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

Jana Care

Status: Completed

Conditions: Heart Failure

Treatments: Behavioral: Heart Failure Education and Management App; Behavioral: Heart Failure Literature

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03238729

CHF-MGH-001

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

28 participants in 2 patient groups

CHF App

Experimental group

Description:

Patients will be provided with a mobile app on a smartphone for education and management of heart failure.

Treatment:

Behavioral: Heart Failure Education and Management App

Standard of Care

Active Comparator group

Description:

Patients will be provided standard literature on heart failure management.

Treatment:

Behavioral: Heart Failure Literature