Clinical trial NCT02475577: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Keywords: telemedicine
heart failure
home blood pressure monitoring
Lead sponsor: NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH
Sponsor class: OTHER
Collaborators: name: Welch Allyn
First posted: 2015-06-18
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: Number of subjects with unplanned re- hospitalization (heart failure-related and other hospitalization)
timeFrame: 31 days
Secondary outcomes:
measure: Communication with healthcare provider or emergency department
timeFrame: 31 days
measure: Number of non-conformity issues
timeFrame: 31 days
measure: Health-related quality of life Questionnaire
timeFrame: 31 days
measure: Subject satisfaction Questionnaire
timeFrame: 31 days
measure: Physician satisfaction Questionnaire
timeFrame: 31 days
measure: Cost of system and intervention per subjects
timeFrame: 31 days
Other outcomes:
measure: Number and type of incidents
timeFrame: 31 days
measure: Subject attrition
timeFrame: 31 days
Locations:
city: Naples
country: United States
facility: NCH Healthcare System
state: Florida
Study officials:
affiliation: NCH Healthcare System Inc
name: Theresa Morrison, PhD
role: PRINCIPAL_INVESTIGATOR
References: