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| Name | Class |
|---|---|
| Ministry of Health, Czech Republic | OTHER_GOV |
| University Hospital Hradec Kralove | OTHER |
| University of Hradec Hralove | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All project participants | Other | Education of inhalation technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education in inhalation technique | Other | Education in inhalation technique |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessment of adherence to inhaled treatment within 12 months. |
| 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. | 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. | 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 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. | 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. | Critical skills related to inhalation techniques in healthcare professionals caring for patients with COPD and bronchial asthma within 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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PATIENTS
Inclusion Criteria:
Exclusion Criteria:
HEALTHCARE PROFESSIONALS
Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Josef Malý, Assoc. Prof. PhD. | Contact | 00420 495 067 421 | malyj@faf.cuni.cz |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Hradec Králové | Recruiting | Hradec Králové | 500 05 | Czechia |
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| Label | URL |
|---|---|
| Related Info | View source |
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Due to sensitivity of personal and medical data of participants.
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| Assessment of clinical and laboratory biomarkers potentially indicating the stability of COPD and bronchial asthma within 12 months. |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001982 | Bronchial Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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