Abstract
BackgroundWith 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.MethodsThe 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.ResultsThe 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 < 0.001). The number of in-office visits was similar in both groups (TM: 1.24 vs HM: 1.12; P = 0.30).ConclusionsThe 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 registrationClinicalTrials.gov NCT02237404, September 11, 2014.
Highlights
With an ageing population and widening indications for pacemakers implantation, the number of persons carrying an implant is steadily increasing
Principal findings Among the main results of the NORDLAND study, we found that, a) there was not significant differences in Health-Related Quality of Life (HRQoL) assessed through EQ-5D utilities and visual analogue scale (VAS) questionnaires administered at 1 and 6 months after implant between users included in the two groups of follow-up, b) in MLHF questionnaire were found significant differences in both groups between the enrolment and the end of follow-up period, c) safety was similar between both groups and no significant differences were found, d) that number of visits to hospital
Values are expressed as means [95CI: 95% confidence interval of means] EQ5D EuroQoL-5D, VAS visual analog scale, MLHFQ Minnesota Living with Heart Failure Questionnaire
Summary
With an ageing population and widening indications for pacemakers implantation, the number of persons carrying an implant is steadily increasing. The aim of this study was to assess the effectiveness of telemonitoring (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. Every hospital visit usually involves an assessment of pacemakers function, cardiovascular events and an analysis of patient physical status and, whether is necessary the medication is modified and/or the device is re-configured again [1, 3]. The routine follow-up is a heavy burden for the respective national health services [4] as well as for the pacemakers users and their caregivers [5, 6]. A study published recently affirms that telemedicine is not significantly more effective than usual care on mental and physical Health-Related Quality of Life (HRQoL) [19]
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