Assessment of the Feasibility of a Systematic Multidimensional Evaluation of the Outcome of Traumatic Brain Injury Patients and Their Relatives.
- Conditions
- Traumatic Brain Injury
- Interventions
- Other: Completion of questionnaires and on-site visits during an 18 months follow-up after TBI
- Registration Number
- NCT06194071
- Lead Sponsor
- Nantes University Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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.
- Patients under 18 years of age
- Single patient, without relative or informal caregiver
- Non-French-speaking patient
- Refusal of consent
- Patient under guardianship
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with Traumatic Brain Injury Completion of questionnaires and on-site visits during an 18 months follow-up after TBI Patients with all types of TBI will be recruited (mild, moderate and severe). They mus accept participation in the prolonged follow-up (up to 18 months after the accident). Relatives will also accept to participate. Patients will undergo routine care regarding TBI in our institution. Only the prolonged follow-up and monitoring is proposed which combines remote questionnaire completion, and on-site visits at 3 time-points (6, 12 and 18 months). No on-site visit is proposed for relatives who will fill out questionnaires. However, they may accompany patients during on-sites visits.
- Primary Outcome Measures
Name Time Method Analysis of the feasibility of multidimensional analysis 6 months Study the reasons for drop out of the follow-up
- Secondary Outcome Measures
Name Time Method Evolution over time of the outcome 18 months Modification of the medico-economic progress assessment using EQ5D-5L questionnaire results during follow-up
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
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
Trial Locations
- Locations (1)
CHU de Nantes
🇫🇷Nantes, France