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Telemedical Interventional Management in Heart Failure II (TIM-HF II)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
German Federal Ministry of Education and Research
University of Leipzig
Information provided by (Responsible Party):
Friedrich Koehler, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01878630
First received: June 12, 2013
Last updated: May 15, 2017
Last verified: May 2017
  Purpose

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

Condition Intervention Phase
Chronic Heart Failure Device: Remote Patient Management Other: Usual Care Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Remote patient management with telemedical devices (ECG, scale, blood-pressure device)
Masking: No masking
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Friedrich Koehler, Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Days lost due to unplanned cardiovascular hospitalization or death. [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • all-cause mortality (time-to-event) [ Time Frame: 12 months ]
  • cardiovascular mortality (time-to-event) [ Time Frame: 12 months ]
  • days lost regarding 12month follow-up due to unplanned cardiovascular hospitalizations [ Time Frame: 12 months ]
  • days lost regarding 12month follow-up due to HF-hospitalization; number of unplanned cardiovascular hospitalizations (adjusted to death) [ Time Frame: 12 months ]
  • number of unplanned HF-hospitalizations (adjusted to death) [ Time Frame: 12 months ]
  • number of unplanned cardiovascular re-admissions within 30 days after discharge from unplanned cardiovascular hospitalization [ Time Frame: 12 months ]
  • quality of life, depression and self-care behaviour [ Time Frame: 12 months ]
    Quality of life measured by Minnesota Living with Heart Failure Questionnaire; EQ-5D-3L, depression by PHQ-9 and self-care behaviour by EHFScBS-9

  • cost-utility analysis (QALY-analysis) [ Time Frame: 12 months ]

Enrollment: 1535
Study Start Date: August 2013
Estimated Study Completion Date: May 2018
Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Remote Patient Management
intervention group
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 Name: R&D project "Fontane"
Active Comparator: Usual Care
control group
Other: Usual Care
Guideline-based care in heart failure including at least 5 scheduled doctor's visits within 12 months (GP and specialist)

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • chronic heart failure New York Heart Association (NYHA) class II or III
  • echocardiographically determined left ventricular ejection fraction (LVEF) ≤45% or >45% + minimum 1 diuretic in permanent medicinal therapy
  • hospitalization due to decompensated HF within the last 12months before randomization
  • informed consent

Exclusion Criteria:

  • hospitalization within the last 7 days before randomization
  • implanted cardiac assist system
  • acute coronary syndrome within the last 7 days before randomization
  • high urgent listed for heart transplantation (HTx)
  • planned revascularization, Transcatheter Aortic Valve Implantation (TAVI), MitraClip and/or Cardiac Resynchronization Therapy (CRT)-implantation within the last 3 months before randomization
  • revascularization and/or CRT-implantation within 28 days before randomization
  • known alcohol or drug abuse
  • terminal renal insufficiency with hemodialysis
  • impairment or unwillingness to use the telemonitoring equipment (e.g. dementia, impaired self-determination, lacking ability to communicate)
  • existence of any disease reducing life expectancy to less than 1 year
  • age <18 years
  • pregnancy
  • participation in other treatment studies or remote patient management programmes (register studies possible)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01878630

