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

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Другое 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

Первичные конечные точки

• clinical asthma control [Срок оценки: Baseline and 4 weeks]
• Retention of information about asthma knowledge and inhalation therapy [Срок оценки: Baseline and 4 weeks]

Вторичные конечные точки (2)

• hospitalizations and emergency room visits [Срок оценки: Baseline and 4 weeks]
• Pulmonary function - Spirometry [Срок оценки: Baseline and 4 weeks]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• Pulmonary Function Clinic of the Department of Physiotherapy at Federal University of Para — João Pessoa

Идентификаторы

NCT: NCT06878352 · 6.968.418

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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