The INFluence of Remote monitoring on Anxiety/depRession, quality of lifE, and Device acceptance in ICD patients: a prospective, randomized, controlled, single-center trial
Open Access
- 16 May 2020
- journal article
- research article
- Published by Springer Science and Business Media LLC in Clinical Research in Cardiology
- Vol. 110 (6), 789-800
- https://doi.org/10.1007/s00392-020-01667-0
Abstract
Background Impact of telemedicine with remote patient monitoring (RPM) in implantable cardioverter–defibrillator (ICD) patients on clinical outcomes has been investigated in various clinical settings with divergent results. However, role of RPM on patient-reported-outcomes (PRO) is unclear. The INFRARED-ICD trial aimed to investigate the effect of RPM in addition to standard-of-care on PRO in a mixed ICD patient cohort. Methods and results Patients were randomized to RPM (n = 92) or standard in-office-FU (n = 88) serving as control group (CTL). At baseline and on a monthly basis over 1 year, study participants completed the EQ-5D questionnaire for the primary outcome Quality of Life (QoL), the Hospital Anxiety and Depression Scale, and the Florida Patient Acceptance Survey questionnaire for secondary outcomes. Demographic characteristics (82% men, mean age 62.3 years) and PRO at baseline were not different between RPM and CTL. Primary outcome analysis showed that additional RPM was not superior to CTL with respect to QoL over 12 months [+ 1.2 vs. + 3.9 points in CTL and RPM group, respectively (p = 0.24)]. Pre-specified analyses could not identify subgroups with improved QoL by the use of RPM. Neither levels of anxiety (− 0.4 vs. − 0.3, p = 0.88), depression (+ 0.3 vs. ± 0.0, p = 0.38), nor device acceptance (+ 1.1 vs. + 1.6, p = 0.20) were influenced by additional use of RPM. Conclusion The results of the present study show that PRO were not improved by RPM in addition to standard-of-care FU. Careful evaluation and planning of future trials in selected ICD patients are warranted before implementing RPM in routine practice. Graphic abstractKeywords
This publication has 39 references indexed in Scilit:
- The MOnitoring Resynchronization dEvices and CARdiac patiEnts (MORE-CARE) Randomized Controlled Trial: Phase 1 Results on Dynamics of Early Intervention With Remote MonitoringJournal of Medical Internet Research, 2013
- A randomized study of remote follow-up of implantable cardioverter defibrillators: safety and efficacy report of the ECOST trialEuropean Heart Journal, 2012
- Monitoring Device Acceptance in Implantable Cardioverter Defibrillator Patients Using the Florida Patient Acceptance SurveyPacing and Clinical Electrophysiology, 2012
- The CONNECT (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision) Trial: The Value of Wireless Remote Monitoring With Automatic Clinician AlertsJournal of the American College of Cardiology, 2011
- Does ICD Indication Affect Quality of Life and Levels of Distress?Pacing and Clinical Electrophysiology, 2009
- Quality of Life with Defibrillator Therapy or Amiodarone in Heart FailureThe New England Journal of Medicine, 2008
- Remote monitoring of implantable cardioverter defibrillator patients: a safe, time-saving, and cost-effective means for follow-upEP Europace, 2008
- A single European currency for EQ-5D health statesThe European Journal of Health Economics, 2003
- EQ-SD: a measure of health status from the EuroQol GroupAnnals of Medicine, 2001
- The Hospital Anxiety and Depression ScaleActa Psychiatrica Scandinavica, 1983