Expanding Access to Care Through Telemedical Support for Vital Sign Monitoring in High-risk Patients With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- To determine whether remote blood pressure monitoring improves adherence to recommendations for daily systolic and diastolic blood pressure monitoring compared to usual care
研究概览
简要总结
A randomized trial of remote blood pressure monitoring, compared to usual care, in patients receiving bevacizumab to determine whether remote blood pressure monitoring improves the collection of blood pressure data, identification and management of clinically significant hypertension, and patient satisfaction.
详细描述
Remote patient monitoring (RPM) technology has the potential to improve the early detection and management of clinically significant hypertension in cancer patients undergoing therapy with bevacizumab, by allowing immediate communication of abnormal measurements to the clinical care team. Additionally, RPM may decrease patients' and caregivers' burdens of ongoing cancer care through an improved user experience compared to usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Participant is a male or female 18 years of age or older.
- •Participant is a current patient at West Michigan Cancer Center/Bronson Cancer Center.
- •Participant is receiving bevacizumab as part of active treatment.
- •Participant is willing and able to provide written informed consent.
排除标准
- •Participant is unable to understand English.
- •Participant is hospitalized.
- •Participants are unable to obtain blood pressure readings at home.
研究组 & 干预措施
Smart Cuff Group
Smart blood pressure cuff
干预措施: Cellular enabled blood pressure cuff (Device)
Control Group
Standard of care
干预措施: Standard of Care Cuff (Device)
结局指标
主要结局
To determine whether remote blood pressure monitoring improves adherence to recommendations for daily systolic and diastolic blood pressure monitoring compared to usual care
时间窗: Through study completion, an average of 12 weeks
Comparing the number of participants who complete the recommended daily blood pressure readings available for clinician assessment via review of a remote blood pressure monitoring platform versus a patient recorded blood pressure log book
次要结局
- Improvement of early identification of bevacizumab-induced hypertension with usual care blood pressure monitoring(Through study completion, an average of 18 months)
- Improvement of early identification of bevacizumab-induced hypertension with remote blood pressure monitoring(Through study completion, an average of 18 months)
- Patient satisfaction with usual care blood pressure monitoring(1 week after enrollment, 6 weeks after enrollment and 12 weeks after enrollment)
- Patient satisfaction with remote blood pressure monitoring(1 week after enrollment, 6 weeks after enrollment and 12 weeks after enrollment)
研究者
David Shalowitz
Principal Investigator
West Michigan Cancer Center