<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/NCT02240225</url>
  </required_header>
  <id_info>
    <org_study_id>GZIRD-20140910</org_study_id>
    <nct_id>NCT02240225</nct_id>
  </id_info>
  <brief_title>Validation of Chinese SRI Questionnaire</brief_title>
  <acronym>VCSRI</acronym>
  <official_title>Validation of Chinese Severe Respiratory Insufficiency （SRI）Questionnaire for COPD Patients With Chronic Hypercapnic Respiratory Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangzhou Institute of Respiratory Disease</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Southern Medical University, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Second Affiliated Hospital, Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Third Affiliated Hospital, Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shaoguan People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dongguan People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The center hospital of Wuhan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Guangzhou Institute of Respiratory Disease</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Assessment of health-related quality of life in COPD patients with severe chronic respiratory&#xD;
      failure requires appropriate and highly specific measurement tools. We attempt to validate&#xD;
      the Chinese version of the Severe Respiratory Insufficiency Questionnaire (SRI)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2014</start_date>
  <completion_date type="Anticipated">October 2014</completion_date>
  <primary_completion_date type="Anticipated">October 2014</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Weeks</target_duration>
  <primary_outcome>
    <measure>Reliability of Severe Respiratory Insufficiency Questionnaire</measure>
    <time_frame>2 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Construct validity of Severe Respiratory Insufficiency Questionnaire</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Criterion validity of Severe Respiratory Insufficiency Questionnaire</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <condition>Hypercapnic Respiratory Failure</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adult COPD patients with chronic hypercapnic respiratory failure receiving home noninvasive&#xD;
        ventilation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult COPD Patients with chronic hypercapnic respiratory failure established on home&#xD;
             noninvasive ventilation for at least 1 month&#xD;
&#xD;
          2. Patients are in a clinically stable state,without any changes of medication during the&#xD;
             previous 4 weeks.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. patient's refusal to participate&#xD;
&#xD;
          2. Patients with evidence of acute respiratory failure i.e.patients with worsening of&#xD;
             symptoms during the previous 2 weeks, a pH ,7.35, or with signs of respiratory&#xD;
             infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Zhou LuQian, Doctor</last_name>
    <phone>+86-15622236759</phone>
    <email>zhlx09@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Guangzhou Institute of Respiratory Disease</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510120</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chen RongChang, Doctor</last_name>
      <phone>008613902273260</phone>
      <email>icelucy@126.com</email>
    </contact>
    <investigator>
      <last_name>Chen Rongchang, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <last_update_submitted>September 11, 2014</last_update_submitted>
  <last_update_submitted_qc>September 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guangzhou Institute of Respiratory Disease</investigator_affiliation>
    <investigator_full_name>LuQian Zhou</investigator_full_name>
    <investigator_title>Assistant professor of Guangzhou Institute of Respiratory Disease</investigator_title>
  </responsible_party>
  <keyword>COPD;SRI;Reliability;validity;</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Hypercapnia</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/NCT02240225
org study id: GZIRD-20140910
nct id: NCT02240225
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Assessment of health-related quality of life in COPD patients with severe chronic respiratory
      failure requires appropriate and highly specific measurement tools. We attempt to validate
      the Chinese version of the Severe Respiratory Insufficiency Questionnaire (SRI)
time perspective: Prospective
measure: Reliability of Severe Respiratory Insufficiency Questionnaire
time frame: 2 weeks
measure: Construct validity of Severe Respiratory Insufficiency Questionnaire
time frame: 2 weeks
measure: Criterion validity of Severe Respiratory Insufficiency Questionnaire
time frame: 2 weeks
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Zhou LuQian, Doctor
phone: +86-15622236759
email: zhlx09@163.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Guangzhou Institute of Respiratory Disease
investigator full name: LuQian Zhou
investigator title: Assistant professor of Guangzhou Institute of Respiratory Disease
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Respiratory Insufficiency
mesh term: Hypercapnia