e-Diary in Heart Failure

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03452683
• Other study ID #: e-Diary in Heart Failure
• Status: Withdrawn
• Phase: N/A
• Start date: April 2018
• Est. completion date: December 2018

Study information

• Verified date: June 2018
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
United States	John Muir Medical Center	Concord	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.