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A significant percentage of patients with asthma and COPD do not use their inhalers properly. Experts recommend that in patients with obstructive lung diseases, inhalation technique and patient adherence should be evaluated at every visit. The assessment of inhalation skills depends on the method of evaluation. There are few different methods of assessment of inhalation technique, however none of them is recommended as the most accurate.
Therefore, the aim of the study is:
to compare three different methods of assessment of inhalation technique in patients with asthma and COPD.
These methods include:
to analyze the influence of Vitalograph®AIM based inhalation technique training on inhalation skills
One hundred and thirty patients with asthma or COPD, who use inhaled medication on a regular basis will be enrolled. Inhalation technique will be evaluated by two observers independently at the same time with all three methods (checklist, 4 grade scale, Vitalograph®AIM). To compare these methods, the investigators will analyze method reliability and validity. Additionally, inhalation technique will be evaluated 30 minutes after Vitalograph®AIM based training to analyze the potential benefit of its application in practicing inhalation skills.
Asthma and chronic obstructive pulmonary disease (COPD) are common respiratory diseases. Inhaled therapy is the cornerstone of treatment in these two diseases. However, a significant proportion of patients with asthma and COPD do not use their inhalers properly. Experts recommend that in patients with obstructive lung diseases, inhalation technique and patient adherence should be evaluated at every visit, particularly before introducing changes to the patient's inhalation therapy. The assessment of inhalation skills depends on the method of evaluation. There are few different methods of assessment of inhalation technique, however, none of these methods is recommended as the most accurate.
Therefore, the aim of the study is:
to compare three different methods of assessment of inhalation technique in patients with asthma and COPD.
These methods include:
to analyze an influence of using Vitalograph®AIM based inhalation technique training on inhalation skills.
Type of study: prospective, interventional, without randomization. Patients with asthma or COPD treated in hospital or in an out-patient clinic will be asked to participate in the study.
Study design One hundred and thirty patients with asthma or COPD, who use inhaled medication on a regular basis will be enrolled. Inhalation technique will be evaluated by two observers independently at the same time with all three methods (checklist, 4 grade scale, Vitalograph®AIM). To compare these methods, the investigators will analyze method reliability and validity. The reference assessment will be performed by two experienced pulmonologists.
Additionally, inhalation technique will be evaluated 30 minutes after Vitalograph®AIM based training to analyze the potential benefit of its application in practicing inhalation skills.
Outcomes
Investigators expect that results of this study will allow to identify the most accurate method for assessment of inhalation technique. Furthermore, the impact of Vitalograph®AIM based training on inhalation skills will be assessed..
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults with asthma or COPD | Experimental | Assessment of inhalation technique by three methods in all patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assessment of inhalation technique | Other | Assessment of inhalation technique by 3 methods in every patient |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of reliability of assessment of inhalation technique by checklist method in patients with asthma and COPD | Assessment of reliability of checklist method measured by 2 observers by kappa Cohen coefficient | baseline |
| Comparison of reliability of assessment of inhalation technique by 4 grade scale in patients with asthma and COPD | Assessment of reliability of 4 grade scale measured by 2 observers by kappa Cohen coefficient | baseline |
| Comparison of validity of assessment of inhalation technique by checklist method in patients with asthma and COPD | Assessment of validity of checklist method measured by convergence between observer and an expert baseline by kappa Cohen coefficient | baseline |
| Comparison of validity of assessment of inhalation technique by 4 grade scale in patients with asthma and COPD | Assessment of validity of 4 grade scale measured by convergence between observer and an expert baseline by kappa Cohen coefficient | baseline |
| Comparison of validity of assessment of inhalation technique by Vitalograph®AIM in patients with asthma and COPD | Assessment of validity of Vitalograph®AIM method (convergence between assessment of Vitalograph®AIM and an expert) | 30 minutes from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Utility of Vitalograph® AIM in inhalation technique training | Difference in number of inhalation mistakes before and after Vitalograph® AIM based training | baseline and in 30 minutes |
| Comparison of repeatability of assessment of inhalation technique by checklist method in patients with asthma and COPD |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rafał Krenke, MD,PhD,Prof | Medical University of Warsaw | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw | Warsaw | 02-097 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29338792 | Background | Usmani OS, Lavorini F, Marshall J, Dunlop WCN, Heron L, Farrington E, Dekhuijzen R. Critical inhaler errors in asthma and COPD: a systematic review of impact on health outcomes. Respir Res. 2018 Jan 16;19(1):10. doi: 10.1186/s12931-017-0710-y. | |
| 21310878 | Result | Laube BL, Janssens HM, de Jongh FH, Devadason SG, Dhand R, Diot P, Everard ML, Horvath I, Navalesi P, Voshaar T, Chrystyn H; European Respiratory Society; International Society for Aerosols in Medicine. What the pulmonary specialist should know about the new inhalation therapies. Eur Respir J. 2011 Jun;37(6):1308-31. doi: 10.1183/09031936.00166410. Epub 2011 Feb 10. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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comparison of three methods of assessment of inhaltion technique
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Assessment of reliability of checklist method measured by 1 observer baseline and in 30 minutes by kappa Cohen coefficient |
| baseline and in 30 minutes |
| Comparison of repeatability of assessment of inhalation technique by 4 grade scale in patients with asthma and COPD | Assessment of reliability of 4 grade scale measured by 1 observer baseline and in 30 minutes by kappa Cohen coefficient | baseline and in 30 minutes |
| 21367593 | Result | Melani AS, Bonavia M, Cilenti V, Cinti C, Lodi M, Martucci P, Serra M, Scichilone N, Sestini P, Aliani M, Neri M; Gruppo Educazionale Associazione Italiana Pneumologi Ospedalieri. Inhaler mishandling remains common in real life and is associated with reduced disease control. Respir Med. 2011 Jun;105(6):930-8. doi: 10.1016/j.rmed.2011.01.005. Epub 2011 Mar 2. |
| 27060726 | Result | Sanchis J, Gich I, Pedersen S; Aerosol Drug Management Improvement Team (ADMIT). Systematic Review of Errors in Inhaler Use: Has Patient Technique Improved Over Time? Chest. 2016 Aug;150(2):394-406. doi: 10.1016/j.chest.2016.03.041. Epub 2016 Apr 7. |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |