<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/NCT03813498</url>
  </required_header>
  <id_info>
    <org_study_id>IN-CN-987-5377</org_study_id>
    <nct_id>NCT03813498</nct_id>
  </id_info>
  <brief_title>Hepatitis C Patient Management and Family Health Education</brief_title>
  <official_title>Health Education Based on We Media to Promote Patient Adherence to HCV Treatment: A Nationwide Online Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China Liver Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Peking University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>China Liver Health</source>
  <oversight_info>
    <has_dmc>No</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>
      INTRODUCTION: Hepatitis C virus (HCV) is recognized as the leading cause of chronic liver&#xD;
      disease worldwide. However, the screening rate and treatment rate of HCV-infected patients in&#xD;
      China is low, which increases the burden of patients and the infection risk of their family&#xD;
      members. WeChat, an instant messaging software, is used in a very high proportion in China.&#xD;
      Health promotion based on WeChat public platform is a very convenient and effective way of&#xD;
      health education. Therefore, this study plans to apply WeChat to conduct health intervention&#xD;
      for HCV-infected patients. The objective is to explore the effect of We-media-based health&#xD;
      promotion method on the detection rate and treatment rate of HCV-infected and their family&#xD;
      members.&#xD;
&#xD;
      METHOD: Recruitment will be conduct in 10 hospitals in Jilin, Beijing, Henan and Anhui&#xD;
      provinces. The subjects should be patients new diagnosed with hepatitis C at the hospital and&#xD;
      aged 18 to 69. After signing the consent form, eligible participants were selected through&#xD;
      the inclusion and exclusion criteria. 1000 participants will be recruited for the trial.&#xD;
      After completing an baseline reseach by a online questionnaire, patients will be randomly&#xD;
      assigned to receive a targeted short article on HCV weekly or a general health article with&#xD;
      no mention of HCV. The intervention will last three months and a follow-up will be conduct at&#xD;
      three month after the last intervention.&#xD;
&#xD;
      OUTCOMES: The primary outcome is antiviral therapy. The secondary outcomes are cognition and&#xD;
      attitude towards hepatitis C, factors influencing antiviral therapy, time to first treatment&#xD;
      and the compliance of treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2019</start_date>
  <completion_date type="Anticipated">November 2019</completion_date>
  <primary_completion_date type="Anticipated">November 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of antiviral therapy</measure>
    <time_frame>6 months after the first intervention</time_frame>
    <description>The rate of antiviral therapy is equal to the number of subjects received antiviral therapy divide by the number of all subjects.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to first treatment</measure>
    <time_frame>6 months after the first intervention</time_frame>
    <description>This is the interval time between the first intervention and first treatment. We want to know from this outcome how long it takes the subject to receive the health intervention before starting treatment. Thus, we can analyze the relationship between intervention time and treatment behavior.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognition and attitude towards hepatitis C</measure>
    <time_frame>6 months after the first intervention</time_frame>
    <description>Investigators designed a standardized questionnaire that asked questions about subjects' knowledge and attitudes toward hepatitis C. The scores of the questionnaire were used to evaluate the cognition and attitude of the subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Factors influencing antiviral therapy</measure>
    <time_frame>6 months after the first intervention</time_frame>
    <description>The investigators designed a ranking question of factors that interfered with the subjects' treatment in the questionnaire. These factors include: (1) My condition is not serious; (2) I am worried about the side effects of treatment; (3) I am afraid of being discriminated against because someone know I have the disease; (4) I have financial difficulties (or the treatment costs are too high); (5) The process of visiting a doctor is complicated. Subjects can also fill in their own ideas in the blank if they have other factors not mentioned in this questionnaire. Investigators will analyze the extent to which each factor affects a patient's treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The rate of giving up treatment halfway</measure>
    <time_frame>6 months after the first intervention</time_frame>
    <description>This rate is used to assess compliance with treatment. This rate is equal to the number of subjects who give up treatment halfway divided by the number of subjects who get treatment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Hepatitis C</condition>
  <arm_group>
    <arm_group_label>intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>HCV articles</intervention_name>
    <description>The intervention group receive a targeted short article on HCV from WeChat weekly.</description>
    <arm_group_label>intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>general health articles</intervention_name>
    <description>The control group receive a general health article with no mention of HCV from WeChat weekly.</description>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Permanent residents in the province&#xD;
&#xD;
          -  Ages 18-69 (inclusive)&#xD;
&#xD;
          -  Both blood anti-HCV test and HCV-RNA test is positive&#xD;
&#xD;
          -  Familiar with the use of mobile phones and WeChat&#xD;
&#xD;
          -  Informed consent and voluntary participation in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Temporary staff who come to the city to work, travel or visit relatives, or those who&#xD;
             will be living in other cities for a long time&#xD;
&#xD;
          -  Suffering from other serious diseases&#xD;
&#xD;
          -  Patients with mental disorder or memory disorder&#xD;
&#xD;
          -  Pregnant women or those who have a plan to prepare for pregnancy within one year&#xD;
&#xD;
          -  Refuse to participate in the investigation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>69 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fuqiang Cui, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Peking University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tianshuo Zhao</last_name>
    <role>Principal Investigator</role>
    <affiliation>Study Director</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yingsheng Shen</last_name>
    <role>Principal Investigator</role>
    <affiliation>China Liver Health</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mingyang Li</last_name>
    <phone>8610-57158696</phone>
    <email>clh@liver.org.cn</email>
  </overall_contact>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 19, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>January 19, 2019</last_update_submitted>
  <last_update_submitted_qc>January 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis</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/NCT03813498
org study id: IN-CN-987-5377
nct id: NCT03813498
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
INTRODUCTION: Hepatitis C virus (HCV) is recognized as the leading cause of chronic liver
      disease worldwide. However, the screening rate and treatment rate of HCV-infected patients in
      China is low, which increases the burden of patients and the infection risk of their family
      members. WeChat, an instant messaging software, is used in a very high proportion in China.
