NCT01878630

Telemedical Interventional Management in Heart Failure II

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,571 (actual)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Superiority of additional Remote Patient Management (RPM) in patients with chronic heart failure (CHF) in comparison to usual care in terms of, e.g.: * days lost due to unplanned cardiovascular hospitalization or death * all-cause mortality * cardiovascular mortality * quality of life

Detailed description

The clinical trial assesses 1,500 patients over a period of 12 months each (2013 until 2015). All participants will continue to receive usual care from their general practitioner and specialist. All patients will be examined at the beginning of the study and will undergo a check-up every 3 months. 750 of the patients will be randomly allocated to receive devices for Remote Patient Management (RPM) which will measure various parameters on a daily basis (e.g. weight, blood pressure, heart rate). The devices are mobile and can be used at home or elsewhere.

Conditions

• Chronic Heart Failure

Interventions

Type	Name	Description
DEVICE	Remote Patient Management	Guideline-based care in heart failure including at least 5 scheduled doctor's visits within 12 months (GP and specialist) plus devices for Remote Patient Management at patient site for daily monitoring of ECG, weight, blood pressure, self-report of health status: * weighing scale (Seca 861 with bluetooth, seca gmbh \& co. kg.) * blood pressure device (UA767PBT with bluetooth, A\&D Ltd.) * ECG-eventrecorder (PhysioMem® PM 1000, getemed Medizin- und Informationstechnik AG) * patient-communication platform (Physio-Gate® PG 1000, getemed Medizin- und Informationstechnik AG) * help call device (DORO Easy 510/ Doro HandlePlus 334gsm, doro AB) at center site: \- electronic patient record (eHealth connect 2.0, T-Systems International)
OTHER	Usual Care	Guideline-based care in heart failure including at least 5 scheduled doctor's visits within 12 months (GP and specialist)

Timeline

• Start date: 2013-08-08
• Primary completion: 2017-05-12
• Completion: 2018-05-17
• First posted: 2013-06-17
• Last updated: 2018-08-03

Locations

109 sites across 1 country: Germany