Clinical trial NCT02234245: Economic Evaluation in Cardiology: Remote Monitoring of Pacemakers
Official title: Economic Evaluation in Cardiology: Remote Monitoring of Pacemakers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: Follow-Up studies
Biological Pacemakers
Telemedicine
Efficiency
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
First posted: 2014-09-09
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this research is to estimate the outcomes in health and cost of the follow-up of patients with pacemakers.

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.

Detailed description: Cardiovascular Diseases are a major cause of global morbidity and mortality, being responsible according to the World Health Organization of the 30% of overall mortality.

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.

Eligibility criteria: Inclusion Criteria:

* Be 18 years of age
* Have a pacemaker implanted
* Understand and be able to properly perform self-monitoring at home

Exclusion Criteria:

* Be participating in another study
* Refuse to participate in the study
* Have implanted a different cardiac device to the pacemaker

Primary outcomes:
measure: Clinical features
timeFrame: 12 months
Secondary outcomes:
measure: Health-Related Quality of Life
timeFrame: 5 years
measure: Functional capacity
timeFrame: 5 years
measure: Direct costs
timeFrame: 5 years
measure: Indirect cost
timeFrame: 5 years
measure: Informal costs
timeFrame: 5 years
measure: Number of patients with Adverse Events
timeFrame: 5 years
measure: Consultations and Hospitalizations unscheduled
timeFrame: 5 years
Other outcomes:
Locations:
city: El Ejido
country: Spain
facility: Hospital de Poniente
state: Almeria
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.