Hepatitis CNCT03813498
Hepatitis C Patient Management and Family Health Education
A study testing HCV articles and general health articles in people with Hepatitis C, run by China Liver Health.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- HCV articles and general health articles
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2019to Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Hepatitis C
- Being tested
- HCV articles, general health articles
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCV articlesBehavioural
The intervention group receive a targeted short article on HCV from WeChat weekly.
general health articlesBehavioural
The control group receive a general health article with no mention of HCV from WeChat weekly.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Not described Receives: Behavioral: HCV articles |
| control group | Other | Not described Receives: Behavioral: general health articles |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after the first intervention
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months after the first intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study startJan 2019 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Liver Health
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University
- Responsible party
- Sponsor
- Investigators
- Fuqiang Cui, PhD, Study director, Peking UniversityTianshuo Zhao, Principal investigator, Study DirectorYingsheng Shen, Principal investigator, China Liver Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03813498
- Sponsor's protocol ID
- IN-CN-987-5377
- Status last verified
- Jan 2019
- First submitted
- 18 Jan 2019
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Education Based on We Media to Promote Patient Adherence to HCV Treatment: A Nationwide Online Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03813498
- Acronym / sponsor ID
- IN-CN-987-5377
- Conditions
- Hepatitis C
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- China Liver HealthUniversity, hospital or other
- Collaborators
- Peking University
- Study start
- Jan 2019 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 23 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: HCV articles |
| control group | Other | Behavioral: general health articles |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HCV articlesThe intervention group receive a targeted short article on HCV from WeChat weekly. | Behavioural | intervention group |
| general health articlesThe control group receive a general health article with no mention of HCV from WeChat weekly. | Behavioural | control group |
Primary outcome
Rate of antiviral therapy
Time frame: 6 months after the first intervention
The rate of antiviral therapy is equal to the number of subjects received antiviral therapy divide by the number of all subjects.
4 secondary outcomes
Time to first treatment
Time frame: 6 months after the first intervention
Cognition and attitude towards hepatitis C
Time frame: 6 months after the first intervention
Factors influencing antiviral therapy
Time frame: 6 months after the first intervention
The rate of giving up treatment halfway
Time frame: 6 months after the first intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fuqiang Cui, PhD study director
Peking University
Tianshuo Zhao principal investigator
Study Director
Yingsheng Shen principal investigator
China Liver Health
Questions about this trial
What is this clinical trial studying?
A study testing HCV articles and general health articles in people with Hepatitis C, run by China Liver Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mingyang Li (8610-57158696, clh@liver.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of antiviral therapy (time frame: 6 months after the first intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019.