Traumatic Brain InjuryNCT04074850
The Long-term Consequences After Traumatic Brain Injury in the Elderly
An observational study of Traumatic Brain Injury and Aging, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Traumatic Brain Injury, Aging, Cognitive Impairment
- How many people
- 47 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Aug 2019to 3 Nov 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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
Who may be able to join
- ≥ 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.
Who cannot join
- < 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Long-term Consequences After Traumatic Brain Injury in the Elderly: a Prospective Study
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.
Read the detailed description
A database of over 1200 patients will be created by the retrospective capture of the following data in UZ Leuven database:
Injury mechanisms data:
In order to create a map of injury patterns, severity and criteria that allow for identifying which accident circumstances ageing adults should reasonably be protected against, including a kinematics tolerance curve for the elderly brain that can be used for protection purposes, a retrospective analysis of data related to injury mechanisms, registered in the patient's clinical records, will be performed for the cohort of patients.
Clinical data:
Data regarding the following parameters will be retrospectively collected in UZ Leuven database for the studty cohort: age, sex, cause of injury, GCS, pupillary reactivity, hypoxia, hypotension, hypothermia and Marshall CT classification at the time of admission. Moreover, Glasgow Outcome Scale (GOSE) at 6 months after the accident, obtained in the context of routine clinical practice, will also be considered.
These data will be correlated with the results obtained during the injury patterns, injury severity and risk profiles mapping, in order to better understand what accident types are most risky to eventually result in poor outcome.
Economic data:
In order to know what is the economic impact that TBI in the elderly has on society, hospital costs for the clinical management in the study cohort will be retrospectively extracted from the financial database of UZ Leuven.
All these data will be anonymized and no informed consent will be used in this part of the study.
Current status assessment:
In this part of the project, all the patients ≥65 years old admitted to UZ Leuven due to TBI between 1999 and 2019, and fulfilling previously explained inclusion and exclusion criteria, will be contacted through a phone call by an investigator of this project, and offered to participate in the study.
UZ Leuven administration (MIR) has access to a central national database, so the list of patients will be screened prior to the start of the phone calls in order to exclude the patients that are deceased and avoid calling them.
The informed consent form will be distributed among the patients via post or e-mail, depending on their preferences. Patients will have to send the signed informed consent form back to the researchers via post or e-mail in order to be assessed.
Once the researchers receive the signed informed consent form, patients will be called again and they will have the cognitive and quality of life evaluation, which consists of:
-Cognitive evaluation: the Telephone Interview for Cognitive Status (TICS) tool will be used to study cognitive functions in the cohort. It is a 11-items screening test for cognitive functions, including word list memory, orientation, attention, repetition, conceptual knowledge and nonverbal praxis. 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.
- Sleep quality assessment: the sleep quality in our cohort will be assessed using the Pittsburgh Sleep Quality Index.
- Quality of life evaluation: the Quality of Life after Brain Injury (QOLIBRI) tool will be used to assess the quality of life in the cohort. It 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 approximate time necessary to fill this questionnaire in is 10 min.
Once the investigators get the signed informed consent, injury mechanisms data, clinical data and clinical-care related economic data will be collected from UZ Leuven database and correlated to the cognitive, sleep quality and quality of life outcomes. Also, for all the patients in the study cohort that live in the surrounding areas of Leuven and have UZ Leuven as a reference hospital after TBI, a retrospective revision of the clinical records will be performed for the identification of diagnosis for neurodegenerative diseases that developed after TBI.
Based on previous statistical figures, the investigators expect to have a cohort of over 500 patients for this current status assessment.
- 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
- Medical subject headings
- Brain Injuries, Traumatic, Cognitive Dysfunction, Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: August 2020-November 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start1 Aug 2019
- Primary completion3 Nov 2022
- Study completion3 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bart Depreitere, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04074850
- Sponsor's protocol ID
- S62848
- Status last verified
- Nov 2022
- First submitted
- 25 Jul 2019
- Last updated
- 27 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long-term Consequences After Traumatic Brain Injury in the Elderly: a Prospective Study
- ClinicalTrials.gov ID
- NCT04074850
- Acronym / sponsor ID
- S62848
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 3 Nov 2022 (actual)
- Study completion
- 3 Nov 2022 (actual)
- First posted
- 30 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A database of over 1200 patients will be created by the retrospective capture of the following data in UZ Leuven database:
Injury mechanisms data:
In order to create a map of injury patterns, severity and criteria that allow for identifying which accident circumstances ageing adults should reasonably be protected against, including a kinematics tolerance curve for the elderly brain that can be used for protection purposes, a retrospective analysis of data related to injury mechanisms, registered in the patient's clinical records, will be performed for the cohort of patients.
