UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012688 |
|---|---|
| Receipt number | R000014825 |
| Scientific Title | A study on screening tests for the mental health of elderly people |
| Date of disclosure of the study information | 2013/12/25 |
| Last modified on | 2013/12/25 15:48:00 |
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Basic information
Public title
A study on screening tests for the mental health of elderly people
Acronym
Screening test for mental health of elderly
Scientific Title
A study on screening tests for the mental health of elderly people
Scientific Title:Acronym
Screening test for mental health of elderly
Region
| Japan |
Condition
Condition
dementia
mild cognitive impairment
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to build a screening test system which can detect the early congnitive deterioration for elderly
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Scores of neuropsychological tests for eldlerly people with normal levels scored by a brief cognitive test such as the mini-mental state examintaion
Key secondary outcomes
#ADL, iADL
#depression scale 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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
elederly people aged 65 years or older
residents in Eiheiji Town, Fukui prefecture
Key exclusion criteria
None
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Higashima |
Organization
Fuculty of Medical Sciences, University of Fukui
Division name
Department of Neuropsychiatry
Zip code
Address
23-1 Matsuokashimoaizuki, Eiheiji-cho, Fukui
TEL
0776-61-3111
mtohma@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masato Higashima |
Organization
Fuculty of Medical Sciences, University of Fukui
Division name
Department of Neuropsychiatry
Zip code
Address
23-1 Matsuokashimoaizuki, Eiheiji-cho, Fukui
TEL
0776-61-3111
Homepage URL
mtohma@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
Funding Source
Organization
Fukui Prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 12 | Month | 25 | 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 | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Two-hundred subjects have been registered for this study so far
Management information
Registered date
| 2013 | Year | 12 | Month | 25 | Day |
Last modified on
| 2013 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014825
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
