NCT05618665

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 16, 2022

Completed
Last Updated

November 16, 2022

Status Verified

November 1, 2022

Enrollment Period

9 months

First QC Date

November 3, 2022

Last Update Submit

November 9, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    4 Months

Study Arms (3)

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.

Other: Asthma EducationOther: 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.

Other: Asthma EducationOther: Delivery of booklets

Control group

NO INTERVENTION

No intervention was applied to the control group.

Interventions

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.

Intervention Group - ChildrenIntervention Group - Children and parents

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

Intervention Group - ChildrenIntervention Group - Children and parents

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nursing Ege University

Izmir, Turkey (Türkiye)

Location

Study Officials

  • Ayla BAYIK TEMEL, Prof.

    Department of Nursing, Ege University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd

Study Record Dates

First Submitted

November 3, 2022

First Posted

November 16, 2022

Study Start

October 1, 2018

Primary Completion

July 1, 2019

Study Completion

July 30, 2019

Last Updated

November 16, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations