Asthma in ChildrenNCT05618665
The Effect of Asthma Education Given by Taking Health Literacy Into Account
A study testing Asthma Education and Delivery of booklets in people with Asthma in Children and Health Literacy, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this randomized controlled trial was to examine the effect of education given to asthmatic children and their parents by taking health literacy into account on disease self-management. The study was conducted with 88 children and their parents between October 2018 and July 2019. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Asthma in Children, Health Literacy, Child Health
- What is being tested?
- Asthma Education and Delivery of booklets
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2018to 30 Jul 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Having asthma children with a physician diagnosis,
- Studying in one of the public primary schools in the district where the study was conducted,
- Using asthma medication,
- Having parents without any reading difficulties.
Who cannot join
- Being in the 1st grade in their school,
- Not using any medication for asthma,
- Having parents with reading difficulties.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Education Given to Asthmatic School Children and Their Parents by Taking Health Literacy Into Account on Disease Self-management
The aim of this randomized controlled trial was to examine the effect of education given to asthmatic children and their parents by taking health literacy into account on disease self-management.
The study was conducted with 88 children and their parents between October 2018 and July 2019. While education and booklets were given to both children and parents in intervention group 1, only the children were given the education and the booklets in intervention group 2. There was no intervention applied for the control group. Post-test was performed 3 weeks after the education and then follow-ups were carried out in the next three months over the phone.
- Conditions
- Asthma in Children, Health Literacy, Child Health, Asthma Management, Nursing
- Being tested
- Asthma Education, Delivery of booklets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asthma EducationOther
Asthma education about asthma disease, its symptoms, diagnosis, treatment, risk factors, use of medication, use of medication apparatus, vaccination treatment, follow-up of the asthmatic child, precautions to be taken in prevention, what to do during an attack, what to do for adaptation to the disease and things to do in school life.
Delivery of bookletsOther
The booklets, prepared by the researchers, included information about the content of the education.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group - Children and parents | Experimental | Asthma education which consisted of asthma disease, its symptoms, diagnosis, treatment, risk factors, use of medication, use of medication apparatus, vaccination treatment, follow-up of the asthmatic child, precautions to be taken in prevention, what to do during an attack, what to do for adaptation to the disease and things to do in school life was prepared and presented in 40 minutes. The booklets about education would be given at the end of the education. Receives: Other: Asthma Education; Other: Delivery of booklets |
| Intervention Group - Children | Experimental | Asthma education which consisted of asthma disease, its symptoms, diagnosis, treatment, risk factors, use of medication, use of medication apparatus, vaccination treatment, follow-up of the asthmatic child, precautions to be taken in prevention, what to do during an attack, what to do for adaptation to the disease and things to do in school life was prepared and presented in 40 minutes. The booklets about education would be given at the end of the education. Receives: Other: Asthma Education; Other: Delivery of booklets |
| Control group | No intervention | No intervention was applied to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Literacy for School-Aged Children - HLSAC
Health Literacy for School-Aged Children - HLSAC, which was developed by Paakkari et al., is a brief, multidimensional, generic, theory-based, cross-national validated, self-administered instrument to measure the subjective health literacy level of school-aged children. This tool assesses health literacy in five areas among school-aged children: theoretical knowledge (items 1 and 5); practical knowledge (items 4 and 7); critical thinking (items 3 and 9); self-awareness (items 8 and 10), and citizenship (items 2 and 6). The scale items are rated on a four-point Likert-type scale (not at all true = 1, barely true = 2, somewhat true = 3, and absolutely true = 4). A score between 10 and 25 implies low health literacy, between 26 and 35, moderate health literacy, and between 36 and 40, high health literacy.
Measured: 4 Months
Health Literacy Scale
The health literacy levels of the parents were measured with the "Health Literacy Scale". The scale is the short form of the Health Literacy Survey in Europe (HLS-E.U). The scale is a 25-item Health Literacy Index form. The scale consists of 25 items and 4 sub-dimensions: Accessing information (items 1-5), understanding information (items 6-12), valuing/evaluating (items 13-20), and implementing/using (items 21-25). The scale is a 5-point Likert type (1 = I am unable to do / I have no ability / impossible, 2 = I have a lot of difficulties, 3 = I sometimes have difficulties, 4 = I have difficulties, 5 = I have no difficulty). The total score that can be obtained from the scale is between 25 and 125.
Measured: 4 Months
Asthma Control Test
An asthma control test involves questions relating to daytime and nighttime asthma symptoms. This test helps determine if a person is controlling their asthma well. The test helps someone identify how their symptoms interfere with their day-to-day life. If individuals do not have sufficient control over their asthma in the long term, it can increase the risk of asthma attacks and lead to other health issues, such as lung infections, which can cause several symptoms. Five questions involve a 4-week recall of symptoms and how they affect a person's daily functioning. Each answer has a value of 1-5, and at the end of the test, the score for each answer is added to the total score, which may range from 5 to 25. The lower the score, the more a person lacks control of their condition. For example, someone does not have their asthma under control if they score 5 or 6. An individual has better control of their asthma if they score 20 or higher.
