The Effect of Education Given to Children With Asthma (RCT)

April 8, 2026 updated by: Atiye Yıldırım, Dokuz Eylul University

Effect of Education on Asthma Knowledge, Control and Quality of Life in School-Age Children Diagnosed With Asthma

The aim of this study is to examine the effects of asthma education on asthma knowledge, control and quality of life of school-aged children (7-11 years old) diagnosed with asthma and followed up in the outpatient clinic.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Asthma is among the most common chronic diseases in childhood. Besides being one of the most common diseases, it is a preventable and controllable disease.In a study analyzing asthma data of children aged 0-17 by the Centers for Disease Control and Prevention (CDC), the prevalence of asthma was 8.7% in 2001, this rate increased to 9.4% in 2010, and decreased to 8.3% in 2016. In the same study, the prevalence of asthma was found to be 9.2% in boys and 7.4% in girls.Asthma is also the leading cause of school absences in children ages 5 to 17, accounting for more than 14 million days of absence from school in 2013.These adverse effects of asthma can be minimized with appropriate education.Studies have found an increase in the quality of life of asthmatic students after asthma education, a decrease in asthma exacerbations, school absences, parental workday loss and medical expenses, and an increase in adherence to treatment, asthma knowledge and correct inhaler use.These findings suggest that asthma management interventions increase children's knowledge about their disease and their self-management skills.Based on this need, the aim of this study is to examine the effects of asthma education given to school-aged children (7-11 years old) diagnosed with asthma and followed up in the outpatient clinic on their asthma knowledge, control and quality of life.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Balcova
      • Izmir, Balcova, Turkey (Türkiye), 35330
        • Dokuz Eylul University Nevvar & Salih İşgören Children's Hospital Pediatric Allergy and Immunology Polyclinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being between the ages of 7-11,
  • Medically diagnosed with asthma and being followed up in the outpatient clinic
  • Family and child agreeing to participate in the study
  • Ability to use a smartphone, computer or tablet
  • Having internet access
  • Children who can read and understand Turkish

Exclusion Criteria:

  • Children who do not have a medical diagnosis of asthma
  • Children who do not agree to participate in the study and their parents
  • Children who do not complete the training and tests

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Education Group
Pre-test forms were applied to the children in the training group face to face by the researchers in the outpatient clinic. Children assigned to the training group received asthma education in a single session, 3 modules/each module lasting at least 15 minutes. Post-test forms were administered immediately after the training.The 2nd and 3rd follow-up tests will be administered online via Google Form in the 1st and 3rd months after the training is completed.
Behavioral: Asthma education
There are very few studies examining the asthma knowledge level, quality of life and asthma control of children in Turkey.
No Intervention: Control group
Pre-test forms will be applied to the control group face-to-face by researchers in the outpatient clinic.In the control group, follow-up tests (three weeks, 1 month and 3 months after the pre-tests) will be administered online via Google Form.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Asthma Quality of Life Scale for Children
Time Frame: About 3 months
The scale was developed for children aged 7-11 and adapted to Turkish by Yüksel et al. (2009) and consists of 3 sub-dimensions, namely 'asthma symptoms', 'activity limitation' and 'emotional function', and 23 questions. Scoring varies between 1-7 for each item.The total score to be obtained from the scale is between 23 and 161. A high score indicates a good quality of life.
About 3 months
Childhood Asthma Control Test
Time Frame: About 3 months
The scale evaluates asthma symptoms in the last 4 weeks for children aged 4-11. Children answer the first 4 questions themselves, while the person responsible for the child's care answers the last 3 questions. The total score to be obtained from the scale is between 0-27. Patients with a total score of 19 points and below are considered to have uncontrolled asthma, and patients with a score of 20 points and above are considered to have controlled asthma.
About 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Asthma Knowledge Survey
Time Frame: About 3 months
The asthma knowledge survey, which was created by the researchers by reviewing the relevant literature, consists of 13 questions. The first 8 questions in the survey are about asthma definition, symptoms, triggers and physical activity status, and the last 5 questions are about asthma treatment. The questions have a 3-point answer option of yes, no/I don't know. 1 point is received for correct answers and 0 points are received for wrong/I don't know. There is a total distribution between 0-13 points. The survey items were rearranged in line with the opinions received from 9 experts. The content validity rates of the scores given by the experts to the items vary between 0.85-1.0. The content validity index was calculated as 0.98 in the study. It was determined that there was a high level and statistically significant consensus among the experts.
About 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dokuz Eylul University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 25, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024/10-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

I haven't decided yet.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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