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

Primary Purpose

Heart Failure

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Heart Failure Education and Management App

Heart Failure Literature

About this trial

This is an interventional other trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CHF App

Standard of Care

Arm Description

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

Patients will be provided standard literature on heart failure management.

Outcomes

Primary Outcome Measures

Number of patients that complete the curriculum

Total number of patients who complete the lessons on the app

Frequency of app use

Measuring how often and how long patients engaged with the app

Secondary Outcome Measures

Score on Atlanta HF Knowledge Test

Assess patients knowledge of heart failure before and after study

Score on Kansas City Cardiomyopathy Questionnaire-12

Assess changes in patients self-reported quality of life

%change in weekly activity as measured by steps

Assess changes in lifestyle measures (diet, activity, etc.)

Self reported frequency of weight measurement, exercise, fluid tracking, and sodium tracking

Compare baseline to end of study on a questionnaire

Full Information

NCT ID

NCT03238729

First Posted

July 28, 2017

Last Updated

May 8, 2018

Sponsor

Jana Care

Collaborators

Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03238729

Brief Title

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

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

September 21, 2017 (Actual)

Primary Completion Date

March 5, 2018 (Actual)

Study Completion Date

March 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jana Care

Collaborators

Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CHF App

Arm Type

Experimental

Arm Description

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

Arm Title

Standard of Care

Arm Type

Active Comparator

Arm Description

Patients will be provided standard literature on heart failure management.

Intervention Type

Behavioral

Intervention Name(s)

Heart Failure Education and Management App

Intervention Description

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

Intervention Name(s)

Heart Failure Literature

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of patients that complete the curriculum

Description

Total number of patients who complete the lessons on the app

Time Frame

6 weeks

Title

Frequency of app use

Description

Measuring how often and how long patients engaged with the app

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Score on Atlanta HF Knowledge Test

Description

Assess patients knowledge of heart failure before and after study

Time Frame

6 weeks

Title

Score on Kansas City Cardiomyopathy Questionnaire-12

Description

Assess changes in patients self-reported quality of life

Time Frame

6 weeks

Title

%change in weekly activity as measured by steps

Description

Assess changes in lifestyle measures (diet, activity, etc.)

Time Frame

6 weeks

Title

Self reported frequency of weight measurement, exercise, fluid tracking, and sodium tracking

Description

Compare baseline to end of study on a questionnaire

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hanna K Gaggin, MD, MPH

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Nasrien E Ibrahim, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24352519

Citation

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Results Reference

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PubMed Identifier

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Citation

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Citation

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Citation

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Citation

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Citation

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Citation

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

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Citation

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derived

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

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