UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049156 |
|---|---|
| Receipt number | R000055994 |
| Scientific Title | Survey research on dementia care models to reduce behavioral and psychological symptoms of dementia: an empirical study using a cluster randomized controlled trial |
| Date of disclosure of the study information | 2022/10/07 |
| Last modified on | 2022/10/07 17:37:42 |
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Basic information
Public title
Survey research on dementia care models to reduce behavioral and psychological symptoms of dementia
Acronym
BPSD Care Study
Scientific Title
Survey research on dementia care models to reduce behavioral and psychological symptoms of dementia: an empirical study using a cluster randomized controlled trial
Scientific Title:Acronym
BPSD Care Study: CRT
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Geriatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the effectiveness of care in accordance with the care intervention program for behavioral and psychological symptoms of dementia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Severity and burden of the Behavioral and Psychological Symptoms of Dementia Questionnaire 25 items version (BPSD25Q) after 9 weeks of intervention
Key secondary outcomes
short version of quality of life questionnaire for Dementia (short QOL-D) after 9 weeks of intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
To begin, care staff will attend a video-based training. Care staff assess behavioral and psychological symptoms of dementia and develop a plan of care using a worksheet. Care staff implement the care according to the care plan for 8 weeks and reassess the behavioral and psychological symptoms of dementia.
Interventions/Control_2
Care staff will assess behavioral and psychological symptoms of dementia. Care staff will reassess behavioral and psychological symptoms of dementia after 8 weeks of care in accordance with the usual plan of care.
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
Patients with a diagnosis of dementia (no differential diagnosis required). Persons with dementia who have a severity score of 3 or more items and a total score of 10 or more points on the Behavioral and Psychological Symptoms of Dementia Questionnaire 25 items version (BPSD25Q).
Key exclusion criteria
Those with a diagnosis or treatment of delirium, or those who have had a change in medication two weeks prior to the start of the study.
Target sample size
185
Research contact person
Name of lead principal investigator
| 1st name | koichi |
| Middle name | |
| Last name | Nakamura |
Organization
Tokyo Center for Dementia Care Research and Practices
Division name
Training department
Zip code
168-0071
Address
12-1-1 Takaido-Nishi, Suginami-Ku, Tokyo, Japan
TEL
03-3334-2155
nakamura4851@dcnet.gr.jp
Public contact
Name of contact person
| 1st name | Naoya |
| Middle name | |
| Last name | Tsukii |
Organization
Tokyo Center for Dementia Care Research and Practices
Division name
Research department
Zip code
168-0071
Address
12-1-1 Takaido-Nishi, Suginami-Ku, Tokyo, Japan
TEL
03-3334-2155
Homepage URL
n.tsukii@dcnet.gr.jp
Sponsor or person
Institute
Tokyo Center for Dementia Care Research and Practices
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Center for Dementia Care Research and Practices
Address
12-1-1 Takaido-Nishi, Suginami-Ku, Tokyo, Japan
Tel
03-3334-2155
n.tsukii@dcnet.gr.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
| 2022 | Year | 10 | Month | 07 | 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
| 2022 | Year | 10 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 07 | Day |
Last modified on
| 2022 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055994
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
