A Pilot Study of Remote Monitoring to Improve Health Related Quality of Life of Men Following Prostate Cancer Treatment.
2019年12月11日 更新者：Johns Hopkins University
The purpose of this study is to determine the feasibility of using digital technology and remote monitoring to track health-related measures in men following prostate cancer treatment.
Half of the participants will receive tools to monitor their activity and weight, as well as personalized feedback on these measures, while the other half will receive standard of care.
Health related quality of life measure will be collected from both groups.
研究概览
详细说明
The purpose of this study is to determine the feasibility of using digital technology and remote monitoring to track health-related measures in men following prostate cancer treatment.
All participants will complete a health-related quality of life survey each month for 3 months.
The digital survey will be administered on a programmed tablet.
The participants in the intervention group will also receive an activity sensor and weight scale.
Health state data from this group will be generated over a 3-6 month period and remotely monitored.
These data will be used to provide personalized feedback regarding the participant's progress towards established goals.
Health-related quality of life will be compared between participants in the intervention group, who receive (1) tools to monitor their activity and weight and (2) personalized feedback, versus participants in the control group, who receive standard of care.
The potential improved adherence to healthy behaviors of the participants receiving personalized feedback may translate to to improved health-related quality of life.
研究类型
介入性
注册 (实际的)
9
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Maryland
-
Baltimore、Maryland、美国、21287
- Johns Hopkins Hospital
-
-
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
- 孩子
- 成人
- 年长者
接受健康志愿者
不
有资格学习的性别
男性
描述
Inclusion Criteria:
- Participants must have localized prostate cancer.
- Participants must have received treatment at Johns Hopkins
- Participants must be classified as overweight (body mass index ≥ 25).
- Participants must have wi-fi in their homes.
Exclusion Criteria:
- Anyone who is unable to give informed consent will be excluded
- Anyone who is physically unable to participate in physical activity will be excluded.
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：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Intervention
The participants will complete a digital health-related quality of life survey on a programmed tablet at baseline and each month for the following 3-6 months.
They will also receive an activity sensor and weight scale.
Health state data from this group will be generated over a 3-6 month period and remotely monitored.
These data will be used to provide personalized feedback regarding the participant's progress towards established goals.
|
A combination of existing technology and a new app developed by InHealth Measurement Corp to (1) remotely monitor a participant's activity level and weight and (2) remotely provide updates to the participants regarding their progress towards the goals established in the Prostate Cancer Foundation Health and Wellness guidelines.
其他名称：
|
|
无干预：Control
The participants will complete a digital health-related quality of life survey on a programmed tablet at baseline and each month for the following 3-6 months.
|
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 |
|---|---|---|
|
Health-Related Quality of Life
大体时间：Baseline
|
36-Item Short Form (SF) Survey.
This survey is a patient-reported survey of patient health.
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section and the scores range from 0-100.
A score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability.
|
Baseline
|
|
Health-Related Quality of Life
大体时间：1 month after baseline
|
36-Item Short Form Survey.
This survey is a patient-reported survey of patient health.
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section and the scores range from 0-100.
A score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability.
|
1 month after baseline
|
|
Health-Related Quality of Life
大体时间：2 months after baseline
|
36-Item Short Form Survey.
This survey is a patient-reported survey of patient health.
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section and the scores range from 0-100.
A score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability.
|
2 months after baseline
|
|
Health-Related Quality of Life
大体时间：3 months after baseline
|
36-Item Short Form Survey.
This survey is a patient-reported survey of patient health.
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section and the scores range from 0-100.
A score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability.
|
3 months after baseline
|
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：Peter Searson, PhD、Johns Hopkins University
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 (实际的)
2018年7月11日
初级完成 (实际的)
2019年10月16日
研究完成 (实际的)
2019年10月16日
研究注册日期
首次提交
2018年2月6日
首先提交符合 QC 标准的
2018年2月13日
首次发布 (实际的)
2018年2月15日
研究记录更新
最后更新发布 (实际的)
2019年12月13日
上次提交的符合 QC 标准的更新
2019年12月11日
最后验证
2019年12月1日
更多信息
与本研究相关的术语
其他研究编号
- IRB00156374
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
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Technology Intervention的临床试验
-
Ege Miray Topcu完全的
-
University of North Carolina, Chapel HillEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)尚未招聘
-
University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动，不招人
-
MicroPort Orthopedics Inc.完全的