NCT06194071

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
OTHER	Completion 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

Timeline

• Start date: 2023-11-11
• Primary completion: 2024-11-01
• Completion: 2025-05-01
• First posted: 2024-01-08
• Last updated: 2024-01-08

Locations

1 site across 1 country: France