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

• Conditions: Subarachnoid Hemorrhage; Traumatic Brain Injury; Acquired Brain Injury; Cerebrovascular 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.

Study Timeline

• Study Start: 2022-03-18
• Study First Submitted: 2022-07-26
• Status Verified: 2022-08
• Study First Submitted QC: 2022-08-11
• Last Update Submitted: 2022-08-11
• Study First Posted: 2022-08-12
• Last Update Posted: 2022-08-12
• Primary Completion: 2023-03-01
• Study Completion: 2024-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 800

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

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)

Isala klinieken; 🇳🇱 Zwolle, Overijssel, Netherlands

Revalidatiecentrum Heliomare Wijk aan Zee; 🇳🇱 Wijk Aan Zee, Netherlands