UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010264
Receipt number R000012012
Scientific Title Cohort study about activity of daily living and cognition in elders who suffered the Great East Japan Earthquake
Date of disclosure of the study information 2013/03/18
Last modified on 2019/03/23 14:06:36

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Basic information

Public title

Cohort study about activity of daily living and cognition in elders who suffered the Great East Japan Earthquake

Acronym

Cohort study in disaster victims

Scientific Title

Cohort study about activity of daily living and cognition in elders who suffered the Great East Japan Earthquake

Scientific Title:Acronym

Cohort study in disaster victims

Region

Japan Asia(except Japan)


Condition

Condition

Elders

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To study of ADL and cognition in elders suffered from disater

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Change in ADL and cognition in elders after the disaster

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


Not applicable

Gender

Male and Female

Key inclusion criteria

elders who live in a temporary apartment

Key exclusion criteria

elders who live in their own house

Target sample size

2500


Research contact person

Name of lead principal investigator

1st name Katsutoshi
Middle name
Last name Furukawa

Organization

Tohoku University IDAC

Division name

Geriatrics and Gerontology

Zip code

9808575

Address

Seiryo-machi Aobaku Sendai

TEL

022-717-7182

Email

kfurukawa-ns@umin.ac.jp


Public contact

Name of contact person

1st name Katsutoshi
Middle name
Last name Katsutoshi

Organization

Tohoku University IDAC

Division name

Geriatrics and Gerontology

Zip code

9808575

Address

Seiryomachi Aobaku Sendai

TEL

022-717-7182

Homepage URL


Email

kfurukawa-ns@umin.ac.jp


Sponsor or person

Institute

Tohoku University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

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 Aobaku Sendai

Tel

022-717-7182

Email

kfurukawa-ns@umin.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

2013 Year 03 Month 18 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

2013 Year 01 Month 17 Day

Date of IRB

2013 Year 02 Month 09 Day

Anticipated trial start date

2013 Year 03 Month 18 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry

2025 Year 05 Month 31 Day

Date trial data considered complete

2025 Year 09 Month 30 Day

Date analysis concluded

2025 Year 12 Month 31 Day


Other

Other related information

We will analyze changes in ADL and cognition in elders who suffered from the Great East Japan Earthquake.


Management information

Registered date

2013 Year 03 Month 18 Day

Last modified on

2019 Year 03 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012012


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name