Assessment of the Feasibility of a Systematic Multidimensional Evaluation of the Outcome of Traumatic Brain Injury Patients and Their Relatives. (MUST²)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Other: Completion of questionnaires and on-site visits during an 18 months follow-up after TBI

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Raphaël CINOTTI, Pr; Phone Number: +33(0)240084731; Email: raphael.cinotti@chu-nantes.fr

Study Locations

• France
  • Nantes, France, 44093
    • Recruiting
    • CHU de Nantes
    • Contact: Raphaël Cinotti, Pr; Email: raphael.cinotti@chu-nantes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Our study population includes patients with mild to severe traumatic brain injury and their relatives (informal caregivers).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients with Traumatic Brain Injury; 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Analysis of the feasibility of multidimensional analysis	the number of missing items per scale	6 months
Analysis of the feasibility of multidimensional analysis	the number of patients seen at the on-site visit	6 months
Analysis of the feasibility of multidimensional analysis	the number of neur-cognitive tests (MoCA) carried out in full	6 months
Analysis of the feasibility of multidimensional analysis	Study the reasons of complete/incomplete items rating	6 months
Analysis of the feasibility of multidimensional analysis	Study the reasons for drop out of the follow-up	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Evolution over time of the outcome	Modification in functional outcomes assessed by GOS-Extended during the follow-up	18 months
Evolution over time of the outcome	Changes in health-related quality of life outcomes assessed by QOLIBRI during the follow-up	18 months
Evolution over time of the outcome	Modification in functional outcomes assessed by Barthel Index during the follow-up	18 months
Evolution over time of the outcome	Changes in MoCA neurocognitive test scores during the follow-up	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	18 months
Evolution over time of the outcome	Modification of mood disorder questionnaire results evaluated by HADS during follow-up	18 months
Evolution over time of the outcome	Modification of the medico-economic progress assessment using EQ5D-5L questionnaire results during follow-up	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	18 months

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2023
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: November 14, 2023
• First Submitted That Met QC Criteria: December 21, 2023
• First Posted (Estimated): January 8, 2024

Study Record Updates

• Last Update Posted (Estimated): January 8, 2024
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Cohort; Pilot Study; Longitudinal follow-up
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: AR_2023_002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No