RT Journal Article
T1 Study design of Heart failure Events reduction with Remote Monitoring and eHealth Support (HERMeS).
A1 Yun, Sergi
A1 Enjuanes, Cristina
A1 Calero, Esther
A1 Hidalgo, Encarnación
A1 Cobo, Marta
A1 Llàcer, Pau
A1 García-Pinilla, José Manuel
A1 González-Franco, Álvaro
A1 Núñez, Julio
A1 Morales-Rull, José Luis
A1 Beltrán, Paola
A1 Delso, Cristina
A1 Freixa-Pamias, Román
A1 Moliner, Pedro
A1 Corbella, Xavier
A1 Comín-Colet, Josep
A1 HERMeS trial investigators group, 
K1 Chronic care model
K1 Chronic heart failure
K1 Outcomes research
K1 Telemedicine
K1 Transitional care
K1 mHealth
AB 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.
YR 2020
FD 2020-09-17
LK http://hdl.handle.net/10668/16269
UL http://hdl.handle.net/10668/16269
LA en
DS RISalud
RD Apr 8, 2025