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Psychological Sequelae After Sudden Cardiac Death in the Patient and His Relatives (TEMPO)

Primary Purpose

Post Traumatic Stress Disorder, Resuscitated Sudden Cardiac Death

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
SASRQ questionnaire
PCL-5 with LEC-5 questionnaire
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Post Traumatic Stress Disorder focused on measuring Sudden cardiac death

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with resuscitated sudden cardiac death and/or their relative
  • Patients who are fluent in French
  • Patients who have given their 'no objection to participation to the research'
  • Patients of both gender over 18 years
  • Women with childbearing potential and effective contraception

Exclusion Criteria:

  • People who are not able to give their 'no objection to participate to the research'
  • People with major cognitive disorders post sudden cardiac death
  • People with known psychiatric disorder
  • Women who are known to be pregnant or lactating
  • Person deprived of liberty by judicial or administrative decision
  • People under legal protection (under the protection of a conservator)

Sites / Locations

  • Bordeaux University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient and relatives

Arm Description

Outcomes

Primary Outcome Measures

Proportion of patients and relatives with PTSD at months 3 post resuscitated SCD
The percentage of patients and relatives is determined using the PCL-5 and LEC-5 questionnaire

Secondary Outcome Measures

Proportion of patients and/or relatives with acute stress disorder
The percentage of patients and relatives is determined using the SASRQ questionnaire
Proportion of patients and/or relatives with trauma vulnerability
The percentage of patients and/or relatives is determined using the LEC-5 included in the PCL-5 questionnaire

Full Information

First Posted
June 4, 2021
Last Updated
March 15, 2023
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT04921514
Brief Title
Psychological Sequelae After Sudden Cardiac Death in the Patient and His Relatives
Acronym
TEMPO
Official Title
Psychological Sequelae After Sudden Cardiac Death in the Patient and His Relatives
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
May 18, 2021 (Actual)
Primary Completion Date
September 26, 2022 (Actual)
Study Completion Date
September 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate and describe the occurrence of Acute traumatic stress and persistence of Post Traumatic Stress Disorder (PTSD) after resuscitated sudden cardiac death (SCD) in patient and relatives present during the event. The population will be composed of 40 patients: 20 with resuscitated SCD and 20 relatives. Two interviews will be performed by a psychologist within one week after resuscitated SCD and at month 3. Questionnaire Stanford Acute Stress Reaction Questionnaire (SASRQ), Life Events Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (LEC-5) and Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) will be filled during these interviews.
Detailed Description
In spite of therapeutic advances, sudden cardiac death (SCD) remains a frequent (60000/year in France) and often fatal disease (5% survival). Because it is by definition unexpected, the psychological impact on resuscitated patients and on relatives may be important. However little studies have evaluated it. Patients who later develop PTSD, generally have acute stress disorder. In patients with resuscitated sudden cardiac death, acute psychological distress is frequent and PTSD was identified in 40% of patients. Concerning relatives, Haywood (2018) call them the "forgotten patients" to emphasize the absence of recognition of his psychological trauma. PTSD was more frequent in people who were witness of the SCD vs those who were not there. Hofland et al (2018) showed that people present during resuscitation maneuvers had more acute stress than others. This study will evaluate acute stress disorder with SASRQ scale in patients with resuscitated SCD and their relative just after the event. At 3 months, presence of PTSD will be evaluated with PCL-5 and LEC-5 in patients and their relatives.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder, Resuscitated Sudden Cardiac Death
Keywords
Sudden cardiac death

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
40 participants (20 patients and 20 relatives)
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient and relatives
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
SASRQ questionnaire
Intervention Description
During an interview with a trained psychologist, the presence of acute stress will be assessed by the SASRQ test within one week of the occurrence of a sudden recovered death. The diagnosis of acute post-traumatic stress disorder is made according to the presence of at least three dissociative symptoms out of five, and other symptoms of re-experiencing, avoidance or marked anxiety or hypervigilance. Each symptom is thus evaluated dichotomously. A symptom is present if the intensity of the response is 3 or more (0 "from 0 to 2" and 1 "from 3 to 5").
Intervention Type
Behavioral
Intervention Name(s)
PCL-5 with LEC-5 questionnaire
Intervention Description
This questionnaire will be completed during an interview with a psychologist trained in the protocol, 3 months after the sudden death. The PCL-5 is a 20-item self-report questionnaire that assesses the 20 symptoms of PTSD according to the DSM-V. It is associated with the LEC-5 questionnaire. The self-reported scale uses ratings of "0 to 4" to assess each of the symptoms. A threshold of 38 on the PCL-5 seems reasonable to suggest the presence of PTSD.
Primary Outcome Measure Information:
Title
Proportion of patients and relatives with PTSD at months 3 post resuscitated SCD
Description
The percentage of patients and relatives is determined using the PCL-5 and LEC-5 questionnaire
Time Frame
Month 3
Secondary Outcome Measure Information:
Title
Proportion of patients and/or relatives with acute stress disorder
Description
The percentage of patients and relatives is determined using the SASRQ questionnaire
Time Frame
Day 0
Title
Proportion of patients and/or relatives with trauma vulnerability
Description
The percentage of patients and/or relatives is determined using the LEC-5 included in the PCL-5 questionnaire
Time Frame
Month3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with resuscitated sudden cardiac death and/or their relative Patients who are fluent in French Patients who have given their 'no objection to participation to the research' Patients of both gender over 18 years Women with childbearing potential and effective contraception Exclusion Criteria: People who are not able to give their 'no objection to participate to the research' People with major cognitive disorders post sudden cardiac death People with known psychiatric disorder Women who are known to be pregnant or lactating Person deprived of liberty by judicial or administrative decision People under legal protection (under the protection of a conservator)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adeline Banos
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bordeaux University Hospital
City
Pessac
ZIP/Postal Code
33604
Country
France

12. IPD Sharing Statement

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Psychological Sequelae After Sudden Cardiac Death in the Patient and His Relatives

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