UMIN-CTR Clinical Trial

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
Email	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/
Email	haruno@m.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 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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051276