UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051133 |
|---|---|
| Receipt number | R000057946 |
| Scientific Title | Verification of a co-creation project for a VR learning program on dementia and caregiving to promote preparation for the simultaneous balance of work and dementia caregiving in the working generation |
| Date of disclosure of the study information | 2023/05/25 |
| Last modified on | 2024/05/23 09:25:47 |
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Basic information
Public title
Verification of a co-creation project for a VR learning program on dementia and caregiving to promote preparation for the simultaneous balance of work and dementia caregiving in the working generation
Acronym
Validation of co-creation project for a VR learning program on dementia and caregiving
Scientific Title
Verification of a co-creation project for a VR learning program on dementia and caregiving to promote preparation for the simultaneous balance of work and dementia caregiving in the working generation
Scientific Title:Acronym
Validation of co-creation project for a VR learning program on dementia and caregiving
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop a learning program (content) using Virtual Reality (VR) materials on dementia and caregiving for people of working age who have no experience or are novices in dementia caregiving, in co-creation with people with dementia, family caregivers and supporters, and to evaluate and discuss the development process.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Opinions and impressions about the co-creation projects as a whole (after completion of activities)
Key secondary outcomes
Opinions, ideas, conversations, and attitudes in the co-creation project process (active)
Empowerment of family caregivers of people with dementia: Empowerment scale for family caregivers of community-dwelling people with dementia in Japan(Family caregivers only, before and after the project begins and 1-2 months after it ends)
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
| Behavior,custom |
Interventions/Control_1
We will develop learning programs (content) using virtual reality (VR) materials on dementia and caregiving with people with dementia, family caregivers, and supporters, targeting working generation who have no experience or are novices in dementia caregiving.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) A person with a diagnosis or suspected diagnosis of dementia who is able to communicate and give consent and whose family caregiver agrees to participate in the study.
(2) Family caregivers of persons with dementia.
(3) Supporters who support people with dementia and their family caregivers at their place of work. (Regardless of whether or not they have obtained certification).
Key exclusion criteria
(1) Persons who are deemed unable to answer the questionnaire or interview due to difficulty in communication or significant physical or mental deterioration
(2) Those who could not give their consent.
(3) Those who have an acute illness under treatment, those who have started taking antipsychotic, anxiolytic, or antidepressant medications within 3 months, or those who have changed the type or dosage.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Sakanashi |
| Middle name | |
| Last name | Sayori |
Organization
Fukuoka University
Division name
School of Nursing, Faculty of Medicine
Zip code
8140180
Address
7-45-1, Nanakuma, Jonan-ku, Fukuoka-shi, Fukuoka, 814-0180 JAPAN
TEL
0928011011
sakanashi@adm.fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Sayori |
| Middle name | |
| Last name | Sakanashi |
Organization
Fukuoka University
Division name
School of Nursing, Faculty of Medicine
Zip code
8140180
Address
7-45-1, Nanakuma, Jonan-ku, Fukuoka-shi, Fukuoka, 814-0180 JAPAN
TEL
0928011011
Homepage URL
sakanashi@adm.fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
Sayori Sakanashi
Funding Source
Organization
Japan Society for the promotion of science
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
Fukuoka University
Address
School of Nursing, Faculty of Medicine
Tel
0928011011
fumed-ethics@fukuoka-u.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 | 05 | Month | 25 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2026 | 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 | 05 | Month | 23 | Day |
Last modified on
| 2024 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057946
