xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05993312</url>
    </required_header>
    <id_info>
      <org_study_id>QLTBIP</org_study_id>
      <nct_id>NCT05993312</nct_id>
    </id_info>
    <brief_title>Quality of Life in Traumatic Brain Injury Patients</brief_title>
    <official_title>Quality of Life in Traumatic Brain Injury Patients: Assessment at Discharge From an Intensive Care Unit.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>General Administration of Military Health, Tunisia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>General Administration of Military Health, Tunisia</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this study is to describe the quality of life of CT patients in our study, at&#xD;
        least 6 months after the occurrence of the trauma. This assessment is related to the&#xD;
        patient's degree of sequelae, using the GOSE scale.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The assessment of patients quality of life would appear to be a particularly relevant tool in&#xD;
        the ongoing drive to improve the quality of care. Thus, we should no longer simply assess how&#xD;
        patients &quot;should feel&quot;, based on objective biomedical criteria, but how they actually&#xD;
        &quot;perceive&quot; themselves, based on subjective criteria.&#xD;
  &#xD;
        This is particularly true in the case of traumatic brain injury , which is a high-incidence&#xD;
        pathology with significant morbidity and mortality consequences that can lead to permanent&#xD;
        sequelae . While research over the past 30 years has focused on the neuropsychological and&#xD;
        functional outcomes of this event, less is known about the views of head injury survivors and&#xD;
        their families on their quality of life, subjective well-being and related factors.&#xD;
  &#xD;
        The aim of this study is to describe the quality of life of CT patients at least 6 months&#xD;
        after the trauma. This assessment is related to the patient's degree of sequelae, using the&#xD;
        Glasgow Outcome Scale Extended GOSE.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 1, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <target_duration>6 Months</target_duration>
    <primary_outcome>
      <measure>quality of life in patients with BI / The short form12 SF12 questionnaire</measure>
      <time_frame>6 month</time_frame>
      <description>To describe the relationship between distant sequelae of trauma assessed by the GOSE scale and quality of life in patients with BI.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>All Adult Patients Admitted to theHMPIT ICU for Management of Head Trauma</condition>
    <arm_group>
      <arm_group_label>A bras actif</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>quality of life</intervention_name>
      <description>To describe the relationship between distant sequelae of trauma assessed by the GOSE scale and quality of life</description>
      <arm_group_label>A bras actif</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Collection of patients: medical data from the ICU medical record. Data collection of&#xD;
          quality of life : outpatient clinic: the interview will be conducted by telephone.&#xD;
  &#xD;
          If number phone patient cannot be reached, the questionnaire will be sent by post to the&#xD;
          patient's address&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          All adult patients (age 18 or over) admitted to the HMPIT intensive care unit for&#xD;
          management of head trauma (isolated or as part of a polytrauma).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Patients lost to follow-up after discharge. Incomplete ICU medical records. Patients or&#xD;
          their families who refused to participate in the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Aicha N REBAI</last_name>
      <role>Study Chair</role>
      <affiliation>hopital militaire de TUNIS</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Aicha REBAI, FR</last_name>
      <phone>21671391133</phone>
      <email>aicha.rebai@fmt.utm.tn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Military Hospital of Tunis</name>
        <address>
          <city>Tunis</city>
          <state>Montfleury</state>
          <zip>1008</zip>
          <country>Tunisia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hedi Gharsallah, MD</last_name>
        <phone>71391885</phone>
        <phone_ext>00216</phone_ext>
        <email>gharsallahhedi@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>najla stambouli, PhD</last_name>
        <phone>71391133</phone>
        <phone_ext>00216</phone_ext>
        <email>nejlastam@gmail.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>Service de réanimation</name>
        <address>
          <city>Tunis</city>
          <state>Montfleury</state>
          <zip>1008</zip>
          <country>Tunisia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hedi Gharsallah, MD</last_name>
        <phone>71390885</phone>
        <phone_ext>00216</phone_ext>
        <email>gharsallahhedi@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Tunisia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>General Administration of Military Health, Tunisia</investigator_affiliation>
      <investigator_full_name>Hedi Gharsallah</investigator_full_name>
      <investigator_title>DR Aicha REBAI</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Brain Injuries</mesh_term>
      <mesh_term>Brain Injuries, Traumatic</mesh_term>
      <mesh_term>Craniocerebral Trauma</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05993312
  org study id: QLTBIP
  nct id: NCT05993312
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  observational model: Cohort
  time perspective: Other
  measure: quality of life in patients with BI / The short form12 SF12 questionnaire
  time frame: 6 month
  description: To describe the relationship between distant sequelae of trauma assessed by the GOSE scale and quality of life in patients with BI.
  arm group label: A bras actif
  intervention type: Other
  intervention name: quality of life
  description: To describe the relationship between distant sequelae of trauma assessed by the GOSE scale and quality of life
  arm group label: A bras actif
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  last name: Aicha N REBAI
  role: Study Chair
  affiliation: hopital militaire de TUNIS
  last name: Aicha REBAI, FR
  phone: 21671391133
  email: aicha.rebai@fmt.utm.tn
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  facility: 
  status: Recruiting
  contact: 
  country: Tunisia
  responsible party type: Principal Investigator
  investigator affiliation: General Administration of Military Health, Tunisia
  investigator full name: Hedi Gharsallah
  investigator title: DR Aicha REBAI
  mesh term: Brain Injuries
  mesh term: Brain Injuries, Traumatic
  mesh term: Craniocerebral Trauma
  sharing ipd: Undecided