Randomized, Controlled Study to Evaluate the Effectiveness of the Kata® Inhalations-App in Reducing Critical and Non-critical Handling Errors and Improving Adherence to Prescribed Drug Inhalation Therapy and Asthma Control in Adult Patients With Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 18
- 主要终点
- Change in the average number of handling errors per inhalation compared between the intervention and control group
研究概览
简要总结
The Kata® App is a digital therapy assistant for patients with asthma who need to inhale their therapy. Kata features inhalation trainers that shows patients in a simple and understandable way how to improve their inhalation maneuver so that the drug reaches the lungs efficiently. The Kata® App aims to reduce inhalation errors and ensures that inhaled drugs are used as approved and prescribed. Kata has different trainers for different inhalation devices. This study investigates the possible positive effects of the Kata® Inhalation App.
The main goal of the study is to:
- investigate the effect of using the Kata® App on adherence for inhaled drugs in adult asthma patients. It consists of two parts: the correct use of the inhalers; and compliance with the therapy, or how much the patient follows the therapy plan as prescribed.
- investigate the effect of using the Kata® App on asthma symptoms and asthma control, as measured by the Asthma Control Test (ACT) questionnaire.
In addition, asthma-related quality of life, lung function, and ease of use of the app will be assessed during the study.
This multicenter study follows a randomized, controlled, parallel-group, adaptive two-stage design. The study includes two different groups: an intervention and a control group. At the beginning of the study, each patient is randomly assigned to one of these two groups. The total duration of the study is 13 weeks: 1 baseline week and 12 intervention weeks. During the baseline week, the intervention and control group both use the app with limited functionality. Kata records their inhalations but does not provide inhalation training or feedback. This is to first assess how well patients are able to use their inhaler(s) without receiving support. After the first week, the intervention group starts using the app with full functionality for 12 weeks, which means that the app provides them with inhalation training and personalized feedback. The control group continues to use the app with limited functionality for 12 weeks, that means that they continue to use the app to record their inhalations but do not receive any inhalation training or feedback. This study will compare the patients in the intervention and control group, to find out the effect of using the Kata® inhalation app on the number of errors patients make when using their inhaler, therapy compliance, and health-related outcomes (asthma control, quality of life, and lung function).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The Investigator, the subjects and the data analyst will not be blinded. The persons evaluating the recordings of inhalation maneuvers will be blinded to study intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in the average number of handling errors per inhalation compared between the intervention and control group
时间窗: Change in average number of handling errors per inhalation from baseline (study week 1) to the final intervention week (study week 13)
Based on the recordings of the inhalation maneuvers from each data collection period, the inhaler handling and inhalation technique of each subject will be evaluated centrally by trained blinded personnel, based on the applicable German Airway League checklists for inhalation maneuvers (Checklisten Deutsche Atemwegsliga).
Change in Asthma Control Test (ACT) score compared between the intervention and control group
时间窗: Change in ACT score from baseline (study week 1) to the final intervention week (study week 13)
The ACT consists of 5 questions (items) to assess the subject's asthma symptom control within the last 4 weeks. Each question can be answered on a 5-point numerical scale from 1 (worst) to 5 (best). The ACT score is the total score of all items. An ACT score of ≤ 15 points means "no asthma control", a score of 16 to 19 points means "partial asthma control" and a score of ≥ 20 points means "complete asthma control". These are the 3 ACT asthma control classes. The minimal clinically important difference for the ACT is 3 points. The ACT will be completed during each data collection period. The questionnaire will be made available within the smartphone application. Subjects will be reminded to complete the ACT.
次要结局
- Change in the Test of Adherence for Inhalers (TAI) score (patient domain) compared between the intervention and control group(Change in TAI score from baseline (study week 1) to the final intervention week (study week 13))