UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032479
Receipt number 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 2023/12/19 05:58:12

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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
(6) Behavior change and reasons for the change (qualitative description)


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)

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)(Claim analysis)

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 or person

Institute

Graduate School of Biomedical and Health Sciences, Hiroshima University

Institute

Department

Personal name



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

Ethical Committee for Clinical Research of Hiroshima University

Address

Kasumi 1-2-3 Minami-ku, Hiroshima, Japan

Tel

082-257-1974

Email

iryo-seisaku@office.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

492

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events

No

Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

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

2023 Year 08 Month 31 Day

Date trial data considered complete

2023 Year 09 Month 30 Day

Date analysis concluded

2023 Year 10 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 05 Month 06 Day

Last modified on

2023 Year 12 Month 19 Day



Link to view the page

Value
https://center6.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