UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness of early inteventions for BPSD in nursing facilities and general hospitals
Title of the study (Brief title)	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)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Hideyuki Hattori
Organization	National Center for Gerontology and Geriatrics
Division name	Psychiatry
Address	35 Morioka-Gengo, OObu city, Aichi prefecture, Japan
TEL	0562-46-2311
Email	hideyuki@ncgg.go.jp

Public contact
Name of contact person	Koji Fukuda
Organization	National Center for Gerontology and Geriatrics
Division name	Psychiatry
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2013 Year 12 Month 11 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000016661