Study Stopped
Competing trials
e-Diary in Heart Failure
The Use of a Symptom and Weight e-Diary Among Patients With Heart Failure
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2018
Shorter than P25 for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2018
CompletedFirst Posted
Study publicly available on registry
March 2, 2018
CompletedStudy Start
First participant enrolled
April 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedJune 26, 2018
June 1, 2018
6 months
February 26, 2018
June 22, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Quality of Life
Quality of life will be measured at two timepoints-- baseline and month 3.
Depression
Depression will be measured at baseline and month 3.
Satisfaction with the app
Satisfaction with the app will be measured at month 3.
Study Arms (2)
Usual Care
NO INTERVENTIONParticipants randomized to the Usual Care arm will receive educational handouts.
Movn Mobile App
EXPERIMENTALParticipants 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.
Interventions
Movn is a mobile application that is downloaded to a cell phone where participants can enter their weight and symptoms every day.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
John Muir Medical Center
Concord, California, 94520, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 26, 2018
First Posted
March 2, 2018
Study Start
April 1, 2018
Primary Completion
October 1, 2018
Study Completion
December 1, 2018
Last Updated
June 26, 2018
Record last verified: 2018-06