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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Helicobacter Pylori Infection; Patient Education; Helicobacter Pylori Eradication
• Intervention / Treatment: Other: oral and written education; Other: Wechat group

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 Type: Interventional
• Enrollment (Anticipated): 438
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 257000
      • Recruiting
      • Qilu hosipital
      • Sub-Investigator: Yueyue Li, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control group; 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; oral and written education
Experimental: Wechat group; 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; oral and written education; Other: Wechat group; Wechat group: oral and written education plus Wechat group based interactive education provided by medical professional

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
compliance of patients in the two groups	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

Collaborators and Investigators

• Sponsor: Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2021
• Primary Completion (Anticipated): August 10, 2022
• Study Completion (Anticipated): September 10, 2022

Study Registration Dates

• First Submitted: April 7, 2021
• First Submitted That Met QC Criteria: April 18, 2021
• First Posted (Actual): April 20, 2021

Study Record Updates

• Last Update Posted (Actual): August 26, 2021
• Last Update Submitted That Met QC Criteria: August 22, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: patient education; helicobacter pylori; eradication; Wechat group
• Other Study ID Numbers: 2021SDU-QILU-067

Drug and device information, study documents

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