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Analysis and Valuation of the Expertise of Use of the Close Friends of People Victims of Traumatic Brain Injury (AVEC-TC)

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ClinicalTrials.gov Identifier: NCT02341092
Recruitment Status : Unknown
Verified January 2015 by University Hospital, Angers.
Recruitment status was:  Recruiting
First Posted : January 19, 2015
Last Update Posted : January 19, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Brief Summary:
Post-traumatic behavioral disorders : analysis and valuation of the expertise of use of the close friends of people victims of traumatic brain injury.

Condition or disease Intervention/treatment
Traumatic Brain Injury Behavioral: Traumatic brain injury

Detailed Description:
Collection of the expertise of use of the close friends of people victims of traumatic brain injury. The objective of the work is to collect, to describe, to analyze the corpus of knowledge of the close friends and to transcribe it in two registers, theoretical and practical..

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Study Type : Observational
Estimated Enrollment : 130 participants
Time Perspective: Prospective
Official Title: AVEC-TC : Post-traumatic Behavioral Disorders : Analysis and Valuation of the Expertise of Use of the Close Relations of People Victims of Traumatic Brain Injury
Study Start Date : February 2013
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine



Intervention Details:
  • Behavioral: Traumatic brain injury
    Collection of the use of expertise relatives of victims of traumatic brain injury


Primary Outcome Measures :
  1. Collection of the expertise of the close friends(relations) of people victims of a post traumatic brain injury. [ Time Frame: 1 day ]
    The main assessment criteria will be the definition of a list of skills to acquire on behalf of close friends(relations) of a person with a post traumatic brain injury to face, warn and adapt itself to the behavior disorders pos traumatic.


Secondary Outcome Measures :
  1. Evaluation of the adequacy of therapeutic medicinal with the recommendations . [ Time Frame: 1 Day ]

    Assessment criteria for the evaluation of the use of the therapeutic and their adequacy with the recommendations will be:

    • Patients percentage under psychotropics
    • Patients percentage under neuroleptic first generation

  2. Evaluation of the resounding of the disorders(confusions) on the social participation. [ Time Frame: 1 Day ]

    Assessment criteria for the resounding of the disorders(confusions) on the social participation will be:

    • The scores Qolibri
    • The scores CIQ
    • The correlation between scores ISDC and Qolibri
    • The correlation between score ISDC and the SF36 score of quality of life of the close friends(relations)
    • The correlation between score ISDC and CIQ

  3. Quantification of the frequency of the post-traumatic behavior disorders. [ Time Frame: One day ]
    The assessment criteria for the quantification of the frequency of the behavior disorders will be the ISDC score (Inventory of dysexecutive syndrome).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Victim of a grave or moderate traumatic brain injury and existence of at least a referent close friend (relation): parent (relative), child, spouse, professionnal, other.
Criteria

Inclusion Criteria:

  • Victim of a grave or moderate traumatic brain injury.
  • Living at home or in institution
  • Seen in consultation in the UH of Angers in neurology and/or in the center of rehabilitation specialized the Capuins and/or followed by Arch Anjou and/or sent by the associations of families.
  • 18 - 65 years at the time of the inclusion
  • Moderate or grave traumatic brain injury, defined by the score of initial Glasgow 13 and/or a hospitalization of at least 48 hours in intensive care.
  • Existence of at least a referent Close friend(relation) : parent(relative), child, spouse, professionnal or other.
  • Obtaining of the informed consent of the cranial traumatized, the close friend and the guardian if necessary.

Exclusion Criteria:

  • Lack of consent to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02341092


Contacts
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Contact: Isabelle Richard-Crémieux, Md-PHD (0)2-41-35-17-19 ext 33 Isabelle.richard@univ-angers.fr
Contact: Virginie Saout, MD 02 41 35 17 09 ext 33 virginie.saout@les-capucins-angers.fr

Locations
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France
Les Capucins Recruiting
Angers, Pays de la Loire, France, 49103
Contact: Isabelle PI Richard-cremieux, Md-PhD    (0)2-41-35-17-19 ext 33    Isabelle.richard@univ-angers.fr   
Contact: Virginie IV Saout, MD    02 41 35 17 09 ext 33    virginie.saout@les-capucins-angers.fr   
Sponsors and Collaborators
University Hospital, Angers
Investigators
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Principal Investigator: Isabelle Richard-Crémieux, Md-PHD University Hospital, Angers

Additional Information:
Publications of Results:
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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT02341092     History of Changes
Other Study ID Numbers: 2012/34
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: January 19, 2015
Last Verified: January 2015

Keywords provided by University Hospital, Angers:
Traumatic brain injury

Additional relevant MeSH terms:
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Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System