Clinical trial NCT06396780: Treatment Adherence And Influencing Factors in Children With Helicobacter Pylori Infection During Eradication Therapy
Official title: Treatment Adherence And Influencing Factors in Children With Helicobacter Pylori Infection During Eradication Therapy: A Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Helicobacter Pylori Infection
Children, Only
Keywords: H.pylori infection
Medication Adherence
Medication Beliefs
Medication Knowledge
Medication Support
Helicobacter pylori knowledge
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 233
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eradication of helicobacter pylori in children

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.

Detailed description: 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.

Eligibility criteria: Children 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

Children 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

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

Primary outcomes:
measure: Status of adherence
timeFrame: baseline
Secondary outcomes:
measure: Medication literacy
timeFrame: Baseline
measure: Beliefs about medicine
timeFrame: Baseline
measure: Medication support
timeFrame: Baseline
measure: Helicobacter pylori knowledge
timeFrame: Baseline
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Wei Xia, PhD
role: PRINCIPAL_INVESTIGATOR
References: