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NCT Number: NCT06878352

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

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).

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pulmonary Function Clinic of the Department of Physiotherapy at Federal University of Paraiba

João Pessoa, Paraíba, 58051-900, Brazil

Location status: Recruiting

Location contact

Renata Tomaz, PhD

CONTACT

[email protected]

5583999351535

About this study

People with asthma will participate in the study, from the Pulmonary Function Clinic of the Department of Physiotherapy at Federal University of Paraíba - UFPB. Spirometry data, knowledge about asthma and correct control over inhalation therapy, clinical control of the disease using the Asthma Control Test (ACT) and C-ACT questionnaire, number of asthma attacks, amount of medication used, hospitalizations and visit to the emergency room in the last 4 weeks will be assessed. Assessments will be carried out at the first contact (baseline) and twelve weeks after the first contact.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of asthma
  • Assisted by the Pulmonary Function Clinic
  • Ventilatory dysfunction assessed by spirometry

Exclusion criteria

  • Obesity
  • Treatment with systemic corticosteroids
  • Previous chest surgery
  • Unable to perform any of the proposed assessment steps

Treatment and study plan

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

Other

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.

Other names: Health Education, Educational Intervention, Bundle

Primary outcomes

  1. clinical asthma control

    Time frame: Baseline and 4 weeks

    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.

  2. Retention of information about asthma knowledge and inhalation therapy

    Time frame: Baseline and 4 weeks

    Number of correct answers obtained from the asthma knowledge questionnaire at the end of the educational intervention

Secondary outcomes

  1. hospitalizations and emergency room visits

    Time frame: Baseline and 4 weeks

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

  2. Pulmonary function - Spirometry

    Time frame: Baseline and 4 weeks

    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 collaborators

Lead sponsor

Federal University of Paraíba

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 14, 2025
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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