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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Helicobacter Pylori Infection; Children, Only

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.

• Study Type: Observational
• Enrollment (Estimated): 233

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Eradication of helicobacter pylori in children

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication literacy	Medication literacy questionnaire was used to investigate the drug literacy level of children. The questionnaire consisted of 9 items, covering the drug name, dosage and adverse reactions of discharged patients. The 2-point system was used to score points (1 for correct answers and 0 for wrong answers), and the total score of the items was 9 points. Those who scored 0-2 points were considered to have poor drug literacy level, those who scored 3-5 points were considered to have medium drug literacy level, and those who scored 6-7 points were considered to have excellent drug literacy level.	Baseline
Beliefs about medicine	The Medication Beliefs Specific Questionnaire is used to assess the medication belief levels of pediatric patients and their caregivers. The questionnaire comprises two dimensions: medication necessity and medication concerns, totaling 10 items. Responses are rated on a 5-point Likert scale. Scores for medication necessity and medication concerns dimensions range from 5 to 25 points. Medication belief is calculated as the difference between scores for medication necessity and medication concerns (-20 to 20). Belief levels are categorized as low if the total score is less than 0, moderate if the total score is 0, and high if the total score is greater than 0.	Baseline
Medication support	The Medication Support Questionnaire assesses caregiver medication support behaviors. The questionnaire consists of 6 items, with each item offering 4 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 to 4 points sequentially. The score range is from 6 to 24 points, with higher scores indicating better caregiver medication support. A score greater than 21 points indicates good caregiver medication support, while a score of 20 or less indicates poor caregiver medication support.	Baseline
Helicobacter pylori knowledge	Using the Helicobacter pylori Knowledge Questionnaire to investigate the caregivers' level of knowledge about Helicobacter pylori.	Baseline

Collaborators and Investigators

• Sponsor: Wei XIA, PhD
• Investigators: Principal Investigator: Wei Xia, PhD, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2024
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: April 30, 2024
• First Submitted That Met QC Criteria: April 30, 2024
• First Posted (Actual): May 2, 2024

Study Record Updates

• Last Update Posted (Actual): July 22, 2024
• Last Update Submitted That Met QC Criteria: July 18, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Medication Adherence; Medication Knowledge; H.pylori infection; Medication Beliefs; Medication Support; Helicobacter pylori knowledge
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Helicobacter Infections
• Other Study ID Numbers: 039A01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The non-identified individual participant data will be shared after the outcomes have been published.
• IPD Sharing Time Frame: After the publication of the study
• IPD Sharing Access Criteria: Researchers should contact the PI for approval of the study protocol
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No