UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052723 |
|---|---|
| Receipt number | R000060157 |
| Scientific Title | Effects of online dementia education program for general public on attitude toward people with dementia: a randomized controlled trial |
| Date of disclosure of the study information | 2023/11/15 |
| Last modified on | 2026/05/11 11:59:43 |
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Basic information
Public title
Effects of online dementia education program for general public
Acronym
Effects of online dementia education program
Scientific Title
Effects of online dementia education program for general public on attitude toward people with dementia: a randomized controlled trial
Scientific Title:Acronym
Effects of online dementia education program for general public on attitude toward people with dementia: a randomized controlled trial
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 general public's attitudes toward people with dementia and intention to help people with dementia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Attitudes as measured by the Attitudes Towards People with Dementia Scale after the e-learning intervention
Key secondary outcomes
intention to help people with dementia
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
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 two weeks. The program consists of lecture videos, video interviews with people with dementia, drama, VR, and a simulation game.
Group 1: Lecture video
Interventions/Control_2
Group 2: video interviews with people with dementia
Interventions/Control_3
Group 3: drama
Interventions/Control_4
Group 4: drama and VR
Interventions/Control_5
Group 5: simulation game
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
Those who can participate in e-learning using an Android smartphone
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
875
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
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
Hongo7-3-1 Bunkyo-ku, Tokyo, Japan
TEL
03-5841-3597
Homepage URL
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
Hongo7-3-1 Bunkyo-ku, Tokyo, Japan
Tel
03-5841-0818
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
| 2023 | Year | 11 | Month | 15 | Day |
Related information
URL releasing protocol
https://doi.org/10.1080/02701960.2026.2623601
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1080/02701960.2026.2623601
Number of participants that the trial has enrolled
1212
Results
All intervention groups showed significant improvements in attitudes toward dementia and intentions to help people living with dementia after the intervention.
Results date posted
| 2026 | Year | 05 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants ranged in age from their 20s to their 70s, and 52.8% were female. The largest age group was participants in their 40s (36.1%). Forty-five participants (8.5%) were engaged in health or social care jobs, and 24 participants (4.5%) had previously attended a Dementia Supporter Training Program.
Participant flow
A total of 1,212 eligible participants were randomized to one of five groups. Of these, 823 completed the presurvey and 767 completed the post-survey after the intervention. Participants with a program duration longer than 6,000 seconds (n = 10) or shorter than 600 seconds (n = 225) were excluded, resulting in 532 participants being included in the final analysis. Among presurvey respondents, 6.8% were lost to follow-up, and 28.6% were excluded because of abnormal screen time.
Adverse events
No adverse events were observed.
Outcome measures
The primary outcome was attitudes toward people living with dementia, measured using the 14-item scale developed by Kim and Kuroda (2011). Total scores ranged from 14 to 56, with higher scores indicating more positive attitudes. The secondary outcome was helping intention toward people living with dementia, measured using four vignettes, with total scores ranging from 4 to 16. Data on sex, age, engagement in health or social care jobs, and previous Dementia Supporter Training were collected. Baseline dementia knowledge was assessed using the Japanese Dementia Knowledge Assessment Scale. Screen time, defined as time spent on the e-learning course excluding survey responses, was also measured. Participants with program durations longer than 6,000 seconds or shorter than 600 seconds were excluded from the main analysis.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 11 | Month | 07 | Day |
Last modified on
| 2026 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060157
