The Validation of a Novel Adherence Method for Oral Oncolytics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- The change in the number of patients that report high adherence over time via smart phone application alone
研究概览
简要总结
The long-term goal of this research is to apply technologic approaches to improve the use of oral oncolytics. The objective of this study is to assess patient adherence to oral oncolytics and to validate a currently available smart phone application (iRxReminder) partnered with an automated dispensing device, a "Pod", in affecting patient adherence. The rationale for this study is that medication adherence to oncolytics varies and strategies are needed to improve it.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- 否
入选标准
- •Must be > 18 years of age
- •Must have a smart phone
- •Must be able to have their oral oncolytic filled at the University of Michigan Comprehensive Cancer Center pharmacy and be newly prescribed Capecitabine (Xeloda).
排除标准
- •Patients who do not have a smart phone
- •Patients who have a serious mental illness or cognitive impairment, e.g., psychosis or dementia.
- •Patients who do not speak English
- •Patients who cannot fill their oral oncolytic prescription at the University of Michigan Comprehensive Cancer Center Pharmacy
研究组 & 干预措施
Standard Patient Reported Adherence
Adherence assessment via phone call or in person
Smart Phone Application
Adherence assessment via phone app
干预措施: Smart Phone Application (Other)
POD and Smart Phone Application
Adherence assessment via phone app partnered with an automated dispensing machine, a "Pod."
干预措施: Smart Phone Application (Other)
POD and Smart Phone Application
Adherence assessment via phone app partnered with an automated dispensing machine, a "Pod."
干预措施: POD (Other)
结局指标
主要结局
The change in the number of patients that report high adherence over time via smart phone application alone
时间窗: 0, 4, 8 and 12 weeks
Adherence will be assessed via smart phone application at baseline, 4, 8 and 12 weeks. Adherence reported via the phone application will be done using an adherence question assessment.This assessment is ordinal in nature and asks the patient to rate their adherence on a scale (poor, fair, good, very good, excellent).
The change in the number of patients that report high adherence over time via smart phone application and POD
时间窗: 0, 4, 8 and 12 weeks
Adherence will be assessed via smart phone application + POD at baseline, 4, 8 and 12 weeks. Adherence reported via the phone application will be done using an adherence question assessment.This assessment is ordinal in nature and asks the patient to rate their adherence on a scale (poor, fair, good, very good, excellent). For the Pod there will be continuous adherence assessed via the pod each time the patient administers or does not administer a scheduled dose. This will be figured into the overall adherence rating.
The change in the number of patients that report high adherence over time via telephone/face-to-face visit (self-reported)
时间窗: 0, 4, 8 and 12 weeks
Adherence will be assessed via telephone/face-to-face visit (self-reported) at baseline, 4, 8 and 12 weeks. Self-reported adherence will be done using an adherence question assessment.This assessment is ordinal in nature and asks the patient to rate their adherence on a scale (poor, fair, good, very good, excellent).
次要结局
未报告次要终点