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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
For Relatives we will evaluate:
Throughout the follow-up we will nest a qualitative research programs which will focus on several aspects:
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Our study population includes patients with mild to severe traumatic brain injury and their relatives (informal caregivers).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raphaƫl CINOTTI, Pr | Contact | +33(0)240084731 | raphael.cinotti@chu-nantes.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nantes | Recruiting | Nantes | 44093 | France |
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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 |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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