Cohort Study on the Effects of Aging in Acquired Brain Injury Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- Prevalence of the ABI-effect
研究概览
简要总结
A prospective cohort study (questionnaires), with an embedded case control study (neuropsychological assessments) in which the data is gathered within a timeframe of 3 years. A group of 700 patients and a group of 100 healthy volunteers will be participating.
详细描述
In the Netherlands an estimated 650.000 people live with the daily consequences of an Acquired Brain Injury (ABI). A substantial amount of these patients acquired their brain injury (traumatic brain injury, subarachnoid hemorrhage or cerebrovascular accident) at a relatively young age: between 18 and 50 years old. The chain-of-care for ABI aims for recovery in the subacute phase, usually within a period of one year after injury. After an adaptation period, the patients reach a new balance, with stabilization of complaints and reintegration, sometimes with the necessity of modifications. The group of patients who acquired a brain injury at a young age, have to face the effects of aging like decreased cognitive functions, which can cause the participation level to drop. This is called the ABI-effect in the current study. At this moment, insufficient information is available about the functioning of people who suffered ABI multiple years ago and have established a new balance, and now make the transition to an older phase of live.
Primary objective:
Explore the prevalence of the ABI-effect, by mapping the participation level.
Secondary objective:
Substantiate the occurence of the ABI-effect, by mapping cognitive functions of patients and compare these to healthy controls.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 50 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Current age range between 50-67 years [Rationale: having an age that enables the patient to experience the effects of aging with a low risk of neurodegenerative disease]
- •Able to complete questionnaires independently
- •Additionally, patients must also meet the following criteria:
- •Age of acquiring the ABI ≧ 25 years [Rationale: the brain is supposed to be fully developed at a maximum capacity
- •ABI must be ≧ 5 years ago] [Rationale :time period regarded sufficient to have achieved a stable level of cognitive functioning and participation after an ABI]
- •ABI diagnosis at hospital admission with abnormalities at the brain-CT or MRI
- •Independent regarding Activities of Daily Living
- •Not living in a long-term care facility
排除标准
- •Psychiatric disease (for which participant is currently treated)
- •Accompanying disease with reduced life expectancy
- •Neurological disease (including recurrent ABI for patients)
- •Language barriers prohibiting and completion of Dutch questionnaires
- •Alcohol or drug abuse
- •Suspected neurodegenerative disease
结局指标
主要结局
Prevalence of the ABI-effect
时间窗: A minimum of 5 years after ABI
The percentage of patients experiencing the ABI-effect. Also, a 95% confidence interval of this prevalence will be calculated.
次要结局
- Cognitive functions of patients and healthy volunteers(A minimum of 5 years after ABI for patients)
研究者
Joukje van der Naalt
Prof. dr. J. van der Naalt
University Medical Center Groningen