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

Traumatic Brain Injury Clinical Trial

— MUST²  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06194071
• Other study ID #: AR_2023_002
• Status: Recruiting
• Start date: November 11, 2023
• Est. completion date: May 2025

Study information

• Verified date: December 2023
• Source: Nantes University Hospital
• Contact: Raphaël CINOTTI, Pr
• Phone: +33(0)240084731
• Email: raphael.cinotti[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
France	CHU de Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of the feasibility of multidimensional analysis	The number of scales ( GOS-Extended, QOLIBRI, MoCA, BARTHEL INDEX, BICOQ, HADS, EQ5D-5L, ZARIT) entirely completed	6 months
Primary	Analysis of the feasibility of multidimensional analysis	the number of missing items per scale	6 months
Primary	Analysis of the feasibility of multidimensional analysis	the number of patients seen at the on-site visit	6 months
Primary	Analysis of the feasibility of multidimensional analysis	the number of neur-cognitive tests (MoCA) carried out in full	6 months
Primary	Analysis of the feasibility of multidimensional analysis	Study the reasons of complete/incomplete items rating	6 months
Primary	Analysis of the feasibility of multidimensional analysis	Study the reasons for drop out of the follow-up	6 months
Secondary	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	12 and 18 months
Secondary	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	12 and 18 months
Secondary	Evolution over time of the outcome	Modification in functional outcomes assessed by GOS-Extended during the follow-up	18 months
Secondary	Evolution over time of the outcome	Changes in health-related quality of life outcomes assessed by QOLIBRI during the follow-up	18 months
Secondary	Evolution over time of the outcome	Modification in functional outcomes assessed by Barthel Index during the follow-up	18 months
Secondary	Evolution over time of the outcome	Changes in MoCA neurocognitive test scores during the follow-up	18 months
Secondary	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	18 months
Secondary	Evolution over time of the outcome	Modification of mood disorder questionnaire results evaluated by HADS during follow-up	18 months
Secondary	Evolution over time of the outcome	Modification of the medico-economic progress assessment using EQ5D-5L questionnaire results during follow-up	18 months
Secondary	Prognostic models	Elaborate original predictive models between the acute phase of in-hospital TBI management. Collection of routine data during in-hospital management	18 months