Assessment of the Feasibility of a Systematic Multidimensional Evaluation of the Outcome of Head Injury Patients and Their Families. A Single-center Pilot Cohort With Repeated Longitudinal Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Analysis of the feasibility of multidimensional analysis
研究概览
简要总结
The main objective is to assess the feasibility of collecting and implementing a multidimensional evaluation in a sample of patients with a mild to severe traumatic brain injury (TBI) and their relatives, evaluated at 6 months (primary outcome), and at 12 then 18 months post-injury (secondary outcomes).
详细描述
The study aims to assess the feasibility of collecting multidimensional outcomes of patients with traumatic brain injury, taking into account the patient-relative dyad. However, this multidimensional assessment may pose enormous problems of feasibility during the follow-up: loss of the patient's pathway, moderate acceptance by patients and relatives, difficulties of remote assessment sometimes carried out several times.... All these factors can affect the methodological quality of the evaluation of patient outcomes, with measurement and reporting biases influencing the results of biomedical trials. In order to improve the quality of clinical research in this field, it is therefore essential to fully appreciate the factors that facilitate or, on the contrary, hinder high-quality longitudinal follow-up.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to ICU with Glasgow score during initial car ≤ 14 and CT-confirmed head injury
- •Patients admitted to ER with Glasgow score during initial care ≤ 15 or concussion and CT-confirmed head injury or displaying clinicalsigns such as headaches or vomiting.
排除标准
- •Patients under 18 years of age
- •Single patient, without relative or informal caregiver
- •Non-French-speaking patient
- •Refusal of consent
- •Patient under guardianship
结局指标
主要结局
Analysis of the feasibility of multidimensional analysis
时间窗: 6 months
Study the reasons for drop out of the follow-up
次要结局
- Evolution over time of the outcome(18 months)
- Prognostic models(18 months)
- Analysis of the feasibility of multidimensional analysis(12 and 18 months)
- Analysis of engagement and attrition by the dyad(12 and 18 months)
