Skip to main content
OpenTrials
Completed

NCT Number: NCT03238729

Proof-of-Concept Study of Heart Habits Application for Patients With Heart Failure

This study assesses the ability of ambulatory patients with heart failure (HF) to use a smartphone application created for the management of patients with chronic HF. This study will aim:

* To understand the frequency with which ambulatory HF patients engage with this smartphone application. * To determine whether patient's knowledge of HF and its management has improved with the use of this smartphone application. * To assess improvement in quality of life measures related to the use of this smartphone application. * To assess improvement in lifestyle measures related to the use of this smartphone application.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of HFrEF or HFpEF. HFrEF defined as clinical signs and symptoms of HF with a left ventricular (LV) EF ≤ 40% by any imaging modality AND at least 1 hospitalization or emergency department (ED) visit for HF or any outpatient escalation of diuretic therapy in the 12 months prior to study enrollment. HFpEF defined as clinical signs and symptoms of HF with an LVEF ≥ 50% by any imaging modality and at least 1 hospitalization or ED visit for HF or any outpatient escalation of diuretic therapy in the 12 months prior to study enrollment.
  • Adult patients, men and women, > 18 years old.

Exclusion criteria

  • Pregnant

Treatment and study plan

Heart Failure Education and Management App

Behavioral

Patients will be provided with an app on a smartphone that provides a daily checklist with items like reminders for logging weight and food, as well as educational components about heart failure and it's management.

Heart Failure Literature

Behavioral

Patients will be provided standard literature about heart failure and the management of heart failure.

Primary outcomes

  1. Number of patients that complete the curriculum

    Time frame: 6 weeks

    Total number of patients who complete the lessons on the app

  2. Frequency of app use

    Time frame: 6 weeks

    Measuring how often and how long patients engaged with the app

Secondary outcomes

  1. Score on Atlanta HF Knowledge Test

    Time frame: 6 weeks

    Assess patients knowledge of heart failure before and after study

  2. Score on Kansas City Cardiomyopathy Questionnaire-12

    Time frame: 6 weeks

    Assess changes in patients self-reported quality of life

  3. %change in weekly activity as measured by steps

    Time frame: 6 weeks

    Assess changes in lifestyle measures (diet, activity, etc.)

  4. Self reported frequency of weight measurement, exercise, fluid tracking, and sodium tracking

    Time frame: 6 weeks

    Compare baseline to end of study on a questionnaire

Sponsors and collaborators

Lead sponsor

Jana Care

Industry

Collaborators

  • Massachusetts General Hospital

Registry information

Official study title

Proof-of-Concept Study of a Smartphone Application Created to Improve Management of Ambulatory Patients With Heart Failure: the Heart Failure Heart Habits Application

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 3, 2017
Registry last updated
May 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.