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临床试验/NCT04442646
NCT04442646招募中不适用

Role of "Asthma School" in Disease Management

Istituti Clinici Scientifici Maugeri SpA2 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2019年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
92
试验地点
2
主要终点
ER accesses

研究概览

简要总结

According to the definition provided by the GINA guidelines, asthma is characterized by a variable and reversible limitation of expiratory airflow and by the following symptoms: wheezing, dyspnoea, thoracic constriction and/or cough. The type and the severity of airflow limitation can vary over time (1) depending on external agents, such as physical exercise, polluting agents, climate changes and viral infections. The therapy is mainly based on the use of inhaled corticosteroids and bronchodilators. Patients affected by severe asthma (~ 10% of total prevalence of asthma and at high risk of exacerbations and/or hospitalization) may not control their symptoms, even if exposed to maximal doses of inhalation therapy.The behavioural sciences can potentially help to find the psychological factors behind scarce adherence and to develop strategies with the aim of improving the interactive processes between patients, medical doctors and health care professionals

详细描述

Asthma is a chronic inflammatory disease affecting 300 million people worldwide, especially children. In Italy, asthma affects 3 million patients and represents one of the main expenses of the Italian National Heath Care Service. According to the definition provided by the GINA guidelines, asthma is characterized by a variable and reversible limitation of expiratory airflow and by the following symptoms: wheezing, dyspnoea, thoracic constriction and/or cough. The type and the severity of airflow limitation can vary over time (1) depending on external agents, such as physical exercise, polluting agents, climate changes and viral infections. The therapy is mainly based on the use of inhaled corticosteroids and bronchodilators. Patients affected by severe asthma (~ 10% of total prevalence of asthma and at high risk of exacerbations and/or hospitalization) may not control their symptoms, even if exposed to maximal doses of inhalation therapy. More than one third of severe asthma patients receive oral corticosteroids prescriptions, with the risk of severe and irreversible adverse events. Therapy adherence is generally poor when therapeutic regimes are prescribed for chronic diseases, including asthma (4). The behavioural sciences can potentially help to find the psychological factors behind scarce adherence and to develop strategies with the aim of improving the interactive processes between patients, medical doctors and health care professionals (4). Several studies have described intervention models focused on education of the patients to symptoms and exacerbations recognition, therapy management, reduction of the exposure to trigger agents and improvement of social and physical activities (5-6). The intervention is not able to make patients independent in disease managing, but can improve the cooperation in asthma management. Another important aspect in asthma management is the quality of the therapeutic intervention: the correct delivery of inhalation therapy is the key for the disease control (3). Specific educational intervention such as "asthma school" can improve symptoms control and reduce; however, up to day, a universal and standardized protocol is not available and further studies are needed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Asthma diagnosis according to GINA / ATS guidelines.
  • Age ≥18 years

排除标准

  • cognitive impairment

研究组 & 干预措施

ASG= Asthma School Group, with educational intervention

Experimental

experimental "asthma school" group (ASG) will attend control visits as Control Group every three months. In addiction, ASG will attend 3 further meetings consisting in multidisciplinary lessons (pneumologist, nurse, biologist and respiratory therapist) once a week within 1 month after randomization. Study staff will deal with the following topics: asthma physiopathology, recognition of asthma symptoms and exacerbation, educational interventions on therapy and device, nutritional counselling if necessary. Patients will receive a paper diary for symptoms and an expiratory pick flow meter (PFM) to be done twice a day

干预措施: multidisciplinary lessons (Behavioral)

CG= Control Group, With no educational intervention

No Intervention

Control group will attend control visits every three months.

结局指标

主要结局

ER accesses

时间窗: 2 years

ER accesses in a period of 12 months in asthmatic subjects belonging to experimental group compared to controls.

number of exacerbations

时间窗: 2 years

number of exacerbations in a period of 12 months in asthmatic subjects belonging to experimental group compared to controls.

number of asthma related hospitalizations

时间窗: 2 years

number of asthma related hospitalizations in a period of 12 months in asthmatic subjects belonging to experimental group compared to controls.

次要结局

  • St. George Respiratory questionnaire SGRQ (0-100)(2 years)
  • respiratory function(2 years)
  • Asthma control test ACT (0-25)(2 years)
  • Asthma control questionnaire ACQ (0-6)(2 years)
  • airways and systemic inflammation(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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