Versteeg, H3; Pedersen, Susanne S.5; Mastenbroek, M H4; Redekop, W K4; Schwab, J O4; Mabo, P4; Meine, M4
1 Department of Psychology, Det Sundhedsvidenskabelige Fakultet, SDU2 INSIDE, Department of Psychology, Det Sundhedsvidenskabelige Fakultet, SDU3 Department of Cardiology, University Medical Center Utrecht, PO Box 85500, 3508 GA, Utrecht, the Netherlands, firstname.lastname@example.org unknown5 Department of Psychology, Det Sundhedsvidenskabelige Fakultet, SDU
rationale and design of the REMOTE-CIED study
BACKGROUND: Remote patient monitoring is a safe and effective alternative for the in-clinic follow-up of patients with cardiovascular implantable electronic devices (CIEDs). However, evidence on the patient perspective on remote monitoring is scarce and inconsistent. OBJECTIVES: The primary objective of the REMOTE-CIED study is to evaluate the influence of remote patient monitoring versus in-clinic follow-up on patient-reported outcomes. Secondary objectives are to: 1) identify subgroups of patients who may not be satisfied with remote monitoring; and 2) investigate the cost-effectiveness of remote monitoring. METHODS: The REMOTE-CIED study is an international randomised controlled study that will include 900 consecutive heart failure patients implanted with an implantable cardioverter defibrillator (ICD) compatible with the Boston Scientific LATITUDE® Remote Patient Management system at participating centres in five European countries. Patients will be randomised to remote monitoring or in-clinic follow-up. The In-Clinic group will visit the outpatient clinic every 3-6 months, according to standard practice. The Remote Monitoring group only visits the outpatient clinic at 12 and 24 months post-implantation, other check-ups are performed remotely. Patients are asked to complete questionnaires at five time points during the 2-year follow-up. CONCLUSION: The REMOTE-CIED study will provide insight into the patient perspective on remote monitoring in ICD patients, which could help to support patient-centred care in the future.
Netherlands Heart Journal, 2014, Vol 22, Issue 10, p. 423-8