Determine Return on Investment in Heart Failure Remote Monitoring Program

Heart Failure Clinical Trial

Official title:

A Prospective Randomized Controlled Trial to Determine Return on Investment in a Tablet/Smartphone-based Heart Failure Remote Monitoring Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02475577
• Other study ID #: 15-001
• Status: Recruiting
• Phase: N/A
• First received: June 12, 2015
• Last updated: June 17, 2015
• Start date: June 2015
• Est. completion date: August 2016

Study information

• Verified date: June 2015
• Source: NCH Heatlhcare System Inc
• Contact: Theresa Morrison, PhD
• Phone: 239-624-4384
• Email: theresa.morrison[@]nchmd.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 163
• Est. completion date: August 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Peripherals with HealthInterlink technology
home remote monitoring

Locations

Country	Name	City	State
United States	NCH Healthcare System	Naples	Florida

Sponsors (2)

Lead Sponsor	Collaborator
NCH Heatlhcare System Inc	Welch Allyn

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number and type of incidents	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	No
Other	Subject attrition	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	No
Primary	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.	31 days	No
Secondary	Communication with healthcare provider or emergency department	Communication that resulted in unplanned healthcare provider office visits or visit to emergency department	31 days	No
Secondary	Number of non-conformity issues	Number of non-conformity telephone reminder texts, emails, and/or calls.	31 days	No
Secondary	Health-related quality of life Questionnaire	Health-related quality of life	31 days	No
Secondary	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	31 days	No
Secondary	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.	31 days	No
Secondary	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.	31 days	No

External Links

•   Healthcare system web site