Evaluation of mobile health technology combining telemonitoring and teleintervention versus usual care in vulnerable-phase heart failure management (HERMeS): a multicentre, randomised controlled trial
Sergi Yun, Josep Comín‐Colet, E Calero-Molina, Encarnación Hidalgo, N Jose-Bazan, Marta Cobo Marcos, Teresa Soria, Pau Llàcer, Cristina E. Fernández, José Manuel García‐Pinilla, Concepción Cruzado, Álvaro González-Franco, E. García-Marina, José Luís Morales‐Rull, Cristina Solé, Elena García‐Romero, Julio Núñez, José Civera, Coral Fernández, Mercedes Faraudo, Pedro Moliner, Francesç Formiga, Javier de-Juan Bagudá, Isabel Zegrí‐Reiriz, José María Verdú-Rotellar, Emili Vela, David Monterde, Jordi Piera-Jiménez, Gerard Carot-Sans, Cristina Enjuanes, Santiago Jiménez-Marrero, Alberto Garay, Raúl Ramos-Polo, Alexandra Pons-Riverola, Herminio Morillas, Sílvia Jovells-Vaqué, Marta Tajes, Rafael de la Espriella, Elisa Esther Rodríguez, Jessica Paola Rugeles, Maria del Carmen Moreno, Carla Castillo, Ainhoa Robles-Mezcua, Ramon Bascompte, Paola Macarena Beltran Troncoso, Rocío Rodríguez, Román Freixa Pamias, Olga Guri, Cristina Delso Gafarot, Sònia Sarret Vila, Angelique-Casas Thomsen, Jordi Fernández
Abstract
BACKGROUND: The potential of mobile health (mHealth) technology combining telemonitoring and teleintervention as a non-invasive intervention to reduce the risk of cardiovascular events in patients with heart failure during the early post-discharge period (ie, the vulnerable phase) has not been evaluated to our knowledge. We investigated the efficacy of incorporating mHealth into routine heart failure management in vulnerable-phase patients. METHODS: The Heart Failure Events Reduction with Remote Monitoring and eHealth Support (HERMeS) trial was a 24-week, randomised, controlled, open-label with masked endpoint adjudication, phase 3 trial conducted in ten centres (hospitals [n=9] and a primary care service [n=1]) experienced in heart failure management in Spain. We enrolled adults (aged ≥18 years) with heart failure diagnosed according to the 2016 European Society of Cardiology criteria (then-current clinical practice guidelines at the initiation of the trial) who had recently been discharged (within the preceding 30 days of enrolment) from a hospital admission that was due to heart failure decompensation, or who were in the process of discharge planning. After discharge, participants were centrally randomly assigned (1:1) via a web-based system to mHealth, comprising telemonitoring and preplanned structured health-care follow-up via videoconference, or usual care according to each centre's heart failure care framework including a nurse-led educational programme. The primary outcome was a composite of the occurrence of cardiovascular death or worsening heart failure events during the 6-month follow-up period, assessed by time-to-first-event analysis in the full analysis set by the intention-to-treat principle. No prospective systematic collection of harms information was planned. The HERMeS trial is registered with ClinicalTrials.gov, NCT03663907, and is completed. FINDINGS: From May 15, 2018, to April 4, 2022, 506 participants (207 [41%] women and 299 [59%] men) were randomly assigned: 255 to mHealth and 251 to usual care. The mean age of participants was 73 years (SD 13). Follow-up ended prematurely in 51 (20%) of 255 participants in the mHealth group and 36 (14%) of 251 in the usual care group. During follow-up in the mHealth group, cardiovascular death or a worsening heart failure event occurred in 43 (17%) of 255 participants, compared with 102 (41%) of 251 in the usual care group (hazard ratio for time to first event 0·35 [95% CI 0·24-0·50]; p<0·0001; relative risk reduction 65% [95% CI 50-76]). No spontaneously reported harms were reported in either group during follow-up. INTERPRETATION: mHealth-based heart failure care combining teleintervention and telemonitoring reduced the risk of new fatal and non-fatal cardiovascular events compared with usual care in people with a recent hospital admission due to heart failure decompensation. The current findings could help to improve the care of patients with heart failure in the transitional post-discharge period by encouraging integration of mHealth into clinical practice guidelines. FUNDING: The HERMeS trial was funded by an unrestricted grant from Novartis.