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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033313
Receipt No. R000037960
Scientific Title Establishment of the surveillance system exploring risk factors for emergency transportation outside a remote island.
Date of disclosure of the study information 2018/07/06
Last modified on 2019/06/19

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Basic information
Public title Establishment of the surveillance system exploring risk factors for emergency transportation outside a remote island.
Acronym Establishment of the surveillance system exploring risk factors for emergency transportation outside a remote island.
Scientific Title Establishment of the surveillance system exploring risk factors for emergency transportation outside a remote island.
Scientific Title:Acronym Establishment of the surveillance system exploring risk factors for emergency transportation outside a remote island.
Region
Japan

Condition
Condition chronic illness, osteoporosis, and patients with potentially high risk for emergency admissions.
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Establishment of the surveillance system exploring risk factors for emergency transportation outside a remote island.
Basic objectives2 Others
Basic objectives -Others Establishment of the surveillance system
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) Emergency transport to outside the island by any reason
Key secondary outcomes 1) Emergency transport to outside the island by fractures
2) Medical costs per resident
3) 7 ADLs score
4) SF-12 score
5) IPAQ score

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Residents in Koshikijima
2) Able to come to the place where medical examination take place
3) Aged 15 years old or older
4) Informed consent
Key exclusion criteria Not applicable
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Shimada
Organization Research Hospital, The Institute of Medical Science, the University of Tokyo
Division name Department of Palliative Medicine
Zip code
Address 4-6-1 Shirokanedai, Minato-ku, Tokyo, 108-8639, Japan
TEL 03-3443-8111
Email nshimada@ims.u-tokyo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Shimada
Organization Research Hospital, The Institute of Medical Science, the University of Tokyo
Division name Department of Palliative Medicine
Zip code
Address 4-6-1 Shirokanedai, Minato-ku, Tokyo, 108-8639, Japan
TEL 03-3443-8111
Homepage URL
Email nshimada@ims.u-tokyo.ac.jp

Sponsor
Institute The Institute of Medical Science, the University of Tokyo
Institute
Department

Funding Source
Organization Ministry of Internal Affairs and Communications
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
Address
Tel
Email

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 07 Month 06 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 No longer recruiting
Date of protocol fixation
2017 Year 06 Month 12 Day
Date of IRB
2017 Year 03 Month 08 Day
Anticipated trial start date
2017 Year 07 Month 03 Day
Last follow-up date
2018 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1) Observation items at the registration and after a year:
medical interview, blood and urine test, electrocardiography, bone density, physical measurement, measurement of abdominal circumference, evaluation of activity of daily life (7ADLs, SF-12 and IPAQ)

Management information
Registered date
2018 Year 07 Month 06 Day
Last modified on
2019 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037960

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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