- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02305303
Diary for Severe Trauma (Qualitrau)
Impact of an Intensive Care Unit Diary on Long-term Quality of Life After Severe Trauma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Trauma is the third cause of death in France and the first cause of death of people under 40 years (48 000 deaths a year).
Severe trauma defined by an Injury Severity Score ( ISS) > 15 implies intensive care.
Intensive care unit admission induces considerable psychological distress and memory troubles, both promoting posttraumatic stress disorder (PTSD) and symptoms of anxiety and depression. A diary written prospectively during the ICU stay by the staff and relatives has been suggested as a means of help¬ing patients to build a more detailed and factual narrative of their ICU stay than would be possible based only on their fragmented memories. Garrouste et al. have shown that the intensive care unit diary significantly affected posttraumatic stress disorders in surviving patients 12 months after intensive care unit discharge.
Besides, severe trauma by itself may decrease the quality of life (QoL). It is recommended to assess QoL on one year after the trauma. In trauma patients, the change in QoL is associated with the presence of a PTSD.
Consequently, severe trauma patients who undergo a double stress, that of the accident and that of the intensive care unit stay: they may so even more have a decrease of their QoL by developing a PSTD.
The investigator formulate the hypothesis that a diary, written by the staff and relatives from the very acute phase of the ICU stay (first 48 hours) to the discharge of ICU would improve the QoL and would decrease the frequency and the intensity of PTSD of the severe trauma patients one year after the trauma.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75013
- Département d'Anesthésie-Réanimation Groupe Hospitalier Pitié Salpêtrière
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- all patients over 18
- with severe trauma (Injury Severity Score (ISS) > 15)
- admitted in our trauma centered and hospitalized in intensive care unit for more than 48 h
Exclusion Criteria:
- non-French language fluent patients
- Patients with dementia
- Hospitalization in intensive care unit less than
- opposition to data utilization
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Diary
Use of diary
|
A diary written prospectively during the ICU stay by the staff and relatives
|
No Intervention: Without Diary
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life
Time Frame: 12 months after the trauma
|
To assess the quality of life (QoL), investigator will use the WHO Quality of Life questionnaire Brief Version (WHOQOL- Bref) in its french-language version.
exploring four dimensions (physical, psychological, social and environmental).
|
12 months after the trauma
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
post-traumatic stress disorder (PTSD)
Time Frame: 12 months after the trauma
|
To assess the frequency and the intensity of PTSD, investigator will use the Impact of Events Scale-revised questionnaire (IES-R), a valid and reliable 22-item screening tool that assesses symptoms of intrusion, avoid-ance, and hyperarousal
|
12 months after the trauma
|
predictive factors of decrease in QoL after severe trauma
Time Frame: 12 months after the trauma
|
At the admission, investigator will notice trauma data.
Plus, the investigator will ask the conscious patient or his/her next of kin about sociodemographic, professional characteristics at the admission and 12 months after the trauma
|
12 months after the trauma
|
patients' expectations
Time Frame: 12 months after the trauma
|
Conduction of a quality study through a semi-open questionary about the care during and after the intensive care unit stay and about the diary (experimental group only)
|
12 months after the trauma
|
Collaborators and Investigators
Investigators
- Principal Investigator: Marie Benazzour, Nurse, Assistance Publique - Hôpitaux de Paris
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- K131202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Post-traumatic Stress Disorder
-
University of California, Los AngelesDefense Advanced Research Projects Agency; Defense Group, Inc.CompletedPost-traumatic Stress Disorder | Post-Traumatic Stress Disorder, ChronicUnited States
-
Weill Medical College of Cornell UniversityCompletedPost-traumatic Stress Disorder | Complex Post-Traumatic Stress DisorderUnited States
-
University of California, Los AngelesRecruitingPost-traumatic Stress Disorder | Post-Traumatic Stress Disorder in ChildrenUnited States
-
University of UtahEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedPost-Traumatic Stress Disorder in Children | Post-Traumatic Stress Disorder in AdolescenceUnited States
-
University of ZurichCompletedPost Traumatic Stress Disorder (PTSD) | Complex Post-Traumatic Stress Disorder (CPTSD)Switzerland
-
University of NottinghamNottinghamshire Healthcare NHS Trust; Lincolnshire Partnership NHS Foundation...CompletedDomestic Violence | Trauma, Psychological | Post-Traumatic Stress Disorder in Children | Narrative Exposure Therapy | Post-Traumatic Stress Disorder in Adolescence | Post-Traumatic Stress Disorder ComplexUnited Kingdom
-
University Hospital, LilleNot yet recruiting
-
Steinn SteingrimssonRecruiting
-
Direction Centrale du Service de Santé des ArméesRecruitingPost-traumatic Stress DisorderFrance
-
VA Greater Los Angeles Healthcare SystemUniversity of California, Los AngelesRecruitingPost-Traumatic Stress DisorderUnited States
Clinical Trials on Diary
-
Michigan State UniversityKenyan Diabetes Management & Information Centre (DMI)CompletedType 1 DiabetesKenya
-
Augusta UniversityRecruitingConstipation | Diarrhea | Bloating | Distension | GasUnited States
-
Unidade Local de Saúde de Matosinhos, EPERecruitingMigraine Disorders | Episodic MigrainePortugal
-
Augusta UniversityRecruiting
-
Yeditepe UniversityBahçeşehir UniversityCompleted
-
Universiteit AntwerpenRecruitingOveractive Bladder | Lower Urinary Tract Symptoms | Enuresis | Voiding DisordersBelgium
-
Istituto Scientifico Romagnolo per lo Studio e...RecruitingCancer | Solid Tumor | Hematologic Malignancy | Oral Drug AdministrationItaly
-
IRCCS Ospedale San RaffaeleNot yet recruitingStress | Depression, Postpartum | Experience, Life | Support, FamilyItaly
-
Hospitalsenheden VestUniversity of AarhusCompletedDepression | Stress Disorders, Post-Traumatic | AnxietyDenmark
-
Massachusetts General HospitalTerminatedAcute Injury of Upper Extremity