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

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04850209
• Other study ID #: 2021SDU-QILU-067
• Status: Completed
• Phase: N/A
• Start date: July 23, 2021
• Est. completion date: September 10, 2022

Study information

• Verified date: January 2023
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 438
• Est. completion date: September 10, 2022
• Est. primary completion date: August 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Helicobacter Pylori Eradication
• Helicobacter Pylori Infection
• Patient Education

Intervention

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

Locations

Country	Name	City	State
China	Qilu hosipital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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