Clinical trial NCT03238729: Proof-of-Concept Study of Heart Habits Application for Patients With Heart Failure
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Jana Care
Sponsor class: INDUSTRY
Collaborators: name: Massachusetts General Hospital
First posted: 2017-08-03
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of patients that complete the curriculum
timeFrame: 6 weeks
measure: Frequency of app use
timeFrame: 6 weeks
Secondary outcomes:
measure: Score on Atlanta HF Knowledge Test
timeFrame: 6 weeks
measure: Score on Kansas City Cardiomyopathy Questionnaire-12
timeFrame: 6 weeks
measure: %change in weekly activity as measured by steps
timeFrame: 6 weeks
measure: Self reported frequency of weight measurement, exercise, fluid tracking, and sodium tracking
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Hanna K Gaggin, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Nasrien E Ibrahim, MD
role: PRINCIPAL_INVESTIGATOR
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