Why the study?
Does remote monitoring improve patient-reported outcomes in heart failure patients with an ICD compared to standard in-clinic follow-up?
Does remote monitoring improve patient-reported outcomes in heart failure patients with an ICD compared to standard in-clinic follow-up?
The REMOTE-CIED study is designed to evaluate the impact of remote monitoring versus in-clinic follow-up on patient-reported outcomes and cost-effectiveness in heart failure patients with ICDs.
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This RCT will test remote monitoring versus in-clinic follow-up on PROs and cost-effectiveness in HF patients with ICDs; delivers first randomized evidence on the comparison.
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.
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Versteeg et al. (2014) studied this question.
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