UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044901 |
|---|---|
| Receipt number | R000051276 |
| Scientific Title | A randomized controlled trial of DRIVE, Drive for Dementia Readiness Inside Virtual Reality |
| Date of disclosure of the study information | 2021/07/20 |
| Last modified on | 2022/08/30 11:30:27 |
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Basic information
Public title
Effects of a dementia educational program using virtual reality (VR) for the general public
Acronym
Effects of a dementia educational program using virtual reality (VR)
Scientific Title
A randomized controlled trial of DRIVE, Drive for Dementia Readiness Inside Virtual Reality
Scientific Title:Acronym
DRIVE study
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the effects of a dementia educational program using virtual reality (VR) on the attitude toward people with dementia, knowledge of dementia, and intention to provide help
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 after intervention program
Key secondary outcomes
1)Knowledge of dementia
2)Intention to provide help for people with dementia
3) Implicit attitudes toward dementia
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
A ninety minutes dementia education program using virtual reality (VR) technology is delivered. The program consists of short films about people with dementia and their families, VR video to experience the perspective of a person with dementia, lectures equivalent to the dementia supporter training course, and discussion about responses and impressions after watching the short films and VR.
Interventions/Control_2
Participants in control group attend the standardized dementia supporter training course.
This program is conducted at the same time using a different room in the same facility. Those who wish to watch VR video experience VR after the course.
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 who live in Tokyo and wish to participate in this program
2) Those who have never attended the dementia supporter training course
Key exclusion criteria
1) Those who have difficulty in reading Japanese and cannot understand the contents of the research explanatory document
2) Those under 16 years old
3) Those who are healthcare, long-term care, and welfare professionals
Target sample size
122
Research contact person
Name of lead principal investigator
| 1st name | Ayumi |
| Middle name | |
| Last name | Igarashi |
Organization
The University of Tokyo
Division name
Graduate School of Medicine
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3507
aigarashi@m.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Haruno |
| Middle name | |
| Last name | Suzuki |
Organization
The University of Tokyo
Division name
Graduate School of Medicine
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3508
Homepage URL
https://nimpro.info/portal/vr-rct/
haruno@m.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
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 | 07 | Month | 20 | 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
Completed
Date of protocol fixation
| 2021 | Year | 07 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2022 | 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
| 2021 | Year | 07 | Month | 19 | Day |
Last modified on
| 2022 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051276
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
