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Helicobacter Pylori InfectionNCT06396780

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

An observational study of Helicobacter Pylori Infection and Children, Only, run by Wei XIA, PhD at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 8 to 18 years
Conditions the study is for
Helicobacter Pylori Infection, Children, Only
How many people
233 participants
Where
1 siteChina
Study dates
30 Mar 2024to 31 Mar 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: Eradication of helicobacter pylori in children

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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University

    Guangzhou, Guangdong, 510080

Other trials in China

About this study

Official title: 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.

Read the 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.

Keywords
H.pylori infection, Medication Adherence, Medication Beliefs, Medication Knowledge, Medication Support, Helicobacter pylori knowledge
Medical subject headings
Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06396780
Study groupRoleWhat they receive
Participants who meet the inclusion/exclusion criteria will be invited to complete the questionnaireChildren 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 being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: baseline

Secondary outcomes (4)

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: Baseline

  3. 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.

    Measured: Baseline

  4. Helicobacter pylori knowledge

    Using the Helicobacter pylori Knowledge Questionnaire to investigate the caregivers' level of knowledge about Helicobacter pylori.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2024
  2. Study start30 Mar 2024
  3. Primary completion28 Feb 2025 (estimated)
  4. Study completion31 Mar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
233 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06396780
Sponsor's protocol ID
039A01
Status last verified
Jul 2024
First submitted
30 Apr 2024
Last updated
22 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The non-identified individual participant data will be shared after the outcomes have been published.

Questions about this trial

What is this clinical trial studying?

An observational study of Helicobacter Pylori Infection and Children, Only, run by Wei XIA, PhD at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Status of adherence (time frame: baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06396780.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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