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

NCT06396780 | Active Not Recruiting DMC

• 1 other identifier: 039A01
• Study Type: observational
• Target: 233
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Helicobacter Pylori Infection; Children, Only

Keywords

H.pylori infection; Medication Adherence; Medication Beliefs; Medication Knowledge; Medication Support; Helicobacter pylori knowledge

Outcome Measures

Primary Outcomes (1)

• Status of adherence

  Using the Medication Adherence Questionnaire to assess the level of medication adherence in pediatric patients. The questionnaire primarily includes four aspects: adherence to timing, dosage, frequency, and persistence in taking medication. Each aspect consists of four options: (1) Impossible to do; (2) Occasionally possible to do; (3) Basically possible to do; (4) Completely possible to do. Using a scoring method, each option is assigned a score of 1, 2, 3, or 4, respectively, with a score range of 4 to 16 points. Complete adherence is scored as 16 points, basic adherence as 13 to 15 points, minimal adherence as 5 to 12 points, and difficulty as 4 points.

  baseline

Secondary Outcomes (4)

• Medication literacy

  Baseline

• Beliefs about medicine

  Baseline

• Medication support

  Baseline

• Helicobacter pylori knowledge

  Baseline

Study Arms (1)

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.

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Eradication of helicobacter pylori in children

You may qualify if:

• Children aged 8-18 years old
• \. 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)
• \. Children who receive Helicobacter pylori eradication therapy

You may not qualify if:

• Children are diagnosed with other chronic conditions and take other medications for a long time
• Unable to communicate with readers in Chinese normally
• 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)
• Able to communicate normally
• Not living with children
• Not familiar with the use of children

Sponsors & Collaborators

• Wei XIA, PhD: lead

Study Sites (1)

Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Wei Xia, PhD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Association Professor

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 2, 2024
• Study Start: March 30, 2024
• Primary Completion: February 28, 2025
• Study Completion: March 31, 2025
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: After the publication of the study
• Access Criteria: Researchers should contact the PI for approval of the study protocol

Locations

CN (1)