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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Heart Failure

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Heart Failure Patients<br>All Heart Failure Patients seen at 3 major academic medical centers. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Quality of Life using the KCCQ-12 | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalizations | All-cause hospitalizations among patients in registry | 2 years | 
| Death | Rates of death among patients in registry | 2 years | 
| Medication Usage | 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 | Activity information based on synced devices | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Left Ventricular Assist Device, Heart Failure, Heart Transplant