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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042148
Receipt No. R000048110
Scientific Title A prospective study for the effect of literacy education on early diagnosis for dementia
Date of disclosure of the study information 2021/01/01
Last modified on 2021/05/13

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Basic information
Public title Study of literacy education in people with dementia
Acronym Literacy education and dementia
Scientific Title A prospective study for the effect of literacy education on early diagnosis for dementia
Scientific Title:Acronym The literacy education for early diagnosis
for dementia
Region
Japan

Condition
Condition dementia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Early diagnosis is very important in dementia care. The objective of this study is to clarify the effect of literacy education on dementia on early diagnosis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The number of people who have a dementia
screening test in the second year.
Key secondary outcomes Increase in knowledge of dementia
prevention.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Literacy education. 4weeks. We open a class of dementia prevention class
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 Meimai district dwelling people. they are volunteers.
Key exclusion criteria none
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Kiyoshi
Middle name
Last name Maeda
Organization Kobe Gakuin University
Division name School of Rehabilitation
Zip code 651-2180
Address 518 Arise, Ikawadani-cho, Nishi-ku, Kobe, Japan
TEL 078-974-5904
Email maedak@reha.kobegakuin.ac.jp

Public contact
Name of contact person
1st name Kiyoshi
Middle name
Last name Maeda
Organization Kobe Gakuin University
Division name School of Rehabilitation
Zip code 651-2180
Address 518Arise, Ikawadani-cho, Nishi-ku, Kobe, Japan
TEL 078-974-2438
Homepage URL
Email maedak@reha.kobegakuin.ac.jp

Sponsor
Institute Kobe Gakuin University, School of rehabilitation
Institute
Department

Funding Source
Organization Kobe Gakuin University, School of Rehabilitation
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kobe Gakuin University
Address 518Arise, Ikawadani-cho, Nishi-ku, Kobe, Japan
Tel 078-974-2438
Email ethics@reha.kobegakuin.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
2021 Year 01 Month 01 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 Preinitiation
Date of protocol fixation
2021 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2021 Year 01 Month 01 Day
Last follow-up date
2023 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 10 Month 17 Day
Last modified on
2021 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048110

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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