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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05499806
Acronym
BRAINReADAPT
Enrollment
800
Registered
2022-08-12
Start date
2022-03-18
Completion date
2024-02-01
Last updated
2022-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development
CollaboratorOTHER
University Medical Center Groningen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
50 Years to 67 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of the ABI-effectA minimum of 5 years after ABIThe percentage of patients experiencing the ABI-effect. Also, a 95% confidence interval of this prevalence will be calculated.

Secondary

MeasureTime frameDescription
Cognitive functions of patients and healthy volunteersA minimum of 5 years after ABI for patientsThe significant difference in cognitive functions between the patient groep and the healthy controls

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026