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

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Behavioral: Heart Failure Literature; Behavioral: Heart Failure Education and Management App

• Registration Number: NCT03238729
• Lead Sponsor: Jana Care

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-28
• Study First Submitted QC: 2017-07-31
• Study First Posted: 2017-08-03
• Study Start: 2017-09-21
• Primary Completion: 2018-03-05
• Study Completion: 2018-03-05
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-08
• Last Update Posted: 2018-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Heart Failure Literature	Patients will be provided standard literature on heart failure management.
CHF App	Heart Failure Education and Management App	Patients will be provided with a mobile app on a smartphone for education and management of heart failure.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States