UMIN-CTR Clinical Trial

Basic information
Public title	Dissemination and implementation of psychosocial dementia care programme in Japan: an observational study of process evaluation between different service models
Acronym	A process observation and evaluation of dementia care programme
Scientific Title	Research project for dissemination of dementia care programme
Scientific Title:Acronym	Research project for dissemination of dementia care programme
Region	Japan

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

Objectives
Narrative objectives1	We aim to elucidate the barriers to disseminate and implement a psychosocial dementia care programme that has been developed by Tokyo Metropolitan Institute of Medical Science as a delegated project of Tokyo Metropolitan government. We thus plan to introduce the programme into different types of service providers, evaluate the implementation process, and compare the process between the service types.
Basic objectives2	Others
Basic objectives -Others	Process evaluation
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Amount of efforts and time spent for care professionals to hold a multidisciplinary discussion meeting to evaluate level of neuropsychiatric symptoms, to identify unmet needs, and to establish an action plan; time spent to input evaluation into the online tool
Key secondary outcomes	Participating care professionals' level of understanding and competence in dementia care before and after training course; level of neuropsychiatric symptoms of persons with dementia

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Behavior,custom Maneuver Other
Interventions/Control_1	Participating care professionals will complete a 1-day training course of the programme. Each professional will introduce the programme into 2 persons with dementia during 6 months. The professional will hold 3-time multidisciplinary discussion meetings to evaluate level of neuropsychiatric symptoms, identify unmet needs, and establish an action plan for the person with dementia.
Interventions/Control_2
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	Persons with dementia diagnosis who use following types of long-term care insurance services: in-home care management, in-home multiple service, group home, or special nursing home.
Key exclusion criteria	The person with dementia and/or his/her surrogate decision maker does not provide informed consent to participate in the study; the person is in an acute deterioration of physical or mental functioning.
Target sample size	160

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

Public contact
Name of contact person	1st name Niimura Middle name Last name Junko
Organization	Tokyo Metropolitan Institute of Medical Science
Division name	Mental Health Promotion Project
Zip code	156-8506
Address	2-1-6 Kamikitazawa, Setagaya-ku, Tokyo
TEL	+81-3-6834-2293
Homepage URL
Email	niimura-jk@igakuken.or.jp

Sponsor
Institute	Ministry of Health, Labour and Welfare
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	Center for Medical Research Cooperation, Tokyo Metropolitan Institute of Medical Science
Address	2-1-6 Kamikitazawa, Setagaya-ku, Tokyo
Tel	+81-3-6834-2391
Email	renkei@igakuken.or.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	2019 Year 09 Month 13 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://doi.org/10.3233/ADR-200235
Number of participants that the trial has enrolled	125
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2020 Year 03 Month 31 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2019 Year 08 Month 01 Day
Date of IRB	2019 Year 08 Month 29 Day
Anticipated trial start date	2019 Year 09 Month 28 Day
Last follow-up date	2020 Year 02 Month 29 Day
Date of closure to data entry	2020 Year 03 Month 31 Day
Date trial data considered complete	2020 Year 04 Month 30 Day
Date analysis concluded	2020 Year 10 Month 08 Day

Other
Other related information

Management information
Registered date	2019 Year 07 Month 03 Day
Last modified on	2020 Year 10 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042479