UMIN-CTR Clinical Trial

Basic information
Public title	Development of cognitive intervention method through group conversation
Acronym	Development of cognitive intervention method through group conversation
Scientific Title	Development of cognitive intervention method through group conversation
Scientific Title:Acronym	Development of cognitive intervention method through group conversation
Region	Japan

Condition
Condition	Healthy older adults and person with cognitive impairments (including long-term care users)
Classification by specialty	Neurology Geriatrics Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to develop a support method for social activity through group conversations among older adults.
Basic objectives2	Others
Basic objectives -Others	Specifically, (1)preliminary interventions to explore the effects of medium to long-term intervention and the feasibility of intervention for older adults, and (2)data analysis to accumulate knowledges for the development of intervention methods, by analyzing data including conversation and neuropsychological data.
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	*Cognitive test Face-to-face test (depending on the social situation) -Montreal Cognitive Assessment(MoCA) -Mini Mental State Examination(MMSE) -WMS-R Logical memory i,ii -Advanced Trail Making Test(ATMT) -Digit span -Digit symbol -Verbal fluency test Remote test -TICS-J -Verbal fluency test -Digit span *Evaluation Pre, post-intervention, and once a year during the intervention
Key secondary outcomes	*Questionnaires -The WHO Quality of Life questionnaire 26 -The Japanese version of the Geriatric Depression Scale short form -The Tokyo Metropolitan Institute of Gerontology-Index of Competence -Multidimensional scale of perceived social support -UCLA loneliness -WHO 5 *Evaluation Pre, post-intervention, and once a year during the intervention In addition to the above, we collect characteristics (questionnaire, brain structure data) and conversation data, etc. as appropriate.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Intervention program includes around 30 minutes of group conversation (face-to-face or remote) with/without pictures that participants prepared.
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 who can intervene and perform necessary tests on the specified date -Persons who can provide their consent.
Key exclusion criteria	-Persons who have difficulty participating due to serious illness (eg., hospitalization)
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Mihoko Middle name Last name Otake-Matsuura
Organization	RIKEN
Division name	Center for Advanced Intelligence Project
Zip code	103-0027
Address	Nihonbashi 1-chome Mitsui Building, 15th floor, 1-4-1 Nihonbashi, Chuo-ku, Tokyo 103-0027, Japan
TEL	0362252482
Email	mihoko.otake@riken.jp

Public contact
Name of contact person	1st name Mihoko Middle name Last name Otake-Matsuura
Organization	RIKEN
Division name	Center for Advanced Intelligence Project
Zip code	103-0027
Address	Nihonbashi 1-chome Mitsui Building, 15th floor, 1-4-1 Nihonbashi, Chuo-ku, Tokyo 103-0027, Japan
TEL	0362252482
Homepage URL
Email	mihoko.otake@riken.jp

Sponsor
Institute	RIKEN Center for Advanced Intelligence Project
Institute
Department

Funding Source
Organization	RIKEN Center for Advanced Intelligence Project
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	RIKEN
Address	2-1 Hirosawa, Wako, Saitama, 351-0198, Japan
Tel	050-3500-7242
Email	human@riken.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	2022 Year 06 Month 24 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	Individual participant data that underline the results in the article after deidentification, will be available after publication.
IPD sharing Plan description	Individual participant data and the document (study protocol) that underline the results in the article after deidentification, will be available. The data sharing will begin following article publication.No end date. The researchers who provide a methodologically sound proposal can access the data to achieve the aims in the approved proposal. Proposals should be directed to the email of the principal investigator (Mihoko Otake-Matsuura). To gain access, data requestors will need to sign a data access agreement. The data is being considered for availability at third-party registrations. (eg., database of RIKEN, National Institute for Japanese Language and Linguistics, and Informatics Research Data Repository).

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 02 Month 05 Day
Date of IRB	2018 Year 02 Month 05 Day
Anticipated trial start date	2018 Year 02 Month 05 Day
Last follow-up date	2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 06 Month 24 Day
Last modified on	2022 Year 06 Month 24 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054870

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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