Economic Evaluation in Cardiology: Remote Monitoring of Pacemakers
NCT ID: NCT02234245
Last Updated: 2023-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
83 participants
INTERVENTIONAL
2012-10-31
2018-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The initial hypothesize of this study is that remote monitoring of pacemaker will show a best relation of outcomes in costs and effectiveness than the conventional follow-up in hospital.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cost-Effectiveness of Routine Follow-up Visits in Patients With a Pacemaker: The Followpace Study
NCT00135174
Physiological Pacing for AV Block to Prevent Pacemaker-induced Cardiomyopathy
NCT05214365
The Influence of Heart Rate Limitation on Exercise Tolerance in Pacemaker Patients.
NCT02247245
Trajectory Changes of Coronary Sinus Lead Tip and Cardiac Resynchronization Therapy Outcome
NCT02340546
ECG Algorithms for CRT Response Evaluation
NCT04061434
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Since 2001 that the first pacemaker of remote monitoring was implanted in Europe, more than 300,000 pacemaker have been implanted around the world. Despite this sharp expansion, the scientific evidence on economic evaluations of pacemaker with remote monitoring is very limited, and in our knowledge, studies including informal costs have not been conducted.
In the field of cardiology, telemedicine allows consultations with patients through monitoring systems and remote communication analyzing the ongoing heart rates of people with pacemakers, implantable cardioverter defibrillators, cardiac resynchronization therapy and subcutaneous Holter. The use of remote monitoring may save time and efforts to both healthcare professionals and patients, including their informal caregivers, reducing the number of follow up visits to the hospital and reducing the associated costs with patient follow-up, which will help to improve sustainability of healthcare services.
During the 12 months of study, the patients with implant of pacemakers of both groups will be assessed of the same parameters, in 4 different moments (pre-implant and months 1, 6, 12 and 5 years post-implantation).
The study will estimate: 1) The Clinical features of the patients. 2) The effectiveness through of administration of health-related quality of life, functional capacity questionnaires and 3) Finally, the hospital and informal costs of patients with pacemakers will be estimated by the researches.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Hospital monitoring of pacemakers
Patients have to go to the hospital to be monitorized
No interventions assigned to this group
Remote monitoring of pacemakers
Telemedicine System:
Patients have not to go to the hospital to be monitorized
Telemedicine System
Telemedicine System is used in remote monitoring group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Telemedicine System
Telemedicine System is used in remote monitoring group
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Have a pacemaker implanted
* Understand and be able to properly perform self-monitoring at home
Exclusion Criteria
* Refuse to participate in the study
* Have implanted a different cardiac device to the pacemaker
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universidad de Almeria
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Antonio Lopez Villegas
PhD student
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital de Poniente
El Ejido, Almeria, Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Catalan-Matamoros D, Lopez-Villegas A, Leal Costa C, Bautista-Mesa R, Robles-Musso E, Rocamora Perez P, Lopez-Liria R. A non-randomized clinical trial to examine patients' experiences and communication during telemonitoring of pacemakers after five years follow-up. PLoS One. 2021 Dec 23;16(12):e0261158. doi: 10.1371/journal.pone.0261158. eCollection 2021.
Bautista-Mesa RJ, Lopez-Villegas A, Peiro S, Catalan-Matamoros D, Robles-Musso E, Lopez-Liria R, Leal-Costa C. Long-term cost-utility analysis of remote monitoring of older patients with pacemakers: the PONIENTE study. BMC Geriatr. 2020 Nov 16;20(1):474. doi: 10.1186/s12877-020-01883-3.
Lopez-Villegas A, Catalan-Matamoros D, Robles-Musso E, Peiro S. Workload, time and costs of the informal cares in patients with tele-monitoring of pacemakers: the PONIENTE study. Clin Res Cardiol. 2016 Apr;105(4):307-13. doi: 10.1007/s00392-015-0921-5. Epub 2015 Sep 30.
Lopez-Villegas A, Catalan-Matamoros D, Robles-Musso E, Peiro S. [Comparative Effectiveness of Remote Monitoring of People with Cardiac Pacemaker versus Conventional: quality of Life at the 6 Months]. Rev Esp Salud Publica. 2015 Apr;89(2):149-58. doi: 10.4321/S1135-57272015000200004. Spanish.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CEIC-AL 53/2012
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.