A Real-World Assessment of a COPD Disease Management Support Service (Me & My COPD).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 161
- 试验地点
- 1
- 主要终点
- To detect a reduction in the rate of hospitalisations due to COPD exacerbations
研究概览
简要总结
A real world study to determine the effectiveness of a patient support service to aid COPD patients in their self management.
详细描述
The purpose of the study is to evaluate a digital health wellness support tool for patients in primary care with COPD using a smart mobile app, patient web portal and technology attached to the patients SABA reliever inhaler. Using the patients pre-defined COPD self management plan, the active arm of the study complete a daily diary (EXACT PRO) and record their daily SABA inhaler usage. After defining a health and symptom score baseline over a two week period, any significant deviations in SABA reliever use or daily diary scoring will alert patients that they may be having a change in their symptoms and advise them to refer to their self management plan and if they need to start their rescue medication. The primary outcome measure for the study is a 25% reduction in unplanned COPD hospital admissions (n=250 completing the study in each arm).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of COPD
- •FEV1/FVC ratio >0.3-<0.7 and FEV1 > 30% post-bronchodilator
- •Prescribed either ICS, LABA and or LAMA at dose for COPD
- •Exacerbations reported within the last 12 months requiring treatment with >1 systemic steroid and/or antibiotics, OR hospitalisation within last 12 months due to exacerbation, OR have received >12 SABA prescriptions in previous 12 months
- •Patient has a self management plan which includes use of an oral steroid at a dose within NICE guidelines, and additionally antibiotics as appropriate.
排除标准
- •Symptomatic asthma or seasonal allergic rhinitis leading to hospitalisation in previous 12 months
- •Patients unable to use a mobile phone
结局指标
主要结局
To detect a reduction in the rate of hospitalisations due to COPD exacerbations
时间窗: Analysed over a twelve month timeframe
The mean number of COPD related hospitalisations per patient per year for patients who are receiving the digital service in the study will be compared to the rate of COPD related hospitalisations in patients receiving current best care alone over a twelve period.
次要结局
- To detect a reduction in the number of exacerbations requiring treament with antibiotics and or systemic steriods(12 months)
- To detect an improvement in patients own perceived health status, as assessed by St Georges Respiratory Questionnaire-C(12 months)
- To detect a reduction in the duration of hospitalisations due to COPD exacerbations.(12 months)