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e-Diary in Heart Failure

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03452683
Enrollment
0
Registered
2018-03-02
Start date
2018-04-30
Completion date
2018-12-31
Last updated
2018-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

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.

Interventions

BEHAVIORALMovn Mobile App

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

Sponsors

University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in Health Care UtilizationHealth 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

MeasureTime frameDescription
Quality of LifeQuality 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.
DepressionDepression 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 appSatisfaction with the app will be measured at month 3.Participation satisfaction with the mobile app will be assessed through individual interviews.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026