Effectiveness of pacemaker tele-monitoring on quality of life, functional capacity, event detection and workload: The PONIENTE trial

Aims 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