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

Sponsor
Ege University (Other)
Overall Status
Completed
CT.gov ID
NCT05618665
Collaborator
(none)
88
1
3
9.9
8.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Asthma Education
  • Other: Delivery of booklets
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
88 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Education Given to Asthmatic School Children and Their Parents by Taking Health Literacy Into Account on Disease Self-management
Actual Study Start Date :
Oct 1, 2018
Actual Primary Completion Date :
Jul 1, 2019
Actual Study Completion Date :
Jul 30, 2019

Arms and Interventions

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.

Other: Asthma 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.

Other: Delivery of booklets
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.

Other: Asthma 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.

Other: Delivery of booklets
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.

Outcome Measures

Primary Outcome Measures

  1. Health Literacy for School-Aged Children - HLSAC [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.

  2. Health Literacy Scale [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.

  3. Asthma Control Test [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
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:
  • Being in the 1st grade in their school,

  • Not using any medication for asthma,

  • Having parents with reading difficulties.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Nursing Ege University İzmir Turkey

Sponsors and Collaborators

  • Ege University

Investigators

  • Study Director: Ayla BAYIK TEMEL, Prof., Department of Nursing, Ege University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Esma Guney Kizil, Phd, Ege University
ClinicalTrials.gov Identifier:
NCT05618665
Other Study ID Numbers:
  • 2018-05
First Posted:
Nov 16, 2022
Last Update Posted:
Nov 16, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 16, 2022