Treatment Adherence And Influencing Factors in Children With Helicobacter Pylori Infection During Eradication Therapy

NCT ID: NCT06396780

Last Updated: 2024-07-22

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

ACTIVE_NOT_RECRUITING

Total Enrollment

233 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-30

Study Completion Date

2025-03-31

Brief Summary

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

The aim of this study is to describe the current status of treatment adherence in children with Helicobacter pylori infection, understand the medication literacy, medication beliefs of the children, knowledge of H. pylori among caregivers, medication beliefs, medication support, and explore the influencing factors of medication adherence.

Detailed Description

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

Helicobacter pylori infection usually occurs in childhood and persists into adulthood, and is closely related to the occurrence of chronic gastritis, peptic ulcer, and gastric cancer. However, in recent years, the eradication success rate of Helicobacter pylori infection has gradually decreased, while the drug resistance rate has gradually increased, and it is urgent to improve the success rate of first eradication in children. Medication compliance is closely related to drug resistance, so it is necessary to investigate medication compliance and its influencing factors during Helicobacter pylori eradication in children.Children and caregivers who meet the inclusion and exclusion criteria were invited to individually complete questionnaire surveys.

Part One: Children infected with Helicobacter pylori and undergoing treatment were invited to complete the questionnaire surveys independently. The children completed the Medication Literacy Questionnaire, Medication Beliefs Specific Questionnaire, and Medication Adherence Questionnaire.

Part Two: Caregivers of the children completed the survey questionnaires, including a demographic information form, H. pylori knowledge questionnaire, Medication Beliefs Specific Questionnaire, and Medication Support Questionnaire.

Conditions

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

Helicobacter Pylori Infection Children, Only

Study Design

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

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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

Participants who meet the inclusion/exclusion criteria will be invited to complete the questionnaire

Children will be invited to complete the Medication Adherence Questionnaire, Medication Literacy Questionnaire, and Medication Beliefs Specific Questionnaire. Caregivers will be invited to complete the Helicobacter pylori Knowledge Questionnaire, Medication Beliefs Specific Questionnaire, and Medication Support Questionnaire.

No interventions assigned to this group

Eligibility Criteria

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

Inclusion Criteria

* 1.Children aged 8-18 years old
* 2\. whose diagnosis meets the diagnostic criteria for Helicobacter pylori infection in the Expert Consensus on Diagnosis and Treatment of Helicobacter Pylori Infection in Chinese Children (2022)
* 3\. Children who receive Helicobacter pylori eradication therapy


* 1.Caregivers of children who meet the diagnostic criteria for Helicobacter pylori infection in the Expert Consensus on Diagnosis and Treatment of Helicobacter pylori Infection in Children in China (2022)
* 2.Able to communicate normally

Exclusion Criteria

* 1.Children are diagnosed with other chronic conditions and take other medications for a long time
* 2.Unable to communicate with readers in Chinese normally


* 1.Not living with children
* 2.Not familiar with the use of children
Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

Wei XIA, PhD

OTHER

Sponsor Role lead

Responsible Party

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

Wei XIA, PhD

Association Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Wei Xia, PhD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

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

Sun Yat-sen University

Guangzhou, Guangdong, 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.

039A01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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