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

Shandong University438 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

438

Conditions

Helicobacter Pylori Infection Helicobacter Pylori Eradication Patient Education

Interventions

oral and written educationOTHER

oral and written education

Wechat groupOTHER

Wechat group: oral and written education plus Wechat group based interactive education provided by medical professional

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. aged between 18 and 75 years old; 2. H. pylori infection confirmed by any two positive outcomes of rapid urease test (RUT), 13C-urea breath test (UBT) or histopathology. Exclusion Criteria: 1. previous therapy for H. pylori; 2. with significant underlying disease (e.g. decompensated liver cirrhosis, renal failure or malignant tumors) that may interfere the study; 3. history of gastric surgery, 4. pregnancy or lactation; 5. the use of PPI or antibiotics during the 4 weeks prior to enrolment; 6. previous history of allergic reactions to any of the medications used in this protocol; 7. unable to use smartphone and wechat 8. unwilling or incapable to provide informed consents.

Locations (1)

Qilu hosipital

Jinan, Shandong, China

Outcomes

Primary Outcomes

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.

Time frame: 2 months

Secondary Outcomes

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.

Time frame: 14 days

Data from ClinicalTrials.gov

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