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Telemedical Interventional Management in Heart Failure II

NCT01878630 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1571

Last updated 2018-08-03

No results posted yet for this study

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

Conditions

Interventions

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)

Sponsors & Collaborators

  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV

  • University of Leipzig

    collaborator OTHER

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Friedrich Koehler, Prof. Dr. · Charité - Universitaetsmedizin Berlin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-08
Primary Completion
2017-05-12
Completion
2018-05-17

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01878630 on ClinicalTrials.gov