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

NCT ID: NCT04850209

Last Updated: 2023-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

438 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-23

Study Completion Date

2022-09-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Helicobacter Pylori Infection Helicobacter Pylori Eradication Patient Education

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

There are two randomized parallel groups in this study, control group and Wechat group.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The interventions are blind to follow-up personnel who collect and analyze compliance and the incidence of adverse events. The interventions are also blind to the UBT personnel.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type OTHER

oral and written education

Intervention Type OTHER

oral and written education

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.

Group Type EXPERIMENTAL

oral and written education

Intervention Type OTHER

oral and written education

Wechat group

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

oral and written education

oral and written education

Intervention Type OTHER

Wechat group

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shandong University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Xiuli Zuo

Professor, Director of gastroenterology department of Qilu hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Qilu hosipital

Jinan, Shandong, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021SDU-QILU-067

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.