The Impact of WeChat Group Patient Education on the Eradication Rate of Helicobacter Pylori

Study Overview
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Brief Summary
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In this study, effects of oral and written education, WeChat education plus oral and written education on Helicobacter pylori eradication will be compared in a randomized way.

Detailed Description
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There are two randomized parallel groups in this study, control group and Wechat group.All of the patients will be treated with Amoxicillin + Clarithromycin + Bismuth + Vonoprazan fumarate. In control group,the patients will be educated by oral and written way about the regimen. In Wechat group, the patients will be educated by Wechat oral and written way. Then, the eradication rates, compliance, adverse events, patients' satisfaction and experience will be evaluated.

Official Title
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The Impact of Interactive Patient Education Based on WeChat Group on the Eradication Rate of Helicobacter Pylori

Conditions
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Helicobacter Pylori Infection, Helicobacter Pylori Eradication, Patient Education

Intervention / Treatment
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* Other: oral and written education
* Other: Wechat group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged between 18 and 75 years old; H. pylori infection confirmed by any two positive outcomes of rapid urease test (RUT), 13C-urea breath test (UBT) or histopathology. Exclusion Criteria: previous therapy for H. pylori; with significant underlying disease (e.g. decompensated liver cirrhosis, renal failure or malignant tumors) that may interfere the study; history of gastric surgery, pregnancy or lactation; the use of PPI or antibiotics during the 4 weeks prior to enrolment; previous history of allergic reactions to any of the medications used in this protocol; unable to use smartphone and wechat unwilling or incapable to provide informed consents.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There are two randomized parallel groups in this study, control group and Wechat group.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control group<br>Patients in this group will receive clarithromycin based bismuth-containing quadruple therapy, Vonoprazan fumarate 20 mg, colloidal bismuth pectin capsule 200 mg , amoxicillin 1000 mg and clarithromycin 500 mg, twice daily, 14 days.Patients will receive oral and written education | Other: oral and written education<br>* oral and written education<br>|
| Experimental: Wechat group<br>Patients in this group will receive clarithromycin based bismuth-containing quadruple therapy, Vonoprazan fumarate 20 mg, colloidal bismuth pectin capsule 200 mg ,amoxicillin 1000 mg and clarithromycin 500 mg, twice daily, 14 days.Patients will receive oral and written education. And patients will be invited into a Wechat group to obtain interactive education through question and answer,which is provided by medical professionals. | Other: oral and written education<br>* oral and written education<br>Other: Wechat group<br>* Wechat group: oral and written education plus Wechat group based interactive education provided by medical professional<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| eradication rate in each group | Six weeks after completion of treatment，number of patients get H.pylori eradicated supported by negative 13C-UBT results will be investigated by an independent researcher.Then eradication rate in each group will be calculated by using intention-to-treat analysis and per-protocol analysis. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of adverse events | At the follow-up,adverse events complained by patients will be recorded by an independent researcher，meanwhile a 8 point visual analog scale (VAS) was used to evaluate severity of adverse events. | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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helicobacter pylori, eradication, patient education, Wechat group