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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-17
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical diagnosis of asthma.

Prescribed treatment with inhaled corticosteroid.

First-degree relative of the patient.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Educational Intervention

    Other 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.

Treatment groups

428 Participants
are divided into 1 treatment group
Group A: Study population will be pediatric patients with a diagnosis of asthma, scheduled for consultationExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
From the nursing intervention until the following 6 months.

Secondary outcomes

1

Change in Treatment Adherence

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.

Time frame
From the nursing intervention until the following 6 months.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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