Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
| Tilburg University | OTHER |
| Erasmus Medical Center | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote patient management | Experimental | Remote patient management system + yearly in-clinic follow-up |
|
| In-Clinic follow-up | Other | In-clinic follow-up according to standard practice (every 3-6 months) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote patient monitoring | Device | Remote monitoring of ICD and heart failure data |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported satisfaction with care |
| 24 months |
| Cost-effectiveness |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mathias Meine, MD, PhD | UMC Utrecht | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Utrecht | Utrecht | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36245363 | Derived | 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. | |
| 34410384 | Derived |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| In-Clinic check-ups | Other | Calender-based In-Clinic ICD check-up |
|
Data regarding health care utilization is gathered from hospitals and patients.
| 24 months |
| 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. |
| 31168604 | 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. |
| 30536931 | 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. |
| 28606488 | 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. |