title: Effectiveness of pacemaker tele-monitoring on quality of life, functional capacity, event detection and workload: The PONIENTE trial.
abstract: OBJECTIVE
  The purpose of the present study was to assess the effectiveness of the remote monitoring (RM) of older adults with pacemakers on health-related quality of life, functional capacity, feasibility, reliability and safety.
  
  
  METHODS
  The PONIENTE study is a controlled, non-randomized, non-blinded clinical trial, with data collection carried out during the pre-implant stage and after 12 months. Between October of 2012 and November of 2013, 82 patients were assigned to either a remote monitoring group (n = 30) or a conventional hospital monitoring (HM) group (n = 52). The EuroQol-5D (EQ-5D) and the Duke Activity Status Index were used to measure health-related quality of life and functional capacity, respectively. Baseline characteristics and number of hospital visits were also analyzed.
  
  
  RESULTS
  The baseline characteristics of the two study groups were similar for both the EQ-5D (RM 0.74, HM 0.67; P = 0.404) and the Duke Activity Status Index (RM 21.42, HM 19.95; P = 0.272). At the 12-month follow up, the EQ-5D utility score was improved for both groups (RM 0.91, HM 0.81; P = 0.154), unlike the EQ-5D Visual Analog Scale (P = 0.043). The Duke Activity Status Index score was similar to the baseline score. The number of in-hospital visits was 27% lower (3 vs 4; P < 0.001) in the remote group as compared with the hospital group.
  
  
  CONCLUSIONS
  The PONIENTE trial suggests that the remote monitoring of pacemakers in older adults is an equivalent option to hospital monitoring, in terms of health-related quality of life and functional capacity. Furthermore, it allows for the early detection of clinical and pacemaker-related adverse events, and significantly reduces the number of in-hospital visits. Geriatr Gerontol Int 2016; 16: 1188-1195.
authors.affiliation: Division of Medicine, Nordland Hospital, Bodø, Norway.|Institute of Clinical Medicine, Faculty of Health Sciences, University of Tromsø, Tromsø, Norway.
authors.forename: Antonio
authors.initials: A
authors.lastname: Lopez-Villegas
authors.affiliation: Health Communication Unit, Madrid University Carlos III, Madrid, Spain.
authors.forename: Daniel
authors.initials: D
authors.lastname: Catalan-Matamoros
authors.affiliation: Intensive Care Unit, Poniente Hospital, El Ejido-Almeria, Spain.
authors.forename: Emilio
authors.initials: E
authors.lastname: Robles-Musso
authors.affiliation: Research Network in Health Services in Chronic Diseases (REDISSEC), Valencia, Spain.|Health Services Research Area, Foundation for the Promotion of Healthcare and Biomedical Research in the Valencian Community, Valencia, Spain.
authors.forename: Salvador
authors.initials: S
authors.lastname: Peiro
mesh_terms: D000368:Aged; D002304:Cardiac Pacing, Artificial / Q000379:methods / Q000639:trends; D002318:Cardiovascular Diseases / Q000175:diagnosis / Q000628:therapy*; D015577:Geriatric Assessment; D006801:Humans; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000379:methods*; D010138:Pacemaker, Artificial / Q000009:adverse effects / Q000592:standards*; D061214:Patient Safety; D011788:Quality of Life; D013686:Telemetry / Q000379:methods*; D016896:Treatment Outcome; D016526:Workload
keywords: older adults; pacemaker follow up; quality of life; remote monitoring; telemedicine