UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050877 |
|---|---|
| Receipt number | R000057978 |
| Scientific Title | Cognitive training via conversation support to community-living older adults -3 |
| Date of disclosure of the study information | 2023/04/18 |
| Last modified on | 2025/08/30 06:34:25 |
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Basic information
Public title
Cognitive training via conversation support to community-living older adults -3
Acronym
Cognitive training via conversation support to community-living older adults -3
Scientific Title
Cognitive training via conversation support to community-living older adults -3
Scientific Title:Acronym
Cognitive training via conversation support to community-living older adults -3
Region
| Japan |
Condition
Condition
Healthy older adults
Classification by specialty
| Psychiatry | Neurosurgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate the effects of the remote conversation support application on cognitive, psychological, and social aspects in healthy older adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Logical Memory i, ii
Verbal Paired Associates i, ii
Mini-Mental State Examination
Verbal Fluency
Key secondary outcomes
KIHON check list
WHO 5
UCLA Loneliness scale
HUI3
Subjective health and happiness
S-A Creativity test
Blood-based biomarkers (eg., NfL and tau)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention program provides group conversation via an application from the participant`s home. Prior to each session, a photo taken by the participant, on a smartphone or tablet, as per a particular theme, are uploaded on the application. During the intervention session, participants are involved in a remote group conversation via the application. Each participant presents their photos on the application, followed by a question and answer session. The participants receive weekly sessions for 60 minutes for six months.
Interventions/Control_2
No-intervention control.
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
-Age >= 65 years
-Scored >= 24 points in the MMSE examination
-Can intervene and perform necessary tests on the designated date
-Provided consent in writing for participating in the trial
Key exclusion criteria
-Neurological impairment that affects the central nervous system
-Any serious complicating disorder
-History of serious head injury
-Any disease or medication that affects the central nervous system
-Requiring long-term care
Target sample size
64
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
| 2023 | Year | 04 | Month | 18 | Day |
Related information
URL releasing protocol
https://www.researchprotocols.org/2024/1/e56608
Publication of results
Unpublished
Result
URL related to results and publications
Upcoming
Number of participants that the trial has enrolled
66
Results
Of the 66 patients selected for randomization, 60 were selected for analysis. Detailed results will be registered after publication.
Results date posted
| 2025 | Year | 08 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Community-dwelling elderly people aged 65 or older who live in the local government where the collaborative research have been conducted with authors. Those who are in good health and have no signs of cognitive decline were eligible to participate in the study.
Participant flow
Participants were recruited by mail.
Adverse events
No adverse events were observed during the study.
Outcome measures
The primary outcome measure was verbal fluency, including phonological and semantic fluency. Secondary outcomes included other neuropsychiatric measures such as the Mini-Mental State Examination (MMSE), logical memory (immediate and delayed), verbal paired associations, and a questionnaire-based global functional status (including frailty, social status, and well-being).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 04 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 04 | Month | 18 | Day |
Last modified on
| 2025 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057978
