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Creation of a Digital Heart Failure Registry Using a Novel Mobile Health Platform: HUGO-HF (HUGO-HF)

2020年8月3日 更新者:Yale University
The investigators goal is to create a digital registry that allows for seamless integration of patient reported outcomes, electronic health record data, and pharmacy information into data collection. The investigators will accomplish this using a novel patient centered mobile health platform called Hugo that will allow them to engage patients in an entirely novel manner.

研究概览

地位

完全的

条件

详细说明

Heart failure is the most common cause of mortality and morbidity in the United States and in Western Europe. It is a complex and chronic illness, and patient journeys vary considerably. However, to date, guidance about how to best treat patients has relied on large clinical international trials that do not represent contemporary patients and only include snapshots of the syndrome-at times when the patients interact with the health care system. Additionally, patient participation in clinical research in the US is extremely low, approximated at 3% in cancer and far lower for disease states such as heart failure.

One of the key reasons for this is a lack of patient engagement and trust in the research enterprise, especially among the elderly and minorities, groups that are disproportionally impacted by heart failure. To address this, the investigators plan to test a novel patient-powered, smartphone-based mobile health platform (called Hugo) developed at Yale School of Medicine for real-world surveillance of patient reported outcomes in heart failure patients treated at 3 Major Academic Medical Centers. Participants will then be queried about specific symptoms and health conditions at enrollment and prespecified time points for 2 years. The subgroup of participants who own devices that track their activity data will have the option of syncing them to this mobile health platform to provide additional insights into their health and health outcomes. Additionally, participants will have the option to learn about opportunities to participate in heart failure clinical research. This digital registry will also allow seamless integration of patient reported outcomes, electronic health record (EHR) data, and pharmacy information into data collection.

Overall, the aim for this study is to create a digital registry using a novel patient centered mobile health platform of heart failure patients across large health care systems that allows investigators to engage patients in an entirely novel manner.

研究类型

观察性的

注册 (实际的)

85

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

    • Connecticut
      • New Haven、Connecticut、美国、06510
        • Yale New Haven 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

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

We will aim to recruit patients who are admitted to the hospital with a diagnosis of heart failure at or seen in the heart failure clinic.

描述

Inclusion Criteria:

  • Age> 18 Years
  • English Speaking
  • Diagnosis of heart failure
  • Participant is willing and able to read and sign consent and participate in study
  • Participant has an email account

Exclusion Criteria:

- Unable to participate in registry

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

队列和干预

团体/队列
Heart Failure Patients
All Heart Failure Patients seen at 3 major academic medical centers.

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
Changes in Quality of Life using the KCCQ-12
大体时间:2 Years
Short Version of the KCCQ will be used. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is the most validated instrument to measure quality of life in heart failure.
2 Years

次要结果测量

结果测量
措施说明
大体时间
Hospitalizations
大体时间:2 years
All-cause hospitalizations among patients in registry
2 years
Death
大体时间:2 years
Rates of death among patients in registry
2 years
Medication Usage
大体时间:2 years
Use of guideline directed medical therapies will be done by automatically syncing the patients portal with pharmacy data to provide the most uptodate medication information.
2 years
Activity Details
大体时间:2 years
Activity information based on synced devices
2 years

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。

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 (实际的)

2019年1月15日

初级完成 (实际的)

2019年11月25日

研究完成 (实际的)

2019年12月31日

研究注册日期

首次提交

2019年1月17日

首先提交符合 QC 标准的

2019年1月17日

首次发布 (实际的)

2019年1月22日

研究记录更新

最后更新发布 (实际的)

2020年8月4日

上次提交的符合 QC 标准的更新

2020年8月3日

最后验证

2020年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 2000024317

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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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