Effectiveness of an Educational Intervention on Asthmatic Children in Inhaled Technique and Adherence.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Educational Intervention.
- Who it may be relevant to
- Registry conditions: Asthma Childhood. Basic parameters: 6 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessment of Asthma Management in Children Over 6 Years of Age and Their Caregivers. Implications for the Implementation of the SMART Strategy in Pediatrics.
Overview
The goal of this study is to see if a short educational session and demonstration by a nurse can help asthmatic children (6-17 years-old), under hospital control, to manage their asthma better, to use their inhaler correctly, and to know when it should be used. The main question it aims to answer is how much improvement is reached on asthma self-management. The comparison group is the same group. Researchers will compare results before and after educational intervention.
Detailed description
The goal of this study is to see if a short educational session and demonstration by a nurse can help children manage their asthma better, use their inhaler correctly, and know when it should be used.
The study lasts about six months and has two visits:
Visit 1:
Participants will do the usual breathing tests, will show the nurse how to use the inhaler, and answer a few short questionnaires.
Then, the nurse will give some practical education using pictures and demonstrations. She will explain the right way to use the inhaler, to know the device, go over when and why to use inhaled medicine, and teach the participant how to recognize when asthma is getting worse and what can participant do about it.
Visit 2 (after 6 months):
Participants will repeat the same breathing tests and answer questionnaires again, so investigators can see what has changed.
Interventions
- Other Educational Intervention
Educational Intervention: The nurse will deliver a brief health education session focused on: 1. Understanding the treatment. Provide clear information adapted to the patient's level, supported with visual aids. 2. Distinguishing between maintenance and rescue treatment. Explain the role of each medication with practical examples. 3. Assessment and correction of inhaler technique. Carry out a step-by-step demonstration and ask the patient to repeat the technique. Use educational materials (pla
Primary outcome measures
- Change in Correct inhaler technique [Time frame: From the nursing intervention until the following 6 months.]
Secondary outcome measures (1)
- Change in Treatment Adherence [Time frame: From the nursing intervention until the following 6 months.]
Eligibility criteria
Inclusion criteria
- Clinical diagnosis of asthma.
- Prescribed treatment with inhaled corticosteroid.
- First-degree relative of the patient.
Exclusion criteria
. Inability to understand Spanish.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Frey SM, Fagnano M, Halterman JS. Adolescent Knowledge of When to Use Inhaled Asthma Medications: Implications for Management. J Adolesc Health. 2023 Apr;72(4):623-628. doi: 10.1016/j.jadohealth.2022.10.034. Epub 2022 Dec 15. PMID 36528520
- Manti S, Licari A, Leonardi S, Marseglia GL. Management of asthma exacerbations in the paediatric population: a systematic review. Eur Respir Rev. 2021 Jul 13;30(161):200367. doi: 10.1183/16000617.0367-2020. Print 2021 Sep 30. PMID 34261742
- Kosse RC, Koster ES, Kaptein AA, de Vries TW, Bouvy ML. Asthma control and quality of life in adolescents: The role of illness perceptions, medication beliefs, and adherence. J Asthma. 2020 Oct;57(10):1145-1154. doi: 10.1080/02770903.2019.1635153. Epub 2019 Jul 5. PMID 31225980
- Ciprandi G, Licari A, Castagnoli R, Ciprandi R, Marseglia GL. Asthma control in adolescents: the importance of assessing adherence. Acta Biomed. 2022 Aug 31;93(4):e2022264. doi: 10.23750/abm.v93i4.12448. PMID 36043978
- Lizano-Barrantes C, Garin O, Mayoral K, Dima AL, Pont A, Caballero-Rabasco MA, Praena-Crespo M, Valdesoiro-Navarrete L, Guerra MT, Bercedo-Sanz A, Ferrer M. Impact of treatment adherence and inhalation technique on asthma outcomes of pediatric patients: a longitudinal study. Front Pharmacol. 2024 Mar 13;15:1340255. doi: 10.3389/fphar.2024.1340255. eCollection 2024. PMID 38549668
- Basharat S, Jabeen U, Zeeshan F, Bano I, Bari A, Rathore AW. Adherence to asthma treatment and their association with asthma control in children. J Pak Med Assoc. 2018 May;68(5):725-728. PMID 29885170
- McCrossan P, Shields MD, McElnay JC. Medication Adherence in Children with Asthma. Patient Prefer Adherence. 2024 Mar 5;18:555-564. doi: 10.2147/PPA.S445534. eCollection 2024. PMID 38476591
- Gonzalez Betlza M, Bruno I, Yemini L, Zuniga C, Bello Pedrosa O. [Impact of a program of health education for the asthmatic child and their families]. Arch Argent Pediatr. 2020 Apr;118(2):145-149. doi: 10.5546/aap.2020.145. Spanish. PMID 32199068
Identifiers
NCT: NCT07364643 · IIBSP-EMA-2025-05