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

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

Study Overview

• Status: Recruiting
• Conditions: Asthma
• Intervention / Treatment: Other: Educational intervention BUNDLE, prepared in accordance with the recommendations of the Global Initiative for Asthma- GINA (2024)).

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Paraíba
    • João Pessoa, Paraíba, Brazil, 58051-900
      • Recruiting
      • Pulmonary Function Clinic of the Department of Physiotherapy at Federal University of Paraiba
      • Contact: Renata Tomaz, PhD; Phone Number: 5583999351535; Email: renatatomazf@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care; The control group will receive standard follow-up according to the clinic routine.
Experimental: Educational intervention BUNDLE; The experimental group will undergo an educational intervention BUNDLE, prepared in accordance with the recommendations of the Global Initiative for Asthma- 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.	Other: Educational intervention BUNDLE, prepared in accordance with the recommendations of the Global Initiative for Asthma- GINA (2024)).; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 4 weeks
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	Baseline and 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hospitalizations and emergency room visits	number of hospitalizations and emergency room visits in the last four months	Baseline and 4 weeks
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.	Baseline and 4 weeks

Collaborators and Investigators

• Sponsor: Federal University of Paraíba

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: February 19, 2025
• First Submitted That Met QC Criteria: March 12, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Asthma; Spirometry; Respiratory Tract Disease; Heath Education
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: 6.968.418

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No