Traumatic Brain InjuryMUST²NCT06194071
Assessment of the Feasibility of a Systematic Multidimensional Evaluation of the Outcome of Traumatic Brain Injury Patients and Their Relatives.
An observational study of Traumatic Brain Injury, run by Nantes University Hospital at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Completion of questionnaires and on-site visits during an 18 months follow-up after TBI
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 11 Nov 2023to May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Our study population includes patients with mild to severe traumatic brain injury and their relatives (informal caregivers).
Who may be able to join
- 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.
Who cannot join
- Patients under 18 years of age
- Single patient, without relative or informal caregiver
- Non-French-speaking patient
- Refusal of consent
- Patient under guardianship
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Nantes
Nantes, 44093
Raphaël Cinotti, Pr, raphael.cinotti@chu-nantes.fr
About this study
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
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).
Read the 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
- Being tested
- Completion of questionnaires and on-site visits during an 18 months follow-up after TBI
- Keywords
- Cohort, Pilot Study, Longitudinal follow-up
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Completion of questionnaires and on-site visits during an 18 months follow-up after TBIOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Completion of questionnaires and on-site visits during an 18 months follow-up after TBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the feasibility of multidimensional analysis
The number of scales ( GOS-Extended, QOLIBRI, MoCA, BARTHEL INDEX, BICOQ, HADS, EQ5D-5L, ZARIT) entirely completed
Measured: 6 months
Analysis of the feasibility of multidimensional analysis
the number of missing items per scale
Measured: 6 months
Analysis of the feasibility of multidimensional analysis
the number of patients seen at the on-site visit
Measured: 6 months
Analysis of the feasibility of multidimensional analysis
the number of neur-cognitive tests (MoCA) carried out in full
Measured: 6 months
Analysis of the feasibility of multidimensional analysis
Study the reasons of complete/incomplete items rating
Measured: 6 months
Analysis of the feasibility of multidimensional analysis
Study the reasons for drop out of the follow-up
Measured: 6 months
Secondary outcomes (10)
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
Measured: 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
Measured: 12 and 18 months
Evolution over time of the outcome
Modification in functional outcomes assessed by GOS-Extended during the follow-up
Measured: 18 months
Evolution over time of the outcome
Changes in health-related quality of life outcomes assessed by QOLIBRI during the follow-up
Measured: 18 months
Evolution over time of the outcome
Modification in functional outcomes assessed by Barthel Index during the follow-up
Measured: 18 months
Evolution over time of the outcome
Changes in MoCA neurocognitive test scores during the follow-up
Measured: 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
Measured: 18 months
Evolution over time of the outcome
Modification of mood disorder questionnaire results evaluated by HADS during follow-up
Measured: 18 months
Evolution over time of the outcome
Modification of the medico-economic progress assessment using EQ5D-5L questionnaire results during follow-up
Measured: 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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start11 Nov 2023
- Primary completionNov 2024 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194071
- Sponsor's protocol ID
- AR_2023_002
- Acronym
- MUST²
- Status last verified
- Dec 2023
- First submitted
- 14 Nov 2023
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06194071
- Acronym / sponsor ID
- MUST² / AR_2023_002
- Conditions
- Traumatic Brain Injury
- Keywords
- Cohort, Pilot Study, Longitudinal follow-up
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 11 Nov 2023 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 8 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Traumatic Brain Injury | – | Other: Completion of questionnaires and on-site visits during an 18 months follow-up after TBIPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Our study population includes patients with mild to severe traumatic brain injury and their relatives (informal caregivers).
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- Patients under 18 years of age
- Single patient, without relative or informal caregiver
- Non-French-speaking patient
- Refusal of consent
- Patient under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Completion of questionnaires and on-site visits during an 18 months follow-up after TBIWe 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 | Other | Patients with Traumatic Brain Injury |
Primary outcome
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
Analysis of the feasibility of multidimensional analysis
Time frame: 6 months
the number of missing items per scale
Analysis of the feasibility of multidimensional analysis
Time frame: 6 months
the number of patients seen at the on-site visit
Analysis of the feasibility of multidimensional analysis
Time frame: 6 months
the number of neur-cognitive tests (MoCA) carried out in full
Analysis of the feasibility of multidimensional analysis
Time frame: 6 months
Study the reasons of complete/incomplete items rating
Analysis of the feasibility of multidimensional analysis
Time frame: 6 months
Study the reasons for drop out of the follow-up
10 secondary outcomes
Analysis of the feasibility of multidimensional analysis
Time frame: 12 and 18 months
Analysis of engagement and attrition by the dyad
Time frame: 12 and 18 months
Evolution over time of the outcome
Time frame: 18 months
Evolution over time of the outcome
Time frame: 18 months
Evolution over time of the outcome
Time frame: 18 months
Evolution over time of the outcome
Time frame: 18 months
Evolution over time of the outcome
Time frame: 18 months
Evolution over time of the outcome
Time frame: 18 months
Evolution over time of the outcome
Time frame: 18 months
Prognostic models
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raphaël CINOTTI, Pr (+33(0)240084731, raphael.cinotti@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of the feasibility of multidimensional analysis (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2024.