Assessment of Asthma Management in Children Over 6 Years of Age and Their Caregivers. Implications for the Implementation of the SMART Strategy in Pediatrics.
Phase: NA
Conditions: Asthma Childhood
Sponsor: 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 
 
Protocol Version and Date: Version: 1 – Date: 14/05/2025 
Protocol Code: IIBSP-EMA-2025-05 
Short Title: Asthma Management in Children 
Sponsor: Institut de Recerca de l’Hospital de la Santa Creu i Sant Pau – IIB Sant Pau c/ Sant 
Quintí, 77-79 08041 Barcelona Tel: +34 93 556 56 17 Fax: +34 93 553 78 12 
Principal Investigator: Victòria Morón Faura. Pediatric Pulmonology MSc Nurse,  Hospital de la 
Santa Creu i Sant Pau. c/ Sant Antoni Maria Claret, 167. 08025 Barcelona. Tel: +34 647 026 964 
E-mail: vmoron@santpau.cat 
Confidentiality Statement: This Study Protocol is the property of the Institut de Recerca de 
l’Hospital de la Santa Creu i Sant Pau – IIB Sant Pau and is a confidential document. It must 
not be copied or distributed to other parties without prior written authorization from the 
Institut de Recerca. 
 
 
 
 
 
 
 
 
 
 
 
 
 

1. Justification 
Asthma is the most common chronic inflammatory disease in children, affecting quality of life 
and having a significant impact on the individual, their environment, and society. In Spain, its 
prevalence is 10.4% among schoolchildren aged 6–7 years and 15.2% among adolescents 
aged 13–14 years, most of whom will reach adulthood requiring some form of treatment to 
control asthma. 
This study seeks to evaluate the effectiveness of an educational intervention in the 
management of asthma exacerbations, by assessing the competence of children with asthma 
and their caregivers in inhalation technique, the control of exacerbations, and the degree of 
therapeutic adherence, as well as by analyzing the appropriate implementation of action 
protocols during crisis situations. 
1.2. Research Questions 
Do children and adolescents have adequate knowledge about asthma management and 
inhaler technique? Do children and adolescents improve asthma management after a brief 
educational intervention? 
1.3. Hypothesis 
A brief nursing educational intervention on asthma management and inhaler technique will 
improve knowledge and correct use of inhaled treatment in pediatric asthma patients by more 
than 50%, with an increase of over 50% in the proper execution of inhaler technique. 
2. OBJECTIVES: 
2.1. Main Objective: 
Quantify the change in the level of knowledge about asthma management and the correct 
execution of inhaler technique in pediatric asthma patients (or their caregivers) after receiving 
a brief nursing educational intervention, expressed as a percentage of improvement from the 
pre-test. An increase of more than 50% in both dimensions is expected. 
2.2. Secondary Objectives: 
• 
Evaluate the percentage of subjects who move from "incorrect technique" to "correct 
technique" according to InTeQ (39) after the intervention, identifying the critical steps 
that improve the most. 
• 
Measure the change in the Likert scale of autonomy (0 = dependent to 4 = fully 
autonomous) and calculate the proportion of participants who move to the "visual 
supervision" or "autonomous" level. 
• 
Compare the average ACQ score pre- and post-intervention, and calculate the 
percentage of children who move from poorly/partially controlled (≥ 1.0) to well 
controlled (< 1.0). 

• 
Determine the increase in the proportion of participants who correctly identify at least 3 
of the 5 exacerbation signs/symptoms (persistent cough, wheezing, dyspnea, chest 
tightness, tachypnea) after the education. 
• 
Analyze the variation in the number of rescue puffs administered in the last week, 
measuring the average reduction and the percentage of subjects who reduce by at least 
one puff per week. 
• 
Evaluate the change in the total score of the Inhaler Adherence Test (TAI) pre- and post-
intervention, and classify the proportion of patients who improve their adherence 
category (from poor/intermediate to good). 
• 
Identify and compare the frequency of each non-adherence pattern (erratic, deliberate, 
unconscious) before and after the intervention, to detect which one decreases the most 
after the educational program. 
3. MATERIAL AND METHODS: 
3.1. Study Design 
Quasi-experimental study with a pre-test/post-test design in a single cohort. There is no 
randomization or parallel control group; all participants receive the nursing educational 
intervention, and their results before and after are compared. 
3.2. Study Population. Inclusion and Exclusion Criteria 
All patients in follow-up at the pediatric allergy and pulmonology clinic with a diagnosis of 
asthma who use inhalers as prescribed treatment, between September 1, 2025, and February 
28, 2026, will be invited to participate consecutively and/or their primary caregivers. 
Pediatric Population (patients): Patients in follow-up at the pediatric allergy and pulmonology 
clinic. 
Inclusion Criteria: 
1. Age between 6 and 17 years. 
2. Clinical diagnosis of asthma and at least 6 months of follow-up in our center's pediatric 
allergy and pulmonology clinic. 
3. Prescribed treatment with corticosteroid inhalers with or without LABA for at least 6 
months. 
Exclusion Criteria: 
1. Language barriers (lack of Spanish comprehension). 
2. Occasional/occasional use of inhalers (not on a regular schedule). 
3. Significant active or passive smoking. 
4. Significant immunocompromise (immunosuppression, oncological disease, 
transplant). 

