UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047210 |
|---|---|
| Receipt number | R000052090 |
| Scientific Title | A Pilot Study on the Effectiveness of Hobby Classes for People with MCI and Mild Dementia |
| Date of disclosure of the study information | 2022/03/18 |
| Last modified on | 2023/04/28 11:33:25 |
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Basic information
Public title
A Pilot Study on the Effectiveness of Hobby Classes for People with MCI and Mild Dementia
Acronym
Validation of a hobby class for people with MCI and mild dementia
Scientific Title
A Pilot Study on the Effectiveness of Hobby Classes for People with MCI and Mild Dementia
Scientific Title:Acronym
Validation of a hobby class for people with MCI and mild dementia
Region
| Japan |
Condition
Condition
Mild Cognitive Impairment/Mild dementia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines the effects of hobby classes for people with MCI (mild cognitive impairment) and mild dementia on the QOL (mental health status), caregiver burden, and cognitive function of the individuals and their caregivers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mental health status of the individual and family (WHO-5)
Key secondary outcomes
Patient background, years of education, family structure, use of care services, social activities, level of care, functioning in life, depression, self-efficacy, self-esteem, gratitude trait scale, QOL, cognitive function, CDR, impressions
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Take a hobby course once a week for 3 hours for a total of 8 sessions.
Interventions/Control_2
No hobby course for 3 hours once a week for a total of 8 sessions.
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Written consent to participate in the study from the subject himself or herself, age of at least 40 years old, CDR of 0.5 (MCI) to 1.0 (mild dementia), interested in the content of the hobby course and willing to participate in it from the subject himself or herself. Those who have confirmed their willingness to participate in the program.
Key exclusion criteria
Those with CDR 0 (healthy) and CDR 2 or higher (moderate dementia or higher), those who are unable to speak Japanese, those who are unable to conduct interviews and cognitive function tests, those who are judged by the principal investigator and sub-doctors at each institution to be unsuitable as subjects of the study, and those who have failed to obtain consent for any one of the content, duration, or duration of the hobby course.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Eiichi |
| Middle name | |
| Last name | Hishikura |
Organization
All About,Inc.
Division name
President's Office and Wellness Business Promotion Office
Zip code
150-0022
Address
2-8-9 Ebisuminami, Shibuya-ku, Tokyo-to 150-0022 Japan
TEL
080-3519-8506
hishikura@gakusyu-f.jp
Public contact
Name of contact person
| 1st name | Eiichi |
| Middle name | |
| Last name | Hishikura |
Organization
All About,Inc.
Division name
President's Office and Wellness Business Promotion Office
Zip code
150-0022
Address
2-8-9 Ebisuminami, Shibuya-ku, Tokyo-to 150-0022 Japan
TEL
080-3519-8506
Homepage URL
hishikura@gakusyu-f.jp
Sponsor or person
Institute
All About,Inc.
Institute
Department
Personal name
Funding Source
Organization
Ministry of Economy, Trade and Industry
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Institute of Gerontology
Address
35-2 Sakae-cho,Itabashi-ku,Tokyo
Tel
03-3964-3241
mami_yoshioka@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
| 2022 | Year | 03 | Month | 18 | 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
| 2021 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 10 | 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
| 2022 | Year | 03 | Month | 18 | Day |
Last modified on
| 2023 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052090
