UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048149 |
|---|---|
| Receipt number | 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 01:59:17 |
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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
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
mihoko.otake@riken.jp
Sponsor or person
Institute
RIKEN Center for Advanced Intelligence Project
Institute
Department
Personal name
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054870
