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

University of Michigan

Status: Completed

Conditions: Heart Failure

Treatments: Behavioral: Mobile Application

Study type: Interventional

Funder types: Other

Identifiers

NCT03149510

HUM00123222

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 83 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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83 participants in 2 patient groups

Mobile Application

Experimental group

Description:

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

Treatment:

Behavioral: Mobile Application

Control Group

No Intervention group

Description:

Participants will receive standard of care.