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

Charles University, Czech Republic

Status: Enrolling

Conditions: Bronchial Asthma; Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Other: Education in inhalation technique

Study type: Interventional

Funder types: Other

Identifiers

NCT07183657

NW25-09-00434

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

PATIENTS

Inclusion Criteria:

1. signed informed consent,
2. age ≥ 18 years,
3. previously diagnosed BA/COPD meeting GOLD 2024 and GINA 2024 diagnostic criteria,
4. ability to cooperate,
5. at least 8 weeks without exacerbation,
6. use of a particular inhaler for at least 3 months.

Exclusion Criteria:

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

HEALTHCARE PROFESSIONALS

Inclusion Criteria:

1. signed informed consent,
2. completed education in medicine, pharmacy, or nursing,
3. more than one year of working experience,
4. care for patients taking inhaled therapy for BA/COPD.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,000 participants in 1 patient group

All project participants

Other group

Description:

Education of inhalation technique

Treatment:

Other: Education in inhalation technique