In-Home Sensor Monitoring of Older Adults With Cancer
2020年9月14日 更新者：Washington University School of Medicine
In-Home Sensor Monitoring of Older Adults With Cancer: A Pilot Study
The investigators propose a pilot study of monitoring a sample of 6 older patients receiving active cancer treatment over a period of 6 months with in-home sensor monitors installed and maintained by Foresite Healthcare.
The investigators also propose exploring the beliefs and attitudes of those who are not willing to allow in-home sensor monitoring by asking them to complete a brief survey related to in-home sensor monitoring.
The investigators hypothesize that patients will find the equipment acceptable and unintrusive, that changes in home-monitored patient parameters will precede clinical events and that patient trajectories will be more fully characterized with the in home sensors.
研究概览
研究类型
介入性
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
65年 及以上 (年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
Arm A:
- Age ≥ 65
- Receiving systemic cancer therapy, including conventional chemotherapy, novel/targeted agents OR will begin systemic therapy within the next 4 weeks.
- Estimated life expectancy >1 year
- Anticipated to receive ongoing care at Siteman Cancer Center and its satellite sites
- Willing to have sensors installed in 1-2 primary living areas (e.g. living room and bedroom)
- Continuous home internet connection
- Able to understand and willing to sign an IRB-approved written informed consent document
Arm B:
- Age ≥ 65
- Receiving systemic cancer therapy, including conventional chemotherapy, novel/targeted agents OR will begin systemic therapy within the next 4 weeks.
- Estimated life expectancy >1 year
- Anticipated to receive ongoing care at Siteman Cancer Center and its satellite sites
- Able to understand and willing to sign an IRB-approved written informed consent document
Exclusion Criteria:
Arm A:
- Inability to read and understand English
- Only receiving hormonal agents (e.g. anti-estrogen or anti-androgen)
- Lives in institutional setting where instrumental activities of daily living are completed for patient by paid staff
Arm B:
- Inability to read and understand English
- Only receiving hormonal agents (e.g. anti-estrogen or anti-androgen)
- Lives in institutional setting where instrumental activities of daily living are completed for patient by paid staff
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Arm A: In-Home Sensor Monitoring
Older adults with cancer undergoing systemic cancer treatment will undergo passive monitoring with motion sensors and bed sensor.
Passive infrared (PIR) motion sensors will be installed in their homes to detect presence in a particular room (e.g., bathroom or kitchen) as well as for specific activities.
There will also be a bed sensor, which is a pneumatic strip installed under the bed linens, which measures displacement of the resident's upper torso as he or she lies on the bed.
Participants will complete a baseline primarily self-administered survey, an abbreviated assessment with each follow up clinic visit (at least once per month) for 6 months of follow up and a final end of study assessment.
|
-Installed and maintained by Foresite Healthcare
|
|
无干预：Arm B: Survey Only
Patients that choose to not proceed with in-home sensor monitoring will be asked to complete a brief survey that explores attitudes regarding in-home sensor monitoring
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Acceptability of in-home sensor monitoring as measured by a modified version of the Intelligent Systems for Assessment of Aging Technology Survey (Arm A only)
大体时间：6 months
|
|
6 months
|
|
Heart rate (Arm A only)
大体时间：6 months
|
-A meaningful change is heart rate outside the normal range of 60-100
|
6 months
|
|
Changes in gait speed of .1m/s or more (Arm A only)
大体时间：6 months
|
6 months
|
|
|
Stride length (Arm A only)
大体时间：6 months
|
6 months
|
|
|
Number of Falls (Arm A only)
大体时间：6 months
|
6 months
|
|
|
Number of Hospitalizations (Arm A only)
大体时间：6 months
|
6 months
|
|
|
Number of Emergency room visits (Arm A only)
大体时间：6 months
|
6 months
|
|
|
Number of Infections requiring medical intervention (e.g. oral antibiotics) (Arm A only)
大体时间：6 months
|
6 months
|
|
|
Number of grade ≥3 adverse events measured by CTCAE (Arm A only)
大体时间：6 months
|
6 months
|
|
|
Patient reported outcomes of 10 common symptoms (Arm A)
大体时间：6 months
|
|
6 months
|
|
Reason for not choosing in-home monitoring as measured by a modified version of the Intelligent Systems for Assessment of Aging Changes Technology Survey (Arm B only)
大体时间：At the time of invitation to participate in the study (Day 1)
|
|
At the time of invitation to participate in the study (Day 1)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Tanya M Wildes, M.D., MSCI、Washington University School of Medicine
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2020年10月31日
初级完成 (预期的)
2022年4月30日
研究完成 (预期的)
2022年4月30日
研究注册日期
首次提交
2019年11月5日
首先提交符合 QC 标准的
2020年3月9日
首次发布 (实际的)
2020年3月13日
研究记录更新
最后更新发布 (实际的)
2020年9月16日
上次提交的符合 QC 标准的更新
2020年9月14日
最后验证
2020年9月1日
更多信息
与本研究相关的术语
其他研究编号
- 202001189
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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