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Eur J Heart Fail. 2018 Oct;20(10):1485-1493. doi: 10.1002/ejhf.1300. Epub 2018 Sep 19.

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.

Author information

1
Charité - Universitätsmedizin Berlin, Centre for Cardiovascular Telemedicine, Department of Cardiology and Angiology Campus Mitte, Berlin, Germany.
2
Institute of Medical Biometry and Epidemiology, University Medical Center Eppendorf, Hamburg, Germany.
3
Unfallkrankenhaus Berlin, Clinic for Internal Medicine, Berlin, Germany.
4
Hasso Plattner Institute gGmbH, Digital Engineering Faculty, University Potsdam, Potsdam, Germany.
5
Charité - Universitätsmedizin Berlin, Department of Cardiology and Angiology Campus Mitte, Berlin, Germany.
6
Frankfurt am Main, Germany.
7
Nuremberg, Germany.
8
University of Leipzig, Faculty of Medicine, Clinical Trial Centre Leipzig - KKS, Leipzig, Germany.
9
GETEMED Medizin- und Informationstechnik AG, Teltow, Germany.
10
London School of Hygiene and Tropical Medicine, Faculty of Epidemiology and Public Health, London, UK.
11
Department of Cardiology (CVK); and Berlin- Brandenburg Center for Regenerative Therapies (BCRT); German Centre for Cardiovascular Research (DZHK) partner site Berlin; Charité - Universitätsmedizin Berlin, Germany.

Abstract

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 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.

TRIAL REGISTRATION:

ClinicalTrials.gov Identifier NCT01878630.

KEYWORDS:

Chronic heart failure; Hospitalisation; Remote patient management; Telemonitoring

PMID:
30230666
DOI:
10.1002/ejhf.1300
[Indexed for MEDLINE]

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