UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043623
Receipt number R000049813
Scientific Title Effects of online dementia education program for convenience store staff on attitude toward people with dementia: a randomized controlled trial
Date of disclosure of the study information 2021/04/01
Last modified on 2023/03/20 08:14:02

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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 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

Individual

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 or person

Institute

The University of Tokyo

Institute

Department

Personal name



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

https://doi.org/10.1016/j.conctc.2022.100896

Publication of results

Unpublished


Result

URL related to results and publications

https://doi.org/10.1093/geront/gnac182

Number of participants that the trial has enrolled

182

Results

Process evaluations confirmed satisfaction and high completion rates of the program. In total, 150 participants were included in the analysis. The intervention group showed significantly greater improvements in attitude (Hedges' g = 0.70) and knowledge (g = 0.59) after 1 month, compared to the control group. Helping behavior increased in the intervention group, although it did not differ significantly between the groups. All outcomes remained significantly improved after 4 months.

Results date posted

2023 Year 03 Month 20 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

https://doi.org/10.1016/j.conctc.2022.100896

Participant flow

https://doi.org/10.1016/j.conctc.2022.100896

Adverse events

https://doi.org/10.1016/j.conctc.2022.100896

Outcome measures

https://doi.org/10.1016/j.conctc.2022.100896

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

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

2023 Year 03 Month 20 Day



Link to view the page

Value
https://center6.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