Patient Perspective on Remote Monitoring of Cardiovascular Implantable Electronic Devices (REMOTE-CIED)

Study Description

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease
Congestive Heart Failure

Study Design

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Actual Enrollment :	600 participants
Observational Model:	Other
Time Perspective:	Prospective
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

Groups and Cohorts

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Remote patient management; Remote patient management system + yearly in-clinic follow-up
In-Clinic follow-up; In-clinic follow-up according to standard practice (every 3-6 months)

Outcome Measures

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Patient-reported health status [ Time Frame: 24 months ]
   23-item Kansas City Cardiomyopathy Questionnaire (KCCQ)
2. Patient-reported device acceptance [ Time Frame: 24 months ]
   12-item Florida Patient Acceptance Scale (FPAS)

Secondary Outcome Measures :

1. 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
2. Cost-effectiveness [ Time Frame: 24 months ]
   Data regarding health care utilization is gathered from hospitals and patients.

Eligibility Criteria

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Heart failure patients implanted with a first-time ICD/CRT-D device at one of the participating centers.

Criteria

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

Contacts and Locations

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Netherlands
University Medical Center Utrecht
Utrecht, Netherlands

Sponsors and Collaborators

UMC Utrecht

Boston Scientific Corporation

University of Tilburg

Erasmus Medical Center

Investigators

Principal Investigator:	Mathias Meine, MD, PhD	UMC Utrecht

More Information

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Timmermans I, Versteeg H, Meine M, Pedersen SS, Denollet J. Illness perceptions in patients with heart failure and an implantable cardioverter defibrillator: Dimensional structure, validity, and correlates of the brief illness perception questionnaire in Dutch, French and German patients. J Psychosom Res. 2017 Jun;97:1-8. doi: 10.1016/j.jpsychores.2017.03.014. Epub 2017 Mar 23.

Responsible Party:	M. Meine, Principal Investigator, UMC Utrecht
ClinicalTrials.gov Identifier:	NCT01691586 History of Changes
Other Study ID Numbers:	UMCU.DHL.001
First Posted:	September 24, 2012
Last Update Posted:	November 9, 2017
Last Verified:	November 2017

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by M. Meine, UMC Utrecht:

implantable defibrillators; remote patient monitoring; patient-reported outcomes; cost-effectiveness

Additional relevant MeSH terms:

Heart Failure; Heart Diseases; Cardiovascular Diseases