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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000048149
Receipt No. R000054870
Scientific Title Development of cognitive intervention method through group conversation
Date of disclosure of the study information 2022/06/24
Last modified on 2022/06/24

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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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