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

NCT06878352 | Recruiting

• 1 other identifier: 6.968.418
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Asthma

Keywords

Asthma; Heath Education; Spirometry; Respiratory Tract Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• hospitalizations and emergency room visits

  Baseline and 4 weeks

• Pulmonary function - Spirometry

  Baseline and 4 weeks

Study Arms (2)

Standard of care

NO INTERVENTION

The control group will receive standard follow-up according to the clinic routine.

Educational intervention BUNDLE

EXPERIMENTAL

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)).

Interventions

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.

Also known as: Health Education, Educational Intervention, Bundle

Educational intervention BUNDLE

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of Paraíba: lead

Study Sites (1)

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

João Pessoa, Paraíba, 58051-900, Brazil

RECRUITING

MeSH Terms

Conditions

Asthma; Respiratory Tract Diseases

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The researcher responsible for the baseline and endpoint assessments will be blinded to the participant's group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: March 14, 2025
• Study Start: March 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Locations

BR (1)