Patient Perspective on Remote Monitoring of Cardiovascular Implantable Electronic Devices

Congestive Heart Failure Clinical Trial

— REMOTE-CIED  

Official title:

Remote Monitoring of Heart Failure Patients With Cardiovascular Implantable Electronic Device: The Patient Perspective

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01691586
• Other study ID #: UMCU.DHL.001
• Status: Completed
• Phase: N/A
• Start date: April 13, 2013
• Est. completion date: January 15, 2018

Study information

• Verified date: June 2018
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: January 15, 2018
• Est. primary completion date: January 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• first time ICD/CRT-D implanted at one of the participating centers

• left ventricular ejection fraction <35%

• NYHA functional class II or III symptoms

• ICD/CRT-D device compatible with the LATITUDE(r) RPM system from Boston Scientific

Exclusion Criteria:

• On the waiting list for heart transplantation

• History of psychiatric illness others than affective/anxiety disorders

• Cognitive impairments

• Insufficient knowledge of the language to fill in the questionnaires

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Device:
• Remote patient monitoring
Remote monitoring of ICD and heart failure data

Other:
• In-Clinic check-ups
Calender-based In-Clinic ICD check-up

Locations

Country	Name	City	State
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (4)

Lead Sponsor	Collaborator
UMC Utrecht	Boston Scientific Corporation, Erasmus Medical Center, University of Tilburg

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-reported health status	23-item Kansas City Cardiomyopathy Questionnaire (KCCQ)	24 months
Primary	Patient-reported device acceptance	12-item Florida Patient Acceptance Scale (FPAS)	24 months
Secondary	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	24 months
Secondary	Cost-effectiveness	Data regarding health care utilization is gathered from hospitals and patients.	24 months