UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038091 |
|---|---|
| Receipt number | R000043416 |
| Scientific Title | Cognitive training via conversation support to healthy older adults-1(2) |
| Date of disclosure of the study information | 2019/09/24 |
| Last modified on | 2022/09/21 09:37:57 |
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Basic information
Public title
Cognitive training via conversation support to healthy older adults-1(2)
Acronym
Cognitive training via conversation support to healthy older adults-1(2)
Scientific Title
Cognitive training via conversation support to healthy older adults-1(2)
Scientific Title:Acronym
Cognitive training via conversation support to healthy older adults-1(2)
Region
| Japan |
Condition
Condition
Healthy older adults
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study`s purpose is to gather evidence on the mid-term effect of a group conversation intervention on cognition in healthy older adults through followup study for subjects of the UMIN trial ID MIN000036667 once a year after intervention for three years.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function
-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
Evaluation
1, 2, 3 years after 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
-Social Support Scale
-Coimagination Scale
Evaluation
1, 2, 3 years after intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group participants receive weekly 30-minute intervention sessions, each followed by 30 minutes of explanation about intervention. Total number of intervention is 12 times.
Interventions/Control_2
The active control sessions in the control group involved 30 minutes of weekly unstructured conversation among the group and 30 minutes of health education about successful aging.Total number of control is 12 times.
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
(1)>=65 years old
(2)MMSE>=24
(3)Can complete evaluations and interventions
(4)Agree to participate
Key exclusion criteria
(1)Having any neurological impairment known to affect the central nervous system
(2)Having any serious complicating disorder
(3)Having any history of serious head injury
(4)Having any disease or medication known to affect the central nervous system
Target sample size
65
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
The RIKEN Center for Advanced Intelligence Project
Institute
Department
Personal name
Funding Source
Organization
The 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, Bio Safety and Ethics Section
Address
2-1, Hirosawa, Wako, Saitama, Japan
Tel
048-467-9293
mizuho.mamiya@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
| 2019 | Year | 09 | 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
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 09 | Month | 21 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 24 | Day |
Last modified on
| 2022 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043416
