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

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.

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection Helicobacter Pylori Eradication Patient Education
• Intervention / Treatment: Other: patient education; Other: patient education

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 Type: Observational
• Enrollment (Actual): 1017

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu hosipital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group	Other: patient education; patients in experimental group were asked to join a WeChat group, which was governed by experienced gastroenterologists. Relevant knowledge of H. pylori eradication was released in the group chat irregularly. Patients in WeChat group were allowed to ask questions at any time during the whole treatment process, soon afterwards, suggestions were given.; Other: patient education; Patients in the control group received verbal education and a specifically designed printout with detailed instructions.
WeChat group	Other: patient education; patients in experimental group were asked to join a WeChat group, which was governed by experienced gastroenterologists. Relevant knowledge of H. pylori eradication was released in the group chat irregularly. Patients in WeChat group were allowed to ask questions at any time during the whole treatment process, soon afterwards, suggestions were given.; Other: patient education; Patients in the control group received verbal education and a specifically designed printout with detailed instructions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
eradication rate	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.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
compliance	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.	14 days
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

Collaborators and Investigators

• Sponsor: Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): July 31, 2021
• Study Completion (Actual): December 7, 2021

Study Registration Dates

• First Submitted: December 25, 2021
• First Submitted That Met QC Criteria: December 25, 2021
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): March 23, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: helicobacter pylori eradication patient education Wechat group
• Other Study ID Numbers: 2021SDU-QILU-111

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No