UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041679 |
|---|---|
| Receipt number | 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 | 2024/11/06 15:20:52 |
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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
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
aiizuka@tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute of Gerontology
Institute
Department
Personal name
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
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
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
61
Results
Analysis of covariance revealed a significant difference in change scores of the Trail Making Test Part B, which is a measure of executive function, suggesting improvements in the IG compared to the CG. No significant differences were observed in other cognitive functions.
Results date posted
| 2024 | Year | 11 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Intervention group(n=27):age(mean) 74.9(5.5)years, femele(n=23), MMSE score(mean)28.1(1.9)
Control group (n=22): age(mean)75.4(6.3)years, femele(n=18), MMSE score(mean)28.9(1.2)
Participant flow
Three participants in the IG and nine in the CG dropped out of the intervention program for the following reasons: (1) in the IG, one participant was hospitalized with a severe medical disorder, one refused to attend the MONOZUKURI classes, and one refused to participate after the test; and (2) in the CG, two participants were hospitalized with a severe medical disorder, one retired by family reason, two refused to participate in the post-test, and two retired for fear of being infected with COVID-19. Resultantly, 27 and 22 participants in the IG and CG, respectively, were included in the final analysis.
Adverse events
None
Outcome measures
Cognitive test battery, Physical function, Mental health, Social variables, Instrumental Activities of Daily Living, Frequency of participation in group activity
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer 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
| 2024 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047576
