Remote Electronic Patient Monitoring in Gastrointestinal Cancer
2020年11月10日 更新者：Joseph A. Greer, Ph.D.、Massachusetts General Hospital
The goal of this research study is to evaluate a program that involves remote electronic monitoring of vital signs and symptoms of patients with gastrointestinal cancer who were recently hospitalized at Massachusetts General Hospital or presented to the oncology clinic for an unplanned, urgent visit.
研究概览
详细说明
Patients with gastrointestinal cancer often experience troublesome symptoms and side effects related to the cancer and its treatment. Unfortunately, patients commonly require hospital admission or urgent clinic visits to help manage uncontrolled symptoms. For this study, the investigators seek to determine if a program that entails remote electronic monitoring may improve the overall care experience of patients with gastrointestinal cancer who have urgent care needs.
The investigators are asking the participants to take part in this research study because the participants are currently hospitalized at Massachusetts General Hospital or recently presented to the oncology clinic for an urgent visit, and are receiving treatment at the Cancer Center. The goal of this study is to test a program that involves remote electronic monitoring of vital signs and patient-reported health outcomes. This study is a pilot study, and the investigators are evaluating the feasibility of delivering the program, the acceptability and satisfaction with the program, changes in the quality of life and symptoms of patients who receive the program, as well as the frequency of urgent hospital visits while the patient is in the program.
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
18年 及以上 (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:
- Age 18 or older
- Diagnosed with gastrointestinal cancer
- Hospitalized at Massachusetts General Hospital (MGH) or presenting to the ambulatory MGH oncology clinic for an unplanned, urgent visit
- Planning to receive outpatient care at the MGH Cancer Center
- Ability to read and respond to questions in English
Exclusion Criteria:
- Uncontrolled psychiatric illness or impaired cognition that would interfere with completing study procedures
- Enrolled in hospice
- Planning to be discharged to any location other than their home
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：不适用
- 介入模型：单组作业
- 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：Remote Electronic Patient Monitoring
|
The Remote Patient Monitoring intervention is a remote monitoring system intended for use by healthcare professionals for the collection of physiological data in home and healthcare settings.
Patient information is displayed on a computer located at the medical institution.
Throughout the day, patient data from the remote monitoring system are presented on the clinician user interface (e.g., temperature, blood pressure, heart rate, respiration rate).
Data are transmitted from sensors to the patient's smart phone.
|
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 |
|---|---|---|
|
The Feasibility of Remote Electronic Patient Monitoring Intervention
大体时间：4 weeks
|
The intervention will be deemed feasible if at least 50% (95% confidence interval +/- 13%) of patients agree to participate in the study and sign informed consent, and if participants wear the Remote Electronic Patient Monitoring device ≥ 50% (95% confidence interval +/- 13%) of the time within the two weeks following the baseline time point.
|
4 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of participants completing self-reported symptom monitoring through the remote electronic monitoring device during study period
大体时间：4 weeks
|
4 weeks
|
|
|
Proportion of participants completing vital sign monitoring through the remote electronic monitoring device during study period
大体时间：4 weeks
|
4 weeks
|
|
|
Number of concerning issues identified per patient during study period
大体时间：4 weeks
|
4 weeks
|
|
|
Number of intervention-triggered phone calls from clinicians required per patient as well as average duration of these calls during study period
大体时间：4 weeks
|
4 weeks
|
|
|
Number of intervention-triggered emails generated to the primary oncology team during study period
大体时间：4 weeks
|
4 weeks
|
|
|
Proportion of intervention-triggered events that are not clinically acted upon (i.e., no change in patient care based on an intervention trigger) during study period
大体时间：4 weeks
|
4 weeks
|
|
|
Acceptability of Remote Electronic Patient Monitoring Intervention
大体时间：4 weeks
|
Participant report of perceptions of the usefulness, effectiveness, and relevance of the intervention per acceptability ratings and qualitative interviews with patient participants and their clinicians.
|
4 weeks
|
|
Patient-Reported Quality of Life
大体时间：2 weeks and 4 weeks
|
Change in patient-reported quality of life from baseline to 2 and 4 weeks per the Functional Assessment of Cancer Therapy-General
|
2 weeks and 4 weeks
|
|
Patient-Reported Symptoms
大体时间：2 weeks and 4 weeks
|
Change in patient-reported symptoms from baseline to 2 and 4 weeks per the Edmonton Symptom Assessment System-revised
|
2 weeks and 4 weeks
|
|
Patient-Reported Depression and Anxiety Symptoms
大体时间：2 weeks and 4 weeks
|
Change in patient-reported depression and anxiety symptoms from baseline to 2 and 4 weeks per the Patient Health Questionnaire-4
|
2 weeks and 4 weeks
|
|
Health Care Utilization
大体时间：4 weeks
|
Number of urgent clinic visits, emergency department visits, and hospital admissions during study period
|
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：Joseph Greer, MD、Massachusetts General Hospital
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9月1日
初级完成 (实际的)
2020年9月9日
研究完成 (实际的)
2020年9月9日
研究注册日期
首次提交
2019年7月22日
首先提交符合 QC 标准的
2019年7月22日
首次发布 (实际的)
2019年7月24日
研究记录更新
最后更新发布 (实际的)
2020年11月13日
上次提交的符合 QC 标准的更新
2020年11月10日
最后验证
2020年11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)？
是的
IPD 计划说明
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials.
De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement.
Requests may be directed to: [contact information for Sponsor Investigator or designee].
The protocol and statistical analysis plan will be made available on Clinicaltrials.gov
only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD 共享时间框架
Data can be shared no earlier than 1 year following the date of publication
IPD 共享访问标准
BCH - Contact the Technology & Innovation Development Office at www.childrensinnovations.org
or email TIDO@childrens.harvard.edu
BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu
BWH - Contact the Partners Innovations team at http://www.partners.org/innovation
DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
MGH - Contact the Partners Innovations team at http://www.partners.org/innovation
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
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
是的
在美国制造并从美国出口的产品
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.