Skip to main content
OpenTrials
Completed

NCT Number: NCT03747809

Cost-effectiveness Analysis on Remote Monitoring for CIEDs in Japan by Using Systematic Review Methodology

2018 Revision of Health Reimbursement in Japan recognized non face-to-face diagnostics, such as Online Treatment, as the standard of care. There was a significantly additional cost for Cardiovascular Implantable Electronic Devices (CIEDs) Management Fee as well. The adaption of Remote Monitoring for CIEDs patients is recommended by the societies based on the clinical evidences. However, how QALYs earned by CIEDs Remote Monitoring are justified in Japanese reimbursement environment from the cost-effectiveness standpoint is still not so clear. The evaluation about the impact on the health economics about the installation of CIEDs Remote Monitoring has not been enough due to the lack of the researches around this field. Therefore this research is designed to examine the impact of the installation of CIEDs Remote Monitoring from the health economics perspective by considering the health insurance system and the clinical process in Japan, through Systematic Review methodology.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Open University of Japan

Chiba, Japan

About this study

2018 Revision of Health Reimbursement in Japan recognized non face-to-face diagnostics, such as Online Treatment, as the standard of care. There was a significantly additional cost for Cardiovascular Implantable Electronic Devices (CIEDs) Management Fee as well. The adaption of Remote Monitoring for CIEDs patients is recommended by the societies based on the clinical evidences. However, how QALYs earned by CIEDs Remote Monitoring are justified in Japanese reimbursement environment from the cost-effectiveness standpoint is still not so clear. The evaluation about the impact on the health economics about the installation of CIEDs Remote Monitoring has not been enough due to the lack of the researches around this field. Therefore this research is designed to examine the impact of the installation of CIEDs Remote Monitoring from the health economics perspective by considering the health insurance system and the clinical process in Japan, through Systematic Review methodology.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Studies that involves CIEDs Remote Monitoring, such as Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy, and Pacemaker
  • Follow-up periods more than or equal to 12 months
  • Prospective studies
  • QALYs available to make ICER analysis possible
  • Published after Year of 1971

Exclusion criteria

  • Studies that are not related with CIEDs
  • Follow-up periods less than 12 months
  • Not prospective studies
  • QALYs unavailable
  • Published before Year or 1971

Treatment and study plan

CIEDs Remote Monitoring System

Device

Cardiac device remote monitoring system

Primary outcomes

  1. Differences of ICERs based on earned QALYs from selected studies by applying to Japanese reimbursement environment.

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

The Open University of Japan

Other

Registry information

Official study title

Cost-effectiveness Analysis on Remote Monitoring for Cardiovascular Electronic Implantable Devices in Japan by Using Systematic Review Methodology - 2018 Reimbursement Update

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 20, 2018
Registry last updated
Sep 21, 2022

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.

Published trials that share one or more normalized conditions with this study.