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

Study Overview
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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.

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.

Official Title
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A Patient-centered Mobile Intervention to Promote Self-management and Improve Patient Outcomes in Chronic Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Behavioral: Mobile Application


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile Application<br>Participants will be using a mobile application, activity monitor and scale. | Behavioral: Mobile Application<br>* Participants will use the mobile application daily to assess heart failure symptoms.<br>|
| No Intervention: Control Group<br>Participants will receive standard of care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minnesota Living with Heart Failure Questionnaire (MLHFQ) | MLHFQ is a quality of life questionnaire for heart failure. | Change from Baseline MLHFQ at Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Care Heart Failure Index (SCHFI) | SCHFI is a survey of heart failure patient self-management. | Change from Baseline SCHFI at Week 12 | 
| Hospitalizations | Admission to the hospital while enrolled in the trial. | Over 12 weeks | 
| Mortality | Death while enrolled in the trial. | Over 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mobile application, mHealth