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Status unknownNCT02341092AVEC-TCUpdated Jan 19, 2015

Analysis and Valuation of the Expertise of Use of the Close Friends of People Victims of Traumatic Brain Injury

An observational study in Traumatic Brain Injury, sponsored by University Hospital, Angers. Status unknown at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-01-19.

Sponsored by University Hospital, Angers · Observational

The sponsor has not verified this record recently (last verified Jan 2015), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Time perspective
Prospective
Enrollment
130
Ages
18 Years to 65 Years
Sex
All
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Study summary

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

Read the 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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Conditions studied

  • Traumatic Brain Injury

Keywords

  • Traumatic brain injury
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In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's planned enrollment of 130 is above the median of 100 across 690 observational studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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.

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

Exclusion Criteria:

  • Lack of consent to participate in the study
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Study design

Time perspective
Prospective
Enrollment
130 participants (estimated)
Patient registry
No

Interventions

  • BehavioralTraumatic brain injury

    Collection of the use of expertise relatives of victims of traumatic brain injury

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What researchers measure

Primary outcomes

  1. Collection of the expertise of the close friends(relations) of people victims of a post traumatic brain injury.

    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.

    Time frame: 1 day

Secondary outcomes

  1. Evaluation of the adequacy of therapeutic medicinal with the recommendations .

    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

    Time frame: 1 Day

  2. Evaluation of the resounding of the disorders(confusions) on the social participation.

    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

    Time frame: 1 Day

  3. Quantification of the frequency of the post-traumatic behavior disorders.

    The assessment criteria for the quantification of the frequency of the behavior disorders will be the ISDC score (Inventory of dysexecutive syndrome).

    Time frame: One day

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Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • Saout V, Gambart G, Leguay D, Ferrapie AL, Launay C, Richard I. Aggressive behavior after traumatic brain injury. Ann Phys Rehabil Med. 2011 Jun;54(4):259-69. doi: 10.1016/j.rehab.2011.04.003. Epub 2011 May 5. English, French. PubMed 21596642 ↗
  • Bayen E, Pradat-Diehl P, Jourdan C, Ghout I, Bosserelle V, Azerad S, Weiss JJ, Joel ME, Aegerter P, Azouvi P; Steering Committee of the PariS-TBI study. Predictors of informal care burden 1 year after a severe traumatic brain injury: results from the PariS-TBI study. J Head Trauma Rehabil. 2013 Nov-Dec;28(6):408-18. doi: 10.1097/HTR.0b013e31825413cf. PubMed 22691963 ↗
  • Fugate LP, Spacek LA, Kresty LA, Levy CE, Johnson JC, Mysiw WJ. Measurement and treatment of agitation following traumatic brain injury: II. A survey of the Brain Injury Special Interest Group of the American Academy of Physical Medicine and Rehabilitation. Arch Phys Med Rehabil. 1997 Sep;78(9):924-8. doi: 10.1016/s0003-9993(97)90051-4. PubMed 9305262 ↗
  • Osiurak F, Jarry C, Allain P, Aubin G, Etcharry-Bouyx F, Richard I, Bernard I, Le Gall D. Unusual use of objects after unilateral brain damage: the technical reasoning model. Cortex. 2009 Jun;45(6):769-83. doi: 10.1016/j.cortex.2008.06.013. Epub 2008 Nov 8. PubMed 19084221 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 19, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02341092
Lead sponsor
University Hospital, Angers
Responsible party
Sponsor
First posted
Jan 19, 2015
Start date
Feb 2013
Primary completion
Feb 2015 (estimated)
Completion
Jun 2015 (estimated)
Last update
Jan 19, 2015

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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