Quality of Life in Traumatic Brain Injury Patients

August 7, 2023 updated by: Hedi Gharsallah, General Administration of Military Health, Tunisia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Tunisia
    • Montfleury
      • Tunis, Montfleury, Tunisia, 1008
        • Recruiting
        • Military Hospital of Tunis
        • Contact:
        • Contact:
      • Tunis, Montfleury, Tunisia, 1008
        • Recruiting
        • Service de Réanimation
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General Administration of Military Health, Tunisia

Investigators

  • Study Chair: Aicha N REBAI, Hopital Militaire de Tunis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

November 30, 2023

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

August 7, 2023

First Submitted That Met QC Criteria

August 7, 2023

First Posted (Actual)

August 15, 2023

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 7, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QLTBIP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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