The Long-term Consequences After Traumatic Brain Injury in the Elderly: a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Economic cost evaluation
研究概览
简要总结
A better understanding of the injury patterns, injury severity, risk profiles, consequences and impact of Traumatic Brain Injury (TBI) in the elderly population is necessary due to the increasing incidence and prevalence of TBI in this population and its high economic impact on society. Therefore, this study aims at describing the long-term consequences of TBI. In order to achieve that goal, injury patterns, injury severity and risk profiles for TBI in the elderly will be mapped. Moreover, a retrospective assessment of brain damage, co-morbidities and post-traumatic history, and a prospective assessment of cognitive functions and quality of life in a 20 years range after TBI will be performed. Finally, a statistical correlation of TBI and different types of neurodegenerative diseases, and an economic costs analysis will be done. All the obtained results will be used to develop a new prognostic tool for the course of the outcomes of TBI in the elderly population.
详细描述
A database of over 1200 patients will be created by the retrospective capture of the following data in UZ Leuven database:
Injury mechanisms data:
In order to create a map of injury patterns, severity and criteria that allow for identifying which accident circumstances ageing adults should reasonably be protected against, including a kinematics tolerance curve for the elderly brain that can be used for protection purposes, a retrospective analysis of data related to injury mechanisms, registered in the patient's clinical records, will be performed for the cohort of patients.
Clinical data:
Data regarding the following parameters will be retrospectively collected in UZ Leuven database for the studty cohort: age, sex, cause of injury, GCS, pupillary reactivity, hypoxia, hypotension, hypothermia and Marshall CT classification at the time of admission. Moreover, Glasgow Outcome Scale (GOSE) at 6 months after the accident, obtained in the context of routine clinical practice, will also be considered.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 65 years old at the time of the accident
- •admitted to UZ Leuven from 1999 and 2019
- •all injury severities
- •classified by the Glasgow Coma Scale (GCS) (mild (GCS 13-15), moderate (GCS 9-12) or severe (GCS ≤8))
- •having signed the informed consent to participate in the study.
排除标准
- •< 65 years old
- •admitted to UZ Leuven in a different period from 1999-2019
- •diagnosis of other neurodegenerative diseases before the TBI
- •cognitive and motor disturbances caused by any other pathology before the TBI
- •previous alcohol/drugs abuse
- •not having signed the informed consent to participate in the study
结局指标
主要结局
Economic cost evaluation
时间窗: August 2019-June 2021
In order to know what is the economic impact that TBI in the elderly has on society, hospital costs for the clinical management in our cohort will be retrospectively extracted from the financial database of UZ Leuven.
Injury mechanisms evaluation
时间窗: August 2019-June 2021
Injury mechanisms will be studied in order to better understand which accident circumstances ageing adults should reasonably be protected against. Results will be included in a descriptive report.
Sleep quality assessment
时间窗: August 2020-November 2022
A telephonic sleep quality assessment will be performed using the Pittsburgh Sleep Quality Index. In this scale, seven component scores are derived, each scored from 0 (which means no difficulty) to 3 (severe difficulty). The global score ranges between 0 and 21 points. Higher scores indicate worse sleep quality.
Quality of life assessment
时间窗: August 2019-November 2022
A telephonic quality of life evaluation will be performed using the Quality of Life after Brain Injury (QOLIBRI) tool, which is a 37-item questionnaire with six subscales that measure quality of life in the domains of cognition, self, daily life and autonomy, social relationships, emotions, and physical problems.The QOLIBRI scores are reported on a 0-100 scale, where 0=worst possible quality of life and 100=best possible quality of life. The approximate time necessary to fill this questionnaire in is 10 min.
Cognitive functions assessment
时间窗: August 2019-November 2022
A telephonic cognitive evaluation will be performed using the Telephone Interview for Cognitive Status (TICS) tool, which is a 11-items screening test for cognitive functions, including word list memory, orientation, attention, repetition, conceptual knowledge and nonverbal praxis. The TICS total score has a maximum of 41 points and higher scores mean better cognitive outcomes. The necessary time to perform it is 10 min or less. Moreover, the patients' level of education will be asked, registered and correlated with clinical data, cognitive functions and quality of life outcomes.
次要结局
未报告次要终点