e-Diary in Heart Failure

Not Applicable

Withdrawn

• Conditions: Heart Failure
• Interventions: Behavioral: Movn Mobile App

• Registration Number: NCT03452683
• Lead Sponsor: University of California, San Francisco

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-02-26
• Study First Submitted QC: 2018-03-01
• Study First Posted: 2018-03-02
• Study Start: 2018-04
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-22
• Last Update Posted: 2018-06-26
• Primary Completion: 2018-10
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Movn Mobile App	Movn Mobile App	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.

Primary Outcome Measures

Name	Time	Method
Change in Health Care Utilization	Health Care Utilization will be measured at two timepoints-- baseline and month 3.	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.

Secondary Outcome Measures

Name	Time	Method
Quality of Life	Quality of life will be measured at two timepoints-- baseline and month 3.	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.
Depression	Depression will be measured at baseline and month 3.	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.
Satisfaction with the app	Satisfaction with the app will be measured at month 3.	Participation satisfaction with the mobile app will be assessed through individual interviews.

Trial Locations

Locations (1)

John Muir Medical Center; 🇺🇸 Concord, California, United States