Economic Evaluation in Cardiology: Remote Monitoring of Pacemakers

May 9, 2023 updated by: Antonio Lopez Villegas, Universidad de Almeria

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

83

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Almeria
      • El Ejido, Almeria, Spain, 04700
        • Hospital de Poniente

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Hospital monitoring of pacemakers
Patients have to go to the hospital to be monitorized
Experimental: Remote monitoring of pacemakers

Telemedicine System:

Patients have not to go to the hospital to be monitorized
Device: Telemedicine System
Telemedicine System is used in remote monitoring group
Other Names:
  • Patients are monitorized from hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical features
Time Frame: 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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-Related Quality of Life
Time Frame: 5 years
EuroQol-5Dimensions (EQ-5D)
5 years
Functional capacity
Time Frame: 5 years
Duke Activity Status Index (DASI).
5 years
Direct costs
Time Frame: 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
5 years
Indirect cost
Time Frame: 5 years

Maintenance of the medical consultation (hospital):

  • electricity
  • cleaning
  • furniture
  • Health fungible
  • equipment investment
5 years
Informal costs
Time Frame: 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
5 years
Number of patients with Adverse Events
Time Frame: 5 years

Number of patients with Adverse Events

- type of Adverse Events diagnosed
5 years
Consultations and Hospitalizations unscheduled
Time Frame: 5 years
- number of unscheduled visits and hospitalizations
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Almeria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

August 28, 2014

First Submitted That Met QC Criteria

September 4, 2014

First Posted (Estimate)

September 9, 2014

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEIC-AL 53/2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiovascular Disease

Clinical Trials on Telemedicine System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe