Traumatic Brain Injury
Conditions
Keywords
Cohort, Pilot Study, Longitudinal follow-up
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.
Interventions
OTHERCompletion of questionnaires and on-site visits during an 18 months follow-up after TBI
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
Sponsors
Nantes University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analysis of the feasibility of multidimensional analysis | 6 months | The number of scales ( GOS-Extended, QOLIBRI, MoCA, BARTHEL INDEX, BICOQ, HADS, EQ5D-5L, ZARIT) entirely completed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evolution over time of the outcome | 18 months | Modification in functional outcomes assessed by GOS-Extended during the follow-up |
| Analysis of the feasibility of multidimensional analysis | 12 and 18 months | In-depth analysis of the completion of the follow-up at 12 and 18 months by patients and family caregivers |
| Analysis of engagement and attrition by the dyad | 12 and 18 months | The outcomes and questionnaires (GOS-Extended, QOLIBRI, MoCA, BARTHEL INDEX, BICOQ, HADS, EQ5D-5L, ZARIT) will be used throughout the study |
| Prognostic models | 18 months | Elaborate original predictive models between the acute phase of in-hospital TBI management. Collection of routine data during in-hospital management |
Countries
France
Contacts
Primary ContactRaphaël CINOTTI, Pr
Outcome results
None listed