Comparison of 3 Methods to Assess Inhalation Technique

Study Overview
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Brief Summary
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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: Checklist of mistakes in inhalation technique (including critical mistakes) 4 grade scale of inhalation technique Assessment by Vitalograph®AIM (Aerosol Inhaling Monitor) 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.

Detailed Description
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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: Checklist of mistakes in inhalation technique (including critical mistakes) 4 grade scale of inhalation technique Assessment by Vitalograph®AIM (Aerosol Inhaling Monitor) 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 Comparison of three different methods of assessment of inhalation technique in patients with asthma and COPD (reliability, validity and accuracy) Difference in the number of mistakes made during inhalation before and after the Vitalograph® AIM based training. 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..

Official Title
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Comparison of Three Methods of Assessment of INhalation TECHnique in Patients With Asthma and COPD

Conditions
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Asthma, COPD

Intervention / Treatment
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* Other: Assessment of inhalation technique


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: informed consent for participating in the study age 18-85 years COPD or asthma diagnosed at least 3 months prior to enrollment using of at least one inhaler regularly every day using one of the inhalers: Metered Dose Inhalers (MDI), Dry Powder Inhalers (DPI) or Metered Dose Liquid Inhalers (MDLI) Exclusion criteria: lack of informed consent age <18 years or > 85 years diagnosis of asthma or COPD not earlier than 3 months before enrollment using inhalers irregularly. symptoms of infection 5 days prior to beginning of the study comorbidity that could prevent patient from using Vitalograph®AIM to teach patient proper inhalation technique (i.e. advanced cognitive disorders, mental diseases, crucial neurological, vision or hearing disorders).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: comparison of three methods of assessment of inhaltion technique
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adults with asthma or COPD<br>Assessment of inhalation technique by three methods in all patients | Other: Assessment of inhalation technique<br>* Assessment of inhalation technique by 3 methods in every patient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inhalation technique