      Health promotion based on WeChat public platform is a very convenient and effective way of
      health education. Therefore, this study plans to apply WeChat to conduct health intervention
      for HCV-infected patients. The objective is to explore the effect of We-media-based health
      promotion method on the detection rate and treatment rate of HCV-infected and their family
      members.

      METHOD: Recruitment will be conduct in 10 hospitals in Jilin, Beijing, Henan and Anhui
      provinces. The subjects should be patients new diagnosed with hepatitis C at the hospital and
      aged 18 to 69. After signing the consent form, eligible participants were selected through
      the inclusion and exclusion criteria. 1000 participants will be recruited for the trial.
      After completing an baseline reseach by a online questionnaire, patients will be randomly
      assigned to receive a targeted short article on HCV weekly or a general health article with
      no mention of HCV. The intervention will last three months and a follow-up will be conduct at
      three month after the last intervention.

      OUTCOMES: The primary outcome is antiviral therapy. The secondary outcomes are cognition and
      attitude towards hepatitis C, factors influencing antiviral therapy, time to first treatment
      and the compliance of treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Rate of antiviral therapy
time frame: 6 months after the first intervention
description: The rate of antiviral therapy is equal to the number of subjects received antiviral therapy divide by the number of all subjects.
measure: Time to first treatment
time frame: 6 months after the first intervention
description: This is the interval time between the first intervention and first treatment. We want to know from this outcome how long it takes the subject to receive the health intervention before starting treatment. Thus, we can analyze the relationship between intervention time and treatment behavior.
measure: Cognition and attitude towards hepatitis C
time frame: 6 months after the first intervention
description: Investigators designed a standardized questionnaire that asked questions about subjects' knowledge and attitudes toward hepatitis C. The scores of the questionnaire were used to evaluate the cognition and attitude of the subjects.
measure: Factors influencing antiviral therapy
time frame: 6 months after the first intervention
description: The investigators designed a ranking question of factors that interfered with the subjects' treatment in the questionnaire. These factors include: (1) My condition is not serious; (2) I am worried about the side effects of treatment; (3) I am afraid of being discriminated against because someone know I have the disease; (4) I have financial difficulties (or the treatment costs are too high); (5) The process of visiting a doctor is complicated. Subjects can also fill in their own ideas in the blank if they have other factors not mentioned in this questionnaire. Investigators will analyze the extent to which each factor affects a patient's treatment.
measure: The rate of giving up treatment halfway
time frame: 6 months after the first intervention
description: This rate is used to assess compliance with treatment. This rate is equal to the number of subjects who give up treatment halfway divided by the number of subjects who get treatment.
arm group label: intervention group
arm group type: Experimental
arm group label: control group
arm group type: Other
intervention type: Behavioral
intervention name: HCV articles
description: The intervention group receive a targeted short article on HCV from WeChat weekly.
arm group label: intervention group
intervention type: Behavioral
intervention name: general health articles
description: The control group receive a general health article with no mention of HCV from WeChat weekly.
arm group label: control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 69 Years
healthy volunteers: No
last name: Fuqiang Cui, PhD
role: Study Director
affiliation: Peking University
last name: Tianshuo Zhao
role: Principal Investigator
affiliation: Study Director
last name: Yingsheng Shen
role: Principal Investigator
affiliation: China Liver Health
last name: Mingyang Li
phone: 8610-57158696
email: clh@liver.org.cn
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis