CClinicalTrials.gg
CompletedNCT05618665Updated Nov 16, 2022

The Effect of Asthma Education Given by Taking Health Literacy Into Account

An interventional study of Asthma Education and Delivery of booklets in Asthma in Children, Health Literacy and Child Health, sponsored by Ege University. Completed at 1 site in Turkey. Per ClinicalTrials.gov, last updated 2022-11-16.

Sponsored by Ege University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 4 years 1 month after the study started (first participant enrolled Oct 2018, registered Nov 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
88
Allocation
Randomized
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Asthma in Children
  • Health Literacy
  • Child Health
  • Asthma Management
  • Nursing

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03

In context

Asthma

3,920 studies on the registry are indexed under Asthma; 506 are open to participants now.

This study's enrollment of 88 is close to the median of 83 across 2,751 interventional studies indexed under Asthma.

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Lead sponsor

Ege University is the lead sponsor of 365 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Being in the 1st grade in their school,
  • Not using any medication for asthma,
  • Having parents with reading difficulties.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
88 participants (actual)

Study arms

  • Experimental
    Intervention Group - Children and parents

    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.

    Other: Asthma Education · Other: Delivery of booklets

  • Experimental
    Intervention Group - Children

    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.

    Other: Asthma Education · Other: Delivery of booklets

  • No intervention
    Control group

    No intervention was applied to the control group.

Interventions

  • OtherAsthma Education

    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.

  • OtherDelivery of booklets

    The booklets, prepared by the researchers, included information about the content of the education.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4 Months

  2. 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.

    Time frame: 4 Months

  3. 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.

    Time frame: 4 Months

07

Study locations

1 site
  • Department of Nursing Ege University
    İzmir, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05618665
Lead sponsor
Ege University
Responsible party
Esma Guney Kizil (Phd, Ege University) — Principal investigator
First posted
Nov 16, 2022
Start date
Oct 1, 2018
Primary completion
Jul 1, 2019
Completion
Jul 30, 2019
Last update
Nov 16, 2022

Study contacts

Ayla BAYIK TEMEL, Prof.
study director · Department of Nursing, Ege University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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