AsthmaRCTNCT06742320
The Effect of Education Given to Children With Asthma
A study testing Asthma education in people with Asthma, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Asthma
- What is being tested?
- Asthma education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Nov 2024to 15 Apr 2025
- Phase
- Interventional
- 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 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dokuz Eylul University Nevvar & Salih İşgören Children's Hospital Pediatric Allergy and Immunology Polyclinic
Izmir, Balcova, 35330
About this study
Official title: 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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Asthma education
- Keywords
- asthma, children, education, randomized control
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asthma educationBehavioural
There are very few studies examining the asthma knowledge level, quality of life and asthma control of children in Turkey.
| Study group | Role | What they receive |
|---|---|---|
| Education Group | Experimental | 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. Receives: Behavioral: Asthma education |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Asthma Quality of Life Scale for Children
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.
Measured: About 3 months
Childhood Asthma Control Test
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.
Measured: About 3 months
Secondary outcomes (1)
Asthma Knowledge Survey
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.
Measured: About 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start25 Nov 2024
- Primary completion15 Apr 2025
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is an experimental type with a pre-test, post-test and follow-up test control group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atiye Yıldırım, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742320
- Sponsor's protocol ID
- 2024/10-06
- Acronym
- RCT
- Status last verified
- Apr 2026
- First submitted
- 16 Dec 2024
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I haven't decided yet.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Education on Asthma Knowledge, Control and Quality of Life in School-Age Children Diagnosed With Asthma
- ClinicalTrials.gov ID
- NCT06742320
- Acronym / sponsor ID
- RCT / 2024/10-06
- Conditions
- Asthma
- Keywords
- asthma, children, education, randomized control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 19 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The study is an experimental type with a pre-test, post-test and follow-up test control group.
| Arm | Type | Receives |
|---|---|---|
| Education Group | Experimental | Behavioral: Asthma educationPre-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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Asthma educationThere are very few studies examining the asthma knowledge level, quality of life and asthma control of children in Turkey. | Behavioural | Education Group |
Primary outcome
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.
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.
1 secondary outcome
Asthma Knowledge Survey
Time frame: About 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: Undecided. I haven't decided yet.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Asthma education in people with Asthma, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. 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: finished, as of the sponsor's last update on 9 Apr 2026. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Asthma Quality of Life Scale for Children (time frame: About 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2026.