Proof-of-Concept Study of Heart Habits Application for Patients With Heart Failure

Study Overview
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Brief Summary
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This study assesses the ability of ambulatory patients with heart failure (HF) to use a smartphone application created for the management of patients with chronic HF. This study will aim: To understand the frequency with which ambulatory HF patients engage with this smartphone application. To determine whether patient's knowledge of HF and its management has improved with the use of this smartphone application. To assess improvement in quality of life measures related to the use of this smartphone application. To assess improvement in lifestyle measures related to the use of this smartphone application.

Official Title
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Proof-of-Concept Study of a Smartphone Application Created to Improve Management of Ambulatory Patients With Heart Failure: the Heart Failure Heart Habits Application

Conditions
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Heart Failure

Intervention / Treatment
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* Behavioral: Heart Failure Education and Management App
* Behavioral: Heart Failure Literature


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of HFrEF or HFpEF. HFrEF defined as clinical signs and symptoms of HF with a left ventricular (LV) EF ≤ 40% by any imaging modality AND at least 1 hospitalization or emergency department (ED) visit for HF or any outpatient escalation of diuretic therapy in the 12 months prior to study enrollment. HFpEF defined as clinical signs and symptoms of HF with an LVEF ≥ 50% by any imaging modality and at least 1 hospitalization or ED visit for HF or any outpatient escalation of diuretic therapy in the 12 months prior to study enrollment. Adult patients, men and women, > 18 years old. Exclusion Criteria: Pregnant

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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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHF App<br>Patients will be provided with a mobile app on a smartphone for education and management of heart failure. | Behavioral: Heart Failure Education and Management App<br>* Patients will be provided with an app on a smartphone that provides a daily checklist with items like reminders for logging weight and food, as well as educational components about heart failure and it's management.<br>|
| Active Comparator: Standard of Care<br>Patients will be provided standard literature on heart failure management. | Behavioral: Heart Failure Literature<br>* Patients will be provided standard literature about heart failure and the management of heart failure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients that complete the curriculum | Total number of patients who complete the lessons on the app | 6 weeks | 
| Frequency of app use | Measuring how often and how long patients engaged with the app | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on Atlanta HF Knowledge Test | Assess patients knowledge of heart failure before and after study | 6 weeks | 
| Score on Kansas City Cardiomyopathy Questionnaire-12 | Assess changes in patients self-reported quality of life | 6 weeks | 
| %change in weekly activity as measured by steps | Assess changes in lifestyle measures (diet, activity, etc.) | 6 weeks | 
| Self reported frequency of weight measurement, exercise, fluid tracking, and sodium tracking | Compare baseline to end of study on a questionnaire | 6 weeks |