Actively Recruiting
Adherence to Inhaled Therapy in Patients With Chronic Obstructive Pulmonary Disease and Bronchial Asthma Using Artificial Intelligence and the Five Steps Assessment Tool
Led by Charles University, Czech Republic · Updated on 2025-09-30
1000
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
C
Charles University, Czech Republic
Lead Sponsor
M
Ministry of Health, Czech Republic
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to address the widespread problem of not following inhaled therapy properly in patients with bronchial asthma and chronic obstructive pulmonary disease (COPD). The study focuses on assessing how well patients adhere to their inhaled treatments and evaluates the knowledge and skills of healthcare professionals who care for these patients. It uses a validated tool called the Five Steps Assessment (FSA) along with artificial intelligence methods to support this effort across multiple healthcare settings. Participants include outpatients and nursing home residents with bronchial asthma or COPD, as well as healthcare professionals. The study will develop and implement a mobile and web-based app using artificial intelligence to assist both patients and providers. Interventions for patients involve training on correct inhalation techniques, educational materials, and remote contacts through phone or online platforms. Healthcare professionals will receive courses including e-learning and app-based education to improve their inhalation technique skills. During the study, adherence to inhaled treatments will be measured repeatedly over 12 months using the FSA tool and the Medication Adherence Report Scale (MARS). Healthcare professionals' knowledge and skills will also be evaluated using questionnaires and the FSA. Clinical and laboratory biomarkers indicating disease stability will be assessed in a subgroup. The study will monitor how these interventions impact adherence and care quality, with the overall participation lasting up to one year.
CONDITIONS
Brief Title
Adherence to Inhaled Therapy - a Globally Overlooked Problem in Patients With Chronic Obstructive Pulmonary Disease and Bronchial Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Age 18 years or older
- Previously diagnosed bronchial asthma or COPD meeting GOLD 2024 and GINA 2024 criteria
- Ability to cooperate
- At least 8 weeks without exacerbation
- Use of the same inhaler for at least 3 months
- Healthcare professionals with education in medicine, pharmacy, or nursing
- More than one year of work experience
- Caring for patients using inhaled therapy for bronchial asthma or COPD
You will not qualify if you...
- Pre-terminal or terminal stage of any disease
- Uncooperative patient
- Significant limitations in mobility or cognitive functions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 12 months
Participants receive education on correct inhalation technique to improve adherence to inhaled therapy.
Repeated follow-up visits over 12 months
Trial Site Locations
Total: 1 location
1
University Hospital Hradec Králové
Hradec Králové, Czechia, 500 05
Actively Recruiting
Research Team
J
Josef Malý, Assoc. Prof. PhD.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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