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Assessment of the Feasibility of a Systematic Multidimensional Evaluation of the Outcome of Traumatic Brain Injury Patients and Their Relatives.

Recruiting
18 years of age
Both
Phase N/A

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Overview

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).

Description

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.

Eligibility

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients under 18 years of age
  • Single patient, without relative or informal caregiver
  • Non-French-speaking patient
  • Refusal of consent
  • Patient under guardianship

Study details

Traumatic Brain Injury

NCT06194071

Nantes University Hospital

25 January 2024

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