Sudden Death Counselling and Its Impact on Family Members of Sudden Death Victims (SUIVIPROCHE)
Primary Purpose
Sudden Death
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Sudden death counselling
Sponsored by
About this trial
This is an interventional supportive care trial for Sudden Death focused on measuring Family members, sudden death, sudden death counseling, depression
Eligibility Criteria
Inclusion Criteria:
A first-degree relative of a:
- patient aged 18-75 years
- with an out-of-hospital sudden death*
- and cardiopulmonary resuscitation attempted Relative aged ≥ 18 years Given consent for the study. Sudden death definition*: An unexpected cardiac arrest without obvious extracardiac cause, leading to a collapse in front of a witness (or in the absence of witnesses, occurring within the hour after the onset of symptoms).
Exclusion Criteria:
Relative under guardianship/curatorship Relative unable to communicate Relative not affiliated to a medical insurance
Sites / Locations
- Hôpital Necker-Enfants maladesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Sudden death counselling
Usual practice
Arm Description
The emergency physician of the prehospital EMS who intervenes at the scene will systematically give the family member allocated to the intervention the option to attend a sudden death counselling during the first month after the event.
The physician will act as usual. The relatives will not systematically benefit from this option.
Outcomes
Primary Outcome Measures
Hospital Anxiety and Depression Scale, sub-section Depression (HADSD) >10
Percentage of relatives with moderate to severe symptoms of depression evaluated by the 'Hospital Anxiety and Depression Scale' score, subscale Depression (HADSD) >10
Hospital Anxiety and Depression Scale, sub-section Anxiety (HADSA) >10
Percentage of relatives with moderate to severe symptoms of anxiety evaluated by the 'Hospital Anxiety and Depression Scale' score, subscale Anxiety (HADSA) >10
Secondary Outcome Measures
Impact of Event Scale-revised score (IES-R) ≥ 33
Percentage of relatives with symptoms of post-traumatic stress disorder evaluated by the 'Impact of Event Scale' score (IES-R) ≥ 33
Medical Outcome Study Short Form Health Survey (SF-12)
Quality of life questionnaire : the SF-12 is the 12 item abbreviated form of SF-36 survey. It provides information about how participants feel, and how well they have been able to perform their usual activities. SF-12 questions make up 8 scales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health . Transformed physical component summary score (PCS) and transformed mental component summary score (MCS) are derived using the sum of all 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning.
Visits number to the general physician
Drug use
Visits number to the psychologist and/or psychiatrist
Relatives number integrating a grief recovery support group
Number of participants that have integrated a grief recovery support group
Feeling of the sudden death consultation or not by the relatives
Proportion of identified causes of sudden death
Proportion of familial screening
Full Information
NCT ID
NCT03320902
First Posted
October 12, 2017
Last Updated
December 26, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
INSERM U970
1. Study Identification
Unique Protocol Identification Number
NCT03320902
Brief Title
Sudden Death Counselling and Its Impact on Family Members of Sudden Death Victims
Acronym
SUIVIPROCHE
Official Title
Sudden Death Counselling and Its Impact on Family Members of Sudden Death Victims
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2018 (Actual)
Primary Completion Date
January 18, 2024 (Anticipated)
Study Completion Date
May 18, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
INSERM U970
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
Assessment of the psychological benefit of the proposition by prehospital medical team of a sudden death counselling on family members of sudden death victims.
Detailed Description
Family members are often shocked and devastated by the death of their loved one, especially when it is sudden and unexpected. On the scene, families often don't really believe it happened because they didn't have time to absorb the fact of their loss. They hear the words and explanation given by the prehospital emergency medical services (EMS) team, but do not comprehend the full impact. Emotions seem frozen. They feel disoriented, restless, stunned and unable to think.
Most often, after cardiac arrest resuscitation attempt, the prehospital EMS team leaves the scene, letting the family without any further medical bond and support. Families are left alone facing this tragedy. After a while, families need medical counseling trying to understand what happens and why but they don't know who to consult. Instead, they remain without medical explanation or guidance with the fear regarding their own future, in particular, regarding the risk of dying from sudden death. This fear may be based on the knowledge of the eventuality of familial diseases increasing the risk of sudden death, or simply on a mechanism of identification with the deceased.
One important factor credited by experts is to encourage first-degree family members to seek sudden death counselling. However, the literature concerning this problem lacks of reliable data.
