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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

  • Background Heart failure (HF) is a complex, chronic condition that is associated with debilitating symptoms, all of which necessitate close follow-up by health care providers. Lack of disease monitoring may result in increased mortality and more frequent hospital readmissions for decompensated HF. Remote patient management (RPM) in this patient population may help to detect early signs and symptoms of cardiac decompensation, thus enabling a prompt initiation of the appropriate treatment and care before a manifestation of HF decompensation. Objective The objective of the present article is to describe the design of a new trial investigating the impact of RPM on unplanned cardiovascular hospitalisations and mortality in HF patients. Methods The TIM-HF2 trial is designed as a prospective, randomised, controlled, parallel group, open (with randomisation concealment), multicentre trial with pragmatic elements introduced for data collection. Eligible patients with HF are randomised (1:1) to either RPM + usual care or to usual care only andBackground Heart failure (HF) is a complex, chronic condition that is associated with debilitating symptoms, all of which necessitate close follow-up by health care providers. Lack of disease monitoring may result in increased mortality and more frequent hospital readmissions for decompensated HF. Remote patient management (RPM) in this patient population may help to detect early signs and symptoms of cardiac decompensation, thus enabling a prompt initiation of the appropriate treatment and care before a manifestation of HF decompensation. Objective The objective of the present article is to describe the design of a new trial investigating the impact of RPM on unplanned cardiovascular hospitalisations and mortality in HF patients. Methods The TIM-HF2 trial is designed as a prospective, randomised, controlled, parallel group, open (with randomisation concealment), multicentre trial with pragmatic elements introduced for data collection. Eligible patients with HF are randomised (1:1) to either RPM + usual care or to usual care only and are followed for 12 months. The primary outcome is the percentage of days lost due to unplanned cardiovascular hospitalisations or all-cause death. The main secondary outcomes are all-cause and cardiovascular mortality. Conclusion The TIM-HF2 trial will provide important prospective data on the potential beneficial effect of telemedical monitoring and RPM on unplanned cardiovascular hospitalisations and mortality in HF patients.zeige mehrzeige weniger

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Metadaten
Verfasserangaben:Friedrich KoehlerORCiD, Kerstin Koehler, Oliver DeckwartORCiD, Sandra PrescherORCiD, Karl WegscheiderORCiDGND, Sebastian Winkler, Eik VettorazziORCiD, Andreas PolzeORCiDGND, Karl Stangl, Oliver Hartmann, Almuth Marx, Petra Neuhaus, Michael Scherf, Bridget-Anne Kirwan, Stefan D. Anker
DOI:https://doi.org/10.1002/ejhf.1300
ISSN:1388-9842
ISSN:1879-0844
Pubmed ID:https://pubmed.ncbi.nlm.nih.gov/30230666
Titel des übergeordneten Werks (Englisch):European Journal of Heart Failure
Untertitel (Englisch):study design and description of the intervention
Verlag:Wiley
Verlagsort:Hoboken
Publikationstyp:Wissenschaftlicher Artikel
Sprache:Englisch
Datum der Erstveröffentlichung:19.09.2018
Erscheinungsjahr:2018
Datum der Freischaltung:20.09.2021
Freies Schlagwort / Tag:Chronic heart failure; Hospitalisation; Remote patient management; Telemonitoring
Band:20
Ausgabe:10
Seitenanzahl:9
Erste Seite:1485
Letzte Seite:1493
Fördernde Institution:German Federal Ministry of Education and ResearchFederal Ministry of Education & Research (BMBF) [13KQ0904A, 13KQ0904B, 13KQ1104A]; German Federal Ministry of Education and ResearchFederal Ministry of Education & Research (BMBF); European Regional Development FundEuropean Union (EU); Federal State of Brandenburg
Organisationseinheiten:An-Institute / Hasso-Plattner-Institut für Digital Engineering gGmbH
DDC-Klassifikation:6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
Peer Review:Referiert
Publikationsweg:Open Access / Bronze Open-Access
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