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临床试验/NCT06396780
NCT06396780进行中(未招募)不适用

Treatment Adherence And Influencing Factors in Children With Helicobacter Pylori Infection During Eradication Therapy: A Cross Sectional Study

Wei XIA, PhD1 个研究点 分布在 1 个国家目标入组 233 人开始时间: 2024年3月30日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
233
试验地点
1
主要终点
Status of adherence

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
8 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 1.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

排除标准

  • 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
  • Caregiver Inclusion Criteria:
  • 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
  • Caregiver Exclusion Criteria:
  • 1.Not living with children
  • 2.Not familiar with the use of children

结局指标

主要结局

Status of adherence

时间窗: baseline

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.

次要结局

  • Beliefs about medicine(Baseline)
  • Medication literacy(Baseline)
  • Medication support(Baseline)
  • Helicobacter pylori knowledge(Baseline)

研究者

发起方
Wei XIA, PhD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Wei XIA, PhD

Association Professor

Sun Yat-sen University

研究点 (1)

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