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

December 21, 2023 updated by: Nantes University Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Analysis of the feasibility of multidimensional analysis
Time Frame: 6 months
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
Time Frame: 6 months
the number of missing items per scale
6 months
Analysis of the feasibility of multidimensional analysis
Time Frame: 6 months
the number of patients seen at the on-site visit
6 months
Analysis of the feasibility of multidimensional analysis
Time Frame: 6 months
the number of neur-cognitive tests (MoCA) carried out in full
6 months
Analysis of the feasibility of multidimensional analysis
Time Frame: 6 months
Study the reasons of complete/incomplete items rating
6 months
Analysis of the feasibility of multidimensional analysis
Time Frame: 6 months
Study the reasons for drop out of the follow-up
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Analysis of the feasibility of multidimensional analysis
Time Frame: 12 and 18 months
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
Time Frame: 12 and 18 months
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
Time Frame: 18 months
Modification in functional outcomes assessed by GOS-Extended during the follow-up
18 months
Evolution over time of the outcome
Time Frame: 18 months
Changes in health-related quality of life outcomes assessed by QOLIBRI during the follow-up
18 months
Evolution over time of the outcome
Time Frame: 18 months
Modification in functional outcomes assessed by Barthel Index during the follow-up
18 months
Evolution over time of the outcome
Time Frame: 18 months
Changes in MoCA neurocognitive test scores during the follow-up
18 months
Evolution over time of the outcome
Time Frame: 18 months
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
Time Frame: 18 months
Modification of mood disorder questionnaire results evaluated by HADS during follow-up
18 months
Evolution over time of the outcome
Time Frame: 18 months
Modification of the medico-economic progress assessment using EQ5D-5L questionnaire results during follow-up
18 months
Prognostic models
Time Frame: 18 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 11, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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