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Impact of an Intensive Care Diary on Post-traumatic Stress Disorder After a Resuscitated Sudden Death (COREABOR)

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ClinicalTrials.gov Identifier: NCT02874469
Recruitment Status : Recruiting
First Posted : August 22, 2016
Last Update Posted : April 18, 2018
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Lille

Tracking Information
First Submitted Date  ICMJE August 17, 2016
First Posted Date  ICMJE August 22, 2016
Last Update Posted Date April 18, 2018
Actual Study Start Date  ICMJE December 31, 2014
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02874469 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2016)
  • Peritraumatic Distress Inventory (PDI) Scale [ Time Frame: 1 month ]
    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.
  • Psychiatric comorbidities [ Time Frame: 3 and 6 months ]
    Psychiatric comorbidities evaluated by the mini DSM IV (Diagnostic and Statistical Manual of Mental Disorders - IV) for patients
  • Rate of "Post traumatic stress disorder" for patients [ Time Frame: 6 months ]
    Rate of "Post traumatic stress disorder" (CAPS score over 39) for patients
  • Rate of "Post traumatic stress disorder" for relatives [ Time Frame: 3 and 6 months ]
    Rate of "Post traumatic stress disorder" (CAPS score over 39) for relatives
  • Nurse diagnosis [ Time Frame: 3 months ]
    Comparison of nurse diagnosis and diagnosis made by dedicated personal with a specific formation in psychology
  • Qualitative evaluation of the diary [ Time Frame: 6 months ]
    Qualitative evaluation of the diary by satisfaction questionnaire
Original Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2016)
  • Peritraumatic Distress Inventory (PDI) Scale [ Time Frame: 1 month ]
    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.
  • Psychiatric comorbidities [ Time Frame: 3 and 6 months ]
    Psychiatric comorbidities evaluated by the mini DSMIV for patients
  • Rate of "Post traumatic stress disorder" for patients [ Time Frame: 6 months ]
    Rate of "Post traumatic stress disorder" (CAPS score over 39) for patients
  • Rate of "Post traumatic stress disorder" for relatives [ Time Frame: 3 and 6 months ]
    Rate of "Post traumatic stress disorder" (CAPS score over 39) for relatives
  • Nurse diagnosis [ Time Frame: 3 months ]
    Comparison of nurse diagnosis and diagnosis made by dedicated personal with a specific formation in psychology
  • Qualitative evaluation of the diary [ Time Frame: 6 months ]
    Qualitative evaluation of the diary by satisfaction questionnaire
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of an Intensive Care Diary on Post-traumatic Stress Disorder After a Resuscitated Sudden Death
Official Title  ICMJE Impact of an Intensive Care Diary on Post-traumatic Stress Disorder on Patients After a Resuscitated Sudden Death and His Relatives
Brief 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 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Sudden Death
  • Sudden Cardiac Arrest
Intervention  ICMJE Other: Diary

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 Arms  ICMJE
  • No Intervention: Control group (first period)
    Patients treated as recommended with usual care in a center.
  • Experimental: Group with diary (second period)
    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.
    Intervention: Other: Diary
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 17, 2016)
330
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria =

  • 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

Exclusion Criteria =

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hélène Dehaut lndehaut@gmail.com
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02874469
Other Study ID Numbers  ICMJE 2014_06
2014-A01213-44 ( Other Identifier: ID-RCB number, ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Lille
Study Sponsor  ICMJE University Hospital, Lille
Collaborators  ICMJE Ministry of Health, France
Investigators  ICMJE
Principal Investigator: Gilles LESMESLE, MD, PhD University Hospital, Lille
PRS Account University Hospital, Lille
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP