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

NCT06194071 | Unknown

• 1 other identifier: AR_2023_002
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Traumatic Brain Injury

Keywords

Cohort; Pilot Study; Longitudinal follow-up

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (10)

• Analysis of the feasibility of multidimensional analysis

  12 and 18 months

• Analysis of engagement and attrition by the dyad

  12 and 18 months

• Evolution over time of the outcome

  18 months

• Evolution over time of the outcome

  18 months

• Evolution over time of the outcome

  18 months

Study Arms (1)

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

Interventions

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

Patients with Traumatic Brain Injury

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Patients under 18 years of age
• Single patient, without relative or informal caregiver
• Non-French-speaking patient
• Refusal of consent
• Patient under guardianship

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU de Nantes

Nantes, 44093, France

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Raphaël CINOTTI, Pr

CONTACT

+33(0)240084731; raphael.cinotti@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: January 8, 2024
• Study Start: November 11, 2023
• Primary Completion: November 1, 2024
• Study Completion: May 1, 2025
• Last Updated: January 8, 2024

Record last verified: 2023-12

Locations

FR (1)