ECOGStudy of the One-year Outcomes of Patients Hospitalized in the Lariboisière Neurosurgery Department
Data Collection
Collected from today forward - ProspectiveMental Disorders+8
+ Brain Diseases
+ Brain Injuries
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: March 22, 2024
Actual date on which the first participant was enrolled.Traumatic brain injuries (TBI) are responsible for about 262 hospitalizations per 100,000 inhabitants in Europe each year. After a traumatic brain injury, 704 out of 100,000 individuals experience long-term consequences, including motor and/or balance disorders, fatigue, chronic pain, psychological disorders, and cognitive impairments such as memory problems, difficulties in comprehension, attentional deficits, and impairment of working memory. Without adequate rehabilitation, cognitive impairments can persist for several years, leading to significant socio-professional consequences such as job loss and social isolation, as well as medical and economic consequences. The Paris TBI study showed that upon discharge from acute care services, only 45% of patients who had suffered severe traumatic brain injuries were referred to specialized rehabilitation facilities, while 30% returned directly home. Additionally, there is a lack of cognitive assessment in acute care services. For instance, in services that treat stroke patients, only 61% of patients will meet with a rehabilitation professional before their discharge. Short cognitive screening batteries typically used in the acute phase to guide patients' discharge from the hospital include the Montreal Cognitive Assessment (MoCA) or the Mini-Mental State Examination (MMSE). However, these scores are not very specific or sensitive, are examiner-dependent, and require trained personnel. Currently, there are few validated digital cognitive assessment batteries available for acute-phase evaluation and routine use in traumatic brain injury patients. Furthermore, evaluating cognitive impairments early after a traumatic brain injury can be challenging due to various confounding factors (e.g., fatigue, stressful hospitalization context) and organizational factors. Nevertheless, early assessment of cognitive impairments remains essential in order to appropriately refer patients, if necessary, to specialized rehabilitation facilities. To address the need for better early detection of cognitive impairment following brain injuries, the investigators have developed the Cognitive Evaluation of Lariboisière (also known as Cog-First), a screening battery for cognitive impairments on a tablet device that can be quickly and independently completed by patients. Cog-First is now integrated into routine care in Lariboisière as a systematic pre-discharge assessment for patients discharged home without rehabilitation plan. The main goal of this project is to identify patients who are at risk of experiencing cognitive impairments that could significantly impact their long-term functional prognosis. The investigators will evaluate whether the initial results obtained through the systematic evaluation using Cog-First at the time of discharge can accurately predict the functional and cognitive outcomes at one year. This could enable us to identify at-risk patients before discharge from acute care and refer them to specialized rehabilitation units earlier, leading to improved future outcomes for these individuals. During the 1-year follow-up consultation after hospital discharge, eligible patients will be offered the opportunity to participate in the study. If they consent, their functional and cognitive abilities will be assessed using a set of tests and questionnaires. The assessments will include the modified Rankin score, IADL questionnaire, MoCA, Bref, Rivermead questionnaire, SF-36 questionnaire, CIQ-R questionnaire, and PCL-5 questionnaire.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.400 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Neurosurgery - Lariboisière hospital
Paris, FranceOpen Neurosurgery - Lariboisière hospital in Google Maps