NCT06742320

Brief Summary

The aim of this study is to examine the effects of asthma education on asthma knowledge, control and quality of life of school-aged children (7-11 years old) diagnosed with asthma and followed up in the outpatient clinic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable asthma

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

November 25, 2024

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 19, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2025

Completed
Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

December 16, 2024

Last Update Submit

April 8, 2026

Conditions

Keywords

asthmachildreneducationrandomized control

Outcome Measures

Primary Outcomes (2)

  • Asthma Quality of Life Scale for Children

    The scale was developed for children aged 7-11 and adapted to Turkish by Yüksel et al. (2009) and consists of 3 sub-dimensions, namely 'asthma symptoms', 'activity limitation' and 'emotional function', and 23 questions. Scoring varies between 1-7 for each item.The total score to be obtained from the scale is between 23 and 161. A high score indicates a good quality of life.

    About 3 months

  • Childhood Asthma Control Test

    The scale evaluates asthma symptoms in the last 4 weeks for children aged 4-11. Children answer the first 4 questions themselves, while the person responsible for the child's care answers the last 3 questions. The total score to be obtained from the scale is between 0-27. Patients with a total score of 19 points and below are considered to have uncontrolled asthma, and patients with a score of 20 points and above are considered to have controlled asthma.

    About 3 months

Secondary Outcomes (1)

  • Asthma Knowledge Survey

    About 3 months

Study Arms (2)

Education Group

EXPERIMENTAL

Pre-test forms were applied to the children in the training group face to face by the researchers in the outpatient clinic. Children assigned to the training group received asthma education in a single session, 3 modules/each module lasting at least 15 minutes. Post-test forms were administered immediately after the training.The 2nd and 3rd follow-up tests will be administered online via Google Form in the 1st and 3rd months after the training is completed.

Behavioral: Asthma education

Control group

NO INTERVENTION

Pre-test forms will be applied to the control group face-to-face by researchers in the outpatient clinic.In the control group, follow-up tests (three weeks, 1 month and 3 months after the pre-tests) will be administered online via Google Form.

Interventions

There are very few studies examining the asthma knowledge level, quality of life and asthma control of children in Turkey.

Education Group

Eligibility Criteria

Age7 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Being between the ages of 7-11,
  • Medically diagnosed with asthma and being followed up in the outpatient clinic
  • Family and child agreeing to participate in the study
  • Ability to use a smartphone, computer or tablet
  • Having internet access
  • Children who can read and understand Turkish

You may not qualify if:

  • Children who do not have a medical diagnosis of asthma
  • Children who do not agree to participate in the study and their parents
  • Children who do not complete the training and tests

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University Nevvar & Salih İşgören Children's Hospital Pediatric Allergy and Immunology Polyclinic

Izmir, Balcova, 35330, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Children will be randomly assigned to the training and control groups via a computer program.This process was carried out by a person other than the researchers.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study is an experimental type with a pre-test, post-test and follow-up test control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
specialist nurse

Study Record Dates

First Submitted

December 16, 2024

First Posted

December 19, 2024

Study Start

November 25, 2024

Primary Completion

April 15, 2025

Study Completion

April 15, 2025

Last Updated

April 9, 2026

Record last verified: 2026-04

Locations