NCT02341092

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

January 19, 2015

Status Verified

January 1, 2015

Enrollment Period

2 years

First QC Date

January 8, 2015

Last Update Submit

January 13, 2015

Conditions

Traumatic Brain Injury

Keywords

Traumatic brain injury

Outcome Measures

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.

    1 day

Secondary Outcomes (3)

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

    1 Day

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

    1 Day

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

    One day

Interventions

Traumatic brain injuryBEHAVIORAL

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • Lack of consent to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Les Capucins

Angers, Pays de la Loire Region, 49103, France

RECRUITING

Related Publications (4)

  • 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.

    PMID: 21596642RESULT

  • 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.

    PMID: 22691963RESULT

  • 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.

    PMID: 9305262RESULT

  • 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.

    PMID: 19084221RESULT

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Isabelle Richard-Crémieux, Md-PHD

    University Hospital, Angers

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabelle Richard-Crémieux, Md-PHD

CONTACT

(0)2-41-35-17-19Isabelle.richard@univ-angers.fr

Virginie Saout, MD

CONTACT

02 41 35 17 09virginie.saout@les-capucins-angers.fr

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2015

First Posted

January 19, 2015

Study Start

February 1, 2013

Primary Completion

February 1, 2015

Study Completion

June 1, 2015

Last Updated

January 19, 2015

Record last verified: 2015-01

Locations

FR(1)