All Adult Patients Admitted to theHMPIT ICU for Management of Head TraumaNCT05993312
Quality of Life in Traumatic Brain Injury Patients
An observational study of All Adult Patients Admitted to theHMPIT ICU for Management of Head Trauma, run by General Administration of Military Health, Tunisia at 2 sites in Tunisia.
Trial summary
The aim of this study is to describe the quality of life of CT patients in our study, at least 6 months after the occurrence of the trauma. This assessment is related to the patient's degree of sequelae, using the GOSE scale. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- All Adult Patients Admitted to theHMPIT ICU for Management of Head Trauma
- What is being tested?
- quality of life
- How many people
- 100 participants
- Where
- 2 sitesTunisia
- Study dates
- 1 Jun 2023to 30 Dec 2024
- How long will I take part?
- 6 Months
- 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 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Collection of patients: medical data from the ICU medical record. Data collection of quality of life : outpatient clinic: the interview will be conducted by telephone. If number phone patient cannot be reached, the questionnaire will be sent by post to the patient's address
Who may be able to join
- All adult patients (age 18 or over) admitted to the HMPIT intensive care unit for management of head trauma (isolated or as part of a polytrauma).
Who cannot join
- Patients lost to follow-up after discharge. Incomplete ICU medical records. Patients or their families who refused to participate in the study.
Trial locations and contacts
2 sites in 1 country.
Tunisia2 sites, 2 recruiting
- Recruiting
Military Hospital of Tunis
Tunis, Montfleury, 1008
Hedi Gharsallah, MD, 71391885 ext. 00216, gharsallahhedi@gmail.com
najla stambouli, PhD, 71391133 ext. 00216, nejlastam@gmail.com
- Recruiting
Service de réanimation
Tunis, Montfleury, 1008
Hedi Gharsallah, MD, 71390885 ext. 00216, gharsallahhedi@gmail.com
About this study
Official title: Quality of Life in Traumatic Brain Injury Patients: Assessment at Discharge From an Intensive Care Unit.
The aim of this study is to describe the quality of life of CT patients in our study, at least 6 months after the occurrence of the trauma. This assessment is related to the patient's degree of sequelae, using the GOSE scale.
Read the detailed description
The assessment of patients quality of life would appear to be a particularly relevant tool in the ongoing drive to improve the quality of care. Thus, we should no longer simply assess how patients "should feel", based on objective biomedical criteria, but how they actually "perceive" themselves, based on subjective criteria.
This is particularly true in the case of traumatic brain injury , which is a high-incidence pathology with significant morbidity and mortality consequences that can lead to permanent sequelae . While research over the past 30 years has focused on the neuropsychological and functional outcomes of this event, less is known about the views of head injury survivors and their families on their quality of life, subjective well-being and related factors.
The aim of this study is to describe the quality of life of CT patients at least 6 months after the trauma. This assessment is related to the patient's degree of sequelae, using the Glasgow Outcome Scale Extended GOSE.
- Being tested
- quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quality of lifeOther
To describe the relationship between distant sequelae of trauma assessed by the GOSE scale and quality of life
| Study group | Role | What they receive |
|---|---|---|
| A bras actif | Not described Receives: Other: quality of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life in patients with BI / The short form12 SF12 questionnaire
To describe the relationship between distant sequelae of trauma assessed by the GOSE scale and quality of life in patients with BI.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start1 Jun 2023
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for All Adult Patients Admitted to theHMPIT ICU for Management of Head TraumaStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 100 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- General Administration of Military Health, Tunisia
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Hedi Gharsallah, General Administration of Military Health, Tunisia
- Investigators
- Aicha N REBAI, Study chair, hopital militaire de TUNIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05993312
- Sponsor's protocol ID
- QLTBIP
- Status last verified
- Aug 2023
- First submitted
- 7 Aug 2023
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life in Traumatic Brain Injury Patients: Assessment at Discharge From an Intensive Care Unit.
- ClinicalTrials.gov ID
- NCT05993312
- Acronym / sponsor ID
- QLTBIP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- General Administration of Military Health, TunisiaResearch network
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 15 Aug 2023 (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.
The aim of this study is to describe the quality of life of CT patients in our study, at least 6 months after the occurrence of the trauma. This assessment is related to the patient's degree of sequelae, using the GOSE scale.
Detailed description
The assessment of patients quality of life would appear to be a particularly relevant tool in the ongoing drive to improve the quality of care. Thus, we should no longer simply assess how patients "should feel", based on objective biomedical criteria, but how they actually "perceive" themselves, based on subjective criteria.
This is particularly true in the case of traumatic brain injury , which is a high-incidence pathology with significant morbidity and mortality consequences that can lead to permanent sequelae . While research over the past 30 years has focused on the neuropsychological and functional outcomes of this event, less is known about the views of head injury survivors and their families on their quality of life, subjective well-being and related factors.
The aim of this study is to describe the quality of life of CT patients at least 6 months after the trauma. This assessment is related to the patient's degree of sequelae, using the Glasgow Outcome Scale Extended GOSE.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A bras actif | – | Other: quality of life |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Collection of patients: medical data from the ICU medical record. Data collection of quality of life : outpatient clinic: the interview will be conducted by telephone. If number phone patient cannot be reached, the questionnaire will be sent by post to the patient's address
Key inclusion criteria (1 listed)
- All adult patients (age 18 or over) admitted to the HMPIT intensive care unit for management of head trauma (isolated or as part of a polytrauma).
Key exclusion criteria (1 listed)
- Patients lost to follow-up after discharge. Incomplete ICU medical records. Patients or their families who refused to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quality of lifeTo describe the relationship between distant sequelae of trauma assessed by the GOSE scale and quality of life | Other | A bras actif |
Primary outcome
quality of life in patients with BI / The short form12 SF12 questionnaire
Time frame: 6 month
To describe the relationship between distant sequelae of trauma assessed by the GOSE scale and quality of life in patients with BI.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Individual participant dataSharing planned: Undecided
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.
Aicha N REBAI study chair
hopital militaire de TUNIS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of All Adult Patients Admitted to theHMPIT ICU for Management of Head Trauma, run by General Administration of Military Health, Tunisia at 2 sites in Tunisia.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Tunisia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aicha REBAI, FR (21671391133, aicha.rebai@fmt.utm.tn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of life in patients with BI / The short form12 SF12 questionnaire (time frame: 6 month). 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 15 Aug 2023.