Back to resultse-Diary in Heart Failure
Primary Purpose
Heart Failure
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Movn Mobile App
Sponsored by
About this trial
This is an interventional supportive care trial for Heart Failure
Eligibility Criteria
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)
Sites / Locations
- John Muir Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Usual Care
Movn Mobile App
Arm Description
Participants randomized to the Usual Care arm will receive educational handouts.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Satisfaction with the app
Participation satisfaction with the mobile app will be assessed through individual interviews.
Full Information
NCT ID
NCT03452683
First Posted
February 26, 2018
Last Updated
June 22, 2018
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT03452683
Brief Title
e-Diary in Heart Failure
Official Title
The Use of a Symptom and Weight e-Diary Among Patients With Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Competing trials
Study Start Date
April 2018 (Anticipated)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants randomized to the Usual Care arm will receive educational handouts.
Arm Title
Movn Mobile App
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Movn Mobile App
Intervention Description
Movn is a mobile application that is downloaded to a cell phone where participants can enter their weight and symptoms every day.
Primary Outcome Measure Information:
Title
Change in Health Care Utilization
Description
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 Outcome Measure Information:
Title
Quality of Life
Description
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.
Title
Depression
Description
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.
Title
Satisfaction with the app
Description
Participation satisfaction with the mobile app will be assessed through individual interviews.
Time Frame
Satisfaction with the app will be measured at month 3.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
John Muir Medical Center
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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e-Diary in Heart Failure
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