Defibrillator, Pacemaker, Telemedecine
Conditions
Keywords
Implantable cardioverter defibrillator, ICD, Telemedecine, Remote monitoring, Remote programming, Cardiac implantable electronical device, Medically underserved population, Medically underserved area, Health professional shortage area
Brief summary
Cardiac Implantable Electronic Devices (CIEDs) such as pacemakers and implantable cardioverter defibrillators need to be regularly and systematically interrogated and reprogrammed to ensure proper functioning. While remote monitoring allows for partial interrogation at a remote location, full CIED check-up and reprogramming is only possible when the patient visits a cardiologist capable of performing device programming. This can be challenging for patients and may cause unnecessary delays, particularly in settings of limited resources, enforced physical distancing, and quarantines. The aim of this study is to evaluate our previously validated remote programming solution (REACT study, NCT05366660) in outpatient device clinics which are close to the patient's home but remote from the CIED expert.
Detailed description
Remote programming of a CIED offers multiple advantages such as shorter travel distances for the patient, reduced need for presence of specialized cardiologists and the possibility to offer expert support at remote locations or developing countries. Remote programming may be a way to mitigate disparities in health care access. The remote surveillance centre of CHU Bordeaux has previously developed and validated (REACT study, NCT05366660) a remote control system for CIED programmers that eliminates the physical presence of a cardiologist during the interrogation and programming process. The aim of this study is to evaluate this solution for the remote evaluation of CIEDs at the benefit of inhabitant of medically underserved population. Enrolled patients living \>100km from the Bordeaux University Hospital will undergo there an in person evaluation of their CIED which will be compared six months later with a remote evaluation in a nurse office close to the patient's home.
Interventions
OTHERTeleconsultation
Teleconsultation at 6 months
Sponsors
University Hospital, Bordeaux
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Prospective, single-center, single-arm, pairwise comparison trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient of both sexes over the age of 18 * Patients implanted with a cardiac pacemaker or an automatic defibrillator and an indication for device check-up (interrogation ± programming) * Patient followed at the Bordeaux University Hospital but living more than 90km away * Person beneficiary of social security insurance * Informed consent confirmed in writing (at the latest on the day of inclusion and before any examination required by the research) * Women of procreating age with effective contraception
Exclusion criteria
* Patients younger than 18 years old * Patients who are incapable to understand the study design or to give informed consent. * Pregnant or breastfeeding women * Persons placed under legal protection * Subject deprived of liberty on judicial or administrative decision * Persons participating in another study who are still in their period of exclusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| assess the satisfaction of patients benefiting from a teleconsultation compared to a standard consultation at hospital | 6 months | Patient satisfaction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time saving for patient | 6 months | Time of consultation and teleconsultation |
| Savings on medical transport | 6 months | Cost of medical transports for consultation and teleconsultation |
| Costs associated with teleconsultation | 6 months | Global amount of costs for teleconsultation |
| safety of teleconsultation | 6 months | Number of Adverse Events and technical incidents |
Countries
France
Outcome results
None listed