Recruiting

Remote Monitoring

Sponsor:

NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH

Code:

NCT02475577

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Peripherals with HealthInterlink technology

Study Details

Brief summary:

The study will test a hypothesis that the remote monitoring with text and email alerts sent to study subject and optional family/other caregiver (Intervention 1) will have a higher return on investment compared to remote monitoring with nurse researcher follow-up telephone communication to study subject (on Blue alerts) or study subject's healthcare professional (on Red alerts) (Intervention 2) and self-monitoring without intervention (Control).

Conditions

Heart Failure

Study ID

NCT02475577

Start date

Jun, 2015

Status verified date

Mar, 2016

Completion date

Aug, 2017

Anticipated

Primary completion date

Jun, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Absence of significant vision, hearing, or other communication deficits
  • 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:

  • Currently involved in other investigational clinical trials (unless permission is granted by other study PI);
  • 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.

Study Design

Enrollment

163 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

experimental: 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.

Interventions

Peripherals with HealthInterlink technology

home remote monitoring

Primary outcome measure

  • Number of subjects with unplanned re- hospitalization (heart failure-related and other hospitalization) [ Time Frame: 31 days ]

Central Contacts and Locations

Central contacts

Theresa Morrison, PhD

239-624-4384theresa.morrison@nchmd.org

Laurie Zone-Smith, PhD

239-624-4986laurie.zonesmith@nchmd.org

Locations

NCH Healthcare System

Recruiting

Naples, Florida, United States, 34102

Contacts

Theresa L Morrison, PhD

239-624-4384theresa.morrison@nchmd.org

Laurie Zone-Smith, PhD

239-624-4986laurie.zonesmith@nchmd.org

More Information

Sponsor

NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH

Last update posted

Mar 31, 2016

Last verified

Mar, 2016

Keywords

  • telemedicine
  • heart failure
  • home blood pressure monitoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH on 2016-03-31.