<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/NCT01666470</url>
  </required_header>
  <id_info>
    <org_study_id>Chula-ARC 001/12</org_study_id>
    <nct_id>NCT01666470</nct_id>
  </id_info>
  <brief_title>Quality of Life of Patients With a History of Drug Allergy in Thailand</brief_title>
  <official_title>Quality of Life of Patients With a History of Drug Allergy in Thailand</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chulalongkorn University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mahidol University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chulalongkorn University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Quality of life of patients with a history of drug allergy in Thailand will be studied.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Thai patients with a history of drug allergy will be evaluated for their quality of life&#xD;
      based on drug hypersensitivity quality of life questionnaire (DrHy-Q; Thai version) and The&#xD;
      World Health Organization Quality of Life instrument (WHOQOL-BREF-THAI)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2012</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">August 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The quality of life of Thai patients with a history of drug allergy evaluating by DrHy-Q (Thai version)</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The correlation between DrHy-Q (Thai version) and WHOQOL-BREF-THAI</measure>
    <time_frame>1 year</time_frame>
    <description>Pearson correlation coefficient between scores from DrHy-Q (Thai version) and WHOQOL-BREF-THAI in patients with a history of drug allergy will be analyzed.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">306</enrollment>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Drug allergy patients</arm_group_label>
    <description>Patients with a history of drug allergy in Thailand</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>DrHy-Q (Thai version) and WHOQOL-BREF-THAI will be asked</description>
    <arm_group_label>Drug allergy patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Thai patients with a history of drug allergy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have a history of drug allergy&#xD;
&#xD;
          -  At least 18 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not be able to understand Thai language&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jettanong Klaewsongkram, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chulalongkorn University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Medicine, Chulalongkorn University</name>
      <address>
        <city>Bangkok</city>
        <zip>10330</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Faculty of Medicine, Ramathibodi Hospital, Mahidol University</name>
      <address>
        <city>Bangkok</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/30346532</url>
    <description>Reliability and validity of the Thai Drug Hypersensitivity Quality of Life Questionnaire: a multi-center study</description>
  </link>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>August 12, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>February 15, 2019</last_update_submitted>
  <last_update_submitted_qc>February 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chulalongkorn University</investigator_affiliation>
    <investigator_full_name>Jettanong Klaewsongkram</investigator_full_name>
    <investigator_title>Head of Division of Allergy and Clinical Immunology, Department of Medicine</investigator_title>
  </responsible_party>
  <keyword>Quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Drug Hypersensitivity</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT01666470
org study id: Chula-ARC 001/12
nct id: NCT01666470
lead sponsor: 
collaborator: 
has dmc: No
Quality of life of patients with a history of drug allergy in Thailand will be studied.
Thai patients with a history of drug allergy will be evaluated for their quality of life
      based on drug hypersensitivity quality of life questionnaire (DrHy-Q; Thai version) and The
      World Health Organization Quality of Life instrument (WHOQOL-BREF-THAI)
observational model: Cohort
time perspective: Cross-Sectional
measure: The quality of life of Thai patients with a history of drug allergy evaluating by DrHy-Q (Thai version)
time frame: 1 year
measure: The correlation between DrHy-Q (Thai version) and WHOQOL-BREF-THAI
time frame: 1 year
description: Pearson correlation coefficient between scores from DrHy-Q (Thai version) and WHOQOL-BREF-THAI in patients with a history of drug allergy will be analyzed.
arm group label: Drug allergy patients
description: Patients with a history of drug allergy in Thailand
intervention type: Other
intervention name: Questionnaires
description: DrHy-Q (Thai version) and WHOQOL-BREF-THAI will be asked
arm group label: Drug allergy patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jettanong Klaewsongkram, MD
role: Principal Investigator
affiliation: Chulalongkorn University
facility: 
facility: 
country: Thailand
url: https://www.ncbi.nlm.nih.gov/pubmed/30346532
description: Reliability and validity of the Thai Drug Hypersensitivity Quality of Life Questionnaire: a multi-center study
responsible party type: Principal Investigator
investigator affiliation: Chulalongkorn University
investigator full name: Jettanong Klaewsongkram
investigator title: Head of Division of Allergy and Clinical Immunology, Department of Medicine
mesh term: Drug Hypersensitivity