Non-randomized Observational Study to Collate Data Regarding the Safety, Efficacy and Satisfaction of ReX® in the Management of Solid Oral Medications.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Treatment duration
研究概览
简要总结
The goal of this observational study is to evaluate the safety, efficacy and patient satisfaction with the ReX Remote Digital Nurse by patients receiving solid oral medication.
The study will evaluate and monitor use of ReX in respect of:
- treatment duration
- adverse events
- patient adherence and compliance
- engagement with ReX via patient-reported outcomes
Patients participating in the study will receive their normal medication as standard of care via ReX. Progress will be monitored via patients' responses to questions presented on the ReX touch screen.
详细描述
The ReX platform is a class 1 FDA device listed under product code NXB Dispenser Solid Medication. It comprises:
- Hand-held medication dispenser with touch screen (ReX Remote Digital Nurse).
- Disposable cartridge pre-loaded with pills or capsules. The cartridge includes an integral mouthpiece. Patients inhale at the mouthpiece causing pills to be dispensed into the mouth.
- Web application (ReX Treatment Manager) which collects data generated by the ReX hand-held dispenser.
ReX manages and monitors medication-based therapy by means of:
- Reminders to take pills. Reminders are sent to patients and caregivers by email, SMS or via the telephone support team.
- Electronic patient recorded outcomes (ePROs) presented to patients via the dispenser touch screen. ePROs include questions, tips and reminders.
- Notifications sent by email or SMS in the event of the patient exceeding a pre-defined threshold.
In this study, following training, patients will be offered their standard oral medication via the ReX Remote Digital Nurse. They will receive cartridges pre-loaded with medication by the pharmacy. Safety, efficacy and patient satisfaction with the device are monitored over a 24-week period by phone calls and periodic questionnaires.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •18 years of age or older.
- •Care team recommends the use of ReX as a standard of care.
- •Patients have 5th grade reading level.
- •Patient was prescribed oral medication.
- •Patient takes medication at home.
排除标准
- •Patient 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 or use the ReX dispensing unit effectively.
- •Patient failed to pass the learning module during ReX onboarding flow.
- •Patient is at end stage or terminal illness with anticipated life expectancy of 6 months or less.
结局指标
主要结局
Treatment duration
时间窗: 24 weeks
At least 3 months while using ReX
Patient satisfaction
时间窗: 24 weeks
At least 3.5 on a scale up to 5
Adverse events
时间窗: 24 weeks
None related to use of ReX
Patient adherence
时间窗: 24 weeks
No. of pills taken by patient as a percentage of pills prescribed \>80%
Patient compliance
时间窗: 24 weeks
No. of pills taken as percentage of pills to be taken in alloted time frame \>70%
Patient engagement
时间窗: 24 weeks
No. of questions answered as a percentage of questions asked \>70% of ePROs
次要结局
未报告次要终点