Patient Perspective on Remote Monitoring of Cardiovascular Implantable Electronic Devices (REMOTE-CIED)
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.
Congestive Heart Failure
|Study Design:||Time Perspective: Prospective|
|Official Title:||Remote Monitoring of Heart Failure Patients With Cardiovascular Implantable Electronic Device: The Patient Perspective|
- Patient-reported health status [ Time Frame: 24 months ] [ Designated as safety issue: No ]23-item Kansas City Cardiomyopathy Questionnaire (KCCQ)
- Patient-reported device acceptance [ Time Frame: 24 months ] [ Designated as safety issue: No ]12-item Florida Patient Acceptance Scale (FPAS)
- Patient-reported satisfaction with care [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- 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
- Cost-effectiveness [ Time Frame: 24 months ] [ Designated as safety issue: No ]Data regarding health care utilization is gathered from hospitals and patients.
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Remote patient management system + yearly in-clinic follow-up
In-clinic follow-up according to standard practice (every 3-6 months)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01691586
|University Medical Center Utrecht|
|Principal Investigator:||Mathias Meine, MD, PhD||UMC Utrecht|