UMIN-CTR Clinical Trial

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
Institute	Faculty of Medical Science, University of Fukui
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050969