Effectiveness of an Educational Intervention on Asthmatic Children in Inhaled Technique and Adherence.

NCT07364643 | Not Yet Recruiting

• 1 other identifier: IIBSP-EMA-2025-05
• Study Type: interventional
• Target: 428
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Asthma Childhood

Keywords

inhaler technique; treatment adherence; asthma self-management; nursing intervention

Outcome Measures

Primary Outcomes (1)

• Change in Correct inhaler technique

  For the qualitative variable "inhaler technique," the Inhaler Technique Questionnaire (InTeQ), validated in pediatrics for the use of pressurized inhalers, will be used. This questionnaire includes 5 items considered critical, with an additional item, "shake the device," added for those using pMDIs. The 5 critical steps assessed are: exhale completely before inhalation, close lips firmly, inhale deeply, hold breath afterward, and exhale slowly, which are applicable to both pressurized metered-dose inhalers (pMDI) with a spacer and dry powder inhalers (DPI). The item "device activation" was removed, as it is inherent to the procedure and to facilitate practical applicability.

  From the nursing intervention until the following 6 months.

Secondary Outcomes (1)

• Change in Treatment Adherence

  From the nursing intervention until the following 6 months.

Study Arms (1)

Study population will be pediatric patients with a diagnosis of asthma, scheduled for consultation

EXPERIMENTAL

The included population will undergo an objective assessment with pulmonary function tests and will be given questionnaires to evaluate their knowledge about asthma treatment. Afterwards, they will receive a brief educational intervention and will be scheduled for a follow-up visit at 6 months to reassess pulmonary function parameters and knowledge level.

Other: Educational Intervention

Interventions

Educational Intervention OTHER

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 (placebo devices, videos, diagrams) and reinforce learning with the teach-back method. 4. Promoting autonomy. Encourage the patient to take part in administering the medication and foster self-management of the device. 5. Evaluating and improving adherence. Suggest daily routines, reminders, and the use of alarms or mobile apps. 6. Appropriate use of rescue medication. Involve the patient in decision-making, promote self-observation, and provide a clear action plan.

Study population will be pediatric patients with a diagnosis of asthma, scheduled for consultation

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Clinical diagnosis of asthma.
• Prescribed treatment with inhaled corticosteroid.
• First-degree relative of the patient.

You may not qualify if:

• Inability to understand Spanish.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead

Related Publications (16)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Capanoglu M, Dibek Misirlioglu E, Toyran M, Civelek E, Kocabas CN. Evaluation of inhaler technique, adherence to therapy and their effect on disease control among children with asthma using metered dose or dry powder inhalers. J Asthma. 2015 Oct;52(8):838-45. doi: 10.3109/02770903.2015.1028075. Epub 2015 Jun 2.

  PMID: 26037396 BACKGROUND

• Almomani BA, Al-Qawasmeh BS, Al-Shatnawi SF, Awad S, Alzoubi SA. Predictors of proper inhaler technique and asthma control in pediatric patients with asthma. Pediatr Pulmonol. 2021 May;56(5):866-874. doi: 10.1002/ppul.25263. Epub 2021 Jan 26.

  PMID: 33497530 BACKGROUND

• Tao S, Fan Q, Hariharan VS, Zhi H. Effectiveness of nursing interventions for management of children with bronchial asthma: A systematic review and meta-analysis. Int J Nurs Pract. 2023 Dec;29(6):e13139. doi: 10.1111/ijn.13139. Epub 2023 Mar 6.

  PMID: 36879363 BACKGROUND

• Normansell R, Kew KM, Mathioudakis AG. Interventions to improve inhaler technique for people with asthma. Cochrane Database Syst Rev. 2017 Mar 13;3(3):CD012286. doi: 10.1002/14651858.CD012286.pub2.

  PMID: 28288272 BACKGROUND

• Roche N, Aggarwal B, Boucot I, Mittal L, Martin A, Chrystyn H. The impact of inhaler technique on clinical outcomes in adolescents and adults with asthma: A systematic review. Respir Med. 2022 Oct;202:106949. doi: 10.1016/j.rmed.2022.106949. Epub 2022 Sep 2.

  PMID: 36063773 BACKGROUND

• Sanchis J, Gich I, Pedersen S; Aerosol Drug Management Improvement Team (ADMIT). Systematic Review of Errors in Inhaler Use: Has Patient Technique Improved Over Time? Chest. 2016 Aug;150(2):394-406. doi: 10.1016/j.chest.2016.03.041. Epub 2016 Apr 7.

  PMID: 27060726 BACKGROUND

• Price DB, Roman-Rodriguez M, McQueen RB, Bosnic-Anticevich S, Carter V, Gruffydd-Jones K, Haughney J, Henrichsen S, Hutton C, Infantino A, Lavorini F, Law LM, Lisspers K, Papi A, Ryan D, Stallberg B, van der Molen T, Chrystyn H. Inhaler Errors in the CRITIKAL Study: Type, Frequency, and Association with Asthma Outcomes. J Allergy Clin Immunol Pract. 2017 Jul-Aug;5(4):1071-1081.e9. doi: 10.1016/j.jaip.2017.01.004. Epub 2017 Mar 9.

  PMID: 28286157 BACKGROUND

• Moral Gil L, Asensi Monzó M, Juliá Benito JC, Ortega Casanueva C, Paniagua Calzón NM, Pérez García MI, Rodríguez Fernández-Oliva CR, Sanz Ortega J, Valdesoiro Navarrete L, Valverde Molina J. Asma en pediatría. Consenso regAp. Alicante (España): Luis Morales; 2021. Disponible en: https://neumoped.org/wp-content/uploads/2021/02/Asma-en-pediatria-consenso-regap-2021_94549.pdf

  BACKGROUND

MeSH Terms

Conditions

Treatment Adherence and Compliance

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: January 23, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share