Impact of Educational Intervention Protocol on the Level of Knowledge, Clinical Control and Lung Function of People With Asthma

ConditionAsthma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8+
SponsorFederal University of Paraíba

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Educational intervention BUNDLE, prepared in accordance with the recommendations of the Global Initiative for Asthma- GINA (2024)).

    Other intervention

    The 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

28 Participants
are divided into 2 treatment groups
Group A: Standard of careNo intervention 0 interventions
Group B: Educational intervention BUNDLEExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and 4 weeks
2

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

Time frame
Baseline and 4 weeks

Secondary outcomes

1

hospitalizations and emergency room visits

number of hospitalizations and emergency room visits in the last four months

Time frame
Baseline and 4 weeks
2

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.

Time frame
Baseline and 4 weeks

Other outcomes

Sponsors and contacts

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