Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03238729
Enrollment
28
Registered
2017-08-03
Start date
2017-09-21
Completion date
2018-03-05
Last updated
2018-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

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.

Interventions

BEHAVIORALHeart 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.

BEHAVIORALHeart Failure Literature

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

Sponsors

Massachusetts General Hospital
CollaboratorOTHER
Jana Care
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of patients that complete the curriculum6 weeksTotal number of patients who complete the lessons on the app
Frequency of app use6 weeksMeasuring how often and how long patients engaged with the app

Secondary

MeasureTime frameDescription
Score on Atlanta HF Knowledge Test6 weeksAssess patients knowledge of heart failure before and after study
Score on Kansas City Cardiomyopathy Questionnaire-126 weeksAssess changes in patients self-reported quality of life
%change in weekly activity as measured by steps6 weeksAssess changes in lifestyle measures (diet, activity, etc.)
Self reported frequency of weight measurement, exercise, fluid tracking, and sodium tracking6 weeksCompare baseline to end of study on a questionnaire

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026