UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054944 |
|---|---|
| Receipt number | R000062770 |
| Scientific Title | Effectiveness of the Brain Activity Juku Program for the Elderly Residents of Shibukawa City |
| Date of disclosure of the study information | 2024/07/13 |
| Last modified on | 2024/07/12 07:54:48 |
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Basic information
Public title
Effectiveness of the Brain Activity Juku Program for the Elderly Residents of Shibukawa City
Acronym
Effectiveness of the Brain Activity Juku Program for the Elderly Residents of Shibukawa City
Scientific Title
Effectiveness of the Brain Activity Juku Program for the Elderly Residents of Shibukawa City
Scientific Title:Acronym
Effectiveness of the Brain Activity Juku Program for the Elderly Residents of Shibukawa City
Region
| Japan |
Condition
Condition
Recruitment of eligible residents will be done through Shibukawa City PR (July PR for the Akagi Community Center and December PR for the Shibukawa Hot Plaza) throughout the city of Shibukawa.
People 65 years of age or older who do not need nursing care or supervision and who are able to participate.
People who are not certified as needing nursing care
People who do not use day-care services such as long-term care insurance
People who have given consent for the research survey
Classification by specialty
| Geriatrics | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In Shibukawa City, Gunma Prefecture, where the super-aging population is accelerating, dementia prevention activities are also indispensable, and Gunma Yakult Sales Co., Ltd. has been holding the Brain Activity School since FY2022 in cooperation with the government. However, the objective effects of this program have not been clarified, and we decided to clarify the intervention effects of the Brain Activity School for elderly residents of Shibukawa City in FY2024. In addition, the locations of the juku will be held in the mountainous area and the urban area of Shibukawa City, and the characteristics of the effects will be clarified as well as the comparisons between the two locations. By doing so, we will examine the Brain Activity Juku program in consideration of the local characteristics and residents within Gunma Prefecture.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese version of the Montreal Cognitive Assessment (MoCA-J)
Key secondary outcomes
Japanese version of the Rapid Dementia Screening Test, Life-Space Assessment, Short Physical Performance Battery
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
The Brain Activity School program will be implemented to residents and evaluated before and after. The program will be held twice. The first half will be held at the Akagi Community Center every Wednesday starting on Wednesday, September 4 and ending on Wednesday, November 6, for a total of 10 sessions. The second half will be held at Shibukawa Hot Plaza on Thursdays from January 9 to March 13, for a total of 10 sessions.
Interventions/Control_2
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1 Persons participating in the Shibukawa City Brain Activity Juku for this study
2 People who are 65 years old or older and under 90 years old and do not need nursing care or oversight
3 People who are not certified as needing nursing care
4 People who do not use day-care services such as long-term care insurance
5 Persons who have given consent for the research survey
Key exclusion criteria
1 Those who are unable to walk on their own
2 Those who have a diagnosis of dementia
3 Persons with illnesses that would interfere with participation in this Brain Activity Juku (persons who are advised by their doctors not to participate)
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Uchida |
Organization
Gunma University Graduate School of Health Sciences
Division name
School of Health Sciences Nursing
Zip code
371-8514
Address
3-39-22 Showa-machi, Maebashi, Gunma
TEL
0272208931
yuchida@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Uchida |
Organization
Gunma University Graduate School
Division name
School of Health Sciences Nursing
Zip code
371-8514
Address
3-39-22 Showa-machi, Maebashi, Gunma
TEL
0272208931
Homepage URL
yuchida@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University
Address
3-39-22 Showa-machi, Maebashi, Gunma
Tel
0272208931
yuchida@gunma-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
HS2024-059
Org. issuing International ID_1
Gunma University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 13 | 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
| 2024 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 13 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 07 | Month | 12 | Day |
Last modified on
| 2024 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062770
