Study of Patient Use and Perception of the Travatan Dosing Aid
Pilot Study of Patient Acceptance and Impact of the New Travatan™ Compliance Monitoring Dispenser (Travatan™ Dosing Aid)
研究概览
地位
条件
详细说明
Patients enrolled in this study will use the new Travatan compliance monitoring dispenser for 6 weeks. Patients will be informed that some, but not all, patients' compliance will be monitored by the device. Patients are randomly assigned to one of three groups (proportionally in a 2/2/1 ratio):
- Fully functional Travatan compliance monitor
- Travatan compliance monitor with LCD display and alarms disabled, but compliance monitoring intact
- Travatan compliance monitor with LCD display, alarms and compliance monitor disabled.
At end of study, patients fill out questionnaire assessing
- Patient opinion regarding device: ease of use of new device; preference vs Travatan use without device, etc
- patient's belief as to whether their compliance was monitored or not
Rates of adherence are compared across groups and with regard to patients' reported beliefs as to whether they were monitored.
The design of this study should allow the clinicians to ethically monitor compliance in patients who do and do not believe that they are being monitored. The use of monitoring devices without a functioning display and alarm should lead to some patients believing that they are not being monitored. As patients are told at the outset that they may or may not be monitored, this should be an ethically acceptable design. However, the collected data will allow a preliminary assessment of the impact of the patients' beliefs as to whether they are being monitored on their actual compliance, and hence an additional potential value of the device.
研究类型
注册 (实际的)
阶段
- 第四阶段
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Open angle glaucoma or ocular hypertension
- Presently using Travatan eye drops
Exclusion Criteria:
- Allergy to prostaglandin
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:单组作业
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器:1 Fully functional monitoring device
Fully functional monitoring device
|
Pt received fully functional monitoring dispenser for use with their Travatan eye drops
|
有源比较器:2 Partially functional monitoring device
Partially functional monitoring device
|
Patient received a particually functional Travatan Compliance Monitoring Dispenser
|
假比较器:3 Non-functional monitoring device
Non-functional monitoring device
|
Patient received a non functioning Travatan Compliance Monitoring Dispenser
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Assess patients' opinions regarding new Travatan Compliance Monitoring Dispenser
大体时间:6 weeks
|
6 weeks
|
次要结果测量
结果测量 |
大体时间 |
---|---|
Pilot study of the impact of physician monitoring of compliance on patient compliance
大体时间:6 weeks
|
6 weeks
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- IRB #06-762E
- CMS-06-09 (其他标识符:Wills Eye Hospital)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
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