Hepatitis C Patient Management and Family Health Education

Health Education Based on We Media to Promote Patient Adherence to HCV Treatment: A Nationwide Online Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Hepatitis C
• Intervention / Treatment: Behavioral: HCV articles; Behavioral: general health articles

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mingyang Li; Phone Number: 8610-57158696; Email: clh@liver.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group	Behavioral: HCV articles; The intervention group receive a targeted short article on HCV from WeChat weekly.
Other: control group	Behavioral: general health articles; The control group receive a general health article with no mention of HCV from WeChat weekly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months after the first intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months after the first intervention
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.	6 months after the first intervention
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.	6 months after the first intervention
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.	6 months after the first intervention

Collaborators and Investigators

• Sponsor: China Liver Health
• Collaborators: Peking University
• Investigators: Study Director: Fuqiang Cui, PhD, Peking University; Principal Investigator: Tianshuo Zhao, Study Director; Principal Investigator: Yingsheng Shen, China Liver Health

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2019
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): November 1, 2019

Study Registration Dates

• First Submitted: January 18, 2019
• First Submitted That Met QC Criteria: January 19, 2019
• First Posted (Actual): January 23, 2019

Study Record Updates

• Last Update Posted (Actual): January 23, 2019
• Last Update Submitted That Met QC Criteria: January 19, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C
• Other Study ID Numbers: IN-CN-987-5377

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No