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

This study is ongoing, but not recruiting participants.

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: May 19, 2016

Last verified: May 2016

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.


Enrollment:	600
Study Start Date:	April 2013
Estimated Study Completion Date:	December 2017
Estimated Primary Completion Date:	December 2017 (Final data collection date for primary outcome measure)

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

Eligibility


Ages Eligible for Study:	18 Years to 85 Years (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01691586

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


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:	May 19, 2016
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 September 27, 2016

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