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| Name | Class |
|---|---|
| German Federal Ministry of Education and Research | OTHER_GOV |
| University of Leipzig | OTHER |
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Superiority of additional Remote Patient Management (RPM) in patients with chronic heart failure (CHF) in comparison to usual care in terms of, e.g.:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote Patient Management | Experimental | intervention group |
|
| Usual Care | Active Comparator | control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Patient Management | Device | 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:
at center site: - electronic patient record (eHealth connect 2.0, T-Systems International) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months/ individual-patient follow-up time. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | individual patient follow-up time (+28 days of the final visit to a maximum 393 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of life (QoL), depression and self-care behaviour between baseline and 365 days. | QoL measured by European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L), depression by PHQ-9D and self-care behaviour by European Heart Failure Self-care Behaviour Scale (EHFScBS-9) | 12 months (baseline and final visit) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Friedrich Koehler, Prof. Dr. | Charité - Universitaetsmedizin Berlin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum St. Marien Amberg - Medizinische Klinik I | Amberg | Germany | ||||
| GLG Fachklinik Wolletzsee GmbH |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21982700 | Background | Koehler F, Winkler S, Schieber M, Sechtem U, Stangl K, Bohm M, de Brouwer S, Perrin E, Baumann G, Gelbrich G, Boll H, Honold M, Koehler K, Kirwan BA, Anker SD. Telemedicine in heart failure: pre-specified and exploratory subgroup analyses from the TIM-HF trial. Int J Cardiol. 2012 Nov 29;161(3):143-50. doi: 10.1016/j.ijcard.2011.09.007. Epub 2011 Oct 8. | |
| 21444883 |
| Label | URL |
|---|---|
| study website, only in German | View source |
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 17, 2019 | |
| Unrelease | May 20, 2019 | |
| Release | May 20, 2019 |
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Remote patient management with telemedical devices (ECG, scale, blood-pressure device)
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|
|
| Usual Care | Other | 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 hospitalisations during the individual patient follow-up time. |
| 12 months/ individual follow-up time |
| Percentage of days lost due to unplanned HF-hospitalisations during the individual patient follow-up time | 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. | 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 | 12 months/ individual follow-up time |
| Change from baseline in biomarkers (MR-proADM, NT-proBNP, MR-proANP, PCT) stratified by LVEF (>45 vs ≤ 45) at 365 days. |
| 12 months (baseline and final visit) |
| Unplanned cardiovascular hospitalisations and cardiovascular mortality. | Analysed as a recurrent event analysis | individual patient follow-up time (+28 days of the final visit to a maximum 393 days) |
| Unplanned cardiovascular hospitalisations and all-cause mortality. | Analysed as a recurrent event analysis | individual patient follow-up time (+28 days of the final visit to a maximum 393 days) |
| Unplanned heart failure hospitalisations and cardiovascular mortality. | Analysed as a recurrent event analysis | individual patient follow-up time (+28 days of the final visit to a maximum 393 days) |
| Unplanned heart failure hospitalisations and all-cause mortality. | analysed as a recurrent event analysis | 12 month |
| Cost-utility Analysis. | QALY-analysis using EQ-5D-3L | 12 month/individual follow-up time |
| Rate of unplanned cardiovascular hospitalisations after a first cardiovascular hospitalisation | 12 months |
