Mobile Health Monitoring Solution for Heart Failure Patients

NCT02594007 | Completed

• 1 other identifier: 774885-1
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure

Keywords

telehealth; heart failure

Outcome Measures

Primary Outcomes (1)

• Hospital readmission or Emergency Room visit

  within 30 days of hospital discharge

Secondary Outcomes (1)

• Clinical interventions initiated by data collected from Cardiocom, SEEQ, and/or Docview

  Within 30 days of hospital discharge

Study Arms (2)

discharge home

EXPERIMENTAL

SEEQ for 28 days. Cardiocom for 30 days

Device: SEEQ; Device: Cardiocom

discharge to skilled nursing facility

EXPERIMENTAL

SEEQ for 28 days, DocView for 30 days

Device: SEEQ; Device: DocView

Interventions

SEEQ DEVICE

Mobile cardiac telemetry system worn externally for a total of 28 days.

discharge home; discharge to skilled nursing facility

Cardiocom DEVICE

Patient-based interface tool that includes a blood pressure cuff and blue-tooth enabled scale for daily recordings. The patient will also answer a series of behavioral and symptomatic questions daily through 30 days.

discharge home

DocView DEVICE

Patient-based interface tool that analyzes state of wellness. The patient will answer a series of questions daily through day 30.

discharge to skilled nursing facility

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Atlantic Health System: lead

Study Sites (1)

Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

Related Links

• HFSA 2010 Comprehensive Heart Failure Practice Guideline

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Nancy Bonnet, APNc MSN RN

  Morristown Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2015
• First Posted: November 2, 2015
• Study Start: November 1, 2015
• Primary Completion: December 31, 2016
• Study Completion: January 1, 2017
• Last Updated: July 6, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)