UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057738 |
|---|---|
| Receipt number | R000065975 |
| Scientific Title | Development of cognitive intervention method through group conversation |
| Date of disclosure of the study information | 2025/04/29 |
| Last modified on | 2025/11/26 15:47:00 |
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Basic information
Public title
An exploratory study on fostering daily conversation habits centered on perspective-taking and time orientations for maintaining cognitive health
Acronym
An exploratory study on fostering daily conversation habits centered on perspective-taking and time orientations for maintaining cognitive health
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 and younger adults and persons 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 group conversation-based intervention program among older adults.
Basic objectives2
Others
Basic objectives -Others
To explore mid- to long-term intervention effects and implementation feasibility. This study will assess participants' level of engagement with the intervention program, particularly in terms of perspective-taking and time orientations, and examine the relationship between this and the outcomes.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Verbal fluency test
*Evaluation
Pre, post-intervention, and once a year during the intervention
Key secondary outcomes
Interpersonal Reactivity Index
Social Comparison Orientation scale
Zimbardo Time Perspective Inventory
Personal Values Questionnaire II
Lubben Social Network Scale
Kihon Checklist
World Health Organization-Five Well-Being Index
UCLA Loneliness Scale
NEO Five-Factor Inventory
WMS-R Logical Memory I and II
Mini-Mental State Examination
Montreal Cognitive Assessment
National Center for Geriatrics and Gerontology-Functional Assessment Tool
Blood biomarkers
*Evaluation
Pre, post-intervention, and once a year during the intervention (For PVQ-II and MMSE, only at pre- and post-intervention. Due to scheduling constraints, NEO-FFI will be measured at two time points during the intervention period, preferably as close as possible to the baseline and endpoint. For blood biomarkers, measurements will be taken at a time point during the intervention period as close as possible to baseline, annually during the intervention, and after the intervention.)
As implementation outcomes, dropout rate (acceptability) and the number of questions asked per conversation session (adherence) are recorded.
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
A group conversation consisting of about 5 people is conducted. Before the session, participants are asked to take photos of a given theme with their smartphones or tablets and upload them to the application. Participants talk about their photos and participate in a question-and-answer session. After the session, participants review the conversations of other participants.
The program also includes study sessions to learn about the knowledge needed to maintain cognitive function and icebreakers to encourage active participation in conversations. All of these sessions will be held once a month for approximately 90-120 minutes.
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
| 18 | 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
120
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
Institute
Department
Personal name
Funding Source
Organization
RIKEN
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
| 2025 | Year | 04 | Month | 29 | 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
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2025 | Year | 04 | Month | 29 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2031 | 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
| 2025 | Year | 04 | Month | 29 | Day |
Last modified on
| 2025 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065975