| Angermünde |
| Germany |
| Klinik Ernst von Bergmann Bad Belzig gGmbH - Zentrum für Innere Medizin/Kardiologie | Bad Belzig | 14805 | Germany |
| Oder-Spree-Krankenhaus Beeskow GmbH | Beeskow | Germany |
| Charité - Universitaetsmedizin Berlin | Berlin | 10117 | Germany |
| 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 | 09111 | Germany |
| 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 |
| Kreisklinik Ebersberg gGmbH | Ebersberg | 85560 | 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 |
| Kardiologische Praxis Dr. Wehr | Gerlingen | 70839 | Germany |
| Cardiocampus - Kardiologische Gemeinschaftspraxis | Gifhorn | Germany |
| Praxis Dr. med. Frank Warzok | Gotha | 99867 | Germany |
| Praxis Karsten Müller | Gräfenhainichen | 06773 | Germany |
| Praxis Dr. med Karsten Müller | Gräfenhainichen | Germany |
| Universitätsklinikum Halle (Saale) | Halle | 06120 | Germany |
| Albertinen-Krankenhaus/Albertinen-Haus gemeinnützige GmbH | Hamburg | Germany |
| Medizinische Hochschule Hannover -Klinik für Kardiologie und Angiologie/ Zentrum Innere Medizin | Hanover | 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 | Germany |
| Asklepios Klinik Langen | Langen | Germany |
| Universitätsklinikum Leipzig - Abteilung Kardiologie & Angiologie | Leipzig | Germany |
| MVZ Lübbenau GmbH | Lubnjow | Germany |
| Cardio Centrum Ludwigsburg Bietigheim | Ludwigsburg | Germany |
| Kardiologische Gemeinschaftspraxis Dr. med. Bartels, Dr. med. Kausche, Dr. med. Meltendorf | Magdeburg | Germany |
| Dietrich Bonhoeffer Klinikum - Klinik für Innere Medizin 4 | Malchin | 17139 | Germany |
| Praxis Horn | Manschnow | Germany |
| Praxis Dr. med. Dieter Böhm | Marbach | 71672 | Germany |
| Praxis Dr. Jens Taggeselle | Markkleeberg | 04416 | Germany |
| Carl-von-Basedow-Klinikum Saalekreis gGmbH, Klinikum Merseburg | Merseburg | Germany |
| Kardiologische Praxis Dr. Rheinert | Merzig | 66663 | Germany |
| Kardiologie Mühldorf am Inn | Mühldorf | 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 | 14471 | Germany |
| Kardiologische Gemeinschaftspraxis am Park Sanssouci | Potsdam | Germany |
| Poliklinik Ernst von Bergmann GmbH | Potsdam | Germany |
| Praxis Ehlert | Pritzwalk | Germany |
| Gemeinschaftspraxis Dres. Stenzel/Ebert/Otto | Riesa | 01587 | 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 | Germany |
| Thüringen-Kliniken "Georgius Agricola" | Saalfeld | Germany |
| Bergarbeiter-Krankenhaus Schneeberg GmbH - Innere Medizin/Kardiologie | Schneeberg | Germany |
| Kliniken des Landkreises Lörrach GmbH, KKH Schopfheim | Schopfheim | 79650 | Germany |
| Asklepios Klinikum Uckermark GmbH - Asklepios Kliniken GmbH | Schwedt | Germany |
| Praxis für Kardiologie | Seelow | Germany |
| Praxisklinik Herz und Gefäße - ZWEIGPRAXIS Brandenburg | Senftenberg | Germany |
| Johanniter-Krankenhaus Genthin-Stendal GmbH | Stendal | 39576 | Germany |
| 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 |
| Koehler F, Winkler S, Schieber M, Sechtem U, Stangl K, Bohm M, Boll H, Baumann G, Honold M, Koehler K, Gelbrich G, Kirwan BA, Anker SD; Telemedical Interventional Monitoring in Heart Failure Investigators. Impact of remote telemedical management on mortality and hospitalizations in ambulatory patients with chronic heart failure: the telemedical interventional monitoring in heart failure study. Circulation. 2011 May 3;123(17):1873-80. doi: 10.1161/CIRCULATIONAHA.111.018473. Epub 2011 Mar 28. |
| 21856487 | Background | Anker SD, Koehler F, Abraham WT. Telemedicine and remote management of patients with heart failure. Lancet. 2011 Aug 20;378(9792):731-9. doi: 10.1016/S0140-6736(11)61229-4. |
| 26303835 | Background | Cowie MR, Bax J, Bruining N, Cleland JG, Koehler F, Malik M, Pinto F, van der Velde E, Vardas P. e-Health: a position statement of the European Society of Cardiology. Eur Heart J. 2016 Jan 1;37(1):63-6. doi: 10.1093/eurheartj/ehv416. Epub 2015 Aug 24. No abstract available. |
