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

NCT04074850 | Completed

• 1 other identifier: S62848
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury; Aging; Cognitive Impairment; Quality of Life

Keywords

Traumatic Brain Injury; Elderly; Cognitive Impairment; Quality of life; Impact; Health care economic costs

Outcome Measures

Primary Outcomes (5)

• Injury mechanisms evaluation

  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.

  August 2019-June 2021

• Economic cost evaluation

  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.

  August 2019-June 2021

• Cognitive functions assessment

  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 has a maximum of 41 points and higher scores mean better cognitive outcomes. 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.

  August 2019-November 2022

• Quality of life assessment

  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.

  August 2019-November 2022

• Sleep quality assessment

  A telephonic sleep quality assessment will be performed using the Pittsburgh Sleep Quality Index. In this scale, seven component scores are derived, each scored from 0 (which means no difficulty) to 3 (severe difficulty). The global score ranges between 0 and 21 points. Higher scores indicate worse sleep quality.

  August 2020-November 2022

Study Arms (1)

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.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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

You may qualify if:

• ≥ 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.

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Cognitive Dysfunction; Tooth, Impacted

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Bart Depreitere, PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: August 30, 2019
• Study Start: August 1, 2019
• Primary Completion: November 3, 2022
• Study Completion: November 3, 2022
• Last Updated: January 27, 2023

Record last verified: 2022-11

Locations

BE (1)