UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050339 |
|---|---|
| Receipt number | R000057324 |
| Scientific Title | Enhanced Multidisciplinary Collaboration for the Prevention of Delirium in Elderly People with Dementia Development of DX (Digital Transformation) Program |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2023/02/14 17:34:46 |
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Basic information
Public title
Enhanced Multidisciplinary Collaboration for the Prevention of Delirium in Elderly People with Dementia
Development of DX (Digital Transformation) Program
Acronym
the Prevention of Delirium in Elderly People with Dementia Development of DX Program
Scientific Title
Enhanced Multidisciplinary Collaboration for the Prevention of Delirium in Elderly People with Dementia
Development of DX (Digital Transformation) Program
Scientific Title:Acronym
Enhanced Multidisciplinary Collaboration for the Prevention of Delirium in Elderly People with Dementia
Development of DX (Digital Transformation) Program
Region
| Japan |
Condition
Condition
non
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this research, we will use Virtual Reality (VR) (a virtual space that stimulates the five senses and gives a sense of reality) and Augmented Reality (AR) (a virtual space that is close to reality by combining actual images and video) technologies based on Digital Transformation (DX) to develop a program for multidisciplinary professionals (physicians and nurses) involved in treatment and care to prevent delirium. (a virtual space that is close to reality by synthesizing actual images and videos) technologies, we will develop a multi-professional collaborative reinforcement program for elderly people with dementia who have developed delirium and their respective professional perspectives, targeting multiple professions (doctors and nurses) involved in treatment and care, and verify its effectiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Practice self-assessment, awareness of dementia, interdisciplinary team approach practice assessment scale, knowledge of delirium, confidence regarding treatment and care for elderly dementia patients with delirium
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
In this study, using Virtual Reality (VR) "virtual reality" (a virtual space with a sense of realism close to reality that stimulates the five senses) and Augmented Reality (AR) "augmented reality" (a virtual space close to reality that synthesizes actual images and video) technologies, a delirium with delirium A simulation education program will be developed, and training sessions will be conducted using the program to verify its effectiveness.
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
| 22 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Persons who have obtained consent to participate in the research of their own free will by distributing a pamphlet inviting participation in the training for this research.
Key exclusion criteria
Subjects who meet any of the following conditions will not be included in the study
(1) Nurses and physicians who are not involved with delirium patients
(ii) Part-time workers, those on maternity or paternity leave
(iii) Persons who could not give consent to participate in the study.
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
Department of Clinical Nursing
Zip code
431-3192
Address
Handayama higasgiku 1-20-1
TEL
+81534352826
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
Department of Clinical Nursing
Zip code
431-3192
Address
Handayama 1-20-1
TEL
+81534352826
Homepage URL
mizuesuzuki@gmail.com
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
mizue suzuki
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
+81534352826
m~suzuki@hama-med.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 | 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
| 2023 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 31 | 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 | 02 | Month | 14 | Day |
Last modified on
| 2023 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057324
