e-Diary in Heart Failure

University of California, San Francisco

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Conditions

Heart Failure

Interventions

Movn Mobile AppBEHAVIORAL

Movn is a mobile application that is downloaded to a cell phone where participants can enter their weight and symptoms every day.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

John Muir Medical Center

Concord, California, United States

Outcomes

Primary Outcomes

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.

Time frame: Health Care Utilization will be measured at two timepoints-- baseline and month 3.

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Satisfaction with the app will be measured at month 3.

Data from ClinicalTrials.gov

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