UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness and cost-effectiveness of learning therapy for prevention of the progress of care needs
Title of the study (Brief title)	Effectiveness and cost-effectiveness of learning therapy
Region	Japan

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

Objectives
Narrative objectives1	To preliminarily investigate whether learning therapy for the people with dementia in Japan is effective and cost effective or not by analyzing the naturalistic cohort data which includes both experimental and control groups.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The primary outcome of this study is the difference of the mean care time between the groups at 6 months after the starting point.
Key secondary outcomes	1. the difference of the mean care time between the groups at 12 months after the starting point. 2. the difference of mean score of MMSE, FAB, EQ-5D at 3, 6, 12 month after the starting point. 3. cost effectiveness with EQ-5D

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	- participants should be a user of the long term care insurance and the level of 'ADL of people with dementia' is greater than II ('ADL of people with dementia' is the term used for the assessment in long term care insurance schema in Japan). - 65 years or older - consent to participate in writing - the score of MMSE between 10 and 26
Key exclusion criteria	- difficult to follow up for 6 months after start of observation - other severe general medical conditions - judged to be difficult to be involved by the chief researcher with other reason mentioned above.
Target sample size	60

Research contact person
Name of lead principal investigator	Masaru Mimura
Organization	Keio University School of Medicine
Division name	Department of Neuropsychiatry
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	+81-(0)3-3353-1211
Email	mimura@keio.jp

Public contact
Name of contact person	Mitsuhiro Sado
Organization	Keio University School of Medicine
Division name	Department of Neuropsychiatry
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	+81-(0)3-3353-1211
Homepage URL
Email	mitsusado@keio.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	Ministry of Economy, Trade and Industry Kumon Institute of Education Co., Ltd.
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kumon Institute of Education Co., Ltd.
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	2015 Year 07 Month 07 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 07 Month 02 Day
Anticipated trial start date	2015 Year 07 Month 08 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Primary outcome of this study is the difference of the mean care time between groups at 6 month after starting point. Secondary outcomes of this study are - the difference of the mean care time between groups at 12 month after starting point. - the difference of mean score of MMSE, FAB and EQ-5D between groups at 3, 6, 12 month after starting point. - cost effectiveness with EQ-5D

Management information
Registered date	2015 Year 07 Month 07 Day
Last modified on	2017 Year 07 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021084