NCT02293252

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 621 (actual)
• Sponsor: Eckhard Nagel · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Chronic Heart Failure

Interventions

Type	Name	Description
DEVICE	Remote patient monitoring (Motiva)	interactive bi-directional home telemonitoring system that provides remote monitoring

Timeline

• Start date: 2009-03-01
• Primary completion: 2016-03-01
• Completion: 2016-10-01
• First posted: 2014-11-18
• Last updated: 2016-10-25

Locations

1 site across 1 country: Germany