UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052482 |
|---|---|
| Receipt number | R000059720 |
| Scientific Title | Immersive virtual reality intervention to enhance psychological and social well-being in older adults with long-term care needs: A single arm feasibility study |
| Date of disclosure of the study information | 2023/10/16 |
| Last modified on | 2024/02/09 00:56:50 |
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Basic information
Public title
Research virtual reality in older adults with long-term care needs
Acronym
Research of VR in older adults with long-term care needs
Scientific Title
Immersive virtual reality intervention to enhance psychological and social well-being in older adults with long-term care needs: A single arm feasibility study
Scientific Title:Acronym
Feasibility study for immersive VR intervention
Region
| Japan |
Condition
Condition
Older adults with care-needs certification in long-term care system of Japan
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of the present study is to examine the feasibility of immersive virtual reality intervention to improve psychological and social well-being in older adults with long-term care needs.
Basic objectives2
Others
Basic objectives -Others
Feasibility of immersive virtual reality intervention (Do older adults with long-term care needs accept virtual reality intervention? Can we observe any changes in psychological outcomes before and after the intervention?)
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Percentage of participating intervention (actual number of times of participating intervention/number of times intervention was planned)
2) Geriatric depression scale-15
3) UCLA loneliness scale
* Since this study is feasibility study, we do not decide the only one primary outcome
Key secondary outcomes
Autonomic activity (HF value derived from blood volume pulse)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Four participants watch VR movies for 10 minutes at the same time. After that, they make a dialog. This intervention is conducted once a week for 6 weeks.
Interventions/Control_2
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
| 65 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Older adults (65 years or older) with care-needs certification in long-term care system of Japan
Key exclusion criteria
1) Those with significant cognitive decline
2) Persons whose participation is deemed difficult by the caregiving staff who know the person well.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Takazumi |
| Middle name | |
| Last name | Ono |
Organization
The University of Tokyo
Division name
Graduate School of Frontier Sciences
Zip code
277-8563
Address
Environment Building 374, 1-5-5, Kashiwanoha, Kashiwa-shi, Chiba
TEL
08011303364
takazumi-ono-ut@edu.k.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Takazumi |
| Middle name | |
| Last name | Ono |
Organization
The University of Tokyo
Division name
Graduate School of Frontier Sciences
Zip code
277-8563
Address
Environment Building 374, 1-5-5, Kashiwanoha, Kashiwa-shi, Chiba
TEL
08011303364
Homepage URL
takazumi-ono-ut@edu.k.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Ono Takazumi
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
NURVE Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Office for life science research ethics and safety
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
Tel
080-7494-2644
lifescience.adm@gs.mail.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 | 10 | Month | 16 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 11 | 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 | 10 | Month | 13 | Day |
Last modified on
| 2024 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059720
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| Registered date | File name |
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