A Randomised, Parallel-group, Multi-centre Trial Using a Novel INCA Tracker Device to Measure and Monitor Compliance and Technique of Seretide Diskus Inhaler in a Community Pharmacy Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Rate of adherence
研究概览
简要总结
The purpose of this trial is to discover whether providing feedback to patients from a device that records when and how well a patient uses a Seretide Diskus inhaler will lead to:
- Improved compliance with prescribed inhaler use
- Improved technique of inhaler use
- A reduction in respiratory health related outcomes caused by poor inhaler compliance and usage.
- An improvement in patient quality of life scores
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be 18 years old or above
- •Capable of understanding and willing to provide voluntary informed consent before any protocol specific procedures are performed
- •Capable of understanding and complying with the requirements of the protocol, and demonstrating a willingness to attend for all required visits.
- •Able and willing to take inhaled medication.
- •Have a valid prescription for use of a Seretide diskus inhaler or already using a Seretide diskus inhaler.
- •Have a history of regular attendance in the pharmacy in which they are recruited which will be demonstrated by the subject having collected three prescriptions for any medication in that pharmacy in the six months preceeding their recruitment to the study.
排除标准
- •Patient expressly reports that their physician has indicated that they will not be continuing to receive Seretide over the next 6 months
研究组 & 干预措施
Feedback
Feedback on the patient's own inhaler use, with personalized information on the patients technique and timing of use of the diskus inhaler as recorded on the INCA device will be provided to patients in the feedback group after 1,2 and 6 months.
干预措施: Feedback (Device)
Demonstration
Current best practice - inhaler technique education
干预措施: Education (Behavioral)
Control
Usual care in the community pharmacy setting
结局指标
主要结局
Rate of adherence
时间窗: 2 months and 6 months
The rate of adherence is the proportion of correctly taken drugs at the correct time relative to the prescribed interval.
次要结局
- Rescue antibiotic and/or steroid medication use(6 months)
- Adherence in the time domain(Two months and six months)
- Rescue inhaled medication use(Six months)
- Quality of life(2 months and 6 months)
- Technique adherence(Two months and six months)
研究者
Professor Richard Costello
Professor Richard Costello
Beaumont Hospital