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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021966
Receipt No. R000025324
Scientific Title Project for Promotion of Community Care Program for People Living With Dementia
Date of disclosure of the study information 2016/09/01
Last modified on 2018/05/29

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Basic information
Public title Project for Promotion of Community Care Program for People Living With Dementia
Acronym Development of Japanese version of BPSD Program of Care
Scientific Title Project for Promotion of Community Care Program for People Living With Dementia
Scientific Title:Acronym Development of Japanese version of BPSD Program of Care
Region
Japan

Condition
Condition Dementia
Classification by specialty
Geriatrics Psychiatry Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of Japanese version of BPSD Program of Care that has been developed in Sweden to promote psychosocial approaches to challenging behaviors of people with dementia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Frequency and severity of challenging behavior among people with dementia
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -participants are 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 A professional caregiver evaluates frequency and severity of challenging behavior of a person with dementia. Based on the measurement, the caregiver establishes a care plan of daily program that includes contents and frequency of basic communication approach, physical activity, calm environment, massage, music/song, and so on. The caregiver implements the program according to the care plan, and re-evaluates the challenging behavior.
Interventions/Control_2 A professional caregiver evaluates frequency and severity of challenging behavior of a person with dementia. The caregiver does not establish a care plan, either implement the program.
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria A client of participating long-term care providers and has a diagnosis of dementia
6-10 clients from one providers who started the use of service most recently.
Key exclusion criteria Younger than 65 years old
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Miharu Nakanishi
Organization Tokyo Metropolitan Institute of Medical Science
Division name Mental Health Promotion project
Zip code
Address 2-1-6 Kamikitazawa, Setagaya-ku, Tokyo 156-8506 JAPAN
TEL +81-3-6834-2292
Email nakanishi-mh@igakuken.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kaori Endo
Organization Tokyo Metropolitan Institute of Medical Science
Division name Mental Health Promotion Project
Zip code
Address 2-1-6 Kamikitazawa, Setagaya-ku, Tokyo 156-8506 JAPAN
TEL +81-3-6834-2294
Homepage URL
Email endo-kr@igakuken.or.jp

Sponsor
Institute Tokyo Metropolitan Institute of Medical Science
Institute
Department

Funding Source
Organization Tokyo Metropolitan government
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://dx.doi.org/10.3233/JAD-171077
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 Completed
Date of protocol fixation
2016 Year 02 Month 19 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
2017 Year 10 Month 31 Day
Date of closure to data entry
2017 Year 10 Month 31 Day
Date trial data considered complete
2017 Year 12 Month 31 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 04 Month 18 Day
Last modified on
2018 Year 05 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025324

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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