NCT01009606

Brief Summary

The bereavement generated by the loss of a family member can induce pathological situations: depressive state, anxiety, post-traumatic stress disorder and complicated grief. These morbid factors can be influenced by the death circumstances and in particular by the possibility given to the family to attend the medical management of the patient. This clinical trial aims to evaluate the psychological consequences of bereavement on the relatives according to the possibility of witnessing the cardiopulmonary resuscitation of a family member. This possibility lies within the scope of a strategy of global management of the relatives.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
570

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2009

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 6, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 9, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 18, 2013

Status Verified

December 1, 2012

Enrollment Period

2.1 years

First QC Date

November 6, 2009

Last Update Submit

January 17, 2013

Conditions

Cardiac Arrest

Keywords

Out-of-hospitalEmergencyCardiac arrestPost-traumatic stress disorder

Outcome Measures

Primary Outcomes (1)

  • Percentage of relatives having a score of the Impact of Events Scale (IES) > 30

    3 months

Secondary Outcomes (6)

  • Psychological questionnaires as the hospital anxiety and depression scale (HAD), the Mini International Neuropsychiatric Interview (MINI), the Inventory of Complicated Grief (ICG)

    3 and 12 months

  • Psychological follow-up

    3 months

  • Suicide

    3 and 12 months

  • Medico-legal recourse

    12 months

  • Quality of the cardiopulmonary resuscitation

    day 0

  • +1 more secondary outcomes

Study Arms (2)

Arm 1 : Control : usual strategy

ACTIVE COMPARATOR
Other: Usual strategy

Arm 2: Comparator : modified strategy

EXPERIMENTAL
Other: Modified strategy

Interventions

Usual strategyOTHER

Usual strategy

Arm 1 : Control : usual strategy
Modified strategyOTHER

Proposition to a relative to witness the cardiopulmonary resuscitation of a family member and debriefing ot the situation

Arm 2: Comparator : modified strategy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient victim of a cardiac arrest and resuscitation initiated
  • Occurrence of cardiac arrest at home
  • Presence of a relative :
  • husband or spouse
  • father or mother
  • son or daughter
  • brother or sister
  • Patient's age ≥ 18 years
  • Relative's age ≥ 18 years
  • Consent of the relative to the participation in the study

You may not qualify if:

  • No understanding of the explanations (language problem, important agitation)
  • Non-affiliated to social security

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SAMU 93 - Hôpital Avicenne

Bobigny, Île-de-France Region, 93000, France

Location

Related Publications (3)

  • Jabre P, Bougouin W, Dumas F, Carli P, Antoine C, Jacob L, Dahan B, Beganton F, Empana JP, Marijon E, Karam N, Loupy A, Lefaucheur C, Jost D, Cariou A, Adnet F, Rea TD, Jouven X. Early Identification of Patients With Out-of-Hospital Cardiac Arrest With No Chance of Survival and Consideration for Organ Donation. Ann Intern Med. 2016 Dec 6;165(11):770-778. doi: 10.7326/M16-0402. Epub 2016 Sep 13.

    PMID: 27618681DERIVED

  • Jabre P, Tazarourte K, Azoulay E, Borron SW, Belpomme V, Jacob L, Bertrand L, Lapostolle F, Combes X, Galinski M, Pinaud V, Destefano C, Normand D, Beltramini A, Assez N, Vivien B, Vicaut E, Adnet F. Offering the opportunity for family to be present during cardiopulmonary resuscitation: 1-year assessment. Intensive Care Med. 2014 Jul;40(7):981-7. doi: 10.1007/s00134-014-3337-1. Epub 2014 May 23.

    PMID: 24852952DERIVED

  • Jabre P, Belpomme V, Azoulay E, Jacob L, Bertrand L, Lapostolle F, Tazarourte K, Bouilleau G, Pinaud V, Broche C, Normand D, Baubet T, Ricard-Hibon A, Istria J, Beltramini A, Alheritiere A, Assez N, Nace L, Vivien B, Turi L, Launay S, Desmaizieres M, Borron SW, Vicaut E, Adnet F. Family presence during cardiopulmonary resuscitation. N Engl J Med. 2013 Mar 14;368(11):1008-18. doi: 10.1056/NEJMoa1203366.

    PMID: 23484827DERIVED

MeSH Terms

Conditions

Heart ArrestEmergenciesStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Frédéric ADNET, MD,PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2009

First Posted

November 9, 2009

Study Start

November 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

January 18, 2013

Record last verified: 2012-12

Locations

FR(1)