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

NCT ID: NCT03238729

Last Updated: 2018-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-21
• Study Completion Date: 2018-03-05

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

CHF App

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

Group Type: EXPERIMENTAL

Heart Failure Education and Management App

Intervention Type: BEHAVIORAL

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.

Standard of Care

Patients will be provided standard literature on heart failure management.

Group Type: ACTIVE_COMPARATOR

Heart Failure Literature

Intervention Type: BEHAVIORAL

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

Interventions

Heart 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.

Intervention Type: BEHAVIORAL

Heart Failure Literature

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Jana Care

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hanna K Gaggin, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Nasrien E Ibrahim, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

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Other Identifiers

CHF-MGH-001

Identifier Type: -

Identifier Source: org_study_id