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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07364643
Enrollment
428
Registered
2026-01-23
Start date
2026-01-01
Completion date
2027-01-01
Last updated
2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma Childhood

Keywords

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

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.

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

OTHEREducational 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.

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

. Inability to understand Spanish.

Design outcomes

Primary

MeasureTime frameDescription
Change in Correct inhaler techniqueFrom 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

MeasureTime frameDescription
Change in Treatment AdherenceFrom 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026