About this trial
The goal of this randomized controlled clinical trial is to evaluate the effects of a proposed educational intervention on people with asthma. The main question it aims to contribute to a better understanding of the effectiveness of educational intervention strategies in people with asthma.
Participants allocated to the control group will receive standard follow-up according to the clinic routine. Participants allocated to the experimental group will undergo an educational intervention BUNDLE, prepared in accordance with the recommendations of the Global Initiative for Asthma- GINA (2024).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical diagnosis of asthma
Assisted by the Pulmonary Function Clinic
Ventilatory dysfunction assessed by spirometry
Disqualifiers
Obesity
Treatment with systemic corticosteroids
Previous chest surgery
Unable to perform any of the proposed assessment steps
Trial design
Parallel
Treatments tested in this trial
Educational intervention BUNDLE, prepared in accordance with the recommendations of the Global Initiative for Asthma- GINA (2024)).
Other interventionThe educational intervention bundle was designed in accordance with the recommendations of GINA (2024), and will cover topics on the etiopathogenesis and pathophysiology of asthma, inhaler treatment, precipitating factors for crises, self-management skills, environmental control, as well as the importance of drawing up a written therapeutic plan and regular medical follow-up. The educational intervention will be offered as a group activity and will be conducted in a single meeting, lasting approximately sixty minutes. Users will attend a standardized dialogical lecture using audiovisual resources, where they will have the opportunity to discuss and answer any questions related to the topics covered. At the end of the intervention, participants will receive a booklet containing all the points covered in the intervention, as well as a diary to record the amount of medication used, visits to the emergency room and asthma-related hospitalizations.
Treatment groups
Trial outcomes
Primary outcomes
clinical asthma control
Asthma Control Test (ACT)/Childhood Asthma Control Test (C-ACT) score. The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score \>19 indicates well-controlled asthma.
Retention of information about asthma knowledge and inhalation therapy
Number of correct answers obtained from the asthma knowledge questionnaire at the end of the educational intervention
Secondary outcomes
hospitalizations and emergency room visits
number of hospitalizations and emergency room visits in the last four months
Pulmonary function - Spirometry
Predicted percentages of spirometric variables such as the values of Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity (FVC) because the correlation between these values can indicate the presence of respiratory disorders such as asthma.
Sponsors and contacts
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