Patient Perspective on Remote Monitoring of Cardiovascular Implantable Electronic Devices (REMOTE-CIED)
|ClinicalTrials.gov Identifier: NCT01691586|
Recruitment Status : Active, not recruiting
First Posted : September 24, 2012
Last Update Posted : November 9, 2017
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.
|Condition or disease|
|Congestive Heart Failure|
|Study Type :||Observational|
|Actual Enrollment :||600 participants|
|Official Title:||Remote Monitoring of Heart Failure Patients With Cardiovascular Implantable Electronic Device: The Patient Perspective|
|Actual Study Start Date :||April 13, 2013|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
Remote patient management
Remote patient management system + yearly in-clinic follow-up
In-clinic follow-up according to standard practice (every 3-6 months)
- Patient-reported health status [ Time Frame: 24 months ]23-item Kansas City Cardiomyopathy Questionnaire (KCCQ)
- Patient-reported device acceptance [ Time Frame: 24 months ]12-item Florida Patient Acceptance Scale (FPAS)
- Patient-reported satisfaction with care [ Time Frame: 24 months ]
- 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 ]Data regarding health care utilization is gathered from hospitals and patients.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01691586
|University Medical Center Utrecht|
|Principal Investigator:||Mathias Meine, MD, PhD||UMC Utrecht|