Clinical trial NCT01691586: Patient Perspective on Remote Monitoring of Cardiovascular Implantable Electronic Devices
Official title: Remote Monitoring of Heart Failure Patients With Cardiovascular Implantable Electronic Device: The Patient Perspective
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure
Keywords: implantable defibrillators
remote patient monitoring
patient-reported outcomes
cost-effectiveness
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
name: Tilburg University
name: Erasmus Medical Center
First posted: 2012-09-24
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Patient-reported health status
timeFrame: 24 months
measure: Patient-reported device acceptance
timeFrame: 24 months
Secondary outcomes:
measure: Patient-reported satisfaction with care
timeFrame: 24 months
measure: Cost-effectiveness
timeFrame: 24 months
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: UMC Utrecht
name: Mathias Meine, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. 2024 Aug;30(7):1173-1185. doi: 10.1177/1357633X221129176. Epub 2022 Oct 17.
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.
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.
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.
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.