Health-related quality of life on tele-monitoring for users with pacemakers 6 months after implant: the NORDLAND study, a randomized trial

Antonio Lopez-Villegas, Daniel Catalan-Matamoros, Remedios Lopez-Liria, Terje Enebakk, Hilde Thunhaug, Knut Tore Lappegård, Antonio Lopez-Villegas, Daniel Catalan-Matamoros, Remedios Lopez-Liria, Terje Enebakk, Hilde Thunhaug, Knut Tore Lappegård

Abstract

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 < 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.

Keywords: Health-related quality of life; Older adults; Pacemaker follow-up; Randomized study; Remote monitoring; Telemedicine.

Conflict of interest statement

Ethics approval and consent to participate

The protocol was approved by the Regional Ethics Committee - REK Nord (Tromsø, Norway), the committee’s reference number: 2014/383/REK Nord. The study was developed in accordance with the precepts of the Declaration of Helsinki. All patients signed the corresponding informed consent prior to their enrolment and appropriate measures were taken to ensure data privacy. ClinicalTrials.gov NCT02237404.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow (CONSORT) diagram of the study

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