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

Eckhard Nagel

Status

Completed

Conditions

Chronic Heart Failure

Treatments

Device: Remote patient monitoring (Motiva)

Study type

Interventional

Funder types

Other

Identifiers

NCT02293252

01KX0805

Details and patient eligibility

About

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.

Full 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.

Enrollment

621 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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