NCT01308476已完成不适用
Assessment if a Daily SMS (Short Message System) Reminder Improves the Adherence of COPD Patients to Therapy With Spiriva® 18 Microgram
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 5
- 主要终点
- Adherence to Spiriva HandiHaler Over Time
研究概览
简要总结
6 months open label non-interventional observational study acc to § 4, section 23 and § 67, section 6 German Medicines Act with two parallel groups
- the SMS group receiving a daily SMS - a reminder to inhale Spiriva® 18 Microgram
- the control group not receiving a daily SMS reminder
详细描述
Purpose:
Study Design:
observational
研究设计
- 研究类型
- Observational
- 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
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Adherence to Spiriva HandiHaler Over Time
时间窗: Baseline, Week 8, Week 12, Week 16, Week 20 and Week 24
Adherence was defined as percentage of documented applications of Spiriva HandiHaler as compared to the regularly planned seven applications during the week before questioning the patients. Patients in the SMS reminder group and in the control group were asked via SMS how often they had used Spiriva HandiHaler during the last week and were requested to call the IVR system to provide their response. Baseline was defined as week 4.
次要结局
- Change From Baseline in Adherence to Spiriva HandiHaler Over Time(Week 8, Week 12, Week 16, Week 20 and Week 24)
- Response Rate Regarding Adherence(24 weeks)
- Patients Compliance With SMS System(24 weeks)
- Patients Assessment of Usefulness of the SMS System(Visit 2 (12 weeks) and visit 3 (24 weeks))
- Physicians Assessment of Usefulness of the SMS System(Visit 2 (12 weeks) and visit 3 (24 weeks))
- Physicians Recommendation of the SMS System(Visit 2 (12 weeks) and visit 3 (24 weeks))
- Patients Satisfaction With SMS System(Visit 2 (12 weeks) and visit 3 (24 weeks))
研究者
研究点 (5)
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