Diary for Severe Trauma (Qualitrau)
Primary Purpose
Post-traumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Diary
Sponsored by
About this trial
This is an interventional prevention trial for Post-traumatic Stress Disorder focused on measuring Quality of life, post-traumatic stress disorder, trauma
Eligibility Criteria
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
Sites / Locations
- Département d'Anesthésie-Réanimation Groupe Hospitalier Pitié Salpêtrière
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Diary
Without Diary
Arm Description
Use of diary
Outcomes
Primary Outcome Measures
Quality of life
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).
Secondary Outcome Measures
post-traumatic stress disorder (PTSD)
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
predictive factors of decrease in QoL after severe 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
patients' expectations
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)
Full Information
NCT ID
NCT02305303
First Posted
September 9, 2014
Last Updated
October 18, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT02305303
Brief Title
Diary for Severe Trauma
Acronym
Qualitrau
Official Title
Impact of an Intensive Care Unit Diary on Long-term Quality of Life After Severe Trauma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
November 9, 2014 (Actual)
Primary Completion Date
November 8, 2017 (Actual)
Study Completion Date
November 8, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Treatment of severe trauma patients includes intensive cares. Both trauma and intensive care may lead to a post-traumatic stress disorder and then to a decreased quality of life. Diaries may improve the frequency and the intensity of PTSD. Aim of investigator is to assess if diaries may improve quality of life after a severe trauma.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorder
Keywords
Quality of life, post-traumatic stress disorder, trauma
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
226 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diary
Arm Type
Experimental
Arm Description
Use of diary
Arm Title
Without Diary
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Diary
Intervention Description
A diary written prospectively during the ICU stay by the staff and relatives
Primary Outcome Measure Information:
Title
Quality of life
Description
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).
Time Frame
12 months after the trauma
Secondary Outcome Measure Information:
Title
post-traumatic stress disorder (PTSD)
Description
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
Time Frame
12 months after the trauma
Title
predictive factors of decrease in QoL after severe trauma
Description
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
Time Frame
12 months after the trauma
Title
patients' expectations
Description
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)
Time Frame
12 months after the trauma
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Benazzour, Nurse
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Département d'Anesthésie-Réanimation Groupe Hospitalier Pitié Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
Learn more about this trial
Diary for Severe Trauma
We'll reach out to this number within 24 hrs