| 40672055 | Derived | Kerwagen F, Stork S, Koehler K, Vettorazzi E, Bauser M, Zernikow J, Barzen G, Hiddemann M, Groschel J, Gross M, Melzer C, Stangl K, Hindricks G, Koehler F, Winkler S, Spethmann S. Rurality, travel distance, and effectiveness of remote patient management in patients with heart failure in the TIM-HF2 trial in Germany: a pre-specified analysis of an open-label, randomised controlled trial. Lancet Reg Health Eur. 2025 May 18;54:101321. doi: 10.1016/j.lanepe.2025.101321. eCollection 2025 Jul. |
| 38867198 | Derived | Koehler F, Koehler J, Bramlage P, Vettorazzi E, Wegscheider K, Lezius S, Spethmann S, Iakoubov R, Vijayan A, Winkler S, Melzer C, Schutt K, Dessapt-Baradez C, Paar WD, Koehler K, Muller-Wieland D. Impact of telemedical management on hospitalization and mortality in heart failure patients with diabetes: a post-hoc subgroup analysis of the TIM-HF2 trial. Cardiovasc Diabetol. 2024 Jun 12;23(1):198. doi: 10.1186/s12933-024-02285-0. |
| 37368507 | Derived | Kerwagen F, Koehler K, Vettorazzi E, Stangl V, Koehler M, Halle M, Koehler F, Stork S. Remote patient management of heart failure across the ejection fraction spectrum: A pre-specified analysis of the TIM-HF2 trial. Eur J Heart Fail. 2023 Sep;25(9):1671-1681. doi: 10.1002/ejhf.2948. Epub 2023 Jul 31. |
| 36752782 | Derived | Deckwart O, Koehler K, Lezius S, Prescher S, Koehler F, Winkler S. Effects of remote patient management on self-care behaviour in heart failure patients: results from the randomized TIM-HF2 trial. Eur J Cardiovasc Nurs. 2023 Dec 14;22(8):786-794. doi: 10.1093/eurjcn/zvad019. |
| 36062451 | Derived | Prescher S, Winkler S, Riehle L, Hiddemann M, Moeller V, Collins C, Deckwart O, Spethmann S. Patient reported experience and adherence to remote patient management in chronic heart failure patients: a posthoc analysis of the TIM-HF2 trial. Eur J Cardiovasc Nurs. 2023 Apr 12;22(3):245-253. doi: 10.1093/eurjcn/zvac080. |
| 33328035 | Derived | Koehler F, Koehler K, Prescher S, Kirwan BA, Wegscheider K, Vettorazzi E, Lezius S, Winkler S, Moeller V, Fiss G, Schleder J, Koehler M, Zugck C, Stork S, Butter C, Prondzinsky R, Spethmann S, Angermann C, Stangl V, Halle M, von Haehling S, Dreger H, Stangl K, Deckwart O, Anker SD. Mortality and morbidity 1 year after stopping a remote patient management intervention: extended follow-up results from the telemedical interventional management in patients with heart failure II (TIM-HF2) randomised trial. Lancet Digit Health. 2020 Jan;2(1):e16-e24. doi: 10.1016/S2589-7500(19)30195-5. Epub 2019 Dec 12. |
| 30230666 | Derived | Koehler F, Koehler K, Deckwart O, Prescher S, Wegscheider K, Winkler S, Vettorazzi E, Polze A, Stangl K, Hartmann O, Marx A, Neuhaus P, Scherf M, Kirwan BA, Anker SD. Telemedical Interventional Management in Heart Failure II (TIM-HF2), a randomised, controlled trial investigating the impact of telemedicine on unplanned cardiovascular hospitalisations and mortality in heart failure patients: study design and description of the intervention. Eur J Heart Fail. 2018 Oct;20(10):1485-1493. doi: 10.1002/ejhf.1300. Epub 2018 Sep 19. |
| 30153985 | Derived | Koehler F, Koehler K, Deckwart O, Prescher S, Wegscheider K, Kirwan BA, Winkler S, Vettorazzi E, Bruch L, Oeff M, Zugck C, Doerr G, Naegele H, Stork S, Butter C, Sechtem U, Angermann C, Gola G, Prondzinsky R, Edelmann F, Spethmann S, Schellong SM, Schulze PC, Bauersachs J, Wellge B, Schoebel C, Tajsic M, Dreger H, Anker SD, Stangl K. Efficacy of telemedical interventional management in patients with heart failure (TIM-HF2): a randomised, controlled, parallel-group, unmasked trial. Lancet. 2018 Sep 22;392(10152):1047-1057. doi: 10.1016/S0140-6736(18)31880-4. Epub 2018 Aug 25. |
| project website, only in German | View source |
| Reset | Jul 22, 2019 |
| Release | Jun 8, 2020 |
| Reset | Jun 19, 2020 |
| Release | Aug 22, 2022 |
| Reset | Jul 12, 2023 |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 17, 2019 | May 20, 2019 | |||
| May 20, 2019 | Jul 22, 2019 | |||
| Jun 8, 2020 | Jun 19, 2020 | |||
| Aug 22, 2022 | Jul 12, 2023 |