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Completed

NCT Number: NCT04850209

The Impact of WeChat Group Patient Education 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.

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Key information

Conditions

Helicobacter Pylori Infection Helicobacter Pylori Eradication Patient Education

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Qilu hosipital

Jinan, Shandong, 257000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged between 18 and 75 years old;
  • H. pylori infection confirmed by any two positive outcomes of rapid urease test (RUT), 13C-urea breath test (UBT) or histopathology.

Exclusion criteria

  • previous therapy for H. pylori;
  • with significant underlying disease (e.g. decompensated liver cirrhosis, renal failure or malignant tumors) that may interfere the study;
  • history of gastric surgery,
  • pregnancy or lactation;
  • the use of PPI or antibiotics during the 4 weeks prior to enrolment;
  • previous history of allergic reactions to any of the medications used in this protocol;
  • unable to use smartphone and wechat
  • unwilling or incapable to provide informed consents.

Treatment and study plan

oral and written education

Other

oral and written education

wechat group

Other

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

Primary outcomes

  1. eradication rate in each group

    Time frame: 2 months

    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.

Secondary outcomes

  1. prevalence of adverse events

    Time frame: 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.

Other outcomes

  1. compliance of patients in the two groups

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 20, 2021
Registry last updated
Jan 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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