- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05618665
The Effect of Asthma Education Given by Taking Health Literacy Into Account
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
İzmir, Turkey
- Department of Nursing Ege University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- Being in the 1st grade in their school,
- Not using any medication for asthma,
- Having parents with reading difficulties.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
The booklets, prepared by the researchers, included information about the content of the education.
|
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.
|
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.
The booklets, prepared by the researchers, included information about the content of the education.
|
No Intervention: Control group
No intervention was applied to the control group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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4 Months
|
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.
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4 Months
|
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.
|
4 Months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ayla BAYIK TEMEL, Prof., Department of Nursing, Ege University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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