Cohort Study on the Effects of Aging in Acquired Brain Injury Patients
- Conditions
- Subarachnoid HemorrhageTraumatic Brain InjuryAcquired Brain InjuryCerebrovascular Accident
- Registration Number
- NCT05499806
- Lead Sponsor
- University Medical Center Groningen
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 800
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prevalence of the ABI-effect 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.
- Secondary Outcome Measures
Name Time Method Cognitive functions of patients and healthy volunteers A minimum of 5 years after ABI for patients The significant difference in cognitive functions between the patient groep and the healthy controls
Trial Locations
- Locations (2)
Revalidatiecentrum Heliomare Wijk aan Zee
🇳🇱Wijk Aan Zee, Netherlands
Isala klinieken
🇳🇱Zwolle, Overijssel, Netherlands