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

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.

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Key information

Conditions

Asthma Childhood Behavior Health Behavior Treatment Adherence and Compliance

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

. Inability to understand Spanish.

Treatment and study plan

Educational Intervention

Other

Educational Intervention:

The nurse will deliver a brief health education session focused on:

Understanding the treatment. Provide clear information adapted to the patient's level, supported with visual aids.
Distinguishing between maintenance and rescue treatment. Explain the role of each medication with practical examples.
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.
Promoting autonomy. Encourage the patient to take part in administering the medication and foster self-management of the device.
Evaluating and improving adherence. Suggest daily routines, reminders, and the use of alarms or mobile apps.
Appropriate use of rescue medication. Involve the patient in decision-making, promote self-observation, and provide a clear action plan.

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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.

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Jan 23, 2026
Registry last updated: Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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