UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046827 |
|---|---|
| Receipt number | R000053429 |
| Scientific Title | Effects of dementia education to local residents |
| Date of disclosure of the study information | 2022/02/04 |
| Last modified on | 2024/04/19 17:09:31 |
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Basic information
Public title
Effects of dementia education to local residents
Acronym
Effects of dementia education to local residents
Scientific Title
Effects of dementia education to local residents
Scientific Title:Acronym
Effects of dementia education to local residents
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to compare the virtual reality program and the lecture program, and consider the educational needs and methods for local residents.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Attitude toward Dementia Scale and Dementia Knowledge Scale
before / after the intervention and 1 month after intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Dementia learning program using virtual reality teaching materials (90min)
Interventions/Control_2
Dementia learning program by instructor (90min)
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
People who have no problems with visual function (glasses / contact lenses can be used), cognitive function, and language function in daily life.
Persons who are in a mental and physical condition who can cooperate in the programs for about 2 hours.
Person who owns a laptop computer (tablet) and can secure an appropriate Internet environment
Key exclusion criteria
People who have issues with visual function, cognitive function, and language function in daily life.
People who are not in a physical or mental condition who can cooperate in the survey for about 2 hours.
People who do not have a laptop computer (tablet) and cannot secure an internet environment
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kaoru |
| Middle name | |
| Last name | Inoue |
Organization
Tokyo Metropolitan University
Division name
Graduate School of Human Health Sciences
Zip code
1168551
Address
7-2-10,Higashiogu, Arakawa-ku, Tokyo
TEL
03-3819-1211
inoue@tmu.ac.jp
Public contact
Name of contact person
| 1st name | Kaoru |
| Middle name | |
| Last name | Inoue |
Organization
Tokyo Metropolitan University
Division name
Graduate School of Human Health Sciences
Zip code
1168551
Address
7-2-10,Higashiogu, Arakawa-ku, Tokyo
TEL
03-3819-1211
Homepage URL
inoue@tmu.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan University
Address
7-2-10,Higashiogu, Arakawa-ku, Tokyo
Tel
03-3819-1211
inoue@tmu.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
東京都立大学
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 04 | Day |
Related information
URL releasing protocol
https://doi.org/10.1080/02703181.2023.2291361
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1080/02703181.2023.2291361
Number of participants that the trial has enrolled
67
Results
We analyzed the responses of 67 participants. Pre-intervention, most perceived to have a good understanding and a willingness to learn. They also expressed readiness and interest in supporting people with dementia. Post-intervention, participants expressed satisfaction and a deeper understanding.
Results date posted
| 2024 | Year | 04 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Adults interested in dementia care
Participant flow
There are many potentially eligible members, given the population of the study setting. However, the specific number of eligible individuals is not known due to the non-randomized nature of recruitment. Individuals who are interested in joining the research reached out to the research team via email. We have recruited 74 people for the study (recruitment rate of 92.5% out of 80). We offered two timeframes for the VR experience sessions, asked each participant to specify their preferred timeframe, and allocated accordingly. On the day of the program, 72 people showed up (participation rate of 97.3%), 38 of whom participated in the morning session and 34 in the afternoon session. At the start of each session, the research team explained the intervention to the participants and highlighted the voluntary nature of the research. Informed consent was then sought wherein all participants consented to the study. Upon signing the informed consent form, they were then asked to respond to a pre-intervention questionnaire. The program then commenced and was provided to all participants simultaneously. Specific details of the program can be found in the next sub-section. The training was provided by a representative of Silver Wood Co. Ltd., who is not part of the research team. At the end of the session, participants were asked to respond to a self-administered questionnaire.
Adverse events
not applicable
Outcome measures
Original questionare
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 04 | Day |
Last modified on
| 2024 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053429
