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Determine Return on Investment in Heart Failure Remote Monitoring Program

Primary Purpose

Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peripherals with HealthInterlink technology
Sponsored by
NCH Heatlhcare System Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Failure focused on measuring telemedicine, heart failure, home blood pressure monitoring

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • NCH Healthcare SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Control

Intervention 1

Intervention 2

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Number of subjects with unplanned re- hospitalization (heart failure-related and other hospitalization)
31 days post discharge with a heart failure-related hospital re-hospitalization.

Secondary Outcome Measures

Communication with healthcare provider or emergency department
Communication that resulted in unplanned healthcare provider office visits or visit to emergency department
Number of non-conformity issues
Number of non-conformity telephone reminder texts, emails, and/or calls.
Health-related quality of life Questionnaire
Health-related quality of life
Subject satisfaction Questionnaire
Subject satisfaction for peripherals and HealthInterlink tablet/ smartphone judged to be reliable and robust, ease of use, time to complete testing and questionnaire, benefit that promoted better health
Physician satisfaction Questionnaire
Physician satisfaction for peripherals and HealthInterlink tablet/ smartphone judged to be reliable and robust, ease of use of software, benefit that promoted better communication with subject.
Cost of system and intervention per subjects
Economic viability of remote monitoring program based on daily cost of system and intervention per subjects in comparison with control and treatment groups.

Full Information

First Posted
June 12, 2015
Last Updated
March 29, 2016
Sponsor
NCH Heatlhcare System Inc
Collaborators
Welch Allyn
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1. Study Identification

Unique Protocol Identification Number
NCT02475577
Brief Title
Determine Return on Investment in Heart Failure Remote Monitoring Program
Official Title
A Prospective Randomized Controlled Trial to Determine Return on Investment in a Tablet/Smartphone-based Heart Failure Remote Monitoring Program
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NCH Heatlhcare System Inc
Collaborators
Welch Allyn

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
The objective of this remote monitoring study is to evaluate return on investment and end-user clinical outcomes associated with the use of self-monitoring peripherals and tablet/smartphone-based Welch Allyn HealthInterlink technology without intervention (Control), HealthInterlink remote monitoring with text and email alerts sent to study subject and optional family/other caregiver (Intervention 1), and HealthInterlink remote monitoring with nurse research assistant follow-up telephone communication to study subject (on Blue alerts) or study subject's healthcare professional (on Red alerts) (Intervention 2 added to Intervention 1).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
telemedicine, heart failure, home blood pressure monitoring

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
163 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Experimental
Arm Description
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.
Arm Title
Intervention 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Intervention 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Peripherals with HealthInterlink technology
Other Intervention Name(s)
Welch Allyn, Blood Pressure monitor, Weight Scale, Pulse Oximeter, tablet/smartphone-based technology
Intervention Description
home remote monitoring
Primary Outcome Measure Information:
Title
Number of subjects with unplanned re- hospitalization (heart failure-related and other hospitalization)
Description
31 days post discharge with a heart failure-related hospital re-hospitalization.
Time Frame
31 days
Secondary Outcome Measure Information:
Title
Communication with healthcare provider or emergency department
Description
Communication that resulted in unplanned healthcare provider office visits or visit to emergency department
Time Frame
31 days
Title
Number of non-conformity issues
Description
Number of non-conformity telephone reminder texts, emails, and/or calls.
Time Frame
31 days
Title
Health-related quality of life Questionnaire
Description
Health-related quality of life
Time Frame
31 days
Title
Subject satisfaction Questionnaire
Description
Subject satisfaction for peripherals and HealthInterlink tablet/ smartphone judged to be reliable and robust, ease of use, time to complete testing and questionnaire, benefit that promoted better health
Time Frame
31 days
Title
Physician satisfaction Questionnaire
Description
Physician satisfaction for peripherals and HealthInterlink tablet/ smartphone judged to be reliable and robust, ease of use of software, benefit that promoted better communication with subject.
Time Frame
31 days
Title
Cost of system and intervention per subjects
Description
Economic viability of remote monitoring program based on daily cost of system and intervention per subjects in comparison with control and treatment groups.
Time Frame
31 days
Other Pre-specified Outcome Measures:
Title
Number and type of incidents
Description
Number and type of incident based on predefined criteria from the remote monitoring data (clinical signs and symptoms related to worsening of cardiac insufficiency or to its complications).
Time Frame
31 days
Title
Subject attrition
Description
Rate of subjects discontinuing the study due to Patient Request, Patient Complaint, Patient Transferred to higher level of care (ACLF, SNF), Patient Hospitalized, Physician Request Monitoring No Longer Needed (Resolution of Disease Process, Change in Treatment), Physician Complaint, Patient Expired, Patient all-cause mortality or Without other identifiable cause.
Time Frame
31 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Theresa Morrison, PhD
Phone
239-624-4384
Email
theresa.morrison@nchmd.org
First Name & Middle Initial & Last Name or Official Title & Degree
Laurie Zone-Smith, PhD
Phone
239-624-4986
Email
laurie.zonesmith@nchmd.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa Morrison, PhD
Organizational Affiliation
NCH Healthcare System Inc
Official's Role
Principal Investigator
Facility Information:
Facility Name
NCH Healthcare System
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Theresa L Morrison, PhD
Phone
239-624-4384
Email
theresa.morrison@nchmd.org
First Name & Middle Initial & Last Name & Degree
Laurie Zone-Smith, PhD
Phone
239-624-4986
Email
laurie.zonesmith@nchmd.org

12. IPD Sharing Statement

Links:
URL
http://nchmd.org
Description
Healthcare system web site

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Determine Return on Investment in Heart Failure Remote Monitoring Program

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