Eight-year Outcome and Health Care After Severe Traumatic Brain Injury in the Parisian Area
试验速览
- 阶段
- 不适用
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Glasgow Outcome Scale-Extended
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients initially included in the Paris-TBI cohort, alive at time of evaluation. i.e.
- •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)
排除标准
- •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
结局指标
主要结局
Glasgow Outcome Scale-Extended
时间窗: Eight years post-injury (one unique all-including evaluation)
This scale is assessed by a structured interview about the difficulties the patient in simple or elaborate acts of daily life
次要结局
- Quality of life of caregiver(Eight years post-injury (one unique all-including evaluation))
- Caregiver burden (ZARIT questionnaire)(Eight years post-injury (one unique all-including evaluation))
- Capacity of motor vehicle driving, independence in daily living activities(Eight years post-injury (one unique all-including evaluation))
- Socio-professional integration(Eight years post-injury (one unique all-including evaluation))
- Patient's quality of life (0-10 numeric scale, by patient and caregiver)(Eight years post-injury (one unique all-including evaluation))
- 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))
- TBI-related complaints, by patient and caregiver(Eight years post-injury (one unique all-including evaluation))
- Hospital Anxiety and Depression(Eight years post-injury (one unique all-including evaluation))