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

This study is currently recruiting participants.
Verified April 2013 by UMC Utrecht
Sponsor:
Collaborators:
Boston Scientific Corporation
University of Tilburg
Erasmus Medical Center
Information provided by (Responsible Party):
M. Meine, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT01691586
First received: September 20, 2012
Last updated: April 18, 2013
Last verified: April 2013
History of Changes
  Purpose

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
Congestive Heart Failure

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Remote Monitoring of Heart Failure Patients With Cardiovascular Implantable Electronic Device: The Patient Perspective

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Patient-reported health status [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    23-item Kansas City Cardiomyopathy Questionnaire (KCCQ)

  • Patient-reported device acceptance [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    12-item Florida Patient Acceptance Scale (FPAS)


Secondary Outcome Measures:
  • Patient-reported satisfaction with care [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    Data regarding health care utilization is gathered from hospitals and patients.


Estimated Enrollment: 900
Study Start Date: April 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
RPM
RPM + in-clinic follow-up
In-Clinic
In-clinic follow-up

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01691586

Contacts
Contact: Mathias Meine, Dr +31 (0)88 466 6184 mmeine@umcutrecht.nl

Locations
Netherlands
University Medical Center Utrecht Recruiting
Utrecht, Netherlands
Contact: Mathias Meine, MD, PhD            
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

No publications provided

Responsible Party: M. Meine, Principal Investigator, UMC Utrecht
ClinicalTrials.gov Identifier: NCT01691586     History of Changes
Other Study ID Numbers: UMCU.DHL.001
Study First Received: September 20, 2012
Last Updated: April 18, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by UMC Utrecht:
implantable defibrillators
remote patient monitoring
patient-reported outcomes
cost-effectiveness

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013