e-Diary in Heart Failure

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy and feasibility of using a smartphone application to monitor symptoms and weight in patients with advanced heart failure.

Detailed Description
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Attention to symptoms of heart failure and weight gain are central tenets in heart failure patient education and self-care. A key self-care skill for heart failure patients is the early detection of subtle changes in symptoms. Daily diary use can be one method for patients to acknowledge and attend to their symptoms. This study is examining if the use of a diary in the form of an app on a mobile phone will improve patient outcomes. Participants will be randomized to one of two groups-- usual care or the Movn mobile application. Participants randomized to the mobile app will be asked to record their weight and any symptoms every day over the course of two months.

Official Title
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The Use of a Symptom and Weight e-Diary Among Patients With Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Behavioral: Movn Mobile App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years old History of symptomatic heart failure (Class III or IV) Owns a smartphone or tablet compatible with the Movn mobile application Exclusion Criteria: Cognitive impairment Lack of English proficiency/literacy Clinically unstable (decompensated heart failure NYHA class 3-4; unstable arrhythmias, aortic stenosis, thrombophlebitis, dissecting aneurysm, or symptomatic anemia; active infection; uncontrolled blood pressure: resting diastolic higher than 100 mmHg, systolic greater than 180 mmHg; unstable angina, 2nd or 3rd degree heart block; or uncontrolled high grade exercise-induced ventricular ectopy or hemodynamically unstable)

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>Participants randomized to the Usual Care arm will receive educational handouts. | |
| Experimental: Movn Mobile App<br>Participants randomized to the Movn Mobile App arm will have the Movn app downloaded to their cell phone. Participants will enter in their weight and symptoms into the app every day. | Behavioral: Movn Mobile App<br>* Movn is a mobile application that is downloaded to a cell phone where participants can enter their weight and symptoms every day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Health Care Utilization | Health Care Utilization will be measured by a questionnaire that asks about number of office visits, emergency room visits, and hospitalization in the last 60 days. | Health Care Utilization will be measured at two timepoints-- baseline and month 3. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | Quality of life will be measured by the 20-item Short Form Survey (SF-20). Scores range from 0 to 100 with high values indicating higher functioning. | Quality of life will be measured at two timepoints-- baseline and month 3. | 
| Depression | Depression will be measured by the Patient Health Questionnaire (PHQ-9). Scores can range from 5 to greater than 20 with 5 indicating minimal symptoms and 20 indicating severe major depression. | Depression will be measured at baseline and month 3. | 
| Satisfaction with the app | Participation satisfaction with the mobile app will be assessed through individual interviews. | Satisfaction with the app will be measured at month 3. |