UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042148
Receipt number 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 2023/03/23 10:52:26

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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 was done in the last February 3 times a year. We opened a class of dementia prevention class.
And Literacy education will be done in next February 1-3 times.

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 or person

Institute

Kobe Gakuin University, School of rehabilitation

Institute

Department

Personal name



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

145

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

Completed

Date of protocol fixation

2021 Year 01 Month 01 Day

Date of IRB

2020 Year 11 Month 12 Day

Anticipated trial start date

2021 Year 01 Month 01 Day

Last follow-up date

2023 Year 03 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

2023 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=R000048110


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name