UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053306 |
|---|---|
| Receipt number | R000060560 |
| Scientific Title | Study of caregiver burden in patients with Alzheimer's disease: a cross-sectional study |
| Date of disclosure of the study information | 2024/01/13 |
| Last modified on | 2024/07/17 17:02:31 |
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Basic information
Public title
Study of caregiver burden in patients with Alzheimer's disease: a cross-sectional study
Acronym
Caregiver burden related to AD
Scientific Title
Study of caregiver burden in patients with Alzheimer's disease: a cross-sectional study
Scientific Title:Acronym
Caregiver burden related to AD
Region
| Japan |
Condition
Condition
Alzheimer's disease
Classification by specialty
| Medicine in general | Neurology | Geriatrics |
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the actual situation of BPSD (especially Agitation), caregiver burden, quality of life and labour productivity of AD patients. The differences in caregivers' QOL, depending with and without BPSD are then clarified.
Basic objectives2
Others
Basic objectives -Others
epidemiological survey
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The prevalence of BPSD, caregiver burden (J-ZBI), caregiver's QOL (EQ-5D-5L, ASCOT-Carer), caregiver's productivity (WPAI)
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
| 19 | years-old | < |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The prevalence of BPSD, caregiver burden (J-ZBI), caregiver's QOL (EQ-5D-5L,ASCOT-Carer), caregiver's productivity (WPAI)
Key exclusion criteria
Individuals who close the browser or take other actions to abort the response during the answer.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Yamato |
Organization
Otsuka Pharmaceuticals Co., Ltd
Division name
Department of Medical Affairs
Zip code
1088242
Address
Shinagawa Grand Central Tower 2-16-4 Konan, Minato-ku, Tokyo 108-8242, Japan
TEL
03-6717-1400
Yamato.Kentaro@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
1088242
Address
Shinagawa Grand Central Tower 2-16-4 Konan, Minato-ku, Tokyo 108-8242, Japan
TEL
03-6717-1400
Homepage URL
Onuki.keisuke@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceuticals Co., Ltd
Institute
Department
Personal name
Kentaro Yamato
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
The research ethics committee of Otsuka Pharmaceutical Co., Ltd
Address
463-10 Kagasuno,Kawauchi-cho,Tokushima-city,Tokushima
Tel
088-665-2126
Suzuki.Takashi@otsuka.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
| 2024 | Year | 01 | Month | 13 | 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
705
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 | 11 | Month | 09 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 20 | Day |
Date of closure to data entry
| 2023 | Year | 11 | Month | 20 | Day |
Date trial data considered complete
| 2023 | Year | 11 | Month | 20 | Day |
Date analysis concluded
| 2024 | Year | 07 | Month | 31 | Day |
Other
Other related information
This study was a cross-sectional study using a web-based questionnaire survey. The planned number of patients was 600, and in consideration of the accuracy of the responses, we planned to terminate the study when data from about 700 cases had been collected. Recruitment began on November 13, 2023, and ended on November 20, 2023.
Management information
Registered date
| 2024 | Year | 01 | Month | 10 | Day |
Last modified on
| 2024 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060560
