Stress Disorders Post TraumaticICU-diaryNCT02519725
Impact of an ICU Diary on the Well-being of Patients and Families. A Prospective Multicenter Mixed Study
A study testing ICU diary in people with Stress Disorders Post Traumatic, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
The purpose of this study is to assess the influence of an ICU diary implemented during the ICU stay on the psychological well-being of patients and families after ICU discharge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Disorders Post Traumatic
- What is being tested?
- ICU diary
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 715 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jun 2015to 9 Aug 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
- Patients with his family admitted in an ICU and mechanically ventilated more than 48 hours
Who cannot join
- Patients without families admitted in an ICU and mechanically ventilated more than 48 hours
- Patients or families not fluent in French
- Patients moribund
- Patients with a neurologic or psychiatric disease responsible for admission or pre-existing before the ICU admission
- Patients admitted after a cardiac arrest
- Deaf and mute patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ICU Diaries Impact of an ICU Diary on the Psychological Well-being of the Patients and Their Relatives. Mixed Multicenter Randomized Study With Blind Evaluation
The purpose of this study is to assess the influence of an ICU diary implemented during the ICU stay on the psychological well-being of patients and families after ICU discharge.
Read the detailed description
Implementation of an ICU diary in a randomized design in 36 ICUs in France The ICU diary contains entries from staff and families or relatives
Quantitative description of psychological well-being of the patients and families or relatives are evaluated 3 months after ICU discharge
Qualitative evaluation of how the patient uses the diary is scheduled by a phone interview 6 months after ICU discharge.
An amendment of the ethic committee permitted to increase in 2016/02 both the number of eligible patients to 700 and the number of centers.
- Conditions
- Stress Disorders Post Traumatic
- Being tested
- ICU diary
- Keywords
- Family, PTSD, Anxiety disorders, Depression disorders, Qualitative research
- Medical subject headings
- Combat Disorders, Stress Disorders, Post-Traumatic, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICU diaryOther
The intervention is the elaboration of an ICU diary by caregivers and families The first pages of the diary is standardized to include an explanation of the purpose of the diary. The diary is maintained by the family and ICU staff. The only instruction given to the families and staff members about diary entries is to refrain from writing about confidential matters that could not be shared among the patients, the staff and the relatives. Staff members are free to express compassion and their hope, or absence thereof, that the patient would recover. Relatives can speak freely with the patients without receiving guidance from the ICU staff. At the minimum, the ICU staff write a brief entry at each weekly staff meeting. For patients discharged to wards and if he can receive the diary, the diary is given to the patient. If the patient died, the diary is given to the family.
| Study group | Role | What they receive |
|---|---|---|
| With diary | Active comparator | a ICU diary is open by staff for the patient and his relatives during the ICU stay Receives: Other: ICU diary |
| Without diary | No intervention | No diary is open during the ICU stay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post traumatic stress disorder symptoms in patients
IES-R score > 22
Measured: 3 months after ICU discharge as measured by the Impact Evaluation Scale-Revised questionaire
Secondary outcomes (4)
Post traumatic stress disorder symptoms in families
IES-R score > 22
Measured: 3 months after ICU discharge as measured by the Impact Evaluation Scale-Revised questionaire
Anxiety and depression related symptoms in patients
HADS score > 8
Measured: 3 months after ICU discharge as measured by the Hospital Anxiety and Depression Scale
Anxiety and depression related symptoms in families
HADS score > 8
Measured: 3 months after ICU discharge as measured by the Hospital Anxiety and Depression Scale
Recollection of the memories of the ICU stay by the patient
questionnaire ICU tool
Measured: 3 months after ICU discharge as measured by the memory tool questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2015 (estimated)
- Study start11 Jun 2015
- Primary completion2 Feb 2017
- Study completion9 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 715 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de France
- Responsible party
- Sponsor
- Investigators
- Maité Garrouste-Orgeas, MD, Principal investigator, GHPSJoseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02519725
- Sponsor's protocol ID
- ICU DIARY
- Acronym
- ICU-diary
- Status last verified
- Jun 2016
- First submitted
- 13 Jul 2015
- Last updated
- 12 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Flahault C, Vioulac C, Fasse L, Bailly S, Timsit JF, Garrouste-Orgeas M. "A story with gaps": An interpretative phenomenological analysis of ICU survivors' experience. PLoS One. 2022 Mar 3;17(3):e0264310. doi: 10.1371/journal.pone.0264310. eCollection 2022.
