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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041679
Receipt No. R000047576
Scientific Title A randomized controlled trial of the cognitive intervention related to learning new skills: THE MONODZUKURI study
Date of disclosure of the study information 2020/09/11
Last modified on 2020/09/04

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Basic information
Public title A randomized controlled trial of the cognitive intervention related to learning new skills: THE MONODZUKURI study
Acronym THE MONODZUKURI study
Scientific Title A randomized controlled trial of the cognitive intervention related to learning new skills: THE MONODZUKURI study
Scientific Title:Acronym THE MONODZUKURI study
Region
Japan

Condition
Condition community-dwelling older adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of a cognitive intervention related to learning new skills utilizing handy-craft and cooking on cognition, mental health and physical function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II,III

Assessment
Primary outcomes Attention, Executive function (Trail Making Test)
Key secondary outcomes Cognitive test battery, Physical function, Mental health, Social variables, Instrumental Activities of Daily Living, Frequency of participation in group activity

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Participants in the intervention group attend a handy-craft and cooking program (bead stitch, decorating Sushi) held once a week, 90 to 120 minutes each time and total of 12 times on the community space.
Interventions/Control_2 Participants in the control group attend lectures on health maintenance once a month and a total of three 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
60 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1)ADL independent
(2)Older adults with complaints of forgetfulness
(3)Older adults who sufficiently understand the purpose and content of the research, and who have the ability to agree informed consent.
Key exclusion criteria (1)Older adults with visual impairment and hearing loss that interfere their daily life
(2)Participants who already have a habit of manufacturing
(3)Older adults who are found by medical doctors (co-researchers of this study) to be unable to participate in this program due to significant illness, physical dysfunction, dementia, and neuropsychological disorders etc.
Target sample size 104

Research contact person
Name of lead principal investigator
1st name Hiroyuki
Middle name
Last name Suzuki
Organization Tokyo Metropolitan Institute of Gerontology
Division name Research Team for Social Participation and Community Health
Zip code 173-0015
Address 35-2 Sakae-cho,Itabashi-ku,Tokyo,Japan
TEL 0339643241
Email suzukihy@tmig.or.jp

Public contact
Name of contact person
1st name Ai
Middle name
Last name Iizuka
Organization Tokyo Metropolitan Institute of Gerontology
Division name Research Team for Social Participation and Community Health
Zip code 173-0015
Address 35-2 Sakae-cho,Itabashi-ku,Tokyo,Japan
TEL 0339643241
Homepage URL
Email aiizuka@tmig.or.jp

Sponsor
Institute Tokyo Metropolitan Institute of Gerontology
Institute
Department

Funding Source
Organization All About, Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor SEIGAKUIN UNIVERSITY
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo Metropolitan Institute of Gerontology
Address 35-2 Sakae-cho,Itabashi-ku,Tokyo,Japan
Tel 0339643241
Email naomi_hasegawa@tmghig.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 09 Month 11 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
2020 Year 04 Month 01 Day
Date of IRB
2020 Year 07 Month 03 Day
Anticipated trial start date
2020 Year 09 Month 01 Day
Last follow-up date
2023 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
2020 Year 09 Month 04 Day
Last modified on
2020 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047576

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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