Clinical trial NCT03813498: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatitis C
Lead sponsor: China Liver Health
Sponsor class: OTHER
Collaborators: name: Peking University
First posted: 2019-01-23
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Rate of antiviral therapy
timeFrame: 6 months after the first intervention
Secondary outcomes:
measure: Time to first treatment
timeFrame: 6 months after the first intervention
measure: Cognition and attitude towards hepatitis C
timeFrame: 6 months after the first intervention
measure: Factors influencing antiviral therapy
timeFrame: 6 months after the first intervention
measure: The rate of giving up treatment halfway
timeFrame: 6 months after the first intervention
Other outcomes:
Locations:
Study officials:
affiliation: Peking University
name: Fuqiang Cui, PhD
role: STUDY_DIRECTOR
affiliation: Study Director
name: Tianshuo Zhao
role: PRINCIPAL_INVESTIGATOR
affiliation: China Liver Health
name: Yingsheng Shen
role: PRINCIPAL_INVESTIGATOR
References: