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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCharles University, Czech Republic

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Education in inhalation technique

    Other intervention

    Education in inhalation technique

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: All project participantsOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Assessment of adherence to inhaled treatment within 12 months.
2

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.

Time frame
Assessment of adherence to inhaled treatment within 12 months.
3

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.

Time frame
Critical knowledge related to inhalation techniques in healthcare professionals caring for patients with COPD and bronchial asthma within 12 months
4

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.

Time frame
Critical skills related to inhalation techniques in healthcare professionals caring for patients with COPD and bronchial asthma within 12 months.

Secondary outcomes

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.

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.

Time frame
Assessment of clinical and laboratory biomarkers potentially indicating the stability of COPD and bronchial asthma within 12 months.

Other outcomes

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