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start1 Oct 2018
- Primary completion1 Jul 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esma Guney Kizil, Ege University
- Investigators
- Ayla BAYIK TEMEL, Prof., Study director, Department of Nursing, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05618665
- Sponsor's protocol ID
- 2018-05
- Status last verified
- Nov 2022
- First submitted
- 3 Nov 2022
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education Given to Asthmatic School Children and Their Parents by Taking Health Literacy Into Account on Disease Self-management
- ClinicalTrials.gov ID
- NCT05618665
- Acronym / sponsor ID
- 2018-05
- Conditions
- Asthma in Children, Health Literacy, Child Health, Asthma Management, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 16 Nov 2022 (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 randomized controlled trial was to examine the effect of education given to asthmatic children and their parents by taking health literacy into account on disease self-management.
The study was conducted with 88 children and their parents between October 2018 and July 2019. While education and booklets were given to both children and parents in intervention group 1, only the children were given the education and the booklets in intervention group 2. There was no intervention applied for the control group. Post-test was performed 3 weeks after the education and then follow-ups were carried out in the next three months over the phone.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention Group - Children and parents | Experimental | Other: Asthma Education, Other: Delivery of bookletsAsthma education which consisted of asthma disease, its symptoms, diagnosis, treatment, risk factors, use of medication, use of medication apparatus, vaccination treatment, follow-up of the asthmatic child, precautions to be taken in prevention, what to do during an attack, what to do for adaptation to the disease and things to do in school life was prepared and presented in 40 minutes. The booklets about education would be given at the end of the education. |
| Intervention Group - Children | Experimental | Other: Asthma Education, Other: Delivery of bookletsAsthma education which consisted of asthma disease, its symptoms, diagnosis, treatment, risk factors, use of medication, use of medication apparatus, vaccination treatment, follow-up of the asthmatic child, precautions to be taken in prevention, what to do during an attack, what to do for adaptation to the disease and things to do in school life was prepared and presented in 40 minutes. The booklets about education would be given at the end of the education. |
| Control group | No intervention | –No intervention was applied to the control group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Having asthma children with a physician diagnosis,
- Studying in one of the public primary schools in the district where the study was conducted,
- Using asthma medication,
- Having parents without any reading difficulties.
Key exclusion criteria (3 listed)
- Being in the 1st grade in their school,
- Not using any medication for asthma,
- Having parents with reading difficulties.
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 EducationAsthma education about asthma disease, its symptoms, diagnosis, treatment, risk factors, use of medication, use of medication apparatus, vaccination treatment, follow-up of the asthmatic child, precautions to be taken in prevention, what to do during an attack, what to do for adaptation to the disease and things to do in school life. | Other | Intervention Group - Children, Intervention Group - Children and parents |
| Delivery of bookletsThe booklets, prepared by the researchers, included information about the content of the education. | Other | Intervention Group - Children, Intervention Group - Children and parents |
Primary outcome
Health Literacy for School-Aged Children - HLSAC
Time frame: 4 Months
Health Literacy for School-Aged Children - HLSAC, which was developed by Paakkari et al., is a brief, multidimensional, generic, theory-based, cross-national validated, self-administered instrument to measure the subjective health literacy level of school-aged children. This tool assesses health literacy in five areas among school-aged children: theoretical knowledge (items 1 and 5); practical knowledge (items 4 and 7); critical thinking (items 3 and 9); self-awareness (items 8 and 10), and citizenship (items 2 and 6). The scale items are rated on a four-point Likert-type scale (not at all true = 1, barely true = 2, somewhat true = 3, and absolutely true = 4). A score between 10 and 25 implies low health literacy, between 26 and 35, moderate health literacy, and between 36 and 40, high health literacy.
Health Literacy Scale
Time frame: 4 Months
The health literacy levels of the parents were measured with the "Health Literacy Scale". The scale is the short form of the Health Literacy Survey in Europe (HLS-E.U). The scale is a 25-item Health Literacy Index form. The scale consists of 25 items and 4 sub-dimensions: Accessing information (items 1-5), understanding information (items 6-12), valuing/evaluating (items 13-20), and implementing/using (items 21-25). The scale is a 5-point Likert type (1 = I am unable to do / I have no ability / impossible, 2 = I have a lot of difficulties, 3 = I sometimes have difficulties, 4 = I have difficulties, 5 = I have no difficulty). The total score that can be obtained from the scale is between 25 and 125.
Asthma Control Test
Time frame: 4 Months
An asthma control test involves questions relating to daytime and nighttime asthma symptoms. This test helps determine if a person is controlling their asthma well. The test helps someone identify how their symptoms interfere with their day-to-day life. If individuals do not have sufficient control over their asthma in the long term, it can increase the risk of asthma attacks and lead to other health issues, such as lung infections, which can cause several symptoms. Five questions involve a 4-week recall of symptoms and how they affect a person's daily functioning. Each answer has a value of 1-5, and at the end of the test, the score for each answer is added to the total score, which may range from 5 to 25. The lower the score, the more a person lacks control of their condition. For example, someone does not have their asthma under control if they score 5 or 6. An individual has better control of their asthma if they score 20 or higher.
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 16 Nov 2022.
- Individual participant dataSharing planned: No
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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.
Ayla BAYIK TEMEL, Prof. study director
Department of Nursing, Ege University
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 and Delivery of booklets in people with Asthma in Children and Health Literacy, run by Ege 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 4 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 16 Nov 2022. 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?
Health Literacy for School-Aged Children - HLSAC (time frame: 4 Months). The study lists 3 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 16 Nov 2022.