Sudden DeathCOREABORNCT02874469
Impact of an Intensive Care Diary on Post-traumatic Stress Disorder After a Resuscitated Sudden Death
A study testing Diary in people with Sudden Death and Sudden Cardiac Arrest, run by University Hospital, Lille at 1 site in France.
Trial summary
Sudden death is a public health problem with more than 300,000 cases per year in USA and 40,000 cases per year in France. Moreover, despite all recent therapeutic improvements (therapeutic hypothermia, new techniques of resuscitation…), the prognosis remains drastically poor and less than 50% of the patients admitted… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sudden Death, Sudden Cardiac Arrest
- What is being tested?
- Diary
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 1 siteFrance
- Study dates
- 31 Dec 2014to Dec 2023
- 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 who experienced a sudden death and who are admitted alive in our center
- Patients who benefited from therapeutic hypothermia (and/or care to limit fever occurrence)
- Relative's inclusion criteria :
- Relatives of a patient that fit inclusion/exclusion criteria
Who cannot join
- Patient's non-inclusion criteria :
- Death or transfer in another center within the first 8 hours of admission in our center
- Pregnancy
- Patients who refuse to participate after being awake after initial coma
- Relative's non-inclusion criteria :
- Relatives who refuse to participate after being awake after initial coma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of an Intensive Care Diary on Post-traumatic Stress Disorder on Patients After a Resuscitated Sudden Death and His Relatives
Sudden death is a public health problem with more than 300,000 cases per year in USA and 40,000 cases per year in France. Moreover, despite all recent therapeutic improvements (therapeutic hypothermia, new techniques of resuscitation…), the prognosis remains drastically poor and less than 50% of the patients admitted alive at hospital will survive to the event at 1 year.
Outside all medications and technical care to improve patient prognosis, a psychological evaluation looks also critical to detect the occurrence of a "post traumatic stress syndrome". In fact, along with the event severity, a variable period of amnesia related to coma may favor the occurrence of such a syndrome and psychological issues, which at the end may lead to impairment of patient quality of life.
Read more
Previous studies have evaluated the impact of an intensive care unit diary on psychological distress in patients and relatives in the context of severe traumatisms. Such an evaluation has however never been done in the specific setting of sudden death and the frequency of this syndrome is unknown in this context.
Aim The aim of the present study is to evaluate the impact of an intensive care unit diary on the occurrence of a "post traumatic stress syndrome" after a sudden death.
Secondary objectives
- To evaluate the frequency of the occurrence of a "post traumatic stress syndrome" and other psycho traumatic symptoms after sudden death
- To evaluate the impact of an intensive care unit diary on the severity of this syndrome, psycho traumatic symptoms, and psychopathologic comorbidities
- To evaluate the impact of the diary on psycho traumatic symptoms and their severity in patient's relatives
- To evaluate the satisfaction of the patients and their relatives regarding medical cares in both groups (with and without diary)
- Comparison of nurse diagnostic (psychological distress) and diagnostic made by dedicated personal with a specific formation in psychology
- Qualitative evaluation of the diary
- Evaluation of the paramedical feeling before and after the diary input in practice
Read the detailed description
The COREABOR Study is an open label, prospective, that will compare patients with sudden death who will be included during 2 successive periods of time: first a period of control and then a period of intervention.
Interventional study.
Altogether, 330 patients with resuscitated sudden death will be screened during the whole study period allowing to include 96 patients in the study (alive at 3 months after the event, estimated survival rate of 30%). For each screened patient, 2 relatives will be selected to participate to the study (n=660).
To avoid biases, the control group of 48 patients will be included first and treated as recommended with usual care in center. Then, the 48 patients of the intervention group will be included during the second period of the study and the intensive care unit diary will be implemented only at this time.
In the intervention group (second period with diary), a maximal delay of 8 hours is allowed to implement the diary for each patient after admission in centre.
Visit 0 (V0): inclusion The study will recruit patients in the total incapacity to give their own consent for medical reasons (comatose patients) at admission. Subsequently a written inform consent of a relative will first be obtained and the patient's written consent will be obtained as soon as possible afterwards.
Period 1: control group Medical care as usually performed in center and as recommended.
Period 2: intervention group (intensive care unit diary) On top of usual care, an intensive care unit diary will be implemented for all patients within the first 8 hours following their admission. At discharge, the diary will be given to the patients themselves or to their relatives in case of in-hospital death. An anonymous copy will be kept by investigators.