  Hide Study Locations
Locations
Germany
Klinikum St. Marien Amberg - Medizinische Klinik I
Amberg, Germany
GLG Fachklinik Wolletzsee GmbH
Angermünde, Germany
Oder-Spree-Krankenhaus Beeskow GmbH
Beeskow, Germany
Charité - Universitaetsmedizin Berlin
Berlin, Germany, 10117
Bundeswehr Krankenhaus
Berlin, Germany
Cardio Centrum Berlin GmbH
Berlin, Germany
DRK Kliniken Berlin-Köpenick
Berlin, Germany
Gemeinschaftskrankenhaus Havelhöhe Klinik für Anthroposophische Medizin
Berlin, Germany
Gemeinschaftspraxis am Bayerischen Platz
Berlin, Germany
HELIOS Klinikum Berlin-Buch
Berlin, Germany
HELIOS Klinikum Emil von Behring - HELIOS Kliniken GmbH
Berlin, Germany
Herzpraxis Berlin
Berlin, Germany
Jüdisches Krankenhaus Berlin
Berlin, Germany
Kardiologie Weissensee
Berlin, Germany
Kardiologische Praxis im Spreebogen
Berlin, Germany
Krankenhaus Waldfriede e. V.
Berlin, Germany
Kranoldpraxis
Berlin, Germany
Martin-Luther Krankenhaus
Berlin, Germany
MVZ Treffpunkt Geißenweide GmbH
Berlin, Germany
Polikum Institut GmbH Polikum Friede
Berlin, Germany
Praxis am Dachsbau
Berlin, Germany
Praxis Claus
Berlin, Germany
Praxis Dres. Weinrich
Berlin, Germany
Praxis Frank
Berlin, Germany
Praxis Pinkwart
Berlin, Germany
Praxis Roeder
Berlin, Germany
Unfallkrankenhaus Berlin
Berlin, Germany
Vivantes Klinikum Hellersdorf
Berlin, Germany
Vivantes MVZ Wedding
Berlin, Germany
Ärzte Schönhauser Berlin e.V.
Berlin, Germany
Brandenburgklinik Berlin-Brandenburg GmbH
Bernau, Germany
Immanuel Klinikum Bernau, Herzzentrum Brandenburg
Bernau, Germany
Kardiologische Praxis Gola
Bernau, Germany
Gemeinschaftspraxis Hampel/Janoske
Bitterfeld-Wolfen, Germany
Gesundheitszentrum Bitterfeld/Wolfen gGmbH - Zentrum für Innere Medizin/Herzkatheterlabor
Bitterfeld-Wolfen, Germany
Städtisches Klinikum Brandenburg/Havel
Brandenburg/Havel, Germany
Herz - und Gefäßzentrum am Neumarkt
Celle, Germany
Medizinisches Beratungs- und Therapie-Zentrum Chemnitz GmbH
Chemnitz, Germany, 09111
Klinikum Chemnitz gGmbH
Chemnitz, Germany
Carl-Thiem-Klinikum Cottbus
Cottbus, Germany
Klinikum Lippe - Kardiologie
Detmold, Germany
Cardiologicum Dresden & Pirna
Dresden, Germany
Städtisches Klinikum Dresden-Friedrichstadt
Dresden, Germany
Klinikum Barnim GmbH, Werner Forßmann Krankenhaus
Eberswalde, Germany
Praxis Hagenow
Elsterwerda, Germany
Klinikum der Johann-Wolfgang Goethe-Universität
Frankfurt am Main, Germany
Praxis Langel
Gera, Germany
Cardiocampus - Kardiologische Gemeinschaftspraxis
Gifhorn, Germany
Praxis Dr. med Karsten Müller
Gräfenhainichen, Germany
Albertinen-Krankenhaus/Albertinen-Haus gemeinnützige GmbH
Hamburg, Germany
Medizinische Hochschule Hannover -Klinik für Kardiologie und Angiologie/ Zentrum Innere Medizin
Hannover, Germany
Universitätsklinikum Jena
Jena, Germany
Kardiologie im Praxishaus
Kleinmachnow, Germany
Klinikum Dahme-Spreewald GmbH/Achenbach-Krankenhaus
Königs-Wusterhausen, Germany
HELIOS Klinik Köthen - Klinik für Innere Medizin, Schwerpunkt Kardiologie, Internistische Intensivmedizin
Köthen (Anhalt), Germany
Asklepios Klinik Langen
Langen, Germany
Universitätsklinikum Leipzig - Abteilung Kardiologie & Angiologie
Leipzig, Germany
