Clinical trial NCT06194071: Assessment of the Feasibility of a Systematic Multidimensional Evaluation of the Outcome of Traumatic Brain Injury Patients and Their Relatives.
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Traumatic Brain Injury
Keywords: Cohort
Pilot Study
Longitudinal follow-up
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Our study population includes patients with mild to severe traumatic brain injury and their relatives (informal caregivers).

Brief summary: 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).

Detailed 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 criteria: 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

Primary outcomes:
measure: Analysis of the feasibility of multidimensional analysis
timeFrame: 6 months
measure: Analysis of the feasibility of multidimensional analysis
timeFrame: 6 months
measure: Analysis of the feasibility of multidimensional analysis
timeFrame: 6 months
measure: Analysis of the feasibility of multidimensional analysis
timeFrame: 6 months
measure: Analysis of the feasibility of multidimensional analysis
timeFrame: 6 months
measure: Analysis of the feasibility of multidimensional analysis
timeFrame: 6 months
Secondary outcomes:
measure: Analysis of the feasibility of multidimensional analysis
timeFrame: 12 and 18 months
measure: Analysis of engagement and attrition by the dyad
timeFrame: 12 and 18 months
measure: Evolution over time of the outcome
timeFrame: 18 months
measure: Evolution over time of the outcome
timeFrame: 18 months
measure: Evolution over time of the outcome
timeFrame: 18 months
measure: Evolution over time of the outcome
timeFrame: 18 months
measure: Evolution over time of the outcome
timeFrame: 18 months
measure: Evolution over time of the outcome
timeFrame: 18 months
measure: Evolution over time of the outcome
timeFrame: 18 months
measure: Prognostic models
timeFrame: 18 months
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
References: