Creation of a Digital Heart Failure Registry Using a Novel Mobile Health Platform: HUGO-HF (HUGO-HF)
研究概览
地位
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
注册 (实际的)
联系人和位置
学习地点
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Connecticut
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New Haven、Connecticut、美国、06510
- Yale New Haven Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
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
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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Heart Failure Patients
All Heart Failure Patients seen at 3 major academic medical centers.
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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 |
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Changes in Quality of Life using the KCCQ-12
大体时间:2 Years
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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.
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2 Years
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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
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All-cause hospitalizations among patients in registry
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2 years
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Death
大体时间:2 years
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Rates of death among patients in registry
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2 years
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Medication Usage
大体时间:2 years
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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.
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2 years
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Activity Details
大体时间:2 years
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Activity information based on synced devices
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2 years
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合作者和调查者
出版物和有用的链接
一般刊物
- Ahmad T, Freeman JV, Asselbergs FW. Can advanced analytics fix modern medicine's problem of uncertainty, imprecision, and inaccuracy? Eur J Heart Fail. 2019 Jan;21(1):86-89. doi: 10.1002/ejhf.1370. Epub 2018 Dec 10. No abstract available.
- Krumholz HM. Big data and new knowledge in medicine: the thinking, training, and tools needed for a learning health system. Health Aff (Millwood). 2014 Jul;33(7):1163-70. doi: 10.1377/hlthaff.2014.0053.
- Bhavnani SP, Parakh K, Atreja A, Druz R, Graham GN, Hayek SS, Krumholz HM, Maddox TM, Majmudar MD, Rumsfeld JS, Shah BR. 2017 Roadmap for Innovation-ACC Health Policy Statement on Healthcare Transformation in the Era of Digital Health, Big Data, and Precision Health: A Report of the American College of Cardiology Task Force on Health Policy Statements and Systems of Care. J Am Coll Cardiol. 2017 Nov 28;70(21):2696-2718. doi: 10.1016/j.jacc.2017.10.018. No abstract available.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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