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

NCT ID: NCT05499806

Last Updated: 2022-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-18

Study Completion Date

2024-02-01

Brief Summary

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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

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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.

Conditions

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Acquired Brain Injury Subarachnoid Hemorrhage Traumatic Brain Injury Cerebrovascular Accident

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Acquired Brain Injury Patients

Questionnaire and, if the requirements are met, a neuropsychological assessment.

No interventions assigned to this group

Healthy volunteers

Questionnaire and, if the requirements are met, a neuropsychological assessment.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role collaborator

University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Joukje van der Naalt

Prof. dr. J. van der Naalt

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Isala klinieken

Zwolle, Overijssel, Netherlands

Site Status

Revalidatiecentrum Heliomare Wijk aan Zee

Wijk aan Zee, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NL79072.042.21

Identifier Type: -

Identifier Source: org_study_id

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