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Completed

NCT Number: NCT02234245

Economic Evaluation in Cardiology: Remote Monitoring of Pacemakers

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Poniente

El Ejido, Almeria, 04700, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telemedicine System

Device

Telemedicine System is used in remote monitoring group

Other names: Patients are monitorized from hospital

Primary outcomes

  1. 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

Secondary outcomes

  1. Health-Related Quality of Life

    Time frame: 5 years

    EuroQol-5Dimensions (EQ-5D)

  2. Functional capacity

    Time frame: 5 years

    Duke Activity Status Index (DASI).

  3. 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
  4. Indirect cost

    Time frame: 5 years

    Maintenance of the medical consultation (hospital):

    • electricity
    • cleaning
    • furniture
    • Health fungible
    • equipment investment
  5. 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
  6. Number of patients with Adverse Events

    Time frame: 5 years

    Number of patients with Adverse Events

    • type of Adverse Events diagnosed
  7. Consultations and Hospitalizations unscheduled

    Time frame: 5 years

    • number of unscheduled visits and hospitalizations

Sponsors and collaborators

Lead sponsor

Universidad de Almeria

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2018
First posted
Sep 9, 2014
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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