CardioBBEAT - Randomized Controled Trial to Evaluate the Health Economic Impact of Remote Patient Monitoring

Chronic Heart Failure Clinical Trial

Official title:

Gesundheitsökonomische Methodenentwicklung am Beispiel Der Evaluation Einer Technologiebasierten, sektorübergreifenden Intervention Zur Versorgung Chronisch Kranker Patienten

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02293252
• Other study ID #: 01KX0805
• Status: Completed
• Phase: N/A
• First received: November 10, 2014
• Last updated: October 24, 2016
• Start date: March 2009
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: University of Bayreuth
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Education and Research
• Study type: Interventional

Clinical Trial Summary

The primary endpoint is the incremental cost effectiveness ratio (ICER), defined as the combined clinical endpoint "days alive and not in hospital nor stationary care per days in study" and the change in total cost compared to that of the control group.

Description:

Between January 2010 and June 2013, 621 patients with left ventricular ejection fraction (LVEF) ≤ 40% were enrolled and randomly assigned to two study arms comprising usual care and a home telemonitoring group. The 302 patients enrolled in the intervention group are supported by an interactive bi-directional home telemonitoring system (Motiva®) that collects and transfers patient's vital sign data to a dedicated telemedicine data centre. All patients were to remain in the study for one year with an examination at the beginning and both, after 6 and 12 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 621
• Est. completion date: October 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of Chronic Heart Failure (CHF) based on European Society of Cardiology (ESC) guidelines

• Symptoms corresponding to New York Heart Association (NYHA) functional class II-IV

• Left Ventricular Ejection Fraction (LVEF) = 40%

• American Heart Association (AHA) classification stage C or D

• Age > 18 years

• Discharged after hospitalisation for worsening Chronic Heart Failure (CHF) within the last twelve months

• Able to understand the German language

• Sufficient eyesight to understand and follow the instructions communicated by the Motiva® platform

• Willing and able to use the required hard- and software and maintain a patient diary

• Residing within geographical reach of one of the ten study sites in order to receive additional treatment if required as well as follow-up consultation

• Willingness to provide informed consent regarding benefits and risks related to the trial, and to sign a participation agreement for the installation of the telemedicine platform Motiva®

Exclusion Criteria:

• Myocardial infarction within the past four weeks

• Heart surgery or any coronary intervention within the past eight weeks

• Cardiogenic shock within the past four weeks

• Intended cardiac surgery within the next six months or priority status on a waiting list for organ transplantation

• Severe chronic and pulmonary illness with an immediate impact on the main outcome measures

• Renal failure requiring dialysis

• Dementia or other severe cognitive impairment

• Psychiatric disorders rendering patients unable to participate in the trial

• Discharged to or living in a geriatric clinic or a nursing home

• Participation in another clinical trial

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Device:
• Remote patient monitoring (Motiva)
interactive bi-directional home telemonitoring system that provides remote monitoring

Locations

Country	Name	City	State
Germany	University of Bayreuth	Bayreuth	Bayern

Sponsors (2)

Lead Sponsor	Collaborator
Eckhard Nagel	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incremental cost effectiveness ratio (ICER)	consisting of the combined clinical endpoint "days alive and not in hospital nor stationary care per days in study" and the change in total cost	1 year	Yes
Secondary	Clinical Outcomes - total mortality	total mortality	1 year	Yes
Secondary	Clinical Outcome - number of inpatient treatment	number of inpatient treatment	1 year	Yes
Secondary	Clinical Outcome - length of stay in hospital or nursing home	length of stay in hospital or nursing home	1 year	Yes
Secondary	Clinical Outcome - functional state of health	functional state of health	1 year	Yes
Secondary	Clinical Outcome - health related quality of life	health related quality of life	1 year	Yes

External Links

•   CardioBBEAT homepage
•   First outline and baseline data of a randomized, controlled multicenter trial to evaluate the health economic impact of home telemonitoring in chronic heart failure - CardioBBEAT