UMIN-CTR Clinical Trial

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
Last 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
1st 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
Institute	Tohoku University
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012012