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

Sponsor
University Medical Center Groningen (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05499806
Collaborator
ZonMw: The Netherlands Organisation for Health Research and Development (Other)
800
Enrollment
2
Locations
22.5
Anticipated Duration (Months)
400
Patients Per Site
17.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    800 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Cohort Study on the Effects of Aging in Acquired Brain Injury Patients
    Actual Study Start Date :
    Mar 18, 2022
    Anticipated Primary Completion Date :
    Mar 1, 2023
    Anticipated Study Completion Date :
    Feb 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Acquired Brain Injury Patients

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

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 67 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Isala klinieken Zwolle Overijssel Netherlands 8025 AB
    2 Revalidatiecentrum Heliomare Wijk aan Zee Wijk Aan Zee Netherlands

    Sponsors and Collaborators

    • University Medical Center Groningen
    • ZonMw: The Netherlands Organisation for Health Research and Development

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Joukje van der Naalt, Prof. dr. J. van der Naalt, University Medical Center Groningen
    ClinicalTrials.gov Identifier:
    NCT05499806
    Other Study ID Numbers:
    • NL79072.042.21
    First Posted:
    Aug 12, 2022
    Last Update Posted:
    Aug 12, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Brain Injuries
    Brain Injuries, Traumatic
    Subarachnoid Hemorrhage
    Stroke
    Hemorrhage
    Wounds and Injuries

    Study Results

    No Results Posted as of Aug 12, 2022