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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01691586
Recruitment Status : Completed
First Posted : September 24, 2012
Last Update Posted : June 8, 2018
Sponsor:
Collaborators:
Boston Scientific Corporation
Tilburg University
Erasmus Medical Center
Information provided by (Responsible Party):
M. Meine, UMC Utrecht

Study Description
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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 Intervention/treatment Phase
Congestive Heart Failure Device: Remote patient monitoring Other: In-Clinic check-ups Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Remote Monitoring of Heart Failure Patients With Cardiovascular Implantable Electronic Device: The Patient Perspective
Actual Study Start Date : April 13, 2013
Actual Primary Completion Date : January 15, 2018
Actual Study Completion Date : January 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
Experimental: Remote patient management
Remote patient management system + yearly in-clinic follow-up
 Device: Remote patient monitoring
Remote monitoring of ICD and heart failure data
Other Name: Boston Scientific LATITUDE system

Other: In-Clinic check-ups
Calender-based In-Clinic ICD check-up
In-Clinic follow-up
In-clinic follow-up according to standard practice (every 3-6 months)
 Other: In-Clinic check-ups
Calender-based In-Clinic ICD check-up


Outcome Measures
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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
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01691586


Locations
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Netherlands
University Medical Center Utrecht
Utrecht, Netherlands
Sponsors and Collaborators
UMC Utrecht
Boston Scientific Corporation
Tilburg University
Erasmus Medical Center
Investigators
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Principal Investigator: Mathias Meine, MD, PhD UMC Utrecht
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: M. Meine, Principal Investigator, UMC Utrecht
ClinicalTrials.gov Identifier: NCT01691586    
Other Study ID Numbers: UMCU.DHL.001
First Posted: September 24, 2012    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: June 2018

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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:
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Heart Failure
Heart Diseases
Cardiovascular Diseases