Economic Evaluation and Communication in Remote Monitoring of People With Pacemakers

Study Overview
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Brief Summary
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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
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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 06 months of study, the patients with implant of pacemakers of both groups will be assessed of the same parameters, in 3 different moments (pre-implant and months 1, and 6 post-implantation). Pacemakers that are going to be used in the project: Remote monitoring group: Biotronik Estella SR-T and DR-T & Biotronik Evia SR-T and DR-T. Hospital monitoring group: St Jude Medical Endurity SR and DR & Sorin Reply 200 SR and DR. The study will estimate: 1) The Clinical features of the patients. 2) The effectiveness through of administration of Health-Related Quality of Life questionnaires and 3) Finally, hospital and informal costs of patients with pacemakers will be estimated by the researches.

Official Title
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Sustainability of Cardiology Services: Economic Evaluation and Communication in Remote Monitoring of People With Pacemakers.

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Device: Telemedicine System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Hospital monitoring of pacemakers<br>Patients have to go to the hospital to be monitorized | |
| Experimental: Remote monitoring of pacemakers<br>Telemedicine System: Patients have not to go to the hospital to be monitorized | Device: Telemedicine System<br>* Telemedicine System is used in remote monitoring group<br>* Other names: Patients are monitorized from hospital;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical features | Selected variables from the medical history records: Gender Age Indication for the implantation of the pacemaker. Comorbidities Pharmacological treatment Vital signs Pacemaker parameters | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-Related Quality of Life | EuroQol-5Dimensions (EQ-5D) | 6 months | 
| Health-Related Quality of Life | Minnesota Living With Heart Failure Questionnaire (MLHF) | 6 months | 
| Safety | Number of patients with Adverse Events Type of Adverse Events diagnosed | 6 months | 
| Consultations and Hospitalizations unscheduled | Number of unscheduled visits and hospitalizations | 6 months | 
| Direct costs | Direct costs taken into account: Pacemakers' costs (device implanted) Hospitalizations' costs Consultations' costs (hospital) Prescribed medical transport's cost Health personnel costs Pharmaceutical costs | 6 months | 
| Indirect cost | Maintenance of the medical consultation (hospital): Electricity Cleaning Furniture Health fungible Equipment investment | 6 months | 
| Informal costs | Costs related to the care and displacements of patients to hospital: Displacement costs to hospital Accommodation costs Cost of meals Costs for caregivers | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Follow-Up studies, Biological Pacemakers, Telemedicine, Efficiency