Caregiver Population 
Inclusion Criteria: 
1. First-degree relationship with the patient or living together for > 50% of the time. 
2. Ability to understand and respond to the questionnaire. 
Exclusion Criteria: 
1. Language barriers or cognitive difficulties preventing understanding/responding. 
Justification in "Ethical Aspects". 
3.3. Definition of Variables and Instruments 
Main Variables (dependent): 
• 
Level of knowledge about asthma management: total pre/post score on an ad hoc 
questionnaire. 
• 
Correct inhaler technique: categorized by InTeQ as "correct" (0 errors) vs. "incorrect" (≥1 
error). 
Secondary Variables: 
• 
Degree of autonomy (Likert scale 0–4). 
• 
Asthma control (ACQ, average of 5 items): (≤ 0.75) well controlled, (0.75 - 1.50) partially 
controlled, (>1.50) poorly controlled. 
• 
Number of rescue puffs in the last week. 
• 
Adherence (TAI total, 10 items): good (≥50), intermediate (46–49), poor (<45). 
• 
Non-adherence pattern (erratic, deliberate, unconscious). 
• 
Recognition of exacerbations (identification of ≥3 of 5 symptoms). 
The main variable will be the level of knowledge about asthma management in children and the 
primary caregiver. This will be measured through five variables: inhaler technique and 
autonomy in its use, asthma control, adherence to inhaler treatment, recognition of 
exacerbations, and use of rescue inhalers. 
Sociodemographic data collected will include: relationship with the patient if they are not the 
one completing the questionnaire, education level of the accompanying parent/patient, 
patient age, and patient sex. 
For the qualitative variable "inhaler technique," the InTeQ questionnaire, validated for 
pediatrics, will be used to assess the use of pressurized inhalers according to guidelines, with 
5 critical items, to which the item "shake the device" was added for those using pMDI. The 5 
critical steps evaluated are: exhale completely before, close lips tightly, inhale deeply, hold 
breath afterward, exhale slowly, applicable to both pressurized devices with a chamber and 

dry powder devices. The item "device activation" was removed as it is inherent to the 
procedure and to facilitate its applicability. Patients with no errors will be included in the 
"correct technique" group, and those with one or more errors will be included in the "incorrect 
technique" group. The ad hoc questionnaire will ask about the degree of autonomy in 
performing the process, measured with a Likert scale with 5 items rated from 0 to 4: 
“completely dependent,” “needs help in more than one point of the technique,” “needs help in 
one point of the technique,” “only visual supervision,” or “completely autonomous.” 
Asthma control will be measured through the Asthma Control Questionnaire (ACQ), in its ACQ 
version, which has been validated for use in pediatrics, specifically for children over 5 years 
old. It consists of 5 questions about symptoms, with 7 possible responses, and the total ACQ 
score is calculated by averaging the responses to the 5 questions, yielding a score between 0 
and 6, where: 0 indicates complete asthma control (no symptoms), and 6 represents very poor 
asthma control (severe symptoms). Average scores under 0.75 indicate adequate asthma 
control, according to GEMA 5.4 criteria: no symptoms, no nocturnal awakenings, need for 
rescue medication only once a week or less, and no daily life limitations. Scores above 1.5 
indicate poor asthma control. 
To measure the variable "number of puffs administered during a crisis," questions from the ad 
hoc questionnaire will be used to assess the number of rescue inhalations taken during a crisis 
and those administered in the last week. 
To identify the pattern of unconscious adherence non-compliance, the only specific 
questionnaire for measuring inhaler adherence, called the Inhaler Adherence Test (TAI), will be 
used. It is validated only for those over 18 years old, although validation in pediatrics is 
currently underway. It consists of 10 items to be completed by the patient/caregiver if 
identifying low adherence is desired, and 2 additional items to be filled out by the healthcare 
professional, which are specific to determine unconscious non-compliance patterns. The 
patterns of non-adherence identified are: erratic (medication forgetting), deliberate (lack of will 
to follow the schedule), or unconscious (lack of knowledge about the schedule or technique). 
Exacerbations will be measured with items described by the Spanish Society of Pediatric 
Pulmonology (SENP), including the presence of the following symptoms: 
• 
Persistent cough 
• 
Wheezing sounds during breathing 
• 
Difficulty breathing or speaking 
• 
Chest pain or tightness 
• 
Rapid breathing, frequent breaths 
The presence and recognition of these symptoms will be collected through the ad hoc 
questionnaire, which will include closed questions with binary, multiple, or Likert-type 

responses. The ad hoc questionnaire will conclude with a question assessing confidence in the 
use of the chamber in different types of situations. 
3.4. Expected Sample Size 
The sample required to estimate an increase of ≥50% in knowledge and technique, with a 95% 
confidence level (Z = 1.96), expected proportion p = 0.5 (maximum variance), and margin of 
error d = 0.05, was calculated using the formula n = Z² p(1–p)/d² = (1.96²·0.5·0.5)/0.05² = 384.16 
≈ 385 participants. Accounting for an anticipated 10% attrition rate, the adjusted sample size is 
385 / (1–0.10) ≈ 428 participants. 
3.5. Methodology. Sources of Information 
Visit 0 (Screening): At the screening visit, patients and caregivers will be informed about the 
study objectives and procedures. Eligibility will be assessed through an interview and review of 
the medical record, applying inclusion and exclusion criteria. Upon confirmation of eligibility, 
written informed consent will be obtained. Basic sociodemographic variables (age, sex, 
educational attainment of the parent/caregiver and the child) and relevant clinical history will 
be collected. 
The screening visit may coincide with the baseline visit (V1), during which the initial 
assessment (pre-test) and the educational intervention will be conducted, provided the 
following conditions are met: 
• 
The participant must have signed the informed consent form before undergoing any 
study-specific procedure, including completion of the pre-test questionnaire. 
• 
During the same visit, inclusion criteria will be confirmed and exclusion criteria ruled 
out. 
• 
Only participants who have successfully completed the screening process and signed 
informed consent will be considered enrolled in the study. 
Visit 1 (Baseline): At the baseline visit, prior to the educational intervention, inhalation 
technique will be evaluated using the InTeQ checklist, and the level of autonomy will be 
assessed using a Likert scale (0–4). In accordance with the validated Asthma Control 
Questionnaire (ACQ) (40), participants aged ≥11 years will be invited to complete the 
instrument to assess asthma control, while for children ≤10 years, it will be completed by the 
caregiver or, if necessary, by the nurse. To ensure consistency, the Test of Adherence to 
Inhalers (TAI) and an ad hoc questionnaire designed to assess knowledge of exacerbation 
management and inhaled therapy will also be administered. These will be self-completed by 
participants ≥11 years, or by the caregiver (with or without assistance) for younger children. In 
addition, pulmonary function tests (PFTs) will be performed according to standard clinical 
practice protocols. 
Visit 2 (6 months post-intervention): Participants will be scheduled six months after the 
intervention to repeat the evaluation. The InTeQ, autonomy scale, ACQ, TAI, and ad hoc 

questionnaire will be administered again. In addition, pulmonary function tests (PFTs) will be 
performed as deemed necessary by the pulmonologist. Finally, pre- and post-intervention 
results will be compared to analyze changes in knowledge, inhalation technique, asthma 
control, adherence, and recognition of exacerbations. 
3.6. Data Management and Analysis 
To ensure the protection of participants’ privacy and compliance with current data protection 
regulations, the data collected in this study will be pseudonymized prior to analysis. 
Personally identifiable information will be replaced with a unique alphanumeric code assigned 
to each participant. This code will not allow direct identification of the subject without access 
to a correspondence key, which will be securely stored and protected by the principal 
investigator. 
Pseudonymized data will be used for all statistical analyses and publications, and under no 
circumstances will information that enables direct or indirect identification of participants be 
included. 
The dataset will be stored in an Excel file located on the secure server of the Hospital de la 
Santa Creu i Sant Pau (HSCSP). Access will be restricted through unique credentials for 
authorized investigators, ensuring confidentiality and compliance with data protection 
regulations (GDPR). After import from Excel, the data will undergo a cleaning and quality 
control process (detection of outliers, duplicate records, and range checks). 
The principal investigator will be responsible for creating the study database. 
A descriptive analysis will be performed using absolute frequencies and percentages for 
qualitative variables; mean and standard deviation for normally distributed quantitative 
variables; and median and interquartile range for non-normally distributed quantitative 
variables. Subsequently, a bivariate analysis will be conducted using the Chi-square test, 
Fisher’s exact test, Student’s t test for independent samples, or the Mann–Whitney U test, as 
appropriate. To evaluate patient-related factors associated with adherence to inhaled therapy, 
a multivariable logistic regression model will be constructed including variables that showed a 
significant association in the bivariate analysis, in order to identify independently associated 
factors. 
3.7. Limitations of the Study Design, Information Sources, and Analytical Methods 
The limitations of this study may lie in the lack of awareness among patients/caregivers 
regarding the treatment they should be receiving. Although the use of primary sources (data 
collected directly from patients and caregivers) provides information closely aligned with the 
real-world context, it introduces the risk of recall bias and social desirability bias. 
One limitation of this study is the exclusion of patients with significant language barriers. This 
decision may have introduced a selection bias. The exclusion of these patients (although 
minimal) may have led to an overestimation of the effectiveness or comprehension of the 
treatment observed in the sample. We acknowledge this limitation and consider it necessary to 

