About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
signed informed consent,
age ≥ 18 years,
previously diagnosed BA/COPD meeting GOLD 2024 and GINA 2024 diagnostic criteria,
ability to cooperate,
Disqualifiers
pre-terminal/terminal stage of any disease,
uncooperative patient,
significant limitation of mobility or cognitive functions.
signed informed consent,
Trial design
Single group
Treatments tested in this trial
Education in inhalation technique
Other interventionEducation in inhalation technique
Treatment groups
Trial outcomes
Primary outcomes
Adherence to inhaled treatment measured by Five Steps Assessment (FSA).
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).
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.
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.
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.
Secondary outcomes
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.
Changes in relevant clinical (COPD Assessment Test - CAT in patients with COPD; Asthma Control Test - ACT in patients with bronchial asthma; exacerbation frequency, and rescue medication usage) and laboratory (e.g. white blood cell count, C-reactive protein, FeNO level) biomarkers potentially indicating the stability of COPD and bronchial asthma in a subgroup of patients will be assessed.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Charles University, Czech Republic
Lead sponsor
Ministry of Health, Czech Republic
Collaborator
University Hospital Hradec Kralove
Collaborator
University of Hradec Hralove
Collaborator