Health-related quality of life on tele-monitoring for users with pacemakers 6 months after implant: the NORDLAND study, a randomized trial.
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BACKGROUND With an ageing population and widening indications for pacemakers implantation the number of persons carrying an implant is steadily increasing The routine follow up is thus a heavy burden for the respective NHS as well as for the patients and their relatives Most of them of the studies have been performed in densely populated areas and nearby to the hospital It is thus unknown whether these results could be applied also in rural areas such as Northern Norway with a more scattered population The aim of this study was to assess the effectiveness of tele monitoring TM in patients with pacemakers regarding reliability safety and health related quality of life compared to traditional follow up in outpatient clinic in a setting where geographical effects could possible influence the results METHODS The NORDLAND study is a controlled randomized non masked clinical trial in pacemaker patients with data collection carried out during the pre implant stage and after 6 months Between August of 2014 and November of 2015 50 patients were assigned to either a tele monitoring group n 25 or a conventional hospital monitoring HM group n 25 The EuroQol 5D EQ 5D utilities and visual analogue scale VAS and the Minnesota Living with Heart Failure Questionnaire MLHFQ were used to measure Health Related Quality of Life Baseline characteristics and number of hospital visits were also analyzed RESULTS The baseline characteristics of the two study groups were similar for EQ 5D utilities TM 0 81 HM 0 76 p 0 47 EQ 5D VAS TM 64 00 HM 64 88 p 0 86 and the MLHFQ TM 20 20 HM 28 96 p 0 07 At the 6 month follow up there were no significant differences between the groups in EQ 5D utilities TM 0 81 HM 0 76 p 0 54 and EQ 5D VAS scores TM 72 71 HM 59 79 p 0 08 The MLHFQ score was improved in both groups TM 4 40 HM 15 13 p Under 0 001 The number of in office visits was similar in both groups TM 1 24 vs HM 1 12 P 0 30 CONCLUSIONS The NORDLAND trial shows that HRQoL is improved after implant in both groups Without significant differences with regards to effectiveness and safety In addition provides a scientifically rigorous method to the field of HRQoL evaluations in patients with pacemakers TRIAL REGISTRATION ClinicalTrials gov NCT02237404 September 11 2014