<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/NCT04491890</url>
  </required_header>
  <id_info>
    <org_study_id>HKBU JC 001</org_study_id>
    <nct_id>NCT04491890</nct_id>
  </id_info>
  <brief_title>Cross-cultural Adaptation, Evaluation and Validation of Wang Qi's Constitution of TCM Questionnaire (For Old Person)</brief_title>
  <official_title>Cross-cultural Adaptation, Evaluation and Validation of Wang Qi's Constitution of TCM Questionnaire (For Old Person)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hong Kong Baptist University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Hong Kong Jockey Club Charities Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hong Kong Baptist University</source>
  <brief_summary>
    <textblock>
      This is a cross-cultural adaptation, evaluation and validation study of Wang Qi's&#xD;
      Constitution in TCM questionnaire (For Old Person) in Hong Kong to investigate the content&#xD;
      validity, construct validity and reliability of the CTCMQ-C in Cantonese speaking Hong Kong&#xD;
      Chinese elderly population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study includes two steps. Firstly, translation of the questionnaire into Cantonese,&#xD;
      followed by cross-cultural adaptation. Ten Chinese Medicine Practitioners (CMPs) and 30&#xD;
      patients will be recruited from the community and the outpatient clinics of Hong Kong Baptist&#xD;
      University (HKBU) to evaluate the Constitution in TCM Questionnaire (For Old Person)&#xD;
      (Cantonese version) (CTCMQ-C) for content validity by the cognitive debriefing interviews.&#xD;
      The content validity indices (CVI) of clarity, relevance and appropriateness of each item of&#xD;
      the questionnaire rated by CMPs and patients will be quantified. The interpretations of items&#xD;
      and suggestions of rewording by the patients and CMPs will be analyzed qualitatively to&#xD;
      identify any item of the questionnaire that is not valid for the Chinese population in Hong&#xD;
      Kong. Secondly following the validation study, 264 patients will be recruited. A validated&#xD;
      CTCMQ-C will then be generated and will be endorsed by expert panel to use in the subsequent&#xD;
      cross-sectional and cohort studies to evaluate the preventive effect with Chinese Medicine&#xD;
      approaches. The psychometric properties including construct validity by scaling assumptions,&#xD;
      confirmatory factor analysis (CFA) and reliability of the CTMCQ-C will also be tested.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 31, 2019</start_date>
  <completion_date type="Actual">February 8, 2020</completion_date>
  <primary_completion_date type="Actual">February 8, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>To test the psychometric properties including construct validity by scaling assumptions, confirmatory factor analysis (CFA) and reliability of the Constitution in TCM Questionnaire (For Old Person) (Cantonese version) (CTCMQ-C) (final version).</measure>
    <time_frame>30 minutes</time_frame>
  </primary_outcome>
  <other_outcome>
    <measure>To evaluate the content validity of the Constitution in TCM Questionnaire (For Old Person) (Cantonese version) (CTCMQ-C) in a Cantonese speaking Chinese elderly population in Hong Kong.</measure>
    <time_frame>60 minutes</time_frame>
  </other_outcome>
  <enrollment type="Actual">304</enrollment>
  <condition>Cross-cultural Adaptation, Evaluation and Validation Study of Wang Qi's Constitution in TCM Questionnaire (For Old Person)</condition>
  <eligibility>
    <study_pop>
      <textblock>
        For the evaluation study of the Constitution in TCM Questionnaire (For Old Person)&#xD;
        (Cantonese version) (CTCMQ-C), 10 Chinese Medicine Practitioners (CMPs) will be recruited&#xD;
        from the outpatient clinics of Hong Kong Baptist University (HKBU) and 30 participants will&#xD;
        be recruited from the community and the outpatient clinics of Hong Kong Baptist University&#xD;
        (HKBU).&#xD;
&#xD;
        For the validation study of the Constitution in TCM Questionnaire (For Old Person)&#xD;
        (Cantonese version) (CTCMQ-C) (final version), 264 participants will be recruited from the&#xD;
        community and the outpatient clinics of Hong Kong Baptist University (HKBU).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged 65 and above;&#xD;
&#xD;
          -  Hong Kong residents;&#xD;
&#xD;
          -  capable of consenting and have agreed to participate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not fulfill the above inclusion criteria;&#xD;
&#xD;
          -  having serious diseases with undesirable conditions that unable to complete the&#xD;
             survey;&#xD;
&#xD;
          -  having serious mental and behavioral disorders.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Zhao-xiang Bian, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hong Kong Baptist University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>School of Chinese Medicine, Hong Kong Baptist University</name>
      <address>
        <city>Hong Kong</city>
        <state>Hong Kong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>July 26, 2020</last_update_submitted>
  <last_update_submitted_qc>July 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hong Kong Baptist University</investigator_affiliation>
    <investigator_full_name>ZhaoXiang Bian</investigator_full_name>
    <investigator_title>Chair Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT04491890
org study id: HKBU JC 001
nct id: NCT04491890
lead sponsor: 
collaborator: 
This is a cross-cultural adaptation, evaluation and validation study of Wang Qi's
      Constitution in TCM questionnaire (For Old Person) in Hong Kong to investigate the content
      validity, construct validity and reliability of the CTCMQ-C in Cantonese speaking Hong Kong
      Chinese elderly population.
The study includes two steps. Firstly, translation of the questionnaire into Cantonese,
      followed by cross-cultural adaptation. Ten Chinese Medicine Practitioners (CMPs) and 30
      patients will be recruited from the community and the outpatient clinics of Hong Kong Baptist
      University (HKBU) to evaluate the Constitution in TCM Questionnaire (For Old Person)
      (Cantonese version) (CTCMQ-C) for content validity by the cognitive debriefing interviews.
      The content validity indices (CVI) of clarity, relevance and appropriateness of each item of
      the questionnaire rated by CMPs and patients will be quantified. The interpretations of items
      and suggestions of rewording by the patients and CMPs will be analyzed qualitatively to
      identify any item of the questionnaire that is not valid for the Chinese population in Hong
      Kong. Secondly following the validation study, 264 patients will be recruited. A validated
      CTCMQ-C will then be generated and will be endorsed by expert panel to use in the subsequent
      cross-sectional and cohort studies to evaluate the preventive effect with Chinese Medicine
      approaches. The psychometric properties including construct validity by scaling assumptions,
      confirmatory factor analysis (CFA) and reliability of the CTMCQ-C will also be tested.
observational model: Other
time perspective: Other
measure: To test the psychometric properties including construct validity by scaling assumptions, confirmatory factor analysis (CFA) and reliability of the Constitution in TCM Questionnaire (For Old Person) (Cantonese version) (CTCMQ-C) (final version).
time frame: 30 minutes
measure: To evaluate the content validity of the Constitution in TCM Questionnaire (For Old Person) (Cantonese version) (CTCMQ-C) in a Cantonese speaking Chinese elderly population in Hong Kong.
time frame: 60 minutes
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
last name: Zhao-xiang Bian, PhD
role: Principal Investigator
affiliation: Hong Kong Baptist University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Hong Kong Baptist University
investigator full name: ZhaoXiang Bian
investigator title: Chair Professor