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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014308
Receipt No. R000016661
Scientific Title Effectiveness of early inteventions for BPSD in nursing facilities and general hospitals
Date of disclosure of the study information 2014/06/18
Last modified on 2016/06/27

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Basic information
Public title Effectiveness of early inteventions for BPSD in nursing facilities and general hospitals
Acronym Effectiveness of early inteventions for BPSD in nursing facilities and general hospitals
Scientific Title Effectiveness of early inteventions for BPSD in nursing facilities and general hospitals
Scientific Title:Acronym Effectiveness of early inteventions for BPSD in nursing facilities and general hospitals
Region
Japan

Condition
Condition care staffs for dementia
Classification by specialty
Psychiatry Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Among the staffs caring for a dementia, we would like to elucidate whether a care burden feelings of the staffs who use the Guidelines "early period of BPSD correspondence guidelines" (in Hideyuki Hattori supervision, life science company, 2012) is going to be more reduced in comparison with the persons who does not use it.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Japanese version-Neuropsychiatric Inventory - Questionnaire (NPI-Q)
Key secondary outcomes Japanese version-Maslach Burnout Inventory (MBI)
Japanese version-Care Dependency Scale (CDS)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Staffs are going to care patients with dementia using "BPSD initial correspondence guidelines" (Hideyuki Hattori supervision, life science company, 2012) for one month.
Interventions/Control_2 Staffs are going to care patients with dementia without using "BPSD initial correspondence guidelines" (Hideyuki Hattori supervision, life science company, 2012) for one month.
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 Care persons, nurses, occupational therapists, the clinical psychologists who works for nursing facility (care health center for the elderly, care old man welfare institution, group home) and a general hospital
Key exclusion criteria Persons having a specialized qualification about dementia such as dementia authorization (registered) nurses
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideyuki Hattori
Organization National Center for Gerontology and Geriatrics
Division name Psychiatry
Zip code
Address 35 Morioka-Gengo, OObu city, Aichi prefecture, Japan
TEL 0562-46-2311
Email hideyuki@ncgg.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koji Fukuda
Organization National Center for Gerontology and Geriatrics
Division name Psychiatry
Zip code
Address 35 Morioka-Gengo, OObu city, Aichi prefecture, Japan
TEL 0562-46-2311
Homepage URL
Email kojifkd@ncgg.go.jp

Sponsor
Institute National Center for Gerontology and Geriatrics
Institute
Department

Funding Source
Organization National Center for Gerontology and Geriatrics
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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
2014 Year 06 Month 18 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 No longer recruiting
Date of protocol fixation
2013 Year 12 Month 11 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 18 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 04 Month 30 Day
Date trial data considered complete
2016 Year 05 Month 31 Day
Date analysis concluded
2016 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2014 Year 06 Month 18 Day
Last modified on
2016 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016661

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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