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Clinical Trials/NCT05499806
NCT05499806
Unknown
N/A

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

University Medical Center Groningen2 sites in 1 country800 target enrollmentMarch 18, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Acquired Brain Injury
Sponsor
University Medical Center Groningen
Enrollment
800
Locations
2
Primary Endpoint
Prevalence of the ABI-effect
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 18, 2022
End Date
February 1, 2024
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Joukje van der Naalt

Prof. dr. J. van der Naalt

University Medical Center Groningen

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

Outcomes

Primary Outcomes

Prevalence of the ABI-effect

Time Frame: 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 Outcomes

  • Cognitive functions of patients and healthy volunteers(A minimum of 5 years after ABI for patients)

Study Sites (2)

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