UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036869 |
|---|---|
| Receipt number | R000042008 |
| Scientific Title | Epidemiological study of changes in the social environment and health before-and-after the earthquake |
| Date of disclosure of the study information | 2019/07/03 |
| Last modified on | 2020/05/28 21:02:20 |
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Basic information
Public title
Epidemiological study of changes in the social environment and health before-and-after the earthquake
Acronym
Epidemiological study of changes in the social environment and health before-and-after the earthquake
Scientific Title
Epidemiological study of changes in the social environment and health before-and-after the earthquake
Scientific Title:Acronym
Epidemiological study of changes in the social environment and health before-and-after the earthquake
Region
| Japan |
Condition
Condition
Health
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate changes in health status including nutritional status, oral health, the social environment, and social capital
Basic objectives2
Others
Basic objectives -Others
Quantitative evaluation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Onset of disability, dementia and death
Key secondary outcomes
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
| 65 | years-old | <= |
Age-upper limit
| 120 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Non
Key exclusion criteria
Non
Target sample size
12000
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Aida |
Organization
Tohoku University
Division name
Department of International and Community Oral Health, Tohoku University Graduate School of Dentistry
Zip code
980-8575
Address
4-1, Seiryo-machi,Aoba-ku,Sendai, Miyagi 980-8575, Japan
TEL
022-717-7639
aidajun@m.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Aida |
Organization
Tohoku University
Division name
Department of International and Community Oral Health, Tohoku University Graduate School of Dentistr
Zip code
980-8575
Address
4-1, Seiryo-machi,Aoba-ku,Sendai, Miyagi 980-8575, Japan
TEL
022-717-7639
Homepage URL
aidajun@m.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Tohoku University
Address
4-1, Seiryo-machi,Aoba-ku,Sendai, Miyagi 980-8575, Japan
Tel
022-717-7639
aidajun@m.tohoku.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
| 2019 | Year | 07 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
7421
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
| 2019 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Self-report-questionnaires distributed and collected by mail, and visiting interview survey will be conducted.
Management information
Registered date
| 2019 | Year | 05 | Month | 28 | Day |
Last modified on
| 2020 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042008
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
