UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054653 |
|---|---|
| Receipt number | R000062454 |
| Scientific Title | Development of Dementia Care Multidisciplinary Collaborative Program Using Digital Transformation (DX) |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2024/06/13 16:07:22 |
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Basic information
Public title
Development of Dementia Care Multidisciplinary Collaborative Program Using Digital Transformation (DX)
Acronym
Development of DX Dementia Care Multidisciplinary Collaborative Program
Scientific Title
Development of Dementia Care Multidisciplinary Collaborative Program Using Digital Transformation (DX)
Scientific Title:Acronym
Development of DX Dementia Care Multidisciplinary Collaborative Program
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will develop a multidisciplinary collaborative program using Virtual Reality (VR) and Augmented Reality (AR) technologies for multidisciplinary professionals involved in dementia care and examine its effectiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. the International Work Practice Competence Scale (CICS29)
2. Practice Self-Assessment Scale for Person-Centered Care for Cognitively Impaired Elderly Patients in Acute Care Hospitals (19 items)
3. Approaches to Dementia Questionnaire (ADQ)
Key secondary outcomes
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
In this study, we investigated the subjective evaluation of people with cognitive impairment using Digital Transformation (DX) Virtual Reality (VR) "virtual reality" (a virtual space with a sense of presence close to reality that stimulates the five senses) and Augmented Reality (AR) "augmented reality" (a virtual space close to reality that combines actual images and video) technologies. The effectiveness of the program will be verified by developing a dementia IPE (interprofessional education) program based on the subjective experiences of people with dementia using the technology of Augmented Reality (AR) and Augmented Reality (AR) (a virtual space that is close to reality by combining actual images and video). The effectiveness of the program will be verified using a mixed-method, sequential, explanatory design.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Study Subjects:.
Nurses, physicians, physical therapists, occupational therapists, pharmacists, clinical psychologists, medical social workers, etc. who work in acute care hospitals and are involved in the treatment and care of physical diseases of elderly patients with dementia.
Selection Criteria
Persons who have been distributed the recruitment brochure regarding the training for this study and have obtained their consent to participate in the study of their own free will.
Key exclusion criteria
Subjects who meet any of the following conditions will not be included in this study
(i) Professionals who are not in the target wards of the target hospitals
(2) Professionals who are not involved in the treatment and care of elderly people with dementia
(iii) Part-time workers, those on maternity/paternity leave
(iv) Those who could not give consent to participate in the research.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | mizue |
| Middle name | |
| Last name | suzuki |
Organization
Hamamatsu University School of Medicine
Division name
Faculty of Nursing
Zip code
431-3192
Address
Handayama 1-20-1
TEL
0534352826
mizuesuzuki@gmail.com
Public contact
Name of contact person
| 1st name | mizue |
| Middle name | |
| Last name | Suzuki |
Organization
Hamamatsu University School of Medicine
Division name
Faculty of Nursing
Zip code
431-3192
Address
Handayama 1-20-1
TEL
0534352826
Homepage URL
mizuesuzuki@gmail.com
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
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
Hamamatsu University School of Medicine
Address
Handayama 1-20-1
Tel
0534352826
mizuesuzuki@gmail.com
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
| 2024 | Year | 07 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 13 | Day |
Last modified on
| 2024 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062454
