Creation of a Digital Heart Failure Registry Using a Novel Mobile Health Platform: HUGO-HF
- Conditions
- Heart Failure
- Registration Number
- NCT03810638
- Lead Sponsor
- Yale University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 85
- 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
- Unable to participate in registry
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in Quality of Life using the KCCQ-12 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.
- Secondary Outcome Measures
Name Time Method Medication Usage 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.
Activity Details 2 years Activity information based on synced devices
Hospitalizations 2 years All-cause hospitalizations among patients in registry
Death 2 years Rates of death among patients in registry
Trial Locations
- Locations (1)
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States