PariS -TBI Study: Paris Severe Traumatic Brain Injury Study - 8 Years

Brain Injury Clinical Trial

— TCS8  

Official title:

Eight-year Outcome and Health Care After Severe Traumatic Brain Injury in the Parisian Area

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02050633
• Other study ID #: 2013-A00881-44
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 29, 2014
• Last updated: November 17, 2017
• Start date: December 2014
• Est. completion date: April 2018

Study information

• Verified date: November 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of the protocol is to pursue the long-term follow-up of a large cohort of severe traumatic brain injury patients. This outcome is to be described in terms of activity, participation, quality of life, socio-professional outcome, economical consequences and impact on caregivers, and in relation to health care provision.

Secondary objectives are to measure the impact on outcome of several predictive factors; to evaluate evolution of patients since the last (four-year) evaluation.

Description:

This work represents a part of a larger collaborative prospective study called PariS-TBI (Severe Traumatic Brain Injury in the Parisian area) financed by the French National Authority for Health. The Paris-TBI study was undertaken in 2004, to provide epidemiological data. Patients aged 15 or more were included if they had sustained a severe TBI in the Parisian area during a 20-months period (2005-2007), defined by an initial Coma Glasgow Score (GCS) of 8 or less. Data from patients' demographics, injury characteristics, acute and post acute phase were collected prospectively. A total of 504 patients were included, of which 257 were alive at the time of this study. Patients (n = 134) were evaluated through a phone interview at one year post traumatism, and had a face-to-face evaluation at four years post-injury (n = 147).

Investigations of the present work will be undertaken at eight years after the injury. Patients of the initial cohort will be contacted through post and phone call. Information about this follow up study will be given orally and through written form. Informed consent of patient or legal advisor will be obtained before setting an appointment for the evaluation.

Evaluation will take place either in the patient's place of living, or in a clinical setting in the hospitals Broussais, Paris, France or Raymond Poincaré, Garches, France, according to the patient's choice.

A trained neuropsychologist will lead the evaluations, during an interview with the patient and the informal caregiver, defined as the person (family member or friend), most responsible for day-to-day decision making and care for the patient. If a patient cannot attend the interview, a short questionnaire will be proposed to him by the neuropsychologist by phone.

Demographic and pre-traumatism clinical data will be available from the initial study, as well as data on type and severity of traumatism, and on evolution during acute care. Data from the one-year and the four-year assessments will be available.

Data assessed through the present study will include an evaluation of deficiencies: presence of somatic deficiencies, mood difficulties (Hospital Anxiety and Depression Score), cognitive deficiencies (Dysexecutive Questionnaire, questionnaire of complaints, filled in both by the patient himself and by his proxy). Neuropsychological testing will include the California Verbal Learning Test, Trail Making Test, the WAIS-IV Processing Speed Index, and the 6-Elements Test.

Activities will be evaluated by the Glasgow Outcome Scale-Extended, and specifically through questions addressing driving ability, and ability to perform instrumental activities.

Professional activity and change, and quality of life at work will be assessed through a standardized questionnaire.

Data on patients' clinical care and services will be collected, including medical care, therapies, home assistance, socio-vocational assistance. Unmet need of services and barriers to care access will be assessed through a standardized questionnaire.

Data on the quality of life of the informal caregiver and an evaluation of the burden of care will be collected, using the ZARIT questionnaire. Data on economical consequences of the injury on the patient, and on his care provider will be collected.

The exploitation of this large database will enable an up-to-date description of the long term outcomes of severe TBI patients in the Parisian area. It will be used to clarify the role of several factors on long term activities and participations and on informal care burden.

The comparison with the previous evaluations will allow evaluation of late evolution and of its determinants.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 130
• Est. completion date: April 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria: all patients initially included in the Paris-TBI cohort, alive at time of evaluation. i.e.

• Adults

• Severe TBI with a Glasgow Coma Scale (GCS) score of 8 or less before admission to the hospital

• Accident within the Regional Parisian area (Paris and 7 surrounding districts)

Exclusion Criteria:

• Refusal to participate

• Impossibility to contact the person

• Current living place outside the Parisian area

• Impossibility to answer the questionnaire, in the absence of a proxy to assist

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Brain Injury
• Craniocerebral Trauma
• Trauma, Nervous System
• Wounds and Injuries

Locations

Country	Name	City	State
France	CRFTC	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glasgow Outcome Scale-Extended	This scale is assessed by a structured interview about the difficulties the patient in simple or elaborate acts of daily life	Eight years post-injury (one unique all-including evaluation)
Secondary	Neuropsychological testing: memory (California Verbal Learning Test), executive functioning (6-Elements Test, Dysexecutive Questionnaire by patient and caregiver), speed index (Trail Making Test, WAIS-IV Processing Speed Index).		Eight years post-injury (one unique all-including evaluation)
Secondary	TBI-related complaints, by patient and caregiver		Eight years post-injury (one unique all-including evaluation)
Secondary	Capacity of motor vehicle driving, independence in daily living activities		Eight years post-injury (one unique all-including evaluation)
Secondary	Socio-professional integration		Eight years post-injury (one unique all-including evaluation)
Secondary	Hospital Anxiety and Depression		Eight years post-injury (one unique all-including evaluation)
Secondary	Patient's quality of life (0-10 numeric scale, by patient and caregiver)		Eight years post-injury (one unique all-including evaluation)
Secondary	Quality of life of caregiver		Eight years post-injury (one unique all-including evaluation)
Secondary	Caregiver burden (ZARIT questionnaire)		Eight years post-injury (one unique all-including evaluation)