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

NCT ID: NCT03747809

Last Updated: 2022-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-06-16

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiovascular Diseases Heart Failure

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with CIEDs having Remote Monitoring

CIEDs Remote Monitoring System

Intervention Type DEVICE

Cardiac device remote monitoring system

Patients with CIEDs having no Remote Monitoring

No interventions assigned to this group

Interventions

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CIEDs Remote Monitoring System

Cardiac device remote monitoring system

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Open University of Japan

OTHER

Sponsor Role lead

Responsible Party

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Tomoya SHIRANE

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Open University of Japan

Chiba, , Japan

Site Status

Countries

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Japan

Other Identifiers

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OUJ11200212018111801

Identifier Type: -

Identifier Source: org_study_id

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