Adherence to Inhaled Therapy - a Globally Overlooked Problem in Patients With Chronic Obstructive Pulmonary Disease and Bronchial Asthma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Adherence to inhaled treatment measured by Five Steps Assessment (FSA).
研究概览
简要总结
Comprehensive assessment and interventions to promote adherence to inhaled therapy in patients with bronchial asthma and chronic obstructive pulmonary disease involving health care professionals caring for these patients in different settings and using the Five Steps Assessment tool and artificial intelligence methods and tools.
详细描述
Nonadherence to inhaled therapy is a significant problem in patients with bronchial asthma (BA) and chronic obstructive pulmonary disease (COPD), which has a negative impact on the patients´ health as well as increases the healthcare system costs. The present project focuses on multimodal assessment of adherence to inhaled therapy in patients with BA and COPD and knowledge and skills related to inhalation technique in healthcare professionals caring for patients with BA and COPD at different levels of care using our simple and validated Five Steps Assessment (FSA) tool. This is a multicenter prospective observation-interventional study planning to include 800 outpatients treated in health care facilities and nursing home residents and 200 health care professionals. During the project, a mobile/web-based app using artificial intelligence applicable to patients and healthcare professionals will be developed, implemented, and validated. Interventions (e.g., training on correct inhalation technique, educational materials, telephone/online contact, mobile/web app) to promote adherence to inhaled therapy in BA and COPD will be developed and implemented in patients. In the case of healthcare professionals, interventions (e.g., course including e-learning, mobile/web app) will be directed at increasing knowledge and skills related to inhalation technique. The impact of the interventions on patients and healthcare professionals will be verified by repeated follow-up. To be able to assess the improvement in adherence to inhaled therapy in depth, clinical and laboratory biomarkers potentially indicating the stability of COPD and BA will be measured. The outputs of the project may help to identify patients with given diagnoses at high risk of medication nonadherence and to offer simple, effective, and widely available interventions to promote medication adherence as well as to educate healthcare professionals and thereby to improve patient care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •signed informed consent,
- •age ≥ 18 years,
- •previously diagnosed BA/COPD meeting GOLD 2024 and GINA 2024 diagnostic criteria,
- •ability to cooperate,
- •at least 8 weeks without exacerbation,
- •use of a particular inhaler for at least 3 months.
排除标准
- •pre-terminal/terminal stage of any disease,
- •uncooperative patient,
- •significant limitation of mobility or cognitive functions.
- •HEALTHCARE PROFESSIONALS
- •Inclusion Criteria:
- •signed informed consent,
- •completed education in medicine, pharmacy, or nursing,
- •more than one year of working experience,
- •care for patients taking inhaled therapy for BA/COPD.
结局指标
主要结局
Adherence to inhaled treatment measured by Five Steps Assessment (FSA).
时间窗: Assessment of adherence to inhaled treatment within 12 months.
Assessment of adherence to inhaled treatment measured by patients' behavior towards inhaled treatment and a number of mistakes in inhalation technique.
Adherence to inhaled treatment measured by the Medication Adherence Report Scale (MARS).
时间窗: Assessment of adherence to inhaled treatment within 12 months.
Assessment of adherence to inhaled treatment measured by patients' behavior towards inhaled treatment and a number of mistakes in inhalation technique.
Critical knowledge measured by our own questionnaire in healthcare professionals caring for patients with COPD and bronchial asthma.
时间窗: Critical knowledge related to inhalation techniques in healthcare professionals caring for patients with COPD and bronchial asthma within 12 months
Assessment of Critical knowledge by questions on correct usage of particular inhalation systems related to inhalation techniques in healthcare professionals caring for patients with COPD and bronchial asthma.
Critical skills related to inhalation techniques measured by FSA in healthcare professionals caring for patients with COPD and bronchial asthma.
时间窗: Critical skills related to inhalation techniques in healthcare professionals caring for patients with COPD and bronchial asthma within 12 months.
Assessment of critical skills measured by a number of mistakes in inhalation technique in particular inhalation systems related to inhalation techniques in healthcare professionals caring for patients with COPD and bronchial asthma.
次要结局
- Assessment of clinical (e.g. CAT in patients with COPD) and laboratory (e.g. white blood cell count) biomarkers potentially indicating the stability of COPD and bronchial asthma in a subgroup of patients.(Assessment of clinical and laboratory biomarkers potentially indicating the stability of COPD and bronchial asthma within 12 months.)