The Effects of Self-monitoring With a Mobile Application in Heart Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-06

Study Completion Date

2019-04-30

Brief Summary

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In the United States, about 40 percent of heart failure (HF) patients are readmitted within 1-year following their first admission for HF and hospitalization accounts for approximately 70 percent of the costs of HF management. As a result, the management of HF patients is evolving from the traditional model of face-to-face follow-up visits toward a proactive real-time technological model of assisting patients with monitoring and self-management while in the community. The investigators plan to test the impact of a mobile application on clinical outcomes in HF.

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Detailed Description

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HF patients with a reduced ejection fraction will be randomized to the mobile application versus placebo for 12 weeks. The mobile application will provide the participants with a reminder to perform self-monitoring, a health status indicator and heart failure education for self-management.

All participants will complete the Minnesota Living with Heart Failure Questionnaire and Self-Care Heart Failure Index. Hospital admissions and mortality will also be collected.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Mobile Application

Participants will be using a mobile application, activity monitor and scale.

Group Type EXPERIMENTAL

Mobile Application

Intervention Type BEHAVIORAL

Participants will use the mobile application daily to assess heart failure symptoms.

Control Group

Participants will receive standard of care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mobile Application

Participants will use the mobile application daily to assess heart failure symptoms.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 45 years old or older
* Left ventricular ejection fraction \</= 40% or an LVEF \> 40% (with left atrial size \>40mm or BNP \> 200 pg/ml or NT-proBNP \> 800 pg/ml)
* Admitted for acutely decompensated heart failure or recently discharged in the past 4 weeks.
* Smartphone (iOS or Android) with home wifi

Exclusion Criteria

* Unstable coronary syndrome within 8 weeks (unstable angina, NSTEMI, STEMI)
* Primary valvular heart disease
* Known pericardial disease (Sarcoidosis, amyloidosis, rheumatoid arthritis, lupus)
* Uncorrected thyroid disease
* Advanced renal disease (dialysis or creatinine \>4.0 mg/dL)
* End-stage HF (hospice candidate, home milrinone or dobutamine)
* Active cancer
* Pulmonary fibrosis
* Discharge to a setting other than home

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No