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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,571
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)
Guideline-based care in heart failure including at least 5 scheduled doctor's visits within 12 months (GP and specialist)
Percentage of days lost due to unplanned cardiovascular (CV) hospitalisation or due to death for any reason during the individual patient follow-up time.
The primary outcome analysis will be performed on the FAS using the adjudicated data and sensitivity analyses will be performed on a) the PP data set, and b) on the FAS censoring all data at day 365.
Time frame: 12 months/ individual-patient follow-up time.
All-cause mortality during the individual patient follow-up time.
All-cause and cardiovascular mortality will be calculated as: The individual follow-up time as calculated for the primary outcome + 28 days for all patients to a maximum of 393 days.
Time frame: individual patient follow-up time (+28 days of the final visit to a maximum 393 days)
Percentage of days lost due to unplanned cardiovascular hospitalisations during the individual patient follow-up time.
Time frame: 12 months/ individual follow-up time
Percentage of days lost due to unplanned HF-hospitalisations during the individual patient follow-up time
Time frame: 12 months/ individual follow-up time
Change in MLHFQ-questionnaire overall score between baseline and 365 days
The change in MLHFQ (Minnesota Living with Heart Failure Questionnaire) scores will be analysed using an analysis of covariance and the corresponding estimates with 95% confidence intervals and p-values will be provided.
Time frame: 12 months/ individual follow-up time
Change in levels of NT-proBNP and of MR-proADM between baseline and 365 days.
The change in NT-proBNP and of MR-proADM levels will be analysed using an analysis of covariance and the corresponding estimates with 95% confidence intervals and p-values will be provided
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Gemeinschaftskrankenhaus Havelhöhe Klinik für Anthroposophische Medizin
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Gemeinschaftspraxis am Bayerischen Platz
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...and 99 more locations
Time frame: 12 months/ individual follow-up time