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).
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.
Study Type
OBSERVATIONAL
Enrollment
50
We will evaluate the same outcomes and use the same questionnaires at 6, 12 and 18 months post-TBI. For patients we will evaluate: * Functional Outcome (GOS-Extended) * Health-related Quality of Life (QOLIBRI) * Neurocognitive tests (MoCA) * Independence (Barthel Index) * Daily issues (BICOQ) * Anxiety and depression symptoms (HADS) * Medico-economic evaluation (EQ5D-5L) For Relatives we will evaluate: * Symptoms of anxiety and depression (HADS) * The appreciation of the patient's daily issues from their point of view (dedicated Bicoq for relatives) * Burden of care (ZARIT) Throughout the follow-up we will nest a qualitative research programs which will focus on several aspects: * feasibility of such follow-up (6 months is the primary endpoint) defined as the drop-out rate, complete or incomplete completion of scales and their reasons * factors that may lead to drop-out or the contrary that solidifies the follow-up
CHU de Nantes
Nantes, France
RECRUITINGAnalysis of the feasibility of multidimensional analysis
The number of scales ( GOS-Extended, QOLIBRI, MoCA, BARTHEL INDEX, BICOQ, HADS, EQ5D-5L, ZARIT) entirely completed
Time frame: 6 months
Analysis of the feasibility of multidimensional analysis
the number of missing items per scale
Time frame: 6 months
Analysis of the feasibility of multidimensional analysis
the number of patients seen at the on-site visit
Time frame: 6 months
Analysis of the feasibility of multidimensional analysis
the number of neur-cognitive tests (MoCA) carried out in full
Time frame: 6 months
Analysis of the feasibility of multidimensional analysis
Study the reasons of complete/incomplete items rating
Time frame: 6 months
Analysis of the feasibility of multidimensional analysis
Study the reasons for drop out of the follow-up
Time frame: 6 months
Analysis of the feasibility of multidimensional analysis
In-depth analysis of the completion of the follow-up at 12 and 18 months by patients and family caregivers
Time frame: 12 and 18 months
Analysis of engagement and attrition by the dyad
The outcomes and questionnaires (GOS-Extended, QOLIBRI, MoCA, BARTHEL INDEX, BICOQ, HADS, EQ5D-5L, ZARIT) will be used throughout the study
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Time frame: 12 and 18 months
Evolution over time of the outcome
Modification in functional outcomes assessed by GOS-Extended during the follow-up
Time frame: 18 months
Evolution over time of the outcome
Changes in health-related quality of life outcomes assessed by QOLIBRI during the follow-up
Time frame: 18 months
Evolution over time of the outcome
Modification in functional outcomes assessed by Barthel Index during the follow-up
Time frame: 18 months
Evolution over time of the outcome
Changes in MoCA neurocognitive test scores during the follow-up
Time frame: 18 months
Evolution over time of the outcome
Changes in the results of the BICOQ survey evaluating awareness of issues in day-to-day life during the follow-up
Time frame: 18 months
Evolution over time of the outcome
Modification of mood disorder questionnaire results evaluated by HADS during follow-up
Time frame: 18 months
Evolution over time of the outcome
Modification of the medico-economic progress assessment using EQ5D-5L questionnaire results during follow-up
Time frame: 18 months
Prognostic models
Elaborate original predictive models between the acute phase of in-hospital TBI management. Collection of routine data during in-hospital management
Time frame: 18 months