Determine Return on Investment in Heart Failure Remote Monitoring Program
NCT ID: NCT02475577
Last Updated: 2016-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
163 participants
INTERVENTIONAL
2015-06-30
2017-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Control
Control: Peripherals with HealthInterlink technology will record and transmit data, without intervention. Subject is able to view graphed data, bring the HealthInterlink tablet/smartphone to the physician's office and share data with family/other caregiver.
Peripherals with HealthInterlink technology
home remote monitoring
Intervention 1
Intervention 1: Peripherals with HealthInterlink technology will record and transmit data and send out-of-range data (Red) alerts to subject via HealthInterlink tablet/smartphone and also text/email to family/other caregiver, and nonconformity (Blue) alerts to subject's personal text/email and also text/email to family/other caregiver.
Peripherals with HealthInterlink technology
home remote monitoring
Intervention 2
Intervention 2: Peripherals with HealthInterlink technology will record and transmit data and send out-of-range data (Red) alerts to subject via HealthInterlink tablet/smartphone and also text/email to family/other caregiver, and nonconformity (Blue) alerts to subject's personal text/email and also text/email to family/other caregiver, and a call will be placed by the nurse research assistant to study subject (on Blue alerts) or study subject's healthcare professional (on Red alerts). The physicians will have access to the subject's data on a web-based program.
Peripherals with HealthInterlink technology
home remote monitoring
Interventions
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Peripherals with HealthInterlink technology
home remote monitoring
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* English speaking;
* Capable and willing to give informed consent;
* Participated in the in-patient heart failure class within the last three months. Acceptable candidate for elective, non-emergent, remote monitoring as determined by ordering physician;
* Living in a private home;
* Hospital admission for Heart Failure or decompensation in the previous 12 months
* New York Heart Association (NYHA) classes II-IV, as assigned by the nurse researcher, trained by a cardiologist
* Cardiac aetiology: ischaemic, idiopathic, hypertensive, or valvular
* Left ventricular ejection fraction \<40% s an index of systolic dysfunction, combined or not with a left ventricular filling pattern supporting the presence of diastolic dysfunction, according to the American College of Cardiology/American Heart Association Guidelines for chronic heart failure.
or
* NYHA class II-III who had an ejection fraction \>40% and evidence of diastolic left ventricular dysfunction.
* Optional subject with a diagnosis of diabetes (indicated by HbA1c \>7).
Exclusion Criteria
* Females who are pregnant, planning to become pregnant within 3 months, or lactating;
* Requirement for emergent placement other than private home (subject's condition would be compromised if there is a delay in placement).
* Myocardial infarction, revascularization or Implantable Cardioverter Defibrillator (ICD) implantation in the previous 6 months angina or objective myocardial ischaemia requiring future revascularization implanted ventricular or atrial pacemaker (except dual chamber ICD pacemakers with good sinus activity);
* End-stage heart failure requiring regular inotropic drug infusions;
* Chronic renal failure requiring dialysis treatment and
* Unstable angina.
18 Years
89 Years
ALL
No
Sponsors
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Welch Allyn
INDUSTRY
NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH
OTHER
Responsible Party
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Principal Investigators
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Theresa Morrison, PhD
Role: PRINCIPAL_INVESTIGATOR
NCH Healthcare System Inc
Locations
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NCH Healthcare System
Naples, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Theresa L Morrison, PhD
Role: primary
Laurie Zone-Smith, PhD
Role: backup
Related Links
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Healthcare system web site
Other Identifiers
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15-001
Identifier Type: -
Identifier Source: org_study_id