Evaluation of ReX-C System in Measurement and Improvement of Adherence, in Patients Receiving Oral Anti-coagulation Therapy for the Treatment and Prevention of Thromboembolism.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Safety of ReX- C system, measured by incidences of pill overdose, pills malformation and adverse events related to the device use.
研究概览
简要总结
The study aims to evaluate the safety, usability and efficacy of the ReX-C - a novel medication management system - in measurement and improvement of adherence, in patients receiving oral anti-coagulation therapy for the treatment and prevention of thromboembolism.
详细描述
ReX-C is a mobile system intended to provide solid, oral medication on patient demand, according to a pre-programmed treatment protocol. ReX-C addresses poor adherence to medication therapy by providing real-time, reliable adherence data to caregivers and timely, personalized reminders to patients.
During the study, the use of ReX-C system to receive medications will be compared to Standard of Care. Patients' adherence will be evaluated for both methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- •Male or Female, at least 18 years of age
- •Subject is able to swallow pills and use ReX-C device to receive medication.
- •Subject is able to read and understand the Informed Consent Form.
- •Subject receives anti-coagulants for the treatment and prevention of thromboembolism events, (e.g: Arterial Fibrillation (AF), Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)).
- •Subject receives Novel Oral Anti-coagulant (NOAC); including; Pradaxa® (dabigatran), Xarelto® (rivaroxaban) and Eliquis® (apixaban).
- •Subject is recruited at least 1 month after treatment initiation and has stable dose regime.
- •Subject receives stable dose of medication for at least a month.
- •Subject takes medication therapy at home.
排除标准
- •Subject has significant physical disability including; poor fine motor skills, impaired visual or auditory faculties, mental disorders or other impairment affecting ability to provide Informed Consent Form or use the ReX-C dispensing unit effectively.
- •Subject cen not use ReX-C to receive medications.
- •Subject is participating in another clinical study that does not permit participation in two studies simultaneously.
- •Subject is at end stage or terminal illness with anticipated life expectancy of 6 months or less.
研究组 & 干预措施
Arm1 - ReX first
Subjects begin with the ReX-C Intervention stage followed by Standard of Care stage.
干预措施: ReX-C intervention (Device)
Arm1 - ReX first
Subjects begin with the ReX-C Intervention stage followed by Standard of Care stage.
干预措施: Standard of Care (Other)
Arm 2- Standard of Care first
Subjects start with Standard of Care stage followed by ReX-C Intervention.
干预措施: ReX-C intervention (Device)
Arm 2- Standard of Care first
Subjects start with Standard of Care stage followed by ReX-C Intervention.
干预措施: Standard of Care (Other)
结局指标
主要结局
Safety of ReX- C system, measured by incidences of pill overdose, pills malformation and adverse events related to the device use.
时间窗: 18 weeks
incidences of pill overdose, pills malformation and adverse events related to the device use will be measured by a questionnaire.
Ease of use and acceptance of ReX-C system measured by a questionnaire
时间窗: 18 weeks
Patients will be asked about their experience with ReX-C.
ReX-C capability to assess patient's adherence, measured by ReX-C record of missed/ delayed dose.
时间窗: 18 weeks
Any event of delayed pill intake recorded by ReX-C should lead to a personal reminder to patient, who has to confirm the delay and act to take the missing dose.
次要结局
- Adherence rate measured by patient's plasma drug level(18 weeks)