Patient Perspective on Remote Monitoring of Cardiovascular Implantable Electronic Devices

Not Applicable

Completed

• Conditions: Congestive Heart Failure
• Interventions: Device: Remote patient monitoring; Other: In-Clinic check-ups

• Registration Number: NCT01691586
• Lead Sponsor: UMC Utrecht

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-20
• Study First Submitted QC: 2012-09-20
• Study First Posted: 2012-09-24
• Study Start: 2013-04-13
• Primary Completion: 2018-01-15
• Study Completion: 2018-01-15
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-06
• Last Update Posted: 2018-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remote patient management	Remote patient monitoring	Remote patient management system + yearly in-clinic follow-up
Remote patient management	In-Clinic check-ups	Remote patient management system + yearly in-clinic follow-up
In-Clinic follow-up	In-Clinic check-ups	In-clinic follow-up according to standard practice (every 3-6 months)

Primary Outcome Measures

Name	Time	Method
Patient-reported health status	24 months	23-item Kansas City Cardiomyopathy Questionnaire (KCCQ)
Patient-reported device acceptance	24 months	12-item Florida Patient Acceptance Scale (FPAS)

Secondary Outcome Measures

Name	Time	Method
Cost-effectiveness	24 months	Data regarding health care utilization is gathered from hospitals and patients.
Patient-reported satisfaction with care	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

Trial Locations

Locations (1)

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands