UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047211 |
|---|---|
| Receipt number | R000053565 |
| Scientific Title | A study to evaluate the effectiveness of free and paid hobby classes for people with MCI and mild dementia |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2023/04/28 11:33:45 |
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Basic information
Public title
A study to evaluate the effectiveness of free and paid hobby classes for people with MCI and mild dementia
Acronym
The effect of free and paid hobby classes
Scientific Title
A study to evaluate the effectiveness of free and paid hobby classes for people with MCI and mild dementia
Scientific Title:Acronym
The effect of free and paid hobby classes
Region
| Japan |
Condition
Condition
Mild Cognitive Impairment/Mild Dementia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the participation rate of people with MCI/mild dementia in free or paid hobby courses, and the effects of hobby courses on the quality of life, caregiver burden, and cognitive function of the participants and their caregivers
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of participation in hobby courses if free or paid
Key secondary outcomes
Willingness to participate in hobby courses, mental health status, patient background survey, higher life functioning, depression, self-efficacy, self-esteem, gratitude trait scale, quality of life, cognitive functioning, interviews about CDR, impressions of hobby courses, basic ADL, pool activity level, caregiver burden, family members' impressions of hobby courses, changes in family caregiver burden
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
Attend free and paid hobby courses twice a month
Interventions/Control_2
Do not take free and paid hobby courses twice 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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Those who can give their written consent to participate in this study.
2. Those who are 40 years of age or older
3. Have MCI or mild dementia
(CDR (Clinical Dementia Rating) equivalent to 0.5 (MCI) to 1.0 (mild dementia))
4. Those who are interested in the content of the hobby course and have confirmed their wish to participate.
5. Those who participated in the study in 2020 and 2021
Key exclusion criteria
1. Those with moderate dementia (CDR 1.5) or above
2. Those who are unable to communicate in Japanese.
3. Those who have difficulty in conducting interviews and cognitive function tests.
4. Those who are judged as inappropriate for the study by the principal investigators and subordinate doctors at each institution.
5. those who have not given consent for any of the content, duration, or time required for the hobby course.
6. those who did not participate in the study in the 2020 and 2021.
Target sample size
79
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
2-35, Sakae-cho, Itabashi-ku, Tokyo
TEL
03-6905-6781
suzukihy@tmig.or.jp
Public contact
Name of contact person
| 1st name | Kyoko |
| Middle name | |
| Last name | Fujihira |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research Team for Social Participation and Community Health
Zip code
173-0015
Address
2-35, Sakae-cho, Itabashi-ku, Tokyo
TEL
03-6905-6781
Homepage URL
fujihira@tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute of Gerontology
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 | 04 | Month | 01 | 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 | 12 | Month | 03 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 07 | 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=R000053565
