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临床试验/NCT02552472
NCT02552472已完成不适用

Haphazard and Careless Use of Inhalers, an Observational Study

Beaumont Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2012年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
Inhaler Technique Adherence

研究概览

简要总结

This is a prospective cohort observational study of inhaler adherence in a community care setting (ie. general practice clinics and pharmacies in the community).

详细描述

Over a 2-4 week period, consecutive patients with a history of respiratory illness already prescribed a salmeterol/fluticasone Diskus inhaler will be asked to participate in this study. Patients will give informed consent to participate in this study of adherence, which will be assessed with the INCA device. Both clinicians and patients will be fully aware that the device is an acoustic recording device and that both time and technique of inhaler use will be assessed. Once consented, patients will be given an INCA enabled inhaler for 1 month and asked to use it as they normally would and then to return it at the end of one month. The days used and the number of doses used in the study period, as per the dose counter, will also be recorded.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Known history of Respiratory Illness
  • Prescribed salmeterol/fluticasone Diskus Inhaler

排除标准

  • Unable to understand study protocol
  • Refusal to sign consent form

结局指标

主要结局

Inhaler Technique Adherence

时间窗: One Month

This is adherence measured by the INCA device in regards to technique of use. This is measured as a rate.

Inhaler Adherence in Time

时间窗: One month

This is adherence as measured by the INCA device in regards to time of use. This is measured as a rate of use.

次要结局

  • Health Care Use Measured as the number of visits to a General Practitioner in the previous Year(Previous Year)
  • Background Respiratory Diagnosis, divided into Asthma, COPD and other.(Previous History)
  • Age Measured in Years at time of recruitment(one month)
  • Exacerbation Measured as the number of Respiratory Related Exacerbations in the previous year(Previous Year)
  • Gender Measured as Male or Female(One Month)
  • Education Level Measured as either primary, secondary or tertiary school at recruitment.(One Month)
  • Hospitalisation Measured as the number of hospital admissions in the previous year(Previous Year)
  • Socio-economic Class Measured as the patient having either Private or Public Health Insurance(One Month)
  • Smoking History measured by three categories: 1. Current Smoker, 2. Ex-Smoker and 3. Never Smoker(Previous History)

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 Richard W Costello

Beaumont Hospital

研究点 (1)

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