Differential experiences using telemonitoring via smartphone app ore home transmitter: Interim evaluation of the Smart-Monitor Study

Abstract Background Heart failure patients can be protected with implantable cardiac defibrillators (ICDs) to prevent sudden cardiac death due to ventricular arrhythmias. Thanks to the digital transformation and the implementation of remote monitoring (RM) of ICDs, patients can now be followed-up even more closely. However, the comparative efficacy of bluetooth-based RM versus the conventional method via radiofrequency (RF) remains to be evaluated. Research question: The aim of this single-center prospective randomized study was to investigate the patients´ perspective on the risks and benefits of RM in the context of their own smartphone vs. a home-based transmitter. The focus was to characterize differences between the two groups in terms of patient’s well-being. Methods Patients newly implanted with a 1- or 2-chamber ICD (Abbott) were asked to participate. After informed consent, randomization to a smartphone (SP) or a hometransmitter (HT) group was performed. Data collection took place at 3 different time points over 6 month (t0, t2, t3). The study was designed as a mixed-methods design with 2 guideline-based interviews and standardized questionnaires to measure quality of life (SF-36), influence of RM on quality of life (Tele-QoL) and anxiety (GAD-7). In the interim evaluation of the guideline-based interviews (n=26), the subcodes were quantified in accordance with the deductively determined main categories. Results Until now, 31 participants (SP: 17; HT:16) completed the study. The physical (KSK) and mental (PSK) sum scales of the SF-36 and GAD-7 were measured at t0, t2 and t3. There was no significant difference between the two groups in terms of improvement in PSKt3 (p=0.377) and in KSKt3 (p=0.356). The GAD-7 showed a significant change in anxiety behavior (GAD7t3-t0 p=0.020) due to the follow up period of 6 months, but no difference between both groups (p=0,544). The Tele-QoL was measured t3 (p=0.139). The group-specific evaluation after 6 months showed a difference in the unproblematic installation of the RM (SP: 46.2%; HT: 92.3%; p=0.01). The advantages were experienced in permanent monitoring (SP: 15.4%; HT: 46.2%; p=0.089), short-term contact (SP: 53.8%; HT: 7.7%; p=0.01) and sense of security (SP: 61.5%; HT: 38.5%; p=0.24). Concerns mentioned included data protection (SP: 23.1%; HT: 15.4%; p=0.62), unfulfilled expectations (SP: 15.4%; HT: 15.4%; p=1), worries about additional work (HT: 15.4%) and connectivity (SP: 15.4%). Conclusion After 6 months, there was no significant difference between both intervention groups as measured with SF-36, GAD-7 and the TeleQoL. In the analyzed interviews, the ease of use when using an RM with HT was particularly noticeable. In both groups, there was an expectation of an increased need for safety. Further data analysis is required to analyze equivalence in terms of patient needs and to assess the individual influencing factors in the group comparison.