Post-traumatic Stress DisorderQualitrauNCT02305303
Diary for Severe Trauma
A study testing Diary in people with Post-traumatic Stress Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-traumatic Stress Disorder
- What is being tested?
- Diary
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteFrance
- Study dates
- 9 Nov 2014to 8 Nov 2017
- Phase
- Interventional
- 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
Who may be able to join
- 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
Who cannot join
- non-French language fluent patients
- Patients with dementia
- Hospitalization in intensive care unit less than
- opposition to data utilization
Trial locations and contacts
1 site in 1 country.
France1 site
Département d'Anesthésie-Réanimation Groupe Hospitalier Pitié Salpêtrière
Paris, 75013
About this study
Official title: Impact of an Intensive Care Unit Diary on Long-term Quality of Life After Severe Trauma
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.
Read the 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.
- Conditions
- Post-traumatic Stress Disorder
- Being tested
- Diary
- Keywords
- Quality of life, post-traumatic stress disorder, trauma
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiaryProcedure or surgery
A diary written prospectively during the ICU stay by the staff and relatives
| Study group | Role | What they receive |
|---|---|---|
| Diary | Experimental | Use of diary Receives: Procedure: Diary |
| Without Diary | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months after the trauma
Secondary outcomes (3)
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
Measured: 12 months after the trauma
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
Measured: 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)
Measured: 12 months after the trauma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study start9 Nov 2014
- Primary completion8 Nov 2017
- Study completion8 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie Benazzour, Nurse, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02305303
- Sponsor's protocol ID
- K131202
- Acronym
- Qualitrau
- Status last verified
- Oct 2021
- First submitted
- 9 Sep 2014
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Intensive Care Unit Diary on Long-term Quality of Life After Severe Trauma
- ClinicalTrials.gov ID
- NCT02305303
- Acronym / sponsor ID
- Qualitrau / K131202
- Conditions
- Post-traumatic Stress Disorder
- Keywords
- Quality of life, post-traumatic stress disorder, trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 9 Nov 2014 (actual)
- Primary completion
- 8 Nov 2017 (actual)
- Study completion
- 8 Nov 2017 (actual)
- First posted
- 2 Dec 2014 (estimated)
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diary | Experimental | Procedure: DiaryUse of diary |
| Without Diary | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- non-French language fluent patients
- Patients with dementia
- Hospitalization in intensive care unit less than
- opposition to data utilization
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 |
|---|---|---|
| DiaryA diary written prospectively during the ICU stay by the staff and relatives | Procedure or surgery | Diary |
Primary outcome
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).
3 secondary outcomes
post-traumatic stress disorder (PTSD)
Time frame: 12 months after the trauma
predictive factors of decrease in QoL after severe trauma
Time frame: 12 months after the trauma
patients' expectations
Time frame: 12 months after the trauma
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 26 Oct 2021.
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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.
Marie Benazzour, Nurse principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diary in people with Post-traumatic Stress Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 3 inclusion and 4 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 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Quality of life (time frame: 12 months after the trauma). 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 26 Oct 2021.