For all patients A psychological evaluation will be performed at 1 month (V1), 3 months (V2) and 6 months by phone contact only (V3) using the following elements Auto-questioner (PDI) Nurse diagnosis Psychological evaluation by dedicated personal (CAPS and mini-DSMIV)
For relatives A psychological evaluation will be performed at 3 months (V2) and 6 months by phone contact only (V3)
- Conditions
- Sudden Death, Sudden Cardiac Arrest
- Being tested
- Diary
- Keywords
- sudden death, post-traumatic stress disorder, psychological distress, diary, resuscitation
- Medical subject headings
- Death, Sudden, Death, Sudden, Cardiac, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiaryOther
The diary was specifically created for the purpose of the present study by personal working at ICU at CHRU of Lille (France).
All relatives, doctors and paramedics close to the patient during his hospital stay are allowed to write some comments inside the diary when he is comatose.
The diary will be implemented during the second period of the study within the first 8 hours after admission.
It will be given to the patients themselves at discharge or to their relatives in case of in-hospital death. An anonymous copy will be kept by investigators.
| Study group | Role | What they receive |
|---|---|---|
| Control group (first period) | No intervention | Patients treated as recommended with usual care in a center. |
| Group with diary (second period) | Experimental | Intervention group = On top of usual care, an intensive care unit diary will be implemented for patients within the first 8 hours following their admission. Receives: Other: Diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of occurrence of "post traumatic stress disorder"
Rate of occurrence of "post traumatic stress syndrome" (CAPS score over 39) at 3 months after resuscitation after sudden death
Measured: 3 months
Secondary outcomes (6)
Peritraumatic Distress Inventory (PDI) Scale
PDI is a scale of self-evaluation of 13 items to determine distress reactions emotional of a person at the time of a traumatic event and in the minutes and hours. People who have a high risk of distress Peritraumatic develop post-traumatic stress disorder.
Measured: 1 month
Psychiatric comorbidities
Psychiatric comorbidities evaluated by the mini DSM IV (Diagnostic and Statistical Manual of Mental Disorders - IV) for patients
Measured: 3 and 6 months
Rate of "Post traumatic stress disorder" for patients
Rate of "Post traumatic stress disorder" (CAPS score over 39) for patients
Measured: 6 months
Rate of "Post traumatic stress disorder" for relatives
Rate of "Post traumatic stress disorder" (CAPS score over 39) for relatives
Measured: 3 and 6 months
Nurse diagnosis
Comparison of nurse diagnosis and diagnosis made by dedicated personal with a specific formation in psychology
Measured: 3 months
Qualitative evaluation of the diary
Qualitative evaluation of the diary by satisfaction questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study start31 Dec 2014
- Primary completionDec 2023
- Study completionDec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden DeathStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Gilles LESMESLE, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02874469
- Sponsor's protocol ID
- 2014_06
- Other IDs
- 2014-A01213-44
- Acronym
- COREABOR
- Status last verified
- Aug 2020
- First submitted
- 17 Aug 2016
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Intensive Care Diary on Post-traumatic Stress Disorder on Patients After a Resuscitated Sudden Death and His Relatives
- ClinicalTrials.gov ID
- NCT02874469
- Acronym / sponsor ID
- COREABOR / 2014_06
- Conditions
- Sudden Death, Sudden Cardiac Arrest
- Keywords
- sudden death, post-traumatic stress disorder, psychological distress, diary, resuscitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 31 Dec 2014 (actual)
- Primary completion
- Dec 2023 (actual)
- Study completion
- Dec 2023 (actual)
- First posted
- 22 Aug 2016 (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.
Sudden death is a public health problem with more than 300,000 cases per year in USA and 40,000 cases per year in France. Moreover, despite all recent therapeutic improvements (therapeutic hypothermia, new techniques of resuscitation…), the prognosis remains drastically poor and less than 50% of the patients admitted alive at hospital will survive to the event at 1 year.
Outside all medications and technical care to improve patient prognosis, a psychological evaluation looks also critical to detect the occurrence of a "post traumatic stress syndrome". In fact, along with the event severity, a variable period of amnesia related to coma may favor the occurrence of such a syndrome and psychological issues, which at the end may lead to impairment of patient quality of life.
Previous studies have evaluated the impact of an intensive care unit diary on psychological distress in patients and relatives in the context of severe traumatisms. Such an evaluation has however never been done in the specific setting of sudden death and the frequency of this syndrome is unknown in this context.
Aim The aim of the present study is to evaluate the impact of an intensive care unit diary on the occurrence of a "post traumatic stress syndrome" after a sudden death.
