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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
621
interactive bi-directional home telemonitoring system that provides remote monitoring
University of Bayreuth
Bayreuth, Bavaria, Germany
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
Time frame: 1 year
Clinical Outcomes - total mortality
total mortality
Time frame: 1 year
Clinical Outcome - number of inpatient treatment
number of inpatient treatment
Time frame: 1 year
Clinical Outcome - length of stay in hospital or nursing home
length of stay in hospital or nursing home
Time frame: 1 year
Clinical Outcome - functional state of health
functional state of health
Time frame: 1 year
Clinical Outcome - health related quality of life
health related quality of life
Time frame: 1 year
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