PubMed 35239692Garrouste-Orgeas M, Flahault C, Vinatier I, Rigaud JP, Thieulot-Rolin N, Mercier E, Rouget A, Grand H, Lesieur O, Tamion F, Hamidfar R, Renault A, Parmentier-Decrucq E, Monseau Y, Argaud L, Bretonniere C, Lautrette A, Badie J, Boulet E, Floccard B, Forceville X, Kipnis E, Soufir L, Valade S, Bige N, Gaffinel A, Hamzaoui O, Simon G, Thirion M, Bouadma L, Large A, Mira JP, Amdjar-Badidi N, Jourdain M, Jost PH, Maxime V, Santoli F, Ruckly S, Vioulac C, Leborgne MA, Bellalou L, Fasse L, Misset B, Bailly S, Timsit JF. Effect of an ICU Diary on Posttraumatic Stress Disorder Symptoms Among Patients Receiving Mechanical Ventilation: A Randomized Clinical Trial. JAMA. 2019 Jul 16;322(3):229-239. doi: 10.1001/jama.2019.9058.
PubMed 31310299Garrouste-Orgeas M, Flahault C, Fasse L, Ruckly S, Amdjar-Badidi N, Argaud L, Badie J, Bazire A, Bige N, Boulet E, Bouadma L, Bretonniere C, Floccard B, Gaffinel A, de Forceville X, Grand H, Halidfar R, Hamzaoui O, Jourdain M, Jost PH, Kipnis E, Large A, Lautrette A, Lesieur O, Maxime V, Mercier E, Mira JP, Monseau Y, Parmentier-Decrucq E, Rigaud JP, Rouget A, Santoli F, Simon G, Tamion F, Thieulot-Rolin N, Thirion M, Valade S, Vinatier I, Vioulac C, Bailly S, Timsit JF. The ICU-Diary study: prospective, multicenter comparative study of the impact of an ICU diary on the wellbeing of patients and families in French ICUs. Trials. 2017 Nov 15;18(1):542. doi: 10.1186/s13063-017-2283-y.
PubMed 29141694
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICU Diaries Impact of an ICU Diary on the Psychological Well-being of the Patients and Their Relatives. Mixed Multicenter Randomized Study With Blind Evaluation
- ClinicalTrials.gov ID
- NCT02519725
- Acronym / sponsor ID
- ICU-diary / ICU DIARY
- Conditions
- Stress Disorders Post Traumatic
- Keywords
- Family, PTSD, Anxiety disorders, Depression disorders, Qualitative research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 715 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Collaborators
- Fondation de France
- Study start
- 11 Jun 2015 (actual)
- Primary completion
- 2 Feb 2017 (actual)
- Study completion
- 9 Aug 2017 (actual)
- First posted
- 11 Aug 2015 (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.
The purpose of this study is to assess the influence of an ICU diary implemented during the ICU stay on the psychological well-being of patients and families after ICU discharge.
Detailed description
Implementation of an ICU diary in a randomized design in 36 ICUs in France The ICU diary contains entries from staff and families or relatives
Quantitative description of psychological well-being of the patients and families or relatives are evaluated 3 months after ICU discharge
Qualitative evaluation of how the patient uses the diary is scheduled by a phone interview 6 months after ICU discharge.
An amendment of the ethic committee permitted to increase in 2016/02 both the number of eligible patients to 700 and the number of centers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With diary | Active comparator | Other: ICU diarya ICU diary is open by staff for the patient and his relatives during the ICU stay |
| Without diary | No intervention | –No diary is open during the ICU stay |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with his family admitted in an ICU and mechanically ventilated more than 48 hours
Key exclusion criteria (6 listed)
- Patients without families admitted in an ICU and mechanically ventilated more than 48 hours
- Patients or families not fluent in French
- Patients moribund
- Patients with a neurologic or psychiatric disease responsible for admission or pre-existing before the ICU admission
- Patients admitted after a cardiac arrest
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 |
|---|---|---|
| ICU diaryThe intervention is the elaboration of an ICU diary by caregivers and families The first pages of the diary is standardized to include an explanation of the purpose of the diary. The diary is maintained by the family and ICU staff. The only instruction given to the families and staff members about diary entries is to refrain from writing about confidential matters that could not be shared among the patients, the staff and the relatives. Staff members are free to express compassion and their hope, or absence thereof, that the patient would recover. Relatives can speak freely with the patients without receiving guidance from the ICU staff. At the minimum, the ICU staff write a brief entry at each weekly staff meeting. For patients discharged to wards and if he can receive the diary, the diary is given to the patient. If the patient died, the diary is given to the family. | Other | With diary |
Primary outcome
Post traumatic stress disorder symptoms in patients
Time frame: 3 months after ICU discharge as measured by the Impact Evaluation Scale-Revised questionaire
IES-R score > 22
4 secondary outcomes
Post traumatic stress disorder symptoms in families
Time frame: 3 months after ICU discharge as measured by the Impact Evaluation Scale-Revised questionaire
Anxiety and depression related symptoms in patients
Time frame: 3 months after ICU discharge as measured by the Hospital Anxiety and Depression Scale
Anxiety and depression related symptoms in families
Time frame: 3 months after ICU discharge as measured by the Hospital Anxiety and Depression Scale
Recollection of the memories of the ICU stay by the patient
Time frame: 3 months after ICU discharge as measured by the memory tool questionnaire
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 12 Mar 2018.
- Derived from this study: PubMed 35239692Flahault C, Vioulac C, Fasse L, Bailly S, Timsit JF, Garrouste-Orgeas M. "A story with gaps": An interpretative phenomenological analysis of ICU survivors' experience. PLoS One. 2022 Mar 3;17(3):e0264310. doi: 10.1371/journal.pone.0264310. eCollection 2022.
- Derived from this study: PubMed 31310299Garrouste-Orgeas M, Flahault C, Vinatier I, Rigaud JP, Thieulot-Rolin N, Mercier E, Rouget A, Grand H, Lesieur O, Tamion F, Hamidfar R, Renault A, Parmentier-Decrucq E, Monseau Y, Argaud L, Bretonniere C, Lautrette A, Badie J, Boulet E, Floccard B, Forceville X, Kipnis E, Soufir L, Valade S, Bige N, Gaffinel A, Hamzaoui O, Simon G, Thirion M, Bouadma L, Large A, Mira JP, Amdjar-Badidi N, Jourdain M, Jost PH, Maxime V, Santoli F, Ruckly S, Vioulac C, Leborgne MA, Bellalou L, Fasse L, Misset B, Bailly S, Timsit JF. Effect of an ICU Diary on Posttraumatic Stress Disorder Symptoms Among Patients Receiving Mechanical Ventilation: A Randomized Clinical Trial. JAMA. 2019 Jul 16;322(3):229-239. doi: 10.1001/jama.2019.9058.
- Derived from this study: PubMed 29141694Garrouste-Orgeas M, Flahault C, Fasse L, Ruckly S, Amdjar-Badidi N, Argaud L, Badie J, Bazire A, Bige N, Boulet E, Bouadma L, Bretonniere C, Floccard B, Gaffinel A, de Forceville X, Grand H, Halidfar R, Hamzaoui O, Jourdain M, Jost PH, Kipnis E, Large A, Lautrette A, Lesieur O, Maxime V, Mercier E, Mira JP, Monseau Y, Parmentier-Decrucq E, Rigaud JP, Rouget A, Santoli F, Simon G, Tamion F, Thieulot-Rolin N, Thirion M, Valade S, Vinatier I, Vioulac C, Bailly S, Timsit JF. The ICU-Diary study: prospective, multicenter comparative study of the impact of an ICU diary on the wellbeing of patients and families in French ICUs. Trials. 2017 Nov 15;18(1):542. doi: 10.1186/s13063-017-2283-y.
- Impact of an intensive care unit diary on psychological distress in patients and relativesLink provided by the sponsor.
- Phenomenologic analysis of healthcare worker perceptions of intensive care unit diaries.Link provided by the sponsor.
- Writing in and reading ICU diaries: qualitative study of families' experience in the ICU.Link provided by the sponsor.
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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.
Maité Garrouste-Orgeas, MD principal investigator
GHPSJoseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICU diary in people with Stress Disorders Post Traumatic, run by Fondation Hôpital Saint-Joseph 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 1 inclusion and 6 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 12 Mar 2018. 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?
Post traumatic stress disorder symptoms in patients (time frame: 3 months after ICU discharge as measured by the Impact Evaluation Scale-Revised questionaire). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02519725, which also lists 3 linked publications.
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 12 Mar 2018.