UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049526 |
|---|---|
| Receipt number | R000046300 |
| Scientific Title | A multicenter study to longitudinally collect information on behavioral and psychological symptoms and care of people with dementia in real-life situations and to use these data to calculate the success rates of various strategies for various BPSD |
| Date of disclosure of the study information | 2022/11/16 |
| Last modified on | 2022/11/16 11:48:37 |
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Basic information
Public title
A multicenter study to longitudinally collect information on behavioral and psychological symptoms and care of people with dementia in real-life situations and to use these data to calculate the success rates of various strategies for various BPSD
Acronym
BPSD and Care Registry Study
Scientific Title
A multicenter study to longitudinally collect information on behavioral and psychological symptoms and care of people with dementia in real-life situations and to use these data to calculate the success rates of various strategies for various BPSD
Scientific Title:Acronym
BPSD and Care Registry Study
Region
| Japan |
Condition
Condition
Alzheimer's disease, dementia with Lewy bodies, frontotemporal lobar degeneration, vascular dementia
Classification by specialty
| Neurology | Psychiatry | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify which behavioral and psychological symptoms of dementia (BPSD) are troubling to dementia caregivers in real-life situations and how they respond to those BPSDs, and the transition of BPSDs.
Basic objectives2
Others
Basic objectives -Others
To identify the success rate of various methods to BPSD.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Data to be collected every 3 months for 2 years on the BPSD that are troublesome to caregivers of people with dementia in real-life situations and the actual care methods they have used in response to these BPSD.
Key secondary outcomes
Each subitem score of the Neuropsychiatric Inventory (NPI), recorded longitudinally every 3 months for 2 years
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
1. Patients who meet the diagnostic criteria for dementia or mild cognitive impairment (detailed diagnostic criteria are provided in the study protocol).
2. Patients who meet the diagnostic criteria for Alzheimer's disease, dementia with Lewy bodies, frontotemporal lobar degeneration, or vascular dementia (detailed diagnostic criteria are described in the research protocol). However, for the dementia item of each diagnostic criterion, mild cognitive impairment is also acceptable.
3. There are family members, medical staff, or caregivers who are familiar with the BPSD information of the patients and the actual care methods being used.
4. There are no physical illnesses that significantly affect the BPSD.
5. There are no severe coexisting physical illnesses or living conditions that are likely to render them unobservable during the two-year study.
Key exclusion criteria
None.
Target sample size
960
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Kazui |
Organization
Kochi Medical School,Kochi University,
Division name
Department of Neuropsychiatry
Zip code
783-8505
Address
Kohasu Oko-cho,Nankoku,Kochi,Japan
TEL
088-880-2359
kazui@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Akamatsu |
Organization
Kochi Medical School,Kochi University,
Division name
Department of Neuropsychiatry
Zip code
783-8505
Address
Kohasu Oko-cho,Nankoku,Kochi,Japan
TEL
088-880-2359
Homepage URL
m-akamatsu@kochi-u.ac.jp
Sponsor or person
Institute
Department of Neuropsychiatry,
Kochi Medical School, Kochi University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kochi Medical School, Kochi University
Address
Kohasu Oko-cho, Nankoku, Kochi
Tel
088-880-2359
kms-info@kochi-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
高知大学医学部附属病院（高知県）/ Kochi University Hospital (Kochi Prefecture)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 16 | 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
| 2020 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will identify BPSD that are frequently observed in real-life situations. We will also identify the care provided for these BPSD. We will also use BPSD data collected longitudinally every 3 months to identify how each BPSD fluctuates. Furthermore, we will utilize the data collected in this study and publish more and more reliable BPSD methods on Dementia Chie-no-wa website.
Management information
Registered date
| 2022 | Year | 11 | Month | 16 | Day |
Last modified on
| 2022 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046300
