NCT03813498

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 23, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

10 months

First QC Date

January 18, 2019

Last Update Submit

January 19, 2019

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Time to first treatment

    6 months after the first intervention

  • Cognition and attitude towards hepatitis C

    6 months after the first intervention

  • Factors influencing antiviral therapy

    6 months after the first intervention

  • The rate of giving up treatment halfway

    6 months after the first intervention

Study Arms (2)

intervention group

EXPERIMENTAL
Behavioral: HCV articles

control group

OTHER
Behavioral: general health articles

Interventions

HCV articlesBEHAVIORAL

The intervention group receive a targeted short article on HCV from WeChat weekly.

intervention group
general health articlesBEHAVIORAL

The control group receive a general health article with no mention of HCV from WeChat weekly.

control group

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Fuqiang Cui, PhD

    Peking University

    STUDY DIRECTOR

  • Tianshuo Zhao

    Study Director

    PRINCIPAL INVESTIGATOR

  • Yingsheng Shen

    China Liver Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingyang Li

CONTACT

8610-57158696clh@liver.org.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2019

First Posted

January 23, 2019

Study Start

January 1, 2019

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

January 23, 2019

Record last verified: 2019-01