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The Long-term Consequences After Traumatic Brain Injury in the Elderly

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ClinicalTrials.gov Identifier: NCT04074850
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
prof. dr. Bart Depreitere, Universitaire Ziekenhuizen Leuven

Brief Summary:
A better understanding of the injury patterns, injury severity, risk profiles, consequences and impact of Traumatic Brain Injury (TBI) in the elderly population is necessary due to the increasing incidence and prevalence of TBI in this population and its high economic impact on society. Therefore, this study aims at describing the long-term consequences of TBI. In order to achieve that goal, injury patterns, injury severity and risk profiles for TBI in the elderly will be mapped. Moreover, a retrospective assessment of brain damage, co-morbidities and post-traumatic history, and a prospective assessment of cognitive functions and quality of life in a 20 years range after TBI will be performed. Finally, a statistical correlation of TBI and different types of neurodegenerative diseases, and an economic costs analysis will be done. All the obtained results will be used to develop a new prognostic tool for the course of the outcomes of TBI in the elderly population.

Condition or disease
Traumatic Brain Injury Aging Cognitive Impairment Quality of Life

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: The Long-term Consequences After Traumatic Brain Injury in the Elderly: a Prospective Study
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : June 2, 2023

Resource links provided by the National Library of Medicine


Group/Cohort
TBI group

A cohort of patients admitted to UZ Leuven from 1999 to 2019 due to Traumatic Brain Injury and fulfilling our inclusion and exclusion criteria will be recruited.

Inclusion criteria will be: ≥ 65 years old at the time of the accident, admitted to UZ Leuven from 1999 and 2019, all injury severities, classified by the Glasgow Coma Scale (GCS) (mild (GCS 13-15), moderate (GCS 9-12) or severe (GCS ≤8)), and having signed the informed consent to participate in the study.

Exclusion criteria will be: < 65 years old, admitted to UZ Leuven in a different period from 1999-2019, diagnosis of other neurodegenerative diseases before the TBI, cognitive and motor disturbances caused by any other pathology before the TBI, previous alcohol/drugs abuse, and not having signed the informed consent to participate in the study.




Primary Outcome Measures :
  1. Injury mechanisms evaluation [ Time Frame: August 2019-June 2021 ]
    Injury mechanisms will be studied in order to better understand which accident circumstances ageing adults should reasonably be protected against. Results will be included in a descriptive report.

  2. Economic cost evaluation [ Time Frame: August 2019-June 2021 ]
    In order to know what is the economic impact that TBI in the elderly has on society, hospital costs for the clinical management in our cohort will be retrospectively extracted from the financial database of UZ Leuven.

  3. Cognitive functions assessment [ Time Frame: August 2019-June 2021 ]

    A telephonic cognitive evaluation will be performed using the Telephone Interview for Cognitive Status (TICS) tool, which is a 11-items screening test for cognitive functions, including word list memory, orientation, attention, repetition, conceptual knowledge and nonverbal praxis. The TICS total score ranges between 0 and 50 points and can be interpreted in four different categories of qualitative impairment: Unimpaired, Ambiguous, Mildly Impaired, and Moderately to Severely Impaired.The necessary time to perform it is 10 min or less.

    Moreover, the patients' level of education will be asked, registered and correlated with clinical data, cognitive functions and quality of life outcomes.


  4. Quality of life assessment [ Time Frame: August 2019-June 2021 ]
    A telephonic quality of life evaluation will be performed using the Quality of Life after Brain Injury (QOLIBRI) tool, which is a 37-item questionnaire with six subscales that measure quality of life in the domains of cognition, self, daily life and autonomy, social relationships, emotions, and physical problems.The QOLIBRI scores are reported on a 0-100 scale , where 0=worst possible quality of life and 100=best possible quality of life. The approximate time necessary to fill this questionnaire in is 10 min.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients older than 65 years old with a Traumatic Brain Injury diagnose that were admitted in UZ Leuven after the accident between 1999 and 2019
Criteria

Inclusion Criteria:

  • ≥ 65 years old at the time of the accident
  • admitted to UZ Leuven from 1999 and 2019
  • all injury severities
  • classified by the Glasgow Coma Scale (GCS) (mild (GCS 13-15), moderate (GCS 9-12) or severe (GCS ≤8))
  • having signed the informed consent to participate in the study.

Exclusion Criteria:

  • < 65 years old
  • admitted to UZ Leuven in a different period from 1999-2019
  • diagnosis of other neurodegenerative diseases before the TBI
  • cognitive and motor disturbances caused by any other pathology before the TBI
  • previous alcohol/drugs abuse
  • not having signed the informed consent to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04074850


Contacts
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Contact: Rebeca Alejandra Gavrila Laic, MSc +32 16 32 30 17 rebecaalejandra.gavrilalaic@kuleuven.be

Locations
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Belgium
UZ Leuven Recruiting
Leuven, Belgium, 3000
Principal Investigator: Bart Depreitere, PhD         
Sub-Investigator: Rebeca Alejandra Gavrila Laic, MSc         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Bart Depreitere, PhD UZ Leuven

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Responsible Party: prof. dr. Bart Depreitere, Clinical professor, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT04074850     History of Changes
Other Study ID Numbers: S62848
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by prof. dr. Bart Depreitere, Universitaire Ziekenhuizen Leuven:
Traumatic Brain Injury
Elderly
Cognitive Impairment
Quality of life
Impact
Health care economic costs
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Craniocerebral Trauma
Trauma, Nervous System
Cognitive Dysfunction
Central Nervous System Diseases
Nervous System Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders