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

May 8, 2018 updated by: Jana Care

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CHF App
Patients will be provided with a mobile app on a smartphone for education and management of heart failure.
Behavioral: Heart Failure Education and Management App
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.
Active Comparator: Standard of Care
Patients will be provided standard literature on heart failure management.
Behavioral: Heart Failure Literature
Patients will be provided standard literature about heart failure and the management of heart failure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients that complete the curriculum
Time Frame: 6 weeks
Total number of patients who complete the lessons on the app
6 weeks
Frequency of app use
Time Frame: 6 weeks
Measuring how often and how long patients engaged with the app
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score on Atlanta HF Knowledge Test
Time Frame: 6 weeks
Assess patients knowledge of heart failure before and after study
6 weeks
Score on Kansas City Cardiomyopathy Questionnaire-12
Time Frame: 6 weeks
Assess changes in patients self-reported quality of life
6 weeks
%change in weekly activity as measured by steps
Time Frame: 6 weeks
Assess changes in lifestyle measures (diet, activity, etc.)
6 weeks
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
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jana Care

Collaborators

Massachusetts General Hospital

Investigators

  • Principal Investigator: Hanna K Gaggin, MD, MPH, Massachusetts General Hospital
  • Principal Investigator: Nasrien E Ibrahim, MD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2017

Primary Completion (Actual)

March 5, 2018

Study Completion (Actual)

March 5, 2018

Study Registration Dates

First Submitted

July 28, 2017

First Submitted That Met QC Criteria

July 31, 2017

First Posted (Actual)

August 3, 2017

Study Record Updates

Last Update Posted (Actual)

May 9, 2018

Last Update Submitted That Met QC Criteria

May 8, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHF-MGH-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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