跳至主要内容
临床试验/NCT06194071
NCT06194071招募中不适用

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

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年11月11日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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