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Hepatitis C Patient Management and Family Health Education

Primary Purpose

Hepatitis C

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HCV articles
general health articles
Sponsored by
China Liver Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hepatitis C

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Permanent residents in the province
  • Ages 18-69 (inclusive)
  • Both blood anti-HCV test and HCV-RNA test is positive
  • Familiar with the use of mobile phones and WeChat
  • Informed consent and voluntary participation in the study

Exclusion Criteria:

  • Temporary staff who come to the city to work, travel or visit relatives, or those who will be living in other cities for a long time
  • Suffering from other serious diseases
  • Patients with mental disorder or memory disorder
  • Pregnant women or those who have a plan to prepare for pregnancy within one year
  • Refuse to participate in the investigation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    intervention group

    control group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Rate of antiviral therapy
    The rate of antiviral therapy is equal to the number of subjects received antiviral therapy divide by the number of all subjects.

    Secondary Outcome Measures

    Time to first treatment
    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.
    Cognition and attitude towards hepatitis C
    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.
    Factors influencing antiviral therapy
    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.
    The rate of giving up treatment halfway
    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.

    Full Information

    First Posted
    January 18, 2019
    Last Updated
    January 19, 2019
    Sponsor
    China Liver Health
    Collaborators
    Peking University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03813498
    Brief Title
    Hepatitis C Patient Management and Family Health Education
    Official Title
    Health Education Based on We Media to Promote Patient Adherence to HCV Treatment: A Nationwide Online Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2019 (Anticipated)
    Primary Completion Date
    November 2019 (Anticipated)
    Study Completion Date
    November 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    China Liver Health
    Collaborators
    Peking University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis C

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    intervention group
    Arm Type
    Experimental
    Arm Title
    control group
    Arm Type
    Other
    Intervention Type
    Behavioral
    Intervention Name(s)
    HCV articles
    Intervention Description
    The intervention group receive a targeted short article on HCV from WeChat weekly.
    Intervention Type
    Behavioral
    Intervention Name(s)
    general health articles
    Intervention Description
    The control group receive a general health article with no mention of HCV from WeChat weekly.
    Primary Outcome Measure Information:
    Title
    Rate of antiviral therapy
    Description
    The rate of antiviral therapy is equal to the number of subjects received antiviral therapy divide by the number of all subjects.
    Time Frame
    6 months after the first intervention
    Secondary Outcome Measure Information:
    Title
    Time to first treatment
    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.
    Time Frame
    6 months after the first intervention
    Title
    Cognition and attitude towards hepatitis C
    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.
    Time Frame
    6 months after the first intervention
    Title
    Factors influencing antiviral therapy
    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.
    Time Frame
    6 months after the first intervention
    Title
    The rate of giving up treatment halfway
    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.
    Time Frame
    6 months after the first intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    69 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Permanent residents in the province Ages 18-69 (inclusive) Both blood anti-HCV test and HCV-RNA test is positive Familiar with the use of mobile phones and WeChat Informed consent and voluntary participation in the study Exclusion Criteria: Temporary staff who come to the city to work, travel or visit relatives, or those who will be living in other cities for a long time Suffering from other serious diseases Patients with mental disorder or memory disorder Pregnant women or those who have a plan to prepare for pregnancy within one year Refuse to participate in the investigation
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mingyang Li
    Phone
    8610-57158696
    Email
    clh@liver.org.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fuqiang Cui, PhD
    Organizational Affiliation
    Peking University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Tianshuo Zhao
    Organizational Affiliation
    Study Director
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Yingsheng Shen
    Organizational Affiliation
    China Liver Health
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Hepatitis C Patient Management and Family Health Education

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