Comparison of Three Methods of Assessment of INhalation TECHnique in Patients With Asthma and COPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Comparison of validity of assessment of inhalation technique by 4 grade scale in patients with asthma and COPD
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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).
结局指标
主要结局
Comparison of validity of assessment of inhalation technique by 4 grade scale in patients with asthma and COPD
时间窗: baseline
Assessment of validity of 4 grade scale measured by convergence between observer and an expert baseline by kappa Cohen coefficient
Comparison of reliability of assessment of inhalation technique by checklist method in patients with asthma and COPD
时间窗: baseline
Assessment of reliability of checklist method measured by 2 observers by kappa Cohen coefficient
Comparison of reliability of assessment of inhalation technique by 4 grade scale in patients with asthma and COPD
时间窗: baseline
Assessment of reliability of 4 grade scale measured by 2 observers by kappa Cohen coefficient
Comparison of validity of assessment of inhalation technique by checklist method in patients with asthma and COPD
时间窗: baseline
Assessment of validity of checklist method measured by convergence between observer and an expert baseline by kappa Cohen coefficient
Comparison of validity of assessment of inhalation technique by Vitalograph®AIM in patients with asthma and COPD
时间窗: 30 minutes from baseline
Assessment of validity of Vitalograph®AIM method (convergence between assessment of Vitalograph®AIM and an expert)
次要结局
- Comparison of repeatability of assessment of inhalation technique by checklist method in patients with asthma and COPD(baseline and in 30 minutes)
- Comparison of repeatability of assessment of inhalation technique by 4 grade scale in patients with asthma and COPD(baseline and in 30 minutes)
- Utility of Vitalograph® AIM in inhalation technique training(baseline and in 30 minutes)
研究者
Marta Dąbrowska
Principal Investigator
Medical University of Warsaw