Secondary objectives
- To evaluate the frequency of the occurrence of a "post traumatic stress syndrome" and other psycho traumatic symptoms after sudden death
- To evaluate the impact of an intensive care unit diary on the severity of this syndrome, psycho traumatic symptoms, and psychopathologic comorbidities
- To evaluate the impact of the diary on psycho traumatic symptoms and their severity in patient's relatives
- To evaluate the satisfaction of the patients and their relatives regarding medical cares in both groups (with and without diary)
- Comparison of nurse diagnostic (psychological distress) and diagnostic made by dedicated personal with a specific formation in psychology
- Qualitative evaluation of the diary
- Evaluation of the paramedical feeling before and after the diary input in practice
Detailed description
The COREABOR Study is an open label, prospective, that will compare patients with sudden death who will be included during 2 successive periods of time: first a period of control and then a period of intervention.
Interventional study.
Altogether, 330 patients with resuscitated sudden death will be screened during the whole study period allowing to include 96 patients in the study (alive at 3 months after the event, estimated survival rate of 30%). For each screened patient, 2 relatives will be selected to participate to the study (n=660).
To avoid biases, the control group of 48 patients will be included first and treated as recommended with usual care in center. Then, the 48 patients of the intervention group will be included during the second period of the study and the intensive care unit diary will be implemented only at this time.
In the intervention group (second period with diary), a maximal delay of 8 hours is allowed to implement the diary for each patient after admission in centre.
Visit 0 (V0): inclusion The study will recruit patients in the total incapacity to give their own consent for medical reasons (comatose patients) at admission. Subsequently a written inform consent of a relative will first be obtained and the patient's written consent will be obtained as soon as possible afterwards.
Period 1: control group Medical care as usually performed in center and as recommended.
Period 2: intervention group (intensive care unit diary) On top of usual care, an intensive care unit diary will be implemented for all patients within the first 8 hours following their admission. At discharge, the diary will be given to the patients themselves or to their relatives in case of in-hospital death. An anonymous copy will be kept by investigators.
For all patients A psychological evaluation will be performed at 1 month (V1), 3 months (V2) and 6 months by phone contact only (V3) using the following elements Auto-questioner (PDI) Nurse diagnosis Psychological evaluation by dedicated personal (CAPS and mini-DSMIV)
For relatives A psychological evaluation will be performed at 3 months (V2) and 6 months by phone contact only (V3)
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group (first period) | No intervention | –Patients treated as recommended with usual care in a center. |
| Group with diary (second period) | Experimental | Other: DiaryIntervention group = On top of usual care, an intensive care unit diary will be implemented for patients within the first 8 hours following their admission. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who experienced a sudden death and who are admitted alive in our center
- Patients who benefited from therapeutic hypothermia (and/or care to limit fever occurrence)
- Relatives of a patient that fit inclusion/exclusion criteria
Key exclusion criteria (6 listed)
- Death or transfer in another center within the first 8 hours of admission in our center
- Pregnancy
- Patients who refuse to participate after being awake after initial coma
- Relatives who refuse to participate after being awake after initial coma
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 |
|---|---|---|
| DiaryThe diary was specifically created for the purpose of the present study by personal working at ICU at CHRU of Lille (France). All relatives, doctors and paramedics close to the patient during his hospital stay are allowed to write some comments inside the diary when he is comatose. The diary will be implemented during the second period of the study within the first 8 hours after admission. It will be given to the patients themselves at discharge or to their relatives in case of in-hospital death. An anonymous copy will be kept by investigators. | Other | Group with diary (second period) |
Primary outcome
Rate of occurrence of "post traumatic stress disorder"
Time frame: 3 months
Rate of occurrence of "post traumatic stress syndrome" (CAPS score over 39) at 3 months after resuscitation after sudden death
6 secondary outcomes
Peritraumatic Distress Inventory (PDI) Scale
Time frame: 1 month
Psychiatric comorbidities
Time frame: 3 and 6 months
Rate of "Post traumatic stress disorder" for patients
Time frame: 6 months
Rate of "Post traumatic stress disorder" for relatives
Time frame: 3 and 6 months
Nurse diagnosis
Time frame: 3 months
Qualitative evaluation of the diary
Time frame: 6 months
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 16 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Gilles LESMESLE, MD, PhD principal investigator
University Hospital, Lille
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 Sudden Death and Sudden Cardiac Arrest, run by University Hospital, Lille 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 4 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 16 Dec 2025. 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?
Rate of occurrence of "post traumatic stress disorder" (time frame: 3 months). 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 16 Dec 2025.