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临床试验/NCT01529697
NCT01529697已完成不适用

Prospective Study of the Feedback From an Adherence Monitor on Asthma Control

Beaumont Hospital2 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2012年2月1日最近更新:
适应症

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

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

发起方
Beaumont Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Richard Costello

Professor of Medicine

Beaumont Hospital

研究点 (2)

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