UMIN-CTR Clinical Trial

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
Email	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
Email	n.tsukii@dcnet.gr.jp

Sponsor
Institute	Tokyo Center for Dementia Care Research and Practices
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055994