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

January 16, 2026 updated by: Victòria Morón Faura, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Assessment of Asthma Management in Children Over 6 Years of Age and Their Caregivers. Implications for the Implementation of the SMART Strategy in Pediatrics.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

428

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

. Inability to understand Spanish.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study population will be pediatric patients with a diagnosis of asthma, scheduled for consultation
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Correct inhaler technique
Time Frame: From the nursing intervention until the following 6 months.

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Treatment Adherence
Time Frame: From the nursing intervention until the following 6 months.
It will be used the only specific questionnaire designed to measure adherence to inhalers, called the Inhaler Adherence Test (IAT). It consists of 10 items to be completed by the patient/caregiver when we want to identify patients with low adherence, and 2 additional items to be completed by the healthcare professional, which are specifically intended to determine the type of unintentional non-adherence.
From the nursing intervention until the following 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

September 22, 2025

First Submitted That Met QC Criteria

January 16, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-EMA-2025-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The information will be anonymized by the Principal Investigator (PI)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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