Patient Perspective on Remote Monitoring of Cardiovascular Implantable Electronic Devices

NCT01691586 | Completed

• 1 other identifier: UMCU.DHL.001
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Congestive Heart Failure

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Patient-reported health status

  23-item Kansas City Cardiomyopathy Questionnaire (KCCQ)

  24 months

• Patient-reported device acceptance

  12-item Florida Patient Acceptance Scale (FPAS)

  24 months

Secondary Outcomes (2)

• Patient-reported satisfaction with care

  24 months

• Cost-effectiveness

  24 months

Study Arms (2)

Remote patient management

EXPERIMENTAL

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

Device: Remote patient monitoring; Other: In-Clinic check-ups

In-Clinic follow-up

OTHER

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

Other: In-Clinic check-ups

Interventions

Remote patient monitoring DEVICE

Remote monitoring of ICD and heart failure data

Also known as: Boston Scientific LATITUDE system

Remote patient management

In-Clinic check-ups OTHER

Calender-based In-Clinic ICD check-up

In-Clinic follow-up; Remote patient management

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UMC Utrecht: lead
• Boston Scientific Corporation: collaborator
• Tilburg University: collaborator
• Erasmus Medical Center: collaborator

Study Sites (1)

University Medical Center Utrecht

Utrecht, Netherlands

Location

Related Publications (5)

• 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. 2024 Aug;30(7):1173-1185. doi: 10.1177/1357633X221129176. Epub 2022 Oct 17.

  PMID: 36245363 DERIVED

• 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.

  PMID: 34410384 DERIVED

• 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.

  PMID: 31168604 DERIVED

• 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.

  PMID: 30536931 DERIVED

• 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.

  PMID: 28606488 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Mathias Meine, MD, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 20, 2012
• First Posted: September 24, 2012
• Study Start: April 13, 2013
• Primary Completion: January 15, 2018
• Study Completion: January 15, 2018
• Last Updated: June 8, 2018

Record last verified: 2018-06

Locations

NL (1)