Clinical trial NCT05499806: Cohort Study on the Effects of Aging in Acquired Brain Injury Patients
Official title: Cohort Study on the Effects of Aging in Acquired Brain Injury Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acquired Brain Injury
Subarachnoid Hemorrhage
Traumatic Brain Injury
Cerebrovascular Accident
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2022-08-12
Enrollment: 800
Sex: ALL
Minimum age (years): 50
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have suffered an acute ABI defined by a traumatic brain injury, stroke or subarachnoid haemorrhage who have been admitted at the UMCG or one of the other participating centers.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of the ABI-effect
timeFrame: A minimum of 5 years after ABI
Secondary outcomes:
measure: Cognitive functions of patients and healthy volunteers
timeFrame: A minimum of 5 years after ABI for patients
Other outcomes:
Locations:
city: Zwolle
country: Netherlands
facility: Isala klinieken
state: Overijssel
city: Wijk Aan Zee
country: Netherlands
facility: Revalidatiecentrum Heliomare Wijk aan Zee
Study officials:
References: