Joan B Soriano1, Francisco García-Río2, Emma Vázquez-Espinosa3, Jose Ignacio Conforto4, Ascensión Hernando-Sanz5, Luis López-Yepes6, Raúl Galera-Martínez7, Germán Peces-Barba8, Carolina María Gotera-Rivera9, M Teresa Pérez-Warnisher10, Gonzalo Segrelles-Calvo11, Celia Zamarro12, Pablo González-Ponce13, M Inmaculata Ramos14, Syed Jafri15, Julio Ancochea16. 1. Servicio de Neumología e Instituto de Investigación, Hospital Universitario de la Princesa (IISP), Universidad Autónoma de Madrid, Madrid, Spain. Electronic address: jbsoriano2@gmail.com. 2. Servicio de Neumología, Hospital Universitario La Paz, Universidad Autónoma de Madrid, Spain; Centro de Investigación en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain. Electronic address: fgr01m@gmail.com. 3. Servicio de Neumología e Instituto de Investigación, Hospital Universitario de la Princesa (IISP), Universidad Autónoma de Madrid, Madrid, Spain. Electronic address: evazqueze@hotmail.com. 4. Linde Healthcare, Spain. Electronic address: jose.conforto@linde.com. 5. Servicio de Neumología, Hospital 12 de Octubre, Madrid, Spain. Electronic address: ascension.hernando@yahoo.es. 6. Servicio de Neumología, Hospital 12 de Octubre, Madrid, Spain. Electronic address: laloyepes@gmail.com. 7. Servicio de Neumología, Hospital Universitario La Paz, Universidad Autónoma de Madrid, Spain; Centro de Investigación en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain. Electronic address: raulgalera@hotmail.es. 8. Servicio de Neumología, Fundación Jiménez Díaz, Madrid, Spain; Centro de Investigación en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain. Electronic address: gpeces@fjd.es. 9. Servicio de Neumología, Fundación Jiménez Díaz, Madrid, Spain; Centro de Investigación en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain. Electronic address: carolina.gotera@fjd.es. 10. Departamento de Neumología, Clínica Universidad de Navarra, Madrid, Spain. Electronic address: mteresapw@gmail.com. 11. Servicio de Neumología, Hospital Rey Juan Carlos, Móstoles, Spain. Electronic address: gsegrelles@hotmail.com. 12. Servicio de Neumología, Hospital Rey Juan Carlos, Móstoles, Spain. 13. Monitoring Centre for Remote Patient Monitoring, Linde Healthcare, Madrid, Spain. Electronic address: pablo.gonzalez@linde.com. 14. Linde Healthcare, Spain. Electronic address: inma.ramos@linde.com. 15. Linde Healthcare, Germany. Electronic address: Syed.Jafri@linde.com. 16. Servicio de Neumología e Instituto de Investigación, Hospital Universitario de la Princesa (IISP), Universidad Autónoma de Madrid, Madrid, Spain. Electronic address: juli119@gmail.com.
Abstract
BACKGROUND: Evidence is needed to determine the role of telehealth (TH) in COPD management. METHODS: PROMETE II was a multicentre, randomized, 12-month trial. Severe COPD patients in stable condition were randomized to a specific monitoring protocol with TH or routine clinical practice (RCP). The primary objective was to reduce the number of COPD exacerbations leading to ER visits/hospital admissions between groups. RESULTS: Overall, 237 COPD patients were screened, and 229 (96.6%) were randomized toTH (n = 115) or RCP (n = 114), with age of 71 ± 8 years and 80% were men. Overall, 169 completed the full follow-up period. There were no statistical differences at one year between groups in the proportion of participants who had a COPD exacerbation (60% in TH vs. 53.5% in RCP; p = 0.321). There was, however, a marked but non-significant trend towards a shorter duration of hospitalization and days in ICU in the TH group (18.9 ± 16.0 and 6.0 ± 4.6 days) compared to the RCP group (22.4 ± 19.5 and 13.3 ± 11.1 days). The number of all-cause deaths was comparable between groups (12 in TH vs. 13 in RCP) as was total resource utilization cost (7912€ in TH vs. 8918€ in RCP). Telehealth was evaluated highly positively by patients and doctors. CONCLUSIONS: Remote patient management did not reduce COPD-related ER visits or hospital admissions compared to RCP within 12 months.
RCT Entities:
BACKGROUND: Evidence is needed to determine the role of telehealth (TH) in COPD management. METHODS: PROMETE II was a multicentre, randomized, 12-month trial. Severe COPDpatients in stable condition were randomized to a specific monitoring protocol with TH or routine clinical practice (RCP). The primary objective was to reduce the number of COPD exacerbations leading to ER visits/hospital admissions between groups. RESULTS: Overall, 237 COPDpatients were screened, and 229 (96.6%) were randomized to TH (n = 115) or RCP (n = 114), with age of 71 ± 8 years and 80% were men. Overall, 169 completed the full follow-up period. There were no statistical differences at one year between groups in the proportion of participants who had a COPD exacerbation (60% in TH vs. 53.5% in RCP; p = 0.321). There was, however, a marked but non-significant trend towards a shorter duration of hospitalization and days in ICU in the TH group (18.9 ± 16.0 and 6.0 ± 4.6 days) compared to the RCP group (22.4 ± 19.5 and 13.3 ± 11.1 days). The number of all-cause deaths was comparable between groups (12 in TH vs. 13 in RCP) as was total resource utilization cost (7912€ in TH vs. 8918€ in RCP). Telehealth was evaluated highly positively by patients and doctors. CONCLUSIONS: Remote patient management did not reduce COPD-related ER visits or hospital admissions compared to RCP within 12 months.
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