Comparing the Efficacy of WeChat-based Patient Education and Conventional Patient Education in the Management of Helicobacter Pylori Eradication

Completed

• Conditions: Helicobacter Pylori Infection Helicobacter Pylori Eradication Patient Education
• Interventions: Other: patient education

• Registration Number: NCT05186662
• Lead Sponsor: Shandong University

Brief Summary

we conducted a retrospective study to compare the efficacy of WeChat-based patient education and conventional patient education in the management of Helicobacter pylori eradication.

Detailed Description

This is a single-institute retrospective study comparing the efficacy of WeChat-based patient education and conventional patient education in the management of Helicobacter pylori eradication. We identified all patients aged between 18-75 years old and had been prescribed a 14-day course of bismuth-contained quadruple therapy for H. pylori infection in our outpatient clinics between 1 July 2019 and 31 July 2021. H. pylori infection was confirmed by any two positive outcomes of rapid urease test,13C-urea breath test (UBT) and histopathology. Patients who had H. pylori therapy history, using other therapeutic regimens or unwilling to take prescribed medications were excluded. Demographic data, treatment regimens, outcomes of therapy, adherence to therapy and adverse event were retrieved. The main indicator is eradication rate, as the secondary indicators are compliance and adverse events.

Study Timeline

• Study Start: 2019-07-01
• Primary Completion: 2021-07-31
• Study Completion: 2021-12-07
• Study First Submitted: 2021-12-25
• Study First Submitted QC: 2021-12-25
• Study First Posted: 2022-01-11
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1017

Inclusion Criteria

• patients aged between 18 and 75 years old and have not been treated before.

Exclusion Criteria

• Patients who had H. pylori therapy history, using other therapeutic regimens or unwilling to take prescribed medications were excluded. Demographic data, treatment regimens, outcomes of therapy, adherence to therapy and adverse event were retrieved.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
WeChat group	patient education	-
Control group	patient education	-

Primary Outcome Measures

Name	Time	Method
eradication rate	2 months	Six weeks after completion of treatment，numbers 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
compliance	14 days	compliance was evaluated by assessing the total pills patients have taken.Compliance was defined as good when more than 80% or less than 120% of the total pills were taken.
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