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
About this trial
This is an interventional other trial for Hepatitis C
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
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
NCT ID
NCT03813498
First Posted
January 18, 2019
Last Updated
January 19, 2019
Sponsor
China Liver Health
Collaborators
Peking University
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
Learn more about this trial
Hepatitis C Patient Management and Family Health Education
We'll reach out to this number within 24 hrs