Study design of Heart failure Events reduction with Remote Monitoring and eHealth Support (HERMeS)
Yun, Sergi (Hospital Universitari de Bellvitge)
Enjuanes, Cristina (Hospital Universitari de Bellvitge)
Calero, Esther (Hospital Universitari de Bellvitge)
Hidalgo, Encarnación (Hospital Universitari de Bellvitge)
Cobo, Marta (Instituto de Salud Carlos III)
Llàcer, Pau (Instituto de Investigación Sanitaria La Fe)
García-Pinilla, José Manuel (Instituto de Investigación Biomédica de Málaga)
González-Franco, Álvaro (Instituto de Investigación Sanitaria del Principado de Asturias)
Núñez, Julio (Universitat de València)
Morales-Rull, José Luis (Institut de Recerca Biomèdica de Lleida)
Beltrán, Paola (Institut Català de la Salut)
Delso, Cristina (Institut Universitari d'Investigació en Atenció Primària Jordi Gol)
Freixa-Pamias, Román (Universitat Autònoma de Barcelona)
Moliner, Pedro (Hospital Universitari de Bellvitge)
Corbella, Xavier (Universitat Internacional de Catalunya)
Comín-Colet, Josep (Universitat de Barcelona)

Date:	2020
Abstract:	The role of non-invasive telemedicine (TM) combining telemonitoring and teleintervention by videoconference (VC) in patients recently admitted due to heart failure (HF) ('vulnerable phase' HF patients) is not well established. The aim of the Heart failure Events reduction with Remote Monitoring and eHealth Support (HERMeS) trial is to assess the impact on clinical outcomes of implementing a TM service based on mobile health (mHealth), which includes remote daily monitoring of biometric data and symptom reporting (telemonitoring) combined with VC structured, nurse-based follow-up (teleintervention). The results will be compared with those of the comprehensive HF usual care (UC) strategy based on face-to-face on-site visits at the vulnerable post-discharge phase. We designed a 24 week nationwide, multicentre, randomized, controlled, open-label, blinded endpoint adjudication trial to assess the effect on cardiovascular (CV) mortality and non-fatal HF events of a TM-based comprehensive management programme, based on mHealth, for patients with chronic HF. Approximately 508 patients with a recent hospital admission due to HF decompensation will be randomized (1:1) to either structured follow-up based on face-to-face appointments (UC group) or the delivery of health care using TM. The primary outcome will be a composite of death from CV causes or non-fatal HF events (first and recurrent) at the end of a 6 month follow-up period. Key secondary endpoints will include components of the primary event analysis, recurrent event analysis, and patient-reported outcomes. The HERMeS trial will assess the efficacy of a TM-based follow-up strategy for real-world 'vulnerable phase' HF patients combining telemonitoring and teleintervention.
Note:	Funding: The HERMeS trial is funded by an unrestricted research grant by Novartis
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Language:	Anglès
Document:	Estudi clínic ; recerca ; Versió publicada
Subject:	Chronic heart failure ; Telemedicine ; Outcomes research ; Chronic care model ; Transitional care
Published in:	ESC Heart Failure, Vol. 7 (september 2020) , p. 4448-4457, ISSN 2055-5822

DOI: 10.1002/ehf2.12962
PMID: 32940428

10 p, 4.0 MB

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