UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Project for Promotion of Community Care Program for People Living With Dementia
Title of the study (Brief title)	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	Miharu Nakanishi
Organization	Tokyo Metropolitan Institute of Medical Science
Division name	Mental Health Promotion project
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	Kaori Endo
Organization	Tokyo Metropolitan Institute of Medical Science
Division name	Mental Health Promotion Project
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://dx.doi.org/10.3233/JAD-171077
Results
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