- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03810638
Creation of a Digital Heart Failure Registry Using a Novel Mobile Health Platform: HUGO-HF (HUGO-HF)
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Connecticut
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New Haven, Connecticut, 미국, 06510
- Yale New Haven Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Heart Failure Patients
All Heart Failure Patients seen at 3 major academic medical centers.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in Quality of Life using the KCCQ-12
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Hospitalizations
기간: 2 years
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All-cause hospitalizations among patients in registry
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2 years
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Death
기간: 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
기간: 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
기간: 2 years
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Activity information based on synced devices
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2 years
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공동 작업자 및 조사자
스폰서
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .