Traumatic Brain InjuryAVEC-TCNCT02341092
Analysis and Valuation of the Expertise of Use of the Close Friends of People Victims of Traumatic Brain Injury
An observational study of Traumatic Brain Injury, run by University Hospital, Angers at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Traumatic brain injury
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2013to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Lack of consent to participate in the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Les Capucins
Angers, Pays de la Loire Region, 49103
Isabelle PI Richard-cremieux, Md-PhD, (0)2-41-35-17-19 ext. 33, Isabelle.richard@univ-angers.fr
Virginie IV Saout, MD, 02 41 35 17 09 ext. 33, virginie.saout@les-capucins-angers.fr
About this study
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
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..
- Conditions
- Traumatic Brain Injury
- Being tested
- Traumatic brain injury
- Keywords
- Traumatic brain injury
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traumatic brain injuryBehavioural
Collection of the use of expertise relatives of victims of traumatic brain injury
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (3)
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
Measured: 1 Day
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
Measured: 1 Day
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).
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startFeb 2013
- Primary completionFeb 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Isabelle Richard-Crémieux, Md-PHD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02341092
- Sponsor's protocol ID
- 2012/34
- Acronym
- AVEC-TC
- Status last verified
- Jan 2015
- First submitted
- 8 Jan 2015
- Last updated
- 19 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
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 21596642Bayen 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 22691963Fugate 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 9305262Osiurak 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02341092
- Acronym / sponsor ID
- AVEC-TC / 2012/34
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic brain injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Feb 2013
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 19 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post-traumatic behavioral disorders : analysis and valuation of the expertise of use of the close friends of people victims of 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..
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (1 listed)
- Lack of consent to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traumatic brain injuryCollection of the use of expertise relatives of victims of traumatic brain injury | Behavioural | – |
Primary outcome
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.
3 secondary outcomes
Evaluation of the adequacy of therapeutic medicinal with the recommendations .
Time frame: 1 Day
Evaluation of the resounding of the disorders(confusions) on the social participation.
Time frame: 1 Day
Quantification of the frequency of the post-traumatic behavior disorders.
Time frame: One day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2015.
- Results publication: PubMed 21596642Saout 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.
- Results publication: PubMed 22691963Bayen 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.
- Results publication: PubMed 9305262Fugate 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.
- Results publication: PubMed 19084221Osiurak 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Richard-Crémieux, Md-PHD principal investigator
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabelle Richard-Crémieux, Md-PHD ((0)2-41-35-17-19 ext. 33, Isabelle.richard@univ-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of the expertise of the close friends(relations) of people victims of a post traumatic brain injury. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02341092, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2015; AzTrials last refreshed its copy on 8 Nov 2026.