Menu
Recruiting NCT06878352

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

No phase Interventional Asthma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Educational intervention BUNDLE, prepared in accordance with the recommendations of the Global Initiative for Asthma- GINA (2024))..
Who it may be relevant to
Registry conditions: Asthma. Basic parameters: from 8 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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).

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.

Interventions

  • 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 appr

Primary outcome measures

  • clinical asthma control [Time frame: Baseline and 4 weeks]
  • Retention of information about asthma knowledge and inhalation therapy [Time frame: Baseline and 4 weeks]
Secondary outcome measures (2)
  • hospitalizations and emergency room visits [Time frame: Baseline and 4 weeks]
  • Pulmonary function - Spirometry [Time frame: Baseline and 4 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Brazil · 1 center
  • Pulmonary Function Clinic of the Department of Physiotherapy at Federal University of Para — João Pessoa

Identifiers

NCT: NCT06878352 · 6.968.418

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