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Clinical Trials/NCT03452683
NCT03452683
Withdrawn
Not Applicable

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

University of California, San Francisco1 site in 1 countryApril 2018
ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
University of California, San Francisco
Locations
1
Primary Endpoint
Change in Health Care Utilization
Status
Withdrawn
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2018
End Date
December 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Linda Park

Assistant Professor

University of California, San Francisco

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)

Outcomes

Primary Outcomes

Change in Health Care Utilization

Time Frame: 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 Outcomes

  • 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 Sites (1)

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