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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043623
Receipt No. R000049813
Scientific Title Effects of online dementia education program for convenience store staff on attitude toward people with dementia: a cluster randomized controlled trial
Date of disclosure of the study information 2021/04/01
Last modified on 2021/03/16

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Basic information
Public title Effects of online dementia education program for convenience store staff
Acronym Effects of online dementia education program
Scientific Title Effects of online dementia education program for convenience store staff on attitude toward people with dementia: a cluster randomized controlled trial
Scientific Title:Acronym Effects of online dementia education program on attitude toward people with dementia
Region
Japan

Condition
Condition Not applicable
Adult
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To identify the effects of an online dementia education program on convenience store employees' attitudes toward people with dementia, knowledge of dementia, and work-related indicators
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The attitude measured by Attitude toward People with Dementia before randomization, and one months after intervention
Key secondary outcomes 1)Knowledge of dementia(DKAS-J)
2)Helping behavior for customers with dementia
3)Perceived social impact
4)Perceived task significance
5)Intention to leave the job
6)Persistence measured by working hours
7)Job satisfaction
8)Prosocial motivation

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 A forty-five minute dementia education program is delivered using the online system. Participants in intervention group are required to watch the program in the specified order within one month. The program consists of lecture videos, video interviews with people with dementia, quizzes, and a simulation game.
Interventions/Control_2 Participants in control group does not receive the intervention during the intervention period. They watches the same program one month later.
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Those working as employees of convenience stores.
2Those working as a manager or owner of a convenience store
Key exclusion criteria 1)Those who have difficulty in reading Japanese and cannot understand the contents of the research explanation document
2)Those under 16 years old
Target sample size 250

Research contact person
Name of lead principal investigator
1st name Hiroshige
Middle name
Last name Matsumoto
Organization The University of Tokyo
Division name Graduate School of Medicine
Zip code 1130033
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-5841-3508
Email hiroshige-tky@g.ecc.u-tokyo.ac.jp

Public contact
Name of contact person
1st name Hiroshige
Middle name
Last name Matsumoto
Organization The University of Tokyo
Division name Graduate School of Medicine
Zip code 1130033
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-5841-3508
Homepage URL https://nimpro.info/redesign/
Email hiroshige-tky@g.ecc.u-tokyo.ac.jp

Sponsor
Institute The University of Tokyo
Institute
Department

Funding Source
Organization MEXT
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 The University of Tokyo, Clinical Research Review Board
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel 03-5841-0818
Email ethics@m.u-tokyo.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 04 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 04 Month 01 Day
Date of IRB
2021 Year 02 Month 05 Day
Anticipated trial start date
2021 Year 04 Month 01 Day
Last follow-up date
2021 Year 12 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
2021 Year 03 Month 16 Day
Last modified on
2021 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049813

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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