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

Primary Purpose

Congestive Heart Failure

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Remote patient monitoring

In-Clinic check-ups

About this trial

This is an interventional supportive care trial for Congestive Heart Failure focused on measuring implantable defibrillators, remote patient monitoring, patient-reported outcomes, cost-effectiveness

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Medical Center Utrecht

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Remote patient management

In-Clinic follow-up

Arm Description

Remote patient management system + yearly in-clinic follow-up

In-clinic follow-up according to standard practice (every 3-6 months)

Outcomes

Primary Outcome Measures

Patient-reported health status

23-item Kansas City Cardiomyopathy Questionnaire (KCCQ)

Patient-reported device acceptance

12-item Florida Patient Acceptance Scale (FPAS)

Secondary Outcome Measures

Patient-reported satisfaction with care

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

Data regarding health care utilization is gathered from hospitals and patients.

Full Information

NCT ID

NCT01691586

First Posted

September 20, 2012

Last Updated

June 6, 2018

Sponsor

UMC Utrecht

Collaborators

Boston Scientific Corporation, Tilburg University, Erasmus Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01691586

Brief Title

Patient Perspective on Remote Monitoring of Cardiovascular Implantable Electronic Devices

Acronym

REMOTE-CIED

Official Title

Remote Monitoring of Heart Failure Patients With Cardiovascular Implantable Electronic Device: The Patient Perspective

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

April 13, 2013 (Actual)

Primary Completion Date

January 15, 2018 (Actual)

Study Completion Date

January 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

UMC Utrecht

Collaborators

Boston Scientific Corporation, Tilburg University, Erasmus Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Congestive Heart Failure

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

600 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Remote patient management

Arm Type

Experimental

Arm Description

Remote patient management system + yearly in-clinic follow-up

Arm Title

In-Clinic follow-up

Arm Type

Other

Arm Description

In-clinic follow-up according to standard practice (every 3-6 months)

Intervention Type

Device

Intervention Name(s)

Remote patient monitoring

Other Intervention Name(s)

Boston Scientific LATITUDE system

Intervention Description

Remote monitoring of ICD and heart failure data

Intervention Type

Other

Intervention Name(s)

In-Clinic check-ups

Intervention Description

Calender-based In-Clinic ICD check-up

Primary Outcome Measure Information:

Title

Patient-reported health status

Description

23-item Kansas City Cardiomyopathy Questionnaire (KCCQ)

Time Frame

24 months

Title

Patient-reported device acceptance

Description

12-item Florida Patient Acceptance Scale (FPAS)

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Patient-reported satisfaction with care

Description

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

Time Frame

24 months

Title

Cost-effectiveness

Description

Data regarding health care utilization is gathered from hospitals and patients.

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mathias Meine, MD, PhD

Organizational Affiliation

UMC Utrecht

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Medical Center Utrecht

City

Utrecht

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

36245363

Citation

de Graaf G, Timmermans I, Meine M, Alings M, Pedersen SS, Mabo P, Zitron E, Redekop K, Versteeg H. Economic evaluation of remote monitoring of patients with an implantable cardiac defibrillator (REMOTE-CIED study). J Telemed Telecare. 2022 Oct 17:1357633X221129176. doi: 10.1177/1357633X221129176. Online ahead of print.

Results Reference

derived

PubMed Identifier

34410384

Citation

Chiu CSL, Timmermans I, Versteeg H, Zitron E, Mabo P, Pedersen SS, Meine M; REMOTE-CIED Trial Investigators. Effect of remote monitoring on clinical outcomes in European heart failure patients with an implantable cardioverter-defibrillator: secondary results of the REMOTE-CIED randomized trial. Europace. 2022 Feb 2;24(2):256-267. doi: 10.1093/europace/euab221.

Results Reference

derived

PubMed Identifier

31168604

Citation

Versteeg H, Timmermans I, Widdershoven J, Kimman GJ, Prevot S, Rauwolf T, Scholten MF, Zitron E, Mabo P, Denollet J, Pedersen SS, Meine M. Effect of remote monitoring on patient-reported outcomes in European heart failure patients with an implantable cardioverter-defibrillator: primary results of the REMOTE-CIED randomized trial. Europace. 2019 Sep 1;21(9):1360-1368. doi: 10.1093/europace/euz140.

Results Reference

derived

PubMed Identifier

30536931

Citation

Timmermans I, Meine M, Szendey I, Aring J, Romero Roldan J, van Erven L, Kahlert P, Zitron E, Mabo P, Denollet J, Versteeg H. Remote monitoring of implantable cardioverter defibrillators: Patient experiences and preferences for follow-up. Pacing Clin Electrophysiol. 2019 Feb;42(2):120-129. doi: 10.1111/pace.13574. Epub 2019 Jan 2.

Results Reference

derived

PubMed Identifier

28606488

Citation

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.

Results Reference

derived

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Patient Perspective on Remote Monitoring of Cardiovascular Implantable Electronic Devices

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