Cardiopulmonary Resuscitation Witnessing by a Relative (PRESENCE)

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01009606
First received: November 6, 2009
Last updated: January 17, 2013
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Cardiac Arrest
Other: Usual strategy
Other: Modified strategy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Interest for a Relative of Seeing Himself Proposing to Witness Resuscitation of a Family Member Victim of a Cardiac Arrest

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Percentage of relatives having a score of the Impact of Events Scale (IES) > 30 [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Psychological questionnaires as the hospital anxiety and depression scale (HAD), the Mini International Neuropsychiatric Interview (MINI), the Inventory of Complicated Grief (ICG) [ Time Frame: 3 and 12 months ] [ Designated as safety issue: Yes ]
  • Psychological follow-up [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Suicide [ Time Frame: 3 and 12 months ] [ Designated as safety issue: Yes ]
  • Medico-legal recourse [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Quality of the cardiopulmonary resuscitation [ Time Frame: day 0 ] [ Designated as safety issue: Yes ]
  • Questionnaire evaluating the stress of the medical and paramedical team [ Time Frame: day 0 ] [ Designated as safety issue: Yes ]

Enrollment: 570
Study Start Date: November 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1 : Control : usual strategy Other: Usual strategy
Usual strategy
Experimental: Arm 2: Comparator : modified strategy Other: Modified strategy
Proposition to a relative to witness the cardiopulmonary resuscitation of a family member and debriefing ot the situation

Detailed Description:

This clinical trial aims to compare the presence of post-traumatic stress disorder on a relative related to the death of a family member:

Test group: the medical team will propose to the relative to witness the cardiopulmonary resuscitation.

Control group: the medical team will not modify its usual management of care.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • No understanding of the explanations (language problem, important agitation)
  • Non-affiliated to social security
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01009606

Locations
France
SAMU 93 - Hôpital Avicenne
Bobigny, Ile de France, France, 93000
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Investigators
Principal Investigator: Frédéric ADNET, MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided by Assistance Publique - Hôpitaux de Paris

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01009606     History of Changes
Other Study ID Numbers: P071239
Study First Received: November 6, 2009
Last Updated: January 17, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Out-of-hospital
Emergency
Cardiac arrest
Post-traumatic stress disorder

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 20, 2014