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
|Condition or disease|
|Traumatic Brain Injury Aging Cognitive Impairment Quality of Life|
Show Detailed Description
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1200 participants|
|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|
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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Rebeca Alejandra Gavrila Laic, MSc||+32 16 32 30 email@example.com|
|Leuven, Belgium, 3000|
|Principal Investigator: Bart Depreitere, PhD|
|Sub-Investigator: Rebeca Alejandra Gavrila Laic, MSc|
|Principal Investigator:||Bart Depreitere, PhD||UZ Leuven|