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

NCT03320902 | Completed

• 2 other identifiers: K160905J2017-A0098-45
• Study Type: interventional
• Target: 625
• Locations: 1 country
• Sites: 1

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.

Conditions

Sudden Death

Keywords

Family members; sudden death; sudden death counseling; depression

Outcome Measures

Primary Outcomes (2)

• 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

  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

  At 3 months from the sudden death

Secondary Outcomes (9)

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

  at 3 months from the sudden death

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

  At 3 months from the sudden death

• Visits number to the general physician

  At 3 months from the sudden death

• Drug use

  At 3 months from the sudden death

• Visits number to the psychologist and/or psychiatrist

  At 3 months from the sudden death

Study Arms (2)

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.

Behavioral: Sudden death counselling

Usual practice

NO INTERVENTION

The physician will act as usual. The relatives will not systematically benefit from this option.

Interventions

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.

Sudden death counselling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Relative under guardianship/curatorship Relative unable to communicate Relative not affiliated to a medical insurance

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker-Enfants malades

Paris, Paris, 75015, France

Location

MeSH Terms

Conditions

Death, Sudden; Depression

Condition Hierarchy (Ancestors)

Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Patricia JABRE, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: October 25, 2017
• Study Start: January 18, 2018
• Primary Completion: November 13, 2023
• Study Completion: March 25, 2024
• Last Updated: November 20, 2025

Record last verified: 2025-10

Locations

FR (1)