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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||||
Condition | Healthy older adults and person with cognitive impairments (including long-term care users) | |||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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 |
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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 | ||||||
mihoko.otake@riken.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date analysis concluded |
Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |