Cohort Study on the Effects of Aging in Acquired Brain Injury Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Tertiary objective: Gain insight in the need of care for patients, to enhance regular care after ABI.

Official Title
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Cohort Study on the Effects of Aging in Acquired Brain Injury Patients

Conditions
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Acquired Brain Injury, Subarachnoid Hemorrhage, Traumatic Brain Injury, Cerebrovascular Accident

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 67 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acquired Brain Injury Patients<br>Questionnaire and, if the requirements are met, a neuropsychological assessment. | |
| Healthy volunteers<br>Questionnaire and, if the requirements are met, a neuropsychological assessment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of the ABI-effect | The percentage of patients experiencing the ABI-effect. Also, a 95% confidence interval of this prevalence will be calculated. | A minimum of 5 years after ABI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive functions of patients and healthy volunteers | The significant difference in cognitive functions between the patient groep and the healthy controls | A minimum of 5 years after ABI for patients |