UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044621
Receipt number R000050969
Scientific Title Research and development of a new screening method to reduce emergency transportation and emergency hospitalization in shrinking medical care areas
Date of disclosure of the study information 2021/06/22
Last modified on 2021/06/22 16:05:18

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Basic information

Public title

Research and development of a new screening method to reduce emergency transportation and emergency hospitalization in shrinking medical care areas

Acronym

Research on development of new screening methods (Wakasa Town research)

Scientific Title

Research and development of a new screening method to reduce emergency transportation and emergency hospitalization in shrinking medical care areas

Scientific Title:Acronym

Research on development of new screening methods (Wakasa Town research)

Region

Japan


Condition

Condition

Sarcopenia, frailty,Cardiovascular disease,lifestyle-related diseases

Classification by specialty

Medicine in general Cardiology Endocrinology and Metabolism
Geriatrics Laboratory medicine Rehabilitation medicine
Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

1)Early detection of sarcopenia and diseases of the elderly
2)Establishment of a new method of medical intervention in depopulated areas

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Decrease in the number of hospitalizations and emergency transports in the target area

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Factorial

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Nutritional guidance

Interventions/Control_2

exercise guidance

Interventions/Control_3

Nutritional guidance,exercise guidance

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

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Residents of Wakasa-machi, Mikata-Kaminaka-gun, Fukui Prefecture

Key exclusion criteria

(1) Residents who did not give consent for this study
(2) Residents who are hospitalized or admitted to a medical institution
(3) Other residents deemed inappropriate by the researcher.

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Osamu
Middle name
Last name Yamamura

Organization

Faculty of Medical Science, University of Fukui

Division name

Deparement of Community Medicine

Zip code

910-1193

Address

23-3, Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui

TEL

0776-61-3111

Email

kapi@u-fukui.ac.jp


Public contact

Name of contact person

1st name Osamu
Middle name
Last name Yamamura

Organization

Faculty of Medical Science, University of Fukui

Division name

Deparement of Community Medicine

Zip code

910-1193

Address

23-3, Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui

TEL

0776-61-3111

Homepage URL


Email

kapi@u-fukui.ac.jp


Sponsor or person

Institute

Faculty of Medical Science, University of Fukui

Institute

Department

Personal name



Funding Source

Organization

Fukui prefecture

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The Research Ethics Committee of University of Fukui

Address

23-3 Shimoaizuki Matsuoka Eiheiji Yoshida Fukui

Tel

0776-61-8529

Email

chiken@ml.u-fukui.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

2021 Year 06 Month 22 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

2019 Year 04 Month 11 Day

Date of IRB

2019 Year 05 Month 19 Day

Anticipated trial start date

2019 Year 05 Month 20 Day

Last follow-up date

2021 Year 12 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

2021 Year 06 Month 22 Day

Last modified on

2021 Year 06 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050969


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name