The aim of this clinical trial is to evaluate the psychological consequences of a sudden death counselling on family member after a relative's sudden death compared to the usual family management.
This study will compare the percentage of depression in a group of family members after a relative's sudden death for whom a sudden death counselling has been proposed by the prehospital medical team versus a group for whom the medical team has not modified its usual strategy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sudden Death
Keywords
Family members, sudden death, sudden death counseling, depression
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
620 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sudden death counselling
Arm Type
Active Comparator
Arm Description
The emergency physician of the prehospital EMS who intervenes at the scene will systematically give the family member allocated to the intervention the option to attend a sudden death counselling during the first month after the event.
Arm Title
Usual practice
Arm Type
No Intervention
Arm Description
The physician will act as usual. The relatives will not systematically benefit from this option.
Intervention Type
Behavioral
Intervention Name(s)
Sudden death counselling
Intervention Description
The Sudden Death Counselling with included relatives at 1 month (+/-15 days) after the eventafter the event will be at the Europeen Georges Pompidou hospital in Paris.
The purpose of this Sudden Death Counselling is to provide to family members of sudden death victims information, support, referral and follow-up services relating to sudden death and their grief, if needed.
The bereaved people will tell their experience. The Sudden Death Counselling would help them to integrate life's losses by companioning them.
Cardiologist and psychologists will be present to listen to their pain and try to bring comfort by answering to their questionings.
Primary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale, sub-section Depression (HADSD) >10
Description
Percentage of relatives with moderate to severe symptoms of depression evaluated by the 'Hospital Anxiety and Depression Scale' score, subscale Depression (HADSD) >10
Time Frame
at 3 months from the sudden death
Title
Hospital Anxiety and Depression Scale, sub-section Anxiety (HADSA) >10
Description
Percentage of relatives with moderate to severe symptoms of anxiety evaluated by the 'Hospital Anxiety and Depression Scale' score, subscale Anxiety (HADSA) >10
Time Frame
At 3 months from the sudden death
Secondary Outcome Measure Information:
Title
Impact of Event Scale-revised score (IES-R) ≥ 33
Description
Percentage of relatives with symptoms of post-traumatic stress disorder evaluated by the 'Impact of Event Scale' score (IES-R) ≥ 33
Time Frame
at 3 months from the sudden death
Title
Medical Outcome Study Short Form Health Survey (SF-12)
Description
Quality of life questionnaire : the SF-12 is the 12 item abbreviated form of SF-36 survey. It provides information about how participants feel, and how well they have been able to perform their usual activities. SF-12 questions make up 8 scales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health . Transformed physical component summary score (PCS) and transformed mental component summary score (MCS) are derived using the sum of all 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning.
Time Frame
At 3 months from the sudden death
Title
Visits number to the general physician
Time Frame
At 3 months from the sudden death
Title
Drug use
Time Frame
At 3 months from the sudden death
Title
Visits number to the psychologist and/or psychiatrist
Time Frame
At 3 months from the sudden death
Title
Relatives number integrating a grief recovery support group
Description
Number of participants that have integrated a grief recovery support group
Time Frame
At 3 months from the sudden death
Title
Feeling of the sudden death consultation or not by the relatives
Time Frame
At 3 months from the sudden death
Title
Proportion of identified causes of sudden death
Time Frame
At 3 months from the sudden death
Title
Proportion of familial screening
Time Frame
At 3 months from the sudden death
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A first-degree relative of a:
patient aged 18-75 years
with an out-of-hospital sudden death*
and cardiopulmonary resuscitation attempted Relative aged ≥ 18 years Given consent for the study. Sudden death definition*: An unexpected cardiac arrest without obvious extracardiac cause, leading to a collapse in front of a witness (or in the absence of witnesses, occurring within the hour after the onset of symptoms).
Exclusion Criteria:
Relative under guardianship/curatorship Relative unable to communicate Relative not affiliated to a medical insurance
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia JABRE, MD, PhD
Phone
+33 1 44 49 24 51
Email
patricia.jabre@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Nelly BRIAND, PhD
Phone
+33 1 44 38 18 62
Email
nelly.briand@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia JABRE, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Necker-Enfants malades
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia JABRE, MD, PhD
Phone
+33 1 44 49 24 51
Email
patricia.jabre@aphp.fr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Sudden Death Counselling and Its Impact on Family Members of Sudden Death Victims
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