Cardio Centrum Ludwigsburg Bietigheim
Ludwigsburg, Germany
MVZ Lübbenau GmbH
Lübbenau, Germany
Kardiologische Gemeinschaftspraxis Dr. med. Bartels, Dr. med. Kausche, Dr. med. Meltendorf
Magdeburg, Germany
Praxis Horn
Manschnow, Germany
Carl-von-Basedow-Klinikum Saalekreis gGmbH, Klinikum Merseburg
Merseburg, Germany
Kardiologische Praxis Dr. Rheinert
Merzig, Germany, 66663
Kardiologie Mühldorf am Inn
Mühldorf am Inn, Germany
Kardiologische Praxis Nauen
Nauen, Germany
Dietrich Bonhoeffer Klinikum
Neubrandenburg, Germany
Ruppiner Kliniken GmbH
Neuruppin, Germany
Kardiologische Praxis Dr. H.P. Mieg
Oranienburg, Germany
Praxis Donaubauer
Oschatz, Germany
Internist; Facharzt für Innere Medizin
Pasewalk, Germany
Kreiskrankenhaus Prignitz gGmbH
Perleberg, Germany
Cardiologicum
Pirna, Germany
St. Josefs-Krankenhaus Potsdam-Sanssouci
Potsdam, Germany, 14471
Kardiologische Gemeinschaftspraxis am Park Sanssouci
Potsdam, Germany
Poliklinik Ernst von Bergmann GmbH
Potsdam, Germany
Praxis Ehlert
Pritzwalk, Germany
Gemeinschaftspraxis Dres. Stenzel/Ebert/Otto
Riesa, Germany
Kardiologische Praxis Dr. Placke
Rostock, Germany
Facharzt-Zentrum Pneumologie und Kardiologie
Rüdersdorf, Germany
Klinik am See/REHA-Fachklinik für Innere Medizin
Rüdersdorf, Germany
Praxis für Kardiologie
Saalfeld/Saale, Germany
Thüringen-Kliniken "Georgius Agricola"
Saalfeld/Saale, Germany
Bergarbeiter-Krankenhaus Schneeberg GmbH - Innere Medizin/Kardiologie
Schneeberg, Germany
Kliniken des Landkreises Lörrach GmbH, KKH Schopfheim
Schopfheim, Germany, 79650
Asklepios Klinikum Uckermark GmbH - Asklepios Kliniken GmbH
Schwedt/Oder, Germany
Praxis für Kardiologie
Seelow, Germany
Praxisklinik Herz und Gefäße - ZWEIGPRAXIS Brandenburg
Senftenberg, Germany
Johanniter-Krankenhaus Genthin-Stendal GmbH
Stendal, Germany, 39576
Internistische Gemeinschaftspraxis Steiner Thor
Straubing, Germany
Klinikum St. Elisabeth Straubing GmbH
Straubing, Germany
Internistische Praxis am Landsberger Tor
Strausberg, Germany
Kardiologische Facharztpraxis Dr. med. Heike Olthoff
Strausberg, Germany
Robert Bosch Krankenhaus Stuttgart
Stuttgart, Germany
Sana-Kliniken Berlin-Brandenburg GmbH
Templin, Germany
Kardiologische Gemeinschaftspraxis Wittenberg
Wittenberg, Germany
Praxis Stiller
Wittstock, Germany
Ambulantes Herz-Kreislauf Zentrum Wolfsburg
Wolfsburg, Germany
Universitätsklinikum Würzburg
Würzburg, Germany
Praxis Lägel
Zeuthen, Germany
Sponsors and Collaborators
Charite University, Berlin, Germany
German Federal Ministry of Education and Research
University of Leipzig
Investigators
Principal Investigator: Friedrich Koehler, Prof. Dr. Charité - Universitaetsmedizin Berlin
  More Information

Additional Information:
Publications:
Responsible Party: Friedrich Koehler, Prof. Dr. Friedrich Koehler, MD, Senior Physician, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01878630     History of Changes
Other Study ID Numbers: 13KQ0904B
Study First Received: June 12, 2013
Last Updated: May 15, 2017

Keywords provided by Friedrich Koehler, Charite University, Berlin, Germany:
Chronic Heart Failure
CHF

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 22, 2017