develop, in future studies, specific strategies to enable broader and more equitable inclusion 
of these vulnerable groups. 
The TAI questionnaire will be used, which, although still undergoing validation for the pediatric 
population, is widely applied in clinical practice and regarded as an optimal instrument. 
The sample may not be representative due to the lack of randomization. For this reason, it was 
decided to include all patients consecutively to obtain a broader view of the study population. 
The quasi-experimental design without a randomized control group limits the ability to 
establish strong causal inferences. 
This study will be conducted in a single center, which may limit the generalizability of the 
findings to other contexts or settings. Furthermore, the lack of variability could restrict the 
applicability of the results. Conducting the study in multiple centers would be valuable and 
clinically relevant to increase sample diversity and allow greater generalization of the findings 
to the overall population. 
4. ETHICAL CONSIDERATIONS 
Benefit–Risk Assessment of the Research 
The proposed educational intervention entails a favorable balance between benefits and risks. 
Benefits include the potential improvement in knowledge of asthma management, correction 
of inhalation technique, increased adherence, and early recognition of exacerbations, which 
may translate into better clinical control and reduced hospitalizations. Risks are minimal, 
primarily associated with the time required of participants for visits and questionnaires, and 
the potential cognitive fatigue from responding to multiple instruments. No invasive 
procedures or interference with routine clinical practice are anticipated. Data confidentiality 
and informed consent ensure respect for participants’ autonomy and protection. 
Ethical Considerations Regarding Participant Information and Informed Consent 
The study will be conducted in strict accordance with international ethical guidelines for 
medical research in humans. The investigator will be responsible for ensuring that the study 
complies with the principles set out in the Declaration of Helsinki. 
Before the study begins, the Ethics Committee of Hospital de la Santa Creu i Sant Pau must 
approve the study protocol, the information sheet to be provided to participants, and the 
informed consent form to be used. 
The Ethics Committee will be informed of any subsequent amendments to the protocol, and its 
opinion will be sought if a new evaluation of the ethical aspects of the study is required. 
The investigator is responsible for obtaining informed consent from the patient. No patient may 
participate in any study-specific procedure before providing consent, or, when the patient is 
unable to consent due to their clinical condition, before consent is obtained from their legal 
guardian/family member. 
Prior to enrolling any participant and before obtaining informed consent, the investigator or a 

designated delegate will explain to the potential participant or their legal guardian/family 
member the study objectives, methods, potential risks, and any possible inconveniences. The 
explanation regarding the nature, scope, and possible consequences of the study will be 
provided in language that is easily understandable. 
In this study, it was considered necessary to exclude patients with significant language barriers 
that would prevent adequate understanding of study procedures and objectives. This decision 
is grounded in ethical principles. 
From the principle of autonomy, obtaining informed consent requires full comprehension on 
the part of the participant. In cases where substantial language barriers exist, and where 
sufficient resources (e.g., interpreters or cultural mediators) and time to ensure adequate and 
safe understanding are not available, consent could be defective, thereby compromising the 
ethical validity of participation. From the principles of beneficence and non-maleficence, this 
could also undermine the quality of the intervention and patient safety. 
Regarding the principle of justice, although we acknowledge that these patients constitute a 
potentially vulnerable group who may benefit significantly from the intervention, their 
proportion within the sample is very small, and under current circumstances, it is not feasible 
to guarantee equal participation conditions without jeopardizing the methodological and 
ethical integrity of the study. Nevertheless, supportive measures have been implemented 
outside the study protocol to address the needs of these patients through the use of adapted 
graphic materials and individualized care, underscoring the research team’s commitment to 
their well-being. 
This exclusion is therefore considered an ethically necessary measure given real-world 
resource constraints and will be appropriately reported as a study limitation in the results and 
subsequent publications. 
Potential participants or their legal guardians/family members must be given sufficient time to 
consider their decision to participate and the opportunity to ask questions. After this 
explanation, and before enrollment, informed consent must be properly documented by the 
signature of the participant or their legal guardian/family member. 
Given that access to medical records for purposes other than clinical care requires the 
patient’s explicit consent, patients currently under follow-up at the hospital will be asked to 
provide consent for access to the medical record data necessary for the study. Accordingly, the 
Participant Information Sheet / Informed Consent Form will be submitted to the Ethics 
Committee for review.