A relatively new and promising development in the area of cardiovascular implantable electronic device therapy is remote patient monitoring (RPM). RPM systems can interrogate the device automatically and send the data from the patients' home to the physician, thereby reducing in-clinic follow-ups. The purpose of this study is to evaluate the effect of RPM + in-clinic follow-up versus in-clinic follow-up only on patient-reported health status and device-acceptance after implantation with an implantable cardioverter defibrillator (ICD) or cardiac resynchronization defibrillator (CRT-D). Secondary objectives are (1) to identify subgroups of patients who prefer RPM over in-clinic visits or vice versa due to specific clinical and psychological factors and (2) To investigate the cost-effectiveness of RPM + in-clinic follow-up compared to in-clinic follow-up only.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
600
Remote monitoring of ICD and heart failure data
Calender-based In-Clinic ICD check-up
University Medical Center Utrecht
Utrecht, Netherlands
Patient-reported health status
23-item Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: 24 months
Patient-reported device acceptance
12-item Florida Patient Acceptance Scale (FPAS)
Time frame: 24 months
Patient-reported satisfaction with care
* Visual Analogue Scale ranging from 0-100 (with higher score representing more satisfaction with care) * 26-item self-made questionnaire to assess satisfaction with RPM
Time frame: 24 months
Cost-effectiveness
Data regarding health care utilization is gathered from hospitals and patients.
Time frame: 24 months
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