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

Not Applicable

Completed

• Conditions: Helicobacter Pylori Eradication; Patient Education; Helicobacter Pylori Infection

• Registration Number: NCT04850209
• Lead Sponsor: Shandong University

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-04-07
• Study First Submitted QC: 2021-04-18
• Study First Posted: 2021-04-20
• Study Start: 2021-07-23
• Primary Completion: 2022-08-10
• Study Completion: 2022-09-10
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-28
• Last Update Posted: 2023-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 438

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
eradication rate in each group	2 months	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.

Secondary Outcome Measures

Name	Time	Method
prevalence of adverse events	14 days	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.

Trial Locations

Locations (1)

Qilu hosipital; 🇨🇳 Jinan, Shandong, China