Prospective Study of the Feedback From an Adherence Monitor on Asthma Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Adherence rate
研究概览
简要总结
Inhaled medications are the mainstay of the therapeutic management of respiratory disorders. Considered by many to be 'simple' and 'easy' to use, clinicians are aware that inhalers are often improperly used. However, there is no tool that can detect and record errors in either the timing or the method dose administration
The investigators designed a device that makes an acoustic record each time an inhaler is used. Opening the device makes an acoustic file which is recorded, this file is "time-stamped" which means that the timing of drug administration is recorded. When the device is retrieved and acoustic analysis performed, the steps involved in using the inhaler can be determined. Hence, the subjects inhaler technique is assessed and errors in the inhaler use identified. Together this means that errors in inhaler technique and timing of use can be quantified.
In this study the investigators attached the device to a discus dry powder inhaler. In order to eliminate the behavioral component of adherence and identify the mechanical issues associated with effective inhaler use the investigators studied subjects who were already in Hospital and already prescribed a discus inhaler. The investigators hypothesized that the device would identify which errors in technique were the most common and that this would provide insight into how these errors might be eliminated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
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
- •Patients prescribed therapy equivalent to step 3 or higher on the Asthma Management Guidelines for at least 3 months
- •At least one exacerbation in the previous year with systemic glucocorticoids
- •Uncontrolled/Partially Controlled Asthma by GINA guidelines
排除标准
- •Allergy to salmeterol/fluticasone
- •Patients Controlled by GINA guidelines
结局指标
主要结局
Adherence rate
时间窗: at three months
The rate of actual adherence at baseline and at the end of the study, which at the end of the 3 month of study will be assessed. The actual inhaler adherence, expressed as cumulative drug exposure, is calculated by combining the time of use along with the interval between doses (correct time is twice a day, in a period not less than 6 hours between the last dose and the subsequent dose or at a time greater than 18 hours apart from the previous dose.) and incorporating, by audio analysis, if the inhaler was used correctly.
次要结局
- Peak Expiratory Flow Rate(at 3 months)
- Asthma quality of life score(at 3 months)
- Asthma Reliever Medication Use(over 3 months)
- Asthma Control Test(at 3 months)
- Asthma Exacerbations(over 3 months)
研究者
Professor Richard Costello
Professor of Medicine
Beaumont Hospital
