in applying this programme, having used it for at least 5 months (Kalfon et al, 2017) .
The originality and interest of this research, in comparison with the IPREA3 study, lie in the following aspects:
Hospitalisation in intensive care is always traumatic and can lead to a long rehabilitation process, slowed down by symptoms of anxiety and/or depression, and/or post-traumatic stress disorder (PTSD). These psychiatric disorders, or post-intensive care syndrome (PICS), can persist for several years after hospitalisation in intensive care and cause functional disability. They are associated with the use of psychotropic drugs and mental health services, and impair health-related quality of life.
This research is based on the hypothesis that the traumatic nature of intensive care hospitalisation can be reduced by implementing programmes to improve intensive care hospitalisation conditions, promoting changes in the practices of all healthcare professionals involved in intensive care.
IPREA3 study (Kalfon et al, 2017) demonstrated that implementation of a tailor-made, multi-component programme, led by a doctor/non-medical caregiver duo and based on:
The originality and interest of this research, in comparison with the IPREA3 study, lie in the following aspects:
200 studies on the registry are indexed under Combat Disorders; 90 are open to participants now.
This study's planned enrollment of 1,242 is above the median of 72 across 167 interventional studies indexed under Combat Disorders.
Browse Combat Disorders studies →Almaviva Sante is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in this arm will benefit from measures taken from PREMREA program
Other: PREMREA program
Patients in this arm do not benefit from measures taken from PREMREA program
PREMREA is a tailor-made, multi-component program led by a doctor/non-medical caregiver duo, consisting of the following elements: * Systematic completion of the 18-item IPREA questionnaire by the patient on the day of discharge. * Monthly feedback to all intensive care staff presenting the monthly results of the department and other participating departments, led by the doctor/non-medical caregiver duo. * Implementation of specific measures in the department, decided collectively and coordinated by the doctor/non-medical caregiver duo, and monitoring of these measures.
Overall discomfort score
Overall discomfort score is obtained from the 18-item IPREA questionnaire. It consists of 18 pre-established items describing the most common sources of discomfort in intensive care : noise, excessive light, discomfort related to unfamiliar bedding, lack of sleep, thirst, hunger, cold, heat, pain, restriction of autonomy due to cables and infusion lines, lack of privacy, anxiety, isolation, limited visits from loved ones, lack of a telephone, insufficient information about current health status, difficulty breathing, depression (Baumstarck et al, 2019). For each of the 18 discomfort items, the patient gives a score between 0 (no discomfort at all) and 10 (maximum discomfort imaginable). The overall discomfort score is calculated as the average of the 18 discomfort scores multiplied by 10, resulting in a score between 0 and 100
Time frame: 3 months
Plan to share: No
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