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

NCT ID: NCT06194071

Last Updated: 2024-01-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-11
• Study Completion Date: 2025-05-31

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.

Conditions

Traumatic Brain Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Completion of questionnaires and on-site visits during an 18 months follow-up after TBI

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Nantes

Nantes, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Raphaël CINOTTI, Pr

Role: CONTACT

raphael.cinotti@chu-nantes.fr

+33(0)240084731

Facility Contacts

Raphaël Cinotti, Pr

Role: primary

raphael.cinotti@chu-nantes.fr

Other Identifiers

AR_2023_002

Identifier Type: -

Identifier Source: org_study_id