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

September 19, 2022 updated by: Tomoya SHIRANE, The Open University of Japan

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

1

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

  • Japan
      • Chiba, Japan
        • The Open University of Japan

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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults implanted with CIEDs such as Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy, or Pacemaker

Description

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

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

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with CIEDs having Remote Monitoring
Device: CIEDs Remote Monitoring System
Cardiac device remote monitoring system
Patients with CIEDs having no Remote Monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Differences of ICERs based on earned QALYs from selected studies by applying to Japanese reimbursement environment.
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

The Open University of Japan

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 (Actual)

September 1, 2018

Primary Completion (Actual)

June 16, 2019

Study Completion (Actual)

June 16, 2019

Study Registration Dates

First Submitted

November 17, 2018

First Submitted That Met QC Criteria

November 17, 2018

First Posted (Actual)

November 20, 2018

Study Record Updates

Last Update Posted (Actual)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 19, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OUJ11200212018111801

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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.

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