Sudden DeathSUIVIPROCHENCT03320902
Sudden Death Counselling and Its Impact on Family Members of Sudden Death Victims
A study testing Sudden death counselling in people with Sudden Death, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sudden Death
- What is being tested?
- Sudden death counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 625 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jan 2018to 25 Mar 2024
- 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
- 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).
Who cannot join
- Relative under guardianship/curatorship Relative unable to communicate Relative not affiliated to a medical insurance
Trial locations and contacts
1 site in 1 country.
About this study
Assessment of the psychological benefit of the proposition by prehospital medical team of a sudden death counselling on family members of sudden death victims.
Read the 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.
- Conditions
- Sudden Death
- Being tested
- Sudden death counselling
- Keywords
- Family members, sudden death, sudden death counseling, depression
- Medical subject headings
- Death, Sudden, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sudden death counsellingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Sudden death counselling | Active comparator | 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. Receives: Behavioral: Sudden death counselling |
| Usual practice | No intervention | The physician will act as usual. The relatives will not systematically benefit from this option. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 3 months from the sudden death
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
Measured: At 3 months from the sudden death
Secondary outcomes (9)
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
Measured: at 3 months from the sudden death
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.
Measured: At 3 months from the sudden death
Visits number to the general physician
Measured: At 3 months from the sudden death
Drug use
Measured: At 3 months from the sudden death
Visits number to the psychologist and/or psychiatrist
Measured: At 3 months from the sudden death
Relatives number integrating a grief recovery support group
Number of participants that have integrated a grief recovery support group
Measured: At 3 months from the sudden death
Feeling of the sudden death consultation or not by the relatives
Measured: At 3 months from the sudden death
Proportion of identified causes of sudden death
Measured: At 3 months from the sudden death
Proportion of familial screening
Measured: At 3 months from the sudden death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start18 Jan 2018
- Primary completion13 Nov 2023
- Study completion25 Mar 2024
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 Assistance Publique - Hôpitaux de ParisThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 625 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Patricia JABRE, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320902
- Sponsor's protocol ID
- K160905J
- Other IDs
- 2017-A0098-45
- Acronym
- SUIVIPROCHE
- Status last verified
- Oct 2025
- First submitted
- 12 Oct 2017
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sudden Death Counselling and Its Impact on Family Members of Sudden Death Victims
- ClinicalTrials.gov ID
- NCT03320902
- Acronym / sponsor ID
- SUIVIPROCHE / K160905J
- Conditions
- Sudden Death
- Keywords
- Family members, sudden death, sudden death counseling, depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 625 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, URC-CIC Paris Descartes Necker Cochin
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 13 Nov 2023 (actual)
- Study completion
- 25 Mar 2024 (actual)
- First posted
- 25 Oct 2017 (actual)
- 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sudden death counselling | Active comparator | Behavioral: Sudden death counsellingThe 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. |
| Usual practice | No intervention | –The physician will act as usual. The relatives will not systematically benefit from this option. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (1 listed)
- Relative under guardianship/curatorship Relative unable to communicate Relative not affiliated to a medical insurance
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 |
|---|---|---|
| Sudden death counsellingThe 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. | Behavioural | Sudden death counselling |
Primary outcome
Hospital Anxiety and Depression Scale, sub-section Depression (HADSD) >10
Time frame: at 3 months from the sudden death
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
Time frame: At 3 months from the sudden death
Percentage of relatives with moderate to severe symptoms of anxiety evaluated by the 'Hospital Anxiety and Depression Scale' score, subscale Anxiety (HADSA) >10
9 secondary outcomes
Impact of Event Scale-revised score (IES-R) ≥ 33
Time frame: at 3 months from the sudden death
Medical Outcome Study Short Form Health Survey (SF-12)
Time frame: At 3 months from the sudden death
Visits number to the general physician
Time frame: At 3 months from the sudden death
Drug use
Time frame: At 3 months from the sudden death
Visits number to the psychologist and/or psychiatrist
Time frame: At 3 months from the sudden death
Relatives number integrating a grief recovery support group
Time frame: At 3 months from the sudden death
Feeling of the sudden death consultation or not by the relatives
Time frame: At 3 months from the sudden death
Proportion of identified causes of sudden death
Time frame: At 3 months from the sudden death
Proportion of familial screening
Time frame: At 3 months from the sudden death
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 20 Nov 2025.
- Individual participant dataSharing planned: Undecided
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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.
Patricia JABRE, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sudden death counselling in people with Sudden Death, run by Assistance Publique - Hôpitaux de Paris 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 1 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 20 Nov 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?
Hospital Anxiety and Depression Scale, sub-section Depression (HADSD) >10 (time frame: at 3 months from the sudden death). The study lists 2 primary outcomes in all. 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 20 Nov 2025.