Quality of Life in Traumatic Brain Injury Patients

Sponsor
General Administration of Military Health, Tunisia (Other)
Overall Status
Recruiting
CT.gov ID
NCT05993312
Collaborator
(none)
100
2
19
50
2.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: quality of life

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

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Quality of Life in Traumatic Brain Injury Patients: Assessment at Discharge From an Intensive Care Unit.
Actual Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Nov 30, 2023
Anticipated Study Completion Date :
Dec 30, 2024

Arms and Interventions

Arm Intervention/Treatment
A bras actif

Other: quality of life
To describe the relationship between distant sequelae of trauma assessed by the GOSE scale and quality of life

Outcome Measures

Primary Outcome Measures

  1. quality of life in patients with BI / The short form12 SF12 questionnaire [6 month]

    To describe the relationship between distant sequelae of trauma assessed by the GOSE scale and quality of life in patients with BI.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Inclusion Criteria:

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).

Exclusion Criteria:

Patients lost to follow-up after discharge. Incomplete ICU medical records. Patients or their families who refused to participate in the study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Military Hospital of Tunis Tunis Montfleury Tunisia 1008
2 Service de réanimation Tunis Montfleury Tunisia 1008

Sponsors and Collaborators

  • General Administration of Military Health, Tunisia

Investigators

  • Study Chair: Aicha N REBAI, hopital militaire de TUNIS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hedi Gharsallah, DR Aicha REBAI, General Administration of Military Health, Tunisia
ClinicalTrials.gov Identifier:
NCT05993312
Other Study ID Numbers:
  • QLTBIP
First Posted:
Aug 15, 2023
Last Update Posted:
Aug 15, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 15, 2023