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Stepping Up: A Trial of Activity Monitoring Devices in Patients Undergoing Autologous Stem Cell Transplant

2022年10月5日 更新者:Ronald Paquette、Cedars-Sinai Medical Center
The purpose the research is to obtain preliminary data about the change in fitness from admission to discharge in patients undergoing an Autologous Stem Cell Transplant (ASCT) , assessed by the 6 minute walk test as the primary objective and the SF-36 as the secondary objective. All subjects will wear a Fitbit monitor while admitted for the ASCT to record their daily activity.

研究概览

详细说明

This study will enroll 20 subjects with a diagnosis of multiple myeloma or lymphoma (10 with each diagnosis) scheduled to undergo ASCT at Cedars-Sinai Medical Center.

After signing the informed consent form, intake data will be collected on all subjects will include age, diagnosis, Karnofsky performance status, and comorbidity index. Subjects will complete an SF-36 questionnaire that assesses their functional and emotional status. Each subject will undergo a 6-minute walk test (6MWT) while wearing a Fitbit monitor to record the number of steps taken. After admission, subjects will be randomly assigned to either the control or intervention group. Subjects in the control arm will receive an activity monitor but the physician, nurse, and patient will not receive any feedback from the device. Patients will be blinded to any data capture from their activity monitor. Participants in the intervention arm will receive an activity monitor and they will receive feedback from the activity tracker and the in-room TV screen. Study participants in this arm will engage with their physicians and nurses around achievement of daily step goals by viewing the in-room TV display of daily step counts on rounds. After discharge, all subjects will again complete the SF-36 questionnaire and perform a 6MWT at a routine clinic visit, within 30 days of the transplant procedure. Descriptive statistics in the form of mean and standard deviation will be used to summarize patient physical activity as measured by 6MWT.

研究类型

介入性

注册 (实际的)

23

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

    • California
      • Los Angeles、California、美国、90048
        • Cedars-Sinai Medical Center

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

18年 至 80年 (成人、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:

  • diagnosis of multiple myeloma or lymphoma with plan to undergo autologous stem cell transplant
  • at least 18 years of age
  • English or Spanish speaking
  • have access to an IOS or Android device
  • able to provide informed consent.

Exclusion Criteria:

  • pre-existing physical limitations which would preclude achievement of the ambulation goals
  • inability to wear the activity monitor
  • Jehovah's Witness patients enrolled in the bloodless transplant program are excluded as they require strict bed rest for long periods of time

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:诊断
  • 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:Feedback
Participants in the intervention arm will receive a Fitbit upon admission and will receive feedback from the activity tracker and the in-room TV screen as demonstrated by the Study Navigator. Study participants in this arm will be engaging with their physicians around achievement of daily step goals by viewing the in-room TV display of their daily step counts on rounds.
The system uses Sonifi health (TV content and visualizations) and Fitabase (3rd party server to process Fitbit data and export to Sonifi). The system utilizes the patient's TVs to engage the patient and multidisciplinary team in monitoring ambulation status.
无干预:Control
Subjects in the control arm will receive a Fitbit upon admission for their transplant but neither the physician, nurse, nor patient will receive any feedback from the device. They will be blinded to any data capture by their activity monitor. Nurses and doctors will not monitor ambulation with the activity monitor, they will use standard methods to encourage ambulation.

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
Fitness measured by 6 minute walk test after discharge
大体时间:3-4 weeks
Standard 6 minute walk test will be performed
3-4 weeks

次要结果测量

结果测量
措施说明
大体时间
Fitness assessed by SF-36 questionnaire after discharge
大体时间:3-4 weeks
Standard SF-36 questionnaire will be completed
3-4 weeks

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:Ron Paquette, MD、Cedars-Sinai Medical Center

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)

2021年10月26日

初级完成 (实际的)

2022年10月1日

研究完成 (实际的)

2022年10月1日

研究注册日期

首次提交

2021年7月23日

首先提交符合 QC 标准的

2021年7月23日

首次发布 (实际的)

2021年8月2日

研究记录更新

最后更新发布 (实际的)

2022年10月7日

上次提交的符合 QC 标准的更新

2022年10月5日

最后验证

2022年10月1日

更多信息

与本研究相关的术语

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

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.

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