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

J

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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