- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02341092
Analysis and Valuation of the Expertise of Use of the Close Friends of People Victims of Traumatic Brain Injury (AVEC-TC)
January 13, 2015 updated by: University Hospital, Angers
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
Post-traumatic behavioral disorders : analysis and valuation of the expertise of use of the close friends of people victims of traumatic brain injury.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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..
Study Type
Observational
Enrollment (Anticipated)
130
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Isabelle Richard-Crémieux, Md-PHD
- Phone Number: 33 (0)2-41-35-17-19
- Email: Isabelle.richard@univ-angers.fr
Study Contact Backup
- Name: Virginie Saout, MD
- Phone Number: 33 02 41 35 17 09
- Email: virginie.saout@les-capucins-angers.fr
Study Locations
-
-
Pays de la Loire
-
Angers, Pays de la Loire, France, 49103
- Recruiting
- Les Capucins
-
Contact:
- Isabelle PI Richard-cremieux, Md-PhD
- Phone Number: 33 (0)2-41-35-17-19
- Email: Isabelle.richard@univ-angers.fr
-
Contact:
- Virginie IV Saout, MD
- Phone Number: 33 02 41 35 17 09
- Email: virginie.saout@les-capucins-angers.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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:
|
1 Day
|
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:
|
1 Day
|
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).
|
One day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Isabelle Richard-Crémieux, Md-PHD, University Hospital, Angers
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Anticipated)
February 1, 2015
Study Completion (Anticipated)
June 1, 2015
Study Registration Dates
First Submitted
January 8, 2015
First Submitted That Met QC Criteria
January 13, 2015
First Posted (Estimate)
January 19, 2015
Study Record Updates
Last Update Posted (Estimate)
January 19, 2015
Last Update Submitted That Met QC Criteria
January 13, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012/34
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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