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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039489
Receipt No. R000045027
Scientific Title Cognitive training via conversation support to community-living older adults
Date of disclosure of the study information 2020/02/14
Last modified on 2020/02/14

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Basic information
Public title Cognitive training via conversation support to community-living older adults
Acronym Cognitive training via conversation support to community-living older adults
Scientific Title Cognitive training via conversation support to community-living older adults
Scientific Title:Acronym Cognitive training via conversation support to community-living older adults
Region
Japan

Condition
Condition Community-living 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 effect of a group conversation intervention on cognition in community-living older adults.
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
-Trail Making Test (TMT)
-Digit span
-Digit symbol
-Verbal fluency
-CogEvo
Brain Imaging
-MRI
-fMRI
-DTI

Evaluation
Before intervention and after intervention (12 weeks)
(1, 2, 3 years after intervention for Cognitive function)
Key secondary outcomes Blood test
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

Evaluation
Before intervention and after intervention (12 weeks)
(1, 2, 3 years after intervention for Questionnaires)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
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.
Interventions/Control_2 Control group participants take photos every week. They take lectures on health and successful aging, and investigators check the photos, for two hours once a month.
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)Report subjective cognitive decline
(4)Can complete evaluations and interventions
(5)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
(5)Having a medical history of stroke
(6)Requiring care
Target sample size 80

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
Email 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
Email mihoko.otake@riken.jp

Sponsor
Institute The RIEKN Center for Advanced Intelligence Project
Institute
Department

Funding Source
Organization The RIEKN 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 0484679293
Email 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
2020 Year 02 Month 14 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 Preinitiation
Date of protocol fixation
2020 Year 02 Month 12 Day
Date of IRB
Anticipated trial start date
2020 Year 02 Month 26 Day
Last follow-up date
2023 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
2020 Year 02 Month 14 Day
Last modified on
2020 Year 02 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045027

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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