e-Diary in Heart Failure

NCT ID: NCT03452683

Last Updated: 2018-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-30

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Usual Care

Participants randomized to the Usual Care arm will receive educational handouts.

Group Type NO_INTERVENTION

No interventions assigned to this group

Movn Mobile App

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.

Group Type EXPERIMENTAL

Movn Mobile App

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Linda Park

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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John Muir Medical Center

Concord, California, United States

Site Status

Countries

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United States

Other Identifiers

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e-Diary in Heart Failure

Identifier Type: -

Identifier Source: org_study_id

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