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

Sponsor

Jana Care (Industry)

Overall Status

Completed

CT.gov ID

NCT03238729

Collaborator

Massachusetts General Hospital (Other)

Enrollment

Location

Arms

5.4

Actual Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Behavioral: Heart Failure Education and Management App Behavioral: Heart Failure Literature	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official 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

Actual Study Start Date :

Sep 21, 2017

Actual Primary Completion Date :

Mar 5, 2018

Actual Study Completion Date :

Mar 5, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Number of patients that complete the curriculum [6 weeks]
Total number of patients who complete the lessons on the app
Frequency of app use [6 weeks]
Measuring how often and how long patients engaged with the app

Secondary Outcome Measures

Score on Atlanta HF Knowledge Test [6 weeks]
Assess patients knowledge of heart failure before and after study
Score on Kansas City Cardiomyopathy Questionnaire-12 [6 weeks]
Assess changes in patients self-reported quality of life
%change in weekly activity as measured by steps [6 weeks]
Assess changes in lifestyle measures (diet, activity, etc.)
Self reported frequency of weight measurement, exercise, fluid tracking, and sodium tracking [6 weeks]
Compare baseline to end of study on a questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

Jana Care
Massachusetts General Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Jana Care

ClinicalTrials.gov Identifier:

NCT03238729

Other Study ID Numbers:

CHF-MGH-001

First Posted:

Aug 3, 2017

Last Update Posted:

May 9, 2018

Last Verified:

May 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of May 9, 2018