Adherence to Inhaled Therapy - a Globally Overlooked Problem in Patients With Chronic Obstructive Pulmonary Disease and Bronchial Asthma

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Education in inhalation technique
  Education in inhalation technique

Первичные конечные точки

• Adherence to inhaled treatment measured by Five Steps Assessment (FSA). [Срок оценки: Assessment of adherence to inhaled treatment within 12 months.]
• Adherence to inhaled treatment measured by the Medication Adherence Report Scale (MARS). [Срок оценки: Assessment of adherence to inhaled treatment within 12 months.]
• Critical knowledge measured by our own questionnaire in healthcare professionals caring for patients with COPD and bronchial asthma. [Срок оценки: Critical knowledge related to inhalation techniques in healthcare professionals caring for patients with COPD and bronchial asthma within 12 months]
• Critical skills related to inhalation techniques measured by FSA in healthcare professionals caring for patients with COPD and bronchial asthma. [Срок оценки: Critical skills related to inhalation techniques in healthcare professionals caring for patients with COPD and bronchial asthma within 12 months.]

Вторичные конечные точки (1)

• 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. [Срок оценки: Assessment of clinical and laboratory biomarkers potentially indicating the stability of COPD and bronchial asthma within 12 months.]

Критерии участия

PATIENTS

Критерии включения

• 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.

Критерии исключения

• pre-terminal/terminal stage of any disease,
• uncooperative patient,
• significant limitation of mobility or cognitive functions.

HEALTHCARE PROFESSIONALS

Критерии включения

• 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.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Чехия · 1 центр

• University Hospital Hradec Králové — Hradec Králové

Идентификаторы

NCT: NCT07183657 · NW25-09-00434

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