UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061702 |
|---|---|
| Receipt number | R000070607 |
| Scientific Title | Quantitative and Qualitative Evaluation of Burden among Formal Caregivers in Managing Agitation among Patients with Alzheimers Disease |
| Date of disclosure of the study information | 2026/05/27 |
| Last modified on | 2026/05/27 11:45:29 |
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Basic information
Public title
Quantitative and Qualitative Evaluation of Burden among Formal Caregivers in Managing Agitation among Patients with Alzheimers Disease
Acronym
Quantitative and Qualitative Evaluation of Burden among Formal Caregivers in Managing Agitation among Patients with Alzheimers Disease
Scientific Title
Quantitative and Qualitative Evaluation of Burden among Formal Caregivers in Managing Agitation among Patients with Alzheimers Disease
Scientific Title:Acronym
Quantitative and Qualitative Evaluation of Burden among Formal Caregivers in Managing Agitation among Patients with Alzheimers Disease
Region
| Japan |
Condition
Condition
Altzheimer's disease
Classification by specialty
| Geriatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to identify whether professional caregivers working in Japanese long-term care facilities experience caregiver burden when responding to agitation in patients with Alzheimer's dementia, as well as to clarify the extent of that burden. To achieve this, the study examines the conceptual framework for measuring such burden and quantitatively evaluates the burden experienced by professional caregivers using a questionnaire composed of appropriate psychological scales.
Basic objectives2
Others
Basic objectives -Others
epidemiological survey
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The burden of Agitation for professional caregivers
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals who are directly engaged in providing care to persons with dementia who are using long-term care services, or who have been engaged in such care within the past six months.
Individuals who have provided informed consent to participate in this study.
Key exclusion criteria
Including those whose workplace is a medical institution.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Onuki |
Organization
Otsuka Pharmaceuticals Co., Ltd
Division name
Department of Medical Affairs
Zip code
108-8242
Address
Shinagawa Grand Central Tower 2-16-4 Konan, Minato-ku, Tokyo 108-8242, Japan
TEL
03-6717-1400
onuki.keisuke@otsuka.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Onuki |
Organization
Otsuka Pharmaceuticals Co., Ltd
Division name
Department of Medical Affairs
Zip code
1088241
Address
Shinagawa Grand Central Tower 2-16-4 Konan, Minato-ku, Tokyo 108-8242, Japan
TEL
08052859128
Homepage URL
onuki.keisuke@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceuticals Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceuticals Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation TOUKEIKAI Kitamachi Clinic ERB
Address
1-1-3,Kichijoji-kitamachi,Musashino-shi,Tokyo,180-0001,Japan
Tel
03-6779-8116
chi-pr-ec-kitamachi@cmicgroup.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
| 2026 | Year | 05 | Month | 27 | 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
Suspended
Date of protocol fixation
| 2025 | Year | 12 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Participant recruitment for the qualitative study has been completed, and analysis is ongoing.
Management information
Registered date
| 2026 | Year | 05 | Month | 27 | Day |
Last modified on
| 2026 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070607
