Mobile Health Monitoring Solution for Heart Failure Patients

Completed · Not applicable

Conditions studied: Heart Failure

In brief

Heart Failure (HF) affects 5.7 million Americans and is the only major cardiovascular disorder on the rise. The primary aim of this study is to formally study the combined effects of several different tele-health modalities, all currently approved and available for general use, to determine if such combinations will result in an increase in early intervention and a resultant decrease in acute cardiac decompensation requiring a hospitalization or Emergency Room (ER) visit. This study will attempt to characterize the frequency of health care interventions attributable to the use of these technologies, and any relationship between these interventions and the frequency of hospitalization or ER visits. Secondary objectives include characterization of healthcare utilization, healthcare costs, and patient experiences with regard to the use the provided technologies.

Key facts

Study ID

NCT02594007

Run by

Atlantic Health System

People needed

31

Starts

2015-11-01

Expected to finish

2017-01-01

Last updated by the study team

2017-07-06

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Admitted patients to Morristown Medical Center located on Gagnon 1 Heart Failure (HF) dedicated unit with an anticipated Discharge DRG of HF
• Subjects with acute decompensated HF
• Subject > 55 years of age
• Subject meets the indications for the use of the external patch
• Subject is able and willing to provide informed consent

You may not qualify if…

• Subjects with an implantable cardiac device or scheduled to receive a cardiac device within 30 days of enrollment
• Skilled Nursing Facility (SNF) bound patients who are unwilling/unable to receive care at CareOne Madison
• Subject with a scheduled readmission within 30 days of discharge
• Subjects weighing > 500 lbs
• Subjects with potentially life-threatening arrhythmias, or who require inpatient/hospital monitoring
• Subject who is expected to receive a heart transplant or a ventricular assist device within 6 months of enrollment
• Subject with known allergies or hypersensitivities to adhesives or hydrogels
• Subject who cannot tolerate placement of external patch monitor on chest in the proposed location (electrocardiogram lead II orientation)
• Subject who will not comply with project protocol requirements (i.e. Docview/Cardiocom engagement). This includes completing required data collection, and attending required follow up visits
• Prior enrollment in this study
• Subjects who are pregnant
• Subjects who are non-English speaking.

Where it is running

• Morristown Medical Center — Morristown, New Jersey, United States

Full record on ClinicalTrials.gov

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