Clinical data:
Data regarding the following parameters will be retrospectively collected in UZ Leuven database for the studty cohort: age, sex, cause of injury, GCS, pupillary reactivity, hypoxia, hypotension, hypothermia and Marshall CT classification at the time of admission. Moreover, Glasgow Outcome Scale (GOSE) at 6 months after the accident, obtained in the context of routine clinical practice, will also be considered.
These data will be correlated with the results obtained during the injury patterns, injury severity and risk profiles mapping, in order to better understand what accident types are most risky to eventually result in poor outcome.
Economic data:
In order to know what is the economic impact that TBI in the elderly has on society, hospital costs for the clinical management in the study cohort will be retrospectively extracted from the financial database of UZ Leuven.
All these data will be anonymized and no informed consent will be used in this part of the study.
Current status assessment:
In this part of the project, all the patients ≥65 years old admitted to UZ Leuven due to TBI between 1999 and 2019, and fulfilling previously explained inclusion and exclusion criteria, will be contacted through a phone call by an investigator of this project, and offered to participate in the study.
UZ Leuven administration (MIR) has access to a central national database, so the list of patients will be screened prior to the start of the phone calls in order to exclude the patients that are deceased and avoid calling them.
The informed consent form will be distributed among the patients via post or e-mail, depending on their preferences. Patients will have to send the signed informed consent form back to the researchers via post or e-mail in order to be assessed.
Once the researchers receive the signed informed consent form, patients will be called again and they will have the cognitive and quality of life evaluation, which consists of:
-Cognitive evaluation: the Telephone Interview for Cognitive Status (TICS) tool will be used to study cognitive functions in the cohort. It is a 11-items screening test for cognitive functions, including word list memory, orientation, attention, repetition, conceptual knowledge and nonverbal praxis. 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.
- Sleep quality assessment: the sleep quality in our cohort will be assessed using the Pittsburgh Sleep Quality Index.
- Quality of life evaluation: the Quality of Life after Brain Injury (QOLIBRI) tool will be used to assess the quality of life in the cohort. It 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 approximate time necessary to fill this questionnaire in is 10 min.
Once the investigators get the signed informed consent, injury mechanisms data, clinical data and clinical-care related economic data will be collected from UZ Leuven database and correlated to the cognitive, sleep quality and quality of life outcomes. Also, for all the patients in the study cohort that live in the surrounding areas of Leuven and have UZ Leuven as a reference hospital after TBI, a retrospective revision of the clinical records will be performed for the identification of diagnosis for neurodegenerative diseases that developed after TBI.
Based on previous statistical figures, the investigators expect to have a cohort of over 500 patients for this current status assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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
Key inclusion criteria (5 listed)
- ≥ 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.
Key exclusion criteria (6 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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-November 2022
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.
Quality of life assessment
Time frame: August 2019-November 2022
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.
Sleep quality assessment
Time frame: August 2020-November 2022
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
Related trials for Traumatic Brain Injury
RecruitingPhase 1
Rehabilitation Through Virtual Immersion & Integrated Exposure for Mild Traumatic Brain Injury (ReVIVE for mTBI)
Traumatic Brain Injuries, TBI (Traumatic Brain Injury)
Recruiting
Feasibility and Acceptability of an LLM-based Chatbot for Family Caregivers: Evaluation Study
Caregivers
Not yet recruitingObservational study
Prospective Observational Multimodal Neuromonitoring in Adult NSICU Patients
Subarachnoid Hemorrhage, Aneurysmal, Brain Injuries, Traumatic
Not yet recruitingObservational study
The Systemic Nature of Severe Traumatic Brain Injury
Severe Traumatic Brain Injury
Not yet recruitingObservational study
Cognitive Effects of Hyperbaric Oxygen Therapy (HBOT) After a Traumatic Brain Injury
Traumatic Brain Injury, Post-Concussion Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bart Depreitere, PhD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and Aging, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Injury mechanisms evaluation (time frame: August 2019-June 2021). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2023.