Determine Return on Investment in Heart Failure Remote Monitoring Program
A Prospective Randomized Controlled Trial to Determine Return on Investment in a Tablet/Smartphone-based Heart Failure Remote Monitoring Program
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Theresa Morrison, PhD
- Phone Number: 239-624-4384
- Email: theresa.morrison@nchmd.org
Study Contact Backup
- Name: Laurie Zone-Smith, PhD
- Phone Number: 239-624-4986
- Email: laurie.zonesmith@nchmd.org
Study Locations
-
-
Florida
-
Naples, Florida, United States, 34102
- Recruiting
- NCH Healthcare System
-
Contact:
- Laurie Zone-Smith, PhD
- Phone Number: 239-624-4986
- Email: laurie.zonesmith@nchmd.org
-
Contact:
- Theresa L Morrison, PhD
- Phone Number: 239-624-4384
- Email: theresa.morrison@nchmd.org
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
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.
|
home remote monitoring
Other Names:
|
|
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.
|
home remote monitoring
Other Names:
|
|
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.
|
home remote monitoring
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of subjects with unplanned re- hospitalization (heart failure-related and other hospitalization)
Time Frame: 31 days
|
31 days post discharge with a heart failure-related hospital re-hospitalization.
|
31 days
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Communication with healthcare provider or emergency department
Time Frame: 31 days
|
Communication that resulted in unplanned healthcare provider office visits or visit to emergency department
|
31 days
|
|
Number of non-conformity issues
Time Frame: 31 days
|
Number of non-conformity telephone reminder texts, emails, and/or calls.
|
31 days
|
|
Health-related quality of life Questionnaire
Time Frame: 31 days
|
Health-related quality of life
|
31 days
|
|
Subject satisfaction Questionnaire
Time Frame: 31 days
|
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
|
31 days
|
|
Physician satisfaction Questionnaire
Time Frame: 31 days
|
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.
|
31 days
|
|
Cost of system and intervention per subjects
Time Frame: 31 days
|
Economic viability of remote monitoring program based on daily cost of system and intervention per subjects in comparison with control and treatment groups.
|
31 days
|
Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number and type of incidents
Time Frame: 31 days
|
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).
|
31 days
|
|
Subject attrition
Time Frame: 31 days
|
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.
|
31 days
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Theresa Morrison, PhD, NCH Healthcare System Inc
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (Anticipated)
Primary Completion
Study Completion (Anticipated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Estimate)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 15-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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