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Completed

NCT Number: NCT03320902

Sudden Death Counselling and Its Impact on Family Members of Sudden Death Victims

Assessment of the psychological benefit of the proposition by prehospital medical team of a sudden death counselling on family members of sudden death victims.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Necker-Enfants malades

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sudden death counselling

Behavioral

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 outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Impact of Event Scale-revised score (IES-R) ≥ 33

    Time frame: at 3 months from the sudden death

    Percentage of relatives with symptoms of post-traumatic stress disorder evaluated by the 'Impact of Event Scale' score (IES-R) ≥ 33

  2. Medical Outcome Study Short Form Health Survey (SF-12)

    Time frame: At 3 months from the sudden death

    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.

  3. Visits number to the general physician

    Time frame: At 3 months from the sudden death

  4. Drug use

    Time frame: At 3 months from the sudden death

  5. Visits number to the psychologist and/or psychiatrist

    Time frame: At 3 months from the sudden death

  6. Relatives number integrating a grief recovery support group

    Time frame: At 3 months from the sudden death

    Number of participants that have integrated a grief recovery support group

  7. Feeling of the sudden death consultation or not by the relatives

    Time frame: At 3 months from the sudden death

  8. Proportion of identified causes of sudden death

    Time frame: At 3 months from the sudden death

  9. Proportion of familial screening

    Time frame: At 3 months from the sudden death

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: SUIVIPROCHE

Important dates

Study start
2018
Primary completion
2023
Study completion
2024
First posted
Oct 25, 2017
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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