Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06194071
Status:
RECRUITING
Last Update Posted:
2024-01-08
First Post:
2023-11-14
Brief Title:
Assessment of the Feasibility of a Systematic Multidimensional Evaluation of the Outcome of Traumatic Brain Injury Patients and Their Relatives
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MUST²
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None