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

Not Applicable

Completed

• Conditions: Heart Failure

• Registration Number: NCT03149510
• Lead Sponsor: University of Michigan

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-03-06
• Study First Submitted: 2017-04-20
• Study First Submitted QC: 2017-05-09
• Study First Posted: 2017-05-11
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-01
• Last Update Posted: 2020-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Minnesota Living with Heart Failure Questionnaire (MLHFQ)	Change from Baseline MLHFQ at Week 12	MLHFQ is a quality of life questionnaire for heart failure.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

University of Michigan Health System; 🇺🇸 Ann Arbor, Michigan, United States