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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032479
Receipt No. R000037036
Scientific Title Examining a method of extracting and preventively intervening late in elderly people who are at high risk for spending high medical expenditure by using the health check-up system: A pilot study
Date of disclosure of the study information 2018/05/07
Last modified on 2019/05/21

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Basic information
Public title Examining a method of extracting and preventively intervening late in elderly people who are at high risk for spending high medical expenditure by using the health check-up system: A pilot study
Acronym Examination of the late-elderly health check-up items
Scientific Title Examining a method of extracting and preventively intervening late in elderly people who are at high risk for spending high medical expenditure by using the health check-up system: A pilot study
Scientific Title:Acronym Examination of the late-elderly health check-up items
Region
Japan

Condition
Condition None
Classification by specialty
Nursing Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 (1)To make it possible to avoid hospitalization by adding items which can identify disease risks leading to the use of high medical expenses for health check-up items of late elderly people and taking preventive measures (countermeasures) by early detection, (2) To conduct health check-up and countermeasures in the area (a part of Kure City), compare the effect of decreasing the onset of diseases and hospitalization with the receipt data, and measure the effect (A pilot study)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes This is an exploratory study; therefore, set various evaluation indicators.
(1) Number of hospitalization (change) (ICD-10: S72, I63, N18, I50, G30, F00-F03, J15 to J18, J69, J40, J41 to J44)(number of hospitalized patients/ICD-10 code, number of hospitalization/ICD-10, hospital length of stay/hospitalization per year)
(2) Number of users/usages of the emergency unit and intensive care unit (number of patients, and the per person)
(3) Number of patients who have newly initiated dialysis
Key secondary outcomes (1) Medical expenditure of hospitalization of diseases above
(2) Number of patients and medical expenditure of outpatients and inpatients per ICD-10
(3) Describe ICD-10 diseases who have used emergency unit and intensive care unit, its medical expenditure and average costs
(4) Describe ICD-10 diseases who have newly initiated dialysis, inpatient, and outpatients
(5) Describe health check-up data

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 (1) Add new items on the basic health check-up for the late elderly (Pulse, Respiratory, SpO2, BNP/NT-proBNP, Total protein, Albumin, Hematocrit, Hemoglobin, Creatinine, Kihon checklist, Cognitive function test, Timed-Up and Go Test)
(2) Inform the results of (1), provide health education, and refer the elderly to a primary care physician and related services
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1)Late elderly living in Kure City, Hiroshima Prefecture, having basic health check-up in 2018 and 2019 FY, and agree to participate
(2)The insured of the late-stage medical care system for the elderly (who are eligible from 2017 to 2021 FY)
-The elderly persons, age 65 and over and under 75, having specified diseases and insured of the late-stage medical care system for the elderly are included
Key exclusion criteria -Persons who are not eligible for the late-stage medical care system for the elderly
-Persons who did not agree to participate (requested opt-out)
Target sample size 600

Research contact person
Name of lead principal investigator
1st name Michiko
Middle name
Last name Moriyama
Organization Hiroshima University
Division name Graduate School of Biomedical and Health Sciences
Zip code 734-8553
Address Kasumi 1-2-3, Minami-ku, Hiroshima, Hiroshima
TEL +81-82-257-5365
Email morimich@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name Michiko
Middle name
Last name Moriyama
Organization Hiroshima University
Division name Graduate School of Biomedical and Health Sciences
Zip code 734-8553
Address Kasumi 1-2-3, Minami-ku, Hiroshima, Hiroshima
TEL +81-82-257-5365
Homepage URL
Email morimich@hiroshima-u.ac.jp

Sponsor
Institute Graduate School of Biomedical and Health Sciences, Hiroshima University
Institute
Department

Funding Source
Organization Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hiroshima University research ethics committee
Address Kasumi 1-2-3 Minami-ku, Hiroshima, Japan
Tel 082-257-1752
Email protocol@cimr.hiroshima-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 05 Month 07 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 04 Month 26 Day
Date of IRB
2018 Year 04 Month 26 Day
Anticipated trial start date
2018 Year 08 Month 06 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 06 Day
Last modified on
2019 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037036

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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