Economic Evaluation in Cardiology: Remote Monitoring of Pacemakers

Not Applicable

Completed

• Conditions: Cardiovascular Disease
• Interventions: Device: Telemedicine System

• Registration Number: NCT02234245
• Lead Sponsor: Universidad de Almeria

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.

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2013-11
• Study First Submitted: 2014-08-28
• Study First Submitted QC: 2014-09-04
• Study First Posted: 2014-09-09
• Study Completion: 2018-10
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remote monitoring of pacemakers	Telemedicine System	Telemedicine System: Patients have not to go to the hospital to be monitorized

Primary Outcome Measures

Name	Time	Method
Clinical features	12 months	Selected variables from the medical history records: * gender; * age; * indication for the implantation of the pacemaker.; * comorbidities; * pharmacological treatment; * vital signs; * pacemaker parameters

Secondary Outcome Measures

Name	Time	Method
Direct costs	5 years	Direct costs taken into account: * pacemakers' costs´(device implanted); * hospitalizations' costs; * consultations' costs (hospital); * prescribed medical transport's cost; * health personnel costs; * pharmaceutical costs
Number of patients with Adverse Events	5 years	Number of patients with Adverse Events; - type of Adverse Events diagnosed
Consultations and Hospitalizations unscheduled	5 years	- number of unscheduled visits and hospitalizations
Health-Related Quality of Life	5 years	EuroQol-5Dimensions (EQ-5D)
Informal costs	5 years	Costs related to the care and displacements of patients to hospital: * displacement costs to hospital; * Accommodation costs; * Cost of meals; * Costs for caregivers
Functional capacity	5 years	Duke Activity Status Index (DASI).
Indirect cost	5 years	Maintenance of the medical consultation (hospital): * electricity; * cleaning; * furniture; * Health fungible; * equipment investment

Trial Locations

Locations (1)

Hospital de Poniente; 🇪🇸 El Ejido, Almeria, Spain