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

Traumatic Brain Injury Clinical Trial

— AVEC-TC  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02341092
• Other study ID #: 2012/34
• Status: Recruiting
• Phase: N/A
• First received: January 8, 2015
• Last updated: January 13, 2015
• Start date: February 2013
• Est. completion date: June 2015

Study information

• Verified date: January 2015
• Source: University Hospital, Angers
• Contact: Isabelle Richard-Crémieux, Md-PHD
• Phone: (0)2-41-35-17-19
• Email: Isabelle.richard[@]univ-angers.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

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..

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: June 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Intervention

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

Locations

Country	Name	City	State
France	Les Capucins	Angers	Pays de la Loire

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

References & Publications (4)

Bayen E, Pradat-Diehl P, Jourdan C, Ghout I, Bosserelle V, Azerad S, Weiss JJ, Joël 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 Pari — View Citation

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 Rehabilitatio — View Citation

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 — View Citation

Saoût 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day	No
Secondary	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	1 Day	No
Secondary	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	1 Day	No
Secondary	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).	One day	No

External Links

•   Web site of specialized rehabilitation center of Capucins